bluuebunny/crossref_metadata_2025 huggingface dataset:
Acceptability of family planning in a changing context in Uganda: a realist evaluation at two time points
Authors: Krishnaratne Shari , Hoyt Jenna , Hamon Jessie K , Ariko Angela Barbra , Atayo Carol , Morukileng Job , Spilotros Nathaly , Webster Jayne
Published: April 2022

Objectives

This study sought to understand, during an intervention which integrated family planning (FP) and immunisation, (1) if and how prevailing contextual factors influenced acceptability and use of modern contraceptive methods (MCMs) in a pastoral community in Uganda, (2) what mechanisms were triggered by these contextual factors (3) if these contextual factors changed between two time points 2 years apart and (4) the impact of contextual changes on mechanisms triggered and acceptability and use outcomes.

Design

Qualitative realist evaluation over two time points.

Setting

Government health facilities in Moroto District, Karamoja, Uganda.

Participants

69 participants involved in the delivery and uptake of integrated FP and childhood immunisation services.

Intervention

Integrated delivery of FP and childhood immunisation services offered to women accessing immunisation services in health facilities between January 2016 and December 2019.

Results

Four key themes were identified that encompassed context and mechanisms influencing acceptability of MCMs across both time points of the evaluation. These were: (1) fear of side effects of MCMs; (2) preference for natural FP methods; (3) pastoral lifestyles in the community and (4) food insecurity. The context of these themes changed over time leading to the triggering of mechanisms with an overall increase in acceptability of MCMs over time. Key mechanisms of acceptability triggered included: affective attitude, intervention coherence, self-efficacy, perceived effectiveness and opportunity cost, leading to the development of three context-acceptability theories.

Conclusions

In this study, social and cultural norms played a strong role in influencing acceptability of the intervention. The context combined with intervention components were found to trigger several mechanisms that mapped to constructs of diffusion of innovations and acted as catalysts for mechanisms of acceptability. The context in which the intervention was implemented changed leading to the triggering of mechanisms and an increase in the perceived value and acceptability of MCM use.
Differences in occupational stress by smoking intensity and gender in cross-sectional study of 59 355 Japanese employees using the Brief Job Stress Questionnaire (BJSQ): the Niigata Wellness Study
Authors: Tashiro Shigemi , Kato Kiminori , Kitazawa Masaru , Fujihara Kazuya , Kodama Satoru , Tashiro Minoru , Matsuda Kazuhiro , Otsuka Masato , Sato Koji , Sone Hirohito
Published: April 2022

Objectives

It has been hypothesised that smoking intensity may be related to occupational stress. This study aimed to investigate whether stress, including problems with superiors or co-workers, is a driver of smoking.

Design

Cross-sectional study.

Setting and participants

59 355 employees (34 865 men and 24 490 women) across multiple occupations who completed a self-reported questionnaire-based occupational stress survey between April 2016 and March 2017 in Niigata Prefecture.

Main outcome measures

Stress scores for the Brief Job Stress Questionnaire subscales summed up after assigning high points for high stress and converted to Z-scores based on the mean of all participants. Heavy smokers (HS) smoked ≥15 cigarettes/day and light smokers (LS) smoked <15 cigarettes/day and were compared with non-smokers (NS) by gender.

Results

The main subscale items that were significantly associated with smoking status in both genders included ‘physical burden’, ‘irritation’ and ‘physical symptoms’. In the analysis that included smoking intensity, the stress score for ‘co-workers’ support’ was significantly lower for LS men than NS men (NS 0.091±0.98, LS −0.027±1.00, HS 0.033±0.99), and was significantly higher for HS women than NS women (NS −0.091±1.00, LS −0.080±1.05, HS 0.079±1.03). However, the stress score for ‘co-workers’ support’ was low among LS women aged ≤39 years in the manufacturing industry.

Conclusions

It was speculated that LS men and some LS women gained ‘co-workers’ support’ using smoking as a communication tool while reducing the degree of smoking. The existence of such ‘social smokers’ suggested that to promote smoking cessation, measures are essential to improve the communication between workers in addition to implementing smoking restrictions in the workplace.
Utility of a smartphone application in assessing palmar circulation prior to radial artery harvesting for coronary artery bypass grafting: rationale and design of the randomised CAPITAL iRADIAL-CABG trial
Authors: Goh Cheng Yee , Parlow Simon , Di Santo Pietro , Simard Trevor , Jung Richard , Ahmed Zeeshan , Verreault-Julien Louis , Kuhar Peter , Chan Vincent , Al-Atassi Talal , Toeg Hadi , Bernick Jordan , Wells George A , Ruel Marc , Hibbert Benjamin
Published: April 2022

Introduction

There is emerging evidence supporting the use of the radial artery (RA) as a preferred secondary conduit for coronary artery bypass grafting (CABG) as it is associated with higher rates of graft patency at 5 years when compared with saphenous vein grafts (SVG). The modified Allen’s test (MAT) is traditionally regarded as the standard of care in the assessment of ulnar artery (UA) patency prior to RA harvesting. Unfortunately, due to high false-positive rates, a substantial number of pre-CABG patients are found to have an abnormal MAT despite normal UA patency, resulting in inappropriate exclusion from RA harvesting. The SVG is generally used in its place when this occurs, resulting in potentially lower rates of long-term graft patency.

