ResearchPad - 1506 Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[What is the meaning of health literacy? A systematic review and qualitative synthesis]]> The objective of this review was to clarify what health literacy represents. A systematic review with qualitative syntheses was performed (CRD42017065149). Studies concerning health literacy in all settings were included. Studies before 15 March 2017 were identified from PubMed, Medline, Embase, Web of Science, Scopus, PsycARTICLES and the Cochrane Library. The included literature either had defined the concept of health literacy or made a detailed explanation of health literacy. A total of 34 original studies met the inclusion criteria, including 13 involved in previous systematic reviews and 21 new studies. Health literacy was commonly conceptualised as a set of knowledge, a set of skills or a hierarchy of functions (functional-interactive-critical). The construct of health literacy covers three broad elements: (1) knowledge of health, healthcare and health systems; (2) processing and using information in various formats in relation to health and healthcare; and (3) ability to maintain health through self-management and working in partnerships with health providers. Health literacy is defined as the ability of an individual to obtain and translate knowledge and information in order to maintain and improve health in a way that is appropriate to the individual and system contexts. This definition highlights the diversity of needs from different individuals and the importance of interactions between individual consumers, healthcare providers and healthcare systems.

<![CDATA[Conversion of ATP to adenosine by CD39 and CD73 in multiple myeloma can be successfully targeted together with adenosine receptor A2A blockade]]> PD1/PDL1-directed therapies have been unsuccessful for multiple myeloma (MM), an incurable cancer of plasma cells in the bone marrow (BM). Therefore, other immune checkpoints such as extracellular adenosine and its immunosuppressive receptor should be considered. CD39 and CD73 convert extracellular ATP to adenosine, which inhibits T-cell effector functions via the adenosine receptor A2A (A2AR). We set out to investigate whether blocking the adenosine pathway could be a therapy for MM.MethodsExpression of CD39 and CD73 on BM cells from patients and T-cell proliferation were determined by flow cytometry and adenosine production by Liquid chromatograpy-mass spectrometry (HPCL/MS). ENTPD1 (CD39) mRNA expression was determined on myeloma cells from patients enrolled in the publicly available CoMMpass study. Transplantable 5T33MM myeloma cells were used to determine the effect of inhibiting CD39, CD73 and A2AR in mice in vivo.ResultsElevated level of adenosine was found in BM plasma of MM patients. Myeloma cells from patients expressed CD39, and high gene expression indicated reduced survival. CD73 was found on leukocytes and stromal cells in the BM. A CD39 inhibitor, POM-1, and an anti-CD73 antibody inhibited adenosine production and reduced T-cell suppression in vitro in coculture of myeloma and stromal cells. Blocking the adenosine pathway in vivo with a combination of Sodium polyoxotungstate (POM-1), anti-CD73, and the A2AR antagonist AZD4635 activated immune cells, increased interferon gamma production, and reduced the tumor load in a murine model of MM.ConclusionsOur data suggest that the adenosine pathway can be successfully targeted in MM and blocking this pathway could be an alternative to PD1/PDL1 inhibition for MM and other hematological cancers. Inhibitors of the adenosine pathway are available. Some are in clinical trials and they could thus reach MM patients fairly rapidly. ]]> <![CDATA[Correction: Cellular cytotoxicity is a form of immunogenic cell death]]> <![CDATA[The Society for Immunotherapy in Cancer statement on best practices for multiplex immunohistochemistry (IHC) and immunofluorescence (IF) staining and validation]]> The interaction between the immune system and tumor cells is an important feature for the prognosis and treatment of cancer. Multiplex immunohistochemistry (mIHC) and multiplex immunofluorescence (mIF) analyses are emerging technologies that can be used to help quantify immune cell subsets, their functional state, and their spatial arrangement within the tumor microenvironment.MethodsThe Society for Immunotherapy of Cancer (SITC) convened a task force of pathologists and laboratory leaders from academic centers as well as experts from pharmaceutical and diagnostic companies to develop best practice guidelines for the optimization and validation of mIHC/mIF assays across platforms.ResultsRepresentative outputs and the advantages and disadvantages of mIHC/mIF approaches, such as multiplexed chromogenic IHC, multiplexed immunohistochemical consecutive staining on single slide, mIF (including multispectral approaches), tissue-based mass spectrometry, and digital spatial profiling are discussed.ConclusionsmIHC/mIF technologies are becoming