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Sarilumab monotherapy versus sarilumab and methotrexate combination therapy in patients with rheumatoid arthritis
No full textAbstractObjective. Sarilumab, as monotherapy or in combination with conventional synthetic DMARDs, such as methotrexate (MTX), has demonstrated improvement in clinical outcomes in patients with RA. The primary objective of this post hoc analysis was to compare the efficacy of sarilumab (200 mg every 2 weeks) monotherapy (MONARCH study) with that of sarilumab and MTX combination therapy (MOBILITY study) at Week 24.Methods. The endpoints assessed were mean change from baseline in the Clinical Disease Activity Index (CDAI), 28-joint Disease Activity using C-Reactive Protein (DAS28-CRP), CRP, haemoglobin (Hb), pain visual analogue scale (VAS) and Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue. Least square (LS) mean change from baseline (95% confidence interval [CI]) at Week 24 for all endpoints was compared between the treatment arms for adjusted comparisons. Results. This analysis included 184 patients on sarilumab monotherapy and 399 patients on sarilumab plus MTX. Differences (P < 0.05) were observed in ethnicity, region, body mass index group, rheumatoid factor, anti-cyclic citrullinated peptide antibodies, swollen joint count, CRP, CDAI and oral glucocorticoid use between these treatment groups. After adjusting for these differences in a mixed-effect model repeated measure, LS mean change from baseline for all assessments was similar between the treatment groups with overlapping CIs: CDAI, −28.79 vs −26.21; DAS28-CRP, −2.95 vs −2.81; CRP, −18.31 vs −16.46; Hb, 6.59 vs 8.09; Pain VAS, −33.62 vs −31.66; FACIT-Fatigue, 9.90 vs 10.24. Conclusion. This analysis demonstrated that the efficacy of sarilumab monotherapy was similar to that of sarilumab and MTX combination therapy.Keywords: rheumatoid arthritis, sarilumab, IL-6Ri, MONARCH, MOBILITY, monotherapy, combination with MTX
Resected Pancreatic Ductal Adenocarcinoma: understanding tumour tropism to maximise benefit from surgery.
No full textIntroduction Relapse-rate in pancreatic ductal adenocarcinoma (PDAC) remains high. Identification of modifiable factors associated with relapse could improve patient selection for surgery. Methods All consecutive patients diagnosed with PDAC undergoing curative surgery between Jan’05 and Sep’17 were retrospectively analysed. Recurrence-Free Survival (RFS)/Overall Survival (OS) were estimated with Kaplan-Meier method and survival analysis performed with univariate/multivariable Cox-regression (Cox). Logistic-regression (LR) was used for identification of risk factors of tumour recurrence. Results One-hundred-eighty-two patients eligible: microscopically involved resection-margins (R1) 65.7%; adjuvant chemotherapy (adj) 62.1%; 78.6% relapsed. Median (months) RFS and OS were 11.4 (95%CI=9.4-13.7) and 21.6 (95%CI=17.9-18.9), respectivelly. Relapse patterns identified included: “local-only” 30.1%, “distant-only” 40.5%, “combined” 29.4%; overall, distant metastases were identified in 69.9% of patients; distant metastases were located mainly in the liver (41.3%) with a median time-to-liver recurrence of 6.64 months (95%CI 4.99-8.56)). Factors impacting on risk of relapse were: R1 [(any-pattern) (LR-multivariable: OR=4.02; 95%CI=0.02-0.23)], pre-adj CA19.9>normal limit (NL) [(‘local-only’) (LR-univariate: OR=0.23; 95%CI=0.08-0.62)] and adj [(‘combined’) (LR-univariate: OR=0.46; 95%CI=0.22-0.96)]. R1 associated with shorter OS (Cox-multivariable: OR=1.90; 95%CI=1.13-3.19) while pre-adj CA19.9>LN implied shorter RFS (Cox-multivariable: OR=2.28; 95%CI=1.38-3.76) and OS (Cox-multivariable: OR=1.84; 95%CI=1.08-3.14). Preoperative magnetic resonance imaging (MRI) liver was associated with a lower risk of relapse [(any pattern) (LR-multivariable: OR=0.06; 95%CI=0.02-0.23)] and was prognostic for longer OS (LR-multivariable: OR=0.27; 95%CI=0.09-0.74). Conclusion Majority of resected-PDAC patients will recur with distant metastases (liver); integrating preoperative MRI liver to patients’ pathway may improve patient selection and maximise benefit from surgery
Dosage, intensity and frequency of language therapy for aphasia: an individual participant data network meta-analysis
No full textBackground and purposeOptimizing speech-language therapy (SLT) regimens for maximal aphasia recovery is a clinical-research priority. We examined associations between SLT intensity (hours/weekly), dosage (total hours), frequency (days/weekly), duration (weeks), delivery (face-to-face, computer-supported, individual-tailoring, home-practice), content, and language outcomes for people with aphasia.MethodsDatabases including MEDLINE and Embase were searched (inception-09/2015). Published, unpublished and emerging trials including SLT and ≥10 Individual Participants’ Data (IPD) on aphasia, language outcomes and time post-onset were selected. Patient-level data on stroke, language, SLT and trial risk of bias were independently extracted. Outcome measurement scores were standardized. A statistical inferencing, one-stage, random effects, network meta-analysis approach filtered IPD into an optimal model examining SLT regimen for