bluuebunny/crossref_metadata_2025 huggingface dataset:
Time trends in health-related quality of life assessment and reporting within publications of oncology randomised phase III trials: a meta-research study
Authors: Marandino Laura , Trastu Federica , Ghisoni Eleonora , Lombardi Pasquale , Mariniello Annapaola , Reale Maria Lucia , Aimar Giacomo , Audisio Marco , Bungaro Maristella , Caglio Andrea , Di Liello Raimondo , Gamba Teresa , Gargiulo Piera , Paratore Chiara , Rossi Alessandro , Tuninetti Valentina , Turco Fabio , Perrone Francesco , Di Maio Massimo
Published: March 2023

Objective

To assess time trends in the inclusion of health-related quality of life (QoL) among study endpoints and in the reporting of QoL results in study publications, randomised phase III oncology trials published between 2017 and 2021 were compared with the trials published in the previous 5 years.

Methods and analysis

All issues published between 2012 and 2021 by 11 major journals were handsearched for primary publications of phase III trials in adult patients with solid tumours. Trials published in 2017–2021 were compared with trials published in 2012–2016 for three endpoints: (1) proportion of publications including QoL among endpoints out of all the eligible publications; (2) proportion of publications presenting QoL results out of those including QoL among endpoints and (3) proportion of publications presenting QoL data out of all the eligible publications.

Results

388 publications between 2017 and 2021 were eligible and compared with 446 publications between 2012 and 2016. QoL was included among endpoints in 67.8% of trials in 2017–2021 vs 52.9% in 2012–2016 (univariate OR 1.87, 95% CI 1.41 to 2.48, p<0.001). QoL results were available in 52.1% in 2017–2021 vs 62.3% in 2012–2016 of primary publications of trials including QoL among endpoints (OR 0.66, 95% CI 0.46 to 0.94, p=0.02). Overall, QoL was analysed and presented in 35.3% of primary publications in 2017–2021 vs 33.0% in 2012–2016 (OR 1.11, 95% CI 0.83 to 1.48, p=0.48).

Conclusions

The proportion of oncology trials including QoL among endpoints increased in 2017–2021 compared with 2012–2016. However, the proportion of primary publications reporting QoL results remains suboptimal.
Organ-specific immune checkpoint inhibitor treatment in lung cancer: a systematic review and meta-analysis
Authors: Yu Shufei , Zhang Shuyang , Xu Haiyan , Yang Guangjian , Xu Fei , Yang Liang , Chen Duo , An Guangyu , Wang Yan
Published: March 2023

Objectives

Based on the acknowledged organ-specific immune microenvironment, little is known regarding the efficacy of immunotherapy in patients with lung cancer according to metastatic sites. This meta-analysis aimed to explore the efficacy of immune checkpoint inhibitors (ICIs) vs chemotherapy in patients with lung cancer with liver metastases (LM) or brain metastases (BM).

Design

Meta-analysis and systematic review.

Data sources

We systematically searched in electronic databases (PubMed, EMBASE, Cochrane Library and Web of Science), up to 31 January 2022. We also reviewed the abstracts from major international conferences. Eligibility criteria were randomised controlled phase II or III trials reporting the overall survival (OS) or progression-free survival (PFS) of LM or BM subsets.

Data extraction and synthesis

Hazard ratios (HRs) with 95% CIs for OS and PFS were extracted and aggregated using a random-effects model.

Results

Twenty-four randomised controlled trials with available outcomes for patients with BMs or LMs were identified. A total of 1124 patients with BM and 2077 patients with LM were included in the analysis. The pooled OS HR of patients with LMs was 0.83 (95% CI 0.72 to 0.95), and that of patients without LM 0.73 (95% CI 0.69 to 0.79). LM was associated with less benefits from ICIs. In patients with BM treated with ICIs, the pooled OS HR compared with the control arms was 0.71 (95% CI 0.53 to 0.94). Subgroup analyses by histology suggested that only patients with non-small cell lung cancer (NSCLC) with BM could gain benefit from ICIs (HR 0.53, 95% CI 0.41 to 0.68). BM negatively influenced efficacy of immunotherapy in patients with small cell lung cancer.

Conclusions

Our results showed immunotherapy demonstrated efficacy in patients with lung cancer with LM and BM, survival benefits dominantly favoured patients with NSCLC. Patients with lung cancer with LM obtained less benefits from ICIs than those without. Therefore, organ-specific immunotherapeutic approaches should be considered.

PROSPERO registration number

CRD42020212797.
Allostatic load in opioid use disorder: a scoping review protocol
Authors: Fan Jaimie Qiuyun , Miller Hillary , Adams Amanda , Bryan Rebecca , Salzman Matthew
Published: March 2023

Introduction

Opioid use disorder affects 2.1 million individuals in the USA, causing more than 100 000 overdose-related deaths annually. While the neurobiological model of addiction is well described and accepted, there is a lack of morbidity and mortality prognosticators for patients struggling with opioid use disorder. Allostatic load index is a promising candidate for the basis of a prognostication tool. Previous studies show that allostatic load predicts both morbidity and mortality in a variety of cohorts. This scoping review protocol provides the rationale and steps for summarising and presenting existing evidence surrounding allostatic load in the context of opioid use disorder. Identification of current knowledge gaps will pave the way for subsequent prospective studies.

