bluuebunny/crossref_metadata_2025 huggingface dataset:
‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India
Authors: Kulkarni Bharati , Augustine Little Flower , Pullakhandam Raghu , Pradhan Anju Sinha , Dasi Teena , Palika Ravindranadh , Banjara Santosh Kumar , Sachdev Harshpal Singh
Published: December 2021

Introduction

Current anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population.

Methods and analysis

An open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering.

Ethics and dissemination

The study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders.

Trial registration number

CTRI/2019/01/016918.
Protocol for a diagnostic accuracy study to develop diagnosis algorithm for biliary atresia using MMP-7 (DIABA-7 study): a study recruiting from Chinese Biliary Atresia Collaborative Network
Authors: Jiang Jingying , Deng Jiale , Chen Gong , Dong Rui , Sun Song , Du Min , Yang Dake , Fang Zhuo , Zheng Shan
Published: December 2021

Introduction

Biliary atresia is a severe liver disease in neonates, and the prognosis partially depends on the age at which infants undergo the Kasai procedure. Matrix metalloproteinase-7 (MMP-7) was confirmed to have significant value in the diagnosis of biliary atresia. However, so far, the reference range and its cut-off value for diagnosing biliary atresia have not been established yet.

Methods and analysis

DIagnosis Algorithm for Biliary Atresia (DIABA-7) is a prospective diagnostic test. Cholestatic infants and normal controls within 150 days of age are recruiting from the Chinese Biliary Atresia Collaborative Network. The serum samples and dried blood spot (DBS) samples are obtained to detect MMP-7 concentrations using an ELISA kit. The reference standard is the intraoperative exploration and subsequent histological examination of liver biopsies. Lambda-Mu-Sigma (LMS) method is used to calculate the normal range of serum MMP-7 of each age group. Receiver operating characteristics (ROC) curves are constructed to calculate the best cut-off point and area under the curve for the index test. The sensitivity, specificity, positive predictive value and negative predictive value are used to show the diagnostic accuracy. Pearson correlation coefficient test is applied to assess the correlation of serum MMP-7 and DBS MMP-7.

Ethics and dissemination

This study was reviewed and approved by the Ethics Committee of Children’s Hospital of Fudan University (Number 2020–296). Dissemination will be guided by investigators and patients. The aim is to publish the study results in a high-quality peer-reviewed journal and present the findings at international academic meetings.

Trial registration number

ChiCTR2000032983.
Survival of mechanically ventilated ward patients and association with organisational factors: a multicentre prospective study
Authors: Wong Wai-Tat , Lee Anna , Gomersall Charles David , Shek Lam-hin , Chan Alfred , So Sheung-on , Sin Kai-cheuk , Tang Wai-ming , Sinn Maria , Ling Lowell
Published: December 2021

Objectives

Determine 90-day mortality of mechanically ventilated ward patients outside the intensive care unit (ICU) and its association with organisational factors.

Design

Multicentre prospective observational study of mechanically ventilated ward patients. Modified Poisson regression was used to assess association between nurse to patient ratio (NPR) and 90-day mortality, adjusted for designated medical team, Society of Critical Care Medicine (SCCM) triage priority and centre effect. NPR was divided into low (1:9.6 to 1:10), medium (1:6 to 1:8) and high (1:2.6). Sensitivity analysis was conducted for pneumonia with or without acute respiratory distress syndrome (ARDS) to assess magnitude of association.

Setting

7 acute public hospitals in Hong Kong.

Participants

All 485 mechanically ventilated patients in wards from participating hospitals between 18 January 2016 and 17 April 2016 were recruited. Three hundred patients were included after excluding patients with limitation of therapy within 24 hours of intubation.

Main outcomes

90-day mortality, Mortality Prediction Model III Standardised mortality ratio (MPMIII0SMR).

Results

201 patients died within 90 days after intubation (67.0%, 95% CI 61.5% to 72.1%), with MPMIII0SMR 1.88, 95% CI 1.63 to 2.17. Compared with high NPR, medium and low NPRs were associated with higher risk of 90-day mortality (adjusted relative risk (RRadj) 1.84, 95% CI 1.70 to 1.99 and 1.64, 95% CI 1.47 to 1.83, respectively). For 114 patients with pneumonia with or without ARDS, low to medium NPR, too sick to benefit from ICU (SCCM priority 4b), no ICU consultation and designated medical team were associated with risk of 90-day mortality (RRadj1.49, 95% CI 1.40 to 1.58; RRadj1.60, 95% CI 1.49 to 1.72; RRadj1.34, 95% CI 1.27 to 1.40; RRadj0.85, 95% CI 0.78 to 0.93, respectively).

