bluuebunny/crossref_metadata_2025_split huggingface dataset:
Barriers and facilitators to implementation of shared medical appointments in primary care for the management of long-term conditions: a systematic review and synthesis of qualitative studies
Authors: Graham Fiona , Tang Mei Yee , Jackson Katherine , Martin Helen , O'Donnell Amy , Ogunbayo Oladapo , Sniehotta Falko F , Kaner Eileen 
Published: August 2021

ObjectiveTo synthesise the published literature on practitioner, patient and carer views and experiences of shared medical appointments (SMAs) for the management of long-term conditions in primary care.DesignSystematic review of qualitative primary studies.MethodsA systematic search was conducted using MEDLINE (Ovid), PsycINFO (Ovid), CINAHL (EBSCOhost), Web of Science, Social Science Premium Collection (Proquest) and Scopus (SciVerse) from database starting dates to June 2019. Practitioner, patient and carer perspectives were coded separately. Deductive coding using a framework approach was followed by thematic analysis and narrative synthesis. Quality assessment was conducted using the Critical Appraisal Skills Programme for qualitative studies.ResultsWe identified 18 unique studies that reported practitioner (n=11), patient (n=14) and/or carer perspectivs(n=3). Practitioners reported benefits of SMAs including scope for comprehensive patient-led care, peer support, less repetition and improved efficiency compared with 1:1 care. Barriers included administrative challenges and resistance from patients and colleagues, largely due to uncertainties and unclear expectations. Skilled facilitators, tailoring of SMAs to patient groups, leadership support and teamwork were reported to be important for successful delivery. Patients’ reported experiences were largely positive with the SMAs considered a supportive environment in which to share and learn about self-care, though the need for good facilitation was recognised. Reports of carer experience were limited but included improved communication between carer and patient.ConclusionThere is insufficient evidence to indicate whether views and experiences vary between staff, medical condition and/or patient characteristics. Participant experiences may be subject to reporting bias. Policies and guidance regarding best practice need to be developed with consideration given to resource requirements. Further research is needed to capture views about wider and co-occurring conditions, to hear from those without SMA experience and to understand which groups of patients and practitioners should be brought together in an SMA for best effect.PROSPERO registration numberCRD42019141893.
Relationship between weight retention at 6 weeks postpartum and the risk of large-for-gestational age birth in a second pregnancy in China: a retrospective cohort study
Authors: Liu Jing , Song Guang , Zhao Ge , Meng Tao 
Published: August 2021

ObjectiveWe aimed to investigate the association between weight retention at 6 weeks postpartum after the first pregnancy and large-for-gestational age (LGA) risk in a subsequent pregnancy.Study designA retrospective cohort study.SettingA tertiary hospital of China.Participants5950 Chinese singleton pregnancies that delivered their second singletons between 28 and 42 weeks of gestation.Outcomes measuresWe calculated the weight retention at 6 weeks postpartum after the first pregnancy (the body mass index (BMI) at 6 weeks after the first birth minus the prepregnant BMI of the first pregnancy) and the gestational weight gain in the second pregnancy. We used the logistic regression to obtain adjusted OR. We determined the relationship between maternal BMI change at 6 weeks after the first pregnancy and LGA risk in the second pregnancy.ResultsRelative to other categories of BMI change at 6 weeks postpartum, women who gained ≥3 kg/m2compared with the prepregnancy BMI were at increased LGA risk. The stratified analysis showed that LGA risk was increased in the second pregnancy in underweight and normal weight women who gained ≥3 kg/m2when using remain stable women as the reference group (OR=3.35, 95% CI 1.11 to 10.12 for underweight women; OR=2.23, 95% CI 1.43 to 3.45 for normal weight women) at 6 weeks postpartum. For the women who gained ≥3 kg/m2at 6 weeks postpartum, LGA risk was increased in normal weight women with an adequate (OR=3.21, 95% CI 1.10 to 9.33) and excessive (OR=2.62, 95% CI 1.02 to 6.76) gestational weight in the second pregnancy when using obese women as the reference.ConclusionPostpartum weight retention at 6 weeks after the first pregnancy provides us a new early window to identify LGA risk in a subsequent pregnancy and allows us to implement primary preventative strategies.
What is the extent of COVID-19 vaccine hesitancy in Bangladesh? A cross-sectional rapid national survey
Authors: Ali Mohammad , Hossain Ahmed 
Published: August 2021