Methods and analysis

This scoping review protocol will follow the five-step method designed by Arksey and O’Malley. All studies written in English on allostatic load in the context of opioid use disorder, as defined in our inclusion criteria, will be included. There will be no limit on the year of publication. We will search PubMed, Embase, CINAHL, PsycINFO and Google Scholar. We will hand-review reference lists of included articles, and we will hand search grey literature. We will then group, analyse and present the data in narrative, tabular and diagrammatic format according to themes identified in the scoping review.

Ethics and dissemination

Ethics approval is not necessary, as data are gathered from publicly accessible sources. The results will be disseminated through a peer-reviewed journal and reported at conferences related to addiction medicine.

Trial registration number

10.17605/OSF.IO/4J6DQ.
Association of the COVID-19 pandemic on stroke admissions and treatment globally: a systematic review
Authors: Van Dusen Rachel A , Abernethy Kiera , Chaudhary Nagendra , Paudyal Vibhu , Kurmi Om
Published: March 2023

Objectives

The COVID-19 pandemic has highlighted insufficiencies and gaps within healthcare systems globally. In most countries, including high-income countries, healthcare facilities were over-run and occupied with too few resources beyond capacity. We carried out a systematic review with a primary aim to identify the influence of the COVID-19 pandemic on the presentation and treatment of stroke globally in populations≥65 years of age.

Design

A systematic review was completed. In total, 38 papers were included following full-text screening.

Data sources

PubMed, MEDLINE and Embase.

Eligibility criteria

Eligible studies included observational and real-world evidence publications with a population who have experienced stroke treatment during the COVID-19 pandemic. Exclusion criteria included studies comparing the effect of the COVID-19 infection on stroke treatment and outcomes.

Data extraction and synthesis

Primary outcome measures extracted were the number of admissions, treatment times and patient outcome. Secondary outcomes were severity on admission, population risk factors and destination on discharge. No meta-analysis was performed.

Results

This review demonstrated that 84% of studies reported decreased admissions rates during the COVID-19 pandemic. However, among those admitted, on average, had higher severity of stroke. Additionally, in-hospital stroke treatment pathways were affected by the implementation of COVID-19 protocols, which resulted in increased treatment times in 60% of studies and increased in-hospital mortality in 82% of studies by 100% on average. The prevalence of stroke subtype (ischaemic or haemorrhagic) and primary treatment methods (thrombectomy or thrombolysis) did not vary due to the COVID-19 pandemic.

Conclusions

During the COVID-19 pandemic, many populations hesitated to seek medical attention, decreasing hospital admissions for less severe strokes and increasing hospitalisation of more severe cases and mortality. The effect of the pandemic on society and healthcare systems needs to be addressed to improve stroke treatment pathways and prepare for potential future epidemics.

PROSPERO registration number

CRD42021248564.
Secular trends of epidemiologic patterns of chronic kidney disease over three decades: an updated analysis of the Global Burden of Disease Study 2019
Authors: Feng Xiaojin , Hou Ningning , Chen Zhenna , Liu Jing , Li Xue , Sun Xiaodong , Liu Yongping
Published: March 2023

Objectives

To assess the characteristics of the global death burden imposed by chronic kidney disease (CKD) and the attributable risk factors from 1990 to 2019 to help inform a framework for policy discussions, resource allocation and research priorities.

Design

A population-based observational study.

Setting

The death data and relative risk factors were obtained from the Global Burden of Disease (GBD) Study 2019 database.

Main outcome measures

Based on the GBD database, we estimated the death burden attributable to CKD stratified by sociodemographic index (SDI), geographic location, sex, age group, time period and risk factors from 1990 to 2019.

Results

Over three decade study period, the global number of CKD-related deaths increased from 0.60 million (95% uncertainty interval (UI): 0.57–0.63 million) in 1990 to 1.43 million (95% UI: 1.31–1.52 million) in 2019. The age-standardised death rate (ASDR) of CKD, among all causes, increased from 15th in 1990 to 10th in 2019. Globally, the ASDR in males was higher than that in females. CKD-related deaths mainly occurred in those aged over 50 years, especially in regions with higher SDIs. The ASDR was negatively related to SDI (ρ=−0.603, p<0.0001). Among risk factors, metabolic risk factors, especially systolic blood pressure, fasting plasma glucose and body mass index, were the main contributors to CKD-related deaths. Although the high-temperature-related death burden was low, the trend increased sharply in lower SDI regions.

Conclusions

CKD-related deaths continue to increase, with the majority occurring in elderly adults. The CKD-related death burden is higher in males than in females. Additionally, the increasing high-temperature-related death burdens in lower SDI regions should receive social attention.
Effect of date seed (Phoenix dactylifera) supplementation as functional food on cardiometabolic risk factors, metabolic endotoxaemia and mental health in patients with type 2 diabetes mellitus: a blinded randomised controlled trial protocol
Authors: Mohammadi Zadeh Mehdi , Dehghan Parvin , Eslami Zahra
Published: March 2023

Introduction

Recently, the improvement of chronic hyperglycaemia-related damage of type 2 diabetes mellitus (T2DM) through functional food consumption has attracted the attention of many clinicians. This study aims to determine the effectiveness of date seed powder (DSP) as a functional food (prebiotic) on the cardiometabolic risk factors, oxidative stress, anti-/inflammatory biomarkers, metabolic endotoxaemia (gut microbiota), adipokines, hypothalamic–pituitary–adrenal axis biomarkers, immune system, anthropometric indices and mental health in patients with T2DM.

