'Towards a conceptualization of nurses' support of hospitalised patients' self-management-A modified Delphi study'.

AIM: To determine patients', nurses' and researchers' opinions on the appropriateness and completeness of the proposed conceptualization of nurses' support of hospitalised patients' self-management. DESIGN: A modified Delphi study. METHODS: We conducted a two-round Delphi survey. The panel group consisted of patients, nurses and researchers. The conceptualization of nurses' support of hospitalised patients' self-management presented in the first Delphi round was based on previous research, including a scoping review of the literature. Data was analysed between both rounds and after the second round. Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES). RESULTS: In the first round all activities of the proposed conceptualization were considered appropriate to support the patients' self-management. Panel members' comments led to the textual adjustment of 19 activities, the development of 15 new activities, and three general questions related to self-management support during hospitalisation. In the second round the modified and the newly added activities were also deemed appropriate. The clarification statements raised in the first Delphi round were accepted, although questions remained about the wording of the activities and about what is and what is not self-management support. CONCLUSION: After textual adjustments and the addition of some activities, the proposed conceptualization of nurses' support in patients' self-management while hospitalised have been considered appropriate and complete. Nevertheless, questions about the scope of this concept still remains. The results provide a starting point for further discussion and the development of self-management programs aimed at the hospitalised patient. IMPLICATION FOR THE PROFESSION AND/OR PATIENT CARE: The results can be considered as a starting point for practice to discuss the concept of nurses' support for hospitalised patients' self-management and develop, implement and research self-management programs specific for their patient population. REPORTING METHOD: Results are reported in accordance with the guidance on Conducting and Reporting Delphi Studies (CREDES). PATIENT OR PUBLIC CONTRIBUTION: Patients were involved as expert panellist in this Delphi study. Impact statement What problem did the study address? Self-management support during hospitalisation is understudied, which undermines the development of evidence-based interventions. What were the main findings? A panel, consisting of patients, nurses and researchers, agreed on the appropriateness of a conceptualization of nurses' support of inpatients' self-management, and identified some points for discussion, mainly related to the boundaries of the concept self-management. Where and on whom will the research have an impact? This study is crucial for generating conceptual understanding of how nurses support patients' self-management during hospitalisation. This is necessary for policy, clinical practice, education, and research on this topic.

'Nurses' self-management support to hospitalised patients: A scoping review.

AIMS AND OBJECTIVES: To review the current literature to map and explore the interventions that have been considered or used by nurses to support adult patients' self-management during hospitalisation. BACKGROUND: Nurses can play an important role in supporting patients' self-management. Currently, however, it is unclear how nurses perform this task during a patient's stay in hospital. Traditionally, nurses take the primary role in managing patients' care during hospitalisation. Ideally, patients should have the opportunity to continue applying strategies to manage their health conditions as much as possible while in the hospital. This can increase patients' self-efficacy and decrease unnecessary readmissions. DESIGN: Scoping review informed by the Joanna Briggs Institute methodology. METHODS: A database search was undertaken using Pubmed, CINAHL, PsycInfo, Cochrane, Embase and grey literature sources. Data from the included studies were mapped and summarised in a narrative summary. To synthesise the information that was given about each intervention, we conducted a qualitative inductive content analysis. Results are reported in accordance with the guidelines for reporting Items for systematic review and meta-analyses extension for scoping review (PRISMA-ScR) (Supplementary File 1). RESULTS: 83 documents were included in this review. Based on the information about the interventions, three themes were identified: 'self-management support activities', 'focus of self-management support' and the 'intervention procedure'. Five self-management support activities can be distinguished: 'giving education', 'counselling and coaching', 'enhancing responsibility', 'engaging family-caregivers' and 'supporting transition from hospital to home'. The interventions focused on improving disease-related knowledge and on strengthening several self-management skills. Information about the procedure, development and the theoretical underpinning of the intervention was often limited. CONCLUSIONS: Most activities within the nursing interventions to support adult patients' self-management during hospitalisation are the part of regular nursing care. However, the transfer of responsibility for care task to the patient is relatively new. Further research could focus on developing interventions addressing all aspects of self-management and that are embedded in the patient's care pathway across settings. RELEVANCE TO CLINICAL PRACTICE: Clinical nurses may improve nursing care by supporting all aspects of patients' self-management and facilitate patients as much as possible for taking responsibility for self-management tasks during hospitalisation.