standard tools for biomarker studies and are likely to enter routine clinical practice in the near future. Careful assay optimization and validation will help ensure outputs are robust and comparable across laboratories as well as potentially across mIHC/mIF platforms. Quantitative image analysis of mIHC/mIF output and data management considerations will be addressed in a complementary manuscript from this task force. ]]> <![CDATA[Maximising comfort: how do patients describe the care that matters? A two-stage qualitative descriptive study to develop a quality improvement framework for comfort-related care in inpatient settings]]> To develop a multidimensional framework representing patients’ perspectives on comfort to guide practice and quality initiatives aimed at improving patients’ experiences of care.DesignTwo-stage qualitative descriptive study design. Findings from a previously published synthesis of 62 studies (stage 1) informed data collection and analysis of 25 semistructured interviews (stage 2) exploring patients’ perspectives of comfort in an acute care setting.SettingCardiac surgical unit in New Zealand.ParticipantsCulturally diverse patients in hospital undergoing heart surgery.Main outcomesA definition of comfort. The Comfort ALways Matters (CALM) framework describing factors influencing comfort.ResultsComfort is transient and multidimensional and, as defined by patients, incorporates more than the absence of pain. Factors influencing comfort were synthesised into 10 themes within four inter-related layers: patients’ personal (often private) strategies; the unique role of family; staff actions and behaviours; and factors within the clinical environment.ConclusionsThese findings provide new insights into what comfort means to patients, the care required to promote their comfort and the reasons for which doing so is important. We have developed a definition of comfort and the CALM framework, which can be used by healthcare leaders and clinicians to guide practice and quality initiatives aimed at maximising comfort and minimising distress. These findings appear applicable to a range of inpatient populations. A focus on comfort by individuals is crucial, but leadership will be essential for driving the changes needed to reduce unwarranted variability in care that affects comfort. ]]> <![CDATA[Cannabidiol (CBD) and Δ<sup>9</sup>-tetrahydrocannabinol (THC) for chronic insomnia disorder (‘CANSLEEP’ trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial]]> Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.Methods and analysisA randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution (‘ETC120’) containing 10 mg Δ9-tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35–60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.Ethics and disseminationEthics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.Trial registration numberANZCTRN12619000714189. ]]> <![CDATA[Postpartum lifestyle interventions among women with pre-eclampsia: a scoping review protocol]]> Compared to women with normotensive pregnancies, women with a history of pre-eclampsia have a roughly fourfold increased risk of developing chronic arterial hypertension and a twofold increased risk of developing cardiovascular disease (CVD). Lifestyle changes, such as increased physical activity, weight loss, smoking cessation and healthy diet, are effective for CVD prevention in the general population. However, no scoping review or systematic review of postpartum lifestyle interventions among women with pre-eclampsia have, to our best knowledge, been performed. The objective of this scoping review is to provide an overview of the available research literature on postpartum lifestyle interventions to reduce the risk of CVD among women with pre-eclampsia.Methods and analysisThe protocol is based on the framework outlined by Arksey and O’Malley. Databases to be searched include: PubMed, Embase CINAHL and the JBI Database of Systematic Reviews and Implementation Reports. The search will be performed after the publication of this protocol (estimated to be 1 June 2020) and will be repeated 1 month prior to the submission for publication of the final review (estimated to be 1 January 2021). The review will consider studies that include women in the postpartum period (in particular, but not restricted to, the first 12 months after delivery), with a history of pre-eclampsia. Data will be extracted by two independent reviewers using a data extraction tool including specific details about the population, concept, context, study methods and key findings relevant to the review objective. Any disagreements between the reviewers will be resolved through discussion, or with a third reviewer. The extracted data will be presented in diagrammatic or tabular form that align with the objective of this scoping review. A narrative summary will accompany the tabulated and/or charted results and will describe how the results relate to the reviews objective and questions.Ethics and disseminationSince