Methods and analysis

The CAPITAL iRADIAL-CABG trial is currently enrolling participants 18 years of age or older undergoing CABG for whom the treating physician is considering the use of an RA conduit. Eligible patients will be randomised in a 1:1 fashion to MAT or smartphone-based photoplethysmography application assessment to assess collateral palmar circulation prior to RA harvesting. The primary outcome of the trial is the use of the RA as a conduit during CABG. The primary safety outcome is postoperative palmar ischaemia as determined by clinical assessment or requirement of vascular intervention. Secondary outcomes include vascular complications, early graft failure, need for rescue percutaneous coronary intervention during the index hospitalisation and a composite cardiovascular outcome of myocardial infarction, stroke and cardiovascular death prior to discharge from hospital. A total of 236 participants are planned to be recruited.

Ethics and dissemination

The study was approved by the Ottawa Heart Science Network Research Ethics Board (approval number 20180865-01H). The study results will be disseminated via conference presentations and peer-reviewed publications.

Trial registration number

NCT03810729.
Lifespan healthcare transitions among individuals with intersex traits in Canada: a mixed-methods and qualitative study
Authors: Sanders Caroline , Amyot Emma , Usipuik Megan , Crawford Leigh , Callens Nina , Chanoine Jean-Pierre , Jones Tiffany
Published: April 2022

Objectives

To: (1) complete an integrative literature review of transition studies that focus on individuals with intersex traits; (2) conduct an environmental scan of the current resources (practice guidelines, policies and procedures) used by healthcare providers working with Canadians with intersex traits; (3) investigate the experiences of Canadians with intersex traits in their healthcare transitions across the lifespan and (4) assess the understanding of healthcare providers about these transitions.

Design

A qualitative prospective community participation study was conducted. It used mixed methods including an environmental scan and semistructured engagement sessions.

Setting

The environmental scan examined resources available throughout Canada. The engagement sessions took place in British Columbia and Ontario, Canada.

Participants

Sixteen participants were recruited. These included 13 individuals with intersex traits (a heterogeneous group of congenital conditions affecting the development of sex characteristics) and three caregivers.

Methods

Mixed methods included an integrated literature review, environmental scan and qualitative approaches developed in collaboration with community partners.

Results

The literature review identified gaps in transition care for individuals with intersex traits. The environmental scan uncovered no specific resources used by healthcare providers working with patients with intersex traits, though several general guidelines were used. Engaging providers in the study was problematic. Thematic analysis generated three main themes that emerged from the engagement sessions: (1) transition is a lifespan activity; (2) building personal agency is valuable and (3) well-being promotion is an application of health literacy.

Conclusions

Transition resources for individuals living in Canada with intersex are scarce. Transitions happen across the lifespan with ownership of thought and actions seen as acts of personal agency. Health literacy skills and knowledge change with increased age, yet the primary source of knowledge often remained important in the individual’s autobiographical self.
Connectomic profiling and Vagus nerve stimulation Outcomes Study (CONNECTiVOS): a prospective observational protocol to identify biomarkers of seizure response in children and youth
Authors: Siegel Lauren , Yan Han , Warsi Nebras , Wong Simeon , Suresh Hrishikesh , Weil Alexander G , Ragheb John , Wang Shelly , Rozzelle Curtis , Albert Gregory W , Raskin Jeffrey , Abel Taylor , Hauptman Jason , Schrader Dewi V , Bollo Robert , Smyth Matthew D , Lew Sean M , Lopresti Melissa , Kizek Dominic J , Weiner Howard L , Fallah Aria , Widjaja Elysa , Ibrahim George M
Published: April 2022

Introduction

Vagus nerve stimulation (VNS) is a neuromodulation therapy that can reduce the seizure burden of children with medically intractable epilepsy. Despite the widespread use of VNS to treat epilepsy, there are currently no means to preoperatively identify patients who will benefit from treatment. The objective of the present study is to determine clinical and neural network-based correlates of treatment outcome to better identify candidates for VNS therapy.

Methods and analysis

In this multi-institutional North American study, children undergoing VNS and their caregivers will be prospectively recruited. All patients will have documentation of clinical history, physical and neurological examination and video electroencephalography as part of the standard clinical workup for VNS. Neuroimaging data including resting-state functional MRI, diffusion-tensor imaging and magnetoencephalography will be collected before surgery. MR-based measures will also be repeated 12 months after implantation. Outcomes of VNS, including seizure control and health-related quality of life of both patient and primary caregiver, will be prospectively measured up to 2 years postoperatively. All data will be collected electronically using Research Electronic Data Capture.

