Understanding the processes underpinning IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a process evaluation within a cluster randomised controlled implementation trial.

BACKGROUND: Providing supported self-management for people with asthma can reduce the burden on patients, health services and wider society. Implementation, however, remains poor in routine clinical practice. IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a UK-wide cluster randomised implementation trial that aims to test the impact of a whole-systems implementation strategy, embedding supported asthma self-management in primary care compared with usual care. To maximise opportunities for sustainable implementation beyond the trial, it is necessary to understand how and why the IMP2ART trial achieved its clinical and implementation outcomes. METHODS: A mixed-methods process evaluation nested within the IMP2ART trial will be undertaken to understand how supported self-management was implemented (or not) by primary care practices, to aid interpretation of trial findings and to inform scaling up and sustainability. Data and analysis strategies have been informed by mid-range and programme-level theory. Quantitative data will be collected across all practices to describe practice context, IMP2ART delivery (including fidelity and adaption) and practice response. Case studies undertaken in three to six sites, supplemented by additional interviews with practice staff and stakeholders, will be undertaken to gain an in-depth understanding of the interaction of practice context, delivery, and response. Synthesis, informed by theory, will combine analyses of both qualitative and quantitative data. Finally, implications for the scale up of asthma self-management implementation strategies to other practices in the UK will be explored through workshops with stakeholders. DISCUSSION: This mixed-methods, theoretically informed, process evaluation seeks to provide insights into the delivery and response to a whole-systems approach to the implementation of supported self-management in asthma care in primary care. It is underway at a time of significant change in primary care in the UK. The methods have, therefore, been developed to be adaptable to this changing context and to capture the impact of these changes on the delivery and response to research and implementation processes.

A pilot randomised controlled trial investigating a Mediterranean diet intervention in pregnant women for the primary prevention of allergic diseases in infants.

BACKGROUND: Observational studies suggest a potentially protective role of the Mediterranean diet (MD) in allergic diseases, including asthma. Large scale randomised controlled trials (RCTs) are needed to test the hypothesised allergy-prevention benefits of a MD during pregnancy. The present two-arm pilot RCT in pregnant women at high-risk of having a child who would develop allergic disease investigated maternal recruitment, retention and acceptability of an MD dietary intervention in the UK. The trial also assessed the effect of the intervention on MD adherence scores at 12 and at 24 weeks post-randomisation. METHODS: Thirty women were recruited at around 12 weeks of gestation. Retention was high (28 out of 30; 93%). The intervention was acceptable to participants. Mean (SD) adherence to the MD at baseline was 12.4 (2.9) in the intervention arm (n = 14) and 13.0 (1.9) in the control arm (n = 16), where 24 represents maximal adherence. There was a favourable short-term change in MD score: the adjusted mean difference (intervention - control) in the change in MD score from baseline to 12 weeks post-randomisation was 2.4 (95% confidence interval = 0.6-4.2, P = 0.012). CONCLUSIONS: The trial provides important insights into recruitment, retention and sustaining the dietary intervention, which will be used in the design of a large RCT.

Communication about colorectal cancer screening in Britain: public preferences for an expert recommendation.

BACKGROUND: Informed decision-making approaches to cancer screening emphasise the importance of decisions being determined by individuals' own values and preferences. However, advice from a trusted source may also contribute to autonomous decision-making. This study examined preferences regarding a recommendation from the NHS and information provision in the context of colorectal cancer (CRC) screening. METHODS: In face-to-face interviews, a population-based sample of adults across Britain (n=1964; age 50-80 years) indicated their preference between: (1) a strong recommendation to participate in CRC screening, (2) a recommendation alongside advice to make an individual decision, and (3) no recommendation but advice to make an individual decision. Other measures included trust in the NHS and preferences for information on benefits and risks. RESULTS: Most respondents (84%) preferred a recommendation (47% strong recommendation, 37% recommendation plus individual decision-making advice), but the majority also wanted full information on risks (77%) and benefits (78%). Men were more in favour of a recommendation than women (86% vs 81%). Trust in the NHS was high overall, but the minority who expressed low trust were less likely to want a recommendation. CONCLUSION: Most British adults want full information on risks and benefits of screening but they also want a recommendation from an authoritative source. An 'expert' view may be an important part of autonomous health decision-making.