Methods

This study protocol will be conducted as randomised, triple-blind, placebo-controlled trial with the inclusion of 48 patients with T2DM. The participants will be randomly assigned into two equal groups of intervention (n=24) and placebo (n=24) and receive 5 g/day of DSP or placebo for 8 weeks, respectively. At baseline and post-intervention, fasting blood samples will be collected to assess the serum levels of lipid profile, glycaemic indices, antioxidant and oxidative stress, anti-/inflammatory biomarkers, lipopolysaccharide, 8-hydroxy-guanine, adipokines, hypothalamic–pituitary–adrenal axis biomarkers, immune system and mental health. Data will be analysed using the SPSS software (V.16.0). To compare the quantitative variables, paired and unpaired Student’s t-tests and covariance analyses will be used.

Discussion

In this study, the potential effects of DSP on patients with T2DM will be evaluated for the first time. It is hoped that the results would increase the body of scientific knowledge about DSP supplementation on the cardiometabolic risk factors, oxidative stress, anti-/inflammatory biomarkers, metabolic endotoxaemia, adipokines, hypothalamic–pituitary–adrenal axis biomarkers, immune system, anthropometric indices and mental health in patients with T2DM.

Ethics and dissemination

The study protocol was approved by the Ethical Committee of the Tabriz University of Medical Sciences, Tabriz, Iran (code: IR.TBZMED.REC.1400.752).

Trial registration number

Iranian Registry of Clinical Trials (www.irct.ir/IRCT20150205020965N10).
Exposure to traumatic events and use of over-the-counter analgesics in adolescents: cross-sectional findings from the Young-HUNT study
Authors: Baumann-Larsen Monica , Dyb Grete , Wentzel-Larsen Tore , Zwart John-Anker , Storheim Kjersti , Stensland Synne Øien
Published: March 2023

Objective

Frequent and increasing use of over-the-counter analgesics (OTCA) among adolescents is a public health concern. Prior research indicates that adolescents exposed to traumatic events may be at increased risk of suffering from headaches and musculoskeletal pain. In this study, we assessed the association between trauma exposure and use of OTCA for headaches and musculoskeletal pain.

Design

A cross-sectional population study among adolescents, self-reported data on trauma exposure, pain and use of OTCA.

Setting and participants

All 10 608 adolescents aged 13–19 years in a region of Norway were invited in this school-based survey, participation rate was 76%.

Outcome measure

Frequency of OTCA use for headache and musculoskeletal pain served as separate outcomes in ordinal logistic regression analyses.

Results

Trauma exposure was significantly and consistently related to higher frequency use of OTCA for headache and musculoskeletal pain, of which associations for bullying (OR 1.79, 95% CI 1.50 to 2.12, and OR 2.12, 95% CI 1.70 to 2.66), physical violence (OR 1.49, 95% CI 1.25 to 1.78 and OR 1.83, 95% CI 1.45 to 2.32) and sexual abuse (OR 1.83, 95% CI 1.55 to 2.18 and OR 1.53, 95% CI 1.18 to 1.90) were particularly strong. A dose–response relationship was found between interpersonal violence and OTCA use for headache (OR 1.46, 95% CI 1.29 to 1.66 for one type and OR 1.81, 95% CI 1.53 to 2.14 for two or more types) and musculoskeletal pain (OR 1.61, 95% CI 1.91 to 3.00 for one type and OR 2.39, 95% CI 1.91 to 3.00 for two or more types). The associations remained significant after adjustment for pain, although an attenuation in strength was observed.

Conclusion

Trauma exposed adolescents use OTCA for headaches and musculoskeletal pain more frequently than those not exposed. The higher frequency of pain conditions among trauma exposed only partially explained their more frequent OTCA use, indicating an increased risk relating to features beyond frequency of pain.
Use of qualitative systems mapping and causal loop diagrams to understand food environments, diet and obesity: a scoping review protocol
Authors: Stankov Ivana , Henson Rosie Mae , Headen Irene , Purtle Jonathan , Langellier Brent A
Published: March 2023

Introduction

Food systems can shape dietary behaviour and obesity outcomes in complex ways. Qualitative systems mapping using causal loop diagrams (CLDs) can depict how people understand the complex dynamics, inter-relationships and feedback characteristic of food systems in ways that can support policy planning and action. To date, there has been no attempt to review this literature. The objectives of this review are to scope the extent and nature of studies using qualitative systems mapping to facilitate the development of CLDs by stakeholders to understand food environments, including settings and populations represented, key findings and the methodological processes employed. It also seeks to identify gaps in knowledge and implications for policy and practice.