Conclusion

The 90-day mortality rates of mechanically ventilated ward patients were high. NPR was an independent predictor of survival for mechanically ventilated ward patients.
New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia
Authors: Alonso-Vega Cristina , Urbina Julio A , Sanz Sergi , Pinazo María-Jesús , Pinto Jimy José , Gonzalez Virginia R , Rojas Gimena , Ortiz Lourdes , Garcia Wilson , Lozano Daniel , Soy Dolors , Maldonado Rosa A , Nagarkatti Rana , Debrabant Alain , Schijman Alejandro , Thomas M Carmen , López Manuel Carlos , Michael Katja , Ribeiro Isabela , Gascon Joaquim , Torrico Faustino , Almeida Igor C
Published: December 2021

Introduction

Chagas disease (CD) affects ~7 million people worldwide. Benznidazole (BZN) and nifurtimox (NFX) are the only approved drugs for CD chemotherapy. Although both drugs are highly effective in acute and paediatric infections, their efficacy in adults with chronic CD (CCD) is lower and variable. Moreover, the high incidence of adverse events (AEs) with both drugs has hampered their widespread use. Trials in CCD adults showed that quantitative PCR (qPCR) assays remain negative for 12 months after standard-of-care (SoC) BZN treatment in ~80% patients. BZN pharmacokinetic data and the nonsynchronous nature of the proliferative mammal-dwelling parasite stage suggested that a lower BZN/NFX dosing frequency, combined with standard or extended treatment duration, might have the same or better efficacy than either drug SoC, with fewer AEs.

Methods and analysis

New ThErapies and Biomarkers for ChagaS infEctiOn (TESEO) is an open-label, randomised, prospective, phase-2 clinical trial, with six treatment arms (75 patients/arm, 450 patients). Primary objectives are to compare the safety and efficacy of two new proposed chemotherapy regimens of BZN and NFX in adults with CCD with the current SoC for BZN and NFX, evaluated by qPCR and biomarkers for 36 months posttreatment and correlated with CD conventional serology. Recruitment of patients was initiated on 18 December 2019 and on 20 May 2021, 450 patients (study goal) were randomised among the six treatment arms. The treatment phase was finalised on 18 August 2021. Secondary objectives include evaluation of population pharmacokinetics of both drugs in all treatment arms, the incidence of AEs, and parasite genotyping.

Ethics and dissemination

The TESEO study was approved by the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), federal regulatory agency of the Plurinational State of Bolivia and the Ethics Committees of the participating institutions. The results will be disseminated via publications in peer-reviewed journals, conferences and reports to the NIH, FDA and participating institutions.

Trial registration number

NCT03981523.
Comorbidity patterns and associated characteristics in children with obstructive sleep apnoea–hypopnoea syndrome in Shanghai, China: a cross-sectional study
Authors: Li Ziyun , Gao Xiang , Chen Ning , Zhou Liang , Wang Hui , Chen Chen , Yang Yan , Yu Dehua , Jin Hua , Zhou Huining , Hou Tianchun , Huang Jiaoling , Wang Zhaoxin , Shi Jianwei
Published: December 2021

Objectives

Paediatric obstructive sleep apnoea–hypopnoea syndrome (OSAHS), which usually cooccurs with various diseases, significantly impacts health and social resources. Domestic paediatric OSAHS studies have not included comorbidity patterns or distribution characteristics. Thus, we investigated the comorbid characteristics of paediatric OSAHS in Shanghai, China.

Design

Large hospital-based cross-sectional study.

Setting

Paediatric ward medical data from the Pudong New Area, Shanghai, China from 2013 to 2016.

Participants

4045 Chinese children aged 0–18 years.

Primary and secondary outcome measures

Paediatric OSAHS was diagnosed using the Paediatric Sleep Questionnaire with a cut-off score of 8 points. The outcomes were comorbidity patterns and their characteristics. χ2tests were performed to compare differences among the top comorbidity patterns.

Results

Major comorbidities were otolaryngological morbidities. Among one-comorbidity patterns, OSAHS+chronic rhinitis (37.53%) and OSAHS+allergic rhinitis (28.13%) were most common. Among two-comorbidity patterns, OSAHS+chronic rhinitis +chronic exudative otitis media (10.88%), OSAHS+allergic rhinitis +chronic exudative otitis media (7.94%), OSAHS+allergic rhinitis +chronic tonsillitis (4.43%) and OSAHS+chronic rhinitis +chronic tonsillitis (4.23%) were most common. Males predominated in all comorbidity groups. Age differences for the top five patterns in both the one-comorbidity (p=0.035) and two comorbidities (p<0.001) groups were statistically significant. In the one-comorbidity group, patients were more likely to have one operation (p<0.001), and in the two comorbidities group, patterns of ‘OSAHS+chronic rhinitis +chronic exudative otitis media’ and ‘OSAHS+allergic rhinitis +chronic exudative otitis media’ were more common in the ≥2 operations group (p<0.001). Notably, the top five patterns of the 2-comorbidities group were significantly associated with the length of stay (LOS) (p<0.001), while those in the one-comorbidity group were not.

