A systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitus.

BACKGROUND The need for an approach to measuring health results that incorporates patients' and payers' perspectives has generated a wide range of health care outcomes (HCOs), but it is yet unknown whether these HCOs are appropriate or valid for the health care decision-making process. OBJECTIVE The goal of this study was to assess HCOs, patient-reported outcomes (PROs), and economic outcomes in terms of validity and appropriateness to health care decision making in type 2 diabetes mellitus (T2DM). METHODS This systematic review of studies published between January 1, 1996, and November 1, 2010, comprised an electronic literature search of MEDLINE and Centre for Reviews and Dissemination databases. Studies included were clinical trials, observational studies, economic analyses, and studies on the development and validation of HCOs in T2DM in the adult population. HCOs were assessed and classified according to their relevance for decision makers in terms of feasibility for routine use, validity, sensitivity, reliability, understanding, and scope. RESULTS Two independent reviewers screened 4497 citations. Of these, 281 potentially eligible full articles were retrieved, and 185 met the inclusion criteria. A total of 121 HCOs in T2DM were identified: 80 (66.1%) PROs and 41 (33.9%) economic outcomes. Only 44.6% of the outcomes assessed were appropriate and valid for health care decision making. Greater deficiencies in evidence were found for PROs (61.3%), followed by economic outcomes (43.9%). CONCLUSIONS A large number of HCOs are being used in the health care decision-making process, but a significant proportion of these new outcomes have not been properly validated. Despite the fact that appropriate measures will depend on the specific needs of the decision makers, researchers need to use HCOs for which evidence of quality and appropriateness is available.

[1]  D. Feeny,et al.  Construct validity of the RAND-12 and Health Utilities Index Mark 2 and 3 in type 2 diabetes , 2004, Quality of Life Research.

[2]  J. Takala,et al.  Good continuity of care may improve quality of life in Type 2 diabetes. , 2001, Diabetes research and clinical practice.

[3]  Elizabeth Broadbent,et al.  The brief illness perception questionnaire. , 2006, Journal of psychosomatic research.

[4]  Linda Bren,et al.  The importance of patient-reported outcomes...it's all about the patients. , 2006, FDA consumer.

[5]  I. Perry,et al.  Quality of Life and Quality of Care in Patients With Diabetes Experiencing Different Models of Care , 2009, Diabetes Care.

[6]  S. Pohar,et al.  A cross-sectional study of health-related quality of life deficits in individuals with comorbid diabetes and cancer , 2006, Health and quality of life outcomes.

[7]  Wan Ariffin Bin Abdullah.  Singapore Med J , 1993 .

[8]  David W. Smith,et al.  Productivity and economic burden associated with diabetes. , 2001, American journal of public health.

[9]  J. Ioannidis,et al.  The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration , 2009, Annals of Internal Medicine [serial online].

[10]  S. Bolge,et al.  Economic and Humanistic Outcomes Associated With Comorbid Type-2 Diabetes, High Cholesterol, and Hypertension Among Individuals Who Are Overweight or Obese , 2008, Journal of occupational and environmental medicine.

[11]  J. Jordan,et al.  Resource utilization and work or school loss reported by patients with diabetes: experience in diabetes training programs. , 1997, The American journal of managed care.

[12]  D. Hendrie,et al.  Determinants of diabetes-attributable non-blood glucose-lowering medication costs in type 2 diabetes: the Fremantle Diabetes Study. , 2005, Diabetes care.

[13]  R. Fitzpatrick,et al.  Patient‐assessed health outcome measures for diabetes: a structured review , 2002, Diabetic medicine : a journal of the British Diabetic Association.

[14]  J. Díez,et al.  Calidad de vida relacionada con la salud en pacientes con diabetes mellitus tipo 2 , 2007 .

[15]  D. Feeny,et al.  Understanding the determinants of health for people with type 2 diabetes. , 2006, American journal of public health.

[16]  Alexandra A. García.  Clinical and life quality differences between Mexican American diabetic patients at a free clinic and a hospital-affiliated clinic in Texas. , 2008, Public health nursing.

[17]  Y. Khader,et al.  The Arabic version of Diabetes-39: psychometric properties and validation , 2008, Chronic illness.

[18]  Jaime Caro,et al.  Estimates of direct medical costs for microvascular and macrovascular complications resulting from type 2 diabetes mellitus in the United States in 2000. , 2003, Clinical therapeutics.