Methods and analysis

This protocol describes a scoping review guided by the Joanna Briggs Institute manual, the framework by Khalil and colleagues and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist reporting guidelines. A search strategy was iteratively developed with two academic librarians and the research team. This strategy will be used to search six databases, including Ovid MEDLINE, Embase, EmCare, Web of Science, Scopus and ProQuest Central. Identified citations will be screened by two independent reviewers; first, by title and abstract, and then full-text articles to identify papers eligible for inclusion. The reference lists of included studies and relevant systematic reviews will be searched to identify other papers eligible for inclusion. Two reviewers will extract information from all included studies and summarise the findings descriptively and numerically.

Ethics and dissemination

The scoping review will provide an overview of how CLDs developed by stakeholders have been elicited to understand food environments, diet and obesity, the insights gained and how the CLDs have been used. It will also highlight gaps in knowledge and implications for policy and practice. The review will be disseminated through publication in an academic journal and conference presentations.
Patient-reported burden and overall impact of dry eye disease across eight European countries: a cross-sectional web-based survey
Authors: Boboridis Kostas G , Messmer Elisabeth M , Benítez-del-Castillo José , Meunier Juliette , Sloesen Brigitte , O’Brien Paul , Quadrado Maria Joao , Rolando Maurizio , Labetoulle Marc
Published: March 2023

Objective

Dry eye disease (DED) is a multifactorial disease involving the tears and ocular surface. It impacts a patient’s quality of life (QoL) and ability to perform daily activities. This study assessed the burden of self-reported DED among adults in eight European countries.

Design

Online cross-sectional survey.

Setting

General population in France, Italy, Germany, Greece, the Netherlands, Portugal, Spain and Sweden.

Participants

Adults aged ≥18 years with (n=6084) and without (n=6161) self-reported DED were recruited via emails and screened.

Main outcome measures

All participants completed National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) and EuroQol-5 Dimension-5 Level Questionnaire (EQ-5D-5L). All DED participants completed the Eye Dryness Score (EDS) Visual Analogue Scale, and Ocular Comfort Index and Work Productivity and Activity Impairment Questionnaire: Specific Health Problem questionnaires. In addition, half of the respondents with DED completed Survey A (Impact of Dry Eye on Everyday Life) and the other half completed Survey B (Standard Patient Evaluation of Eye Dryness Questionnaire) and Dry Eye Questionnaire-5.

Results

Participants with self-reported DED had lower functional vision and lower overall health status than participants without self-reported DED as measured by the NEI-VFQ and EQ-5D-5L, respectively.

Increasing self-reported DED severity as measured by the EDS was shown to correspond with worse symptom severity/frequency, lower functional vision, higher impact on work productivity, daily activities and QoL.

Conclusion

This study showed that patients’ reported burden of self-reported DED was similar across the eight European countries. Those with self-reported DED reported lower health status and functional vision compared to those without self-reported DED and these parameters worsen with increasing disease severity.
Uptake of COVID-19 vaccines and associated factors among adults in Uganda: a cross-sectional survey
Authors: Ndejjo Rawlance , Chen Nuole , Kabwama Steven N , Namale Alice , Wafula Solomon Tsebeni , Wanyana Irene , Kizito Susan , Kiwanuka Suzanne N , Sambisa William , Tsai Lily L , Wanyenze Rhoda K
Published: March 2023

Objective

COVID-19 pandemic remains one of the most significant public health challenges ever faced globally. Vaccines are key to ending the pandemic as well as minimise its consequences. This study determined the uptake of COVID-19 vaccines and associated factors among adults in Uganda.

Design, setting and participants

We conducted a cross-sectional mobile phone survey among adults in Uganda.

Main outcome variable

Participants reported their uptake of COVID-19 vaccines.

Results

Of the participants contacted, 94% (1173) completed the survey. Overall, 49.7% had received COVID-19 vaccines with 19.2% having obtained a full dose and 30.5% an incomplete dose. Among the unvaccinated, 91.0% indicated intention to vaccinate. Major reasons for vaccine uptake were protection of self from COVID-19 (86.8%) and a high perceived risk of getting the virus (19.6%). On the other hand, non-uptake was related to vaccine unavailability (42.4%), lack of time (24.1%) and perceived safety (12.5%) and effectiveness concerns (6.9%). The factors associated with receiving COVID-19 vaccines were older age (≥65 years) (Adjusted Prevalence Ratio (APR)=1.32 (95% CI: 1.08 to 1.61)), secondary (APR=1.36 (95% CI: 1.12 to 1.65)) or tertiary education (APR=1.62 (95% CI: 1.31 to 2.00)) and health workers as a source of information on COVID-19 (APR=1.26 (95% CI: 1.10 to 1.45)). Also, reporting a medium-income (APR=1.24 (95% CI: 1.02 to 1.52)) and residence in Northern (APR=1.55, 95% CI: 1.18 to 2.02) and Central regions (APR=1.48, 95% CI: 1.16 to 1.89) were associated with vaccine uptake.