Conclusion

OSAHS+rhinitis (chronic rhinitis or allergic rhinitis) was the most common diagnosis. Age, number of operations, and LOS are significantly associated with the patterns. This emphasises the importance of better understanding complex otolaryngological comorbidity diagnoses and treatments in paediatric OSAHS to reverse clinical outcomes and save health resources.
Glasgow Prognostic Score and modified Glasgow Prognostic Score and survival in patients with hepatocellular carcinoma: a meta-analysis
Authors: Lu Lingling , Lin Kunzhe , Zheng Jiaolong , Wu Haicong , Li Dongliang
Published: December 2021

Objective

To evaluate the association between inflammation-related markers, modified Glasgow Prognostic Score (mGPS) and Glasgow Prognostic Score (GPS), and survival outcome and recurrence risk in patients with hepatocellular carcinoma (HCC) after treatment.

Design

Systematic reviews and meta-analysis of cohort studies.

Date sources

Embase, Scopus, Web of Science and PubMed were searched through 10 March 2021.

Eligibility criteria

We included cohort studies that assessed the effect of pretreatment mGPS/GPS levels on survival outcomes in patients with HCC.

Data extraction and synthesis

Two researchers independently selected the data and reached a consensus. In case of disagreement, a third researcher was required to assist. The HRs and 95% CIs were used as the effect size indexes. Newcastle-Ottawa Scale was used to assess risk of bias and quality assessment of the included studies.

Results

The meta-analysis included 23 studies, most of which were retrospective. Participants were grouped according to the score of mGPS/GPS. When analysed into two groups (1/2 vs 0), the results showed that patients with a mGPS/GPS of 1 or 2 had poorer overall survival (OS) than those with a score of 0 (both p<0.001). When analysed into three groups (1 vs 0 and 2 vs 0), the results revealed that an mGPS/GPS of 2 is related to poorer OS in patients with HCC (HR=2.46, 95% CI 2.06 to 2.95, and HR=3.45, 95% CI 1.68 to 7.10, respectively). However, a GPS of 1 (p=0.005) but not an mGPS of 1 (p=0.177) had a significant association with OS. No association was found between mGPS/GPS and disease-free survival or recurrence-free survival.

Conclusion

GPS was more closely associated the survival in patients with HCC than mGPS. A higher GPS has an association with poorer survival. It can be combined with tumour staging to assess the OS of HCC more accurately.

PROSPERO registration number

CRD42021242049.
Diseases with oral manifestations among adult asthmatics in Finland: a population-based matched cohort study
Authors: Lemmetyinen Riikka , Karjalainen Jussi , But Anna , Renkonen Risto , Pekkanen Juha , Haukka Jari , Toppila-Salmi Sanna
Published: December 2021

Objectives

Many comorbidities are associated with adult asthma and may exacerbate the asthma burden of disease. This study aims to investigate the risk for major oral diseases or oral-manifesting diseases in asthmatic compared with non-asthmatic adults.

Design

We conducted a population-based matched cohort study with a 13.8-year follow-up.

Setting

A baseline questionnaire was completed by participants in 1997 and follow-up data were extracted from the national hospital discharge registry of the National Institute for Health and Welfare in Finland from 1997 to 2014.

Participants

A total of 1394 adults with asthma were matched with 2398 adults without asthma based on sex, age and area of residence. Asthmatic adults were identified from the Drug Reimbursement Register of the Finnish Social Insurance Institution based on a special drug reimbursement right resulting from asthma. Participants without asthma were identified from the Population Register.

Main outcomes and measures

Oral health-related primary diagnoses were retrieved using codes from the International Classification of Diseases, 10th edition and divided into groups of diseases. Cox’s proportional hazards models stratified by matching unit and models matched and adjusted for pack-years, education level and body mass index (when possible) were used to evaluate the matched and further adjusted HRs for diseases comparing asthmatic and non-asthmatic cohorts.

Results

Adult asthma was associated with a higher risk for any oral-manifesting disease (adjusted HR 1.41, 95% CI 1.11 to 1.80), herpes zoster (adjusted HR 6.18, 95% CI 1.21 to 31.6), benign tumours of the oral cavity and pharynx (matched HR 1.94, 95% CI 1.05 to 3.56) and dermatological diseases (pemphigus, pemphigoid, dermatitis herpetiformis, psoriasis and lichen planus, HR 1.67, 95% CI 1.01 to 2.78).

Conclusions

In this study, adult asthmatics experienced a higher risk for a major oral disease or oral-manifesting disease.
Assessment of the effects of methodological choice in continuity of care research: a real-world example with dyslipidaemia cohort
Authors: Choo Eunjung , Choi Eunyoung , Lee Juhee , Siachalinga Linda , Jang Eun Jin , Lee Iyn-Hyang
Published: December 2021

Objective

To determine if the choice of methodological elements affects the results in continuity of care studies.

Design

This is a retrospective cohort study. The association between continuity of care and clinical outcome was investigated using the Continuity of Care Index. The association was explored in 12 scenarios based on four definitions of the relative timing of continuity and outcome measurements in three populations (threePs × fourTs).

Setting

National Health Insurance claims from all primary and secondary care facilities in South Korea between 2007 and 2015.

