Les Toop

Evaluation of a self-management plan for chronic obstructive pulmonary disease

We hypothesized that the use of an Action Plan might assist self-management for patients with chronic obstructive pulmonary disease (COPD). A pilot process and randomized, controlled study were undertaken to evaluate an Action Plan that provided advice on management of usual care and exacerbations, together with a booklet on self-management. Fifty six subjects with COPD recruited through general practitioners (GPs) completed the 6 month study, 27 in the control group and 29 in the intervention group. The control group received usual care from their GP, and the intervention group received a booklet and Action Plan from their practice nurse plus a supply of prednisone and antibiotic from their GP. The two groups were demographically similar with a mean age of 68 yrs. The resources were well received by GPs, practice nurses and intervention group subjects. After 6 months, there were no differences in quality of life scores or pulmonary function. There were significant changes in self-management behaviour in the intervention group compared to controls. In response to deteriorating symptoms, 34 versus 7% (p=0.014) initiated prednisone treatment and 44 versus 7% (p=0.002) initiated antibiotics. Subjects in the intervention group readily adopted self-management skills but did not show any difference in quality of life or lung function parameters. A larger, prospective, controlled, clinical trial of this approach is warranted.

Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial

Importance Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D. Objective To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population. Design, Setting, and Participants The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis. Interventions Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years). Main Outcomes and Measures The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis. Results Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes. Conclusions and Relevance Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study. Trial Registration clinicaltrials.gov Identifier: ACTRN12611000402943

Respiratory effects of air pollution in chronic obstructive pulmonary disease: a three month prospective study.

BACKGROUND: A study was undertaken to investigate the relationship between air pollution levels and respiratory symptoms and peak expiratory flow rate (PEFR) in subjects with chronic obstructive pulmonary disease (COPD) living in Christchurch, New Zealand. METHODS: Forty subjects aged over 55 years with COPD completed twice daily diaries for three months during the winter of 1994. Subjects recorded respiratory symptoms, PEFR, outdoor activity, visits to doctor or hospital, and medication use. All were resident within a 5 km radius of the regional councils air pollution monitoring site. Daily and hourly mean pollutant levels (particulates (PM10, nitrogen dioxide (NO2), sulphur dioxide (SO2) and carbon monoxide (CO)) were measured at the monitoring site. RESULTS: Pollution levels were generally low relative to those recorded in previous years. The New Zealand Ministry for the Environment guidelines for PM10 were exceeded on five occasions, and for CO six times. No association was found between PEFR and any of the pollution variables. A rise in the PM10 concentration equivalent to the interquartile range was associated with an increase in night time chest symptoms (relative risk 1.38, 95% CI 1.07 to 1.78). A rise in NO2 concentrations equivalent to the interquartile range was associated with increased reliever inhaler use (relative risk 1.42, 95% CI 1.13 to 1.79) and for 24 hour lag analysis with increased nebuliser use (relative risk 2.81, 95% CI 1.81 to 4.39). There was no increase in the relative risk of other symptoms in relation to pollution levels. CONCLUSIONS: These effects, demonstrated in a small susceptible group of subjects with COPD, indicate that adverse outcomes can be measured in response to pollution levels that are within current guidelines.

Primary care: core values. Patient centred primary care.

This is the second in a series of six articles reflecting on the core values that will underpin the development of primary care The importance and primacy of the clinician-Fpatient relationship cannot be overstated. The perceived intrinsic quality of this relationship initially allows two individuals, previously unknown to each other, to feel comfortable with an often high level of intimacy. With time the relationship may develop to allow safe and constructive discussion of intensely personal and private matters. The bond that forms may be healing in and of itself.1 However, the changing expectations of both clinicians and patients, together with changes to the context in which the interactions take place, challenge the future of this relationship. In this article, the generic term clinician has been chosen deliberately to reflect the increasing variety of health professionals not just doctors now involved in providing primary health care to individuals in the community.2 The term patient has been retained for want of a better one.3 #### Summary points Although it is central to the discipline of medicine, the clinician-patient relationship is under attack from within through evolving expectations of both parties—and from outside, through changing norms in society Models of the consultation in which the doctor maintains a more mature, and controlling, role than the patient have persisted through to the present day The doctor of the future will find that such models are increasingly unacceptable, particularly in primary care The sustained partnership model ensures a patient centred relationship that does not devalue special skills of the clinician The way the clinician and the patient relate to each other is a major determinant of the outcomes of a consultation. Satisfaction for both and degree of patients compliance with management plans are directly related to the quality of various elements of the clinician-patient relationship. …

Plasma brain natriuretic peptide after long-term treatment for heart failure in general practice.

Plasma brain natriuretic peptide (BNP) concentrations are known to have high sensitivity and specificity in the diagnosis of heart failure in newly symptomatic patients. The relationship of plasma BNP to cardiac function in stable patients on long‐term established treatment for heart failure is unknown. Plasma BNP was assessed for its ability to predict echocardiographic abnormality in 100 patients receiving long‐term treatment in general practice for a provisional diagnosis of heart failure.

The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures

Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.

