Background Shared decision making (SDM) is a patient-centered approach in which clinicians and patients work together to find and choose the best course of action for each patient’s particular situation. Six SDM key elements can be identified: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences, and making the decision. The International Patient Decision Aid Standards (IPDAS) require that a decision aid (DA) support these key elements. Yet, the extent to which DAs support these six key SDM elements and how this relates to their impact remain unknown. Methods We searched bibliographic databases (from inception until November 2017), reference lists of included studies, trial registries, and experts for randomized controlled trials of DAs in patients with cardiovascular, or chronic respiratory conditions or diabetes. Reviewers worked in duplicate and independently selected studies for inclusion, extracted trial, and DA characteristics, and evaluated the quality of each trial. Results DAs most commonly clarified options (20 of 20; 100%) and discussed their harms and benefits (18 of 20; 90%; unclear in two DAs); all six elements were clearly supported in 4 DAs (20%). We found no association between the presence of these elements and SDM outcomes. Conclusions DAs for selected chronic conditions are mostly designed to transfer information about options and their harms and benefits. The extent to which their support of SDM key elements relates to their impact on SDM outcomes could not be ascertained. Systematic review registration PROSPERO registration number: CRD42016050320 . Electronic supplementary material The online version of this article (10.1186/s13643-019-1034-4) contains supplementary material, which is available to authorized users.

Background In children physical activity has been shown to be associated with health-related quality of life (HRQoL). This study further explores this association for specific characteristics of sports participation, namely membership of a sports club, frequency of sports participation, performing individual versus team sports, performing indoor versus outdoor sports, while differentiating between specific dimensions in the physical, psychological and social domain of HRQoL. Methods Cross-sectional data were collected from Dutch primary school children aged 10 to 12 years. They completed the Movement and Sports Monitor Questionnaire Youth aged 8 to 12 years (MSMQ) and the KIDSCREEN-52, an HRQoL questionnaire for children and adolescents. The data were examined using linear multilevel analyses because of the clustering of children in schools. Results The questionnaires were completed by 1876 children (response rate 81.3%). Membership of a sports club, moderate or high frequency of sports participation, and performing outdoor sports were all significantly associated with better HRQoL. These associations were largely found in the physical domain of HRQoL, to a lesser degree in the social domain, and to a limited extent in the psychological domain. Conclusion The association between sports participation and HRQoL in children depends on both characteristics of sports participation and the domain of life that is concerned. These differences offer starting points for developing tailor-made sports programs for children. Electronic supplementary material The online version of this article (10.1186/s12955-019-1124-y) contains supplementary material, which is available to authorized users.

BackgroundShared decision-making (SDM) is a patient-centred approach in which clinicians and patients work side-by-side to decide together on the best course of action for each patient’s particular situation. Six key elements of SDM can be distinguished: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences and making the decision. Decision aids (DAs) are tools that facilitate SDM. The impact of DAs for chronic illnesses on SDM, clinical and patient reported outcomes remains uncertain.MethodsWe will perform a systematic review aiming to describe (a) which SDM elements are incorporated in DAs for adult patients with chronic conditions and (b) the effects of DA use on SDM, clinical and patient reported outcomes. This manuscript reports on the protocol for this systematic review. The following databases will be searched for relevant articles: PubMed, Embase, Web of Science, CINAHL and PsycINFO, from their inception to October 2016. We will ascertain ongoing research by querying experts and searching trial registries. To enhance feasibility, we will limit the review to randomized controlled trials (RCTs) including patients with chronic cardiovascular and/or respiratory diseases and/or diabetes. SDM elements incorporated in DAs, DA effects and DA itself will be described.DiscussionThis study will characterize DAs for chronic illness and will provide an overview of their effects on SDM, clinical and patient reported outcomes. We anticipate this review will bring to light knowledge gaps and inform further research into the design and use of DAs for patients with chronic conditions.Systematic review registrationPROSPERO registration number: CRD42016050320.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0557-9) contains supplementary material, which is available to authorized users.

ObjectiveInsulin glargine 300 (Gla-300) provides less hypoglycemia risk and more flexibility in injection time. The extent to which these effects translate into improved patient-reported outcomes (PROs) is unknown, and is the subject of this observational study.Research design and methodsAdults with type 2 diabetes treated with basal insulin for at least 6 months initiating Gla-300 were included. Data were collected at baseline (start Gla-300) and at 3-month and 6-month follow-up. Patients and physicians gave reasons for switching to Gla-300 at baseline and the extent to which Gla-300 fulfilled their expectations at 6 months. Mixed model analyses examined PRO changes over time, with emotional well-being (WHO-5 Well-Being Index) as the primary outcome. The secondary outcomes were hypoglycemia incidence, hemoglobin A1c (HbA1c), hypoglycemia worries (worry subscale of the Hypoglycemia Fear Survey), diabetes distress (short form of the Dutch version of the Problem Areas In Diabetes Scale), diabetes medication convenience (Diabetes Medication System Rating Questionnaire (DMSRQ)), sleep quality and duration (Pittsburgh Sleep Quality Index), and adherence (Summary of Diabetes Self-Care Activities).Results162 patients participated: 53.70% were men, the mean age was 65.54 years (9.05), baseline mean HbA1c was 7.87% (1.15) (62.48 mmol/mol (12.61)), and mean diabetes duration was 15.14 years (6.65). Mean WHO-5 Well-Being Index scores improved non-significantly from 61.94 (19.52) at baseline (T0) to 63.83 (19.67) at 6 months (T2). Mean DMSRQ scores improved significantly from 32.96 (9.02) (T0) to 36.70 (8.85) (T2) (p<0.001). Dose (less volume) was a switching reason in 69.60% of patients and 63% of physicians, and flexibility in 33.30% and 24.70%, respectively. Gla-300 fulfilled the expectations or even better than expected in 92.30% of patients and 88.90% of physicians.ConclusionIn a relatively well-controlled sample of adults with type 2 diabetes, switching to Gla-300 improves diabetes medication convenience.