[19]  Dianne Davis,et al.  Addressing Literacy and Numeracy to Improve Diabetes Care , 2009, Diabetes Care.

[20]  The European EUCCLID pilot study on care and complications in an unselected sample of people with type 2 diabetes in primary care. , 2010, Primary care diabetes.

[21]  M. Sadler,et al.  Validation of a structured interview for the assessment of diabetes self-management. , 2000, Diabetes care.

[22]  C. Bundy,et al.  The associations of anxiety, depression and personal illness representations with glycaemic control and health-related quality of life in patients with type 2 diabetes mellitus. , 2004, Journal of psychosomatic research.

[23]  K. Stavem,et al.  Health-related quality of life in diabetes: The associations of complications with EQ-5D scores , 2010, Health and quality of life outcomes.

[24]  J. Levy,et al.  A psychosocial taxonomy of patients with diabetes: validation in a primary care setting , 2008, Diabetic medicine : a journal of the British Diabetic Association.

[25]  N. Mier,et al.  Health-related quality of life in a binational population with diabetes at the Texas-Mexico border. , 2008, Revista panamericana de salud publica = Pan American journal of public health.

[26]  L. Naing,et al.  Type 2 diabetes mellitus patients with poor glycaemic control have lower quality of life scores as measured by the Short Form-36. , 2010, Singapore medical journal.

[27]  P. Guillausseau,et al.  Influence of oral antidiabetic drugs compliance on metabolic control in type 2 diabetes. A survey in general practice. , 2003, Diabetes & metabolism.

[28]  R. Coelho,et al.  Coping styles and quality of life in patients with non-insulin-dependent diabetes mellitus. , 2003, Psychosomatics.

[29]  K. Petrie,et al.  The illness perception questionnaire: A new method for assessing the cognitive representation of illness , 1996 .

[30]  C. Berne.  Diabetes mellitus – a more solid ground for treatment , 2001, Journal of internal medicine.

[31]  D. Marrero,et al.  A Novel Application of the Problem Areas in Diabetes (PAID) Instrument to Improve Glycemic Control and Patient Satisfaction , 2010, The Diabetes educator.

[32]  Y. Khader,et al.  Factors associated with poor glycemic control among patients with type 2 diabetes. , 2010, Journal of diabetes and its complications.

[33]  J. Speight,et al.  FDA guidance on patient reported outcomes , 2010, BMJ : British Medical Journal.

[34]  K. Okma.  European Health Care Reform: Analysis of Current Strategies (review) , 1999 .

[35]  C. Östenson,et al.  Direct medical costs for patients with type 2 diabetes in Sweden , 2000, Journal of internal medicine.

[36]  M A Koopmanschap,et al.  Resource consumption and costs in Dutch patients with Type 2 diabetes mellitus. Results from 29 general practices , 2002, Diabetic medicine : a journal of the British Diabetic Association.

[37]  K. Wallston,et al.  Psychometric Properties of the Perceived Diabetes Self-Management Scale (PDSMS) , 2007, Journal of Behavioral Medicine.

[38]  R. Mikolajczyk,et al.  Health-related quality of life in diabetic patients and controls without diabetes in refugee camps in the Gaza strip: a cross-sectional study , 2006, BMC public health.

[39]  Direct Health Care Costs of Patients With Type 2 Diabetes Within a Privately Insured Employed Population, 2000 and 2005 , 2009, Journal of occupational and environmental medicine.

[40]  J. Nagpal,et al.  Direct cost of ambulatory care of type 2 diabetes in the middle and high income group populace of Delhi: the DEDICOM survey. , 2008, The Journal of the Association of Physicians of India.

[41]  Volker Foos,et al.  The CORE Diabetes Model: Projecting Long-term Clinical Outcomes, Costs and Costeffectiveness of Interventions in Diabetes Mellitus (Types 1 and 2) to Support Clinical and Reimbursement Decision-making , 2004, Current medical research and opinion.

[42]  A. Mushlin,et al.  Reductions in individual work productivity associated with type 2 diabetes mellitus , 2012, PharmacoEconomics.

[43]  A. Michalos,et al.  Understanding relationships between diabetes mellitus and health-related quality of life in a rural community. , 2005, Rural and remote health.

[44]  J. Casado,et al.  Diabetes mellitus tipo 2 y calidad de vida relacionada con la salud: resultados del Estudio Hortega , 2006 .

