An overview of the management of Congestive Heart Failure in Malta

Background: In July 2003 the National Institute of Clinical Excellence (NICE) issued guidelines on the management of congestive heart failure. We set out to assess the management of congestive heart failure in St. Luke's Hospital (SLH), Malta. Methods: The files of patients admitted to SLH during the month of January 2002 were retrieved. Eligible patients were those with a history of congestive heart failure. Patients who had passed away by the time of the audit or whose files were untraceable were excluded from the audit. Data from the file pertaining to that specific admission was entered in a preprepared data sheet. This includes demographic data about the patient, investigations performed to reach diagnosis and assess severity, pharmacological and non-pharmacological management of heart failure, and planned follow-up at time of discharge. Results: The management of 97 patients was assessed. All patients with a clinical diagnosis of congestive heart failure had an electrocardiogram, chest X-ray, urea, electrolytes and creatinine estimation and a full blood count. Regarding the other tests recommended by NICE, echocardiography was performed in 28% of patients, serum glucose was assayed in 87%, liver function tests in 36%, thyroid function tests in 24%, urinalysis in 13%, lipids in 8% and spirometry in none. Two per cent of patients had lifestyle modification advice documented in the file. Pharmacological treatment consisted of diuretics (98%), ACE inhibitors (71%), angiotensin II receptor blockers (4%), ß-blockers (9%), spironolactone (12%) and digoxin (25%). Conclusions: There is still scope for improvement in the management of congestive heart failure locally.peer-reviewe

Inhaled corticosteroids for chronic obstructive pulmonary disease-the shifting treatment paradigm

Chronic obstructive pulmonary disease (COPD) guidelines suggest using inhaled corticosteroids (ICS) in patients with severe airflow limitation or those at high risk of exacerbations. This recommendation is based on evidence demonstrating that ICS, especially when prescribed in fixed-dose combinations (FDC) with long-acting β2 agonists (LABA), improve quality of life (QoL), decrease exacerbations and hospitalisations, and have been associated with a trend towards a reduction in all-cause mortality. Audit shows that routine prescribing practice frequently uses inhaler therapies outside current guidelines recommendations; severe to very severe disease constitutes about 20% of all COPD patients, but up to 75% of COPD patients are prescribed an ICS, with significant numbers given ICS/LABA as first-line maintenance therapy. The role of ICS in the treatment paradigm for COPD is changing, driven by the growing evidence of increased risk of pneumonia, and the introduction of a new class of FDC; LABA and long-acting muscarinic antagonists (LAMA), which simplify dual bronchodilation and present a plausible alternative therapy. As the evidence base for dual therapy bronchodilation expands, it is likely that maximal bronchodilation will move up the treatment algorithm and ICS reserved for those with more severe disease who are not controlled on dual therapy. This change has already manifested in local COPD algorithms, such as those at Tayside, and represents a significant change in recommended prescribing practice. This review reassesses the role of ICS in the shifting treatment paradigm, in the context of alternative treatment options that provide maximal bronchodilation

Determinants of motivation to quit in smokers screened for the early detection of lung cancer:a qualitative study

BACKGROUND: The promotion of smoking cessation within lung cancer screening could lead to benefits for smoking-related disease and improve cost-effectiveness of screening. Little is known about how smokers respond to lung cancer screening and how this impacts smoking behaviour. We aimed to understand how lung cancer screening influences individual motivations about smoking, including in those who have stopped smoking since screening.METHODS: Thirty one long-term smokers aged 51-74 took part in semi-structured interviews about smoking. They had been screened with the EarlyCDT-Lung Test (13 positive result; 18 negative) as part of the Early Cancer Detection Test Lung Cancer Scotland Study. They were purposively sampled for interview based on their self-reported post-screening smoking behaviour. Eleven participants had stopped smoking since screening. Verbatim interview transcripts were analysed using thematic analysis.RESULTS: Two key overarching themes were interpretations of screening test results and emotional responses to those interpretations. Participants' understanding of the risk implied by their test result was often inaccurate, for example a negative result interpreted as an 'all-clear' from lung cancer and a positive result as meaning lung cancer would definitely develop. Those interpretations led to emotional responses (fear, shock, worry, relief, indifferSaveence) influencing motivations about smoking. Other themes included a wake-up call causing changes in perceived risk of smoking-related disease, a feeling that now is the time to stop smoking and family influences. There was no clear pattern in smoking motivations in those who received positive or negative test results. Of those who had stopped smoking, some cited screening experiences as the sole motivation, some cited screening along with other coinciding factors, and others cited non-screening reasons. Cues to change were experienced at different stages of the screening process. Some participants indicated they underwent screening to try and stop smoking, while others expressed little or no desire to stop.CONCLUSIONS: We observed complex and individualised motivations about smoking following lung cancer screening. To be most effective, smoking cessation support in this context should explore understanding of screening test results and may need to be highly tailored to individual emotional responses to screening.</p

