A model-based approach to estimating the prevalence of disease combinations in South Africa.

BACKGROUND: The development of strategies to better detect and manage patients with multiple long-term conditions requires estimates of the most prevalent condition combinations. However, standard meta-analysis tools are not well suited to synthesising heterogeneous multimorbidity data. METHODS: We developed a statistical model to synthesise data on associations between diseases and nationally representative prevalence estimates and applied the model to South Africa. Published and unpublished data were reviewed, and meta-regression analysis was conducted to assess pairwise associations between 10 conditions: arthritis, asthma, chronic obstructive pulmonary disease (COPD), depression, diabetes, HIV, hypertension, ischaemic heart disease (IHD), stroke and tuberculosis. The national prevalence of each condition in individuals aged 15 and older was then independently estimated, and these estimates were integrated with the ORs from the meta-regressions in a statistical model, to estimate the national prevalence of each condition combination. RESULTS: The strongest disease associations in South Africa are between COPD and asthma (OR 14.6, 95% CI 10.3 to 19.9), COPD and IHD (OR 9.2, 95% CI 8.3 to 10.2) and IHD and stroke (OR 7.2, 95% CI 5.9 to 8.4). The most prevalent condition combinations in individuals aged 15+ are hypertension and arthritis (7.6%, 95% CI 5.8% to 9.5%), hypertension and diabetes (7.5%, 95% CI 6.4% to 8.6%) and hypertension and HIV (4.8%, 95% CI 3.3% to 6.6%). The average numbers of comorbidities are greatest in the case of COPD (2.3, 95% CI 2.1 to 2.6), stroke (2.1, 95% CI 1.8 to 2.4) and IHD (1.9, 95% CI 1.6 to 2.2). CONCLUSION: South Africa has high levels of HIV, hypertension, diabetes and arthritis, by international standards, and these are reflected in the most prevalent condition combinations. However, less prevalent conditions such as COPD, stroke and IHD contribute disproportionately to the multimorbidity burden, with high rates of comorbidity. This modelling approach can be used in other settings to characterise the most important disease combinations and levels of comorbidity.

Is diabetic retinopathy screening worthwhile among people first diagnosed with diabetes at older ages? A cohort study of Norfolk diabetic retinopathy screening programme.

AIMS: England's Diabetic Eye Disease Screening Programme offers screening to every resident over age 12 with diabetes, starting as soon as possible after diagnosis and repeated annually. People first diagnosed with diabetes at older ages have shorter life expectancy and therefore may be less likely to benefit from screening and treatment. To inform decisions about whether diabetic eye screening policy should be stratified by age, we investigated the probability of receiving treatment according to age at first screening episode. METHODS: This was a cohort study of participants in the Norfolk Diabetic Retinopathy Screening Programme from 2006 to 2017, with individuals' programme data linked to hospital treatment and death data recorded up to 2021. We estimated and compared the probability, annual incidence and screening costs of receiving retinal laser photocoagulation or intravitreal injection and of death, in age groups defined by age at first screening episode. RESULTS: The probability of death increased with increasing age at diagnosis, while the probability of receiving either treatment decreased with increasing age. The estimated cost of screening per person who received either or both treatments was £18,608 among all participants, increasing with age up to £21,721 in those aged 70-79 and £26,214 in those aged 80-89. CONCLUSIONS: Diabetic retinopathy screening is less effective and less cost-effective with increasing age at diagnosis of diabetes, because of the increasing probability of death before participants develop sight-threatening diabetic retinopathy and can benefit from treatment. Upper age limits on entry into screening programmes or risk stratification in older age groups may, therefore, be justifiable.

Characteristics and result reporting of registered COVID-19 clinical trials of Chinese and Indian traditional medicine: A comparative analysis.