Conclusions

Uptake of COVID-19 vaccines was moderate in this sample and was associated with older age, secondary and tertiary education, medium-income, region of residence and health workers as a source of COVID-19 information. Efforts are needed to increase access to vaccines and should use health workers as champions to enhance uptake.
Analysis of national and subnational prevalence of adolescent pregnancy and changes in the associated sexual behaviours and sociodemographic determinants across three decades in Ghana, 1988–2019
Authors: Mohammed Shamsudeen
Published: March 2023

Objective

Understanding the determinants of adolescent pregnancy and how they have changed over time is essential for measuring progress and developing strategies to improve adolescent reproductive health. This study examined changes over time in the prevalence and determinants of adolescent pregnancy in Ghana.

Methods

A total of 11 nationally representative surveys from the Ghana Demographic and Health Survey (1988, 1993, 1998, 2003, 2008, 2014), Multiple Indicator Cluster Survey (2006, 2011, 2017–2018) and Malaria Indicator Survey (2016 and 2019) provided data on 14 556 adolescent girls aged 15–19 for this analysis. A random-effect meta-analysis, time trends and multivariable logistic regression models were used to track the prevalence and determinants of adolescent pregnancy.

Results

The pooled prevalence of adolescent pregnancy in Ghana was 15.4% (95% CI=13.49% to 17.30%). Rural areas (19.5%) had a higher prevalence of adolescent pregnancy than urban areas (10.6%). In the overall sample, middle adolescents (15–17 years) (aOR=0.30, 95% CI=0.23 to 0.39), adolescents in urban areas (aOR=0.56, 95% CI=0.43 to 0.74), large households (aOR=0.62, 95% CI=0.49 to 0.78), not working (aOR=0.62, 95% CI=0.43 to 0.90) and those unaware of contraceptive methods (aOR=0.49, 95% CI=0.27 to 0.90) were less likely to become pregnant. Adolescents from middle-income (aOR=0.91, 95% CI=0.67 to 1.24) or high-income (aOR=0.59, 95%CI=0.36 to 0.94) households, those who were semiliterate (aOR=0.56, 95%CI=0.39 to 0.82) or literate (aOR=0.28, 95%CI=0.21 to 0.37) and those with fewer previous sex partners were less likely to become pregnant. Not all determinants in the overall sample were consistently associated with adolescent pregnancy in the last three decades. Between 1988 and 1998, determinants of adolescent pregnancy were age, literacy, employment, household size and whether the mother was alive. Between 2003 and 2008, age, literacy, household size, income, age of last sexual partner, number of previous partners and contraception knowledge determined adolescent pregnancy. From 2011 to 2019, age, residence, literacy and menstrual cycle knowledge were determinants of adolescent pregnancy.

Conclusion

Interventions and policies to prevent adolescent pregnancy should prioritise adolescents from disadvantaged backgrounds.
Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar
Authors: Farmer Chris , Santer Ellie , West Alan , Darby John , Rees-Roberts Melanie , Doulton Timothy , MacInnes Douglas , O'Driscoll Jamie , Borthwick Rachel , Pellatt-Higgins Tracy , Gousia Katerina , Short Vanessa , Swift Pauline A , Wiles Jonathan
Published: March 2023

The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of ‘lockdown’ requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study.
Comparison of social gradient in cardiometabolic health in Czechia and Venezuela: a cross-sectional study
Authors: Bartoskova Polcrova Anna , Nieto-Martinez Ramfis , Mechanick Jeffrey I , Maranhao Neto Geraldo A , Infante-Garcia Maria M , Pikhart Hynek , Bobak Martin , Medina-Inojosa Jose , Gonzalez-Rivas Juan P
Published: March 2023

Objectives

This study compared the relationships of social determinants with cardiometabolic risk in different socioeconomic contexts: sociopolitically unstable Venezuela (VE) and stable Czechia (CZ).

Design: cross-sectional analysis involving two population-based studies.

Setting

Brno, Czechia and 23 cities of Venezuela.

Participants

25–64 years old subjects from CZ (2013–2014, n=1579, 56% females) and VE (2014–2017, n=1652, 70% females).

Main outcome measures

The composite cardiometabolic risk score (CMRS) (scaled 0–8) was calculated using eight biomarkers (body mass index, waist circumference, blood glucose, systolic and diastolic blood pressure, total and high-density lipoprotein-cholesterol, triglycerides). Social characteristics included education in both countries, income in CZ and a composite measure of social position (SP) in VE. Sex stratified ordinal regression examined the social gradient in having less favourable CMRS.

Results

In CZ, men and women with low education and women with low income had higher odds of higher CMRS compared with those with high education and income with OR 1.45 (95% CI 1.01 to 2.21), 2.29 (95% CI 1.62 to 3.24) and 1.69 (95% CI 1.23 to 2.35). In VE, women with low education and low SP had higher odds to have higher CMRS OR 1.47 (95% CI 1.09 to 1.97) and 1.51 (95% CI 1.16 to 1.97), while men with low education and low SP had lower odds to have higher CMRS OR 0.64 (95% CI 0.41 to 1.00) and 0.61 (95% CI 0.40 to 0.97), compared with those with high education and high SP. Independently of age, sex and socioeconomic characteristics, Venezuelans had higher odds to have higher CMRS than Czechs (OR 2.70; 95% CI 2.37 to 3.08).

