64
Views
4
CrossRef citations to date
0
Altmetric
Original Research

Patient-reported outcomes in type 2 diabetes mellitus: patients’ and primary care physicians’ perspectives in the Spanish health care system

, , , , &
Pages 1413-1422 | Published online: 08 Oct 2015

Abstract

Objective

Understanding patients’ and physicians’ perceptions of type 2 diabetes mellitus (T2DM) management and treatment has important implications for diabetes care, allowing the identification of clinical practice issues that could be improved, leading to patients’ better understanding of the illness and, consequently, healthier self-management behaviors. The objective of this study was to identify differences between physicians’ and T2DM patients’ perceptions related to health status, patient-reported outcomes assessments, and T2DM management and treatment, in routine clinical practice in Spain.

Methods

This was an observational, cross-sectional study including 1,012 T2DM patients and 974 physicians from 47 and 52 Spanish provinces, respectively. An electronic structured self-administered questionnaire containing 17 questions was designed aiming to address both physicians’ and patient’s perceptions on overall T2DM health status and patient-reported outcomes.

Results

T2DM patients perceived a worse health status (40% reported having a “good” and 38% a “neither good nor bad” health status) compared with physicians’ perceptions (77% thought patients had a “good” health status). Most patients answered being “satisfied” or “neither satisfied nor unsatisfied” with the given information, while physicians considered that patients were “satisfied” or “very satisfied” with the information for self-monitoring blood glucose and treatment administration. Fifty-seven percent of patients reported that medical recommendations were “important”, while 58% of physicians considered it as “very important”. Fifty-three percent of patients perceived that their current T2DM treatment suited their preferences “quite a lot”, and this was lower than the proportion of physicians (69%) that believed this for their patients. Additionally, a lower percentage of patients (53%) than physicians (79%) believed that their treatment improved their health-related quality of life “quite a lot”. All differences between patients and physicians were statistically significant (P<0.001).

Conclusion

Patients and physicians demonstrate different views concerning all questions related to T2DM health status and diabetes management and treatment (information, recommendations, satisfaction, and preferences).

Introduction

Worldwide, the 2013 prevalence of diabetes mellitus (DM) was estimated at 8.3%, affecting 387 million people and producing 5.1 million deaths.Citation1 This prevalence is expected to increase up to 439 million adults by 2030.Citation2 In Spain, DM prevalence among adults is 13.8% (95% confidence interval: 10; 15), with up to 6% of the population remaining underdiagnosedCitation3 and having a mortality risk up to three times greater than the general population.Citation4 Type 2 DM (T2DM) accounts for 85%–95% of all diabetes in developed countries,Citation1 and it is associated with a two to four times greater probability of cardiovascular disease than in the general population, as well as an increased mortality risk.Citation5,Citation6

It is widely recognized that an appropriate management of hyperglycemia can lead to an achievement of optimal diabetes control, thereby reducing the risk of cardiovascular events by approximately 50%.Citation7 However, the micro- and macrovascular complications associated with long-term disease continue to be the main factor for the social and economic burden of T2DM.Citation8 In addition to clinical and economic aspects, T2DM may have a direct influence on daily personal, family, social, and working life, affecting patients’ functional capacity and health-related quality of life (HRQoL).Citation9

Therefore, T2DM is considered a complex chronic disease, which requires continuous medical care with multifactorial risk reduction strategies beyond glycemic control.Citation10 In addition, the successful management of diabetes should include the active behavioral involvement of patients. Patients diagnosed with T2DM need to implement certain habits that require self-commitment and responsibility (eg, blood glucose monitoring in diabetes; adherence to medication, etc).Citation11,Citation12 For this purpose, patient education regarding glucose monitoring, injection techniques, and lifestyle interventions, focusing on diet and on the importance of physical activity, should be integrated into the treatment program. The involvement of patients is crucial for the management of T2DM, for the prevention of acute complications, and for the reduction of long-term complications.Citation10,Citation13 In Spain, where T2DM patients are mainly managed in the primary care (PC) setting,Citation14 a patient–physician partnership is key to achieving optimal treatment results and to improving patients’ empowerment and disease management.Citation11

Moreover, patients’ involvement in decision making may improve adherence to therapy.Citation13 When patients feel that their disease perspective and experience (patient-reported outcomes [PROs]) are taken into account by PC physicians, they increase their medication adherence and cooperate more actively with lifestyle recommendations, improving personal satisfaction, clinical results,Citation11 and overall quality of care.Citation15 In this study, it is proposed that the knowledge from both patients’ and health care professionals’ perspectives and experience in real-life clinical practice may have important implications for diabetes care. Recognizing such information allows the identification of practice issues that could be improved or the potential introduction of changes in health care plans.Citation16 Nevertheless, it has been difficult to find in the literature studies that elicit patient self-perceived HRQoL added to their perception of PROs assessment, and that compare patients’ perceptions and beliefs with those of PC physicians.