Unconditional and conditional monetary incentives to increase response to mailed questionnaire : a randomised controlled study within a trial (SWAT)

Rationale, aims, and objectives: High response rates to research questionnaires can help to ensure results are more representative of the population studied and provide increased statistical power, on which the study may have been predicated. Improving speed and quality of response can reduce costs.Method: We conducted a randomised Study Within A Trial (SWAT) to assess questionnaire response rates, reminders sent and data completeness with unconditional compared to conditional monetary incentives. Eligible individuals were mailed a series of psychological questionnaires as a follow-up to a baseline host trial questionnaire. Half received a £5 gift voucher with questionnaires (unconditional) and half were promised the voucher after returning questionnaires (conditional).Results: Of 1079 individuals, response rates to the first follow-up questionnaire were 94.2% and91.7% in the unconditional and conditional monetary incentive groups respectively (OR 1.78, 95% CI0.85 to 3.72). There were significantly greater odds of returning repeat questionnaires in the unconditional group at six months (OR 2.97, 95% CI 1.01 to 8.71; p = 0.047) but not at 12 months(OR 1.12, 95% CI 0.44 to 2.85). Incentive condition had no impact at any time point on the proportion of sent questionnaires that needed reminders. Odds of incomplete questionnaires were significantly greater at three months in the unconditional compared to the conditional incentive group (OR 2.45, 95% CI 1.32 to 4.55; p = 0.004).Conclusions: Unconditional monetary incentives can produce a transitory greater likelihood of mailed questionnaire response in a clinical trial participant group, consistent with the direction of effect in other settings. However, this could have been a chance finding. The use of multiple strategies to promote response may have created a ceiling effect. This strategy has potential to reduce administrative and postage costs, weighed against the cost of incentives used, but could risk compromising the completeness of data

Cardiovascular events after clarithromycin use in lower respiratory tract infections:analysis of two prospective cohort studies

Objective: To study the association of clarithromycin with cardiovascular events in the setting of acute exacerbations of chronic obstructive pulmonary disease and community acquired pneumonia.Design: Analysis of two prospectively collected datasets.Setting: Chronic obstructive pulmonary disease dataset including patients admitted to one of 12 hospitals around the United Kingdom between 2009 and 2011; Edinburgh pneumonia study cohort including patients admitted to NHS Lothian Hospitals between 2005 and 2009.Population: 1343 patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease and 1631 patients admitted with community acquired pneumonia.Main outcome measures: Hazard ratios for cardiovascular events at one year (defined as hospital admissions with acute coronary syndrome, decompensated cardiac failure, serious arrhythmia, or sudden cardiac death) and admissions for acute coronary syndrome (acute ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina). Secondary outcomes were all cause and cardiovascular mortality at one year.Results: 268 cardiovascular events occurred in the acute exacerbations of chronic obstructive pulmonary disease cohort and 171 in the community acquired pneumonia cohort over one year. After multivariable adjustment, clarithromycin use in acute exacerbations of chronic obstructive pulmonary disease was associated with an increased risk of cardiovascular events and acute coronary syndrome—hazard ratios 1.50 (95% confidence interval 1.13 to 1.97) and 1.67 (1.04 to 2.68). After multivariable adjustment, clarithromycin use in community acquired pneumonia was associated with increased risk of cardiovascular events (hazard ratio 1.68, 1.18 to 2.38) but not acute coronary syndrome (1.65, 0.97 to 2.80). The association between clarithromycin use and cardiovascular events persisted after matching for the propensity to receive clarithromycin. A significant association was found between clarithromycin use and cardiovascular mortality (adjusted hazard ratio 1.52, 1.02 to 2.26) but not all cause mortality (1.16, 0.90 to 1.51) in acute exacerbations of chronic obstructive pulmonary disease. No association was found between clarithromycin use in community acquired pneumonia and all cause mortality or cardiovascular mortality. Longer durations of clarithromycin use were associated with more cardiovascular events. Use of β lactam antibiotics or doxycycline was not associated with increased cardiovascular events in patients with acute exacerbations of chronic obstructive pulmonary disease, suggesting an effect specific to clarithromycin.Conclusions: The use of clarithromycin in the setting of acute exacerbations of chronic obstructive pulmonary disease or community acquired pneumonia may be associated with increased cardiovascular events. These findings require confirmation in other datasets

Non-typeable Haemophilus influenzae protein vaccine in adults with COPD:A phase 2 clinical trial

