bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy: study protocol
Authors: Siltari Aino , Riikonen Jarno , Koskimäki Juha , Pakarainen Tomi , Ettala Otto , Boström Peter , Seikkula Heikki , Kotsar Andres , Tammela Teuvo , Helminen Mika , Raittinen Paavo V , Lehtimäki Terho , Fode Mikkel , Østergren Peter , Borre Michael , Rannikko Antti , Marttila Timo , Salonen Arto , Ronkainen Hanna , Löffeler Sven , Murtola Teemu J 
Published: May 2022

IntroductionBlood cholesterol is likely a risk factor for prostate cancer prognosis and use of statins is associated with lowered risk of prostate cancer recurrence and progression. Furthermore, use of statins has been associated with prolonged time before development of castration resistance (CR) during androgen deprivation therapy (ADT) for prostate cancer. However, the efficacy of statins on delaying castration-resistance has not been tested in a randomised placebo-controlled setting.This study aims to test statins’ efficacy compared to placebo in delaying development of CR during ADT treatment for primary metastatic or recurrent prostate cancer. Secondary aim is to explore effect of statin intervention on prostate cancer mortality and lipid metabolism during ADT.Methods and analysisIn this randomised placebo-controlled trial, a total of 400 men with de novo metastatic prostate cancer or recurrent disease after primary treatment and starting ADT will be recruited and randomised 1:1 to use daily 80 mg of atorvastatin or placebo. All researchers, study nurses and patients will be blinded throughout the trial. Patients are followed until disease recurrence or death. Primary outcome is time to formation of CR after initiation of ADT. Serum lipid levels (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and trigyserides) are analysed to test whether changes in serum cholesterol parameters during ADT predict length of treatment response. Furthermore, the trial will compare quality of life, cardiovascular morbidity, changes in blood glucose and circulating cell-free DNA, and urine lipidome during trial.Ethics and disseminationThis study is approved by the Regional ethics committees of the Pirkanmaa Hospital District, Science centre, Tampere, Finland (R18065M) and Tarto University Hospital, Tarto, Estonia (319/T-6). All participants read and sign informed consent form before study entry. After publication of results for the primary endpoints, anonymised summary metadata and statistical code will be made openly available. The data will not include any information that could make it possible to identify a given participant.Trial registration numberClinicaltrial.gov:NCT04026230, Eudra-CT: 2016-004774-17, protocol code: ESTO2, protocol date 10 September 2020 and version 6.
Physical morbidity and psychological and social comorbidities at five stages during pregnancy and after childbirth: a multicountry cross-sectional survey
Authors: McCauley Mary , White Sarah , Bar-Zeev Sarah , Godia Pamela , Mittal Pratima , Zafar Shamsa , van den Broek Nynke 
Published: May 2022

ObjectiveMaternal morbidity affects millions of women, the burden of which is highest in low resource settings. We sought to explore when this ill-health occurs and is most significant.SettingsA descriptive observational cross-sectional study at primary and secondary-level healthcare facilities in India, Pakistan, Kenya and Malawi.ParticipantsWomen attending for routine antenatal care, childbirth or postnatal care at the study healthcare facilities.Primary and secondary outcomesPhysical morbidity (infectious, medical, obstetrical), psychological and social comorbidity were assessed at five stages: first half of pregnancy (≤20 weeks), second half of pregnancy (>20 weeks), at birth (within 24 hours of childbirth), early postnatal (day 1–7) and late postnatal (week 2–12).Results11 454 women were assessed: India (2099), Malawi (2923), Kenya (3145) and Pakistan (3287) with similar numbers assessed at each of the five assessment stages in each country. Infectious morbidity and anaemia are highest in the early postnatal stage (26.1% and 53.6%, respectively). For HIV, malaria and syphilis combined, prevalence was highest in the first half of pregnancy (10.0%). Hypertension, pre-eclampsia and urinary incontinence are most common in the second half of pregnancy (4.6%, 2.1% and 6.6%). Psychological (depression, thoughts of self-harm) and social morbidity (domestic violence, substance misuse) are significant at each stage but most commonly reported in the second half of pregnancy (26.4%, 17.6%, 40.3% and 5.9% respectively). Of all women assessed, maternal morbidity was highest in the second half of pregnancy (81.7%), then the early postnatal stage (80.5%). Across the four countries, maternal morbidity was highest in the second half of pregnancy in Kenya (73.8%) and Malawi (73.8%), and in the early postnatal stage in Pakistan (92.2%) and India (87.5%).ConclusionsWomen have significant maternal morbidity across all stages of the continuum of pregnancy and childbirth, and especially in the second half of pregnancy and after childbirth.
Barriers and facilitators to resuming meaningful daily activities among critical illness survivors in the UK: a qualitative content analysis
Authors: Scheunemann Leslie , White Jennifer S , Prinjha Suman , Eaton Tammy L , Hamm Megan , Girard Timothy D , Reynolds Charles , Leland Natalie , Skidmore Elizabeth R 
Published: May 2022