How nurses support self-management of hospitalized patients through verbal communication: a qualitative study.

BACKGROUND: Patients' self-management of the implications of their disease(s) is becoming increasingly important. Research shows that hospitalization disrupts established self-management routines. Nurses can play an important role in supporting patients' self-management. The aim of this study is to describe how nurses support the self-management of hospitalized patients through verbal communication during routine nursing care. METHODS: A qualitative descriptive study, using overt, non-participant observations was conducted on three wards of a general teaching hospital in the Netherlands. A total of 215 hours of nursing work during 49 shifts was observed. Data was analyzed using thematic analysis based on the six phases of Braun and Clarke. RESULTS: Our observations showed that nurses discuss patients' self-management mainly in short conversations during the care provision. Nurses ask patients about their self-management at home and stimulate patients to express their opinions and to be involved in the care process. Three themes reflect how nurses support self-management: 'Discussing patient's self-management', 'Enhancing patient's involvement in care' and 'Focusing on patient's perspective'. CONCLUSION: Hospital nurses have methods to support hospitalized patients' self-management but it does not seem to be an integral part of daily practice. Given current developments in healthcare, it is reasonable to argue that self-management should be given greater emphasis within the hospital setting, requiring a collaborative approach with patients and other healthcare professionals across the care continuum.

Family caregivers' perceived level of collaboration with hospital nurses: A cross-sectional study.

AIM: To describe the extent of perceived collaboration between family caregivers of older persons and hospital nurses. BACKGROUND: Collaboration between hospital nurses and family caregivers is of increasing importance in older patient's care. Research lacks a specific focus on family caregiver's collaboration with nurses. METHOD: Using a cross-sectional design, 302 caregivers of older patients (≥70 years) completed the 20-item Family Collaboration Scale with the subscales: trust in nursing care, accessible nurse and influence on decisions. Data were analysed with descriptive statistics and bivariate correlations. RESULTS: Family caregivers rated their level of trust in nurses and nurses' accessibility higher than the level of their influence on decisions. Family caregivers who had more contact with nurses perceived higher levels of influence on decisions (p ≤ .001) and overall collaboration (p ≤ .001). CONCLUSION: Family caregivers' collaboration with nurses can be improved, especially in recognizing and exploiting family caregivers as partner in the care for older hospitalized persons and regarding their level of influence on decisions. IMPLICATIONS FOR NURSING MANAGEMENT: Insight into family caregivers' collaboration with nurses will help nurse managers to jointly develop policy with nurses on how to organise more family caregivers' involvement in the standard care for older persons.

Nurses' perceptions of self-management and self-management support of older patients during hospitalization.

Four focus group interviews were held with nurses, recruited from eight wards of two general hospitals, to explore nurses' perceptions of self-management and self-management support of older patients during hospitalization. A thematic analyze of the interview transcripts was conducted. Regarding nurses understanding of self-management two perceptions emerged namely 'being self-reliant' and 'being in control'. In terms of their understanding self-management support three perceptions emerged: encouraging patients to perform activities of daily living (ADL); stimulating patient participation; and increasing patients' awareness. We also found seven themes relating to nurses' beliefs regarding older patients' self-management and self-management support during hospitalization. Results indicate that nurses have a limited understanding of self-management and do not fully understand what is expected from them with regards to inpatients' self-management. It is feasible to argue that addressing nurses' beliefs can influence nurses intention and behavior regarding supporting older inpatients' self-management.

The importance of families in nursing care: attitudes of nurses in the Netherlands.

INTRODUCTION: Positive attitudes towards family involvement in nursing care are essential for improving the involvement of and collaboration with patients' families. The aim of this study is to explore nurses' attitudes towards the importance of families in nursing care. METHOD: Using a cross-sectional design, hospital and homecare nurses completed the Families Importance to Nursing Care (FINC-NA) scale, Dutch language version, consisting of four subscales. Data were analysed using descriptive statistics and regression analyses. RESULTS: A total of 426 hospital and homecare nurses were eligible for analysis (mean (SD) age 42 years (13), 93% female). The mean (SD) attitude of nurses was 63.8 (12) (100-point scale) on the FINC-NA. Less than half of the nurses (44%) considered family as a collaboration partner, and 37% of nurses stated that families should be invited to actively participate in planning patient care. The nurses' attitudes were explained by years of work experience in nursing, work setting and existing policy regarding families in patient care. CONCLUSION: This study identifies areas of improvement regarding to nurses' attitudes towards the importance of families in nursing care in order to establish a more family-focused approach in nursing care. Nursing policies should facilitate working with families as part of regular nursing processes. Furthermore, the importance of family involvement in care should be an explicit matter of concern for nursing educational institutions and for policy making within healthcare organisations.