Loss of airway microbial diversity is associated with non-typeable Haemophilus influenzae (NTHi) infection and increased risk of exacerbation in chronic obstructive pulmonary disease (COPD). We assessed the safety and immunogenicity of an investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant in adults with moderate/-severe COPD and prior exacerbations. In this phase 2, observer-blind, controlled trial (NCT02075541), 145 COPD patients aged 40-80 years randomly (1:1) received two doses of NTHi vaccine or placebo 60 days apart, on top of standard care. Reactogenicity in the 7-day post-vaccination period was higher following NTHi vaccine than placebo. Most solicited adverse events (AEs) were mild/moderate. At least one unsolicited AE was reported during the 30-day post-vaccination period by 54.8% of NTHi vaccine and 51.4% of placebo recipients. One serious AE (placebo group) was assessed by the investigator as vaccine-related. Anti-PD, anti-PE and anti-PiIA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2. The frequency of specific CD4(+) T cells increased following two doses of NTHi vaccine and remained higher than baseline. Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo (1.49 versus 1.73) in the one-year period post-dose 2, with estimated vaccine efficacy of 13.3% (95% confidence interval -24.2 to 39.5; p = 0.44). The NTHi vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in adults with COPD

Psychological impact of lung cancer screening using a novel antibody blood test followed by imaging: the ECLS randomised controlled trial

Background: The Early CDT®-Lung antibody blood test plus serial CT-scans for test-positives reduces late-stage lung cancer presentation. This study assessed psychological outcomes of this approach.Methods: Randomised controlled trial (n=12,208) comparing psychological outcomes 1-12 months post-recruitment in a subsample (n=1032) of test-positive (TPG), test-negative (TNG) and control groups (CG).Results: Compared to TNG, TPG had lower positive affect (Difference between means (DBM), 3-months (3m):-1.49 (-2.65, - 0.33)), greater impact of worries (DBM 1m:0.26 (0.05, 0.47); 3m:0.28 (0.07, 0.50)), screening distress (DBM 1m:3.59 (2.28, 4.90); 3m:2.29 (0.97, 3.61); 6m:1.94 (0.61, 3.27)) worry about tests (OR 1m:5.79 (2.66, 12.63) and more frequent lung cancer worry (Odds ratio (OR) 1m:2.52 (1.31, 4.83); 3m:2.43 (1.26, 4.68); 6m:2.87 (1.48, 5.60)). Compared to CG, TPG had greater worry about tests (OR 1m:3.40 (1.69, 6.84)). TNG had lower negative affect (log-transformed DBM 3m:-0.08 (-0.13, -0.02)), higher positive affect (DBM 1m:1.52 (0.43, 2.61); 3m:1.43 (0.33, 2.53); 6m:1.27 (0.17, 2.37)), less impact of worries (DBM 3m:-0.27 (-0.48, -0.07)) and less frequent lung cancer worry (OR 3m:0.49 (0.26, 0.92)). Conclusions: Negative psychological effects in TPG and positive effects in TNG were short-lived and most differences were small

The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial.

BACKGROUND: Written participant information materials are important for ensuring that potential trial participants receive necessary information so that they can provide informed consent. However, such materials are frequently long and complex, which may negatively impact patient understanding and willingness to participate. Improving readability, ease of comprehension and presentation may assist with improved participant recruitment. The Systematic Techniques for Assisting Recruitment to Trials (MRC START) study aimed to develop and evaluate interventions to improve trial recruitment. This study aimed to assess the effectiveness of an optimised participant information brochure and cover letter developed by MRC START regarding response and participant recruitment rates. METHODS: We conducted a study within a trial (SWAT) embedded in the EarlyCDT Lung Cancer Scotland (ECLS) trial that aimed to assess the effectiveness of a new test in reducing the incidence of patients with late-stage lung cancer at diagnosis compared with standard care. Potential participants approached for ECLS were randomised to receive the original participant information brochure and accompanying letter (control group) or optimised versions of these materials which had undergone user testing and a process of re-writing, re-organisation and professional graphic design (intervention group). The primary outcome was the number of patients recruited to ECLS. The secondary outcome was the proportion of patients expressing an interest in participating in ECLS. RESULTS: In total, 2262 patients were randomised, 1136 of whom were sent the intervention materials and 1126 of whom were sent the control materials. The proportion of patients enrolled and randomised into ECLS was 180 of 1136 (15.8%) in the intervention group and 176 of 1126 (15.6%) in the control group (OR = 1.016, 95% CI, 0.660 to 1.564). The proportion of patients who positively responded to the invitation was 224 of 1136 (19.7%) in the intervention group and 205 of 1126 (18.2%) in the control group (OR = 1.103, 95% CI, 0.778 to 1.565). CONCLUSIONS: Optimised patient information materials made little difference to the proportion of patients positively responding to a trial invitation or to the proportion subsequently randomised to the host trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01925625 . Registered on 15 August 2015. Study Within A Trial, SWAT-23. Registered on 12 April 2016