Conclusions

The results suggest that the associations of socioeconomic status indices and cardiometabolic risk differed between CZ and VE, likely reflecting differences in the social environment among countries. Further research is needed to confirm and quantify these differences.
Trends in antineoplastic drug use, cost and prescribing patterns among patients with lung cancer in nine major cities of China, 2016–2020: a retrospective observational study based on inpatient and outpatient hospital data
Authors: Shang Jingyuan , Zhou Lixin , Huang Lin , Yang Feng , Liu Yanguo , Zhang Chunyan , Zu Li'an , Fan Rongrong , Zhang Xiaohong , Liu Yi , Feng Yufei
Published: March 2023

Objectives

It is unclear whether the use of antineoplastic drugs for patients with lung cancer in China has changed after the implementation of the national drug price negotiation in 2016 and continual update of clinical guidelines. This study aims to evaluate the trends in antineoplastic drug use, cost and prescribing patterns among patients with lung cancer in major cities of China.

Design

We conducted a retrospective observational study using data from January 2016 to December 2020.

Setting

This study used prescription records based on inpatient and outpatient hospital data from 97 hospitals in 9 major cities of China.

Participants

A total of 218 325 antineoplastic drug prescriptions in patients with lung cancer were retrospectively collected from the Hospital Prescription Analysis Cooperative Project during the study period.

Outcome measures

Trends in antineoplastic drug use, cost and prescribing patterns among patients with lung cancer.

Results

The yearly antineoplastic prescriptions increased by 85.6% from 28 594 in 2016 to 53 063 in 2020 (Z=1.71, p=0.086). Significant increases were seen in the prescriptions for protein kinase inhibitors (PKIs) and monoclonal antibodies (mAbs), whereas significant decreases were observed in antimetabolites, plant alkaloids and platinum compounds. The yearly cost increased progressively by 145.0% from ¥113.6 million in 2016 to ¥278.3 million in 2020 (Z=2.20, p=0.027). The top three anticancer drug classes in terms of total cost were PKIs, antimetabolites and mAbs. In prescribing patterns of antineoplastic agents for lung cancer, monotherapy, and triple or more drug combinations gradually increased, while dual combinations decreased significantly from 30.8% to 19.6%.

Conclusions

Prescription practices among patients with lung cancer in China underwent major changes during the study period. The observed trends can aid in understanding the present medication use status of patients with lung cancer in China and provide information for future drug management.
Cohort profile: InfCareHIV, a prospective registry-based cohort study of people with diagnosed HIV in Sweden
Authors: Carlander Christina , Brännström Johanna , Månsson Fredrik , Elvstam Olof , Albinsson Pernilla , Blom Simon , Mattsson Lena , Hovmöller Sanne , Norrgren Hans , Mellgren Åsa , Svedhem Veronica , Gisslén Magnus , Sönnerborg Anders
Published: March 2023

Purpose

The Swedish InfCareHIV cohort was established in 2003 to ensure equal and effective care of people living with HIV (PLHIV) and enable long-term follow-up. InfCareHIV functions equally as a decision support system as a quality registry, ensuring up-to-date data reported in real time.

Participants

InfCareHIV includes data on >99% of all people with diagnosed HIV in Sweden and up to now 13 029 have been included in the cohort. InfCareHIV includes data on HIV-related biomarkers and antiretroviral therapies (ART) and also on demographics, patient-reported outcome measures and patient-reported experience measures.

Findings to date

Sweden was in 2015 the first country to reach the UNAIDS (United Nations Programme on HIV/AIDS)/WHO’s 90-90-90 goals. Late diagnosis of HIV infection was identified as a key problem in the Swedish HIV-epidemic, and low-level HIV viraemia while on ART associated with all-cause mortality. Increased HIV RNA load in the cerebrospinal fluid (CSF) despite suppression of the plasma viral load was found in 5% of PLHIV, a phenomenon referred to as ‘CSF viral escape’. Dolutegravir-based treatment in PLHIV with pre-existing nucleoside reverse transcriptase inhibitor-mutations was non-inferior to protease inhibitor-based regimens. An increase of transmitted drug resistance was observed in the InfCareHIV cohort. Lower efficacy for protease inhibitors was not due to lower adherence to treatment. Incidence of type 2 diabetes and insulin resistance was high in the ageing HIV population. Despite ART, the risk of infection-related cancer as well as lung cancer was increased in PLHIV compared with HIV-negative. PLHIV were less likely successfully treated for cervical precancer and more likely to have human papillomavirus types not included in current HPV vaccines. Self-reported sexual satisfaction in PLHIV is improving and is higher in women than men.

