Using the SF-36 with older adults: a cross-sectional community-based survey

OBJECTIVES: To assess the practicality and validity of using the SF-36 in a community-dwelling population over 65 years old, and obtain population scores in this age group. DESIGN: Postal survey, using a questionnaire booklet containing the SF-36 and other health related items, of all those aged 65 or over registered with twelve general practices. Non-respondents received up to two reminders at three-weekly intervals. SETTING: Twelve randomly selected general practices in Sheffield. SAMPLE: 9897 subjects aged 65 to 104. MAIN OUTCOME MEASURES: Scores for the eight dimensions of the SF-36 and a modified version of the physical functioning dimension. RESULTS: The SF-36 achieved a response rate of 82% (n=8117) and dimension completion rates of 86.4% to 97.7%. Internal consistency measured by Cronbach’s a exceeded 0.80 for all dimensions except social functioning. These results compare favourably with postal surveys of younger adults. Scores for older adults were calculated by age and sex. Comparison with data from younger people showed how physical health declines steeply with age, in marked contrast with mental health. CONCLUSIONS: The SF-36 is a practical and valid instrument to use in postal surveys of older people living in the community. The population scores provided here may facilitate its use in future surveys of older adults

Comparison of outcome measures for patients with chronic obstructive pulmonary disease (COPD) in an outpatient setting

BACKGROUND: To assist clinicians and researchers in choosing outcome measures for patients with chronic obstructive pulmonary disease attending routine outpatient clinics, a comparative assessment was undertaken of four questionnaires designed to reflect the patients' perception of their physical and emotional health in terms of their feasibility, validity, reliability, and responsiveness to health change. METHODS: Two condition specific questionnaires, the St George's Respiratory Questionnaire (SGRQ) and Guyatt's Chronic Respiratory Questionnaire (CRQ), and two generic questionnaires, the Short Form-36 Health Survey (SF-36) and Euroqol (EQ), were compared for their discriminative and evaluative properties. Spirometric tests and a walking test were also performed. One hundred and fifty six adults who were clinically judged to have COPD and who attended an outpatient chest clinic were assessed at recruitment and six and 12 months later. Patients were also asked whether their health had changed since their last assessment. RESULTS: Completion rates and consistency between items for dimensions of the SGRQ were lower than for dimensions of the other questionnaires. The distributions of responses were skewed for certain dimensions in all questionnaires except the CRQ. Validity was supported for all instruments insofar as patients' scores were associated with differences in disease severity. The generic questionnaires better reflected other health problems. All instruments were reliable over time. The condition specific questionnaires were more responsive between baseline and first follow up visit but this difference did not persist. While certain dimensions of the SF-36 were responsive to patient perceived changes, this did not apply to the derived single index of the EQ. The rating scale of the EQ, however, provided a quick and easy indicator of change. CONCLUSIONS: Evidence from this study supports the CRQ and the SF-36 as comprehensive outcome measures for patients with longstanding COPD

Symptoms at lung cancer diagnosis are associated with major differences in prognosis

We report a cohort study of survival of patients with lung cancer presenting to a single multidisciplinary team between 1997 and 2011, according to symptoms at presentation. The overall median survival of the 3800 lung cases was 183 days (95% CI 171 to 195). There was a statistically significant difference in survival between the 12 symptom groups identified both without and with adjustment for the prognostic variables of age, gender and histology (P<0.001). Compared with the cough-alone symptom group, the risks of dying or HRs were significantly higher for the groups presenting with breathlessness (HR 1.86, 95% CI 1.54 to 2.24, n=359), systemic symptoms (HR 1.91, 95% CI 1.48 to 2.45, n=95), weight loss (HR 2.46, 95% CI 1.90 to 3.18, n=106), chest pain (HR 1.96, 95% CI 1.56 to 2.45, n=159), cough with breathlessness (HR 1.59 95% CI 1.28 to 1.98, n=177), neurological symptoms (HR 3.07, 95% CI 2.45 to 3.84, n=155) and other symptom combinations (HR 2.05, 95% CI 1.75 to 2.40, n=1963). Cough may deserve particular prominence in public health campaigns

Cost effectiveness of community leg ulcer clinics: randomised controlled trial

Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. Design: Randomised controlled trial with 1 year of follow up. Setting: Eight community based research clinics in four trusts in Trent. Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89). Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used

Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol.