all data will be obtained from publicly available materials, the proposed scoping review does not require ethical approval. The results will be submitted for publication in an open-access peer-reviewed journal and presented at relevant conferences. ]]> <![CDATA[Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial]]> Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.Methods and analysisA two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.Ethics and disseminationEthical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations’ newsletters.Trial registration numberNCT03963570. ]]> <![CDATA[Developing a typology of the roles public contributors undertake to establish legitimacy: a longitudinal case study of patient and public involvement in a health network]]> To identify how public contributors established their legitimacy in the functioning of a patient and public involvement programme at a health network.DesignA longitudinal case study with three embedded units (projects) involving public contributors. Interviews (n=24), observations (n=27) and documentary data collection occurred over 16 months.SettingThe West of England Academic Health Science Network (WEAHSN), 1 of 15 regional AHSNs in England.ParticipantsInterviews were conducted with public contributors (n=5) and professionals (n=19) who were staff from the WEAHSN, its member organisations and its partners.ResultsPublic contributors established their legitimacy by using nine distinct roles: (1) lived experience, as a patient or carer; (2) occupational knowledge, offering job-related expertise; (3) occupational skills, offering aptitude developed through employment; (4) patient advocate, promoting the interests of patients; (5) keeper of the public purse, encouraging wise spending; (6) intuitive public, piloting materials suitable for the general public; (7) fresh-eyed reviewer, critiquing materials; (8) critical friend, critiquing progress and proposing new initiatives and (9) boundary spanner, urging professionals to work across organisations. Individual public contributors occupied many, but not all, of the roles.ConclusionsLived experience is only one of nine distinct public contributor roles. The WEAHSN provided a benign context for the study because in a health network public contributors are one of many parties seeking to establish legitimacy through finding valuable roles. The nine roles can be organised into a typology according to whether the basis for legitimacy lies in: the public contributor’s knowledge, skills and experience; citizenship through the aspiration to achieve a broad public good; or being an outsider. The typology shows how public contributors can be involved in work where lived experience appears to lack relevance: strategic decision making; research unconnected to particular conditions; or acute service delivery. ]]> <![CDATA[Internet-based cognitive–behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial]]> The objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysisThe target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and disseminationThe study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration numberUMIN000038190; Pre-results. ]]> <![CDATA[Association between chronic kidney disease and incident diagnosis of dementia in England: a cohort study in Clinical Practice Research Datalink]]> To investigate the association between chronic kidney disease (CKD) and dementia diagnosis in a real-world primary care setting in England.DesignMatched cohort study.SettingsEnglish primary care in the Clinical Practice Research Datalink.ParticipantsPeople aged ≥18 years with predialysis CKD (stages 3–5, defined as two measurements of estimated glomerular filtration rate <60 mL/min/1.73 m2 for 3 months) from 2004 to 2014, and people without known CKD who were matched on age, sex, general practice and calendar time in a 1:1 ratio.Primary and secondary outcome measuresFirst-ever diagnosis of dementia recorded by GPs. We also examined all-cause death as a secondary outcome to discuss potential competing risk of mortality in the association between CKD and dementia diagnosis.ResultsIn a matched cohort of 242 349 pairs with and without CKD (mean age 75.4±9.7 years, 39.3% male), the crude incidence rate of dementia diagnosis was 11.4/1000 and 9.4/1000 person-years, respectively. There was an association between CKD status and incident dementia diagnosis in the first 6 months of the follow-up (adjusted rate ratio (aRR) 1.58, 95% CI 1.44 to 1.74), which attenuated after 6 months (aRR 1.12, 95% CI 1.08 to 1.16). Among patients with CKD, there was no evidence of association between CKD stage and incident dementia diagnosis; compared with stage 3a, aRR (95% CI) was 1.04 (0.91 to 1.18) for stage 3b and 0.94 (0.74 to 1.20) for stages 4 or 5 in the first 6 months, and 0.97 (0.92 to 1.01) and 0.89 (0.80 to 0.98) thereafter. We found a strong association between worsening CKD stage and all-cause mortality.ConclusionWe identified a co-occurrence of