The quality, safety and content of telephone and face-to-face consultations: a comparative study.

INTRODUCTION: Telephone consulting is increasingly used to improve access to care and optimise resources for day-time work. However, there remains a debate about how such consultations differ from face-to-face consultations in terms of content quality and/or safety. To investigate this, a comparison of family doctors' telephone and face-to-face consultations was conducted. METHODS: 106 audio-recordings (from 19 doctors in nine practices) of telephone and face-to-face consultations, stratified at doctor level, were compared using the Roter Interaction Analysis Scale (RIAS) (content measure), the OPTION (observing patient involvement in decision making scale) and a modified scale based on the Royal College of General Practitioners (RCGP) consultation assessment instrument (measuring quality and safety). Patient satisfaction and enablement were measured using validated instruments. The Roter Interaction Analysis Scale scores were compared by multiple linear regression adjusting for covariates; other continuous measures by chi(2) and Student t tests and binary measures as odds ratios. RESULTS: Telephone consultations were shorter (4.6 vs 9.7 min, p<0.001), presented fewer problems (1.2 vs 1.8, p<0.001) and included less data gathering, counselling/advice and rapport building (all p<0.001) than face-to-face consultations. These differences remained significant when consultation length and number of problems were taken into account. Telephone consultations were judged less likely to include sufficient information to exclude important serious illnesses. Patient involvement and satisfaction outcomes were similar in both consultation types. CONCLUSION: Although telephone consultations are convenient and judged satisfactory by patients and doctors, they may compromise patient safety more than face-to-face consultations and further research is required to elucidate this. Telephone consultations may be more suited to follow-up and management of long-term conditions than for in-hours acute management.

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study.

OBJECTIVE: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell's palsy, improves the chances of recovery at 3 and 9 months. DESIGN: A 2 x 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. SETTING: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. PARTICIPANTS: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. INTERVENTIONS: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 x 25-mg capsules) and aciclovir (2000 mg per day, 5 x 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. OUTCOME MEASURES: The primary outcome was recovery of facial function assessed by the House-Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and cost-effectiveness. RESULTS: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24-48 hours and the remainder within 48-72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the aciclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of -5.3%. There was no significant prednisolone-aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir-prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir-prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. CONCLUSIONS: This study provided robust evidence to support the early use of oral prednisolone in Bell's palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

Drugs to support smoking cessation in UK general practice: are evidence based guidelines being followed?

BACKGROUND: Prescribing drugs to support smoking cessation is one of the most cost effective interventions in primary care, but there is evidence they are underused. Little is known about how far guidelines have been adopted. AIMS: To examine the context in which nicotine replacement therapy (NRT) and bupropion are prescribed in UK general practice and whether guidelines are being followed. DESIGN: Patient questionnaire survey. SETTING: Twenty five general practices from the Trent Focus Collaborative Research Network in South Yorkshire and East Midlands, UK. METHODS: Participating practices posted a questionnaire to up to 40 patients prescribed NRT and bupropion respectively in the previous 3-9 months. RESULTS: The response rate for people prescribed NRT was 44.7% (323/723) and for bupropion 42.5% (77/181). Patients reported initiating the prescription request in 258 cases (65%), whereas GPs were reported as suggesting it in 49 (12%), smoking cessation services (SCS) in 38 (10%), and practice nurses in 36 (9%). Of those who could recall the content of the consultation in which NRT or bupropion was prescribed, 191 (79%) reported receiving advice on treatment use and 209 (68%) were encouraged to set a quit date. Follow up by SCS was recommended to 186 (64%) and practice follow up was offered to 212 (63%), but 41 (15%) reported no offer of follow up support. CONCLUSIONS: The majority of patients reported receiving advice and follow up in line with guidelines. However, relatively few prescriptions were suggested by GPs or practice nurses and, in a significant minority of cases, neither follow up by the practice nor additional support from SCS was recommended. More active implementation of guidelines could increase the impact of general practice on the prevalence of smoking.