Participants

Participants were patients diagnosed with dyslipidaemia, made ≥2 ambulatory visits and were newly prescribed with ≥1 antihyperlipidaemic agent at an ambulatory setting in 2008. Three study populations were defined based on the number of ambulatory visits: 10 084 patients in population 1 (P1), 8454 in population 2 (P2) and 4754 in population 3 (P3).

Main outcome measure

Hospitalisation related to one of the four atherosclerotic cardiovascular diseases, including myocardial infarction, stable or unstable angina, ischaemic stroke and transient ischaemic attack.

Results

Concurrent measure of continuity and outcome (T1) showed a significantly higher risk of hospitalisation (adjusted HRs: 2.73–3.07, p<0.0001) in the low continuity of care group, whereas T2, which measured continuity until the outcome occurred, showed no risk difference between the continuity of care groups. T3, which measured continuity as a time-varying variable, had adjusted HRs of 1.31–1.55 (p<0.05), and T4, measuring continuity for a predefined period and measuring outcomes in the remaining period, had adjusted HRs of 1.34–1.46 (p<0.05) in the low continuity of care. Within each temporal relationship, the effect estimates became more substantial as the inclusion criteria became stricter.

Conclusions

The study design in continuity of care studies should be planned carefully because the results are sensitive to the temporal relationship between continuity and outcome and the population selection criteria.
What are the financial implications of an open right hemicolectomy to hospital trusts within NHS England? A cost analysis
Authors: Daniels Ian , Tuson Richard , Hargreaves Judith
Published: December 2021

Objective

This study aimed to quantify the actual costs to National Health Service (NHS) England of open right/extended right hemicolectomy (ORH) patient episodes compared with national tariffs to determine whether the total cost of care for these patients is adequately reimbursed to NHS Trusts.

Design

2017–2018 NHS Improvement reference cost data for elective and non-elective ORH Healthcare Resource Group 4+ (HRG4+)-coded procedures were used to calculate the actual mean initial admission costs of ORH and compare with corresponding 2017–2018 national tariffs. Costs of postoperative complications were estimated based on 2017–2018 Hospital Episode Statistics (intensive care unit (ICU)/high-dependency unit (HDU) stay and surgical site infection (SSI)) or further associated HRG4+-coded procedures (anastomotic leakage, SSI or hernia).

Setting and patient cohort

Data were analysed for all ORH inpatients reported as treated at 140 secondary care Hospital Trusts in England during the 2017–2018 financial year.

Results

9812 ORH HRG4+-coded procedures were reported across 140 Hospital Trusts (74.0% elective; 26.0% non-elective). A total 1-year deficit of £993 335 was estimated between actual initial admission costs incurred and tariffs reimbursed for all patient episodes, 93.7% of which was associated with elective admissions. The cost of the average length of stay (LoS) in ICU/HDU after an ORH was £6818. The additional cost of an extended LoS in ICU/HDU due to an SSI was £45 316.

Conclusion

The total cost of delivering care for these patients declared by NHS England was far higher than the tariff provided, which may be significantly underestimating the true cost of an ORH, leading to inadequate national tariff-setting by NHS Improvement.
’We weren't checked in on, nobody spoke to us’: an exploratory qualitative analysis of two focus groups on the concerns of ethnic minority NHS staff during COVID-19
Authors: Jesuthasan Jehanita , Powell Richard A , Burmester Victoria , Nicholls Dasha
Published: December 2021

Objective

To gain exploratory insights into the multifaceted, lived experience impact of COVID-19 on a small sample of ethnic minority healthcare staff to cocreate a module of questions for follow-up online surveys on the well-being of healthcare staff during the pandemic.

Design

A cross-sectional design using two online focus groups among ethnic minority healthcare workers who worked in care or supportive roles in a hospital, community health or primary care setting for at least 12 months.

Participants

Thirteen healthcare workers (11 female) aged 26–62 years from diverse ethnic minority backgrounds, 11 working in clinical roles.

Results

Five primary thematic domains emerged: (1)viral vulnerability, centring around perceived individual risk and vulnerability perceptions; (2)risk assessment, comprising pressures to comply, perception of a tick-box exercise and issues with risk and resource stratification; (3)interpersonal relations in the workplace, highlighting deficient consultation of ethnic minority staff, cultural insensitivity, need for support and collegiate judgement; (4)lived experience of racial inequality, consisting of job insecurity and the exacerbation of systemic racism and its emotional burden; (5)community attitudes, including public prejudice and judgement, and patient appreciation.

Conclusions

Our novel study has shown ethnic minority National Health Service (NHS) staff have experienced COVID-19 in a complex, multidimensional manner. Future research with a larger sample should further examine the complexity of these experiences and should enumerate the extent to which these varied thematic experiences are shared among ethnic minority NHS workers so that more empathetic and supportive management and related occupational practices can be instituted.
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Authors: Dhruva Sanket S , Shah Nilay D , Vemulapalli Sreekanth , Deshmukh Abhishek , Beatty Alexis L , Gamble Ginger M , Freeman James V , Hummel James P , Piccini Jonathan P , Akar Joseph G , Ervin Keondae , Arges Kristine L , Emanuel Lindsay , Noseworthy Peter A , Hu Tiffany , Bartlett Victoria , Ross Joseph S
Published: December 2021

Introduction

Personal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.

