bluuebunny/crossref_metadata_2025 huggingface dataset:
PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study
Authors: Boesen Victor Brun , Christoffersen Thea , Watt Torquil , Borresen Stina Willemoes , Klose Marianne , Feldt-Rasmussen Ulla
Published: March 2023

Introduction

Patients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials.

Methods and analysis

The PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations.

Ethics and dissemination

The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer-reviewed journals and presented at international conferences.

Trial registration number

EudraCT201400203932.
Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction: the NARES trial. A study protocol for a pilot, factorial randomised controlled trial
Authors: Schults Jessica A , Cooke Marie , Long Debbie A , Schibler Andreas , Ware Robert S , Mitchell Marion L
Published: March 2023

Introduction

Endotracheal suction (ETS) is a frequent and necessary airway intervention for the intubated child. The aim of ETS is to clear the endotracheal tube and airways of respiratory secretions; however, the methods of performing ETS are varied. Internationally a number of ETS treatments are in use. Many have not been rigorously evaluated in a randomised controlled trial setting, and it is uncertain whether any are associated with better outcomes for the critically ill child. With approximately 50% of paediatric intensive care admissions requiring intubation, ETS interventions that maximise the efficacy and minimise the complications of ETS could translate to improved health for substantial numbers of critically ill children, and significant cost savings. The primary aim of the study is to examine two ETS interventions, normal saline instillation and lung recruitment, to determine if it is feasible to conduct a full efficacy trial.

Methods and analysis

NARES (Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction) is a single-centre, pilot, factorial randomised controlled trial conducted in a tertiary referral paediatric centre in Brisbane, Australia. Children (aged 0–16 years) are eligible if they are intubated with an endotracheal tube and mechanically ventilated. Two intervention pairs will be compared using a 2×2 factorial design: (1) normal saline instillation versus no normal saline instillation; and (2) lung recruitment versus no lung recruitment. The primary outcome is study feasibility measured by a composite analysis of eligibility, recruitment, retention, protocol adherence and missing data. Secondary outcomes are ventilator-associated pneumonia, SpO2/FiO2ratio, lung compliance, end expiratory level and regional tidal volume.

Ethics and dissemination

Ethical approval to conduct the research has been obtained. Dissemination of the research findings will be untaken, guided by the Consolidated Standards of Reporting Trials statement recommendations. Protocol content was guided by the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement.

Trial registration number

ACTRN12617000609358; Pre-results.
Income and obesity: what is the direction of the relationship? A systematic review and meta-analysis
Authors: Kim Tae Jun , von dem Knesebeck Olaf
Published: March 2023

Objective

It was repeatedly shown that lower income is associated with higher risks for subsequent obesity. However, the perspective of a potential reverse causality is often neglected, in which obesity is considered a cause for lower income, when obese people drift into lower-income jobs due to labour–market discrimination and public stigmatisation. This review was performed to explore the direction of the relation between income and obesity by specifically assessing the importance of social causation and reverse causality.

Design

Systematic review and meta-analysis.

Methods

A systematic literature search was conducted in January 2017. The databases Medline, PsycINFO, Sociological Abstracts, International Bibliography of Social Sciences and Sociological Index were screened to identify prospective cohort studies with quantitative data on the relation between income and obesity. Meta-analytic methods were applied using random-effect models, and the quality of studies assessed with the Newcastle-Ottawa Scale.

Results

In total, 21 studies were eligible for meta-analysis. All included studies originated from either the USA (n=16), the UK (n=3) or Canada (n=2). From these, 14 studies on causation and 7 studies on reverse causality were found. Meta-analyses revealed that lower income is associated with subsequent obesity (OR 1.27, 95% CI 1.10 to 1.47; risk ratio 1.52, 95% CI 1.08 to 2.13), though the statistical significance vanished once adjusted for publication bias. Studies on reverse causality indicated a more consistent relation between obesity and subsequent income, even after taking publication bias into account (standardised mean difference −0.15, 95% CI −0.30 to 0.01). Sensitivity analyses implied that the association is influenced by obesity measurement, gender, length of observation and study quality.

Conclusions

Findings suggest that there is more consistent evidence for reverse causality. Therefore, there is a need to examine reverse causality processes in more detail to understand the relation between income and obesity.

PROSPERO registration number

42016041296.
Cardiovascular toxicity of targeted therapies for cancer: a protocol for an overview of systematic reviews
Authors: van Leeuwen Marina T , Luu Steven , Gurney Howard , Brown Martin R , Webber Kate , Pearson Sallie-Anne , Hunt Lee , Vajdic Claire M
Published: March 2023

Introduction

The introduction of targeted therapies for cancer has contributed to dramatic improvements in patient survival. Nevertheless, several targeted therapies have been associated with ‘off-target’ adverse effects, based on varying levels of evidence. To date, this evidence has not been systematically synthesised. We will synthesise published systematic review evidence of cardiovascular toxicity associated with targeted cancer therapies.