detection of CKD and dementia in real-world clinical practice and a strong competing risk of mortality in the association between CKD stage and dementia, while a weak association between CKD status and dementia was suggested in the long term. ]]> <![CDATA[Patients’ views on involving general practice in bowel cancer screening: a South Australian focus group study]]> To explore patients’ experiences of bowel cancer screening and its promotion, and perspectives on possible input from general practice for improving screening rates.DesignQualitative focus group study underpinned by a phenomenological approach.SettingThree general practice clinics in metropolitan South Australia.ParticipantsThirty active general practice patients, aged 50–74 years (60% female) who were eligible for the National Bowel Cancer Screening Program.FindingsFactors affecting screening were described, with particular concerns regarding the nature of the test, screening process and culture. There were mixed views on the role for general practice in bowel cancer screening; some participants appreciated the current process and viewed screening as out of scope of primary care services, while others were in support of general practice involvement. Roles for general practice were proposed that comprised actions across the continuum from providing information through to reminders and the provision and collection of screening kits. With a view that multifaceted strategies are required to encourage participation, community-based solutions were suggested that centred on improving screening culture and education.ConclusionsThere was a view among participants that general practice could play a useful role in supporting the uptake of the National Bowel Cancer Screening Program, however participants saw a need for multiple strategies at different levels and under different jurisdictions. ]]> <![CDATA[Place, poverty and prescriptions: a cross-sectional study using Area Deprivation Index to assess opioid use and drug-poisoning mortality in the USA from 2012 to 2017]]> To identify the relationships between county-level area deprivation and patterns of both opioid prescriptions and drug-poisoning mortality.Design, setting and participantsFor this retrospective cross-sectional study, we used the IQVIA Xponent data to capture opioid prescriptions and Centres for Disease Control and Prevention National Vital Statistics System to assess drug-poisoning mortality. The Area Deprivation Index (ADI) is a composite measure of social determinants of health comprised of 17 US census indicators, spanning four socioeconomic domains. For all US counties with available opioid prescription (2712 counties) and drug-poisoning mortality (3133 counties) data between 2012 and 2017, we used negative binomial regression to examine the association between quintiles of county-level ADI and the rates of opioid prescriptions and drug-poisoning mortality adjusted for year, age, race and sex.Primary outcome measuresCounty-level opioid prescription fills and drug-poisoning mortality.ResultsBetween 2012 and 2017, overall rates of opioid prescriptions decreased from 96.6 to 72.2 per 100 people, while the rates of drug-poisoning mortality increased from 14.3 to 22.8 per 100 000 people. Opioid prescription and drug-poisoning mortality rates were consistently higher with greater levels of deprivation. The risk of filling an opioid prescription was 72% higher, and the risk of drug-poisoning mortality was 36% higher, for most deprived compared with the least deprived counties (both p<0.001).DiscussionCounties with greater area-level deprivation have higher rates of filled opioid prescriptions and drug-poisoning mortality. Although opioid prescription rates declined across all ADI quintiles, the rates of drug-poisoning mortality continued to rise proportionately in each ADI quintile. This underscores the need for individualised and targeted interventions that consider the deprivation of communities where people live. ]]> <![CDATA[Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men]]> This study aims to clarify the role(s) of endogenous sex hormones to influence health outcomes in men, specifically to define the associations of plasma testosterone with incidence of cardiovascular events, cancer, dementia and mortality risk, and to identify factors predicting testosterone concentrations. Data will be accrued from at least three Australian, two European and four North American population-based cohorts involving approximately 20 000 men.Methods and analysisEligible studies include prospective cohort studies with baseline testosterone concentrations measured using mass spectrometry and 5 years of follow-up data on incident cardiovascular events, mortality, cancer diagnoses or deaths, new-onset dementia or decline in cognitive function recorded. Data for men, who were not taking androgens or drugs suppressing testosterone production, metabolism or action; and had no prior orchidectomy, are eligible. Systematic literature searches