Objective: To assess the main characteristics and result reporting of registered COVID-19 interventional trials of traditional Chinese medicine and traditional Indian medicine. Materials and methods: We assessed design quality and result reporting of COVID-19 trials of traditional Chinese medicine (TCM) and traditional Indian medicine (TIM) registered before 10 February 2021, respectively, on Chinese Clinical Trial Registry (ChiCTR) and Clinical Trial Registry-India (CTRI). Comparison groups included registered COVID-19 trials of conventional medicine conducted in China (WMC), India (WMI), and in other countries (WMO). Cox regression analysis was used to assess the association between time from trial onset to result reporting and trial characteristics. Results: The proportion of COVID-19 trials investigating traditional medicine was 33.7% (130/386) among trials registered on ChiCTR, and 58.6% (266/454) on CTRI. Planned sample sizes were mostly small in all COVID-19 trials (median 100, IQR: 50-200). The proportion of trials that were randomized was 75.4 and 64.8%, respectively, for the TCM and TIM trials. Blinding measures were used in 6.2% of the TCM trials, and 23.6% of the TIM trials. Cox regression analysis revealed that planned COVID-19 clinical trials of traditional medicine were less likely to have results reported than trials of conventional medicine (hazard ratio 0.713, 95% confidence interval: 0.541-0.939; p = 0.0162). Conclusion: There were considerable between-country and within-country differences in design quality, target sample size, trial participants, and reporting of trial results. Registered COVID-19 clinical trials of traditional medicine were less likely to report results than trials of conventional medicine.

Multimorbidity pattern and risk of dementia in later life: an 11-year follow-up study using a large community cohort and linked electronic health records.

BACKGROUND: Several long-term chronic illnesses are known to be associated with an increased risk of dementia independently, but little is known how combinations or clusters of potentially interacting chronic conditions may influence the risk of developing dementia. METHODS: 447 888 dementia-free participants of the UK Biobank cohort at baseline (2006-2010) were followed-up until 31 May 2020 with a median follow-up duration of 11.3 years to identify incident cases of dementia. Latent class analysis (LCA) was used to identify multimorbidity patterns at baseline and covariate adjusted Cox regression was used to investigate their predictive effects on the risk of developing dementia. Potential effect moderations by C reactive protein (CRP) and Apolipoprotein E (APOE) genotype were assessed via statistical interaction. RESULTS: LCA identified four multimorbidity clusters representing Mental health, Cardiometabolic, Inflammatory/autoimmune and Cancer-related pathophysiology, respectively. Estimated HRs suggest that multimorbidity clusters dominated by Mental health (HR=2.12, p<0.001, 95% CI 1.88 to 2.39) and Cardiometabolic conditions (2.02, p<0.001, 1.87 to 2.19) have the highest risk of developing dementia. Risk level for the Inflammatory/autoimmune cluster was intermediate (1.56, p<0.001, 1.37 to 1.78) and that for the Cancer cluster was least pronounced (1.36, p<0.001, 1.17 to 1.57). Contrary to expectation, neither CRP nor APOE genotype was found to moderate the effects of multimorbidity clusters on the risk of dementia. CONCLUSIONS: Early identification of older adults at higher risk of accumulating multimorbidity of specific pathophysiology and tailored interventions to prevent or delay the onset of such multimorbidity may help prevention of dementia.

Corrigendum to: Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semistructured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN14213432.

Vaccination against COVID-19 and society's return to normality in England: a modelling study of impacts of different types of naturally acquired and vaccine-induced immunity.

OBJECTIVES: To project impacts of mass vaccination against COVID-19, and investigate possible impacts of different types of naturally acquired and vaccine-induced immunity on future dynamics of SARS-CoV-2 transmission from 2021 to 2024 in England. DESIGN: Deterministic, compartmental, discrete-time Susceptible-Exposed-Infectious-Recovered (SEIR) modelling. PARTICIPANTS: Population in England. INTERVENTIONS: Mass vaccination programmes. OUTCOME MEASURES: Daily and cumulative number of deaths from COVID-19. RESULTS: If vaccine efficacy remains high (85%), the vaccine-induced sterilising immunity lasts ≥182 days, and the reinfectivity is greatly reduced (by ≥60%), annual mass vaccination programmes can prevent further COVID-19 outbreaks in England. Under optimistic scenarios, with annual revaccination programmes, the cumulative number of COVID-19 deaths is estimated to be from 130 000 to 150 000 by the end of 2024. However, the total number of COVID-19 deaths may be up to 431 000 by the end of 2024, under scenarios with compromised vaccine efficacy (62.5%), short duration of natural and vaccine immunity (365/182 days) and small reduction in reinfectivity (30%). Under the assumed scenarios, more frequent revaccinations are associated with smaller total numbers and lower peaks of daily deaths from COVID-19. CONCLUSIONS: Under optimistic scenarios, mass immunisation using efficacious vaccines may enable society safely to return to normality. However, under plausible scenarios with low vaccine efficacy and short durability of immunity, COVID-19 could continue to cause recurrent waves of severe morbidity and mortality despite frequent vaccinations. It is crucial to monitor the vaccination effects in the real world, and to better understand characteristics of naturally acquired and vaccine-induced immunity against SARS-CoV-2.

