{"doc_desc":{"title":"CoDiab-VD: Cohort of Patients with Diabetes in the Canton of Vaud (Switzerland)","idno":"DDI-CHE-QDiab-2017-V1","producers":[{"name":"Racine C\u00e9line","abbreviation":"","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","role":"Metadata XML document creator"}],"version_statement":{"version":"Version 1.0 (July 2019)"}},"study_desc":{"title_statement":{"idno":"DDI-CHE-QDiab-2017-V1","title":"CoDiab-VD: Cohort of Patients with Diabetes in the Canton of Vaud (Switzerland)","alt_title":"CoDiab-VD","translated_title":"Codiab-VD : Cohorte des patient\u00b7e\u00b7s diab\u00e9tiques du canton de Vaud (Suisse)"},"authoring_entity":[{"name":"Peytremann-Bridevaux, Isabelle","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland"}],"oth_id":[{"name":"","affiliation":"","email":"","role":"Recruitment of individuals with diabetes in 2011-12 and 2017"},{"name":"","affiliation":"","email":"","role":"Communication of some participants\u2019 health results in 2011, 2012 and 2014 "},{"name":"","affiliation":"","email":"","role":"Answers to the self-assessed questionnaires"},{"name":"","affiliation":"","email":"","role":"Enveloping of the documents and data entry "},{"name":"","affiliation":"","email":"","role":"Development of the study and of the core questionnaire"}],"production_statement":{"producers":[{"name":"Antille-Zuercher, Emilie","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","role":"Project manager"},{"name":"Carron, Tania","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","role":"Scientific associate"}],"copyright":"(c) 2019, Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","funding_agencies":[{"name":"Direction g\u00e9n\u00e9rale de la sant\u00e9, canton de Vaud","abbreviation":"DGS","role":"Funding"},{"name":"Programme cantonal Diab\u00e8te","abbreviation":"PcD","role":"Funding"},{"name":"Swiss School of Public Health","abbreviation":"SSPH+","role":"Assistant Professorship grant to I. Peytremann-Bridevaux"},{"name":"Swiss National Science Fondation","abbreviation":"SNSF","role":"Funding to I. Peytremann-Bridevaux [PROSPER Nos. 32333B-123817 and 32333B-139789]"}],"grant_no":"PROSPER Nos. 32333B-123817 PROSPER Nos. 32333B-139789"},"distribution_statement":{"contact":[{"name":"Prof. Peytremann-Bridevaux Isabelle (Principal Investigator)","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland)","email":"isabelle.peytremann-bridevaux@unisante.ch","uri":""},{"name":"Racine, C\u00e9line (Unit of Documentation and Data, DFRI, Unisant\u00e9) - for technical problems with the repository only","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"celine.racine@unisante.ch","uri":""}]},"series_statement":{"series_name":"Prospective cohort study","series_info":"The first recruitment in the cohort of individuals with diabetes took place in 2011-12. Since then, participants were followed up annually up to 2017. A second recruitment was performed in 2017. Participants will be followed up every two years from 2017, up to 2021."},"version_statement":{"version":"Version 1.0"},"study_info":{"keywords":[{"keyword":"Diabetes","vocab":"","uri":""},{"keyword":"cohort study","vocab":"","uri":""},{"keyword":"quality of care","vocab":"","uri":""},{"keyword":"patients\u2019 reported outcomes and experience measures","vocab":"","uri":""},{"keyword":"canton of Vaud","vocab":"","uri":""},{"keyword":"Switzerland","vocab":"","uri":""},{"keyword":"CoDiab-VD","vocab":"","uri":""}],"abstract":"The Department of Health and Social Welfare (DSAS) of the canton of Vaud launched in 2010, through its Public Health Service (SSP), an innovative programme to tackle the burden of diabetes in the canton of Vaud: the Programme cantonal Diab\u00e8te (PcD). Its aims was to lower diabetes incidence and prevalence, and to improve quality of diabetes care.\nAs part of the development and the evaluation of the PcD, the Institute of Social and Preventive Medicine (IUMSP) of Lausanne was mandated to conduct a survey aiming at characterising individuals with diabetes in the canton of Vaud and describing their diabetes care. Individuals participating in the study in 2011-2012 constituted the baseline of the cohort (CoDiab-VD). Participants were followed up annually from 2013 to 2017. In 2017 a second recruitment of individuals with diabetes was performed. Further follow-ups are planned in 2019 and 2021.\nRecruitments were performed through community pharmacies. Were eligible: adult individuals (\u226518 years) with a diagnosis of any type of diabetes for at least 12 months, going to a pharmacy with a diabetes-related prescription, who were non-institutionalized (in an institution for elderly or disabled people), who were living in the canton of Vaud (Switzerland) and who consented to participate in the study. Were not eligible: individuals with gestational diabetes, without sufficient French knowledge to understand and fill in the questionnaire, and with cognitive impairment. Individuals accepting to participate received a questionnaire that they filled in at home and sent back to the investigators. Annual follow-up questionnaires were sent to the participants by regular post mail.