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Background Regular laboratory test monitoring of patient parameters offers a route for improving the quality of chronic disease care. We evaluated the effects of brief educational messages attached to laboratory test reports on diabetes care. Methods A programme of cluster randomised controlled trials was set in primary care practices in one primary care trust in England. Participants were the primary care practices' constituent healthcare professionals and patients with diabetes. Interventions comprised brief educational messages added to paper and electronic primary care practice laboratory test reports and introduced over two phases. Phase one messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control, and foot inspection. Main outcome measures comprised practice mean HbA1c and cholesterol levels, diastolic and systolic BP, and proportions of patients having undergone foot inspections. Results Initially, 35 out of 37 eligible practices participated. Outcome data were available for a total of 8,690 patients with diabetes from 32 practices. The BP message produced a statistically significant reduction in diastolic BP (-0.62 mmHg; 95% confidence interval -0.82 to -0.42 mmHg) but not systolic BP (-0.06 mmHg, -0.42 to 0.30 mmHg) and increased the odds of achieving target BP control (odds ratio 1.05; 1.00, 1.10). The foot inspection message increased the likelihood of a recorded foot inspection (incidence rate ratio 1.26; 1.18 to 1.36). The glycaemic control message had no effect on mean HbA1c (increase 0.01%; -0.03 to 0.04) despite increasing the odds of a change in likelihood of HbA1c tests being ordered (OR 1.06; 1.01, 1.11). The cholesterol message had no effect (decrease 0.01 mmol/l, -0.04 to 0.05). Conclusions Three out of four interventions improved intermediate outcomes or process of diabetes care. The diastolic BP reduction approximates to relative reductions in mortality of 3% to 5% in stroke and 3% to 4% in ischaemic heart disease over 10 years. The lack of effect for other outcomes may, in part, be explained by difficulties in bringing about further improvements beyond certain thresholds of clinical performance. Trial Registration Current Controlled Trials, ISRCTN2186314.

Background Type 2 diabetes is an increasingly prevalent chronic illness and an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of primary care teams. This study aimed to: investigate theoretically-based organisational, team, and individual factors determining the multiple behaviours needed to manage diabetes; and identify multilevel determinants of different diabetes management behaviours and potential interventions to improve them. This paper describes the instrument development, study recruitment, characteristics of the study participating practices and their constituent healthcare professionals and administrative staff and reports descriptive analyses of the data collected. Methods The study was a predictive study over a 12-month period. Practices (N = 99) were recruited from within the UK Medical Research Council General Practice Research Framework. We identified six behaviours chosen to cover a range of clinical activities (prescribing, non-prescribing), reflect decisions that were not necessarily straightforward (controlling blood pressure that was above target despite other drug treatment), and reflect recommended best practice as described by national guidelines. Practice attributes and a wide range of individually reported measures were assessed at baseline; measures of clinical outcome were collected over the ensuing 12 months, and a number of proxy measures of behaviour were collected at baseline and at 12 months. Data were collected by telephone interview, postal questionnaire (organisational and clinical) to practice staff, postal questionnaire to patients, and by computer data extraction query. Results All 99 practices completed a telephone interview and responded to baseline questionnaires. The organisational questionnaire was completed by 931/1236 (75.3%) administrative staff, 423/529 (80.0%) primary care doctors, and 255/314 (81.2%) nurses. Clinical questionnaires were completed by 326/361 (90.3%) primary care doctors and 163/186 (87.6%) nurses. At a practice level, we achieved response rates of 100% from clinicians in 40 practices and > 80% from clinicians in 67 practices. All measures had satisfactory internal consistency (alpha coefficient range from 0.61 to 0.97; Pearson correlation coefficient (two item measures) 0.32 to 0.81); scores were generally consistent with good practice. Measures of behaviour showed relatively high rates of performance of the six behaviours, but with considerable variability within and across the behaviours and measures. Discussion We have assembled an unparalleled data set from clinicians reporting on their cognitions in relation to the performance of six clinical behaviours involved in the management of people with one chronic disease (diabetes mellitus), using a range of organisational and individual level measures as well as information on the structure of the practice teams and across a large number of UK primary care practices. We would welcome approaches from other researchers to collaborate on the analysis of this data.

Background Studies included in a related systematic review used a variety of statistical methods to summarise clinical behaviour and to compare proxy (or indirect) and direct (observed) methods of measuring it. The objective of the present review was to assess the validity of these statistical methods and make appropriate recommendations. Methods Electronic bibliographic databases were searched to identify studies meeting specified inclusion criteria. Potentially relevant studies were screened for inclusion independently by two reviewers. This was followed by systematic abstraction and categorization of statistical methods, as well as critical assessment of these methods. Results Fifteen reports (of 11 studies) met the inclusion criteria. Thirteen analysed individual clinical actions separately and presented a variety of summary statistics: sensitivity was available in eight reports and specificity in six, but four reports treated different actions interchangeably. Seven reports combined several actions into summary measures of behaviour: five reports compared means on direct and proxy measures using analysis of variance or t-tests; four reported the Pearson correlation; none compared direct and proxy measures over the range of their values. Four reports comparing individual items used appropriate statistical methods, but reports that compared summary scores did not. Conclusions We recommend sensitivity and positive predictive value as statistics to assess agreement of direct and proxy measures of individual clinical actions. Summary measures should be reliable, repeatable, capture a single underlying aspect of behaviour, and map that construct onto a valid measurement scale. The relationship between the direct and proxy measures should be evaluated over the entire range of the direct measure and describe not only the mean of the proxy measure for any specific value of the direct measure, but also the range of variability of the proxy measure. The evidence about the relationship between direct and proxy methods of assessing clinical behaviour is weak.

Background Type 2 diabetes is an increasingly prevalent chronic illness and is an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of the primary care team. Studies of the quality of care for patients with diabetes suggest less than optimum care in a number of areas. Aim The aim of this study is to improve the quality of care for patients with diabetes cared for in primary care in the UK by identifying individual, team, and organisational factors that predict the implementation of best practice. Design Participants will be clinical and non-clinical staff within 100 general practices sampled from practices who are members of the MRC General Practice Research Framework. Self-completion questionnaires will be developed to measure the attributes of individual health care professionals, primary care teams (including both clinical and non-clinical staff), and their organisation in primary care. Questionnaires will be administered using postal survey methods. A range of validated theories will be used as a framework for the questionnaire instruments. Data relating to a range of dimensions of the organisational structure of primary care will be collected via a telephone interview at each practice using a structured interview schedule. We will also collect data relating to the processes of care, markers of biochemical control, and relevant indicator scores from the quality and outcomes framework (QOF). Process data (as a proxy indicator of clinical behaviours) will be collected from practice databases and via a postal questionnaire survey of a random selection of patients from each practice. Levels of biochemical control will be extracted from practice databases. A series of analyses will be conducted to relate the individual, team, and organisational data to the process, control, and QOF data to identify configurations associated with high quality care. Study registration UKCRN ref:DRN120 (ICPD)