Joost C. Keers

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.

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.

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

OBJECTIVEnTo 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.nnnMETHODSnSurvey 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.nnnRESULTSnOf 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.nnnCONCLUSIONnTreatment 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.

Improving self-management in insulin-treated adults participating in diabetes education. The role of overprotection by the partner

Aimsu2003 To examine the role of overprotection by the partner—i.e. excessive protection, unnecessary help, excessive praise for accomplishments, or attempts to restrict activities as a consequence of underestimating the patients capabilities—in changes in patient self‐management in the context of diabetes education.

Randomized Trial on the Influence of the Length of Two Insulin Pen Needles on Glycemic Control and Patient Preference in Obese Patients with Diabetes

OBJECTIVEnThis study determined the influence of needle length for insulin administration on metabolic control and patient preference in obese patients with diabetes mellitus.nnnMETHODSnIn this multicenter, open-label crossover study, insulin pen needles of two different lengths (5u2009mm and 8u2009mm) were compared. A total of 130 insulin-treated type 1 and type 2 diabetes patients with a body mass index ≥30u2009kg/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.nnnRESULTSnNo 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 7.47u2009±u20090.9%; 8-mm, 7.59u2009±u20091.0%; Pu2009=u20090.02). Patients reported less bleeding with the 5-mm needle (Pu2009=u20090.04) and less insulin leakage from the skin with the 8-mm needle (Pu2009=u20090.01). 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.nnnCONCLUSIONSnA 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.

Diabetes rehabilitation: development and first results of a Multidisciplinary Intensive Education Program for patients with prolonged self-management difficulties

For a number of diabetes patients regular care may be insufficient. A Multidisciplinary Intensive Education Program (MIEP), based on the empowerment approach, has been developed to help patients obtain their treatment goals (adequate self-management, glycemic control and quality of life). The aim of this pilot study is to determine the effects of MIEP and its mechanisms of influence. MIEP consisted of 12 days group-sessions and individual counseling. At baseline and 3-months follow-up, blood-glucose (HbA1c), quality of life, health locus of control, distress, and knowledge were obtained (N = 51). Paired T-tests and regression analyses were conducted. HbA1c, and knowledge improved significantly, patients rated themselves healthier and were more internal and less powerful others oriented. Baseline scores explained effects in HbA1c, and quality of life. Locus of control significantly contributed in effects on quality of life. MIEP benefited patients with prolonged self-management difficulties, and this form of care seems to complement regular care.

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 ones 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.

The impact of social comparison information on motivation in patients with diabetes as a function of regulatory focus and self-efficacy.

OBJECTIVEnOur aim was to determine whether the impact of upward and downward social comparison information on individuals motivation to manage their diabetes is dependent on their regulatory focus (promotion or prevention focus) and self-efficacy.nnnDESIGNnThe hypotheses were examined in a cross-sectional study. Patients with diabetes (N = 234) read a fictitious interview with a fellow patient, either an upward or a downward target, and they filled out questionnaires.nnnMAIN OUTCOME MEASURESnMotivation to work on diabetes regulation.nnnRESULTSnHigh promotion-focused patients reported more motivation than low promotion-focused patients when confronted with the upward target (positive role model). High prevention-focused patients reported more motivation than low prevention-focused patients when confronted with the downward target (negative role model). This latter finding was qualified by patients self-efficacy, as it applied only to patients with relatively high levels of self-efficacy.nnnCONCLUSIONnThe current study highlights the importance of considering individual differences when using role models to encourage self-care activities in persons with diabetes.

Screening for depression and diabetes-related distress in a diabetes outpatient clinic

Aimsu2003 To investigate: (1) the willingness of patients with diabetes to participate in a screening programme; (2) the extent to which patients with diabetes who screen positive endorse need for psychosocial care; (3) the rate of referral to psychosocial care during screening vs. usual care.

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.