Future plans

InfCareHIV provides a unique base to study and further improve long-term treatment outcomes, comorbidity management and health-related quality of life in people with HIV in Sweden.
Novel patient-centred outcome in cancer care, days at home: a scoping review protocol
Authors: Ribeiro Tiago , Mahar Alyson , Jerath Angela , Bondzi-Simpson Adom , Barabash Victoria , Barr Austin A , Wright Frances C , Kosyachkova Ekaterina , Deleemans Julie , Coburn Natalie G , Hallet Julie
Published: March 2023

Introduction

Patient-centred care is valued by patients and providers. As management of cancer becomes increasingly complex, the value of providing care that incorporates an individual’s values and preferences along with demographic and tumour factors is increasingly important. To improve care, patients with cancer need easily accessible information on the outcomes important to them. The patient-centred outcome, days at home (DAH), is based on a construct that measures the time a patient spends alive and out of hospitals and healthcare institutions. DAH is accurately measured from various data sources and has shown construct validity with many patient-centred outcomes. There is significant heterogeneity in terms used and definitions for DAH in cancer care. This scoping review aims to consolidate information on the outcome DAH in cancer care and to review definitions and terms used to date to guide future use of DAH as a patient-centred care, research and policy tool.

Methods and analysis

This scoping review protocol has been designed with joint guidance from theJBI Manual for Evidence Synthesisand the expanded framework from Arksey and O’Malley. We will systematically search MEDLINE, Embase and Scopus for studies measuring DAH, or equivalent, in the context of active adult cancer care. Broad inclusion criteria have been developed, given the recent introduction of DAH into cancer literature. Editorials, opinion pieces, case reports, abstracts, dissertations, protocols, reviews, narrative studies and grey literature will be excluded. Two authors will independently perform full-text selection. Data will be extracted, charted and summarised both qualitatively and quantitively.

Ethics and dissemination

No ethics approval is required for this scoping review. Results will be disseminated through scientific publication and presentation at relevant conferences.
Developing a best practice framework for musculoskeletal outpatient physiotherapy delegation: the MOPeD mixed-methods research study protocol
Authors: Sarigiovannis Panos , Foster Nadine E , Jowett Sue , Saunders Benjamin
Published: March 2023

Introduction

Physiotherapy assistants/support workers are an important part of the physiotherapy workforce in the UK. Many of them work in National Health Service (NHS) physiotherapy outpatient services treating patients with musculoskeletal (MSK) conditions. In many services, they take responsibility, under professional supervision, for types of clinical work traditionally undertaken by physiotherapists such as leading exercise classes and treating individual patients. Nevertheless, their role(s) are relatively undefined and as such, there is considerable variation in the duties and tasks they undertake. This study aims to design a framework of ‘best practice’ in delegation to guide the work of clinicians in NHS physiotherapy MSK services and facilitate standardisation of practice to ensure that patients receive safe and effective treatment by the most appropriate person.

Methods and analysis

This mixed-methods study will be conducted in four stages. In stage 1, a focused ethnography in two MSK outpatient physiotherapy services will explore how the current use of delegation is informed by the culture within the clinical setting as well as views, attitudes about, and experiences of, delegation among clinicians, managers and patients. In stage 2a, nominal group technique will be used with three separate groups (physiotherapists/physiotherapy assistants/support workers, managers) to reach a consensus about what components should be included in a best practice framework of delegation. In stage 2b, a discrete choice experiment will elicit patients’ preferences between care from physiotherapists and physiotherapy assistants/support workers within MSK physiotherapy services. In the final stage, the results of all previous stages will be triangulated to inform the development of a best practice delegation framework for future testing and use within NHS MSK outpatient physiotherapy services.

Ethics and dissemination

Ethical approval has been granted by the South West-Frenchay Research Ethics Committee. The findings will be disseminated in peer-reviewed journals, conference presentations, the lay press and social media.
Measuring the patient safety culture at a tertiary care hospital in Pakistan using the Hospital Survey on Patient Safety Culture (HSOPSC)
Authors: Ahmed Fasih Ali , Asif Fozia , Munir Tahir , Halim Muhammad Sohail , Feroze Ali Zehra , Belgaumi Asim , Zafar Hasnain , Latif Asad
Published: March 2023

Background

Patient safety is a top priority for many healthcare organisations worldwide. However, most of the initiatives aimed at the measurement and improvement of patient safety culture have been undertaken in developed countries. The purpose of this study was to measure the patient safety culture at a tertiary care hospital in Pakistan using the Hospital Survey on Patient Safety Culture (HSOPSC).

Methods

The HSOPSC was used to measure the patient safety culture across 12 dimensions at Aga Khan University Hospital, Karachi. 2,959 individuals, who had been working at the hospital, were administered the HSOPSC in paper form between June and September 2019.

Results

The response rate of the survey was 50%. In the past 12 months, 979 respondents (33.1%) had submitted at least one event report. Results showed that the personnel viewed the patient safety culture at their hospital favourably. Overall, respondents scored highest in the following dimensions: ‘feedback and communication on error’ (91%), ‘organisational learning and continuous improvement’ (85%), ‘teamwork within units’ (83%), ‘teamwork across units’ (76%). The dimensions with the lowest positive per cent scores included ‘staffing’ (40%) and ‘non-punitive response to error’ (41%). Only the reliability of the ‘handoffs and transitions’, ‘frequency of events reported’, ‘organisational learning’ and ‘teamwork within units’ was higher than Cronbach’s alpha of 0.7. Upon regression analysis of positive responses, physicians and nurses were found to have responded less favourably than the remaining professional groups for most dimensions.