The association of collaboration between family caregivers and nurses in the hospital and their preparedness for caregiving at home.

Family caregivers of an older person who was recently hospitalized often feel unprepared for their new or expanded tasks. Quality and continuity of care for older people is expected to improve when nurses collaborate with family caregivers as partners in care. The aim of this study was to explore the unique contribution of collaboration between family caregivers of older patients and hospital nurses as a possible predictor for preparedness of caregiving after hospital discharge. With a cross sectional design, a postal survey was sent to 777 family caregivers of home-dwelling hospitalized patients (≥70 years). Regression analyses were used to test the association between collaboration and preparedness for caregiving. In total, 506 (68%) family caregivers responded of whom 281 (38%) were eligible. Their mean (SD) age was 65 (13) and 71% were female. Family caregivers' level of collaboration with nurses was significantly associated with their preparedness for caregiving.

Psychometric evaluation of a revised Family Collaboration Scale.

Measuring family caregivers' experiences of collaboration with nurses is important in the context of health care reforms that advocate an increased role of families in care. The Family Collaboration Scale (FCS) measures collaboration between nurses and family caregivers, however, the scale has a broad scope. Thus, the aim of this study was to construct a measure that is focused on collaboration only. After revision, a 25-item version of the FCS was sent to 777 family caregivers of hospitalized patients (≥70 years). Psychometric evaluation was employed by the Non-Parametric Item Response Theory to evaluate how items of the revised FCS behave. In total, 302 (39%) family caregivers were found eligible, mean (SD) age 65 (13) and 71% female. A 20-item FCS is proposed showing good psychometric properties. This study contributes to the limited knowledge of measuring collaboration between family caregivers and nurses.

Older patients' motives of whether or not to perform self-management during a hospital stay and influencing factors✰.

Semi-structured in-depth interviews (n = 12) were held to explore older patients' motives of whether or not to perform self-management while hospitalized and to identify factors influencing self-management during hospitalization. These interviews were analyzed using the Quacol method. Self-management during hospitalization is operationalized as: collaboration with the nursing staff, having a proactive role, and having control over personal care. Three main themes, i.e., patients' abilities, expectations and opinions, as well as their perceived behavior of nurses were identified along with eight influencing factors. Results indicate that older inpatients perform self-management when they know that it impacts their recovery, when they perceive that a mistake is impending, when their own personal limits are exceeded, or when they are invited to self-manage by nurses. This study provides several suggestions for developing interventions to support patients' self-management during hospitalization.

The effect of a multifaceted evidence-based practice programme for nurses on knowledge, skills, attitudes, and perceived barriers: A cohort study.

BACKGROUND: The Dutch professional nursing standard of 2012 stipulates that Dutch nursing practices are to be evidence-based. Not all practicing nurses can satisfy these requirements, therefore, an educational programme about Evidence-Based Practice (EBP) was developed for a Dutch teaching hospital. OBJECTIVE: The aim of this study was to measure the effects of a six month in-house EBP programme on knowledge, skills, attitudes, and perceived barriers of nurses (four European Credits equals two US Credit Hours). METHODS: A multiple-cohort study was conducted with a pre-post-test design. In the period of 2011-2015, a total of 58 nurses (9 cohorts) followed the programme. Baseline and follow-up assessments consisted of three questionnaires each: the Dutch Modified Fresno, the two subscales of the McColl questionnaire, and the BARRIER scale to assess knowledge and skills, attitudes, and perceived barriers, respectively. RESULTS: Fifty nurses completed both assessments. The results demonstrated that actual knowledge and skills significantly increased by approximately 40%. Self-perceived knowledge increased significantly, while attitudes towards EBP remained (moderately) positive. Perceived barriers did not notably change except for the Research subscale which received many "no opinion" responses prior to the programme but fewer afterwards. CONCLUSIONS: Our multifaceted in-house EBP programme led to a significant improvement of approximately 40% in EBP knowledge and skills of participating nurses. Most nurses who followed the EBP programme are currently applying their knowledge and skills in practice. Managerial support and allocated time for EBP are important facilitators for its implementation. Furthermore, to maintain and expand nurses' EBP knowledge and skills and translate them into practice, follow-up interventions, such as journal clubs, may well be beneficial. Based on the positive results of our programme, we will implement it throughout the hospital with an emphasis on training more groups of nurses.