Methods and analysis

We will include systematic reviews of randomised controlled trials and observational studies that report on cardiovascular outcomes for individual agents. We will identify systematic reviews by applying predeveloped, standardised search strategies within Embase, Medline and Cochrane Central. Two independent reviewers will identify reviews published up to 31 December 2016 using predefined eligibility criteria. They will resolve ambiguous cases through consensus, arbitrated by a third reviewer if required. The reviewers will extract and report data according to methodological guidelines for overviews provided by the Cochrane Collaboration, Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. They will assess the quality of included reviews by applying the Assessment of Multiple Systematic Reviews tool. They will judge the quality of evidence in included reviews based on their assessment of bias and incorporation into the interpretation of findings. In synthesising the evidence, we will classify agents based on systematic review evidence of toxicity (sufficient, probable, possible or indeterminate) for specific cardiovascular outcomes (congestive heart failure, myocardial infarction, ischaemic heart disease, left ventricular ejection fraction decline, cerebrovascular disease, pulmonary embolism, thrombosis and hypertension). This will provide clinicians and patients with an accessible synthesis based on robust methodology.

Ethics and dissemination

Ethics approval is not required for overviews. We will conduct the study in collaboration with consumer representatives. We will submit results for peer-review publication, and disseminate them through established clinical and consumer networks.

PROSPERO registration number

CRD42017080014.
Career orientation and its impact factors of general practitioners in Shanghai, China: a cross-sectional study
Authors: Wang Jian , Zhao Qi , Liu Tianwei , An Melissa , Pan Zhigang
Published: March 2023

Objectives

To understand the career orientation and impact factors of general practitioners (GPs) in Shanghai.

Design

A cross-sectional study was carried out from August 2014 to December 2015 using the Career Orientations Inventory (short form).

Setting and participants

We conducted a cross-sectional study of 1159 GPs, of which 1067 (92.06%) completed the assessment tools, from 223 community healthcare centres in Shanghai

Results

The top career orientation was organisational job security (71.60%), followed by technical competence (12.18%). Compared with female GPs, male GPs scored higher in managerial competence (p<0.001), creativity and entrepreneurship (p<0.001), and lower in organisational job security (p=0.034). Compared with GPs younger than 40, those aged 40 years and older scored higher in sense of service (p=0.003) and lower in autonomy (p=0.022) and lifestyle integration (p=0.039). Compared with GPs with lower education levels, those with at least a bachelor’s degree scored higher in managerial competence (p=0.001 and autonomy (p=0.025). In addition, those with fewer than 10 years of work experience scored higher in managerial competence (p=0.008) and scored lower in geographical security (p=0.032) compared with GPs with longer durations of work experience. GPs with senior professional positions scored higher in technical competence (p=0.012) compared with those with lower professional positions.

Conclusions

The search for job stability and the lack of career prospect planning are two factors that impact community GP growth. Individualised skills training and career development planning should be provided to GPs of specific genders, educational background and vocational competence, in order to enhance their job satisfaction and service quality, thereby achieving retention of this staff group.
Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial
Authors: Nordenskjöld Jesper , Lauritzson Anna , Waldén Markus , Kopylov Philippe , Atroshi Isam
Published: March 2023

Introduction

There is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD.

Methods and analysis

The study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients’ group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment.

Ethics and dissemination

Ethical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals.

Trial registration

NCT03406338; Pre-results.
Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial
Authors: Kjølhede Preben , Bergdahl Olga , Borendal Wodlin Ninnie , Nilsson Lena
Published: March 2023

Objectives

We aimed to determine whether regional analgesia with intrathecal morphine (ITM) in an enhanced recovery programme (enhanced recovery after surgery [ERAS]) gives a shorter hospital stay with good pain relief and equal health-related quality of life (QoL) to epidural analgesia (EDA) in women after midline laparotomy for proven or assumed gynaecological malignancies.

Design

An open-label, randomised, single-centre study.

Setting

A tertiary referral Swedish university hospital.

Participants

Eighty women, 18–70 years of age, American Society of Anesthesiologists I and II, admitted consecutively to the department of Obstetrics and Gynaecology.

Interventions

The women were allocated (1:1) to either the standard analgesic method at the clinic (EDA) or the experimental treatment (ITM). An ERAS protocol with standardised perioperative routines and standardised general anaesthesia were applied. The EDA or ITM started immediately preoperatively. The ITM group received morphine, clonidine and bupivacaine intrathecally; the EDA group had an epidural infusion of bupivacaine, adrenalin and fentanyl.