Applying preventable drug-related morbidity indicators to the electronic patient record in UK primary care: methodological development.

BACKGROUND AND OBJECTIVE: Measuring and assessing the quality of health care services is an issue of high international importance. Providing data can be reliably extracted, making use of the electronic patient record (EPR) could help practitioners fulfil clinical governance obligations and ultimately improve the quality of patient care. The objective of this paper is to describe (i) the process used to apply a series of clinical indicators for preventable drug-related morbidity (PDRM) in the EPR, (ii) problems encountered and (iii) our attempts to resolve them. METHOD: The PDRM indicators were applied retrospectively in the EPR of all patients aged 18 years and over in nine general practices using the Morbidity Information and Query Export Syntax (MIQUEST) computer software programme. RESULTS: Issues identified as requiring attention when attempting to extract data from the EPR include considering the ranges to be used for age and biochemical test results, accuracy of diagnosis and drug coding, the level of complexity of the information needed, and how best to manipulate the resulting data. Practical difficulties encountered were ensuring the query coding schemes were sufficiently robust and comprehensive to secure reliable data extraction, the number of MIQUEST queries required to express each indicator, the time-consuming nature of the stages involved in the data manipulation process. DISCUSSION: Despite some practical difficulties, we have successfully used MIQUEST to identify potential preventable drug-related morbidities from the EPR. The quality of information that can be extracted from the EPR is obviously limited by the accuracy and completeness of the data on the system and the ability of the enquirer to reliably extract and manipulate that data. CONCLUSION: Although some of the problems encountered were specific to the MIQUEST software, many, including considering appropriate ranges for age and biochemical test results and paying careful attention to the reliability of drug and diagnosis coding, are relevant whenever data are extracted from the EPR for any purpose.

Indicators for preventable drug related morbidity: application in primary care.

AIM: To apply in practice a series of validated indicators for preventable drug related morbidity (PDRM). DESIGN: A pilot study to identify retrospectively potential PDRM events over a 2 year 3 month time frame using the MIQUEST computer software program. SUBJECTS AND SETTING: The electronic patient record of all patients aged 18 years and over in nine English general practices. OUTCOME MEASURES: The number of potential PDRM events identified, as defined by the indicators. RESULTS: Five hundred and seven potential PDRM events were identified from 49 658 electronic patient records, giving an overall incidence of 1.0%. A small number of the indicators (n = 4) accounted for approximately 60% of the events, while for many indicators few events were identified. The most common events related to the use of non-steroidal anti-inflammatory drugs in patients with congestive heart failure or hypertension, lack of monitoring in patients prescribed angiotensin converting enzyme inhibitors, and the use of hypnotic-anxiolytic agents. CONCLUSIONS: A small number of indicators contributed to the majority of the PDRM events. Interrogation of electronic patient records in primary care using computerised queries shows potential for detecting PDRM.

Antidepressants as risk factor for ischaemic heart disease: case-control study in primary care.