Ethics and dissemination

This study was approved by the Hospital for Sick Children Research Ethics Board (REB number 1000061744). All participants, or substitute decision-makers, will provide informed consent prior to be enrolled in the study. Institutional Research Ethics Board approval will be obtained from each additional participating site prior to inclusion. This study is funded through a Canadian Institutes of Health Research grant (PJT-159561) and an investigator-initiated funding grant from LivaNova USA (Houston, TX; FF01803B IIR).
Healthcare provider’s experiences of supporting breastfeeding: protocol for a systematic review of qualitative evidence
Authors: Wu Jiaojiao , Zhang Qingning , Chung Loretta Yuet Foon , Wu Xinxin , Jiao Ruoshui , Chen Yundie , Wang Yanhong
Published: April 2022

Introduction

Breastfeeding provides various health benefits to both mothers and infants. Despite the efforts that have been made, breastfeeding rates remain lower than recommended worldwide. Healthcare providers often fail to provide the support women need due to various reasons such as lack of time and competency, discontinuity of care and so on. Synthesis of the primary qualitative studies exploring healthcare providers’ experience with supporting breastfeeding can provide greater insights into their perceived barriers and facilitators and further provide evidence for the implementation of interventions to improve breastfeeding services.

Methods and analysis

Qualitative studies exploring healthcare providers’ experiences with breastfeeding services will be searched in the following databases: PubMed, Embase, CINAHL, Scopus, ProQuest, PsycINFO, the Cochrane Library, Web of Science, China Biology Medicine disc, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Chinese Wanfang Data, ProQuest Dissertations and Theses, Open Grey collection. Studies reported in English or Chinese and conducted between January 1990 to July 2021 will be included. The Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research will be used to assess the methodological quality of included studies. The JBI standardised data extraction tools will be used to extract data. The JBI meta-aggregation method will be used to synthesise the data. The synthesised findings will be graded finally according to the ConQual approach to establish confidence. Two authors will independently screen and select the search output, extract data, assess methodological quality and cluster findings. Any disagreements that arise between the two reviewers will be adjudicated by a third reviewer to reach a consensus.

Ethics and dissemination

This review will use published data, so it will not require ethical approval. The findings of this systematic review will be disseminated via an international peer-reviewed journal publication and several scientific conference presentations.

PROSPERO registration number

CRD42021254542.
Study protocol for the development and internal validation of Schizophrenia Prediction of Resistance to Treatment (SPIRIT): a clinical tool for predicting risk of treatment resistance to antipsychotics in first-episode schizophrenia
Authors: Farooq Saeed , Hattle Miriam , Dazzan Paola , Kingstone Tom , Ajnakina Olesya , Shiers David , Nettis Maria Antonietta , Lawrence Andrew , Riley Richard , van der Windt Danielle
Published: April 2022

Introduction

Treatment-resistant schizophrenia (TRS) is associated with significant impairment of functioning and high treatment costs. Identification of patients at high risk of TRS at the time of their initial diagnosis may significantly improve clinical outcomes and minimise social and functional disability. We aim to develop a prognostic model for predicting the risk of developing TRS in patients with first-episode schizophrenia and to examine its potential utility and acceptability as a clinical decision tool.

Methods and analysis

We will use two well-characterised longitudinal UK-based first-episode psychosis cohorts: Aetiology and Ethnicity in Schizophrenia and Other Psychoses and Genetics and Psychosis for which data have been collected on sociodemographic and clinical characteristics. We will identify candidate predictors for the model based on current literature and stakeholder consultation. Model development will use all data, with the number of candidate predictors restricted according to available sample size and event rate. A model for predicting risk of TRS will be developed based on penalised regression, with missing data handled using multiple imputation. Internal validation will be undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model’s performance. The clinical utility of the model in terms of clinically relevant risk thresholds will be evaluated using net benefit and decision curves (comparative to competing strategies). Consultation with patients and clinical stakeholders will determine potential thresholds of risk for treatment decision-making. The acceptability of embedding the model as a clinical tool will be explored using qualitative focus groups with up to 20 clinicians in total from early intervention services. Clinicians will be recruited from services in Stafford and London with the focus groups being held via an online platform.