Primary and secondary outcome measures

Primary endpoint was length of hospital stay (LOS). Secondary endpoints were QoL and pain assessments.

Results

LOS was statistically significantly shorter for the ITM group compared with the EDA group (median [IQR]3.3 [1.5–56.3] vs 4.3 [2.2–43.2] days; p=0.01). No differences were observed in pain assessment or QoL. The ITM group used postoperatively the first week significantly less opioids than the EDA group (median (IQR) 20 mg (14–35 mg) vs 81 mg (67–101 mg); p<0.0001). No serious adverse events were attributed to ITM or EDA.

Conclusions

Compared with EDA, ITM is simpler to administer and manage, is associated with shorter hospital stay and reduces opioid consumption postoperatively with an equally good QoL. ITM is effective as postoperative analgesia in gynaecological cancer surgery.

Trial registration number

NCT02026687; Results.
Coaching Ongoing Momentum Building On stroKe rEcovery journeY (’COMBO-KEY'): a randomised controlled trial protocol
Authors: Lo Suzanne Hoi Shan , Chau Janita Pak Chun , Chang Anne Marie , Choi Kai Chow , Wong Rebecca Yee Man , Kwan Jackie Cheuk Yin
Published: March 2023

Introduction

Systematic reviews reporting self-management interventions are associated with significant improvements in stroke survivors’ self-efficacy, health-related quality of life (HRQoL) and independence. However, common barriers such as transportation and availability of carers were identified. Health coaching is suggested as an innovative and cost-effective care model with potential benefits in managing chronic diseases. A randomised controlled trial is proposed to evaluate the effectiveness of an enhanced self-management programme by health coaches on stroke survivors’ recovery outcomes.

Methods and analysis

All adult community-dwelling stroke survivors with a modified Rankin Scale Score ≥3 will be recruited from a community rehabilitation network. Eligible participants will be randomly allocated to receive either the enhanced stroke self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY [COMBO-KEY]) plus usual care or usual care only. COMBO-KEY is an 8-week programme underpinned by Bandura’s principles of self-efficacy and outcome expectation. It consists of four home visits and five phone-coaching sessions delivered by trained health coaches. Each participant will receive a resource package containing a workbook, a quick reference guide, a planning toolkit and 15 videos of peer survivors’ stroke survival experience. Survivors’ outcomes include self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours, HRQoL, depressive symptoms and community reintegration. Assessment will be conducted at baseline and immediately after completing the programme. Generalised estimating equations' model will be used to analyse the data.

Discussion

It is anticipated that the programme will build community capacity in supporting stroke survivors. The results will shed light on integrating the programme into the current stroke rehabilitation services.

Ethics and dissemination

The Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has approved this protocol (CREC Ref. No.: 2018.009). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.

Trial registration number

ClinicalTrials.gov Identifier:NCT03741842; Pre-results
Association between hypertension and hearing impairment in health check-ups among Japanese workers: a cross-sectional study
Authors: Umesawa Mitsumasa , Sairenchi Toshimi , Haruyama Yasuo , Nagao Masanori , Kobashi Gen
Published: March 2023

Objectives

Prevention of hearing impairment (HI) is important because recovery of hearing is typically difficult. Epidemiological studies have examined the risk factors for HI. However, the association between hypertension and HI remains unclear. We aimed to clarify the association between hypertension and HI.

Design

Cross-sectional study.

Setting

Japanese workers in an information and communication technologies company.

Participants

Of 24 823 employees of the same company, we recruited 13 475 participants who underwent hearing testing by audiometry in annual health check-ups and did not have missing data regarding body measurement, blood test results and drinking/smoking status (mean age: 49.4 years; males: 86.4%).

Primary outcomes

Hearing tests were performed at two frequencies (1 kHz, 4 kHz). We defined the inability of participants to respond to 30 dB at 1 kHz and/or 40 dB at 4 kHz as overall moderate HI. We also defined moderate HI at 1 or 4 kHz as an abnormal finding at 1 or 4 kHz. We defined hypertension as ≥140 mm Hg systolic blood pressure and/or ≥90 mm Hg diastolic blood pressure and/or taking medication for hypertension. We examined the association between hypertension and HI after adjusting for age, sex, body mass index, smoking/drinking status, diabetes mellitus, hyperlipidaemia and proteinuria.