were conducted from 14 June 2019 to 31 December 2019, with no date range set for searches. Aggregate level data will be sought where individual participant data (IPD) are not available. One-stage IPD random-effects meta-analyses will be performed, using linear mixed models, generalised linear mixed models and either stratified or frailty-augmented Cox regression models. Heterogeneity in estimates from different studies will be quantified and bias investigated using funnel plots. Effect size estimates will be presented in forest plots and non-negligible heterogeneity and bias investigated using subgroup or meta-regression analyses.Ethics and disseminationEthics approvals obtained for each of the participating cohorts state that participants have consented to have their data collected and used for research purposes. The Androgens In Men Study has been assessed as exempt from ethics review by the Human Ethics office at the University of Western Australia (file reference number RA/4/20/5014). Each of the component studies had obtained ethics approvals; please refer to respective component studies for details. Research findings will be disseminated to the scientific and broader community via the publication of four research articles, with each involving a separate set of IPD meta-analyses (articles will investigate different, distinct outcomes), at scientific conferences and meetings of relevant professional societies. Collaborating cohort studies will disseminate findings to study participants and local communities.PROSPERO registration numberCRD42019139668. ]]> <![CDATA[Effectiveness of psychological, psychoeducational and psychosocial interventions to prevent postpartum depression in adolescent and adult mothers: study protocol for a systematic review and meta-analysis of randomised controlled trials]]> The prevalence of postpartum depression (PPD) is 17%, and the incidence is 12% worldwide. Adverse consequences for mothers and babies have been associated with this disease. To assess the effectiveness of psychological, psychoeducational and psychosocial interventions in preventing PPD, a systematic review and meta-analysis (SR/MA) will be conducted.Methods and analysisA SR/MA will be performed following the indications of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies will be identified through MEDLINE (Ovid and PubMed), PsycINFO, Web of Science, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, OpenGrey, Australian New Zealand Clinical Trial Registry, and from inception until 31 January 2020. Bridging searches will be also conducted until the review is completed. The selection criteria will be as follows: (1) subjects will be pregnant females or females who have given birth in the last 12 months and who were non-depressive at baseline; (2) psychological, psychoeducational and psychosocial interventions; (3) comparator will be usual care, attention control, waiting list or no intervention; (4) outcomes will be specific results on PPD; and (5) the design of the studies will be randomised controlled trials. No restrictions regarding the year of publication, the setting of the intervention or the language of publication will be considered. Pooled standardised mean differences and 95% CIs will be calculated. The risk of bias of the studies will be assessed through the Cochrane Collaboration risk of bias tool. Heterogeneity between the studies will be determined by the I2 and Cochran’s Q statistics. Sensitivity and subgroup analyses will also be performed. Publication bias will be checked with funnel plots and Egger’s test. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationThe ethical assessment was not required. The results will be presented at conferences and disseminated through publications.PROSPERO registration numberCRD42018109981. ]]> <![CDATA[Behavioural and pharmaceutical interventions for the prevention of skin cancers in solid organ transplant recipients: a systematic review of randomised controlled trials]]> Solid organ transplant recipients are at increased risk of skin cancer, affecting more than 50% of recipients. We aimed to determine the effectiveness of interventions for behavioural change for sun protection or skin cancer prevention in solid organ transplant recipients.DesignSystematic review.Data sourcesWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL from inception to November 2019.Eligibility criteriaWe included randomised controlled trials that evaluated the effect of behavioural or pharmaceutical interventions on behavioural change or skin cancer prevention in solid organ transplant recipients.Data extraction and synthesisRisks of bias and evidence certainty were assessed using Cochrane and the Grading of Recommendations Assessment Development and Evaluation framework.ResultsTwenty trials (n=2295 participants) were included. It is uncertain whether behavioural interventions improve sun protection behaviour (n=3, n=414, standardised mean difference (SMD) 0.89, 95% CI −0.84 to 2.62, I2=98%) and