\nData collected with the self-assessed questionnaires encompass several aspect of diabetes and diabetes care, such as processes and outcomes of care, self-management, daily diabetes management and healthcare utilisation, as well as general health status, health habits, and sociodemographic characteristics. Participants\u2019 GP and\/or diabetologist were also contacted in 2011-12 and 2014 when their contact details were provided, to get some clinical and processes data. \nIn 2011-2012, 519 patients with diabetes were included in the study. Their mean age was 65 years, 60% were males, more than 80% were overweight or obese, 17% smoked, 30% were physically inactive and 83% had at least one other chronic condition. A large majority of participants had type 2 diabetes (85%), were treated by oral antidiabetics (80%) and 53% had no diabetes-related complications.\nAmong processes of care received during the past 12 months, the processes relating to usual controls performed during a medical appointment and those relating to laboratory analyses were considered satisfactory, with more than 90% of respondents reporting glycated haemoglobin (HbA1c), lipid, blood pressure and weight measurements. However, diabetes-specific processes were less satisfactory, with less than 70% of the participants mentioning urine microalbuminuria, diabetic retinopathy and foot controls as well as influenza vaccination. Recommendations about physical activity and dietetics were reported by 69% and 49%, respectively. By contrast, only 5% of the total sample were smokers who did not receive tobacco cessation advice. If more than 80% of respondents reported home glucose monitoring, only 33% had ever participated in a diabetes education class.\nOn the outcomes of care side, the mean HbA1c was 7.3%, and 6% of patients had a value higher than 9.0%. Regarding generic health-related quality of life, the mental dimension scored better than the physical dimension. The aspects of diabetes-specific quality of life that were the most impacted by diabetes were \u201cfreedom to eat\u201d, \u201csex life\u201d, \u201cfreedom to drink\u201d and \u201cfeelings about future\u201d. The evaluation of the congruence of care with the Chronic Care Model (CCM) got the lowest score for the two questions regarding \u201cencouragement to attend group or class to help cope with diabetes\u201d and \u201cencouragement to attend community programmes that could be of help\u201d, and the highest score for the question regarding \u201csatisfaction with healthcare organisation\u201d.\nA large majority of participants reported a least one consultation per year with a physician (general practitioner or diabetologist, 97%). The consultation of other healthcare professionals involved in diabetes care were less frequently reported; most respondents had no visit to specialised nurse (80%), dietician (76%) and podiatrist (62%) during the past 12 months.\nGlobally, this first picture showed that diabetes care was good with respects to recommendations made by the Swiss Society of Endocrinology and Diabetology, but that room for improvement remained. Six years after this initial recruitment, the second picture obtained in 2017 showed quite similar results.\nThe CoDiab-VD study is registered with ClinicalTrials.gov, identifier NCT01902043. \nThe protocol of the study has been published and is available under the reference: Zuercher E, Bordet J, Burnand B, Peytremann-Bridevaux I. CoDiab-VD: protocol of a prospective population-based cohort study on diabetes care in Switzerland. BMC Health Serv Res. 2015;15:329. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26272346 \nhttp:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4536695\/pdf\/12913_2015_Article_991.pdf\nRecruitments\u2019 results are available from:\nPeytremann-Bridevaux I, Bordet J, Zuercher E, Burnand B. Caract\u00e9ristiques des patients diab\u00e9tiques vaudois et \u00e9valuation de leur prise en charge : Rapport final (Recrutements 2011 et 2012). Lausanne Institut universitaire de m\u00e9decine sociale et pr\u00e9ventive, 2013. (Raisons de sant\u00e9 211). Available from: http:\/\/www.iumsp.ch\/Publications\/pdf\/rds211_fr.pdf\n\nAntille-Zuercher E, Carron T, Peytremann-Bridevaux I. Cohorte CoDiab-VD : Caract\u00e9ristiques des patient\u00b7e\u00b7s diab\u00e9tiques vaudois\u00b7es et \u00e9valuation de leur prise en charge : Etat des lieux en 2017 et comparaison avec 2011-2012. Lausanne: Institut universitaire de m\u00e9decine sociale et pr\u00e9ventive (IUMSP), 2019. (Raisons de sant\u00e9 293). Available from: https:\/\/www.iumsp.ch\/Publications\/pdf\/rds293_fr.pdf\n\nPeytremann-Bridevaux I, Bordet J, Santschi V, Collet TH, Eggli M, Burnand B. Community-based pharmacies: an opportunity to recruit patients? International journal of public health. 