Results

Moderate HI was identified in 980 participants (7.3%). Of these, 441 participants (3.3%) exhibited moderate HI at 1 kHz, and 787 participants (5.8%) exhibited moderate HI at 4 kHz. Subjects with hypertension showed a higher prevalence of any HI. The prevalence of overall moderate HI, moderate HI at 1 kHz and moderate HI at 4 kHz among subjects with hypertension was 8.7%, 4.3% and 6.8%, while those among subjects without hypertension was 6.9%, 3.0% and 5.6% (p<0.01, p<0.01 and p=0.01, respectively).

Conclusions

Hypertension was associated with moderate HI in Japanese workers.
Impact of the KidneyWise toolkit on chronic kidney disease referral practices in Ontario primary care: a prospective evaluation
Authors: Brimble Kenneth Scott , Boll Philip , Grill Allan K , Molnar Amber , Nash Danielle M , Garg Amit , Akbari Ayub , Blake Peter G , Perkins David
Published: March 2023

Objectives

Chronic kidney disease (CKD) is common; therefore, coordination of care between primary care and nephrology is important. Ontario Renal Network’s KidneyWise toolkit was developed to provide guidance on the detection and management of people with CKD in primary care (www.kidneywise.ca). The aim of this study was to evaluate the impact of the April 2015 KidneyWise toolkit release on the characteristics of primary care referrals to nephrology.

Design and setting

The study was a prospective pre-post design conducted at two nephrology sites (community site: Trillium Health Partners in Mississauga, Ontario, Canada, and academic site: St Joseph’s Healthcare in Hamilton, Ontario, Canada). Referrals were compared during the 3-month time period immediately prior to, and during a 3-month period 1 year after, the toolkit release.

Primary and secondary outcome measures

The primary outcome was the change in proportion of referrals for CKD that met the KidneyWise criteria. Additional secondary referral and quality of care outcomes were also evaluated. Multivariable logistic regression was used to evaluate preselected variables for their independent association with referrals that met the KidneyWise criteria.

Results

The proportion of referrals for CKD among people who met the KidneyWise referral criteria did not significantly change from pre-KidneyWise to post-KidneyWise implementation (44.7% vs 45.8%, respectively, adjusted OR 1.16, 95% CI 0.85 to 1.59, p=0.36). The proportion of referrals for CKD that provided a urine albumin-creatinine ratio significantly increased post-KidneyWise (25.8% vs 43.8%, adjusted OR 1.45, 95% CI 1.06 to 1.97, p=0.02). The significant independent predictors of meeting the KidneyWise referral criteria were academic site, increased age and use of the KidneyWise referral form.

Conclusions

We did not observe any change in the proportion of appropriate referrals for CKD at two large nephrology centres 1 year after implementation of the KidneyWise toolkit.
Progression criteria in loading exercise programmes in lower limb tendinopathy: a protocol for a systematic review and meta-analysis
Authors: Escriche-Escuder Adrian , Casaña Jose , Cuesta-Vargas Antonio I
Published: March 2023

Introduction

Lower limb tendinopathies have high rates of incidence and prevalence. Their symptomatology affects the functional capacity of people to exercise and work, being an important cause of economic and social burden. The evidence from the last decades points to therapeutic exercise as the first-line treatment in tendinopathies due to its good short-term and long-term clinical outcomes. However, there is no consensus about how the load progression should be managed throughout the therapeutic exercise programmes.

Methods and analysis

This systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The present protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO). The search will be performed through PubMed and Scopus by two reviewers, including references, from inception to 31 August 2019. It will include randomised controlled trials that: included patients with Achilles, patellar or gluteal tendinopathy; assessed pain, function or performance; and included at least one group where progressive physical exercise was administered as monotherapy. The quality of the studies included will be assessed using the Physiotherapy Evidence Database scale. The Grading of Recommendations, Assessment, Development and Evaluation Working Group approach will be used to assess the quality of the evidence. A meta-analysis will be performed if there is sufficient homogeneity across the interventions and outcomes measures to ensure pooling.

Ethics and dissemination

Ethical approval is not necessary for this systematic review protocol. Regardless of its nature, the results obtained in this study will be published in a peer-reviewed journal and presented at a relevant conference.

PROSPERO registration number

CRD42018110997
Identifying characteristics of high-poverty counties in the United States with high well-being: an observational cross-sectional study
Authors: Arora Anita , Spatz Erica S , Herrin Jeph , Riley Carley , Roy Brita , Rula Elizabeth Y , Kell Kenneth Patton , Krumholz Harlan M
Published: March 2023

Objective

To identify county characteristics associated with high versus low well-being among high-poverty counties.