[45]  R. Rubin,et al.  Correlates of Health‐Related Quality of Life in Overweight and Obese Adults with Type 2 Diabetes , 2006, Obesity.

[46]  M. Campbell,et al.  Problems with the performance of the SF-36 among people with type 2 diabetes in general practice , 2004, Quality of Life Research.

[47]  S. Keinänen-Kiukaanniemi,et al.  Quality of life in NIDDM patients assessed with the SF-20 questionnaire. , 1998, Diabetes research and clinical practice.

[48]  Cde,et al.  The Diabetes Empowerment Scale A measure of psychosocial self-efficacy , 2022 .

[49]  L. Matza,et al.  Obese versus non-obese patients with type 2 diabetes: patient-reported outcomes and utility of weight change , 2007, Current medical research and opinion.

[50]  J. Apelqvist,et al.  Health-related quality of life in patients with diabetes mellitus and foot ulcers. , 2000, Journal of diabetes and its complications.

[51]  Direct medical costs unequivocally related to diabetes in Italian specialized centers , 2004, The European Journal of Health Economics, formerly: HEPAC.

[52]  G. Bonsel,et al.  Labor and Health Status in Economic Evaluation of Health Care: The Health and Labor Questionnaire , 1996, International Journal of Technology Assessment in Health Care.

[53]  W. Chaveepojnkamjorn,et al.  Quality of life and compliance among type 2 diabetic patients. , 2008, The Southeast Asian journal of tropical medicine and public health.

[54]  T. Rosemann,et al.  Additional impact of concomitant hypertension and osteoarthritis on quality of life among patients with type 2 diabetes in primary care in Germany – a cross-sectional survey , 2009, Health and quality of life outcomes.

[55]  V. Preedy,et al.  Scottish Intercollegiate Guidelines Network , 2010 .

[56]  D. Simonson,et al.  Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial. , 1998, JAMA.

[57]  James S Goodwin,et al.  Inconsistent use of diabetes medications, diabetes complications, and mortality in older mexican americans over a 7-year period: data from the Hispanic established population for the epidemiologic study of the elderly. , 2003, Diabetes care.

[58]  L. Abetz,et al.  The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials , 2002 .

[59]  M. Crawford,et al.  Systematic review of involving patients in the planning and development of health care , 2002, BMJ : British Medical Journal.

[60]  J. Caro,et al.  Economic Outcomes Associated with Microvascular Complications of Type 2 Diabetes Mellitus , 2012, PharmacoEconomics.

[61]  S. Pang,et al.  Health literacy, complication awareness, and diabetic control in patients with type 2 diabetes mellitus. , 2008, Journal of advanced nursing.

[62]  Y. Suzukamo,et al.  Development of a diabetes diet-related quality-of-life scale. , 2004, Diabetes care.

[63]  M. Pibernik-Okanović.  Psychometric properties of the World Health Organisation quality of life questionnaire (WHOQOL-100) in diabetic patients in Croatia. , 2001, Diabetes research and clinical practice.

[64]  M. Happich,et al.  Direct costs and health-related resource utilisation in the 6 months after insulin initiation in German patients with type 2 diabetes mellitus in 2006: INSTIGATE study* , 2008, Current medical research and opinion.

[65]  D L Patrick,et al.  Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire. , 1999, Medical care.

[66]  J. Earp,et al.  The development of an instrument for assessing the quality of life of people with diabetes. Diabetes-39. , 1997, Medical care.

[67]  G Nowacek,et al.  Fear of Hypoglycemia: Quantification, Validation, and Utilization , 1987, Diabetes Care.

[68]  D. Niakas,et al.  Predictors of health-related quality of life in type II diabetic patients in Greece , 2007, BMC public health.

[69]  J. Rosenstock,et al.  Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen. , 2002, Clinical therapeutics.

[70]  M. Koopmanschap,et al.  Coping with Type II diabetes: the patient’s perspective , 2002, Diabetologia.

[71]  C. Todd,et al.  The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: the ADDQoL , 2004, Quality of Life Research.

[72]  R. Rubin,et al.  Validity and reliability of an instrument for assessing health-related quality of life and treatment preferences: the Insulin Delivery System Rating Questionnaire. , 2005, Diabetes care.

[73]  X. Badia,et al.  [Health outcomes research]. , 2000, Medicina clinica.