Ethics and dissemination

The development of the prognostic model will be based on anonymised data from existing cohorts, for which ethical approval is in place. Ethical approval has been obtained from Keele University for the qualitative focus groups within early intervention in psychosis services (ref: MH-210174). Suitable processes are in place to obtain informed consent for National Health Service staff taking part in interviews or focus groups. A study information sheet with cover letter and consent form have been prepared and approved by the local Research Ethics Committee. Findings will be shared through peer-reviewed publications, conference presentations and social media. A lay summary will be published on collaborator websites.
Influence of the statistical significance of results and spin on readers’ interpretation of the results in an abstract for a hypothetical clinical trial: a randomised trial
Authors: Jankowski Sofyan , Boutron Isabelle , Clarke Mike
Published: April 2022

Objectives

To assess the impact on readers’ interpretation of the results reported in an abstract for a hypothetical clinical trial with (1) a statistically significant result (SSR), (2) spin, (3) both an SSR and spin compared with (4) no spin and no SSR.

Participants

Health students and professionals from universities and health institutions in France and the UK.

Interventions

Participants completed an online questionnaire using Likert scales and free text, after reading one of the four versions of an abstract about a hypothetical randomised trial evaluating ‘Naranex’ and ‘Bulofil’ (two hypothetical drugs) for chronic low back pain. The abstracts differed in (1) reported result of ‘mean difference of 1.31 points (95% CI 0.08 to 2.54, p= 0.04)’ or ‘mean difference of 1.31 points (95% CI −0.08 to 2.70, p= 0.06)’ and (2) presence or absence of spin. The effect size for the trial’s primary outcome (pain disability score) was the same in each abstract, slightly in favour of Naranex.

Primary outcome

The reader’s interpretation of the trial’s results, based on their answer (1, disagree; 4, neutral; 7, agree) to the following statement: ‘About the main findings of the study, what is your opinion about the following statement: ‘Naranex is better than Bulofil’?’

Results

Two hundred and ninety-seven of the 404 people randomised to receive one of the four abstracts completed the study. Respondents were more likely to favour Narenex when the abstract reported an SSR without spin, a statistically significant result with spin, a non-statistically significant result with spin, compared with when it reported a non-SSR without spin.

Conclusion

Statistical significance appears to have influenced readers’ perception whatever the level of spin, while spin influenced readers’ perception when the results were not statistically significant but did not appear to have an impact when results were statistically significant.
WHO Standards-based questionnaire to measure health workers’ perspective on the quality of care around the time of childbirth in the WHO European region: development and mixed-methods validation in six countries
Authors: Valente Emanuelle Pessa , Covi Benedetta , Mariani Ilaria , Morano Sandra , Otelea Marina , Nanu Ioana , Nanu Micaela Iuliana , Elden Helen , Linden Karolina , Zaigham Mehreen , Vik Eline Skirnisdottir , Kongslien Sigrun , Nedberg Ingvild , Costa Raquel , Rodrigues Carina , Dias Heloísa , Drandić Daniela , Kurbanović Magdalena , Sacks Emma , Muzigaba Moise , Lincetto Ornella , Lazzerini Marzia
Published: April 2022

Objectives

Develop and validate a WHO Standards-based online questionnaire to measure the quality of maternal and newborn care (QMNC) around the time of childbirth from the health workers’ perspective.

Design

Mixed-methods study.

Setting

Six countries of the WHO European Region.

Participants and methods

The questionnaire is based on lessons learnt in previous studies, and was developed in three sequential phases: (1) WHO Quality Measures were prioritised and content, construct and face validity were assessed through a Delphi involving a multidisciplinary board of experts from 11 countries of the WHO European Region; (2) translation/back translation of the English version was conducted following The Professional Society for Health Economics and Outcomes Research guidelines; (3) internal consistency, intrarater reliability and acceptability were assessed among 600 health workers in six countries.

Results

The questionnaire included 40 items based on WHO Standards Quality Measures, equally divided into four domains: provision of care, experience of care, availability of human and physical resources, organisational changes due to COVID-19; and its organised in six sections. It was translated/back translated in 12 languages: Bosnian, Croatian, French, German, Italian, Norwegian, Portuguese, Romanian, Russian, Slovenian, Spanish and Swedish. The Cronbach’s alpha values were ≥0.70 for each questionnaire section where questions were hypothesised to be interrelated, indicating good internal consistence. Cohen K or Gwet’s AC1 values were ≥0.60, suggesting good intrarater reliability, except for one question. Acceptability was good with only 1.70% of health workers requesting minimal changes in question wording.

Conclusions

Findings suggest that the questionnaire has good content, construct, face validity, internal consistency, intrarater reliability and acceptability in six countries of the WHO European Region. Future studies may further explore the questionnaire’s use in other countries, and how to translate evidence generated by this tool into policies to improve the QMNC.

Trail registration number

NCT04847336
Identifying features of quality in rural placements for health students: scoping review
Authors: Green Elyce , Quilliam Claire , Sheepway Lyndal , Hays Catherine A , Moore Leigh , Rasiah Rohan L , Bailie Jodie , Howard Christine , Hyde Sarah , Inyang Imo , Matthews Kylie , Ferns Jane , Brown Leanne J , Jones Sara , Collett Marjorie
Published: April 2022

Objectives

To explore and synthesise the evidence relating to features of quality in rural health student placements.

