Developing quality criteria for patient-directed knowledge tools related to clinical practice guidelines. A development and consensus study.

BACKGROUND: Patient-directed knowledge tools such as patient versions of guidelines and patient decision aids are increasingly developed to facilitate shared decision making. In this paper, we report how consensus was reached within the Netherlands on quality criteria for development, content and governance of these tools. METHOD: A 12-month development and consensus study. The consortium worked on four work packages: (a) reviewing existing criteria; (b) drafting the quality criteria; (c) safe-guarding the acceptability and feasibility of the draft criteria by participatory research in on-going tool development projects; and (d) gaining formal support from national stakeholders on the quality criteria. RESULTS: We reached consensus on a 8-step guidance; describing minimal quality criteria for (a) the team composition; (b) setting the scope; (c) identifying needs; (d) the content and format; (e) testing the draft; (f) finalizing and approval; (g) dissemination and application, and (h) ownership and revision. The participants of the on-going tool development projects were positive about the quality criteria in general, but divided as to the degree of detail. Whereas some expressed a clear desire for procedural standards, others felt that it would be sufficient to provide only general directions. Despite the different views as to the degree of detail, consensus was reached in three stakeholder meetings. DISCUSSION: We successfully collaborated with all stakeholders and achieved formal support from national stakeholders on a set of minimum criteria for the development process, content and governance of patient-directed knowledge tools.

Users' Experiences With Web-Based Health Care Information: Qualitative Study About Diabetes and Dementia Information Presented on a Governmental Website.

BACKGROUND: Information on health and health care is abundant on the internet. To make informed choices, patients need reliable and easy-to-understand information about quality and availability of care providers and treatment options. However, the reliability of such Web-based information is difficult to assess. OBJECTIVE: This study aimed to test Web-based information about diabetes and dementia and specifically a new presentation format of care routes to see if people are able to understand and use the information. METHODS: Overall, 38 cognitive interviews were held; 20 people viewed the information about diabetes and 18 viewed the dementia information. Participants were asked what they would want to know about either diabetes or dementia, what choices they would want to make concerning their preferred care provider and treatment, and what information they would like to find to make these choices. They were then asked to view the relevant pages and comment on them. The interview was focused on general information about the condition, the care route, and the quality information for choosing a hospital. The interviews were transcribed verbatim and then systematically coded and ordered into themes. RESULTS: The themes that were developed for both Web pages during the analysis were information needs, findability, usability, comprehension and readability, recognizability, care route, quality information, and usefulness. Information needs were found to be very diverse and dependent on the personal situation and condition of the participant. Several participants were unable to find specific items because they were not where they expected them to be. Most participants were positive about the layout, font, and color scheme of the test pages. However, options of clicking through to another website and indications where information can be expanded and collapsed could be made clearer. Participants generally found the information easy to understand but felt a need for a more detailed explanation of the medical terms. Recognition of the information played an important role: participants assessed whether the information they found matched their experiences. The term care route meant little to most of the participants, but the layout of the care route itself was found to be clear. Not many respondents spontaneously went to the quality information, and a number of participants had difficulty understanding it. Overall, the participants thought the information on the website was useful and helpful. CONCLUSIONS: The cognitive interviews gave numerous insights into how Web-based information is processed and understood. The care route offers a clear overview of the various stages as the condition progresses, but the name care route is not clear to everyone. We gained insight into differences between subgroups of people in terms of information needs, comprehension, and use of the information because the diversity within the group of participants was lower than expected.

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin.

BACKGROUND: Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin. OBJECTIVES: To assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin. SEARCH METHODS: Multiple electronic bibliographic and ongoing trial databases were searched supplemented with handsearches of references of retrieved articles (date of last search: 07 July 2011). SELECTION CRITERIA: Randomised controlled trials investigating the effects of SMBG compared with usual care, self-monitoring of urine glucose (SMUG) or both in patients with type 2 diabetes who where not using insulin. Studies that used glycosylated haemoglobin A(1c) (HbA(1c)) as primary outcome were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from included studies and evaluated the studies' risk of bias. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. Primary outcomes were HbA(1c), health-related quality of life, well-being and patient satisfaction. Secondary outcomes were fasting plasma glucose level, hypoglycaemic episodes, morbidity, adverse effects and costs. MAIN RESULTS: Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA(1c) at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group.There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity. AUTHORS' CONCLUSIONS: From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.

Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial.

BACKGROUND: Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy. METHODS AND DESIGN: Six hundred patients with T2DM (45 < or = 75 years) who receive care in a structured diabetes care system, HbA1c > or = 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG), Self-monitoring of Urine Glucose (SMUG) and usual care (n = 200 per group). Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs. DISCUSSION: The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to experienced threats, and influences the patients ability to perform and maintain self-management skills.

Clinical prediction rules in practice: review of clinical guidelines and survey of GPs.

BACKGROUND: The publication of clinical prediction rules (CPRs) studies has risen significantly. It is unclear if this reflects increasing usage of these tools in clinical practice or how this may vary across clinical areas. AIM: To review clinical guidelines in selected areas and survey GPs in order to explore CPR usefulness in the opinion of experts and use at the point of care. DESIGN AND SETTING: A review of clinical guidelines and survey of UK GPs. METHOD: Clinical guidelines in eight clinical domains with published CPRs were reviewed for recommendations to use CPRs including primary prevention of cardiovascular disease, transient ischaemic attack (TIA) and stroke, diabetes mellitus, fracture risk assessment in osteoporosis, lower limb fractures, breast cancer, depression, and acute infections in childhood. An online survey of 401 UK GPs was also conducted. RESULTS: Guideline review: Of 7637 records screened by title and/or abstract, 243 clinical guidelines met inclusion criteria. CPRs were most commonly recommended in guidelines regarding primary prevention of cardiovascular disease (67%) and depression (67%). There was little consensus across various clinical guidelines as to which CPR to use preferentially. SURVEY: Of 401 responders to the GP survey, most were aware of and applied named CPRs in the clinical areas of cardiovascular disease and depression. The commonest reasons for using CPRs were to guide management and conform to local policy requirements. CONCLUSION: GPs use CPRs to guide management but also to comply with local policy requirements. Future research could focus on which clinical areas clinicians would most benefit from CPRs and promoting the use of robust, externally validated CPRs.

Self-monitoring of blood glucose in noninsulin-using type 2 diabetic patients: it is time to face the evidence.

Given the importance of glycemic control in the development of diabetes complications, the plethora of tools now available to monitor the day-to-day trends in glycemia is remarkable. In this regard, self-monitoring of blood glucose (SMBG) has been considered a key component of patient management. Arguably, there remains almost universal agreement that SMBG should be available to all diabetic patients regardless of current treatment strategy. However, recently there have been reports that have challenged the current paradigm that all patients should use SMBG and concluded that SMBG for type 2 diabetic patients not on insulin may not be beneficial on glycemic control and must be weighed against the expense and inconvenience. In this two-part point-counterpoint narrative, Malanda et al. and Polonsky and Fisher take opposing views on the utility of SMBG to be valuable for individuals with type 2 diabetes not using insulin. In the narrative below, Malanda et al. suggest that the evidence for potentially beneficial SMBG-induced effects on glycemic control, hypoglycemic periods, and potential harms in type 2 diabetic patients who are not treated with insulin does not justify the use of SMBG. Moreover, the use of SMBG is associated with huge costs, which should be better redirected to effective strategies to improve health for this category of patients. -William T. Cefalu, MD Editor in Chief, Diabetes Care.