[74]  Julia L. Lin,et al.  The effects of trust in physician on self-efficacy, adherence and diabetes outcomes. , 2009, Social science & medicine.

[75]  E. Heiby,et al.  The Diabetes Time Management Questionnaire , 1999, The Diabetes educator.

[76]  J. Peters,et al.  Evaluation of the costs and outcomes from changes in risk factors in type 2 diabetes using the Cardiff stochastic simulation cost-utility model (DiabForecaster) , 2006, Current medical research and opinion.

[77]  A. M. Salinas-Martínez,et al.  The cost of diabetes mellitus and its impact on health spending in Mexico. , 2000, Archives of medical research.

[78]  M. Engelgau,et al.  Valuing health-related quality of life in diabetes. , 2002, Diabetes care.

[79]  G. Spinas,et al.  Direct medical costs of type 2 diabetes and its complications in Switzerland. , 2004, European journal of public health.

[80]  A. Bahnassy,et al.  Health-related quality of life in type 2 diabetic patients , 2008, Annals of Saudi medicine.

[81]  F. Camacho,et al.  Investigating correlates of health related quality of life in a low-income sample of patients with diabetes , 2002, Quality of Life Research.

[82]  B. Bolinder,et al.  The economic and quality of life impact of hypoglycemia , 2005, The European Journal of Health Economics.

[83]  A. Bagust,et al.  Modelling EuroQol health-related utility values for diabetic complications from CODE-2 data. , 2005, Health economics.

[84]  V. Vázquez,et al.  [Assessment of health outcomes in the type 2 diabetes process]. , 2011, Atencion primaria.

[85]  A. Reunanen,et al.  Nationwide survey of comorbidity, use, and costs of all medications in Finnish diabetic individuals. , 2000, Diabetes care.

[86]  R. Heine,et al.  Development and validation of the diabetes fear of injecting and self‐testing questionnaire (D‐FISQ): first findings , 1997, Diabetic medicine : a journal of the British Diabetic Association.

[87]  G. Dailey,et al.  Patient compliance and persistence with antihyperglycemic drug regimens: evaluation of a medicaid patient population with type 2 diabetes mellitus. , 2001, Clinical therapeutics.

[88]  Evaluation of the Diabetes Quality-of-Life Questionnaire in a Spanish Population , 1996, PharmacoEconomics.

[89]  T. Volmer,et al.  Dimensions of quality of life in people with non-insulin-dependent diabetes , 2000, Quality of Life Research.

[90]  S. Di Nuovo,et al.  Psychological stress measure in type 2 diabetes. , 2006, European review for medical and pharmacological sciences.

[91]  Alexandra A. García.  Symptom Prevalence and Treatments Among Mexican Americans With Type 2 Diabetes , 2005, The Diabetes educator.

[92]  R Legood,et al.  The impact of diabetes‐related complications on healthcare costs: results from the United Kingdom Prospective Diabetes Study (UKPDS Study No. 65) , 2003, Diabetic medicine : a journal of the British Diabetic Association.

[93]  Larry D Gruppen,et al.  The Diabetes Empowerment Scale-Short Form (DES-SF). , 2003, Diabetes care.

[94]  G. Nichols,et al.  Health care costs associated with escalation of drug treatment in type 2 diabetes mellitus. , 2001, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[95]  J. Fitzgerald,et al.  The Reliability and Validity of a Brief Diabetes Knowledge Test , 1998, Diabetes Care.

[96]  The influence of treatment modality and ethnicity on attitudes in type 2 diabetes. , 2000, Diabetes care.

[97]  S. González-Romero,et al.  Excess hospitalizations, hospital days, and inpatient costs among people with diabetes in Andalusia, Spain. , 2004, Diabetes care.

[98]  A. Farmer,et al.  Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetes , 2006, Diabetic medicine : a journal of the British Diabetic Association.

[99]  M. Brod,et al.  Measuring the Impact of Diabetes Through Patient Report of Treatment Satisfaction, Productivity and Symptom Experience , 2006, Quality of Life Research.

[100]  Subjective health values of individuals with diabetes in Japan: comparison of utility values with the SF-36 scores. , 2003, Diabetes research and clinical practice.

[101]  H. Bilo,et al.  The influence of cardiovascular disease on quality of life in type 2 diabetics , 2002, Quality of Life Research.