ObjectivesTo assess COVID-19 vaccine hesitancy in Bangladesh and identify population subgroups with higher odds of vaccine hesitancy.DesignA nationally representative cross-sectional survey was used for this study. Descriptive analyses helped to compute vaccine hesitancy proportions and compare them across groups. Multiple logistic regression analyses were performed to compute the adjusted OR.SettingBangladesh.ParticipantsA total of 1134 participants from the general population, aged 18 years and above participated in this study.Outcome measuresPrevalence and predictors of vaccine hesitancy.ResultsOf the total participants, 32.5% showed COVID-19 vaccine hesitancy. Hesitancy was high among respondents who were men, over 60, unemployed, from low-income families, from central Bangladesh, including Dhaka, living in rented houses, tobacco users, politically affiliated, doubtful of the vaccine’s efficacy for Bangladeshis and those who did not have any physical illnesses in the past year. In the multiple logistic regression models, transgender respondents (adjusted OR, AOR=3.62), married individuals (AOR=1.49), tobacco users (AOR=1.33), those who had not experienced any physical illnesses in the past year (AOR=1.49), those with political affiliations with opposition parties (AOR=1.48), those who believed COVID-19 vaccines would not be effective for Bangladeshis (AOR=3.20), and those who were slightly concerned (AOR=2.87) or not concerned at all (AOR=7.45) about themselves or a family member getting infected with COVID-19 in the next year were significantly associated with vaccine hesitancy (p<0.05).ConclusionsGiven the high prevalence of COVID-19 vaccine hesitancy, in order to guarantee that COVID-19 vaccinations are widely distributed, the government and public health experts must be prepared to handle vaccine hesitancy and increase vaccine awareness among potential recipients. To address these issues and support COVID-19 immunisation programs, evidence-based educational and policy-level initiatives must be undertaken especially for the poor, older and chronically diseased individuals.
Sex disparity in subsequent outcomes in survivors of coronary heart disease
Authors: Akyea Ralph Kwame , Kontopantelis Evangelos , Kai Joe , Weng Stephen F , Patel Riyaz S , Asselbergs Folkert W , Qureshi Nadeem 
Published: August 2021

ObjectiveEvidence on sex differences in outcomes after developing coronary heart disease (CHD) has focused on recurrent CHD, all-cause mortality or revascularisation. We assessed sex disparities in subsequent major adverse cardiovascular events (MACE) in adults surviving their first-time CHD.MethodsUsing a population-based cohort obtained from the Clinical Practice Research Datalink (CPRD GOLD) linked to hospitalisation and death records in the UK, we identified 143 702 adults (aged ≥18 years) between 1 January 1998 and 31 December 2017 with no prior history of MACE. MACE outcome was a composite of recurrent CHD, stroke, peripheral vascular disease, heart failure and cardiovascular-related mortality. Multivariable models (Cox and competing risks regressions) were used to assess differences between sexes.ResultsThere were 143 702 adults with any incident CHD (either angina, myocardial infarction or coronary revascularisation). Women (n=63 078, 43.9%) were older than men (median age, 73 vs 66 years). First subsequent MACE outcome was observed in 91 706 (63.8%). Women had a significantly lower risk of MACE (hazard ratio (HR), 0.68 (95% CI 0.67 to 0.69); sub-hazard ratio (HRsd), 0.71 (0.70 to 0.72), respectively) and recurrent CHD (n=66 543, 46.3%) (HR, 0.60 (0.59 to 0.61); HRsd, 0.62 (0.61 to 0.63)) when compared with men after incident CHD. However, women had a significantly higher risk of stroke (n=5740, 4.0%) (HR, 1.26 (1.19 to 1.33); HRsd, 1.32 (1.25 to 1.39)), heart failure (n=7905, 5.5%) (HR, 1.09 (1.04 to 1.15); HRsd, 1.13 (1.07 to 1.18)) and all-cause mortality (n=29 503, 20.5%) (HR, 1.05 (1.02 to 1.07); HRsd, 1.11 (1.08 to 1.13)).ConclusionsAfter incident CHD, women have lower risk of composite MACE and recurrent CHD outcomes but higher risk of stroke, heart failure, and all-cause mortality compared with men.
Reference standards for gene fusion molecular assays on cytological samples: an international validation study
Authors: Malapelle Umberto , Pepe Francesco , Pisapia Pasquale , Altimari Annalisa , Bellevicine Claudio , Brunnström Hans , Bruno Rossella , Büttner Reinhard , Cirnes Luis , De Andrea Carlos E , de Biase Dario , Dumur Catherine I , Ericson Lindquist Kajsa , Fontanini Gabriella , Gautiero Eugenio , Gentien David , Hofman Paul , Hofman Veronique , Iaccarino Antonino , Lozano Maria Dolores , Mayo-de-Las-Casas Clara , Merkelbach-Bruse Sabine , Pagni Fabio , Roman Ruth , Schmitt Fernando C , Siemanowski Janna , Roy-Chowdhuri Sinchita , Tallini Giovanni , Tresserra Francesc , Vander Borght Sara , Vielh Philippe , Vigliar Elena , Vita Giulia Anna Carmen , Weynand Birgit , Rosell Rafael , Molina Vila Miguel Angel , Troncone Giancarlo 
Published: August 2021

