Safety of fluticasone propionate prescribed for asthma during pregnancy: A UK population-based cohort study

Background: Asthma is commonly treated during pregnancy, yet data on the safety of asthma medicines used during pregnancy are sparse. Objective: The objective of this study was to evaluate the safety of the inhaled corticosteroid (ICS) fluticasone propionate (FP), alone and in fixed-dose combination with salmeterol (FSC) in terms of the risk of all major congenital malformations (MCMs), compared with all other non-FP ICS. Methods: Women with asthma who had a pregnancy between January 1, 2000, and December 31, 2010, were identified in the United Kingdom's Clinical Practice Research Datalink. Exposure to asthma medicines during the first trimester of pregnancy was based on issued prescriptions. The mothers' and infants' medical records were linked where possible, and pregnancy outcomes with an MCM diagnosed by age 1 year were identified based on medical codes in the mother's and infant's medical records, including those MCMs prenatally diagnosed that ended in an induced pregnancy termination. The absolute and relative risks of an MCM after different ICS exposures, stratified by the asthma treatment intensity level, were calculated. Results: A total of 14,654 mother-infant pairs were identified, of which 6,174 received an ICS prescription during the first trimester, in addition to 13 first trimester ICS exposed pregnancies that ended in an induced termination after a prenatal MCM diagnosis. In total, 5,362 pregnancies were eligible for the primary analysis at age 1 year. The absolute risk of an MCM after any first trimester FP exposure was 2.4% (CI95 0.8-4.1) and2.7% (CI95 1.8-3.6) for the "moderate" and "considerable/severe" asthma treatment intensity levels, respectively. The adjusted odds ratios when compared with non-FP ICS were 1.1 (CI95 0.5-2.3) and 1.2 (CI95 0.7-2.0) for the "moderate" and "considerable/severe" intensity levels; risks for any FP and for FSC did not differ substantially. Conclusion: No increase in the overall risk of MCMs was identified after first trimester FP exposure compared with non-FP ICS. © 2015 American Academy of Allergy, Asthma & Immunology

Risk of uveitis and inflammatory bowel disease in people with psoriatic arthritis: a population based cohort study

ObjectivesTo determine the risk of uveitis and inflammatory bowel disease (IBD) in patients with psoriatic arthritis (PsA) compared with the general population and patients with psoriasis.MethodsA cohort study using data from the UK Clinical Practice Research Datalink between 1998 and 2014. Patients with incident PsA aged 18–89 years were identified and matched to a cohort of patients with psoriasis and a general population cohort. The incidence of uveitis, all IBD, Crohn’s disease and ulcerative colitis was calculated for each study cohort and adjusted relative risks (RRadj) were calculated using conditional Poisson regression.Results6783 incident cases of PsA were identified with a median age of 49 years. The risk of uveitis was significantly higher in the PsA cohort than in the general population and psoriasis cohorts (RRadj 3.55, 95% CI 2.21 to 5.70 and RRadj 2.13, 95% CI 1.40 to 3.24, respectively). A significant increase was observed for Crohn’s disease (RRadj 2.96, 95% CI 1.46 to 6.00 and RRadj3.60, 95% CI 1.83 to 7.10) but not for ulcerative colitis (RRadj1.30, 95% CI 0.66 to 2.56 and RRadj0.98, 95% CI 0.50 to 1.92).ConclusionsIn a primary care-based incidence cohort of patients with PsA, there were substantial risks of developing uveitis and/or Crohn’s disease, but not ulcerative colitis, when compared with the general population and psoriasis controls.</jats:sec

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

Objectives: To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability. Setting: Two UK cystic fibrosis (CF) units. Participants: Fourteen adult PWCF; three professionals delivering adherence support (‘interventionists’); five multi-disciplinary CF team members. Interventions: Nebuliser with data recording and transfer capability, linked to a software platform, and strategies to support adherence to nebulised treatments facilitated by interventionists over 5 months (± 1 month). Primary and secondary measures: Feasibility and acceptability of the intervention, assessed through semistructured interviews, questionnaires, fidelity assessments and click analytics. Results: Interventionists were complimentary about the intervention and training. Key barriers to intervention feasibility and acceptability were identified. Interventionists had difficulty finding clinic space and time in normal working hours to conduct review visits. As a result, fewer than expected intervention visits were conducted and interviews indicated this may explain low adherence in some intervention arm participants. Adherence levels appeared to be >100% for some patients, due to inaccurate prescription data, particularly in patients with complex treatment regimens. Flatlines in adherence data at the start of the study were linked to device connectivity problems. Content and delivery quality fidelity were 100% and 60%–92%, respectively, indicating that interventionists needed to focus more on intervention ‘active ingredients’ during sessions. Conclusions: The process evaluation led to 14 key changes to intervention procedures to overcome barriers to intervention success. With the identified changes, it is feasible and acceptable to support medication adherence with this intervention. Trial registration number: ISRCTN13076797; Results

Supporting medication adherence for adults with cystic fibrosis:a randomised feasibility study

Background Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. Methods Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. Participants: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. Interventions: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32). Outcomes: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5). Results The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June–September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. Conclusions With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible

Does current reporting of lung function by the UK Cystic Fibrosis Registry allow a fair comparison of adult centres?

Background:Outcome data for UK cystic fibrosis centres are publicly available in an annual report, which ranks centres by median FEV1% predicted. We wished to assess whether there are differences in lung function outcomes between adult centres that might imply differing standards of care.Methods:UK Registry data from 4761 subjects at 34 anonymised adult centres were used to calculate mean FEV1% and rate of change of lung function for 2007–13. These measures were used to rank centres and compare outcomes.Results:There are minor differences between centres for mean FEV1% for some years of the study and for rate of change of lung function over the study period. However, rankings are critically dependent on the outcome measure chosen and centre variation becomes negligible once patient population characteristics are taken into account.Conclusions:We have demonstrated that the ranking of centres is biased and any apparent difference in respiratory outcomes is unlikely to be related to differing standards of care between centres

Difficulties associated with access to training and clinical support for Reporting Radiographers – A narrative evidence synthesis

Objectives: This narrative synthesis of evidence identifies and explores issues that impact upon the expansion or effectiveness of Reporting Radiographers working in all diagnostic modalities within the United Kingdom (UK). The publication focuses on accessibility to training for prospective Reporting Radiographers as well as clinical support within and beyond training. Key findings: Fifteen studies informed the themes of this article, they were published between 2014 and 2021. Reporting Radiographers often found it difficult find support during training and once qualified, this was usually due to the availability and workload of supervising staff. Although resistance and obstruction were experienced by many. Concerns relating to pay, promotion and interest were expressed by some respondents whilst access to courses and finance were highlighted as areas of variance across the UK. Conclusion: Inadequate support of Reporting Radiographers is impairing expansion of the specialism, whilst impacting capability and morale. This increases risk of patient harm, delays to care and inefficiency, it also threatens the sustainability of services. Negative interactions between Reporting Radiographers and Radiologists or managers is disappointing considering development of the specialism; evidence of Reporting Radiographer effectiveness and current collaboration between Royal College of Radiologists and Society of Radiographers. Issues raised in relation to pay/promotion and litigation could be clarified with ease, this should be considered when guidance is updated. Access to finance and courses is a major barrier in some regions of the UK. Scope exists for further exploration of training. England has used grants to facilitate uptake, these may prove to be an important tool in other countries. Implications for practice: Drivers to increase recruitment should be implemented alongside measures to facilitate accessibility to training and improvements to support infrastructure