Modified early warning score and risk of mortality after acute stroke.

OBJECTIVE: An accurate prediction tool may facilitate optimal management of patients with acute stroke from an early stage. We evaluated the association between admission modified early warning score (MEWS) and mortality in patients with acute stroke. METHOD: Data from the Anglia Stroke Clinical Network Evaluation Study (ASCNES) were analysed. We evaluated the association between admission MEWS and four outcomes; in-patient, 7-day, 30-day and 1-year mortality. Logistic regression models were used to calculate the odds of all mortality timeframes, whereas Cox proportional hazards models were used to calculate mortality at 1 year. Five univariate and multivariate models were constructed, adjusting for confounders. Patients with a moderate (2-3) or high (≥4) scores were compared to patients with a low score (0-1). RESULTS: The study population consisted of 2006 patients. A total of 1196 patients had low MEWS, 666 had moderate MEWS and 144 had a high MEWS. A high MEWS was associated with increased mortality as an in-patient (OR 4.93, 95 % CI: 2.88-8.42), at 7 days (OR 7.53, 95 % CI: 4.24-13.38), at 30 days (OR 5.74, 95 % CI: 3.38-9.76) and 1-year (HR 2.52, 95 % CI 1.88-3.39). At 1 year, model 5 had a 1.02 OR (95 % CI 0.83-1.24) with moderate MEWS and 2.52 (95 % CI 1.88-3.39) with high MEWS. CONCLUSION: Elevated MEWS on admission is a potential marker for acute-stroke mortality and may therefore be a useful risk prediction tool, able to guide clinicians attempting to prognosticate outcomes for patients with acute-stroke.

Experience of point-of-care HbA1c testing in the English National Health Service Diabetes Prevention Programme: an observational study.

INTRODUCTION: To report the observations of point-of-care (POC) glycated hemoglobin (HbA1c) testing in people with non-diabetic hyperglycemia (NDH; HbA1c 42-47 mmol/mol (6.0%-6.4%)), applied in community settings, within the English National Health Service Diabetes Prevention Programme (NHS DPP). RESEARCH DESIGN AND METHODS: A service evaluation assessing prospectively collected national service-level data from the NHS DPP, using data from the first referral received in June 2016-October 2018. Individuals were referred to the NHS DPP with a laboratory-measured HbA1c in the NDH range and had a repeat HbA1c measured at first attendance of the program using one of three POC devices: DCA Vantage, Afinion or A1C Now+. Differences between the referral and POC HbA1c and the SD of the POC HbA1c were calculated. The factors associated with the difference in HbA1c and the association between POC HbA1c result and subsequent attendance of the NHS DPP were also evaluated. RESULTS: Data from 73 703 participants demonstrated a significant mean difference between the referral and POC HbA1c of -2.48 mmol/mol (-0.23%) (t=157, p<0.001) with significant differences in the mean difference between devices (F(2, 73 700)=738, p<0.001). The SD of POC HbA1c was 4.46 mmol/mol (0.41%) with significant differences in SDs between devices (F(2, 73 700)=1542, p<0.001). Participants who were older, from more deprived areas and from Asian, black and mixed ethnic groups were associated with smaller HbA1c differences. Normoglycemic POC HbA1c versus NDH POC HbA1c values were associated with lower subsequent attendance at behavioral interventions (58% vs 67%, p<0.001). CONCLUSION: POC HbA1c testing in community settings was associated with significantly lower HbA1c values when compared with laboratory-measured referrals. Acknowledging effects of regression to the mean, we found that these differences were also associated with POC method, location, individual patient factors and time between measurements. Compared with POC HbA1c values in the NDH range, normoglycemic POC HbA1c values were associated with lower subsequent intervention attendance.

Variations in Rates of Discharges to Nursing Homes after Acute Hospitalization for Stroke and the Influence of Service Heterogeneity: An Anglia Stroke Clinical Network Evaluation Study.

