Jane Chudleigh

Lung function is abnormal in 3-month-old infants with cystic fibrosis diagnosed by newborn screening

Background Long-term benefits of newborn screening (NBS) for cystic fibrosis (CF) have been established with respect to nutritional status, but effects on pulmonary health remain unclear. Hypothesis With early diagnosis and commencement of standardised treatment, lung function at ∼3 months of age is normal in NBS infants with CF. Methods Lung clearance index (LCI) and functional residual capacity (FRC) using multiple breath washout (MBW), plethysmographic (pleth) FRC and forced expirations from raised lung volumes were measured in 71 infants with CF (participants in the London CF Collaboration) and 54 contemporaneous healthy controls age ∼3 months. Results Compared with controls, and after adjustment for body size and age, LCI, FRCMBW and FRCpleth were significantly higher in infants with CF (mean difference (95% CI): 0.5 (0.1 to 0.9), p=0.02; 0.4 (0.1 to 0.7), p=0.02 and 0.9 (0.4 to 1.3), p<0.001, z-scores, respectively), while forced expiratory volume (FEV0.5) and flows (FEF25–75) were significantly lower (−0.9 (−1.3 to −0.6), p<0.001 and −0.7 (−1.1 to −0.2), p=0.004, z-scores, respectively). 21% (15/70) of infants with CF had an elevated LCI (>1.96 z-scores) and 25% (17/68) an abnormally low FEV0.5 (below −1.96 z-scores). While only eight infants with CF had abnormalities of LCI and FEV0.5, using both techniques identified abnormalities in 35% (24/68). Hyperinflation (FRCpleth >1.96 z-scores) was identified in 18% (10/56) of infants with CF and was significantly correlated with diminished FEF25–75 (r=−0.43, p<0.001) but not with LCI or FEV0.5. Conclusion Despite early diagnosis of CF by NBS and protocol-driven treatment in specialist centres, abnormal lung function, with increased ventilation inhomogeneity and hyperinflation and diminished airway function, is evident in many infants with CF diagnosed through NBS by 3 months of age.

Evolution of lung function during the first year of life in newborn screened cystic fibrosis infants.

Rationale Newborn screening (NBS) for cystic fibrosis (CF) allows early intervention. Design of randomised controlled trials (RCT) is currently impeded by uncertainty regarding evolution of lung function, an important trial end point in such infants. Objective To assess changes in pulmonary function during the first year of life in CF NBS infants. Methods Observational longitudinal study. CF NBS infants and healthy controls were recruited between 2009 and 2011. Lung Clearance Index (LCI), plethysmographic lung volume (plethysmographic functional residual capacity (FRCpleth)) and forced expired volume (FEV0.5) were measured at 3 months and 1 year of age. Main results Paired measurements were obtained from 72 CF infants and 44 controls. At 3 months, CF infants had significantly worse lung function for all tests. FEV0.5 improved significantly (0.59 (95% CI 0.18 to 0.99) z-scores; p<0.01) in CF infants between 3 months and 1 year, and by 1 year, FEV0.5 was only 0.52 (0.89 to 0.15) z-scores less than in controls. LCI and FRCpleth remained stable throughout the first year of life, being on average 0.8 z-scores higher in infants with CF. Pulmonary function at 1 year was predicted by that at 3 months. Among the 45 CF infants with entirely normal LCI and FEV0.5 at 3 months, 80% remained so at 1 year, while 74% of those with early abnormalities remained abnormal at 1 year. Conclusions This is the first study reporting improvements in FEV0.5 over time in stable NBS CF infants treated with standard therapy. Milder changes in lung function occurred by 1 year than previously reported. Lung function at 3 months predicts a high-risk group, who should be considered for intensification of treatment and enrolment into RCTs.