Design

Observational cross-sectional study at the county level to investigate the associations of 29 county characteristics with the odds of a high-poverty county reporting population well-being in the top quintile versus the bottom quintile of well-being in the USA. County characteristics representing key determinants of health were drawn from the Robert Wood Johnson Foundation County Health Rankings and Roadmaps population health model.

Setting

Counties in the USA that are in the highest quartile of poverty rate.

Main outcome measure

Gallup-Sharecare Well-being Index, a comprehensive population-level measure of physical, mental and social health. Counties were classified as having a well-being index score in the top or bottom 20% of all counties in the USA.

Results

Among 770 high-poverty counties, 72 were categorised as having high well-being and 311 as having low well-being. The high-well-being counties had a mean well-being score of 71.8 with a SD of 2.3, while the low-well-being counties had a mean well-being score of 60.2 with a SD of 2.8. Among the six domains of well-being, basic access, which includes access to housing and healthcare, and life evaluation, which includes life satisfaction and optimism, differed the most between high-being and low-well-being counties. Among 29 county characteristics tested, six were independently and significantly associated with high well-being (p<0.05). These were lower rates of preventable hospital stays, higher supply of primary care physicians, lower prevalence of smoking, lower physical inactivity, higher percentage of some college education and higher percentage of heavy drinkers.

Conclusions

Among 770 high-poverty counties, approximately 9% outperformed expectations, reporting a collective well-being score in the top 20% of all counties in the USA. High-poverty counties reporting high well-being differed from high-poverty counties reporting low well-being in several characteristics.
Retirement age and type as predictors of frailty: a retrospective cohort study of older businessmen
Authors: Haapanen Markus J , von Bonsdorff Mikaela B , Perttilä Niko M , Törmäkangas Timo , von Bonsdorff Monika E , Strandberg Arto Y , Strandberg Timo E
Published: March 2023

Objectives

To study the association between retirement characteristics and frailty in a homogenous population of former business executives.

Design

Cross-sectional cohort study using data from the Helsinki Businessmen Study.

Setting

Helsinki, Finland.

Participants

1324 Caucasian men, born in 1919–1934, who had worked as business executives and managers and of whom 95.9% had retired by the year 2000. Questions on age at and type of retirement, lifestyle and chronic conditions were embedded in questionnaires.

Primary and secondary outcome measures

Frailty assessed according to a modified phenotype definition at mean age 73.3 years.

Results

Mean age at retirement was 61.3 years (SD 4.3) and 37.1% had retired due to old age. The prevalence of frailty was lowest among men retiring at ages 66–67 years but increased among those who worked up to age 70 years or older. Compared with men who retired before age 55 years, those retiring at ages 58–69 years were at decreased risk of frailty in old age relative to non-frailty (adjusted ORs 0.07–0.29, p<0.05). Compared with men who transitioned into old age retirement, those who retired due to disability were at increased risk of prefrailty (adjusted OR 1.53, 95% CI 1.01 to 2.32) and frailty (adjusted OR 3.52, 95% CI 1.97 to 6.29), relative to non-frailty.

Conclusion

Exiting working life early and continuing to be occupationally active until age 70 years and older were both associated with increased risk of frailty among the men. Promotion of longer work careers could, however, promote healthier ageing, as the lowest prevalence of frailty was observed in former business executives who retired at ages 66–67 years.
Optimising antimicrobial stewardship interventions in English primary care: a behavioural analysis of qualitative and intervention studies
Authors: Borek Aleksandra J. , Wanat Marta , Atkins Louise , Sallis Anna , Ashiru-Oredope Diane , Beech Elizabeth , Butler Christopher C. , Chadborn Tim , Hopkins Susan , Jones Leah , McNulty Cliodna A. M. , Roberts Nia , Shaw Karen , Taborn Esther , Tonkin-Crine Sarah
Published: March 2023

Objective

While various interventions have helped reduce antibiotic prescribing, further gains can be made. This study aimed to identify ways to optimise antimicrobial stewardship (AMS) interventions by assessing the extent to which important influences on antibiotic prescribing are addressed (or not) by behavioural content of AMS interventions.

Settings

English primary care.

Interventions

AMS interventions targeting healthcare professionals’ antibiotic prescribing for respiratory tract infections.

Methods

We conducted two rapid reviews. The first included qualitative studies with healthcare professionals on self-reported influences on antibiotic prescribing. The influences were inductively coded and categorised using the Theoretical Domains Framework (TDF). Prespecified criteria were used to identify key TDF domains. The second review included studies of AMS interventions. Data on effectiveness were extracted. Components of effective interventions were extracted and coded using the TDF, Behaviour Change Wheel and Behaviour Change Techniques (BCTs) taxonomy. Using prespecified matrices, we assessed the extent to which BCTs and intervention functions addressed the key TDF domains of influences on prescribing.