Nursing home placement after stroke indicates a poor outcome but numbers placed vary between hospitals. The aim of this study is to determine whether between-hospital variations in new nursing home placements post-stroke are reliant solely on case-mix differences or whether service heterogeneity plays a role. A prospective, multi-center cohort study of acute stroke patients admitted to eight National Health Service acute hospitals within the Anglia Stroke and Heart Clinical Network between 2009 and 2011 was conducted. We modeled the association between hospitals (as a fixed-effect) and rates of new discharges to nursing homes using multiple logistic regression, adjusting for important patient risk factors. Descriptive and graphical data analyses were undertaken to explore the role of hospital characteristics. Of 1335 stroke admissions, 135 (10%) were discharged to a nursing home but rates varied considerably from 6% to 19% between hospitals. The hospital with the highest adjusted odds ratio of nursing home discharges (OR 4.26; 95% CI 1.69 to 10.73), was the only hospital that did not provide rehabilitation beds in the stroke unit. Increasing hospital size appeared to be related to an increased odds of nursing home placement, although attenuated by the number of hospital stroke admissions. Our results highlight the potential influence of hospital characteristics on this important outcome, independently of patient-level factors.

Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the ProLife program.

Alcohol and tobacco use may lead to negative treatment outcomes in tuberculosis (TB) patients, and even more so if they are HIV-infected. We developed and tested the feasibility of a complex behavioral intervention (ProLife) delivered by lay health workers (LHWs) to improve treatment outcomes in TB patients who smoke tobacco and/or drink alcohol, at nine clinics in South Africa. The intervention comprised three brief motivational interviewing (MI) sessions augmented with a short message service (SMS) program, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients received SMSs twice a week. We measured recruitment and retention rates and assessed fidelity to the MI technique (MI Treatment Integrity 4.1 tool). Finally, we explored LHWs' and patients' experiences through interviews and semi-structured questionnaires, respectively. We screened 137 TB patients and identified 14 smokers, 13 alcohol drinkers, and 18 patients with both behaviors. Participants' mean age was 39.8 years, and 82.2% were men. The fidelity assessments pointed to the LHWs' successful application of key MI skills, but failure to reach MI competency thresholds. Nevertheless, most patients rated the MI sessions as helpful, ascribed positive attributes to their counselors, and reported behavioral changes. SMSs were perceived as reinforcing but difficult language and technical delivery problems were identified as problems. The LHWs' interview responses suggested that they (a) grasped the basic MI spirit but failed to understand specific MI techniques due to insufficient training practice; (b) perceived ProLife as having benefitted the patients (as well as themselves); (c) viewed the SMSs favorably; but (d) considered limited space and privacy at the clinics as key challenges. The ProLife program targeting multiple risk behaviors in TB patients is acceptable but LHW training protocol, and changes in wording and delivery of SMS are necessary to improve the intervention. Trial registration: ISRCTN62728852.

Hospital-Level Variations in Rates of Inpatient Urinary Tract Infections in Stroke.

Background and purpose: Urinary tract infection (UTI) is one of the most common complications following stroke and has prognostic significance. UTI rates have been shown to vary between hospitals, but it is unclear whether this is due to case-mix differences or heterogeneities in care among hospitals. Methods: A prospective multi-center cohort study of acute stroke patients admitted to eight National Health Service (NHS) acute hospital trusts within the Anglia Stroke & Heart Clinical Network between 2009 and 2011 was conducted. We modeled the association between hospital (as a fixed-effect) and inpatient UTI using a multivariable logistic regression model, adjusting for established patient-level risk factors. We graphically and descriptively analyzed heterogeneities in hospital-level characteristics. Results: We included 2,241 stroke admissions in our analysis; 171 (7.6%) acquired UTI as an inpatient. UTI rates varied significantly between the eight hospitals, ranging from 3 to 11%. The hospital that had the lowest odds of UTI [odds ratio (OR) = 0.50 (95% confidence interval (CI) 0.22-.11)] in adjusted analysis, had the highest number of junior doctors and occupational therapists per five beds of all hospitals. The hospital with the highest adjusted UTI rate [OR=2.69 (1.56-4.64)] was tertiary, the largest and had the highest volume of stroke patients, lowest number of stroke unit beds per 100 admissions, and the highest number of hospital beds per CT scanner. Conclusions: There is hospital-level variation in post-stroke UTI. Our results suggest the potential influence of service characteristics independently of patient-level factors which may be amenable to be addressed to improve the ultimate stroke outcome.

Geographical access to GPs and modes of cancer diagnosis in England: a cross-sectional study.