[102]  H. Bilo,et al.  Cross-sectional relationship between glycaemic control, hyperglycaemic symptoms and quality of life in type 2 diabetes (ZODIAC-2). , 2005, The Netherlands journal of medicine.

[103]  D. Berwick,et al.  What can the UK learn from the USA about improving the quality and safety of healthcare? , 2006, Clinical medicine.

[104]  Rita Furst Seifert,et al.  Distinguishing the economic costs associated with type 1 and type 2 diabetes. , 2009, Population health management.

[105]  Peggy Soule Odegard,et al.  Barriers to Medication Adherence in Poorly Controlled Diabetes Mellitus , 2008, The Diabetes educator.

[106]  P. Clarke,et al.  Which health-related quality of life score? A comparison of alternative utility measures in patients with Type 2 diabetes in the ADVANCE trial , 2007, Health and quality of life outcomes.

[107]  L. Matza,et al.  Utilities and disutilities for type 2 diabetes treatment-related attributes , 2007, Quality of Life Research.

[108]  Sumit R. Majumdar,et al.  Understanding the complex associations between patient–provider relationships, self-care behaviours, and health-related quality of life in type 2 diabetes: A structural equation modeling approach , 2005, Quality of Life Research.

[109]  G. Melkus,et al.  Grandparenthood status and health outcomes in midlife African American women with type 2 diabetes. , 2008, Ethnicity & disease.

[110]  M. M. Cases,et al.  Impacto de la diabetes mellitus tipo 2 en la calidad de vida de los pacientes tratados en las consultas de atención primaria en España , 2003 .

[111]  R. Griffiths,et al.  Development of a client‐generated health outcome measure for community nursing , 2000, Australian and New Zealand journal of public health.

[112]  J. Foreyt,et al.  Validity and Reliability of the General Well-Being Schedule with Northern Plains American Indians Diagnosed with Type 2 Diabetes Mellitus , 2003, Psychological reports.

[113]  J. Dale,et al.  Development and validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with Type 2 diabetes , 2007, Diabetic medicine : a journal of the British Diabetic Association.

[114]  W. Duckworth,et al.  Reliability and Validity of the DCP Among Hispanic Veterans , 2005, Evaluation & the health professions.

[115]  M. Hill,et al.  Health-related quality of life in urban African Americans with type 2 diabetes , 2002, Journal of General Internal Medicine.

[116]  Robert M. Anderson,et al.  Social Support, Quality of Life, and Self-Care Behaviors Among African Americans With Type 2 Diabetes , 2008, The Diabetes educator.

[117]  R. Ikem,et al.  A comparison of two measures of quality of life of Nigerian clinic patients with type 2 diabetes mellitus. , 2009, African health sciences.

[118]  B. Bolinder,et al.  Cost of hypoglycemia in patients with Type 2 diabetes in Sweden. , 2006, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[119]  J Alonso,et al.  [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. , 1995, Medicina clinica.

[120]  F. Brancati,et al.  Thirty-six-item short-form outcomes following a randomized controlled trial in type 2 diabetes. , 2005, Diabetes care.

[121]  B. Anderson,et al.  Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire , 2003, Diabetic medicine : a journal of the British Diabetic Association.

[122]  David Wilkin,et al.  Measures of Need and Outcome for Primary Health Care , 1992 .

[123]  Myfanwy Morgan,et al.  What is 'continuity of care'? , 2006, Journal of health services research & policy.

[124]  E. Toth,et al.  Diabetes care and health status of First Nations individuals with type 2 diabetes in Alberta. , 2009, Canadian family physician Medecin de famille canadien.

[125]  L. Egede,et al.  Development and Psychometric Properties of the 12-Item Diabetes Fatalism Scale , 2009, Journal of General Internal Medicine.

[126]  M. Koopmanschap,et al.  Health-related quality of life and treatment satisfaction in Dutch patients with type 2 diabetes. , 2002, Diabetes care.

[127]  C. Kozma,et al.  Economic, clinical, and humanistic outcomes: a planning model for pharmacoeconomic research. , 1993, Clinical therapeutics.

[128]  Alastair Gray,et al.  Estimating Utility Values for Health States of Type 2 Diabetic Patients Using the EQ-5D (UKPDS 62) , 2002, Medical decision making : an international journal of the Society for Medical Decision Making.