Design

Scoping review.

Data sources

MEDLINE, CINAHL, Embase, ProQuest, Informit, Scopus, ERIC and several grey literature data sources (1 January 2005 to 13 October 2020).

Study selection

The review included peer-reviewed and grey literature from Organisation for Economic Co-operation and Development listed countries that focused on quality of health student placements in regional, rural and remote areas.

Data extraction

Data were extracted regarding the methodological and design characteristics of each data source, and the features suggested to contribute to student placement quality under five categories based on a work-integrated learning framework.

Results

Of 2866 resulting papers, 101 were included for data charting and content analysis. The literature was dominated by medicine and nursing student placement research. No literature explicitly defined quality in rural health student placements, although proxy indicators for quality such as satisfaction, positive experiences, overall effectiveness and perceived value were identified. Content analysis resulted in four overarching domains pertaining to features of rural health student placement quality: (1) learning and teaching in a rural context, (2) rural student placement characteristics, (3) key relationships and (4) required infrastructure.

Conclusion

The findings suggest that quality in rural health student placements hinges on contextually specific features. Further research is required to explore these findings and ways in which these features can be measured during rural health student placements.
Family bereavement care interventions during the COVID-19 pandemic: a scoping review protocol
Authors: Laranjeira Carlos , Moura Débora , Marcon Sonia , Jaques André , Salci Maria Aparecida , Carreira Ligia , Cuman Roberto , Querido Ana
Published: April 2022

Introduction

The COVID-19 pandemic has caused significant disruptions to daily social routines and to the lived experience of bereaved families. This article outlines the protocol for a scoping review of published studies to evaluate psychosocial and psychotherapeutic interventions intended to help family carers adjust to grief, loss and bereavement due to COVID-19. This review addresses one broad research question: ‘What do we know about bereavement support interventions for family carers of COVID-19 victims?’

Methods and analysis

The seminal framework by Arksey and O’Malley will guide the review process, which will cover both the qualitative and quantitative scientific literature on grief support during COVID-19. We will search for relevant studies in several databases, namely PubMed, Web of Science, CINAHL Complete, PsycINFO, Scopus and Directory of Open Access Journals. Moreover, we will search the reference lists of included studies and grey literature sources. The database search will be limited to studies from February 2020 (first death by COVID-19) to 1 January 2022. Only literature written in English, Portuguese and Spanish shall be included. Two independent reviewers will screen the literature, select articles and extract data, in an iterative process. Any disagreements will be solved through consensus-based discussion. Results will be reported with descriptive statistics, accompanied by a thematic analysis.

Ethics and dissemination

The study will use information acquired from previously published papers and hence does not require ethical approval. This protocol is registered with the Open Science Framework (https://osf.io/bw7fn/). Scoping results will be disseminated via posters and oral presentations to both academic and clinical audiences, as well as through peer-reviewed journals.
Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study
Authors: García-Pérez Lidia , Ramallo-Fariña Yolanda , Vallejo-Torres Laura , Rodríguez-Rodríguez Leticia , González-Pacheco Himar , Santos-Hernández Beatriz , García-Bello Miguel Angel , Wägner Ana María , Carmona Montserrat , Serrano-Aguilar Pedro G
Published: April 2022

Objective

To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective.

Design

An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study.

Setting

Primary care in the Canary Islands, Spain.

Participants

2334 patients with T2DM without complications were included.

Interventions

Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group.

Outcomes

The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included.

Analysis

Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure.

Results

There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (€2571, 95% CI €2317 to €2826) was lower than the cost in the UC arm (€2750, 95% CI €2506 to €2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option.

Conclusions

The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term.

Trial registration number

NCT01657227.
Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020
Authors: Polak Tobias B , Cucchi David GJ , Darrow Jonathan J , Versteegh Matthijs M
Published: April 2022

Objectives

To evaluate the incremental value of new drugs across disease areas receiving favourable coverage decisions by the UK’s National Institute for Health and Care Excellence (NICE) over the past decade.

Design, setting, and participants

This cross-sectional study assessed favourable appraisal decisions of drugs between 1 January 2010 and 31 December 2020. Estimates of incremental benefit were extracted from NICE’s evidence review groups reports.

Primary outcome measure

Incremental benefit of novel drugs relative to the best alternative therapeutic option, expressed in quality-adjusted life-years (QALYs).

Results

184 appraisals of 129 drugs provided QALYs. The median incremental value was 0.27 QALY (IQR: 0.07–0.73). Benefits varied across drug-indication pairs (range: −0.49 to 5.22 QALY). The highest median benefits were found in haematology (0.70, IQR: 0.55–1.22) and oncology (0.46, IQR: 0.20–0.88), the lowest in ophthalmology (0.09, IQR: 0.04–0.22) and endocrinology (0.02, IQR: 0.01–0.06). Eight appraisals (4.3%) found contributions of more than two QALYs, but one in four (50/184) drug-indication pairs provided less than the equivalent of 1 month in perfect health compared to existing treatments.