Health-Related Quality of Life in Relation to Obesity Grade, Type 2 Diabetes, Metabolic Syndrome and Inflammation.

BACKGROUND: Health-related quality of life (HR-QoL) may be compromised in obese individuals, depending on the presence of other complications. The aim of this study is to assess the effect of obesity-related conditions on HR-QoL. These conditions are i) grade of obesity with and without type 2 diabetes (T2D), ii) metabolic syndrome (MetS), and iii) level of inflammation. METHODS: From the Dutch LifeLines Cohort Study we included 13,686 obese individuals, aged 18-80 years. HR-QoL was measured with the RAND 36-Item Health Survey which encompasses eight health domains. We calculated the percentage of obese individuals with poor HR-QoL, i.e. those scoring below the domain and sex specific cut-off value derived from the normal weight population. Logistic regression analysis was used to calculate the probability of having poor domain scores according to the conditions under study. RESULTS: Higher grades of obesity and the additional presence of T2D were associated with lower HR-QoL, particularly in the domains physical functioning (men: odds ratios (ORs) 1.48-11.34, P<0.005, and women: ORs 1.66-5.05, P<0.001) and general health (men: ORs 1.44-3.07, P<0.005, and women: ORs 1.36-3.73, P<0.001). A higher percentage of obese individuals with MetS had a poor HR-QoL than those without MetS. Furthermore, we observed a linear trend between inflammation and the percentage of obese individuals with poor scores on the HR-QoL domains. Individuals with MetS were more likely to have poor scores in the domains general health, vitality, social functioning and role limitations due to emotional problems. Obese women with increased inflammation levels were more likely to have poor scores on all domains except role limitations due to emotional problems and mental health. CONCLUSIONS: The impact of obesity on an individual's quality of life is enhanced by grade of obesity, T2D, MetS and inflammation and are mainly related to reduced physical health. The mental well-being is less often impaired.

Bilateral versus unilateral interlaminar approach for bilateral decompression in patients with single-level degenerative lumbar spinal stenosis: a multicenter retrospective study of 175 patients on postoperative pain, functional disability, and patient satisfaction.

OBJECT: The bilateral and unilateral interlaminar techniques for bilateral decompression both demonstrate good results for the treatment of degenerative lumbar spinal stenosis (DLSS). Although there is some discussion about which approach is more effective, studies that directly compare these two popular techniques are rare. To address this shortcoming, this study compares postoperative functional disability, pain, and patient satisfaction among patients with single-level DLSS who underwent bilateral decompression using either a bilateral or unilateral approach. METHODS: This retrospective study included patients who underwent operations between November 1, 2009, and October 1, 2011. These patients underwent single-level bilateral decompressive surgery using either the bilateral or unilateral interlaminar approach at one of 5 participating hospitals. Exclusion criteria included previous lumbar surgery, additional disc surgery, and spondylolisthesis requiring fusion surgery. Primary outcome measures included bodily pain (as reported using the visual analog scale [VAS]), the Roland-Morris Disability Questionnaire (RMDQ), and the Oswestry Disability Index (ODI). In addition, reductions in leg and back symptoms and the patient's general evaluation of the procedure were queried. Finally, patient satisfaction and surgical parameters were evaluated. Questionnaires were sent to each patient's home, and electronic patient files were used to collect the data. RESULTS: One hundred and seventy-five patients returned the questionnaire (74.4% response rate; 68 and 107 patients who underwent the bilateral or unilateral approach, respectively). Mean age at surgery was 68 years (range 34-89 years), and the mean follow-up period was 14.2 months (range 3.3-27.4 years). There were no significant differences in ODI (20.3 vs 22.6 for the bilateral and unilateral approaches, respectively), RMDQ (3.99 vs 4.8, respectively), or pain scores between treatment groups. Back symptoms were reduced in 74.8% (bilateral: 74.6% vs unilateral: 75%; not significant), and leg symptoms in 80.6% of the patients (bilateral: 73.1% vs unilateral: 85.4%; p = 0.048). In total, 72.1% (bilateral) and 80.0% (unilateral) of patients reported good overall treatment results (p = 0.226). Significantly more patients in the unilateral group reported a better overall satisfaction with the procedure (82.1% vs 69.1%; p = 0.047). CONCLUSIONS: There were no differences in postoperative functional disability and pain between the surgical techniques. The significant differences in patient satisfaction and reduction in leg symptoms were unrelated to surgical technique. The overall treatment results were satisfactory. Both techniques are safe and effective options for treating patients with single-level DLSS.