OBJECTIVES: To determine whether antidepressants are a risk factor for ischaemic heart disease and to compare the risk for different subgroups of antidepressants and individual antidepressants. DESIGN: Case-control study. SETTING: Nine general practices recruited from the Trent Focus Collaborative Research Network. PARTICIPANTS: 933 men and women with ischaemic heart disease matched by age, sex, and practice to 5516 controls. MAIN OUTCOME MEASURE: Adjusted odds ratio for ischaemic heart disease calculated by logistic regression. RESULTS: Odds ratios for ischaemic heart disease were significantly raised for patients who had ever received a prescription for tricyclic antidepressants even after diabetes, hypertension, smoking, body mass index, and use of selective serotonin reuptake inhibitors had been adjusted for (1.56; 95% confidence interval 1.18 to 2.05). Patients who had ever taken dosulepin (dothiepin) had a significantly raised odds ratio for ischaemic heart disease after adjustment for confounding factors and use of other antidepressants (1.67, 1.17 to 2.36). There was no significant increase in the odds ratios for amitriptyline, lofepramine, and selective serotonin reuptake inhibitors in multivariate analysis. Increasing maximum doses of dosulepin were associated with increasing odds ratios for ischaemic heart disease. Similarly, there was a significant positive trend associated with increasing numbers of prescriptions of dosulepin (adjusted odds ratio 1.52 for 1 prescription, 1.39 for 2-3, and 1.96 for >/=4, P<0.002). CONCLUSION: There is good evidence for an association between dosulepin and subsequent ischaemic heart disease and for a dose-response relation.

Do single handed practices offer poorer care? Cross sectional survey of processes and outcomes.

OBJECTIVES: To determine whether there are important differences in performance between group practices and singlehanded general practitioners and the extent to which any differences are explained by practice characteristics such as deprivation. DESIGN: Cross sectional survey. SETTING: 206 singlehanded practices and 606 partnerships in Trent region, United Kingdom. METHOD: Comparison of process and outcome measures derived from routinely collected data on hospital admissions and target payments for singlehanded practices and partnerships. Multivariate analysis was used to adjust for the confounding effects of general practice characteristics-deprivation (Townsend score), percentage of Asian residents, percentage of black residents, proportion of men over 75 years, proportion of women over 75 years, rurality, presence of a female general practitioner, and vocational training status. RESULTS: Differences in achievement of immunisation and cytology targets apparent on univariate analysis were not seen after adjustment for other general practice characteristics. Similarly, significant differences (>15%; P<0.01) for three types of hospital admission seen on univariate analysis were not present after adjustment for other practice characteristics. CONCLUSIONS: This study provides no evidence that singlehanded general practitioners are underperforming clinically. Our results offer insight into the structural difference between the two types of practice and underline the importance of the effect of other practice characteristics on process and outcome measures.

Time changes in new cases of ischaemic heart disease in general practice.

BACKGROUND: There are no recent studies of the presentation of ischaemic heart disease (IHD) in general practice. What information exists is derived from the secondary care setting, where seasonal and daily variation has been reported in admissions for IHD. There are epidemiological studies that show a falling incidence and mortality for IHD. It is not clear, however, if this is also the case in clinical general practice. OBJECTIVES: The aims of the present study were to (i) estimate the number of cases of IHD in general practice populations; (ii) determine the recorded diagnosis and time of first presentation of IHD during a 5 year period; and (iii) perform time series analysis on the above data. METHODS: The design of the study was a retrospective survey, using MIQUEST software, of computer databases in five general practices with a combined population of nearly 40,000 patients. The five practices were selected randomly from volunteering practices in the Trent Focus Collaborative Research Network. All patients with a new diagnosis of IHD recorded between January 1993 and December 1997 inclusive were included in the study. The number of new cases of IHD, the recorded diagnosis and time of first presentation of IHD were the main outcome measures. RESULTS: A total of 644 new cases of IHD were identified during the study period: 54.0% 'angina pectoris', 26. 9% 'acute myocardial infarction', 18.8% 'ischaemic heart disease', 0. 3% 'coronary atherosclerosis'. Time series analysis reveals a seasonal and weekly pattern to new cases of IHD, with peak cases occurring in January and on Mondays/Fridays. A downward trend was detected for new cases of IHD (all diagnoses) over the 5 year period, and for new cases of IHD (excluding acute myocardial infarction). An upward trend was observed for new cases of acute myocardial infarction. CONCLUSION: Presentation of IHD in general practice varies according to season and day of the week. The proportion of new cases recorded as 'angina pectoris' or 'ischaemic heart disease' is falling, and this decline masks a rise in the incidence recordings of 'acute myocardial infarction'.