Impact of observing hand hygiene in practice and research: a methodological reconsideration

The purpose of hand hygiene is to break the chain of healthcare-associated infection. In many countries hand hygiene is regularly audited as part of quality assurance based on recommendations from the World Health Organization. Direct observation is the recommended audit method but is associated with disadvantages, including potential for being observed to alter usual behaviour. The Hawthorne effect in relation to hand hygiene is analogous with productivity improvement by increasing the frequency with which hand hygiene is undertaken. Unobtrusive and/or frequent observation to accustom staff to the presence of observers is considered an acceptable way of reducing the Hawthorne effect, but few publications have discussed how to implement these techniques or examine their effectiveness. There is evidence that awareness of being watched can disrupt the usual behaviour of individuals in complex and unpredictable ways other than simple productivity effect. In the presence of auditors, health workers might defer or avoid activities that require hand hygiene, but these issues are not addressed in guidelines for practice or research studies. This oversight has implications for the validity of hand hygiene audit findings. Measuring hand hygiene product use overcomes avoidance tactics. It is cheaper and generates data continuously to assess the compliance of all clinicians without disrupting patient care. Disadvantages are the risk of overestimating uptake through spillage, wastage, or use by visitors and non-clinical staff entering patient care areas. Electronic devices may overcome the Hawthorne and avoidance effects but are costly and are not widely used outside research studies.

Positive parental attitudes to participating in research involving newborn screened infants with CF

BACKGROUND Information regarding recruitment of infants to research studies following the diagnosis of cystic fibrosis (CF) via newborn screening (NBS) is not currently available. This study aimed to assess parental attitudes and the feasibility of recruiting and retaining both NBS infants with CF and healthy control infants to a longitudinal, observational study. METHODS All infants underwent pulmonary function tests (PFTs) at ~3 and ~12months of age. Infants with CF had additional combined chest high resolution computed tomography (HRCT), bronchoscopy and broncho-alveolar lavage (BAL) at ~12months of age. Parental attitude questionnaires (PAQs) were administered to all parents following the ~3month PFTs and to parents of infants with CF after completion of all tests at ~12months. RESULTS 86% (92/107) of families whose infant had CF consented to participate, of whom 92% had PFTs at ~3months of age with 99% of these having PFTs at ~12months of age. Recruitment of healthy controls was feasible but more challenging; 29% of those contacted agreed to participate; 73% of these had PFTs at ~3months of age; of whom 83% had repeated PFTs at ~12months of age. Completed PAQs were received from 71% of parents, (both of CF and healthy infants) at ~3months and from 58% parents of infants with CF at ~12months. Responses from the PAQs were generally positive, 95% of parents indicated they would recommend participation in such studies to other families. Discrepancies between responses at 3 and 12months suggested that parental understanding of what the research entailed developed during the course of the study. CONCLUSIONS The high recruitment and retention rates for newly diagnosed CF NBS infants to this observational study are encouraging. These findings will help inform future study design both in the field of CF and other conditions diagnosed by NBS.

The evidence base and infection risks from flowers in the clinical setting

he need for evidence-based practice in health care is now well accepted. Best practice is likely to change over time with the emergence of new research evidence and may be influenced by other factors, such as acceptability to the general public. Controlled clinical trials supply the most robust evidence, but in the field of infection control trials are often difficult to conduct because of expense (large sample sizes are usually necessary) and ethical constraints. Infection control guidance is frequently based on less robust research evidence and common sense. Occasionally new practices become part of clinical routines despite the lack of supporting evidence. Banning flowers from general hospital wards falls into this category. Although the water in which flowers stand can become a reservoir of potentially pathogenic bacteria, there is no evidence that they have ever caused hospital-acquired infection and simple precautions can be taken to reduce potential risks. Banning flowers from general wards is not popular with the public and is unnecessary according to the evidence available.

Flowers in the clinical setting: Infection risk or workload issue?:

Healthcare-associated infection has become a topic of interest to the general public in the United Kingdom, kindled by media accounts of poor hygiene and the risks of cross-infection. In the spring of 2003, one of the broadsheet newspapers published an article debating the hygiene and infection risks associated with cut flowers brought into clinical areas. There were reports that in many wards this practice is no longer allowed because flowers are considered dirty, trigger allergies and the water is regarded as harbouring bacteria, leading to infection. Discussion with infection control experts revealed that questions concerning the risks associated with flowers are among those most frequently asked. A literature search was undertaken to establish the evidence base, and a questionnaire study was performed with a purposive sample of 39 nurses to document how they manage flowers in the clinical setting. Empirical research studies were difficult to obtain. Early work had been undertaken to explore the added workload associated with maintaining fresh flowers and ways of reducing it. Later studies revealed that the water in flower vases and cut plants both harbour large numbers of Gram-negative pathogens. Cross-infection and cases of clinical infection have never been documented, thus flowers have not been considered a risk, except to severely immunocompromised patients. However, scrutiny of the more general literature relating to Gram-negative sepsis indicated that cross-infection has been documented from a wide range of environmental sources and it is possible that it may take place from flowers via the hands of staff if they are not properly decontaminated. Nevertheless, these risks can be reduced by scrupulous attention to hand hygiene and commonsense measures. Over half the nurses (n = 26, 66.6%) thought that flowers constituted an infection risk and a number of other disadvantages were cited. Most nurses (n = 31, 80%) were not in favour of flowers in the clinical setting and there was some evidence that this attitude was related to the amount of work generated, with infection and other risks used to justify it. Interest in the topic was considerable and the results can be used to stimulate discussion and emphasise the importance of controlling health-related infection.