ObjectiveTo identify critical illness survivors’ perceived barriers and facilitators to resuming performance of meaningful activities when transitioning from hospital to home.DesignSecondary content analysis of semistructured interviews about patients’ experiences of intensive care (primary analysis disseminated on the patient-facing websitewww.healthtalk.org). Two coders characterised patient-perceived barriers and facilitators to resuming meaningful activities. To facilitate clinical application, we mapped the codes onto the Person-Task-Environment model of performance, a patient-centred rehabilitation model that characterises complex interactions among the person, task and environment when performing activities.SettingUnited Kingdom, 2005–2006.Participants39 adult critical illness survivors, sampled for variation among demographics and illness experiences.ResultsPerson-related barriersincluded negative mood or affect, perceived setbacks; weakness or limited endurance; pain or discomfort; inadequate nutrition or hydration; poor concentration/confusion; disordered sleep/hallucinations/nightmares; mistrust of people or information; and altered appearance.Task-related barriersincluded miscommunication and managing conflicting priorities.Environment-related barriersincluded non-supportive health services and policies; challenging social attitudes; incompatible patient–family coping (emotional trauma and physical disability); equipment problems; overstimulation; understimulation; and environmental inaccessibility.Person-related facilitatorsincluded motivation or attitude; experiencing progress; and religion or spirituality.Task-related facilitatorsincluded communication.Environment-related facilitatorsincluded support from family, friends or healthcare providers; supportive health services and policies; equipment; community resources; medications; and accessible housing. Barriers decreased and facilitators increased over time. Six barrier–facilitator domains dominated based on frequency and emphasis across all performance goals: mood/motivation, setbacks/progress, fatiguability/strength; mis/communication; lack/community support; lack/health services and policies.ConclusionsCritical illness survivors described a comprehensive inventory of 18 barriers and 11 facilitators that align with the Person-Task-Environment model of performance. Six dominant barrier–facilitator domains seem strong targets for impactful interventions. These results verify previous knowledge and offer novel opportunities for optimising patient-centred care and reducing disability after critical illness.
Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients’ Attitudes Towards Deprescribing (rPATD) questionnaire
Authors: de Juan-Roldán Jose Ignacio , Castillo-Jimena Marcos , González-Hevilla Alba , Sánchez-Sánchez Clara , García-Ruiz Antonio J , Gavilán-Moral Enrique 
Published: May 2022

ObjectivesSuccessful deprescribing depends largely on factors related to the patient. The revised Patients’ Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties.DesignCross-sectional validation study.SettingPrimary care settings in Málaga (Spain).ParticipantsA sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study.Main outcome measuresIn the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach’s alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test–retest reliability were analysed.ResultsConfirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors:involvement,burden,appropriatenessandconcerns about stopping. The Cronbach’s alpha coefficient of the factors ranged from 0.683 to 0.879. Theburden,appropriatenessandconcerns about stoppingfactors were significantly correlated with the BMQ Specific-Concerns Score, except for theconcerns about stoppingfactor in the older adults’ version. The consistency of the items between administration times (test–retest reliability) showed weighted Cohen’s kappa values ranging from moderate (>0.4) to very good (>0.8).ConclusionsThe Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.
Integration of sex and gender in a continuing professional development course on diabetes and depression: a mixed methods feasibility study
Authors: Deom Tardif Alèxe , Gogovor Amédé , Guay-Bélanger Sabrina , Audet Denis , Parent Nicole , Gaudreau André , Remy-Lamarche Danièle , Vigneault Luc , Ngueta Gérard , Bilodeau André , Légaré France 
Published: May 2022