Conclusions

In our review period, the median incremental value of novel drugs approved for use within the English National Health System, relative to the best alternative therapeutic option, was equivalent to 3–4 months of life in perfect health, but data were heterogeneous. Objective evaluations of therapeutic value helps patients and physicians to develop reasonable expectations of drugs and delivers insights into disease areas where medicinal therapeutic progress has had the most and least impact.
Low-dose naltrexone for the induction of remission in patients with mild to moderate Crohn’s disease: protocol for the randomised, double-blinded, placebo-controlled, multicentre LDN Crohn study
Authors: Paulides Emma , Lie Mitchell R K L , van der Woude Christien Janneke
Published: April 2022

Introduction

Crohn’s disease (CD) is an inflammatory bowel disease (IBD). Several drugs exist to induce and maintain remission, but a significant part of the patients is refractory to current IBD drugs or experiences side effects. Whether low-dose naltrexone (LDN) is a safe and easily accessible alternative treatment option for these patients needs to be investigated. The aim of this study is to assess the efficacy of LDN for the induction of remission in patients with mild to moderate CD.

Methods and analysis

The LDN Crohn study is a randomised, double-blinded, placebo-controlled multicentre trial. Patients with CD are randomised 1:1 to receive treatment with either LDN 4.5 mg once daily or placebo for 12 weeks. The primary objective is endoscopic remission at week 12, defined as Simple Endoscopic Score-CD≤2 and ulcerated surface subscore ≤1 in all five segments. Secondary aims include clinical and endoscopic response, changes in laboratory measures of inflammation, adverse events and patient-reported outcomes. To have 85% power to detect a true difference in the primary outcome measure between placebo and LDN, 61 patients will be needed in both groups.

Ethics and dissemination

The study is approved by the Medical Ethics Committee of the Erasmus MC, Rotterdam, the Netherlands (registration number NL69149.078.19, MEC-2019-0602). Results will be published in peer-reviewed journals and presented at international conferences.

Trial registration numbers

EudraCT2019-000852-32; NL9259.
Research on the influencing factors of fatigue and professional identity among CDC workers in China: an online cross-sectional study
Authors: Cui Qi , Liu Li , Hao Zejun , Li Mengyao , Liu Chunli , Chenxin Yang , Zhang Qiuling , Wu Hui
Published: April 2022

Objective

This study aimed to investigate the status quo and the influencing factors of fatigue and professional identity among the Centers for Disease Control and Prevention (CDC) workers in China during the pandemic.

Design

A cross-sectional design.

Setting

CDC workers employed by the Liaoning CDC system were enrolled (administrative staffs were excluded).

Participants

1020 CDC workers.

Primary outcome measures

Fatigue scores and professional identity scores.

Secondary outcome measures

Postcompetency scores, respect scores, occupational stress scores, resilience scores and self-efficacy scores.

Results

The average scores of fatigue and professional identity were 8.23, 38.88, respectively. Factors including perceived public respect (β=−0.129, p<0.01), resilience (β=−0.104, p<0.05) and self-efficacy (β=−0.22, p<0.01) were negatively associated with fatigue. Educational background (bachelor vs junior college or below) (β=0.105, p<0.01), (master or above vs junior college or below) (β=0.092, p<0.05), workplace (county vs district) (β=0.067, p<0.05), (city vs district) (β=0.085, p<0.05), fighting the COVID-19 on the front line (β=0.059, p<0.05) and occupational stress (β=0.166, p<0.01) were positively correlated with fatigue. Educational background (bachelor vs junior college or below) (β=−0.097, p<0.01), (master or above vs junior college or below) (β=−0.114, p<0.01), workplace (city vs district) (β=−0.114, p<0.01), fighting the COVID-19 on the front line (β=−0.047, p<0.05) and occupational stress (β=−0.105, p<0.01) were negatively associated with professional identity. Factors including postcompetency (β=0.362, p<0.01), perceived public respect (general vs low) (β=0.219, p<0.01), (high vs low) (β=0.288, p<0.01), resilience (β=0.097, p<0.05) and self-efficacy (β=0.113, p<0.01) were positively connected with professional identity.