Conclusion

The measurement of safety culture is both feasible and informative in developing countries and could be broadly implemented to inform patient safety efforts. Current data suggest that it compares favourably with benchmarks from hospitals in the USA. Like the USA, high staff workload is a significant safety concern among staff. This study lays the foundation for further context-specific research on patient safety culture in developing countries.
Experience and opinions relating to pregnancy in patients with chronic intestinal failure: an international survey
Authors: Bond Ashley , Allan Philip , Conley Thomas Edward , Farrer Kirstine , Mackillop Lucy , Bozzetti Federico , Cuerda Cristina , Jeppesen Palle , Joly Francisca , Lamprecht Georg , Mundi Manpreet , Szczepanek Kinga , Van Gossum Andre , Wanten Geert , Pironi Loris , Lal Simon
Published: March 2023

Introduction

Pregnancy in patients with chronic intestinal failure (CIF) is a relatively rare occurrence but is an important contemporary topic given both the increasing use of home parenteral nutrition (HPN) and the demographics of patients with CIF.

Method

An opinion-based survey was produced in a multidisciplinary manner, which was then distributed internationally, via the European Society for Clinical Nutrition and Metabolism network, using a web-based survey tool for healthcare professionals with a specialist interest in the management of CIF.

Results

Seventy specialists from 11 countries completed the survey. Fifty-four per cent of the respondents reported some experience of managing pregnancy in patients with CIF. However, 60% stated that they did not feel that it was their role to discuss the topic of pregnancy with their patients, with fewer than 10% stating that they routinely did so. Respondents felt that an individualised approach was required when considering alterations to parenteral support prior to conception, during pregnancy and in the postnatal period. Most respondents also felt there was no increased risk of catheter-related blood stream infections, while catheter-related thrombosis was deemed to be the most significant HPN-related complication for pregnant women.

Conclusion

This study reports a variable experience, knowledge and confidence of healthcare professionals when considering pregnancy in patients with CIF. The risk of HPN-related complication was felt to be greater during pregnancy, with an individualised approach being the preferred route for most aspects of care. The findings support the need for an international registry and subsequent consensus guidelines for the management of pregnancy in CIF.
Providing recurrence risk counselling for parents after diagnosis of a serious genetic condition caused by an apparently de novo mutation in their child: a qualitative investigation of the PREGCARE strategy with UK clinical genetics practitioners
Authors: Kay Alison C , Wells Jonathan , Hallowell Nina , Goriely Anne
Published: March 2023

Background

Diagnosis of a child with a genetic condition leads to parents asking whether there is a risk the condition could occur again with future pregnancies. If the cause is identified as an apparent de novo mutation (DNM), couples are currently given a generic, population average, recurrence risk of ~1%–2%, depending on the condition. Although DNMs usually arise as one-off events, they can also originate through the process of mosaicism in either parent; in this instance, the DNM is present in multiple germ cells and the actual recurrence risk could theoretically be as high as 50%.

Methods

Our qualitative interview study examined the views and reflections on current practice provided by UK practitioners working in clinical genetics (n=20) regarding the potential impact of PREcision Genetic Counselling And REproduction (PREGCARE)—a new preconception personalised recurrence risk assessment strategy.

Results

Those interviewed regarded PREGCARE as a very useful addition to risk management, especially for cases where it revised the risk downwards or clarified that a couple’s personalised recurrence risk meets National Health Service thresholds for non-invasive prenatal testing, otherwise inaccessible based on the generic DNM recurrence risk.

Conclusion

Participants said it could release some couples requiring reassurance from undergoing unnecessary invasive testing in future pregnancies. However, they regarded mosaicism and PREGCARE as complex concepts to communicate, requiring further training and additional appointment time for pre-test genetic counselling to prepare couples for all the possible outcomes of a personalised risk assessment, including potentially identifying the parental origin of the DNM, and to ensure informed consent.
Supercomputers against strong coupling in gravity with curvature and torsion
Authors: Barker W. E. V.
Published: March 2023

Many theories of gravity are spoiled by strongly coupled modes: the high computational cost of Hamiltonian analysis can obstruct the identification of these modes. A computer algebra implementation of the Hamiltonian constraint algorithm for curvature and torsion theories is presented. These non-Riemannian or Poincaré gauge theories suffer notoriously from strong coupling. The implementation forms a package (the ‘Hamiltonian Gauge Gravity Surveyor’ –HiGGS) for thexActtensor manipulation suite inMathematica. Poisson brackets can be evaluated in parallel, meaning that Hamiltonian analysis can be done on silicon, and at scale. AccordinglyHiGGSis designed to survey the whole Lagrangian space with high-performance computing resources (clusters and supercomputers). To demonstrate this, the space of ‘outlawed’ Poincaré gauge theories is surveyed, in which a massive parity-even/odd vector or parity-odd tensor torsion particle accompanies the usual graviton. The survey spans possible configurations of teleparallel-style multiplier fields which might be used to kill-off the strongly coupled modes, with the results to be analysed in subsequent work. All brackets between the known primary and secondary constraints of all theories are made available for future study. Demonstrations are also given for usingHiGGS– on a desktop computer – to run the Dirac–Bergmann algorithm on specific theories, such as Einstein–Cartan theory and its minimal extensions.