PurposeQuality of Life (QoL) of insulin-naïve people with type 2 diabetes mellitus (T2DM) improves after transition to insulin. Little is known about the role of hypoglycaemia in this context. Secondary analyses of the Study of the Psychological Impact in Real care of Initiating insulin glargine Treatment (SPIRIT) aimed to investigate the relationship between hypoglycaemia and QoL when transitioning to insulin.MethodsInsulin-naïve Dutch people with T2DM in suboptimal glycaemic control (HbA1c >53 mmol/mol; 7.0%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Participants started insulin glargine and completed QoL-questionnaires (WHO-5 Well-being Index (WHO-5; emotional well-being), Hypoglycaemia Fear Survey-worry scale (HFS-w; hypoglycaemia fear) and Diabetes Symptom Checklist-revised (DSC-r; diabetes symptom distress) at baseline, 3 and 6 months follow-up. Linear GEE analyses were used to investigate the association between symptomatic, nocturnal, severe hypoglycaemia (number of episodes during 3 months prior to visit) and QoL over time.Results52.5% men participated, mean age 62.2 years (SD ± 10.92), and median HbA1c 67 mmol/mol (range 61–77) (8.3%). More symptomatic hypoglycaemic episodes were associated with higher HFS-w and DSC-r scores (P < 0.01). Experiencing multiple nocturnal or severe episodes was related to higher symptom distress as well, when compared to no episodes. These associations did not change significantly over time.ConclusionsHypoglycaemia is associated with lower QoL in terms of hypoglycaemia fear and diabetes symptom distress. The transition to insulin does not affect this relationship, suggesting hypoglycaemia in itself has a detrimental effect on diabetes-related QoL independent of treatment regimen.

Aims To systematically review the literature regarding the association between glucose variability (GV) and mood in adults with diabetes, appraise the used methods and make suggestions for future research. Methods A systematic review of literature published up to May 2019 was performed. Abstracts and full texts were screened independently in duplicate. Experimental and observational studies reporting the association between GV and mood in adults with type 1 diabetes or type 2 diabetes were evaluated. A descriptive analysis of the extracted data was conducted, along with a quality assessment. Results Out of the 2.316 studies screened, eight studies met our criteria. Studies used a variety of measures and metrics to determine GV and mood. Four studies used continuous glucose monitoring (CGM). An association between GV and mood was found in four studies when correlating either postprandial glucose rate of increase with current mood or multiday GV with mood measured retrospectively. The other four studies did not find any association. Conclusions There is no clear empirical support for a link between GV and mood in adults with type 1 and type 2 diabetes. More rigorous research is warranted using CGM and ecological momentary assessment of mood to assess if and under what conditions an association between GV and mood exists.

IntroductionThe Diabetes Symptom Checklist-Revised (DSC-R) is a well-validated patient-reported outcome designed to assess symptom burden in persons with type 2 diabetes mellitus (T2DM) across eight domains. The DSC-R has so far primarily been used in research settings. With the aim to make the DSC-R applicable in clinical practice by improving its interpretability, we sought to identify patient characteristics associated with DSC-R (domain) scores as a first initiative toward reference values.Research design and methodsWe used baseline data from two large observational studies to select patient characteristics significantly associated with DSC-R domain and total scores. Multivariable Tobit analyses with the backward procedure per (domain) score were performed.ResultsData from 1531 participants with T2DM were included. On a 0–100 scale, the median DSC-R total score was 15.88 (7.06–29.41), with domain scores ranging from 5.00 (0.00–22.50) (pain) to 35.00 (10.00–60.00) (fatigue). Low well-being status was most profoundly associated with higher scores across all domains. Persons with one or more complication, as well as one or more symptomatic hypoglycemic episode during the past 3 months, scored higher on (almost) all domains and the total scale.ConclusionsComplications, symptomatic hypoglycemia, and low well-being are important characteristics to take into account when using the DSC-R in individual patients. Further validation of our findings is warranted in diverse patient populations.

OBJECTIVEThe extent of shared decision making (SDM) use in the care of Black patients is limited. We explored preferences, needs, and challenges of Black patients to enhance SDM offerings. METHODSWe performed interviews with 32 Black patients receiving type 2 diabetes care in safety-net primary care practices caring predominantly for Black people. RESULTSThe following 4 themes emerged: preference for humanistic communication, need to account for the role of family in decision making, need for medical information sharing, and mistrust of clinicians.CONCLUSION Given the dearth of research on SDM among ethnic and racial minorities, this study offers patient-perspective recommendations to improve SDM offerings for Black patients in primary care settings. To enhance SDM with Black patients, acknowledgment of the importance of storytelling as a strategy, to place medical information in a context that makes it meaningful and memorable, is recommended. Triadic SDM, in which family members are centrally involved in decision making, is preferred over classical dyadic SDM. There is a need to reconsider the universalism assumption underlying contemporary SDM models and the relevancy of current SDM practices that were developed mostly without the feedback of participants of ethnic, racial, and cultural minorities.