Fifteen-year follow-up of quality of life in type 1 diabetes mellitus.

AIM: To evaluate metabolic control and health-related quality of life (HRQOL) in a type 1 diabetes mellitus (T1DM) population. METHODS: As part of a prospective cohort study, 283 T1DM patients treated with various insulin treatment modalities including multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) were examined annually. HRQOL was measured using the SF-36 and EuroQol questionnaires. Data regarding HRQOL, glycaemic and metabolic control from baseline and follow-up measures in 2002 and 2010 were analysed. Linear mixed models were used to calculate estimated values and differences between the three moments in time and the three treatment modalities. RESULTS: Significant changes [mean Δ (95%CI)] in body mass index [2.4 kg/m(2) (1.0, 3.8)], systolic blood pressure [-6.4 mmHg (-11.4, -1.3)] and EuroQol-VAS [-7.3 (-11.4, -3.3)] were observed over time. In 2010, 168 patients were lost to follow-up. Regarding mode of therapy, 52 patients remained on MDI, 28 remained on CSII, and 33 patients switched from MDI to CSII during follow-up. Among patients on MDI, HRQOL decreased significantly over time: mental component summary [-9.8 (-16.3, -3.2)], physical component summary [-8.6 (-15.3, -1.8)] and EuroQol-VAS [-8.1 (-14.0, -2.3)], P < 0.05 for all. For patients using CSII, the EuroQol-VAS decreased [-9.6 (-17.5, -1.7)]. None of the changes over time in HRQOL differed significantly with the changes over time within the other treatment groups. CONCLUSION: No differences with respect to metabolic and HRQOL parameters between the various insulin treatment modalities were observed after 15 years of follow-up in T1DM patients.

Medication beliefs, treatment complexity, and non-adherence to different drug classes in patients with type 2 diabetes.

OBJECTIVE: To assess the relationship of patients' medication beliefs and treatment complexity with unintentional and intentional non-adherence for three therapeutic groups commonly used by patients with type 2 diabetes. METHODS: Survey data about adherence (Medication Adherence Report Scale) and beliefs about medicines (Beliefs about Medicines Questionnaire) were combined with prescription data from the Groningen Initiative to ANalyse Type 2 diabetes Treatment (GIANTT) database. Patients were classified as being adherent, mainly unintentional non-adherent, or partly intentional non-adherent per therapeutic group (glucose-, blood pressure-, and lipid-lowering drugs). Treatment complexity was measured using the Medication Regimen Complexity Index, which includes the dosage form, dosing frequency and additional directions of taking the drug. Analyses were performed using Kruskal-Wallis and Mann-Whitney U-tests. RESULTS: Of 257 contacted patients, 133 (52%) returned the questionnaire. The patients had a mean age of 66years and 50% were females. Necessity beliefs were not significantly different between the adherers, mainly unintentional non-adherers, and partly intentional non-adherers (differences smaller than 5 points on a scale from 5 to 25). For blood pressure-lowering drugs, patients reporting intentional non-adherence had higher concern beliefs than adherers (8 point difference, P=0.01). Treatment complexity scores were lower for adherers but similar for mainly unintentional and partly intentional non-adherers to glucose- and blood pressure-lowering drugs. CONCLUSION: Treatment complexity was related to non-adherence in general. Beliefs about necessity were not strongly associated with non-adherence, while patients' concern beliefs may be associated with intentional non-adherence. However, the role of these determinants differs per therapeutic group.

Thyroid hormone status and health-related quality of life in the LifeLines Cohort Study.