Effect of monthly high-dose vitamin D supplementation on falls and non-vertebral fractures: secondary and post-hoc outcomes from the randomised, double-blind, placebo-controlled ViDA trial

BACKGROUND Adults with low concentrations of 25-hydroxyvitamin D (25[OH]D) in blood have an increased risk of falls and fractures, but randomised trials of vitamin D supplementation have had inconsistent results. We aimed to assess the effect of high-dose vitamin D supplementation on fractures and falls. METHODS The Vitamin D Assessment (ViDA) Study was a randomised, double-blind, placebo-controlled trial of healthy volunteers aged 50-84 years conducted at one centre in Auckland, New Zealand. Participants were randomly assigned to receive either an initial oral dose of 200 000 IU (5·0 mg) colecalciferol (vitamin D3) followed by monthly 100 000 IU (2·5 mg) colecalciferol or equivalent placebo dosing. The prespecified primary outcome was cardiovascular disease and secondary outcomes were respiratory illness and fractures. Here, we report secondary outcome data for fractures and post-hoc outcome data for falls. Cox proportional hazards models were used to estimate hazard ratios (HRs) for time to first fracture or time to first fall in individuals allocated vitamin D compared with placebo. The analysis of fractures included all participants who gave consent and was by intention-to-treat; the analysis of falls included all individuals who returned one or more questionnaires. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000402943. FINDINGS Between April 5, 2011, and Nov 6, 2012, 5110 participants were recruited and randomly assigned either colecalciferol (n=2558) or placebo (n=2552). Two participants allocated placebo withdrew consent after randomisation; thus, a total of 5108 individuals were included in the analysis of fractures. The mean age of participants was 65·9 years (SD 8·3) and 2971 (58%) were men. The mean concentration of 25(OH)D in blood was 63 nmol/L (SD 24) at baseline, with 1534 (30%) having 25(OH)D concentrations lower than 50 nmol/L. Follow-up was until July 31, 2015, with a mean treatment duration of 3·4 years (SD 0·4, range 2·5-4·2). During follow-up, 2638 participants reported having a fall, 1312 (52%) of 2539 in the vitamin D group compared with 1326 (53%) of 2517 in the placebo group. The HR for falls-adjusted for age, sex, ethnic origin, history of recent fall, physical activity, and baseline 25(OH)D-was 0·99 (95% CI 0·92-1·07; p=0·82) for vitamin D compared with placebo. Non-vertebral fractures were reported in 292 individuals, 156 (6%) of 2558 in the vitamin D group and 136 (5%) of 2550 in the placebo group. The adjusted HR for fractures was 1·19 (95% CI 0·94-1·50; p=0·15) for vitamin D compared with placebo. 123 (2%) people died during the trial, 65 assigned vitamin D and 58 allocated placebo; the difference between treatment groups was not significant. INTERPRETATION High-dose bolus vitamin D supplementation of 100 000 IU colecalciferol monthly over 2·5-4·2 years did not prevent falls or fractures in this healthy, ambulatory, adult population. Further research is needed to ascertain the effects of daily vitamin D dosing, with or without calcium. FUNDING Health Research Council of New Zealand and Accident Compensation Corporation of New Zealand.

Preventing cardiovascular disease in primary care.

Primary care p 269 The United Kingdoms national service framework for cardiovascular disease1 is one year old. It describes an ambitious list of standards, milestones, and performance indicators against which the NHS will be held to account. It requires primary care to identify and institute preventive strategies not only for people with established ischaemic heart disease but also for those with a 30% 10 year cardiovascular risk. In this issue Hippisley-Cox and Pringle report a study of 18 computerised general practices to estimate the workload involved in meeting these expectations (p 269).2 Is it matched by the benefits gained? Clearly, the increased workload for primary care is huge. In the absence of additional resources, how should this extra work be prioritised alongside everything else required of primary care? Apparently there will be more doctors and nurses,1 but given a global shortage where will they come from in the time frame of this framework? Without extra staffing the opportunity costs will be high, so which existing activities should stop? Most general practitioners accept the desirability of working towards systematic evidence based management of patients with established ischaemic heart disease. Hippisley-Cox …

Provision of information on regulatory authorities' websites.

Background:  Several organizations have raised concerns about the excessive secrecy maintained by regulatory authorities around the world, in particular in the European Union, France, UK, Canada and Australia. However, limited research has assessed the provision of information by regulatory authorities. This study aimed to assess the type and availability of information provided on the regulatory authorities’ websites.

Chlamydia trachomatis Testing Sensitivity in Midstream Compared With First-Void Urine Specimens

PURPOSE Traditionally first-void urine specimens are used to test for Chlamydia trachomatis. In contrast, midstream urine specimens are traditionally recommended for microscopy and culture of presumptive bacterial urinary tract infections. The ability to test for both C trachomatis and urinary tract infection on a single midstream urine specimen would greatly aid clinical practice, as an urinary tract infection is an extremely common complaint in primary care. This study set out to determine how well positive C trachomatis results obtained on first-void specimens would correlate with positive findings in matched midstream specimens. METHODS One hundred women with a first-void urine specimen positive for C trachomatis also provided midstream specimens for comparison. All specimens had C trachomatis testing performed using a DNA detection method. RESULTS Of the 100 eligible participants with a first-void specimen positive for C trachomatis, 96 (96%) also had a positive midstream specimen (95% exact confidence limits, 90.1%, 98.9%). CONCLUSIONS These results suggest that by using newer nucleic acid amplification techniques (NAATs), timing of specimen collection is not so important in testing for C trachomatis as previously thought. The sensitivity of NAAT testing on midstream urine specimens in women is sufficiently equivalent to testing on first-void specimens to consider in clinical practice and research settings where first-void specimens have formerly been collected.