ObjectivesAssess the feasibility and impact of a continuous professional development (CPD) course on type 2 diabetes and depression on health professionals’ intention to include sex and gender considerations in patient care.Design and settingIn collaboration with CPD organisations and patient-partners, we conducted a mixed-methods feasibility controlled trial with postintervention measures in three Canadian provinces.ParticipantsOf 178 eligible health professionals, 127 completed questionnaires and 67 participated in semistructured group discussions.Intervention and comparatorAn interactive 1 hour CPD course, codesigned with patient-partners, on diabetes and depression that included sex and gender considerations (innovation) was compared with a similar course that did not include them (comparator).OutcomesFeasibility of recruitment and retention of CPD organisations and patient-partners throughout the study; adherence to planned activities; health professionals’ intention to include sex and gender considerations in patient care as measured by the CPD-Reaction questionnaire; and barriers and facilitators using the Theoretical Domains Framework.ResultsAll recruited CPD organisations and patient-partners remained engaged throughout the study. All planned CPD courses occurred. Overall, 71% of eligible health professionals participated (63% under 44 years old; 79.5% women; 67.7% practising in French; 66.9% practising in Quebec; 78.8% in urban practice). After training, mean intention scores for the innovation (n=49) and control groups (n=78) were 5.65±0.19 and 5.19±0.15, respectively. Mean difference was −0.47 (CI −0.95 to 0.01; p=0.06). Adjusted for age, gender and practice settings, mean difference was −0.57 (CI −1.09 to −0.05; p=0.03). We identified eight theoretical domains related to barriers and six related to facilitators for providing sex-adapted and gender-adapted diabetes and depression care.ConclusionsCPD training on diabetes and depression that includes sex and gender considerations is feasible and, compared with CPD training that does not, may prompt health professionals to modify their care. Addressing identified barriers and facilitators could increase intention.Trial registration numberNCT03928132with ClinicalTrials.gov; Post-results.
Coexisting service-related factors preceding suicide: a network analysis
Authors: Rex Malin , Brezicka Thomas , Carlström Eric , Waern Margda , Ali Lilas 
Published: May 2022

ObjectivesThe overall objective was to analyse service-related factors involved in the complex processes that precede suicide in order to identify potential targets for intervention.Design and settingExplorative network analysis study of post-suicide root cause analysis data from Swedish primary and secondary healthcare.Participants217 suicide cases reported to the Swedish national root cause analysis database between 2012 and 2017.Primary and secondary outcome measuresA total of 961 reported incidents were included. Demographic data and frequencies of reported deficiencies were registered. Topology, centrality indices and communities were explored for three networks. All networks have been tested for robustness and accuracy.ResultsLack of follow-up, evaluations and insufficient documentation issues emerged as central in the network of major themes, as did the contributing factors representing organisational problems, failing procedures and miscommunication. When analysing the subthemes of deficiencies more closely, disrupted treatments and staffing issues emerged as prominent features. The network covering the subthemes of contributing factors also highlighted discontinuity, fragile work structures, inadequate routines, and lack of resources and relevant competence as potential triggers. However, as the correlation stability coefficients for this network were low, the results need further investigation. Four communities were detected covering nodes for follow-up, evaluation, cooperation, and procedures; communication, documentation and organisation; assessments of suicide risk and psychiatric status; and staffing, missed appointments and declined treatment.ConclusionThe results of this study suggest that healthcare providers may improve patient safety in suicide preventive pathways by taking active measures to provide regular follow-ups to patients with elevated suicide risk. In some cases, declined or cancelled appointments could be a warning sign. Tentative results show organisational instability, in terms of work structure, resources and staffing, as a potential target for intervention, although this must be more extensively explored in the future.
Association of impaired kidney function with mortality in rural Uganda: results of a general population cohort study
Authors: Kalyesubula Robert , Sekitoleko Isaac , Tomlin Keith , Hansen Christian Holm , Ssebunya Billy , Makanga Ronald , Mbonye Moses Kwizera , Seeley Janet , Smeeth Liam , Newton Robert , Tomlinson Laurie A 
Published: May 2022

ObjectiveTo determine the association between baseline kidney function and subsequent all-cause mortality.Design and settingA general population-based cohort study from rural Uganda.ParticipantsPeople aged 18 years and above with measured baseline estimated glomerular filtration rate (eGFR), recruited from survey rounds in 2011–2012 or 2014–2015 and followed up to March 2019.Outcome measureThe primary outcome was all-cause mortality, identified through reports from community health workers and verified by verbal autopsy. The association between baseline eGFR category and mortality was determined using multivariable Cox regression.ResultsOf 5812 participants in both rounds, we included 5678 (97.7%) participants with kidney function and mortality data; the median age was 36 years (IQR 24–50), 60.7% were female, 10.3% were hypertensive, 9.8% were HIV-positive and 1.5% were diabetic. During a median follow-up of 5.0 years (IQR 3.7–6.0) there were 140 deaths. In age-adjusted and sex-adjusted analyses, eGFR <45 mL/min/1.73 m2at baseline was associated with a 5.97 (95% CI 2.55 to 13.98) increased risk of mortality compared with those with baseline eGFR >90 mL/min/1.73 m2. After inclusion of additional confounders (HIV, body mass index, diabetes, hypertension, alcohol and smoking status) into the model, eGFR <45 mL/min/1.73 m2at baseline remained strongly associated with mortality (HR 6.12, 95% CI 2.27 to 16.45), although the sample size fell to 3102. Test for trend showed strong evidence (p<0.001) that the rate of mortality increased progressively as the category of baseline kidney function decreased. When very high eGFR was included as a separate category in age-adjusted and sex-adjusted analyses, baseline eGFR ≥120 mL/min/1.73 m2was associated with increased risk of mortality (HR 2.68, 95% CI 1.47 to 4.87) compared with the reference category of 90–119 mL/min/1.73 m2.ConclusionIn a prospective cohort in rural Uganda we found that impaired baseline kidney function was associated with subsequently increased total mortality. Improved understanding of the determinants of kidney disease and its progression is needed in order to inform interventions for prevention and treatment.
Mental healthcare utilisation by patients before and after receiving paliperidone palmitate treatment: mirror image analyses
Authors: Kadra-Scalzo Giouliana , Ahn Deborah , Bird Alex , Broadbent Matthew , Chang Chin-Kuo , Pritchard Megan , Shetty Hitesh , Taylor David , Hayes Richard , Stewart Robert 
Published: May 2022