Methods and analysis

We are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings.

Ethics and dissemination

The Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals.

Trial registration number

NCT04468321
INtrinsic Capacity and its RElAtionship With Life-SpacE Mobility (INCREASE): a cross-sectional study of community-dwelling older adults in Singapore
Authors: Lee Jia Qi , Ding Yew Yoong , Latib Aisyah , Tay Laura , Ng Yee Sien
Published: December 2021

Objectives

To examine the association of intrinsic capacity (IC) with life-space mobility (LSM) among community-dwelling older adults and to determine whether age and gender modify this relationship.

Design

Cross-sectional study.

Setting

Public housing blocks, senior activity centres and community centres in the Northeastern region of Singapore.

Participants

751 community-dwelling older adults aged ≥55 years old and able to ambulate independently with or without walking aid.

Primary and secondary outcome measures

IC and LSM. Standardised IC factor scores were calculated through confirmatory factor analysis using variables representing the five IC domains cognition, locomotion, sensory, vitality and psychological. LSM was measured using the University of Alabama at Birmingham Study of Aging Life-Space Assessment instrument. Association of IC with LSM and its effect modification by age and gender were examined with regression analyses.

Results

The participants had a mean age of 67.6 and mean LSM score of 88.6. IC showed a positive and significant association with LSM (β=6.33; 95% CI=4.94 to 7.72) and the effect remained significant even after controlling for potential confounders (β=4.76; 95% CI=3.22 to 6.29), with p<0.001 for both. Age and gender did not demonstrate significant modification on this relationship.

Conclusions

Our findings support the empirical rigour of the International Classification of Functioning, Disability and Health framework, which suggests that IC influences the extent to which a person participates in the community. Our findings also provide guidance for healthcare providers who aim to enhance LSM and promote healthy ageing in older adults.
Associations between diabetes duration and self-stigma development in Japanese people with type 2 diabetes: a secondary analysis of cross-sectional data
Authors: Kato Asuka , Fujimaki Yuko , Fujimori Shin , Isogawa Akihiro , Onishi Yukiko , Suzuki Ryo , Ueki Kohjiro , Yamauchi Toshimasa , Kadowaki Takashi , Hashimoto Hideki
Published: December 2021

Objectives

To examine the associations between self-stigma and diabetes duration in a sample of Japanese people with type 2 diabetes.

Design

A secondary analysis of a cross-sectional study.

Setting

Two university hospitals, one general hospital and one clinic in Tokyo, Japan.

Participants

Outpatients with type 2 diabetes aged 20–74 years and receiving treatment from diabetes specialist physicians (n=209) completed a self-administered questionnaire.

Primary and secondary outcome measures

Self-stigma was measured as the primary outcome. Patient Activation Measure, body mass index and haemoglobin A1c were measured as secondary outcomes.

Results

One-way analysis of covariance showed significant differences in self-stigma levels between the five groups of diabetes duration (≤5 years, 6–10 years, 11–15 years, 16–21 years and 22 years or more) after controlling for age, gender, education, marital status, diabetes treatment (insulin use) and diabetes-related complications, F(4,198)=2.83, p=0.026. Multiple comparisons using Bonferroni correction showed statistically significant differences in self-stigma levels between the groups with ≤5 years (95% CI 59.63 to 69.73) and 11–15 years with diabetes (95% CI 71.12 to 80.82; p=0.020). The highest mean level of self-stigma was observed in the group having diabetes for 11–15 years.

Conclusions

Self-stigma was associated with diabetes duration and was lowest after diagnosis and gradually increased, with its highest levels being observed in those having diabetes for 11–15 years. Self-stigma takes time to develop and gradually increases in individuals as it is learnt through direct experiences of diabetes-related stigma after self-administering treatment in everyday social situations.
Impact of biological agents and tofacitinib for moderate-to-severe ulcerative colitis on health-related quality of life: a protocol for a network meta-analysis
Authors: Ma Xueni , Xu Huimei , Zhang Dekui
Published: December 2021

Introduction

In the past few years, several options have been proposed as alternative and more effective therapeutic drugs for moderate-to-severe ulcerative colitis (UC), such as biological agents and tofacitinib. Most of the clinical studies related to UC aimed to evaluate the efficacy of the drugs on clinical outcomes such as disease activity and side effects. This review aims to compare the impact of infliximab, adalimumab, golimumab, ustekinumab, vedolizumab and tofacitinib for moderate-to-severe UC on health-related quality of life (HRQoL), thereby guiding clinical treatment and scientific research of this disease.