BACKGROUND: Thyroid disorders are prevalent in Western society, yet many subjects experience limited symptoms at diagnosis, especially in hypothyroidism. We hypothesize that health-related quality of life (HR-QOL) is more severely impaired in subjects with more abnormal thyroid hormone function tests. METHODS: This is a cross-sectional study of Dutch adults participating in the LifeLines Cohort Study between December 2009 and August 2010. In 9491 Western European participants (median age 45 years; 3993 men and 5498 women), without current or former use of thyroid medication, we compared HR-QOL using the RAND 36-Item Health Survey between subjects with normal thyrotropin (TSH) values and subjects with disturbed thyroid hormone status (serum TSH, free thyroxine, and free triiodothyronine). The influence of possible confounders (age, smoking, co-morbidity) on HR-QOL was evaluated as well. RESULTS: Suppressed TSH values (TSH < 0.5 mU/L) were found in 114 (1.2%), while 8334 (88.8%) had TSH within the normal range, 973 participants (10.3%) had TSH between 4 and 10 mU/L, and 70 (0.7%) had TSH > 10 mU/L. Men had a higher HR-QOL than women (70-92 vs. 65-89; p < 0.001), except for the domain "general health" (72 vs. 72; p = 0.692). Men with suppressed or elevated TSH values did not score significantly lower than euthyroid men for any of nine domains of the RAND 36-Item Health Survey. Compared with euthyroid women, women with suppressed TSH scored significantly lower in the domains "physical functioning" (84 vs. 89, p = 0.013) and "general health" (67 vs. 72, p = 0.036). Women with markedly elevated TSH (> 10 mU/L) had a score in all HR-QOL domains that was similar to that of women with normal TSH values. There were no differences in the physical component score and the mental component score between any of the TSH groups. Physical component score and mental component score were mainly determined by smoking status, co-morbidity, and body mass index or waist circumference. CONCLUSIONS: In this population-based study, HR-QOL scores of subjects with suppressed TSH values or markedly elevated TSH values were generally not significantly lower than those of subjects with normal or mildly elevated TSH values.

Sexual health of Dutch medical students: nothing to worry about.

INTRODUCTION: Little is known about the sexual lives and development of medical students because of relatively small sample sizes and, in particular, low response rates in research. Enhancing medical students' awareness and understanding of sexual behavior is imperative, as gaps in knowledge might impede effective sexual health consultations in their later professional practice. AIM: The aim of this study was to provide insight into the sexual lives and development of medical students. MAIN OUTCOME MEASURES: The main outcome measures of this study are demographic, contextual, and sexual data based on validated surveys. METHODS: Preclinical medical students aged under 26 years were approached during scheduled classes and by e-mail to complete a web-based questionnaire. Our results were compared with international and Dutch normative data. Ordinal regression analysis and Pearson's correlation analysis were used to assess relationships between variables. RESULTS: A total of 1,598 questionnaires were returned (response rate 52%: 1,198 by women, 400 by men). There were 719 first-year students (mean age 19.17 years) and 879 third-year students (mean age 21.5 years). Gender distribution differences were seen in all the cohorts and were corrected for. Compared with international and Dutch (88%) normative data, our first- (62.7%; P<0.001) and third-year (79.9%; P=0.018) medical students had less sexual experience and showed different advancements in sexual behavior. However, these differences decreased, which suggests that medical students "catch-up" as their age increases. Sexual behavior in our sample did not differ from international data, except for a strikingly high sexual satisfaction (80%). We also confirmed that social and environmental characteristics change with alterations in sexual behavior. Although contraceptive measures were used more frequently (98%; P=0.006), sexually transmitted diseases were more common (4.6%; P=0.008), which suggests inappropriate use of protective measures. Independent predictive determinants for protective sexual behavior were the form of relationship (P<0.001; OR=1.97) and sexual orientation (P=0.009; odds ratio=2.26). CONCLUSION: These data provide insight into the sexuality of medical students. The results of this study reliably clarify previous findings and form a solid basis for further research.

Randomized trial on the influence of the length of two insulin pen needles on glycemic control and patient preference in obese patients with diabetes.

OBJECTIVE: This study determined the influence of needle length for insulin administration on metabolic control and patient preference in obese patients with diabetes mellitus. METHODS: In this multicenter, open-label crossover study, insulin pen needles of two different lengths (5 mm and 8 mm) were compared. A total of 130 insulin-treated type 1 and type 2 diabetes patients with a body mass index ≥30 kg/m(2) were randomized, and 126 patients completed the study. Patients started using the 5-mm needle for 3 months, after which they switched to injecting insulin with the 8-mm needle for another 3 months, or vice versa. Hemoglobin A1c (A1C), fructosamine, and 1,5-anhydroglucitol were measured, and self-reported side effects and patient preference were recorded. RESULTS: No within-group changes were observed with respect to A1C, serum fructosamine, 1,5-anhydroglucitol, hypoglycemic events, bruising, and pain. When data of all 126 subjects were pooled, there was a small, but significant, difference between needle lengths (5-mm, A1C 7.47 ± 0.9%; 8-mm, 7.59 ± 1.0%; P = 0.02). Patients reported less bleeding with the 5-mm needle (P = 0.04) and less insulin leakage from the skin with the 8-mm needle (P = 0.01). There were no significant differences in patient preference, with 46% of the patients preferring the 5-mm needle, 41% the 8-mm needle, and 13% not preferring a particular needle length. CONCLUSIONS: A 5-mm needle is similar to an 8-mm needle in obese patients with diabetes with respect to metabolic control, injection-related complaints, or patient preference and can be used safely.