BACKGROUND: Poor geographical access to health services and routes to a cancer diagnosis such as emergency presentations have previously been associated with worse cancer outcomes. However, the extent to which access to GPs determines the route that patients take to obtain a cancer diagnosis is unknown. METHODS: We used a linked dataset of cancer registry and hospital records of patients with a cancer diagnosis between 2006 and 2010 across eight different cancer sites. Primary outcomes were defined as 'desirable routes to diagnosis' [screen-detected and 2-week wait (TWW) referrals] and 'less desirable routes' [emergency presentations and death certificate only (DCO)]. All other routes (GP referral, inpatient elective and other outpatient) were specified as the reference category. Geographical access was measured as travel time in minutes from patients to their GP, and multinomial logistic regression was used to estimate relative risk ratios (RRR). RESULTS: Longer travel was associated with increased risk of diagnosis via emergency and DCO, but decreased risk of diagnosis via screening and TWW. Patients travelling over 30 minutes had the highest risk of a DCO diagnosis, which was statistically significant for breast, colorectal, lung, prostate, stomach and ovarian cancers (compared with patients with travel times ≤10 minutes: RRR 5.89, 7.02, 2.30, 4.75, 10.41; P < 0.01 and 3.51, P < 0.05). DISCUSSION: Poor access to GPs may discourage early engagement with health services, decreasing the likelihood of screening uptake and increasing the likelihood of emergency presentations. Extra effort is needed to promote early diagnosis in more distant patients.

Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials.

OBJECTIVES: The aim of the article was to assess the appropriateness and rationales of subgroup analyses planned in protocols of randomized controlled trials and reported in subsequent corresponding trial publications. STUDY DESIGN AND SETTING: We searched PubMed to identify trial protocols published in journals during 2006-2017. From a total of 3,774 initially identified records, we included a random sample of 479 protocols and identified 280 trial publications corresponding to the included protocols. RESULTS: Subgroup analyses were specified in 19% of the protocols and reported in 21% of the trial publications. Of the 94 protocols with planned subgroup analyses, 32% mentioned testing for interaction, and only three considered statistical power. Subgroup analyses were not prespecified in 56% of the 59 trial publications with subgroup analyses. Subgroup analyses were stated as prespecified in nine trial publications, without support evidence from the corresponding protocols. Subgroup analyses were often reported insufficiently for assessing the consistency of subgroup effects across studies. Justifications for subgroup analyses were provided in only four trial protocols and seven trial publications. CONCLUSION: Inappropriate specification and reporting of subgroup analyses remain problematic in protocols and reports of randomized controlled trials. Justifications or rationales for subgroup analyses were only rarely provided in trial protocols and reports.

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Brazil.

Brazil's Sistema Único de Saúde, or Unified Health System policy, has delivered major improvements in health coverage and outcomes, but challenges remain, including the rise of non-communicable diseases (NCDs) and variations in quality of care across the country. Some of these challenges may be met through the adaptation and implementation of a South African primary care strategy, the Practical Approach to Care Kit (PACK). Developed by the University of Cape Town's Knowledge Translation Unit (KTU), PACK is intended for in-country adaptation by employing a mentorship model. Using this approach, the PACK Adult guide and training materials were localised for use in Florianópolis, Santa Catarina, Brazil, as part of an initiative to reform primary care, expand care for NCDs and make services more accessible and equitable. The value of the collaboration between the KTU and Florianópolis municipality is the transfer of skills and avoidance of duplication of effort involved in de-novo guide development, while ensuring that materials are locally acceptable and applicable. The collaboration has informed the development of the KTU's PACK mentorship package and led to a relationship between the groups of developers, ensuring ongoing learning and research, with the potential of assisting the further scale-up of PACK in Brazil.

Relapse to smoking and health-related quality of life: Secondary analysis of data from a study of smoking relapse prevention.