Methods and analysis

We will search PubMed, Embase and Cochrane Library from inception until July 2021 for all randomised controlled trials (RCTs) reported in English as double-blind comparing infliximab, adalimumab, golimumab, ustekinumab, vedolizumab or tofacitinib as induction or maintenance therapies with another or with placebo in moderate-to-severe UC on HRQoL. The primary outcome of this study is changes in the mean difference in HRQoL scores. Data of each pairwise comparison will be synthesised to obtain summary standardised mean differences for continuous outcomes and ORs for dichotomous outcomes. Then, a network meta-analysis (NMA) will be performed, and a common-effects Mantel-Haenszel NMA will be conducted for dichotomous outcomes, while a random-effects NMA will be used for all other outcomes. Finally, we will follow the Grading of Recommendations, Assessment, Development and Evaluations approach to assess the confidence in estimates derived from NMA of the main outcomes.

Ethics and dissemination

Only published secondary data will be used in this study, and therefore ethics approval is not required. The findings will be published in a peer-reviewed medical journal.

PROSPERO registration number

CRD42021225048.
General practitioners’ management of depression symptoms in Somali refugee and Norwegian patients: a film vignette experiment
Authors: Harris Samantha Marie , Binder Per-Einar , Diaz Esperanza , Ekroll Vebjørn , Sandal Gro M
Published: December 2021

Objectives

Refugees in comparison with non-refugee patients may face higher unmet mental healthcare needs. The mechanisms underlying these disparities are still poorly understood. The general practitioner (GP) plays a vital role in refugees’ mental health (MH), managing complaints within primary care and acting as gatekeeper to specialist services. However, GPs have reported feeling uncertain about working with refugee patients. Somalis make up one of the largest refugee groups in Norway and use primary care services more than the majority population for physical health, although not for MH. The current study examines GPs’ management of MH complaints in Somali refugee versus Norwegian vignette characters and the role of GP clinical uncertainty.

Design

We distributed an online experimental survey to GPs in Norway (n=133), who were randomised to watch a simulated consultation with a female Norwegian, female Somali, male Norwegian or male Somali vignette character, presenting the same symptoms of depression. GPs indicated which diagnoses, assessments and treatments they would endorse for the patient and their level of certainty.

Outcome measures

We calculated Simpson indices to measure inter-rater reliability and 2×2 analysis of variances as well as Bayesian estimation to examine clinical certainty based on patient background and gender.

Results

GPs’ clinical decisions about Somali and Norwegian vignette characters were similar, with a few exceptions. There was less consensus regarding the first prioritised diagnosis for Somali characters (Simpson index=0.129) versus Norwegian characters (Simpson index=0.208), (p=0.011, one-tailed). Somalis more frequently received diagnoses of post-traumatic stress disorder (PTSD), while Norwegians received diagnoses of feeling depressed. GPs endorsed sick leave more often for Norwegian characters and medication for physical complaints for Somali characters. There were no substantial differences in GPs’ self-reported certainty.

Conclusions

We found few and relatively small effects of patient background and gender on GPs’ clinical decisions. Nevertheless, the validity of certain diagnoses and prescription of sick leave need to be considered by clinicians and in future research.
Association of longitudinal changes in patient-reported health status with return to work in the first 2 years after traumatic injury: a prospective cohort study in the Netherlands
Authors: Horn Lena , de Munter Leonie , Papageorgiou Grigorios , Lansink Koen W W , de Jongh Mariska A C , Joosen Margot C W
Published: December 2021

Objectives

To determine the prognostic value of time driven changes in health status on return to work (RTW) in the first 2 years after traumatic injury.

Design

A prospective longitudinal cohort study. All patient-reported outcomes were measured at 1 week, 1, 3, 6, 12 and 24 months after injury.

Setting

Ten participating hospitals in the Netherlands.

Participants

Employed adult clinical injury patients admitted to the hospital between August 2015 and November 2016 (N=1245 patients).

Main outcome measures

Data about (first) RTW were used from the patient-reported questionnaires (1=yes, 0=no). RTW was measured as the first time a patient started working after hospital admission. Time until RTW was calculated in weeks. Health status was measured with the EuroQol Five Dimensions-3 Levels (EQ5D) including a dimension to measure cognition.

Results

At 24 months, 88.5% (n=1102) of the patients had returned to work. The median time to RTW was 6.6 weeks (IQR: 2–13). Patients’ health status was found to be an independent prognostic factor for RTW: a 0.1-unit increase in EQ5D (scale 0–1) translated into RTW being four times more likely (95% CI 1.60 to 11.94). Patients who had moderate or severe problems (0=no problems, 1=moderate or severe problems) with mobility (HR 0.91, 95% CI 0.84 to 0.98), anxiety/depression (HR 0.86, 95% CI 0.80 to 0.91), usual activities (HR 0.91, 95% CI 0.83 to 0.98), self-care (HR 0.90, 95% CI 0.79 to 0.99) and cognition (HR 0.90, 95% CI 0.85 to 0.94) were significantly less likely to RTW compared with patients with no problems.