ObjectivesTo compare mental healthcare use and healthcare professional (HCP) contacts for patients before and after initiation of paliperidone palmitate.SettingThe South London and Maudsley NHS Foundation Trust (SLAM) Biomedical Research Centre Clinical Record Interactive Search.ParticipantsWe identified all adults with a diagnosis of schizophrenia (International Classification of Diseases 10th Revision: F20.x), who had received paliperidone palmitate prescription for at least 365 days and had at least 1 year of recorded treatment from SLAM, prior to the first recorded receipt of paliperidone palmitate.Primary and secondary outcome measuresInpatient and community mental healthcare service use, such as inpatient bed days, number of active days in the service, face-to-face and telephone HCP use in the 12 months before and after paliperidone palmitate initiation.ResultsWe identified 664 patients initiated on paliperidone palmitate. Following initiation, inpatient bed days were lower, although patients remained active on the service case load longer for both mirror approach 1 (mean difference of inpatient bed days −10.48 (95% CI −15.75 to −5.22); days active 40.67 (95% CI 33.39 to 47.95)) and mirror approach 2 (mean difference of inpatient bed days −23.96 (95% CI −30.01 to −17.92); mean difference of days active 40.69 (95% CI 33.39 to 47.94)). The postinitiation period was further characterised by fewer face-to-face and telephone contacts with medical and social work HCPs, and an increased contact with clinical psychologists.ConclusionsOur findings indicate a change in the profile of HCP use, consistent with a transition from treatment to possible rehabilitation.
Relationship between frailty and long-term care needs in Chinese community-dwelling older adults: a cross-sectional study
Authors: Chen Rui , Zhao Wen Bo , Zhang Xiao Pei , Liang Hao , Song Na Na , Liu Zhu Yun , Xiao Hui , Peng Xue Ting , Song Yang , Liao Ruo Tong , Luo Wang Hui , Wei Lin 
Published: May 2022

ObjectivesOur study aimed to investigate the relationship between the severity of frailty and the long-term care (LTC) needs of older adults from Chinese communities.DesignA cross-sectional study.SettingThree Chinese community health centres. All data were collected by trained researchers through face-to-face collection.ParticipantsWe surveyed a total of 540 older residents who aged 60 or older from community in Guangzhou, China.MeasuresThe Chinese version of the Tilburg frailty indicator was used to assess the frailty status of participants. LTC needs was evaluated by Integrated Home Care Services Questionnaire. Using non-adjusted and multivariate adjusted logistic regression analysis to evaluate frailty and LTC needs, then smoothed plots, threshold effect analysis and P for trend were used to further investigate the relationship between them.ResultsThe prevalence of frailty was 45.2% among the 540 older adults enrolled (aged 70.4±8.3 years; 65.7% females). 27% had higher LTC needs, which increased to 65.1% for individuals with frailty. Logistic regression analysis showed that frailty was strongly associated with LTC needs (OR 3.06, 95% CI 2.06 to 4.55, p<0.01). In the multivariate model, after adjusting for demographic characteristics, economic situation, activities of daily living and comorbidities, frailty remained significantly associated with LTC needs (OR 2.32, 95% CI 1.39 to 3.88, p<0.01). The smoothed plots showed a nearly linear relationship between frailty and LTC needs. Threshold effect analysis showed that every point increase in frailty, the score of LTC needs increased 1.3 points. The IQR to regroup individuals with frailty. Compared with the first quartile (scores ≤2), the incidence of LTC needs increased with the frailty status (p value for trend <0.01).ConclusionThere is a linear relationship between frailty and LTC needs. With the increasing degree of frailty, the LTC needs of older adults dramatically increases.