2013 Jul 1;58(2):319-22. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22752242\nhttp:\/\/link.springer.com\/content\/pdf\/10.1007%2Fs00038-012-0383-8.pdf\n\nPeytremann-Bridevaux I, Bordet J, Burnand B. Diabetes care in Switzerland: good, but perfectible: a population-based cross-sectional survey. BMC Health Serv Res. 2013;13:232. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23800376\nhttp:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3722105\/pdf\/1472-6963-13-232.pdf\n\nZuercher E, Casillas A, Hagon-Traub I, Bordet J, Burnand B, Peytremann-Bridevaux I. Baseline data of a population-based cohort of patients with diabetes in Switzerland (CoDiab-VD). Swiss Med Wkly. 2014;144:w13951. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24863132","coll_dates":[{"start":"2011-09-01","end":"","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"geog_coverage":"Canton of Vaud, Switzerland","analysis_unit":"The analysis unit is the individual. \nAt time of the first recruitment in 2011-12, the number of survey participants were 519. From this baseline number, the participants of the follow-ups were 395 in 2013, 339 in 2014, 323 in 2015, 295 in 2016 and 276 in 2017.\nAt the time of the second recruitment in 2017, 514 new individuals were enrolled in the study and answered the survey questionnaire. \nTherefore, in 2017, 790 participants answered to the questionnaire (276 + 514).","universe":"Non-institutionalized adults with diabetes","data_kind":"Sample survey data [ssd] \/ Self-reported data collected from paper questionnaire"},"method":{"data_collection":{"time_method":"Data collection started on January 27th 2014 and ended on February 25th 2015","sampling_procedure":"Pharmacies accepting to participate in the study recruited individuals with diabetes during six-week periods in 2011-12 and 2017.\nAt time of the first recruitment in 2011-12, the number of survey participants were 519. From this baseline number, the participants of the follow-ups were 395 in 2013, 339 in 2014, 323 in 2015, 295 in 2016 and 276 in 2017.\nAt the time of the second recruitment in 2017, 514 new individuals were enrolled in the study and answered the survey questionnaire. Therefore, in 2017, 790 participants answered to the questionnaire (276 + 514).","coll_mode":"Paper questionnaire, self-administered.\n\nIn 2011-12 and 2014, clinical data were obtained from GPs and\/or diabetologists for some participants.\n\nData were self-reported by the participants, who filled in the questionnaire at home and sent it back to the investigators.\nData collection is still ongoing.","research_instrument":"The annual questionnaire is composed of two parts: 1) the core questionnaire, which is quite similar each year, and 2) a thematic module, which is specific to each year questionnaire. All data are described hereafter, collected every year or not.\n\nThe core questionnaire includes different diabetes-related themes, divided in primary and secondary outcomes, and other variables.\n\nPrimary outcomes:\n\n- Process of care indicators (whether the process was received during the past 12 months): \n--- Glycated haemoglobin (HbA1c) check\n--- Eye examination by ophthalmologist \n--- Urine test for microalbuminuria\n--- Diabetic foot examination\n--- Lipid profile\n--- Influenza vaccination\n--- Physical activity recommendations\n--- Diet recommendations\n\n- Outcomes of care indicators: \n--- Self-reported HbA1c value (last value, for those aware of what HbA1c is)\n--- Health-related quality of life (Short Form-12, SF-12)\n--- Diabetes-specific quality of life (Audit of Diabetes Dependent Quality of Life, ADDQoL)\n--- Patient assessment of diabetes care, congruence of care with the chronic care model (Patient Assessment of Care for Chronic Conditions, PACIC)\n\nSecondary outcomes:\n- Self-management activities and support indicators:\n--- Self-monitoring of blood glucose\n--- Participation in diabetes education courses\n--- Self-efficacy (Stanford diabetes-specific questionnaire)\n\nOther study variables:\n- Diabetes: \n--- Diabetes type\n--- Disease duration\n--- Antidiabetic treatment\n--- Diabetes-related complications:\n------ List of following complications: ischemic heart diseases, stroke, retinopathy, chronic kidney disease (CKD) without dialysis, CKD with dialysis or kidney transplant, neuropathy, foot ulcer, lower limb amputation, severe hypo- or hyperglycemia\n--- Medication adherence (Morisky Medication Adherence Questionnaire)\n\n- Daily diabetes management\n--- HbA1c knowledge\n--- Level and source of information about diabetes\n--- Diabetes care satisfaction\n--- Social support and satisfaction about it\n--- Difficulty in diabetes management (how easy\/difficult is the daily management of diabetes, overall or regarding physical activity, medication and diet)\n--- Overall diabetes management\n--- Membership in the local diabetes association\n--- Knowledge and use of the diabetes passport (a