AimsGene fusions assays are key for personalised treatments of advanced human cancers. Their implementation on cytological material requires a preliminary validation that may make use of cell line slides mimicking cytological samples. In this international multi-institutional study, gene fusion reference standards were developed and validated.MethodsCell lines harbouringEML4(13)–ALK(20) andSLC34A2(4)–ROS1(32) gene fusions were adopted to prepare reference standards. Eight laboratories (five adopting amplicon-based and three hybridisation-based platforms) received, at different dilution points two sets of slides (slide A 50.0%, slide B 25.0%, slide C 12.5% and slide D wild type) stained by Papanicolaou (Pap) and May Grunwald Giemsa (MGG). Analysis was carried out on a total of 64 slides.ResultsFour (50.0%) out of eight laboratories reported results on all slides and dilution points. While 12 (37.5%) out of 32 MGG slides were inadequate, 27 (84.4%) out of 32 Pap slides produced libraries adequate for variant calling. The laboratories using hybridisation-based platforms showed the highest rate of inadequate results (13/24 slides, 54.2%). Conversely, only 10.0% (4/40 slides) of inadequate results were reported by laboratories adopting amplicon-based platforms.ConclusionsReference standards in cytological format yield better results when Pap staining and processed by amplicon-based assays. Further investigation is required to optimise these standards for MGG stained cells and for hybridisation-based approaches.
Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760)
Authors: Leighl Natasha B , Redman Mary W , Rizvi Naiyer , Hirsch Fred R , Mack Philip C , Schwartz Lawrence H , Wade James L , Irvin William J , Reddy Sreekanth C , Crawford Jeffrey , Bradley Jeffrey D , Stinchcombe Thomas E , Ramalingam Suresh S , Miao Jieling , Minichiello Katherine , Herbst Roy S , Papadimitrakopoulou Vassiliki A , Kelly Karen , Gandara David R 
Published: August 2021

IntroductionS1400F is a non-match substudy of Lung Cancer Master Protocol (Lung-MAP) evaluating the immunotherapy combination of durvalumab and tremelimumab to overcome resistance to anti-programmed death ligand 1 (PD-(L)1) therapy in patients with advanced squamous lung carcinoma (sq non-small-cell lung cancer (NSCLC)).MethodsPatients with previously treated sqNSCLC with disease progression after anti-PD-(L)1 monotherapy, who did not qualify for any active molecularly targeted Lung-MAP substudies, were eligible. Patients received tremelimumab 75 mg plus durvalumab 1500 mg once every 28 days for four cycles then durvalumab alone every 28 days until disease progression. The primary endpoint was the objective response rate (RECIST V.1.1). Primary and acquired resistance cohorts, defined as disease progression within 24 weeks versus ≥24 weeks of starting prior anti-PD-(L)1 therapy, were analyzed separately and an interim analysis for futility was planned after 20 patients in each cohort were evaluable for response.ResultsA total of 58 eligible patients received drug, 28 with primary resistance and 30 with acquired resistance to anti-PD-(L)1 monotherapy. Grade ≥3 adverse events at least possibly related to treatment were seen in 20 (34%) patients. The response rate in the primary resistance cohort was 7% (95% CI 0% to 17%), with one complete and one partial response. No responses were seen in the acquired resistance cohort. In the primary and resistance cohorts the median progression-free survival was 2.0 months (95% CI 1.6 to 3.0) and 2.1 months (95% CI 1.6 to 3.2), respectively, and overall survival was 7.7 months (95% CI 4.0 to 12.0) and 7.6 months (95% CI 5.3 to 10.2), respectively.ConclusionDurvalumab plus tremelimumab had minimal activity in patients with advanced sqNSCLC progressing on prior anti-PD-1 therapy.Trial registration numberNCT03373760.
Nomogram to predict the outcomes of patients with microsatellite instability-high metastatic colorectal cancer receiving immune checkpoint inhibitors
Authors: Pietrantonio Filippo , Lonardi Sara , Corti Francesca , Infante Gabriele , Elez Maria Elena , Fakih Marwan , Jayachandran Priya , Shah Aakash Tushar , Salati Massimiliano , Fenocchio Elisabetta , Salvatore Lisa , Curigliano Giuseppe , Cremolini Chiara , Ambrosini Margherita , Ros Javier , Intini Rossana , Nappo Floriana , Damian Silvia , Morano Federica , Fucà Giovanni , Overman Michael , Miceli Rosalba 
Published: August 2021

