Τρίτη 8 Δεκεμβρίου 2020

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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Evidence of sociocultural factors influencing intimate partner violence among young women

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Objective

This study carried out a scoping review of research on intimate partner violence to determine the extent to which studies on sociocultural factors influencing intimate partner violence among young women (15–24 years) have been conducted, and how different geographical areas are represented. It also considered whether the methodologies used were sufficient to describe the risk factors, prevalence and health outcomes associated with intimate partner violence among young women.

Study design

Scoping review.

Methods

Online databases were used to identify studies published between 2008 and 2019. The Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines by Arksey and O'Malley were used to select studies, and primary studies were assessed using the Mixed Method Appraisal Tool, V.2011. Thematic content analysis was used to summarise the findings of the scoping review.

Results

The majority of publications eight (61.5%) reported cross-sectional studies, while four (31.5%) were qualitative studies. One of the studies (7%) collected measured data. Overall, 13 (100%) of the publications examined factors influencing intimate partner violence.

Using a customised quality assessment instrument, 12 (92.3%) of studies achieved a 'high'-quality ranking with a score of 100%, and 7.7% of studies achieved an 'average' quality ranking with a score of 75%.

Conclusions

While the quality of the studies is generally high, researches on sociocultural factors influencing intimate partner violence among young women would benefit from a careful selection of methods and reference standards, including direct measures of the violence affecting young women. Prospective cohort studies are required linking early exposure with individual, sociocultural and community factors, and detailing the abuse experienced from childhood, adolescence and youth.

PROSPERO registration number

CRD42018116463.

Scoping protocol publication

https://doi.org/10.1186/s13643-019-1234-y

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Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis

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Objective

To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs).

Design

Systematic review and meta-analysis.

Data sources

MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020.

Eligibility criteria

All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions.

Data extraction and synthesis

Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane).

Results

We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.

Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI –0.74 to –0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%).

Conclusions

While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations.

Prospero registration number

CRD42017057908.

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Relationship between acute pain trajectories after an emergency department visit and chronic pain: a Canadian prospective cohort study

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Objectives

Inadequate acute pain management can reduce the quality of life, cause unnecessary suffering and can often lead to the development of chronic pain. Using group-based trajectory modelling, we previously identified six distinct pain intensity trajectories for the first 14-day postemergency department (ED) discharge; two linear ones with moderate or severe pain during follow-up (~40% of the patients) and four cubic polynomial order trajectories with mild or no pain at the end of the 14 days (low final pain trajectories). We assessed if previously described acute pain intensity trajectories over 14 days after ED discharge are predictive of chronic pain 3 months later.

Design

Prospective cohort study.

Setting

Tertiary care trauma centre academic hospital.

Participants

This study included 18 years and older ED patients who consulted for acute (≤2 weeks) pain conditions that were discharged with an opioid prescription. Patients completed a 14-day diary in which they listed their daily pain intensity (0–10 numeric rating scale).

Outcomes

Three months after ED visit, participants were questioned by phone about their current pain intensity (0–10 numeric rating scale). Chronic pain was defined as patients with current pain intensity ≥4 at 3 months.

Results

A total of 305 participants remained in the study at 3 months, 49% were women and a mean age of 55±15 years. Twelve per cent (11.9; 95% CI 8.2 to 15.4) of patients had chronic pain at the 3-month follow-up. Controlling for age, sex and pain condition, patients with moderate or severe pain trajectories and those with only a severe pain trajectory were respectively 5.1 (95% CI 2.2 to 11.8) and 8.2 (95% CI 3.4 to 20.0) times more likely to develop chronic pain 3 months later compared with patients in the low final pain trajectories.

Conclusion

Specific acute pain trajectories following an ED visit are closely related to the development of chronic pain 3 months later.

Trial registration number

NCT02799004; Results.

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Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study

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Objective

Pegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the incidence of safety outcomes.

Methods

We conducted a retrospective descriptive study using data from two US commercial insurance claims databases (2010–2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase infusions. We assessed the risk of anaphylaxis or anaphylactoid reactions, cardiovascular events, including myocardial infarction or stroke, and hospitalisation for heart failure (new onset or exacerbations) while undergoing pegloticase therapy.

Results

Among 2.9 million patients with ≥1 diagnosis of gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46% and heart failure in 21% of the patients. The median number of infusions was four and the duration of therapy was 3 months. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalisations and 3 (0.6%) deaths.

Conclusion

Pegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-based study, while heart failure hospitalisations were common.

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Association between age-related macular degeneration and arthritis

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Objective

To explore the association between age-related macular degeneration (AMD) and arthritis in a representative sample of the US population.

Design

Population-based, cross-sectional study.

Setting

The National Health and Nutrition Examination Survey (NHANES) 2005–2008.

Participants

A total of 4813 participants aged 40 years and older with available information on AMD and arthritis in the 2005–2008 NHANES.

Methods

The status and types of arthritis were obtained from questionnaires. Non-mydriatic fundus photographs were collected. The types of AMD were assessed using the modified Wisconsin Age-Related Maculopathy Grading Classification Scheme. The association between arthritis and AMD was evaluated using logistic regression models.

Results

After adjusting for covariates, participants with any or early AMD had significantly lower odds of having any type of arthritis (any AMD: OR=0.56, 95% CI: 0.36–0.86; early AMD: OR=0.55, 95% CI: 0.34–0.88) or osteoarthritis (OA) (any AMD: OR=0.43, 95% CI: 0.26–0.71; early AMD: OR=0.44, 95% CI: 0.25–0.76) compared with those without AMD. When considering AMD as the outcome, significant negative associations were also found between any arthritis or OA and any (any arthritis: OR=0.64, 95% CI: 0.43–0.94; OA: OR=0.52, 95% CI: 0.33–0.82) or early AMD (any arthritis: OR=0.61, 95% CI: 0.40–0.93; OA: OR=0.51, 95% CI: 0.31–0.86) in the multivariable logistic models. There was no significant association between different types of arthritis and late AMD.

Conclusions

People with arthritis, especially those with OA, were less likely to have AMD compared with those without arthritis and vice versa. Further studies are needed to confirm this potential protective effect of arthritis and/or arthritis treatment on AMD and to explore the underlying mechanisms.

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