[129]  A. Škerjanc,et al.  Sickness absence in diabetic employees , 2001, Occupational and environmental medicine.

[130]  A. Lloyd,et al.  Impact of long-term complications on quality of life in patients with type 2 diabetes not using insulin. , 2001, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[131]  Pablo A. Mora,et al.  The development and validation of a neuropathy- and foot ulcer-specific quality of life instrument. , 2003, Diabetes care.

[132]  C. Schwartz,et al.  Disease-related emotional distress of Hispanic and non-Hispanic type 2 diabetes patients. , 2007, Ethnicity & disease.

[133]  R. Clifford,et al.  Effect of insulin therapy on quality of life in Type 2 diabetes mellitus: The Fremantle Diabetes Study. , 2001, Diabetes research and clinical practice.

[134]  B. Lyoussi,et al.  Disease-specific health-related quality of life instruments among adults diabetic: A systematic review. , 2008, Diabetes research and clinical practice.

[135]  K. Barnard,et al.  Not all roads lead to Rome—a review of quality of life measurement in adults with diabetes , 2009, Diabetic medicine : a journal of the British Diabetic Association.

[136]  L. Gaal,et al.  Le cout du diabete de type 2: resume de l'enquete europeenne CODE-2 et analyse de la situation en Belgique. , 2005 .

[137]  J. Siegel.  Development of an FDA guidance document for clinical trials in SLE , 1999, Lupus.

[138]  P. Kind,et al.  Health-related Quality of Life in Type 2 Diabetes (T 2 ARDIS-2) , 2000 .

[139]  Deborah E. Jones,et al.  Depression, quality of life, and glycemic control in individuals with type 2 diabetes , 2009, Journal of the American Academy of Nurse Practitioners.

[140]  G. Charpentier,et al.  Electronic pill-boxes in the evaluation of oral hypoglycemic agent compliance. , 2005, Diabetes & metabolism.

[141]  J Alonso,et al.  Performance of a perceived health measure in different groups of the population: a comprehensive study in Spain. , 2001, Journal of Clinical Epidemiology.

[142]  G. Grunberger,et al.  The Reliability of the Diabetes Care Profile for African Americans , 1998, Evaluation & the health professions.

[143]  D. Huet,et al.  Therapeutic compliance: a prospective analysis of various factors involved in the adherence rate in type 2 diabetes. , 2006, Diabetes & metabolism.

[144]  Kathleen King,et al.  Medication Adherence and Associated Hemoglobin A1c in Type 2 Diabetes , 2004, The Annals of pharmacotherapy.

[145]  F. Andrade.  Measuring the impact of diabetes on life expectancy and disability-free life expectancy among older adults in Mexico. , 2010, The journals of gerontology. Series B, Psychological sciences and social sciences.

[146]  Ronald C. Kessler,et al.  The World Health Organization Health and Work Performance Questionnaire (HPQ) , 2003, Journal of occupational and environmental medicine.

[147]  Janet Sansoni,et al.  Selecting tools for ACAT assessment: a report for the Aged Care Assessment Program (ACAP) Expert Clinical Reference Group (May 2010) , 2010 .

[148]  Biao Xu,et al.  How do type 2 diabetes mellitus-related chronic complications impact direct medical cost in four major cities of urban China? , 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[149]  P. Valensi,et al.  Quality of life and clinical correlates in patients with diabetic foot ulcers. , 2005, Diabetes & metabolism.

[150]  Á. B. Plá,et al.  Cómo influye el tratamiento intensivo de los factores de riesgo cardiovascular en la calidad de vida relacionada con la salud de los pacientes diabéticos , 2007 .

[151]  F J Snoek,et al.  Development of a Type 2 Diabetes Symptom Checklist: a Measure of Symptom Severity , 1994, Diabetic medicine : a journal of the British Diabetic Association.

[152]  Gordon H Guyatt,et al.  Patient-important outcomes in registered diabetes trials. , 2008, JAMA.

[153]  L. Miller,et al.  Quality of life, health status and clinical outcomes in Type 2 diabetes patients , 2007, Quality of Life Research.

[154]  Jeffrey A. Johnson,et al.  Performance of the RAND-12 and SF-12 summary scores in type 2 diabetes , 2004, Quality of Life Research.

[155]  S. Bhattacharyya,et al.  Medical costs of managed care in patients with type 2 diabetes mellitus. , 1999, Clinical therapeutics.