Conclusion

The fatigue among the CDC workers was at a higher level. The level of professional identity was high, and administrators should take measures to alleviate fatigue and maintain professional identity. In addition, methods aiming to attenuate occupational stress, and improve resilience and self-efficacy should be immediately put into action.
Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial
Authors: Gargadennec Thomas , Oilleau Jean-Ferréol , Rozec Bertrand , Nesseler Nicolas , Lasocki Sigismond , Futier Emmanuel , Amour Julien , Durand Michel , Bougle Adrien , Kerforne Thomas , Consigny Maëlys , Eddi Dauphou , Huet Olivier
Published: April 2022

Introduction

Incidence of delirium after cardiac surgery remains high and delirium has a significant burden on short-term and long-term outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Preserving the circadian rhythm with overnight infusion of low-dose dexmedetomidine has been shown to lower the occurrence of delirium in older patients after non-cardiac surgery. However, these results remain controversial. The aim of this study was to demonstrate the usefulness of sleep induction by overnight infusion of dexmedetomidine to prevent delirium after cardiac surgery.

Methods and analysis

Dexmedetomidine after Cardiac Surgery for Prevention of Delirium is an investigator-initiated, randomised, placebo-controlled, parallel, multicentre, double-blinded trial. Nine centres in France will participate in the study. Patients aged 65 years or older and undergoing cardiac surgery will be enrolled in the study. The intervention starts on day 0 (the day of surgery) until intensive care unit (ICU) discharge; the treatment is administered from 20:00 to 08:00 on the next day. Infusion rate is modified by the treating nurse or the clinician with an objective of Richmond Agitation and Sedation Scale score from −1 to +1. The primary outcome is delirium occurrence evaluated with confusion assessment method for the ICU two times per day during 7 days following surgery. Secondary outcomes include incidence of agitation related events, self-evaluated quality of sleep, cognitive evaluation 3 months after surgery and quality of life 3 months after surgery. The sample size is 348.

Ethics and dissemination

The study was approved for all participating centers by the French Central Ethics Committee (Comité de Protection des Personnes Ile de France VI, registration number 2018-000850-22). The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03477344.
Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden
Authors: Feldthusen Caroline , Bergenheim Anna , Barenfeld Emmelie , Gjertsson Inger , Larsson Anette , Mannerkorpi Kaisa
Published: April 2022

Objectives

The aim of this study was to gain deeper knowledge about how people with chronic widespread pain (CWP) experience the co-creation of a health plan for sustainable physical activity, working in partnership with a physiotherapist, supported by a digital platform.

Design

Qualitative semistructured in-depth individual interviews were analysed with qualitative content analysis.

Setting

Five primary healthcare centres in western Sweden.

Participants

The interviewees comprised 19 individuals with CWP who had previously participated in a person-centred intervention involving co-creation of a health plan and support via a digital platform. The interviews were carried out from late 2019 to spring 2020, 1–6 months after the respondents’ final follow-up.

Results

The analysis resulted in an overarching theme; hope for physical activity that actually works, illustrating the experience of taking part in co-creating a reasonable health plan, based on the respondents’ own goals and interests with the potential to actually work. This theme was based on two categories: a plan tailored for me and a frame for participation and accessibility to help fulfil the plan. The digital platform provided a way to participate and an assurance that there was someone there for them if necessary.

Conclusions

The co-creation of a health plan nurtured hope of having developed a manageable plan for physical activity that could lead to improved future health and well-being. Digital support may serve as a valuable complement in order to sustain and adjust the planned physical activity.

Trial registration number

ClinicalTrials.gov Identifier: NCT03434899.
Durvalumab with or without tremelimumab combined with particle therapy for advanced hepatocellular carcinoma with macrovascular invasion: protocol for the DEPARTURE phase Ib trial
Authors: Ogasawara Sadahisa , Koroki Keisuke , Makishima Hirokazu , Wakatsuki Masaru , Takahashi Asahi , Yumita Sae , Nakagawa Miyuki , Ishino Takamasa , Ogawa Keita , Fujiwara Kisako , Iwanaga Terunao , Sakuma Takafumi , Fujita Naoto , Kojima Ryuta , Kanzaki Hiroaki , Kobayashi Kazufumi , Kiyono Soichiro , Nakamura Masato , Kanogawa Naoya , Saito Tomoko , Kondo Takayuki , Nakagawa Ryo , Nakamoto Shingo , Muroyama Ryosuke , Chiba Tetsuhiro , Ozawa Yoshihito , Kawasaki Yohei , Kurokawa Tomoya , Hanaoka Hideki , Tsuji Hiroshi , Kato Naoya
Published: April 2022

Introduction

Advanced hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) has the worst prognosis among all phenotypes. This trial aims to evaluate whether treatment with durvalumab, alone or in combination with tremelimumab, plus particle therapy is a safe and synergistically effective treatment in patients with advanced HCC and MVI.