overall-language, auditory comprehension, naming and functional-communication pre-post intervention gains, adjusting for a-priori defined covariates (age, sex, time post-stroke, baseline aphasia severity), reporting estimates of mean change scores (95% CI).ResultsData from 959 IPD (25 trials) were included. Greatest gains in overall-language and comprehension were associated with >20 to 50 hours SLT dosage (18·37 [10.58, 26·16] Western Aphasia Battery-Aphasia-Quotient; 5.23 [1·51, 8·95] Aachen Aphasia Test-Token Test). Greatest clinical overall-language, functional-communication and comprehension gains were associated with 2-4 and 9+ SLT hours/weekly. Greatest clinical gains were associated with frequent SLT for overall-language, functional-communication (3-5+ days/weekly) and comprehension (4-5 days/weekly). Evidence of comprehension gains was absent for SLT ≤20 hours, <3 hours/weekly and ≤3 days/weekly. Mixed receptive-expressive therapy, functionally-tailored, with prescribed home-practice was associated with greatest overall gains. Relative variance was <30%. Risk of trial-bias was low-to-moderate; low for meta-biases.ConclusionsGreatest language recovery was associated with frequent, functionally-tailored, receptive-expressive SLT, with prescribed home-practice at a greater intensity and duration than reports of usual clinical services internationally. These exploratory findings suggest critical therapeutic ranges, informing hypothesis-testing trials and tailoring of clinical services.RegistrationPROSPERO CRD4201811094
The structure format of abstracts: A survey of leading dental journals and their editors
No full textObjectives: To present the actual usage of different structure formats in abstracts of randomizedcontrolled trials (RCTs) and systematic reviews (SRs) published in SCIE-indexed dental journals,and to assess the awareness, knowledge, as well as attitudes towards the structured formats of RCTand SR abstracts among editors-in-chief (EICs) of dental journals.Methods: In the first part of this study, we selected SCIE-indexed dental journals and assessed theireligibility according to pre-determined criteria. All RCTs and SRs published in the included journalsduring January-June 2020 were identified through a hand-search. The actual usage of differentstructure formats and headings, as well as relevant editorial policies were extracted. In the secondpart, an anonymous online survey among the EICs of included dental journals was conducted.Results: A total of 88 journals were included, from which 364 RCT abstracts and 130 SR abstractswere identified. For RCT abstracts, 86% were structured, with 83% in IMRaD format (Introduction,Methods, Results, and Discussion) and 3% in highly structured (HS) format. For SR abstracts, 80%were structured, including 73% in IMRaD and 7% in HS format. According to the “instructions toauthors”, most journals required either IMRaD (68%) or HS (5%) for RCTs, while less than halfrequired either IMRaD (36%) or HS (9%) for SRs. Twenty-one (24%) EICs participated in oursurvey, among which 18 agreed that structured formats could improve the reporting quality of RCTabstracts, while only 12 of them thought HS format should be widely recommended in the dentalfield.Conclusions: Compared with the HS format, IMRaD was more frequently used and required amongRCT and SR abstracts in dentistry. Structured formats held a relatively high degree of recognitionamong EICs of dental journals. Joint efforts are needed for improving the awareness and usage ofHS format
Analysis of Accelerometer Data for Personalised Abnormal Behaviour Detection in Activities of Daily Living
No full textThis paper proposes a novel approach to identify personalised abnormal behaviour in Activities of Daily Living (ADLs) using accelerometer sensor data. The ADLs considered are: (i) preparing and drinking tea, and (ii) preparing and drinking coffee. Abnormal behaviour identified in the context of these activities can be an indicator of a progressive health problem or the occurrence of a hazardous incident. Monitoring ADLs for detecting abnormal behaviour is of particular importance due to the potential life changing consequences that could result from not acting timely. Prior to performing ADLs, the participants were asked six questions related to their well-being and mood. In addition to data collected from accelerometers, data was also collected from contact and thermal sensors, and radar. The work presented is a first step towards a more personalised approach in which individual user profiles are considered as it is acknowledged that people behave differently from each other. Thus, data was collected seven times for each participant. We have evaluated our approach with accelerometer data collected from 15 participants. The experimental results show that accelerometer data is sufficient to identify the main stages of the ADLs considered, and therefore, any unusual changes in the signals and duration could mean that abnormal behaviour occurred.Keywords: Activities of Daily Living · ADLs · Activity Recognition · Accelerometer · Mood · Sensors.<br/
Involving patients and carers in patient safety in primary care: a qualitative study of a co-designed patient safety guide.