BackgroundThe efficacy of immune checkpoint inhibitors (ICIs) in patients with microsatellite instability (MSI)-high metastatic colorectal cancer (mCRC) is unprecedented. A relevant proportion of subjects achieving durable disease control may be considered potentially ‘cured’, as opposed to patients experiencing primary ICI refractoriness or short-term clinical benefit. We developed and externally validated a nomogram to estimate the progression-free survival (PFS) and the time-independent event-free probability (EFP) in patients with MSI-high mCRC receiving ICIs.MethodsThe PFS and EFP were estimated using a cure model fitted on a developing set of 163 patients and validated on a set of 146 patients with MSI-high mCRC receiving anti-programmed death (ligand)1 (PD-(L)1) ± anticytotoxic T-lymphocyte antigen 4 (CTLA-4) agents. A total of 23 putative prognostic factors were chosen and then selected using a random survival forest (RSF). The model performance in estimating PFS probability was evaluated by assessing calibration (internally—developing set and externally—validating set) and quantifying the discriminative ability (Harrell C index).ResultsRFS selected five variables: ICI type (anti-PD-(L)1 monotherapy vs anti-CTLA-4 combo), ECOG PS (0 vs >0), neutrophil-to-lymphocyte ratio (≤3 vs >3), platelet count, and prior treatment lines. As both in the developing and validation series most PFS events occurred within 12 months, this was chosen as cut-point for PFS prediction. The combination of the selected variables allowed estimation of the 12-month PFS (focused on patients with low chance of being cured) and the EFP (focused on patients likely to be event-free at a certain point of their follow-up). ICI type was significantly associated with disease control, as patients receiving the anti-CTLA-4-combination experienced the best outcomes. The calibration of PFS predictions was good both in the developing and validating sets. The median value of the EFP (46%) allowed segregation of two prognostic groups in both the developing (PFS HR=3.73, 95% CI 2.25 to 6.18; p<0.0001) and validating (PFS HR=1.86, 95% CI 1.07 to 3.23; p=0.0269) sets.ConclusionsA nomogram based on five easily assessable variables including ICI treatment was built to estimate the outcomes of patients with MSI-high mCRC, with the potential to assist clinicians in their clinical practice. The web-based system ‘MSI mCRC Cure’ was released.
Use of a sheathless 8-French balloon guide catheter (Walrus) through the radial artery for mechanical thrombectomy: technique and case series
Authors: Dossani Rimal H , Waqas Muhammad , Monteiro Andre , Cappuzzo Justin M , Almayman Faisal , Snyder Kenneth V , Levy Elad I , Siddiqui Adnan H , Davies Jason M 
Published: August 2021