Results

We identified 13 qualitative studies, 41 types of influences on antibiotic prescribing and 6 key TDF domains of influences: ‘beliefs about consequences’, ‘social influences’, ‘skills’, ‘environmental context and resources’, ‘intentions’ and ‘emotions’. We identified 17 research-tested AMS interventions; nine of them effective and four nationally implemented. Interventions addressed all six key TDF domains of influences. Four of these six key TDF domains were addressed by 50%–67% BCTs that were theoretically congruent with these domains, whereas TDF domain'skills' was addressed by 24% of congruent BCTs and 'emotions' by none.

Conclusions

Further improvement of antibiotic prescribing could be facilitated by: (1) national implementation of effective research-tested AMS interventions (eg, electronic decision support tools, training in interactive use of leaflets, point-of-care testing); (2) targeting important, less-addressed TDF domains (eg,'skills', 'emotions'); (3) using relevant, under-used BCTs to target key TDF domains (eg, ‘forming/reversing habits’, ‘reducing negative emotions’, ‘social support’). These could be incorporated into existing, or developed as new, AMS interventions.
Patients’ preferences for occupational therapy after upper extremity fractures: a discrete choice experiment
Authors: Napora Joshua Kyle , Demyanovich Haley , Mulliken Alexandra , Oslin Kimberly , Pensy Raymond , Slobogean Gerard , O'Toole Robert V , O'Hara Nathan
Published: March 2023

Objective

Occupational therapy is often prescribed after the acute treatment of upper extremity fractures. However, high out-of-pocket expenses and logistical constraints can reduce access to formal therapy services. We aimed to quantify preferences of patients with upper extremity fracture for attending occupational therapy, when considering possible differences in clinical outcomes.

Design

Discrete choice experiment.

Setting

Level 1 trauma centre in Baltimore, Maryland, USA.

Participants

134 adult patients with upper extremity fractures.

Primary outcome measures

The scenarios were described with five attributes: cost, duration of therapy session, location of therapy, final range of motion and pain. We report the relative importance of each attribute as a proportion of total importance, and the willingness to pay for benefits of the therapy services.

Results

Of the 134 study participants, the mean age was 47 years and 53% were men. Cost (32%) and range of motion (29%) were the attributes of greatest relative importance. Pain (17%), duration of therapy (13%) and location of therapy (8%) were of lesser importance. Patients were willing to pay $85 more per therapy session for a 40% improvement in their range of motion. Patients were willing to pay $43 more per therapy session to improve from severe pain to mild pain. Patients were indifferent to whether the therapy treatment was home-based or in a clinical environment.

Conclusions

When deciding on an upper extremity fracture therapy programme, out-of-pocket costs are a paramount consideration of patients. Improvements in range of motion are of greater importance than residual pain, the duration of therapy sessions and the location of service provision. Patients with upper extremity fracture should be prescribed occupational therapy services that align with these patients’ preferences.
Trauma-focused psychodynamic therapy and STAIR Narrative Therapy of post-traumatic stress disorder related to childhood maltreatment: trial protocol of a multicentre randomised controlled trial assessing psychological, neurobiological and health economic outcomes (ENHANCE)
Authors: Leichsenring Falk , Steinert Christiane , Beutel Manfred E. , Feix Lila , Gündel Harald , Hermann Andrea , Karabatsiakis Alexander , Knaevelsrud Christine , König Hans-Helmut , Kolassa Iris T. , Kruse Johannes , Niemeyer Helen , Nöske Fatima , Palmer Sebastian , Peters Eva , Reese Jens-Peter , Reuss Alexander , Salzer Simone , Schade-Brittinger Carmen , Schuster Patrick , Stark Rudolf , Weidner Kerstin , von Wietersheim Jörn , Witthöft Michael , Wöller Wolfgang , Hoyer Jürgen
Published: March 2023

Introduction

Success rates of psychotherapy in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM) are limited.