INTRODUCTION: Lumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence into new and innovative management strategies and the timings of those strategies for LRS. This pilot trial is an essential preliminary to a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of early physiotherapy intervention for patients with LRS. The study will test the protocol, the intervention, the use of outcome measures and the ability to set-up and run the trial to enable refinement of a future definitive RCT. METHODS AND ANALYSIS: This is a mixed-methods study encompassing an external pilot RCT with integrated qualitative interviews with patients, clinicians and other key stakeholders. 80 patients will be recruited from primary care and randomised, after consent into 1 of 2 groups. Both groups will receive individually tailored, goal orientated physiotherapy. The usual care group will begin their physiotherapy 6 weeks after randomisation and the intervention group at 2 weeks after randomisation. Outcome measures will primarily be feasibility parameters including the ability to recruit and retain patients and to deliver the intervention. Data will be collected at baseline, and 6, 12 and 26 weeks following randomisation. ETHICS AND DISSEMINATION: The study has received favourable ethical review from the East of Scotland Research Ethics Service (EoSRES) on the 20 August 2015 (15/ES/0130). Recruitment began on the 1 March 2016 and is expected to close in January 2017. Data collection is anticipated to be complete in July 2017. The study results will be made available to participants, clinicians involved in the study and the wider clinical community through publication in a peer reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN: 25018352, Pre-results; Clinical Trials.Gov: NCT02618278 Document version V1.1 23.9.2016

Understanding FEV1 for the purpose of cystic fibrosis registry comparisons: Does bias in annual review FEV1 affect between-centre comparison within the UK? An analysis of registry data

Rationale, aims and objective: We previously demonstrated that annual review %FEV1 under-estimates lung health of adults with CF compared to %FEV1 captured during periods of clinical stability. This has implications in the comparisons against registries with encounter-based FEV1, such as the US. It is uncertain whether this bias affects between-centre comparison within the UK. Previous funnel plot analyses have identified variation in annual review %FEV1 according to centre size, hence we investigated whether paired differences between annual review and best %FEV1 also vary according to centre size. Methods: This registry analysis included 18 adult CF centres in the UK with ≥80% completeness for best FEV1 data in 2014. Mean discrepancy between annual review and best %FEV1 is a surrogate for the extent by which annual review %FEV1 underestimates lung health; and was plotted against centre size. A Local Polynomial Regression (LOESS) curve was used to explore the relationship between the two variables. An appropriate model is fitted based on the LOESS curve to determine the strength of relationship between discrepancies in %FEV1 and centre size. Results: There is an inverted U-shaped relationship between mean discrepancies in %FEV1 and centre size. A regression of the paired mean difference in %FEV1 against centre size showed a significant improvement in the goodness of fit for a quadratic model (R2 = 23.8% for a quadratic model compared with 0.4% for a linear one; p = 0.048 for the quadratic term). Conclusions: Annual review %FEV1 under-estimated lung health of adults from small and large centres in the UK to a greater extent compared to medium-sized centres. A plot of %FEV1 against centre size (e.g. funnel plot comparison) would be affected by systematic bias in annual review %FEV1. Therefore, annual review %FEV1 is an unreliable metric to compare health outcomes of adult CF centres within the UK

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

BACKGROUND/AIMS: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. METHODS: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland-Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. RESULTS: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was -4.4% with limits of agreement of -37.1% to 28.2%. Limits of agreement for randomisation rates were -47.8% to 77.5%. CONCLUSION: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate

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

Background and objective: Intravenous (i.v.) antibiotics are needed for rescue when preventative therapy fails to achieve stability among adults with cystic fibrosis (CF). Understanding the distribution of i.v. days can provide insight into the care that adults with CF need. We aim to determine the baseline characteristics that are associated with higher i.v. use, in particular to test the hypothesis that prior-year i.v. use is associated with future-year i.v. use. Methods: This is a cross-sectional analysis of the 2013–2014 UK CF registry data. Stepwise logistic regression was performed using current-year i.v. days as the dependent variable, and demographic variables including prior-year i.v. days as the covariates. Based on these results, study sample was divided into clinically meaningful subgroups using analysis similar to tree-based method. Results: Data were available for 4269 adults in 2013 and 4644 adults in 2014. Prior-year i.v. use was the strongest predictor for current-year i.v. use followed by forced expiratory volume in 1 s (FEV1). Adults with high prioryear i.v. use (>14 days) continued to require high levels of i.v., regardless of FEV1. Those with high prior-year i. v. use and FEV1 ≥70% had higher current-year i.v. days compared to adults with low prior-year i.v. use and FEV1 <40% (28 days, interquartile range (IQR): 11–41 days vs 14 days, IQR: 0–28 days; Mann–Whitney P-value <0.001 in 2013). Conclusion: CF people with prior high levels of rescue often continue to need high levels of rescue even if they have good FEV1. The reasons for this require further investigations

Exploring the implications of different approaches to estimate centre-level adherence using objective adherence data in an adult cystic fibrosis centre - a retrospective observational study

Background Accurate centre-level medication adherence measurement allows identification of highly performing CF centres, drives shared learning and informs quality improvement. Self-reported adherence is unreliable but data-logging nebulisers can capture objective data. However, adherence levels in current literature are limited by the use of agreed prescriptions and convenience sampling. In this single-centre retrospective study, we quantified the differences in centre-level adherence with different methods of calculating adherence (unadjusted vs normative adherence) and different data sampling frames (convenience sampling vs including difficult to obtain data). Methods Adherence data were objectively captured using I-neb® from 2013-2016 in Sheffield Adult CF Centre. Adults on non data-logging devices, on ivacaftor or with previous lung transplantation were excluded. Adherence was calculated based on agreed regimen (‘unadjusted adherence’) or minimum required regimen (‘normative adherence’). I-nebs® not brought to clinic were downloaded during home visits. Adults not on any inhaled therapy but with chronic Pseudomonas aeruginosa infection were included by counting their adherence as “0”. Results Of the 131 included adults, 126 provided I-neb® data. Calculating unadjusted adherence from I-nebs® brought to clinics resulted in the highest centre-level adherence (median 41.8% in 2013). Median adherence reduced after sequentially accounting for minimum required regimen (40.0% in 2013), I-nebs® not brought to clinics (32.9% in 2013) and adults not on any inhaled therapy (31.0% in 2013). Conclusions Different approaches of calculating adherence produced different adherence levels. Adherence levels based only on agreed regimen among adults who readily brought their nebulisers to clinics can over-estimate the effective adherence of CF centres

A review of public health economic modelling in the National Institute for Health and Care Excellence (NICE)

Background: The National Institute for Health and Care Excellence (NICE) use economic modelling to inform judgements whenever further insight is required for decision-making. Doing so for public health guidance poses several challenges. The study’s objective was to investigate the level of heterogeneity in NICE’s public health economic models with regards to economic evaluation techniques, perspectives on outcomes and the measurement of non-health benefits. Methods: A review of all economic modelling reports published by NICE’s Centre for Public Health (CPH) as part of their guidance. Results: The review identified 56 eligible pieces of public health over the relevant period. Of these, 43 used economic modelling and 13 used no formal economic model. In total 61 economic models were used. Though the CPH specifies a reference case, in practice there is a large amount of variability from one model to the next. The most common perspective used for evaluations was that of the National Health Service (NHS); the most common economic evaluation approach was cost-utility analysis (CUA). 23 of the 56 topics used other combinations of perspective and technique, which allowed them to incorporate non-health effects, such as productivity, the effect on taxes raised and benefits spending, costs to the criminal justice sector, the effect on educational attainment and general wellbeing. Conclusions: NICE regularly updates its reference case, and non-CUA evaluation techniques have become more prominent in recent years. The results highlight the genuine advantages of having a variety of economic evaluation techniques available, which can be matched with the given topic. While it is always necessary to be wary of the possibility of gamesmanship and cherry picking, there is a surprising alignment between many approaches in certain circumstances