Rescue therapy within the <scp>UK C</scp>ystic <scp>F</scp>ibrosis <scp>R</scp>egistry: <scp>A</scp>n exploration of predictors of intravenous antibiotic use amongst adults with <scp>CF</scp>

Hoo, Zhe Hui; Wildman, Martin J; Curley, Rachael; Walters, Stephen J; Campbell, Mike

doi:10.1111/resp.13174

Cited by 5 publications

(10 citation statements)

References 47 publications

(81 reference statements)

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“…For most participants we obtained consent to have their adherence data collected beyond their active trial period, until 30 April 2017. Participants were randomised to intervention or control arms using a computer-generated pseudo-random list and random permuted blocks of varying sizes (2,4 and 6), stratified by site and number of IVAB days in the previous 12 months (≤/> 14 days) [24].…”

Section: Methodsmentioning

confidence: 99%

“…Low adherence predicts exacerbations requiring intravenous antibiotics (IVAB) [15, 16], which carry a risk of systemic side effects and increased mortality [17, 18], and result in higher care costs [19–21]. During 2012 the total UK spend for CF was estimated to be £110 million [22]of which £30 million was spent on inhaled antibiotics and mucolytics [23]; the following year the UK adults with CF population received 103,453 days of IVAB [24] with 54% occurring in hospital, [25].…”

Section: Introductionmentioning

confidence: 99%

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

Hind

Drabble²,

Arden

et al. 2019

BMC Pulm Med

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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; FEV 1 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 FEV 1 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. Trial registration ISRCTN13076797...

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Hind

Drabble²,

Arden

et al. 2019

BMC Pulm Med

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“…Negative binomial regression was used to analyse exacerbation and IV use events, since these are count data with over-dispersion (~40% of the population have no IV use over a 1-year period [24]).…”

Section: Methodsmentioning

confidence: 99%

“…IV use was consistently associated with pancreatic status, P. aeruginosa status, gender and %FEV1 in recent UK registry analysis. [24] %FEV1 were categorised as <40%, 40-69.9% and ≥70%, since these are internationally accepted to reflect different states of lung health [29] and are also applicable to UK data [24]. SPSS v25 (IBM Corp) was used for analyses.…”

Section: Methodsmentioning

confidence: 99%

Intravenous antibiotic use and exacerbation events in an adult cystic fibrosis centre: A prospective observational study

Hoo

Bramley

Curley

et al. 2019

Respiratory Medicine

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Introduction In CF, people with higher FEV1 are less aggressively treated with intravenous (IV) antibiotics, with resultant negative impact on their health outcomes. This could be entirely clinician-driven, but patient choice may also influence IV use. In this prospective observational study, we explored IV recommendations by clinicians and IV acceptance by adults with CF to understand how clinical presentations consistent with exacerbations resulted in IV use. Methods Clinical presentations consistent with exacerbations, IV recommendation by clinicians and IV acceptance by patients were prospectively identified for every adult with CF in Sheffield throughout 2016, excluding those who had lung transplantation (n=7) or on ivacaftor (n=13). Relevant demographic data, e.g. %FEV1, were extracted from medical records. Multi-level mixed-effects logistic regression models were used to compare IV recommendations vs non-recommendations for all clinical encounters, and IV acceptance vs non-acceptance for all IV recommendations. Results Among 186 adults (median age 27 years, median FEV1 78.5%), there were 434 exacerbation events and 318 IV use episodes following 1010 clinical encounters. Only 254 (58.5%) of exacerbations were IV treated. A diagnosis of exacerbation, higher number of symptoms and lower %FEV1 were independent predictors for IV recommendation by clinicians. Higher number of symptoms and lower %FEV1 were also independent predictors for IV acceptance by adults with CF. Conclusions Lower IV use among adults with higher %FEV1 was influenced by both clinicians' and patients' decisions. Using IV antibiotics as an exacerbation surrogate could underestimate exacerbation rates and conceal differential treatment decisions according to varying clinical characteristics.

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“…46,[58][59][60] Depressed CF patients are hospitalized for treatment of PEx more than three times as often as those without depression, but no studies have examined the impact of mental health on the overall rate of PEx including those treated as an outpatient. 61 Interestingly, the strongest predictor of IV treatment of PEx seems to be prior IV treatment of PEx 62,63 ; while it has been inferred that this may reflect a proclivity of some patients to more frequent PEx, given clinicians' subjectivity in diagnosing and treating PEx, it may just as well reflect clinician bias toward diagnosing and treating PEx in patients who have previously been treated for PEx.…”

Section: Epidemiology Of Pulmonary Exacerbationsmentioning

confidence: 99%

Reevaluating approaches to cystic fibrosis pulmonary exacerbations

Schechter

2018

Pediatric Pulmonology

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Cystic Fibrosis (CF) lung disease is characterized by intermittent acute episodes of worsening signs, symptoms, and pulmonary function; these so-called pulmonary exacerbations (PEx) appear to be important drivers of long-term declines in lung function, quality of life, and life expectancy. Surveillance for development of PEx and their treatment is a fundamental component of chronic CF management, and the merits of novel CF therapies are often judged based on their ability to reduce the frequency of PEx. Given the central role that they play, it is surprising how poorly PEx are understood, how thin is the evidence base for their treatment and how often they are left unrecognized and untreated in clinical practice. This paper reviews what is known and what is unknown regarding the nature of PEx, and discusses the impact of missed recognition and treatment of these episodes as well as the apparent variation in practice across CF care centers. The arguments supporting a liberal, highly sensitive approach to the diagnosis of PEx are presented, as well as recommendation for how care programs can achieve consistency in their early recognition and treatment. A stepwise approach to personalized treatment supported by close follow-up to ensure the successful resolution of all signs and symptoms will lead to the stabilization of patients' lung function and quality of life. Recommendations are made regarding important priorities for research into evidence-based approaches to improving the care of PEx.

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Rescue therapy within the UK Cystic Fibrosis Registry: An exploration of predictors of intravenous antibiotic use amongst adults with CF

Cited by 5 publications

References 47 publications

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

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

Intravenous antibiotic use and exacerbation events in an adult cystic fibrosis centre: A prospective observational study

Reevaluating approaches to cystic fibrosis pulmonary exacerbations

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