small booklet with data, information, reminders\u2026)\n\n- Healthcare utilisation indicators (during the past 12 months):\n--- Ambulatory care visits to: \n------ general practitioner\n------ diabetologist\n------ diabetes specialist nurse\n------ dietician\n------ podiatrist\n------ dentist\n------ pharmacist\n------ physiotherapist\n--- Hospitalisation \n--- Emergency visits\n--- Home care services\n--- Home support\n--- Forgoing care because of cost and care forgone\n\t\n- Health status and health habits: \n--- Weight measurement during a medical visit (past 12 months)\n--- Anthropometric values: \n------ Weight\n------ Height\n--- Blood pressure measurement during a medical visit (past 12 months)\n--- Blood pressure (systolic and diastolic values, in mmHg)\n--- Smoking\n--- Drinking habits (AUDIT-C questionnaire)\n--- Physical activity levels (Questions from the Swiss Health Survey)\n--- Depression screening (two validated questions for the screening of depression)\n--- Comorbidities: \n------ List of following chronic diseases: heart disease (heart failure, valve disease, heart muscle disease), chronic lung disease (asthma, chronic bronchitis, emphysema), osteoporosis, osteoarthritis or arthritis, cancer or malignancy or lymphoma (with the exception of skin cancer), gastric or duodenal ulcer, depression, Parkinson\u2019s disease, hypertension, hyperlipidaemia, other chronic condition\n\n- Health literacy\n\n- Sociodemographic characteristics:\n--- Age\n--- Gender\n--- Marital status\n--- Household size\n--- Household income\n--- Difficulty paying bills\n--- Education\n--- Employment\n--- Health insurance status and receipt of subvention for the health insurance\n--- Place of residence\n--- Nationality\n\n- Knowledge of, and participation in, PcD activities\n\n\nThematic modules\nThe themes of the annual modules were the following:\n- In 2013: diabetic foot\n- In 2014: psychosocial aspects of diabetes\n- In 2015: eyes and diabetes; coordination and continuity of care\n- In 2016: the chronic health problems other than diabetes; needs for therapeutic education\n- In 2017: pharmacy care","cleaning_operations":"Data were checked first upon receipt of the questionnaires, for inconsistency (multiple check marks when only one allowed, incoherent numbers or inconsitency between related questions); second, throughout the scanning process, for data entry; and last, by proofing the output Excel file obtained after the entry process."}},"data_access":{"dataset_use":{"cit_req":"Peytremann-Bridevaux I, Antille-Zuercher E, Carron T. Cohorte des patient\u00b7e\u00b7s diab\u00e9tiques vaudois\u00b7es CoDiab-VD. Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (July 2019), provided by Unisant\u00e9 DOI: 10.16909\/dataset\/18","conditions":"Licensed datasets, accessible under conditions\n\t\t  The datasets are not directly available.\nAfter the receipt of the request through the website, and conditionally upon its acceptance, the investigator will contact the requestor to specify the variables to include in the specific dataset. A customised dataset will be generated for each specific request.\nPlease be aware that access to the dataset will take some time.\n\n\nTo request access to licensed datasets, please register to the website to continue (https:\/\/data.iumsp.ch\/index.php\/auth\/register). Once your registration will be approved you must login and go to the \"GET MICRODATA\" tab and fill in the application form for access to the licensed dataset.\n\nThis form includes our Data access agreement and must be filled and submitted by the Lead Researcher. Lead Researcher refers to the person who serves as the main point of contact for all communications involving this agreement. Access to licensed datasets will only be granted when the Lead Researcher is an employee of a legally registered receiving agency (university, company, research centre, national or international organization, etc.) on behalf of which access to the data is requested. The Lead Researcher assumes all responsibility for compliance with all terms of this Data Access Agreement by employees of the receiving organization.\n\nThis request will be reviewed by the Primary Investigator, who may decide to approve the request, to deny access to the data, or to request additional information from the Lead Researcher. A signed copy of this request form may also be requested.\n\nIf special conditions apply to the transfer of the requested data (e.g. transfer under a contract between Unisant\u00e9 and a third party), the references of the contract concerned or the document in which the conditions are specified must be referenced in the request form. The person who makes the request will still need to check the box confirming the acceptance of the terms of use, it being understood that the conditions written in the above mentioned contract will apply.","disclaimer":"The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses."}}},"schematype":"survey"}