Influenza A among community-dwelling elderly persons in Leicestershire during winter 1993-4; cigarette smoking as a risk factor and the efficacy of influenza vaccination.

In a prospective study of community-dwelling people 60-90 years of age, we examined the coverage of influenza vaccine during 1992-3 and 1993-4, the efficacy of vaccination in reducing serologically-confirmed clinical episodes of influenza A during 1993, and the effect of cigarette smoking. During 1992 and 1993, influenza vaccine was given to 106/215 (49%) and 120/204 (59%) people with risk conditions, and 84/225 (37%) and 103/235 (44%) without risk conditions. Influenza vaccination and general practitioner consultations during 1992 were independent predictors of vaccination in 1993, but current smoking was a negative predictor. Of 209 unimmunized people, 8/35 (23%) smokers had clinical influenza as compared with 11/174 (6%) non-smokers (OR 4.4, 95% CI 1.6 to 11.9). Of 371 non-smokers, 1/197 (0.5%) vaccinees had influenza as compared with 11/174 (6%) non-vaccinees (OR 0.075, 95% CI 0.587 to 0.009). No cases of influenza occurred among 21 current smokers who were vaccinated.

Acute viral infections of upper respiratory tract in elderly people living in the community: comparative, prospective, population based study of disease burden.

OBJECTIVE: To evaluate the disease burden of upper respiratory infections in elderly people living at home. DESIGN: Prospective surveillance of elderly people. INTERVENTION: None. SETTING: Leicestershire, England SUBJECTS: 533 subjects 60 to 90 years of age. MAIN OUTCOME MEASURES: Pathogens, symptoms, restriction of activity, duration of illness, medical consultations, interval between onset of illness and medical consultation, antibiotic use, admission to hospital, and death. RESULTS: 231 pathogens were identified for 211 (43%) of 497 episodes for which diagnostic specimens were available: 121 (52%) were rhinoviruses, 59 (26%) were coronaviruses, 22 (9.5%) were influenza A or B, 17 (7%) were respiratory syncytial virus, 7 (3%) were parainfluenza viruses, and 3 (1%) were Chlamydia species; an adenovirus and Mycoplasma pneumoniae caused one infection each. Infections occurred at a rate of 1.2 episodes per person per annum (95% confidence interval 1.0 to 1.7; range 0-10) and were clinically indistinguishable. Lower respiratory tract symptoms complicated 65% of upper respiratory infections and increased the medical consultation rate 2.4-fold (chi 2 test P < 0.001). The median interval between onset of illness and medical consultation was 3 days for influenza and 5 days for other infections. Rhinoviruses caused the greatest disease burden overall followed by episodes of unknown aetiology, coronaviruses, influenza A and B, and respiratory syncytial virus. CONCLUSIONS: Respiratory viruses cause substantial morbidity in elderly people. Although respiratory syncytial virus and influenza cause considerable individual morbidity, the burden of disease from rhinovirus infections and infections of unknown aetiology seems greater overall. The interval between onset of illness and consultation together with diagnostic difficulties raises concern regarding the role of antiviral drugs in treating influenza.

Influenza vaccination in patients with asthma: effect on peak expiratory flow, asthma symptoms and use of medication.