Pulmonary function deficits in newborn screened infants with cystic fibrosis managed with standard UK care are mild and transient

With the advent of novel designer molecules for cystic fibrosis (CF) treatment, there is huge need for early-life clinical trial outcomes, such as infant lung function (ILF). We investigated the degree and tracking of ILF abnormality during the first 2 years of life in CF newborn screened infants. Forced expiratory volume in 0.5 s (FEV0.5), lung clearance index (LCI) and plethysmographic functional residual capacity were measured at ∼3 months, 1 year and 2 years in 62 infants with CF and 34 controls. By 2 years there was no significant difference in FEV0.5 z-score between CF and controls, whereas mean LCI z-score was 0.81 (95% CI 0.45–1.17) higher in CF. However, there was no significant association between LCI z-score at 2 years with either 3-month or 1-year results. Despite minimal average group changes in any ILF outcome during the second year of life, marked within-subject changes occurred. No child had abnormal LCI or FEV0.5 on all test occasions, precluding the ability to identify “high-risk” infants in early life. In conclusion, changes in lung function are mild and transient during the first 2 years of life in newborn screened infants with CF when managed according to a standardised UK treatment protocol. Their potential role in tracking disease to later childhood will be ascertained by ongoing follow-up. Lung function changes in newborn screened infants with cystic fibrosis are mild and transient up to age 2 years http://ow.ly/7gkW30etHtb

Research essentials: How to make a successful grant application

TO MAXIMISE success, a research grant application should: ■ Have a clear purpose with demonstrable and measurable outcomes. ■ Be in line with government policies, healthcare agendas and health priorities. ■ Meet objectives of the funding body and application criteria.

Interventions to improve hand hygiene compliance in patient care: Reflections on three systematic reviews for the Cochrane Collaboration 2007-2017

This article presents highlights from a recently updated systematic Cochrane review evaluating the effectiveness of interventions to improve hand hygiene compliance in patient care. It is an advance on the two earlier reviews we undertook on the same topic as it has, for the first time, provided very rigorous synthesis of evidence that such interventions can improve practice. In this article, we provide highlights from a recently updated Cochrane systematic review. We identify omissions in the information reported and point out important aspects of hand hygiene intervention studies that were beyond the scope of the review. A full report of the review is available free of charge on the Cochrane website.

Isolating infectious patients: organisational, clinical and ethical issues

Background: Isolating infectious patients is essential to reduce infection risk. Effectiveness depends on identifying infectious patients, transferring them to suitable accommodations, and maintaining precautions. Methods: Online study to address identification of infectious patients, transfer, and challenges of maintaining isolation in hospitals in the United Kingdom. Results: Forty‐nine responses were obtained. Decision to isolate is made by infection prevention teams, clinicians, and managers. Respondents reported situations where isolation was impossible because of the patients physical condition or cognitive status. Very sick patients and those with dementia were not thought to tolerate isolation well. Patients were informed about the need for isolation by ward nurses, sometimes with explanations from infection prevention teams. Explanations were often poorly received and comprehended, resulting in complaints. Respondents were aware of ethical dilemmas associated with isolation that is undertaken in the interests of other health service users and society. Organizational failures could delay initaiting isolation. Records were kept of the demand for isolation and/or uptake, but quality was variable. Conclusion: Isolation has received the most attention in countries with under‐provision of accommodations. Our study characterizes reasons for delays in identifying patients and failures of isolation, which place others at risk and which apply to any organization regardless of availability. It also highlights the ethical dilemmas of enforcing isolation.