Conclusion

Increased self-reported health status over time is associated with a higher likelihood of RTW, independent of baseline risk factors, such as injury severity or education. Knowledge on patient-reported outcomes can contribute to the development of tailored RTW treatments. Furthermore, patient-reported outcomes could be used as monitoring tool to guide postinjury care in the clinical setting and RTW process.

Trial registration number

NCT02508675; Results.
Response rate and comparison of clinical features associated with positive or negative responses to a scapular positioning test in patients with neck pain and altered scapular alignment: a cross-sectional study
Authors: Wannaprom Nipaporn , Treleaven Julia , Jull Gwendolen , Uthaikhup Sureeporn
Published: December 2021

Objective

To investigate the frequency and clinical aspects of patients with neck pain who responded and did not respond to scapular repositioning and to determine the clinical features associated with a positive response.

Design

Cross-sectional study.

Setting

Research unit, Department of Physical Therapy, Chiang Mai University.

Participants

Volunteers with non-specific neck pain aged 18–59 years were recruited between May 2020 and February 2021 from hospitals, clinics, university and community.

Outcome measures

Clinical data documented were neck pain (intensity, duration and disability), the presence of headache, type of scapular dysfunction, cervical musculoskeletal impairment (range of motion (ROM), flexion rotation test (FRT) and location of any symptomatic cervical joint dysfunction), upper limb functional limitation and self-reported disability. Manual scapular repositioning was performed on the side of neck pain. Participants were categorised as responsive or non-responsive based on a change in pain and/or cervical rotation range.

Results

A total of 219 people with neck pain responded to advertisements, of which 144 were eligible. Of the eligible participants, 107 (74.3%) demonstrated a clinically relevant improvement in either neck pain or rotation range or both following the scapular repositioning and 37 (25.7%) had no relevant improvement. The responsive group had a high incidence of scapular downward rotation, greater neck pain intensity, headache and cervical musculoskeletal impairment (reduced ROM, positive FRT and symptomatic C1-3 dysfunction) compared with the non-responsive group (p<0.05). A logistic regression model revealed that features strongly associated with a positive response were the presence of headache (Exp(B)=6.0, 95% CI 2.3 to 15.8), scapular downward rotation (Exp(B)=5.3, 95% CI 2.3 to 12.6) and a positive FRT (Exp(B)=4.0, 95% CI 1.5 to 10.6).

Conclusion

Almost 75% of neck pain patients with altered scapular alignment responded to scapular repositioning. The predominance of upper cervical dysfunction with a downwardly rotated scapular in this group suggests a role of poor axioscapular muscle function which might benefit from rehabilitation.
Parental experience of child death in the paediatric intensive care unit: a scoping review
Authors: Tezuka Sonoe , Kobayashi Kyoko
Published: December 2021

Objective

The purpose of this scoping review was to identify the experiences of parents who endured the death of their child in the paediatric intensive care unit (PICU) and what end-of-life care they perceived as supportive.

Design

Scoping review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance.

Data sources

Four databases, PubMed, Embase, CINAHL and PsycINFO, were searched for studies published until 24 August 2021, with no limitation on the year of publication.

Eligibility criteria

We identified qualitative studies published in English that focused on parents’ experiences during the death of their child in the PICU and excluded studies conducted in non-PICU settings, such as neonatal intensive care units and emergency departments.

Data extraction and synthesis

A five-step methodological approach (‘identifying the research question’, ‘searching for relevant studies’, ‘selecting studies’, ‘charting the data’ and ‘collating, summarising and reporting the results’) developed by Arksey and O’Malley was used to chart the purpose and methods of the study and the characteristics of the study participants. The extracted parental experiences were inductively summarised.

Results

Of 435 articles, 14 studies conducted in seven countries were included in the final review. The background regarding the child’s condition varied, including whether it was acute or chronic, and the length of stay in the PICU. Parents needed effective interaction with healthcare providers to fulfil their parental role and be involved in critical decision-making regarding their child’s treatment in a rapidly evolving situation. The themes inductively extracted were ‘parental suffering’, ‘roles and responsibilities of parents’, ‘information sharing’, and ‘support of parents by healthcare providers’.

Conclusions

Although parent–healthcare provider interactions influence parents’ experiences with their dying children in the PICU, by affecting parental roles and level of involvement, there is a lack of research focusing on improving these interactions.
Prevalence and determinant factors of mental health problems among healthcare professionals during COVID-19 pandemic in southern Ethiopia: multicentre cross-sectional study
Authors: Ayalew Mohammed , Deribe Bedilu , Abraham Yacob , Reta Yared , Tadesse Fikru , Defar Semira , Hoyiso Dawit , Ashegu Tebeje
Published: December 2021

Objective

To assess the prevalence of depression, anxiety and stress and its determinant factors during COVID-19 pandemic among healthcare professionals in southern Ethiopia.

Design

Multi-centre cross-sectional study.

Setting and study period

Randomly selected public hospitals in Sidama, southern Ethiopia between 25 September 2020 and 25 October 2020.