Methods and analysis

Observer-blind multicentre randomised clinical trial (A-1) of 4-year duration comparing enhanced methods of STAIR Narrative Therapy (SNT) and of trauma-focused psychodynamic therapy (TF-PDT) each of up to 24 sessions with each other and a minimal attention waiting list in PTSD-CM. Primary outcome is severity of PTSD (Clinician-Administered PTSD Scale for DSM-5 total) assessed by masked raters. For SNT and TF-PDT, both superiority and non-inferiority will be tested. Intention-to-treat analysis (primary) and per-protocol analysis (secondary). Assessments at baseline, after 10 sessions, post-therapy/waiting period and at 6 and 12 months of follow-up. Adult patients of all sexes between 18 and 65 years with PTSD-CM will be included. Continuing stable medication is permitted. To be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions and concurrent psychotherapy. To be assessed for eligibility: n=600 patients, to be e randomly allocated to the study conditions: n=328. Data management, randomisation and monitoring will be performed by an independent European Clinical Research Infrastructure Network (ECRIN)-certified data coordinating centre for clinical trials (KKS Marburg). Report of AEs to a data monitoring and safety board. Complementing study A-1, four inter-related add-on projects, including subsamples of the treatment study A-1, will examine (1) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1); (2) biological parameters (B-2, eg, DNA damage, reactive oxygen species and telomere shortening); (3) structural and functional neural changes by neuroimaging (B-3) and (4) cost-effectiveness of the treatments (B-4, costs and utilities).

Ethics and dissemination

Approval by the institutional review board of the University of Giessen (AZ 168/19). Following the Consolidated Standards of Reporting Trials statement for non-pharmacological trials, results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.

Trial registration number

DRKS 00021142.
Association between duration of residence and prevalence of type 2 diabetes among male South Asian expatriate workers in the United Arab Emirates: a cross-sectional study
Authors: Shah Syed M , Jaacks Lindsay M , Al-Maskari Fatima , Al-Kaabi Juma , Aziz Faisal , Soteriades Elpidoforos , Loney Tom , Farooqi Hamed , Memon Anjum , Ali Raghib
Published: March 2023

Expatriates account for about 80% of the total population in the United Arab Emirates (UAE). This study aimed to evaluate the hypothesis that prevalence of type 2 diabetes in male South Asian expatriates increases with increased length of residence in the UAE.

Design, settings and participants

This cross-sectional study recruited a representative sample (n=1375) of male South Asian expatriates aged ≥18 years in Al Ain, UAE. Sociodemographic, anthropometric and lifestyle data were obtained using a pilot-tested adapted version of the WHO STEPS instrument.

Main outcome measures

Duration of residence was used as a marker for acculturation. Type 2 diabetes was defined as a self-reported physician diagnosis of diabetes or a glycosylated haemoglobin blood level ≥6.5%.

Results

Mean (±SD) age of participants was 34.0±9.9 years. Overall, the prevalence of type 2 diabetes was 8.3% (95% CI 6.8% to 9.8%). Diabetes prevalence was positively associated with longer duration of residence in the UAE, 2.7%, <5 years; 8.2%, 5–10 years; and 18.8%, >10 years. After adjusting for age, nationality, and income and age, expatriates were more likely to develop diabetes if residing in the UAE for 5–10 years (OR=2.18; 95% CI 1.02 to 4.67) or >10 years (OR=3.23; 95% CI 1.52 to 6.85) compared with those residing for <5 years.

Conclusions

After controlling for potential confounding factors, longer duration of residence was significantly associated with a higher prevalence of type 2 diabetes in male South Asian expatriate workers in the UAE.
Rehabilitation for ataxia study: protocol for a randomised controlled trial of an outpatient and supported home-based physiotherapy programme for people with hereditary cerebellar ataxia
Authors: Milne Sarah C , Corben Louise A , Roberts Melissa , Szmulewicz David , Burns J , Grobler Anneke C , Williams Shannon , Chua Jillian , Liang Christina , Lamont Phillipa J , Grootendorst Alison C , Massey Libby , Sue Carolyn , Dalziel Kim , LaGrappe Desiree , Willis Liz , Freijah Aleka , Gerken Paul , Delatycki Martin B
Published: March 2023

Introduction

Emerging evidence indicates that rehabilitation can improve ataxia, mobility and independence in everyday activities in individuals with hereditary cerebellar ataxia. However, with the rarity of the genetic ataxias and known recruitment challenges in rehabilitation trials, most studies have been underpowered, non-randomised or non-controlled. This study will be the first, appropriately powered randomised controlled trial to examine the efficacy of an outpatient and home-based rehabilitation programme on improving motor function for individuals with hereditary cerebellar ataxia.

Methods and analysis

This randomised, single-blind, parallel group trial will compare a 30-week rehabilitation programme to standard care in individuals with hereditary cerebellar ataxia. Eighty individuals with a hereditary cerebellar ataxia, aged 15 years and above, will be recruited. The rehabilitation programme will include 6 weeks of outpatient land and aquatic physiotherapy followed immediately by a 24- week home exercise programme supported with fortnightly physiotherapy sessions. Participants in the standard care group will be asked to continue their usual physical activity. The primary outcome will be the motor domain of the Functional Independence Measure. Secondary outcomes will measure the motor impairment related to ataxia, balance, quality of life and cost-effectiveness. Outcomes will be administered at baseline, 7 weeks, 18 weeks and 30 weeks by a physiotherapist blinded to group allocation. A repeated measures mixed-effects linear regression model will be used to analyse the effect of the treatment group for each of the dependent continuous variables. The primary efficacy analysis will follow the intention-to-treat principle.

