scholarly journals A retrospective observational study to evaluate the clinical outcomes and routine management of patients with chronic lymphocytic leukaemia treated with idelalisib and rituximab in the UK and Ireland (RETRO‐idel)

2021 ◽  
Author(s):  
Toby A. Eyre ◽  
Gavin Preston ◽  
Huseini Kagdi ◽  
Amin Islam ◽  
Toby Nicholson ◽  
...  
Keyword(s):  
Observational Study ◽  
Chronic Lymphocytic Leukaemia ◽  
Clinical Outcomes ◽  
Lymphocytic Leukaemia ◽  
Retrospective Observational Study ◽  
The Uk

scholarly journals A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dena R. Howard ◽  
Anna Hockaday ◽  
Julia M. Brown ◽  
Walter M. Gregory ◽  
Susan Todd ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukaemia ◽  
Type I Error ◽  
Lymphocytic Leukaemia ◽  
Experimental Therapy ◽  
Type I ◽  
Open Label ◽  
Additional Funding ◽  
Trial Structure ◽  
Randomised Controlled ◽  
The Uk

Abstract Background The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to expedite its assessment, greatly reducing the time to reach the primary outcome compared to running a separate trial and without compromising the validity of the research or the ability to recruit to the trial and report the outcomes. The methodological and practical issues are presented, describing how they were addressed to ensure the amendment was a success. Methods FLAIR was designed as a two-arm trial requiring 754 patients. In stage 2, two new arms were added: a new experimental arm and a second control arm to protect the trial in case of a change in practice. In stage 3, the original experimental arm was closed as its planned recruitment target was reached. In total, 1516 participants will be randomised to the trial. Results The changes to the protocol and randomisation to add and stop arms were made seamlessly without pausing recruitment. The statistical considerations to ensure the results for the original and new hypotheses are unbiased were approved following peer review by oversight committees, Cancer Research UK, ethical and regulatory committees and pharmaceutical partners. These included the use of concurrent comparators in case of any stage effect, appropriate control of the type I error rate and consideration of analysis methods across trial stages. The operational aspects of successfully implementing the amendments are described, including gaining approvals and additional funding, data management requirements and implementation at centres. Conclusions FLAIR is an exemplar of how an emerging experimental therapy can be assessed within an existing trial structure without compromising the conduct, reporting or validity of the trial. This strategy offered considerable resource savings and allowed the new experimental therapy to be assessed within a confirmatory trial in the UK years earlier than would have otherwise been possible. Despite the clear efficiencies, treatment arms are rarely added to ongoing trials in practice. This paper demonstrates how this strategy is acceptable, feasible and beneficial to patients and the wider research community. Trial registration ISRCTN Registry ISRCTN01844152. Registered on August 08, 2014

Ibrutinib‐associated invasive fungal diseases in patients with chronic lymphocytic leukaemia and non‐Hodgkin lymphoma: An observational study

Mycoses ◽  
2019 ◽  
Vol 62 (12) ◽  
pp. 1140-1147 ◽  
Author(s):  
Rosa Ruchlemer ◽  
Ronen Ben‐Ami ◽  
Maskit Bar‐Meir ◽  
Jennifer R. Brown ◽  
Marion Malphettes ◽  
...  
Keyword(s):  
Observational Study ◽  
Chronic Lymphocytic Leukaemia ◽  
Hodgkin Lymphoma ◽  
Lymphocytic Leukaemia ◽  
Fungal Diseases ◽  
Non Hodgkin Lymphoma ◽  
Invasive Fungal Diseases

scholarly journals Trends in end digit preference for blood pressure and associations with cardiovascular outcomes in Canadian and UK primary care: a retrospective observational study

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024970 ◽  
Author(s):  
Michelle Greiver ◽  
Sumeet Kalia ◽  
Teja Voruganti ◽  
Babak Aliarzadeh ◽  
Rahim Moineddin ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Observational Study ◽  
Diastolic Pressure ◽  
Cardiovascular Outcomes ◽  
Retrospective Observational Study ◽  
Digit Preference ◽  
The Mean ◽  
The Uk ◽  
Primary Care Practices

ObjectivesTo study systematic errors in recording blood pressure (BP) as measured by end digit preference (EDP); to determine associations between EDP, uptake of Automated Office BP (AOBP) machines and cardiovascular outcomes.DesignRetrospective observational study using routinely collected electronic medical record data from 2006 to 2015 and a survey on year of AOBP acquisition in Toronto, Canada in 2017.SettingPrimary care practices in Canada and the UK.ParticipantsAdults aged 18 years or more.Main outcome measuresMean rates of EDP and change in rates. Rates of EDP following acquisition of an AOBP machine. Associations between site EDP levels and mean BP. Associations between site EDP levels and frequency of cardiovascular outcomes.Results707 227 patients in Canada and 1 558 471 patients in the UK were included. From 2006 to 2015, the mean rate of BP readings with both systolic and diastolic pressure ending in zero decreased from 26.6% to 15.4% in Canada and from 24.2% to 17.3% in the UK. Systolic BP readings ending in zero decreased from 41.8% to 32.5% in the 3 years following the purchase of an AOBP machine. Sites with high EDP had a mean systolic BP of 2.0 mm Hg in Canada, and 1.7 mm Hg in the UK, lower than sites with no or low EDP. Patients in sites with high levels of EDP had a higher frequency of stroke (standardised morbidity ratio (SMR) 1.15, 95% CI 1.12 to 1.17), myocardial infarction (SMR 1.16, 95% CI 1.14 to 1.19) and angina (SMR 1.25, 95% CI 1.22 to 1.28) than patients in sites with no or low EDP.ConclusionsAcquisition of an AOBP machine was associated with a decrease in EDP levels. Sites with higher rates of EDP had lower mean BPs and a higher frequency of adverse cardiovascular outcomes. The routine use of manual office-based BP measurement should be reconsidered.

scholarly journals The association between nurse staffing levels and a failure to respond to patients with deranged physiology: A retrospective observational study in the UK

Resuscitation ◽  
2020 ◽  
Vol 149 ◽  
pp. 202-208 ◽  
Author(s):  
Gary B. Smith ◽  
Oliver Redfern ◽  
Antonello Maruotti ◽  
Alejandra Recio-Saucedo ◽  
Peter Griffiths
Keyword(s):  
Observational Study ◽  
Nurse Staffing ◽  
Retrospective Observational Study ◽  
Staffing Levels ◽  
The Uk
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