BackgroundThe effectiveness of transradial stroke thrombectomy has been limited by guide catheter size and lack of good balloon options. In this study we describe our technique for the use of a sheathless 8-French balloon guide catheter (Walrus) through radial access and present our initial clinical experience.MethodsThis was a retrospective case series of consecutive patients who underwent mechanical thrombectomy for large vessel occlusion using the sheathless catheter over a period of 3 months. Clinical characteristics, procedural details, reperfusion success (modified Thrombolysis in Cerebral Infarction (mTICI) 2b–3 grade), first-pass effect (FPE; mTICI reperfusion grade 2c or 3 with a single pass), access site complications and clinical improvement at discharge were recorded. A descriptive analysis was performed.ResultsAmong the 10 patients in the series, median age was 77 years (IQR 75–79) and three were women. All patients had a baseline modified Rankin Scale score ≤2. Median admission National Institutes of Health Stroke Scale (NIHSS) score was 12.5 (IQR 9–16). Four patients received intravenous alteplase before mechanical thrombectomy. Eight patients had M1 occlusion and two had proximal M2 occlusion. The median radial artery diameter was 2.5 mm (IQR 2.5–2.7). Successful reperfusion was achieved in all patients. FPE was achieved in six patients. No access site-related complications or post-procedural intracranial hemorrhages occurred. All patients had improvement in NIHSS score at discharge.ConclusionsThe use of this sheathless catheter for transradial access was safe and feasible. The technique can potentially improve the outcomes of transradial access for stroke intervention.
Interventional and surgical management of internal jugular venous stenosis: a narrative review
Authors: Pang Sharon , Kolarich Andrew R , Brinjikji Waleed , Nakaji Peter , Hepworth Ed , Hui Ferdinand 
Published: August 2021

BackgroundA small subset of patients with presumed idiopathic intracranial hypertension are found to have isolated internal jugular vein stenosis (IJVS).ObjectiveTo review the current interventions used in patients who present with intracranial hypertension secondary to IJVS.MethodsIn December 2020, we performed a literature search on Pubmed/Medline and Scopus databases for original articles studying surgical and endovascular interventions used for intracranial hypertension in the setting of internal jugular vein stenosis. No date, patient population, or study type was excluded.ResultsAll studies that included at least one case in which a surgical or endovascular intervention was used to treat IJVS were included. Selection criteria for patients varied, most commonly defined by identification of compression of the internal jugular vein. The 17 studies included in this review ranged from case reports to large single-center cohort studies. The most used surgical intervention was styloidectomy. Styloidectomy had an overall better outcome success rate (79%) than angioplasty/stenting (66%). No complications were recorded in any of the surgical cases analyzed. Outcome measures varied, but all studies recorded clinical symptoms of the patients.ConclusionFew current large cohort studies analyze surgical and endovascular interventions for patients with IJVS. Notably, the most common intervention is styloidectomy, followed by internal jugular vein stenting. By understanding the trends and experience of interventionalists and surgeons, more focused and larger studies can be performed to determine effective strategies with the best clinical outcomes.
Safety and efficacy of tenecteplase versus alteplase in patients with acute ischaemic stroke (TRACE): a multicentre, randomised, open label, blinded-endpoint (PROBE) controlled phase II study
Authors: Li Shuya , Pan Yuesong , Wang Ziran , Liang Zhigang , Chen Huisheng , Wang Dong , Sui Yi , Zhao Xingquan , Wang Yilong , Du WanLiang , Zheng Huaguang , Wang Yongjun 
Published: August 2021

BackgroundTenecteplase (TNK) possesses several pharmacological characteristics superior to conventional alteplase (rt-PA), with well-established safety and efficacy profile in Caucasians. There exists controversy over the optimal dose of intravenous rt-PA for East Asians with acute ischaemic stroke (AIS). Current study aimed to determine the safety dose range of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) for patients with AIS in China.MethodsThis multicentre, prospective, randomised, open-label, blinded end-point, phase II study compared three tiers of 0.1, 0.25, 0.32 mg/kg rhTNK-tPA (to a maximum of 40 mg) with standard 0.9 mg/kg rt-PA (to a maximum of 90 mg) in patients who were eligible for intravenous thrombolysis. The safety outcome were symptomatic intracranial haemorrhage (sICH) within 36 hours.ResultsBetween May 2018 and February 2020, 240 patients were randomly assigned to four group, 4 of whom did not receive study treatment. The intention-to-treat analysis included 236 patients. There was no difference in the improvement on National Institutes of Health Stroke Scale at day 14 in the 3 tiers and control group (63.3%, 77.2%, 66.7% vs 62.7%). The number of sICH was 3 of 60 (5.0%) in the 0.1 mg/kg group, none in the 0.25 mg/kg group, 2 of 60 (3.3%) in the 0.32 mg/kg group and 1 (1.7%) of 59 in the rt-PA group. There were no significant between-group differences in severe adverse events.ConclusionsSimilar to the Caucasians, rhTNK-tPA was well tolerated in Chinese patients with AIS at all doses administered within 3 hours of symptom onset. The dose-efficacy profile of rhTNK-tPA needs to be established with future investigations.Trial registration numberNCT04676659.