[156]  J. Audet,et al.  The Assessment of Diabetes-Related Cognitive and Social Factors: The Multidimensional Diabetes Questionnaire , 1997, Journal of Behavioral Medicine.

[157]  G. Gambús,et al.  Tratamiento de los pacientes con diabetes mellitus tipo 2 en atención primaria en España , 2005 .

[158]  L. Egede.  Effects of depression on work loss and disability bed days in individuals with diabetes. , 2004, Diabetes care.

[159]  H. Birnbaum,et al.  Productivity and medical costs of diabetes in a large employer population. , 2002, Diabetes care.

[160]  Biao Xu,et al.  Type 2 diabetes mellitus in China: a preventable economic burden. , 2009, The American journal of managed care.

[161]  R. S. Jorgensen,et al.  Reliability and validity of the Appraisal of Diabetes Scale , 1991, Journal of Behavioral Medicine.

[162]  B. Klapp,et al.  The network of psychological variables in patients with diabetes and their importance for quality of life and metabolic control. , 2002, Diabetes care.

[163]  M. Tafalla,et al.  El coste de la diabetes tipo 2 en España. El estudio CODE-2 , 2002 .

[164]  A. Weeren,et al.  Validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with type 2 diabetes in a Belgian population. , 2009, Primary care diabetes.

[165]  Naoki Ikegami,et al.  Measurement of HRQL using EQ-5D in patients with type 2 diabetes mellitus in Japan. , 2006, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[166]  K. Meadows,et al.  The validity and reliability of the Diabetes Health Profile (DHP) in NIDDM patients referred for insulin therapy , 1996, Quality of Life Research.

[167]  M. Hill,et al.  Medication adherence and diabetes control in urban African Americans with type 2 diabetes. , 2005, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[168]  F. Parazzini,et al.  The outpatient cost of diabetes care in Italian diabetes centers. , 2001, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[169]  C. Gotay,et al.  Outcomes assessment in cancer : measures, methods, and applications , 2004 .

[170]  R. Davis,et al.  Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes , 2005, Current medical research and opinion.

[171]  M. P. Moore,et al.  Treatment satisfaction after commencement of insulin in Type 2 diabetes. , 2004, Diabetes research and clinical practice.

[172]  D. Malone,et al.  Development and Validation of a Diabetes Mellitus Severity Index: A Risk‐Adjustment Tool for Predicting Health Care Resource Use and Costs , 2005, Pharmacotherapy.

[173]  Josep Figueras,et al.  European health care reform. Analysis of current strategies. World Health Organization. , 1997, WHO regional publications. European series.

[174]  F. Antoñanzas,et al.  [The cost of type 2 diabetes in Spain: the CODE-2 study]. , 2002, Gaceta sanitaria.

[175]  Rhys Williams,et al.  Do people with type 2 diabetes and their carers lose income? (T2ARDIS-4). , 2003, Health policy.

[176]  C. Hung,et al.  Quality of Life and Its Predictors for Middle-Aged and Elderly Patients With Type 2 Diabetes Mellitus , 2007, The journal of nursing research : JNR.

[177]  C. Weel,et al.  Insulin therapy in poorly controlled type 2 diabetic patients: does it affect quality of life? , 2001 .

[178]  J. Bosch,et al.  Association of diabetes‐related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes , 2007, Diabetic medicine : a journal of the British Diabetic Association.

[179]  G. Nijpels,et al.  Diabetes-related symptoms and negative mood in participants of a targeted population-screening program for type 2 diabetes: The Hoorn Screening study , 2005, Quality of Life Research.

[180]  Ruth Williams.  It’s all about the patients , 2010 .

[181]  L. Matza,et al.  Validation of two generic patient-reported outcome measures in patients with type 2 diabetes , 2007, Health and quality of life outcomes.

[182]  F J Snoek,et al.  Diabetes Fear of Injecting and Self-Testing Questionnaire: a psychometric evaluation. , 2000, Diabetes care.

[183]  B. Arondekar,et al.  Psychometric evaluation of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS). , 2008, Diabetes research and clinical practice.

[184]  R. Jiménez-García,et al.  Self-perception of health status, mental health and quality of life among adults with diabetes residing in a metropolitan area. , 2010, Diabetes & metabolism.

[185]  C. Abraira,et al.  Health-related quality of life in the VA Feasibility Study on glycemic control and complications in type 2 diabetes mellitus. , 2005, Journal of diabetes and its complications.