Ethics and dissemination

The study has been approved by the Monash Health Human Research Ethics Committee (HREC/18/MonH/418) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (2019/3503). Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Australian ataxia support groups.

Trial registration number

ACTRN12618000908235.
Development and validation of a prognostic nomogram for myocardial infarction patients in intensive care units: a retrospective cohort study
Authors: Guo Qi , Wu Maoxiong , Li Hongwei , Ouyang Huijun , Sun Runlu , Wang Junjie , Liu Zhaoyu , Wang Jingfeng , Zhang Yuling
Published: March 2023

Objectives

We aimed to develop and validate a prognostic nomogram and evaluate the discrimination of the nomogram model in order to improve the prediction of 30-day survival of critically ill myocardial infarction (MI) patients.

Design

A retrospective cohort study.

Setting

Data were collected from the Medical Information Mart for Intensive Care (MIMIC)-III database, consisting of critically ill participants between 2001 and 2012 in the USA.

Participants

A total of 2031 adult critically ill patients with MI were enrolled from the MIMIC-III database.

Primary and secondary outcome

Thirty-day survival.

Results

Independent prognostic factors, including age, heart rate, white blood cell count, blood urea nitrogen and bicarbonate, were identified by Cox regression model and used in the nomogram. Good agreement between the prediction and observation was indicated by the calibration curve for 30-day survival. The nomogram exhibited reasonably accurate discrimination (area under the receiver operating characteristic curve, 0.765, 95% CI, 0.716 to 0.814) and calibration (C-index, 0.758, 95% CI, 0.712 to 0.804) in the validation cohort. Decision curve analysis demonstrated that the nomogram was clinically beneficial. Additionally, participants could be classified into two risk groups by the nomogram, and the 30-day survival probability was significantly different between them (p<0.001).

Conclusion

This five-factor nomogram can achieve a reasonable degree of accuracy to predict 30-day survival in critically ill MI patients and might be helpful for risk stratification and decision-making for MI patients.
Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1–4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin-based chemotherapy
Authors: Minatogawa Hiroko , Izawa Naoki , Kawaguchi Takashi , Miyaji Tempei , Shimomura Kazuhiro , Kazunori Honda , Iihara Hirotoshi , Ohno Yasushi , Inada Yusuke , Arioka Hitoshi , Morita Hajime , Hida Naoya , Sugawara Mitsuhiro , Katada Chikatoshi , Nawata Shuichi , Ishida Hiroo , Tsuboya Ayako , Tsuda Takashi , Yamaguchi Takuhiro , Nakajima Takako Eguchi
Published: March 2023

Introduction

Dexamethasone (DEX) is administered for multiple days to prevent chemotherapy-induced nausea and vomiting for patients receiving highly emetogenic chemotherapy (HEC); however, its notorious side effects have been widely reported. Although our multicentre randomised double-blind comparative study verified non-inferiority of sparing DEX after day 2 of chemotherapy when combined with neurokinin-1 receptor antagonist (NK1-RA) and palonosetron (Palo) for patients receiving HEC regimen, DEX sparing was not non-inferior in patients receiving cisplatin (CDDP)-based HEC regimens in subgroup analysis. Recently, the efficacy of the addition of olanzapine (OLZ) to standard triple antiemetic therapy on HEC has been demonstrated by several phase III trials. This study aims to confirm non-inferiority of DEX sparing when it is combined with NK-1RA, Palo and OLZ in patients receiving CDDP-based HEC regimens.

Methods and analysis

This is a randomised, double-blind, phase III trial. Patients who are scheduled to receive CDDP ≥50 mg/m2as initial chemotherapy are eligible. Patients are randomly assigned to receive either DEX on days 1–4 or DEX on day 1 combined with NK1-RA, Palo and OLZ (5 mg). The primary endpoint is complete response (CR) rate, defined as no emesis and no rescue medications during the delayed phase (24–120 hours post-CDDP administration). The non-inferiority margin is set at −15.0%. We assume that CR rates would be 75% in both arms. Two hundred and sixty-two patients are required for at least 80% power to confirm non-inferiority at a one-sided significance level of 2.5%. After considering the possibility of attrition, we set our final required sample size of 280.

Ethics and dissemination

The institutional review board approved the study protocol at each of the participating centres. The trial result will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

UMIN000032269.