knowledge (n=4, n=489, SMD 0.50, 95% CI 0.12 to 0.87, I2= 76%) as the quality of evidence is very low. We are uncertain of the effects of mammalian target of rapamaycin inhibitors on the incidence of non-melanocytic skin cancer (n=5, n=1080, relative risk 0.46, 95% CI 0.28 to 0.75, I2 =72%) as the quality of evidence is very low.ConclusionsBehavioural and pharmaceutical preventive interventions may improve sun protective behaviour and knowledge, and reduce the incidence of non-melanocytic skin cancer, but the overall quality of the evidence is very low and insufficient to guide decision-making and clinical practice.PROSPERO registration numberCRD42017063962. ]]> <![CDATA[Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial]]> To evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878. ]]> <![CDATA[Psychometric properties of self-reported financial toxicity measures in cancer survivors: a systematic review protocol using COSMIN methodology]]> Due to the higher costs associated with advancements in cancer treatment and longer duration of cancer survivorship, increasing financial toxicity has become a great threat to survivors, caregivers and public healthcare systems. Since accurate and reproducible measures are prerequisites for robust results, choosing an acceptable measure with strong psychometric properties to assess financial toxicity is essential. However, a description of the psychometric properties of existing measures is still lacking. The aim of this study is to apply COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to systematically review the content and structural validity of patient-reported outcome measures (PROMs) of financial toxicity for cancer survivors.Methods and analysisPubMed/Medline, Medline (Ovid), Embase (Ovid), CINAHL (EBSCO), Web of Science, ProQuest Dissertations and Theses, and Cochrane Library (Wiley) will be comprehensively searched from database inception to 15 November 2019. Studies that report the measurement properties of PROMs assessing financial toxicity for cancer survivors will be included. The evaluation of measurement properties, data extraction and data synthesis will be conducted according to the COSMIN methodology.Ethics and disseminationNo individual data are involved in this systematic review. The results will be disseminated to a clinical audience and policy-makers though peer-reviewed journals and conferences and will support researchers in choosing the best measure to evaluate the financial toxicity of cancer survivors. ]]> <![CDATA[Association between obesity-related anthropometric indices and multimorbidity among older adults in Shandong, China: a cross-sectional study]]> Whether the association between obesity-related anthropometric indices and multimorbidity differs by age among Chinese older adults (aged 65+) is unclear. We aimed to investigate the association between body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) with multimorbidity among the young-old (aged 65–79) and old-old (aged 80+) adults.DesignCross-sectional population-based study.SettingShandong province on the eastern coast of China.Participants5493 subjects aged 65 years or above.MeasurementsDetails on sociodemographics, lifestyle characteristics and chronic conditions were collected using a structured questionnaire. The respondents were assessed with anthropometric measurements including height, weight, WC, hip circumference.ResultsThe overall prevalence of multimorbidity in older adults (aged 65+) was 35.2%. The BMI-obesity, WC-obesity and WHR-obesity rates were 7.4%, 57.5% and 80.4%, respectively. In the young-old adults (aged 65–79), the likelihood of multimorbidity was more than two times higher among the BMI-obese than the BMI-normal population (OR 2.08, 95% CI 1.66 to 2.60). Similar but less strong associations were found for the WC-obese and WHR-obese young-old population (OR 1.60, 95% CI 1.42 to 1.81; OR 1.31, 95% CI 1.10 to 1.56, respectively). For the old-old group (aged 80+), the BMI-obese, WC-obese and WHR-obese had a higher likelihood of having multimorbidity compared with the normal weight category (OR 2.10, 95% CI 0.96 to 4.57; OR 1.75, 95% CI 1.21 to 2.54; OR 2.15, 95% CI 1.18 to 3.93, respectively).ConclusionBMI-obesity, WC-obesity and WHR-obesity were associated with a greater risk of multimorbidity, and the associations were different between the young-old and the old-old adults. These age differences need to be considered in assessing healthy body weight in old age. These findings may be vital for public health surveillance, prevention and management strategies for multimorbidity in older adults. ]]> <![CDATA[Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease]]> Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.Methods and analysisThis trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.Ethics and disseminationThe study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union’s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.Trial registration numberNCT03774329. ]]>