This pilot study was undertaken to examine whether killed influenza vaccine causes exacerbations in asthmatic adults. Thirty-three stable asthmatics recorded peak expiratory flow (PEF), asthma symptoms, and use of asthma medication for 2 weeks, and then received killed influenza vaccine. Thereafter they recorded PEF, asthma symptoms and use of medication for a further 2 weeks. Comparison of recordings during the 2 weeks before and after vaccination revealed that influenza vaccine was not associated with reduction in PEF (P = 0.76), increase in asthma symptoms (P = 0.17) or use of asthma medication (P = 0.58). Similar results for PEF (P = 0.49), asthma symptoms (P = 0.17), and asthma medication (P = 0.16) were obtained when the analysis was restricted to the 2 days before and after vaccination.

Risk factors for lower respiratory complications of rhinovirus infections in elderly people living in the community: prospective cohort study.

OBJECTIVE: To assess the role of rhinoviruses in elderly people living in the community. DESIGN: Prospective community based surveillance of elderly people, without intervention. Subjects were telephoned weekly to identify symptomatic upper respiratory tract infections. Symptoms and impact of illnesses were monitored, and specimens were collected for diagnostic serology and human rhinovirus polymerase chain reaction. SETTING: Leicestershire, England. SUBJECTS: 533 subjects aged 60 to 90. MAIN OUTCOME MEASURES: Symptoms, restriction of activity, medical consultations, and antibiotic use during 96 rhinovirus infections. Adjusted odds ratios for lower respiratory syndromes with respect to smoking and health status. RESULTS: A viral cause was established in 211 (43%) of 497 respiratory illnesses; rhinoviruses were identified in 121 (24%) and as single pathogens in 107. The median duration of the first or only rhinovirus infection in the 96 people with 107 rhinovirus infections was 16 days; 18 of the 96 patients were confined to bed and 25 were unable to cope with routine household activities. Overall, 60 patients with rhinovirus infections had lower respiratory tract syndromes; 41 patients consulted their doctor, 31 of them (76%) receiving antibiotics. One patient died. Logistic regression analysis showed that chronic medical conditions increased the estimated probability of lower respiratory rhinovirus illness by 40% (95% confidence interval 17% to 68%) and smoking by 47% (14% to 90%). There were almost six times as many symptomatic rhinovirus infections as influenza A and B infections. CONCLUSIONS: Rhinoviruses are an important cause of debility and lower respiratory illness among elderly people in the community. Chronic ill health and smoking increase the likelihood of lower respiratory complications from such infections. The overall burden of rhinovirus infections in elderly people may approach that of influenza.

Effects of upper respiratory tract infections in patients with cystic fibrosis.

BACKGROUND: The polymerase chain reaction has improved the detection of picornaviruses and rhinoviruses and our understanding of their role in reversible airways disease. The effects of colds on lower respiratory morbidity and bacterial colonisation in cystic fibrosis remain uncertain. METHODS: Children with cystic fibrosis were evaluated regularly in the clinic and the parents notified the investigators when their child developed a cold. Nasopharyngeal specimens were collected at the start of the infection for polymerase chain reaction, bacteriology was also undertaken and again three weeks later, and pulmonary function was measured in children aged > or = 6 years at four day intervals for three weeks. The effects of colds on rate of progression of cystic fibrosis were assessed by pulmonary function, Shwachman scores, and radiology. RESULTS: Thirty eight children suffered 147 colds over 17 months. Picornaviruses were detected in 51 (43%) of 119 nasopharyngeal specimens, and 21 of the 51 were further identified as rhinoviruses. Pulmonary dysfunction was similar following picornavirus and non-picornavirus infections; the mean change from baseline in forced expiratory volume in one second (FEV1) was -16.5% and -10.3% at 1-4 days and 21-24 days, respectively, after onset of a cold. Children who experienced more colds than average had evidence of disease progression with reduction in Shwachman score, increasing Chrispin-Norman score, and greater deterioration in FEV1 per annum. Ten of 12 new bacterial infections were associated with a cold. CONCLUSIONS: Picornavirus and non-picornavirus colds are associated with pulmonary function abnormalities and disease progression in patients with cystic fibrosis, and predispose to secondary bacterial infection and colonisation.