Methods and analysis

This phase Ib, multicentre (two sites in Japan), open-label, single-arm, investigator-initiated clinical trial will assess durvalumab monotherapy in combination with particle therapy (cohort A) and that of durvalumab plus tremelimumab in combination with particle therapy (cohort B) for patients with advanced HCC with MVI. Cohort A will receive 1500 mg durvalumab every 4 weeks. Cohort B will receive 1500 mg durvalumab every 4 weeks in principle and 300 mg tremelimumab only on day 1 of the first cycle. Carbon-ion radiotherapy will be administered after day 8 of the first cycle. The primary endpoints are rates of any and severe adverse events, including dose-limiting toxicities (DLTs); secondary endpoints are overall survival, 6-month survival, objective response, 6-month progression-free survival and time to progression. Patients are initially enrolled into cohort A. If cohort A treatment is confirmed to be tolerated (ie, no DLT in three patients or one DLT in six patients), the trial proceeds to enrol more patients into cohort B. Similarly, if cohort B treatment is confirmed to be tolerated (ie, no DLT in three patients or one DLT in six patients), a total of 15 patients will be enrolled into cohort B.

Ethics and dissemination

This study was approved by the ethics committees of the two participating institutions (Chiba University Hospital and National Institutes for Quantum (approval number: 2020040) and Radiological Science and Technology, QST Hospital (approval number: C20-001)). Participants will be required to provide written informed consent. Trial results will be reported in a peer-reviewed journal publication.

Trial registration number

jRCT2031210046.
Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer
Authors: Singh Saurabh , Mathew Manju , Mertzanidou Thomy , Suman Shipra , Clemente Joey , Retter Adam , Papoutsaki Marianthi-Vasiliki , Smith Lorna , Grussu Francesco , Kasivisvanathan Veeru , Grey Alistair , Dinneen Eoin , Shaw Greg , Carter Martyn , Patel Dominic , Moore Caroline M , Atkinson David , Panagiotaki Eleftheria , Haider Aiman , Freeman Alex , Alexander Daniel , Punwani Shonit
Published: April 2022

Introduction

Multiparametric MRI (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. However, the technique has modest specificity and a high false-positive rate, especially in men with mpMRI scored as indeterminate (3/5) or likely (4/5) to have clinically significant cancer (csPCa) (Gleason ≥3+4). Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively. Before these techniques are translated clinically, robust histological and clinical validation is required.

Methods and analysis

This study aims to clinically validate two advanced MRI techniques in a prospectively recruited cohort of men suspected of prostate cancer. Histological analysis of men undergoing biopsy or prostatectomy will be used for biological validation of biomarkers derived from Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging. In particular, prostatectomy specimens will be processed using three-dimension printed patient-specific moulds to allow for accurate MRI and histology mapping. The index tests will be compared with the histological reference standard to derive false positive rate and true positive rate for men with mpMRI scores which are indeterminate (3/5) or likely (4/5) to have clinically significant prostate cancer (csPCa). Histopathological validation from both biopsy and prostatectomy samples will provide the best ground truth in validating promising MRI techniques which could predict biopsy results and help avoid unnecessary biopsies in men suspected of prostate cancer.

Ethics and dissemination

Ethical approval was granted by the London—Queen Square Research Ethics Committee (19/LO/1803) on 23 January 2020. Results from the study will be presented at conferences and submitted to peer-reviewed journals for publication. Results will also be available on ClinicalTrials.gov.

Trial registration number

NCT04792138.
Models of integrated care for older people with frailty: a horizon scanning review
Authors: A Kjelsnes Ashwanee , Feiring Eli
Published: April 2022

Objectives

Frailty, a multifaceted geriatric condition, is an emerging global health problem. Integrated care models designed to meet the complex needs of the older people with frailty are required. Early identification of innovative models may inform policymakers and other stakeholders of service delivery alternatives they can introduce and locally adapt so as to tackle system fragmentation and lack of coordination. This study used horizon scanning methodologies to systematically search for, prioritise and assess new integrated care models for older people with frailty and investigated experts’ views on barriers and facilitators to the adoption of horizon scanning in health services research.

Methods

A four-step horizon scanning review was performed. Frailty-specific integrated care models and interventions were identified through a review of published literature supplemented with grey literature searches. Results were filtered and prioritised according to preset criteria. An expert panel focus group session assessed the prioritised models and interventions on innovativeness, impact and potential for implementation. The experts further evaluated horizon scanning for its perceived fruitfulness in aiding decision-making.

Results

Nine integrated care models and interventions at system level (n=5) and community level (n=4) were summarised and assessed by the expert panel (n=7). Test scores were highest for the Walcheren integrated care model (system-based model) and EuFrailSafe (community-based intervention). The participants stated that horizon scanning as a decision-making tool could aid in assessing knowledge gaps, criticising the status quo and developing new insights. Barriers to adoption of horizon scanning on individual, organisational and wider institutional level were also identified.

Conclusion

Study findings demonstrated that horizon scanning is a potentially valuable tool in the search for innovative service delivery models. Further studies should evaluate how horizon scanning can be institutionalised and effectively used for serving this purpose.