Participants

387 healthcare professionals were randomly selected.

Outcome measures

Prevalence and determinant factors of depression, anxiety and stress was assessed.

Result

Depression, anxiety and stress prevalence were shown to be 50.1% (95% confidence interval (CI) 45.0% to 55.0%), 55.0% (95% CI 51.1% to 59.9%) and 38.5% (95% CI 33.6% to 43.2%), respectively. Being female (adjusted odd ratio (AOR) 3.71, 95% CI 2.31 to 5.97), married (AOR 2.28, 95% CI 1.34 to 3.86), living alone (AOR 1.87, 95% CI 1.09 to 3.20), nurses (AOR 2.94, 95% CI 1.44 to 5.99) and working in inpatients (AOR 0.53, 95% CI 0.29 to 0.93) were significantly associated with depressive symptoms. Moreover, older age groups (AOR 3.15, 95% CI 1.04 to 6.56), females (AOR 3.25, 95% CI 2.01 to 5.25), married (AOR 1.69, 95% CI 1.01 to 2.87) and nurses (AOR 3.32, 95% CI 1.63 to 6.78) were significantly associated with symptoms of anxiety. Stress symptoms were significantly high among females (AOR 2.47, 95% CI 1.53 to 3.97), married (AOR 2.77, 95% CI 1.60 to 4.78), living alone (AOR 2.01, 95% CI 1.15 to 3.52), nurses (AOR 2.34, 95% CI 1.11 to 4.92) and working in units other than emergency (inpatient (AOR 0.32, 95% CI 0.18 to 0.57) and other units (AOR 0.48, 95% CI 0.25 to 0.95)).

Conclusion

The current study found that healthcare professionals have high levels of depression, anxiety and stress symptoms. Sex, age, marital status, type of profession, living status and working environment were significant factors for mental health problems in healthcare professionals during the pandemic. Healthcare professionals require mental health support at which monitoring and control can be performed during and after the pandemic.
Does androgen deprivation impact associations between cognition and strength, fitness and function in community-dwelling men with prostate cancer? A cross-sectional study
Authors: Mundell Niamh L , Owen Patrick J , Dalla Via Jack , Macpherson Helen , Daly Robin M , Fraser Steve F
Published: December 2021

Objectives

We investigated whether there were differences in associations between cognition with muscle strength, fitness and function in men with prostate cancer (PCa) treated with, and without androgen deprivation therapy (ADT) and non-PCa controls. A secondary aim was to compare differences in the prevalence of cognitive impairment.

Design

This cross-sectional study compared 70 ADT-treated men with PCa aged 50–85 years to non-ADT-treated men (n=52) and non-PCa controls (n=70).

Setting

University clinical exercise laboratory.

Interventions

Nil.

Primary and secondary outcome measures

Standardised assessments were conducted for cognition (learning, memory, attention, processing speed and executive function), muscle strength (grip strength and leg press), fitness (400 m walk), gait speed (4 m walk) and dual-tasking mobility (timed-up-and-go with a cognitive task).

Results

ADT-treated men showed stronger associations between fitness and executive function and task switching relative to controls (both: p≤0.03). For both PCa groups (independent of ADT use), poorer dual-task mobility was more strongly associated with decreased psychomotor attention (both: p≤0.027) and global cognitive function (both: p≤0.031) compared with non-PCa controls. The overall prevalence of cognitive impairment was low (4%–13%) and did not differ between the groups.

Conclusions

The presence of PCa, with or without ADT treatment, did not increase the risk of cognitive impairment relative to non-PCa controls, yet did alter the associations between physical fitness and some measures of functional performance with certain cognitive domains. This highlights the importance of men with PCa maintaining fitness and functional capacity to optimise cognitive health.

Trial registration number

This study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12614000317695).
Oncology palliative care: access barriers: bibliometric study
Authors: Santos Neto Martins Fideles dos , Paiva Carlos Eduardo , de Lima Crislaine , Ribeiro Adeylson Guimarães , Paiva Bianca Sakamoto Ribeiro
Published: December 2021

Objective

To perform a bibliometric analysis of studies that evaluated the barriers to access to cancer palliative care (PC).

Methods

This was a bibliometric review using MEDLINE; EMBASE; Web Of Science; LILACS and the Cochrane Library. A search was conducted with the terms Barriers, Palliative Care and Cancer. Articles whose objectives targeted barriers to access to PC were considered, regardless of the year of publication. The setting is articles published from 1987 to 2020.

Results

A total of 6158 articles were identified, of which 217 were eligible for analysis. The USA and UK being the countries with the largest number of articles on the subject (n=101, n=18, respectively). After expert analysis, the barriers were grouped into nine categories.

Conclusions

Barriers related to symptom control were identified in 19% of the eligible articles, along with barriers related to health, which with 24% of occurrence in the articles, were the most frequently cited barriers. Countries which have implemented PC for some time were those with the greatest number of publications and in journals with the highest impact factors. Cross-sectional study design continues to be the most frequently used in publications.