BACKGROUND: Previous studies have shown that smoking and smoking cessation may be associated with health-related quality of life (HRQoL). In this study, we compared changes in HRQoL in people who maintained abstinence with people who had relapsed to smoking. METHODS: This was a secondary analysis of data from a trial of a relapse prevention intervention in 1,407 short-term quitters. The European Quality of Life -5 Dimensions (EQ-5D) measured HRQoL at baseline, 3 and 12 months. Smoking outcome was continuous abstinence from 2 to 12 months, and 7-day smoking at 3 and 12 months. We used nonparametric test for differences in EQ-5D utility scores, and chi-square test for dichotomised response to each of the five EQ-5D dimensions. Multivariable regression analyses were conducted to evaluate associations between smoking relapse and HRQoL or anxiety/depression problems. RESULTS: The mean EQ-5D tariff score was 0.8252 at baseline. People who maintained abstinence experienced a statistically non-significant increase in the EQ-5D score (mean change 0.0015, P = 0.88), while returning to smoking was associated with a statistically significant decrease in the EQ-5D score (mean change -0.0270, P = 0.004). After adjusting for multiple baseline characteristics, the utility change during baseline and 12 months was statistically significantly associated with continuous abstinence, with a difference of 0.0288 (95% CI: 0.0006 to 0.0571, P = 0.045) between relapsers and continuous quitters. The only difference in quality of life dimensions between those who relapsed and those who maintained abstinence was in the proportion of participants with anxiety/depression problems at 12 months (30% vs. 22%, P = 0.001). Smoking relapse was associated with a simultaneous increase in anxiety/depression problems. CONCLUSIONS: People who achieve short-term smoking abstinence but subsequently relapse to smoking have a reduced quality of life, which appears mostly due to worsening of symptoms of anxiety and depression. Further research is required to more fully understand the relationship between smoking and health-related quality of life, and to develop cessation interventions by taking into account the impact of anxiety or depression on smoking.

Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials.

BACKGROUND: Multimorbidity is increasing common in Brazilian adults. Comorbid chronic lung disease, cardiovascular disease and diabetes are often inaccurately diagnosed or ineffectively treated. The Global Alliance against Chronic Respiratory Diseases (GARD) aims to strengthen health systems to prevent and control non-communicable diseases through primary health care. The Practical Approach to Care Kit (PACK Adult) is a clinical decision support tool that provides evidence-supported algorithmic guidelines for screening, diagnosis and treatment of chronic diseases, and is widely used in South Africa. It was adapted for Brazil by family physicians in the Florianopolis City Health Department, which trains clinic doctors and nurses to use it. METHODS: Effectiveness of PACK Adult training will be evaluated in two pragmatic cluster randomised trials, one enrolling adults with chronic lower respiratory diseases and the other enrolling adults with cardiovascular disease or diabetes. Forty-eight municipal clinics in Florianopolis were randomly allocated to intervention or control arms. In intervention arm clinics, doctors and nurses will receive educational outreach training and the PACK Adult clinical decision support tool. In control arm clinics, doctors and nurses will receive only the tool. Trial outcomes will be measured using patients' electronic medical records during 12 months after completion of basic training. Primary outcomes for the respiratory trial are appropriate prescribing, spirometry and diagnosis rates. Primary outcomes for the cardiovascular trial are testing for cardiovascular risk and diabetes, and systolic blood pressure. Educational outreach to primary care professionals could improve respiratory, cardiovascular and diabetes care in Brazil. TRIAL REGISTRATION: NCT02786030 and NCT02795910 (https://clinicaltrials.gov/).

Discordance in glycemic categories and regression to normality at baseline in 10,000 people in a Type 2 diabetes prevention trial.

The world diabetes population quadrupled between 1980 and 2014 to 422 million and the enormous impact of Type 2 diabetes is recognised by the recent creation of national Type 2 diabetes prevention programmes. There is uncertainty about how to correctly risk stratify people for entry into prevention programmes, how combinations of multiple 'at high risk' glycemic categories predict outcome, and how the large recently defined 'at risk' population based on an elevated glycosylated haemoglobin (HbA1c) should be managed. We identified all 141,973 people at highest risk of diabetes in our population, and screened 10,000 of these with paired fasting plasma glucose and HbA1c for randomisation into a very large Type 2 diabetes prevention trial. Baseline discordance rate between highest risk categories was 45.6%, and 21.3-37.0% of highest risk glycaemic categories regressed to normality between paired baseline measurements (median 40 days apart). Accurate risk stratification using both fasting plasma glucose and HbA1c data, the use of paired baseline data, and awareness of diagnostic imprecision at diagnostic thresholds would avoid substantial overestimation of the true risk of Type 2 diabetes and the potential benefits (or otherwise) of intervention, in high risk subjects entering prevention trials and programmes.

Self-help materials for smoking relapse prevention: a process evaluation of the SHARPISH randomized controlled trial.