[186]  R. Misra,et al.  Predictors of quality of life among adults with type 2 diabetes mellitus. , 2008, Journal of diabetes and its complications.

[187]  J. Speight,et al.  Patient perceptions of diabetes and diabetes therapy: assessing quality of life , 2002, Diabetes/metabolism research and reviews.

[188]  R. Misra,et al.  Ethnic and gender differences in psychosocial factors, glycemic control, and quality of life among adult type 2 diabetic patients. , 2009, Journal of diabetes and its complications.

[189]  D. Feeny,et al.  A Comparison of the Health Utilities Indices Mark 2 and Mark 3 in Type 2 Diabetes , 2003, Medical decision making : an international journal of the Society for Medical Decision Making.

[190]  C. van Weel,et al.  The impact of type 2 diabetes mellitus on daily functioning. , 1999, Family practice.

[191]  Koyin Chang,et al.  Comorbidities, quality of life and patients' willingness to pay for a cure for type 2 diabetes in Taiwan. , 2010, Public health.

[192]  W. Polonsky,et al.  The Problem Areas in Diabetes Scale: An evaluation of its clinical utility , 1997, Diabetes Care.

[193]  D. Orozco,et al.  Multifactorial approach and adherence to prescribed oral medications in patients with type 2 diabetes * , 2006, International journal of clinical practice.

[194]  K. Birkeland,et al.  A comparison of the health-related quality of life in patients with diabetic foot ulcers, with a diabetes group and a nondiabetes group from the general population , 2007, Quality of Life Research.

[195]  P. Deb,et al.  Work disability and diabetes. , 1999, Diabetes care.

[196]  D. Singer,et al.  Polypharmacy and medication adherence in patients with type 2 diabetes. , 2003, Diabetes care.

[197]  Biao Xu,et al.  Factors affecting costs and utilization of type 2 diabetes healthcare: a cross-sectional survey among 15 hospitals in urban China , 2010, BMC health services research.

[198]  D. Feeny,et al.  Health Utilities Index mark 3 demonstrated construct validity in a population-based sample with type 2 diabetes. , 2006, Journal of clinical epidemiology.

[199]  M. Courtney,et al.  Factors that affect health outcomes in adults with type 2 diabetes: a cross-sectional study. , 2010, International journal of nursing studies.

[200]  J. Meigs,et al.  Correlates of health-related quality of life in type 2 diabetes , 2006, Diabetologia.

[201]  L. Gruppen,et al.  The Third Version of the Diabetes Attitude Scale , 1998, Diabetes Care.

[202]  L. Gaal,et al.  Assessing the impact of complications on the costs of Type II diabetes , 2002, Diabetologia.

[203]  A. Vingerhoets,et al.  Pictorial Representation of Illness and Self Measure Revised II (PRISM-RII) – a novel method to assess perceived burden of illness in diabetes patients , 2008, Health and quality of life outcomes.

[204]  J. Salmerón,et al.  Relationship between social support and the physical and mental wellbeing of older Mexican adults with diabetes. , 2009, Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion.

[205]  H. Bilo,et al.  Longitudinal study on glycaemic control and quality of life in patients with Type 2 diabetes mellitus referred for intensified control , 1999, Diabetic medicine : a journal of the British Diabetic Association.

[206]  G. Nijpels,et al.  Health‐related quality of life in the first year following diagnosis of Type 2 diabetes: newly diagnosed patients in general practice compared with screening‐detected patients. The Hoorn Screening Study , 2004, Diabetic medicine : a journal of the British Diabetic Association.

[207]  M. Roden,et al.  Sex-related psychological effects on metabolic control in type 2 diabetes mellitus , 2009, Diabetologia.

[208]  W. Sacco,et al.  Reliability of diabetes-specific social support scales , 2008, Psychology, health & medicine.

[209]  S. Wild,et al.  Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. , 2004, Diabetes care.

[210]  J. Fitzgerald,et al.  Development and Validation of the Diabetes Care Profile , 1996, Evaluation & the health professions.

[211]  E. Faure,et al.  Coste de la diabetes mellitus en España , 2006 .

[212]  D. Meltzer,et al.  Racial/Ethnic Differences in Concerns About Current and Future Medications Among Patients With Type 2 Diabetes , 2009, Diabetes Care.