No full textBackgroundInvolving patients is a key premise of national and international policies on patient safety, which requires understanding how patients or carers want to be involved and developing resources to support this. This paper examines patients and carers views of being involved in patient safety in primary care and their views of potentially using a co-designed patient safety guide for primary care (PSG-PC) to foster both involvement and their safety. MethodsA qualitative study using semi-structured face-to-face interviews with 18 patients and/or carers in primary care. Interviews were transcribed and analysis conducted using an inductive thematic approach.Results Overall participants expressed enthusiasm for the PSG-PC as a tool to support patients and carers to be involved in patient safety in primary care. However, for some participants being involved in patient safety was seen as taking on the role of General Practitioner and had the potential to add an additional workload for patients. Participants’ willingness or ability to be involved in patient safety was influenced by a range of factors including an invisible, often under acknowledged role of everyday safety for patients’ interactions with primary care; the levels of involvement that patients wanted in their care and safety; and the work of embedding the PSG-PC for patients into their routine interactions with primary care. Participants identified components of the PSG-PC that would be useful to them, in particular if they had a responsibility for caring for a family member, if they had more complex care or long-term conditions. ConclusionInvolving patients and carers in patient safety needs a tailored and personalised approach that enables patients and carers to use resources like the PSG-PC routinely and help challenge assumptions about their willingness and ability to be involved in patient safety. Doing so would raise awareness of opportunities to be involved in safety in line with personal preference. Patient or Public contributionPatient and public involvement was central to the research study. This included working in partnership to develop the PSG-PC with patients and carers and throughout our study including in the design of the study, recruiting participants, interpretation of findings.<br/
Development and stabilization of a low-cost single-tilt tricopter ?
No full textIn this paper, a low-cost single-tilting tricopter aerial vehicle is developed withoptical flow estimation for indoor navigation. A dynamic model is derived and experimental data is used to obtain the actuator constants. A CAD model is then developed and is used to obtain the moments of inertia with respect to the three main axes. A control allocation algorithm is also proposed to solve the problem of the number of control inputs being more than the number of actuators since the single rotor tilt tricopter has only four actuators (3 rotors and 1 servo). A cascaded-PID control scheme is then used to stabilize the tricopter in hover mode. The simulation results yield realistic control inputs and the outputs have acceptable performance. The feasibility of the proposed scheme is then validated with some experiments on the developed tricopter platform in hover
Spirometry performed as part of the Manchester community-based lung cancer screening programme detects a high prevalence of airflow obstruction in individuals without a prior diagnosis of COPD
No full textBackground: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality in populations eligible for lung cancer screening. We investigated the role of spirometry in a community-based lung cancer screening programme. Methods: Ever smokers, age 55-74, resident in three deprived areas of Manchester were invited to a ‘Lung Health Check’ (LHC) based in convenient community locations. Spirometry was incorporated into the LHCs alongside lung cancer risk estimation (PLCOM2012), symptom assessment and smoking cessation advice. Those at high risk of lung cancer (PLCOM2012≥1.51%) were eligible for annual low-dose CT (LDCT) screening over two screening rounds. Airflow obstruction was defined as FEV1/FVC<0.7. Primary care databases were searched for any prior diagnosis of COPD. Results: 99.4% (n=2,525) of LHC attendees successfully performed spirometry; mean age was 64.1±5.5, 51% were female, 35% were current smokers. 37.4% (n=944) had airflow obstruction of which 49.7% (n=469) had no previous diagnosis of COPD. 53.3% of those without a prior diagnosis were symptomatic (n=250/469). After multivariate analysis the detection of airflow obstruction without a prior COPD diagnosis was associated with male sex (adjOR 1.84, 95%CI 1.37-2.47; p<0.0001), younger age (p=0.015), lower smoking duration (p<0.0001), fewer cigarettes per day (p=0.035), higher FEV1/FVC ratio (<0.0001) and being asymptomatic (adjOR 4.19, 95%CI 2.95-5.95; p<0.0001). The likelihood of screen detected lung cancer was significantly greater in those with evidence of airflow obstruction who had a previous diagnosis of COPD (adjOR 2.80, 95%CI 1.60-8.42; p=0.002). Conclusions: Incorporating spirometry into a community-based targeted lung cancer screening programme is feasible and identifies a significant number of individuals with airflow obstruction who do not have a prior diagnosis of COPD
Reflections on the forum in the Review of International Studies:A conversation between Cristina Masters and Marysia Zalewski
No full textAdoption, use and non-use of hearing aids: a robust estimate based on Welsh national survey statistics
No full textObjective: To report a robust measure of the proportion of adults who do not use their hearing aids.Design: Data on hearing aid use was extracted from national household survey data, from 2004 to 2018 in Wales, UK.Study sample: A representative sample of 10,000 to 16,000 adults per year.Results: Self-reported hearing difficulty increased smoothly from 14 to 16% during the 12 years when survey administration remained unchanged. The proportion reporting that they had tried a hearing aid increased from 5 to 7% and stabilised at this level since 2011. The proportion who reported using their hearing aid most of the time increased from 47% to 52% during the 15 year period. The proportion who did not use their hearing aids at all decreased from 21% to 18% over the same period.Conclusions: In this extensively-surveyed population, approximately 20% of adults currently do not use their hearing aids at all, 30% use them some of the time and the remaining 50% most of the time. Hearing aids are valued by many, as judged by use, but there is substantial room for improvement. Inclusion of questions on use within a large-scale, regular national survey enables collection of demonstrably reliable data