The role of overprotection by the partner in coping with diabetes: a moderated mediation model.

This study examined whether diabetes-specific self-efficacy mediates the association between overprotection and distress and whether this mediation depends on glycemic control and gender. The research sample of 215 individuals with diabetes and their partners completed a measure of partners' overprotective behaviours towards the patient. Patients also completed measures of diabetes-specific self-efficacy and diabetes-related distress. Further, HbA1c values were obtained as an indication of glycemic control. Diabetes-specific self-efficacy mediated the association between overprotection by the partner and diabetes-related distress especially when glycemic control was relatively poor. Furthermore, diabetes-specific self-efficacy mediated the association between overprotection and diabetes-related distress more strongly in female than in male patients. The findings underscore the importance of studying both moderators and mediators in the association between partner behaviour and distress in patients.

Support behavior and relationship satisfaction in couples dealing with diabetes: main and moderating effects.

This study examined associations between support behavior, i.e. active engagement and protective buffering, and relationship satisfaction in both patients with diabetes and their partners. Active engagement refers to supportive behavior characterized by involving one's partner in discussions, asking how the other feels, and problem solving strategies. Protective buffering refers to less supportive behavior characterized by denying fears and worries, and by pretending everything is fine. Furthermore, we examined whether there were interactive effects of these two support behaviors on patients' and partners' relationship satisfaction. At baseline (T1), 205 couples rated to which degree they received active engagement and protective buffering from their partners, and completed a measure of relationship satisfaction. At three follow-up assessments, couples were asked to fill out the same measures. Using dyadic data analytic approaches, we found relationship satisfaction to be positively associated with active engagement, and negatively with protective buffering, in both patients and partners. Moreover, we found a moderating effect, in that the negative association between protective buffering and relationship satisfaction was only present when levels of active engagement were relatively low. Again, these results were found for patients as well as their partners. We were able to replicate the T1 results at the other three assessment points. Our findings illustrate the need to consider adequate and less adequate support behaviors simultaneously, and to study the effects on both patients and partners.

Quality, quantity and harmony: the DataSHaPER approach to integrating data across bioclinical studies.

BACKGROUND: Vast sample sizes are often essential in the quest to disentangle the complex interplay of the genetic, lifestyle, environmental and social factors that determine the aetiology and progression of chronic diseases. The pooling of information between studies is therefore of central importance to contemporary bioscience. However, there are many technical, ethico-legal and scientific challenges to be overcome if an effective, valid, pooled analysis is to be achieved. Perhaps most critically, any data that are to be analysed in this way must be adequately 'harmonized'. This implies that the collection and recording of information and data must be done in a manner that is sufficiently similar in the different studies to allow valid synthesis to take place. METHODS: This conceptual article describes the origins, purpose and scientific foundations of the DataSHaPER (DataSchema and Harmonization Platform for Epidemiological Research; http://www.datashaper.org), which has been created by a multidisciplinary consortium of experts that was pulled together and coordinated by three international organizations: P³G (Public Population Project in Genomics), PHOEBE (Promoting Harmonization of Epidemiological Biobanks in Europe) and CPT (Canadian Partnership for Tomorrow Project). RESULTS: The DataSHaPER provides a flexible, structured approach to the harmonization and pooling of information between studies. Its two primary components, the 'DataSchema' and 'Harmonization Platforms', together support the preparation of effective data-collection protocols and provide a central reference to facilitate harmonization. The DataSHaPER supports both 'prospective' and 'retrospective' harmonization. CONCLUSION: It is hoped that this article will encourage readers to investigate the project further: the more the research groups and studies are actively involved, the more effective the DataSHaPER programme will ultimately be.