Background: UK Stop Smoking Services are effective at assisting smokers to quit. However, smoking relapse rates are high, representing a significant public health problem. No effective interventions are currently available. This embedded qualitative process evaluation, within a randomized controlled trial of a self-help smoking relapse prevention intervention, aimed to understand patient perspectives in explaining the null trial finding, and to make recommendations for intervention development. Methods: The intervention was a British version of the 'Forever Free' self-help booklets (SHARPISH-ISRCTN 36980856). The qualitative evaluation purposefully sampled 43 interview participants, triangulated with the views of 10 participants and 12 health professionals in focus groups. Data were thematically analysed. Results: Analysis revealed important variation in individual engagement with the self-help booklets. Variation was interpreted by the meta-themes of 'motivation for cessation', and 'positioning on information provision', interacting with the theme of 'mechanisms for information provision'. Conclusions: Targeting self-help information towards those most motivated to engage may be beneficial, considering the social and cultural realities of individual's lives. Individual preferences for the mechanisms of information delivery should be appraised when designing future interventions. Long-term personalized follow-up may be a simple step in improving smoking relapse rates.

Hyperglycaemia and the SOAR stroke score in predicting mortality.

BACKGROUND: We assessed the association between admission blood glucose levels and acute stroke mortality and examined whether there was any incremental value of adding glucose status to the validated acute stroke mortality predictor - the SOAR (stroke subtype, Oxford Community Stroke Project classification, age, and pre-stroke modified Rankin) score. METHODS: Data from Norfolk and Norwich University Hospital stroke and Transient Ischaemic Attack register (2003-2013) and Anglia Stroke Clinical Network Evaluation Study (2009-2012) were analysed. Multivariable logistic regression analysis assessed the association between admission blood glucose levels with inpatient and 7-day mortality. The prognostic ability of the SOAR score was then compared with the SOAR with glucose score. RESULTS: A total of 5575 acute stroke patients (ischaemic stroke: 89.2%) with mean age (standard deviation) of 76.97 ( ± 11.88 ) years were included. Both borderline hyperglycaemia (7.9-11.0 mmol/L) and hyperglycaemia (>11.0 mmol/L) when compared to normoglycaemia (4.0-7.8 mmol/L) were associated with both 7-day and inpatient mortality after controlling for sex, age, Oxford Community Stroke Project classification and pre-stroke modified Rankin score. Both the SOAR stroke score and SOAR-G score were good predictors of inpatient stroke mortality [area under the curve: 0.82 (95% confidence interval: 0.81-0.84) and 0.83 (95% confidence interval: 0.81-0.84)], respectively. These scores were also good at predicting outcomes in both patients with and without diabetes. CONCLUSION: High blood glucose levels at admission were associated with worse acute stroke mortality outcomes. The constituents of the SOAR stroke score were good at predicting mortality after stroke.

Pre-Stroke Modified Rankin Scale: Evaluation of Validity, Prognostic Accuracy, and Association with Treatment.

BACKGROUND AND PURPOSE: The modified Rankin Scale (mRS) was designed to measure poststroke recovery but is often used to describe pre-stroke disability. We sought to evaluate three aspects of pre-stroke mRS: validity as a measure of pre-stroke disability; prognostic accuracy and association of pre-stroke mRS scores, and process of care. METHODS: We used data from a large, UK clinical registry. For analysis of validity, we compared pre-stroke mRS against other markers of pre-stroke function (age, comorbidity index, care needs). For analysis of prognostic accuracy, we described univariable and multivariable models comparing pre-stroke mRS and other prognostic variables against a variety of outcomes (early and late mortality, length of stay, institutionalization, incident complications). Finally, we described association of pre-stroke mRS and components of evidence-based stroke care (early neuroimaging, admission to stroke unit, assessment of swallow). RESULTS: We analyzed data of 2,491 stroke patients. Concurrent validity analyses suggested statistically significant, but modest correlations between pre-stroke mRS and chosen variables (rho >0.40; p < 0.0001 for all). Every point increase of pre-stroke mRS was associated with poorer outcomes for our prognostic variables (unadjusted p < 0.001). This association held when corrected for other covariates. For example, pre-stroke mRS 4-5 odds ratio (OR): 6.84 (95% CI: 4.24-11.03) for 1 year mortality compared to mRS 0 in adjusted model. There was a difference between pre-stroke mRS and treatment, with higher pre-stroke mRS more likely to receive evidence-based care. CONCLUSION: Results suggest that pre-stroke mRS has some concurrent validity and is a robust predictor of prognosis. This association is not explained by the influence of pre-stroke mRS on care pathways.