Therefore, to the authors’ knowledge, this is the first study specifically designed to identify differences between physicians’ and T2DM patients’ perceptions regarding health status, PROs evaluation, and T2DM management and treatment, from the Spanish National Healthcare System (NHS) perspective.

Research design and methods

An observational, cross-sectional study was performed. The study protocol was approved by the Clinical Research Ethics Committee of the Hospital Universitario Puerta de Hierro (Majadahonda, Madrid). All participants in the study received information and gave their consent to participate prior to their inclusion in the study.

Participants

Sample size estimation was calculated based on the 2013 Spanish adult population (34,581,569),Citation17 published data on the prevalence of T2DM patients (10%–15%),Citation3 and the number of PC physicians practicing in the Spanish NHS (28,675).Citation18 Applying the maximum variability standard criteria with a 99% confidence level and 4% precision for both groups, the sample size required was estimated at 1,012 T2DM patients and 974 PC physicians.

Patients

Eligible participants were T2DM patients at least 18 years old who were able to adequately answer the study questions. Patient selection was carried out with the support of a FEDE (Fed-eración de Diabéticos Españoles [Spanish Diabetic Patients Federation]). Members of the different societies belonging to the FEDE from 52 Spanish provinces were invited to participate. The recruitment process was conducted from February to June 2014, until the desired sample size was achieved.

Physicians

PC physicians from 52 Spanish provinces were randomly selected and invited to take part in the study in collaboration with the Spanish Physician Association RedGDPs (Red de Grupos de Estudio de la Diabetes en Atención Primaria de la Salud). Physicians were eligible to participate if they practiced in the Spanish public National Health care System (NHS) and if they had been practicing their profession for at least 5 years post-training residency. The recruitment process was also conducted from February to June 2014, until the desired sample size was achieved.

Survey design

An ad hoc electronic self-administered questionnaire containing 17 questions was developed for both patients and physicians, respectively, based on the information obtained from a literature review. The survey was structured in three parts: 1) two questions about the current health status of T2DM patients; 2) five questions related to PROs evaluation in T2DM (HRQoL and treatment persistence, adherence, satisfaction, and preferences); and 3) ten questions about T2DM management and treatment. All questions were rated using a five-point Likert scale (). In all cases, the answers corresponded to the self-perception of T2DM patients and the perception of physicians about their T2DM population, respectively. In order to facilitate patients’ participation, they could also answer the questionnaire by phone in case of unavailability of Internet access.

Table 1 Ad-hoc self administered survey used in the study

Study variables

Sociodemographic variables were collected for both populations. Specifically, for T2DM patients, the variables collected were age, sex, place of residence, educational level, and employment status. Moreover, patients informed about the following clinical variables: time since T2DM diagnosis, treatment type (oral, injected, combined therapy), and comorbidities (hypertension, hypercholesterolemia, and obesity) and their treatment. Physicians reported the following variables: age, sex, health care center area, and approximate number of T2DM patients attending per month.

Analysis

A descriptive analysis was performed including all participants with completed responses. Absolute and relative frequencies were calculated for qualitative variables. Measurements of central tendency and dispersion were reported for quantitative variables. Scores distribution obtained for each question was compared between groups applying the chi-square test. For all statistical tests, P<0.05 was considered significant. SPSS version 19.0 was used for data analysis.

Results

Description of the participants

Of the 6,747 patients who were invited to participate in the survey, a total of 1,012 (15%) T2DM patients from 47 different Spanish provinces participated in the study. On the other hand, of the 1,021 PC physicians invited to participate in the survey, a total of 974 (95.4%) responded to the questionnaires, distributed among 52 Spanish provinces. The final sample for this analysis was therefore composed of 1,012 patients and 974 independent physicians, being 1.04 patients included in the study per physician.

The patients’ mean age was 54.2 (standard deviation [SD]: 11.2) years, and approximately half of the studied subjects were males (51%). Only 26% (n=266) of participants had college education and 44% (n=445) were retired at the time of the study. The mean time since T2DM diagnosis was 11.3 (SD: 9.7) years. Ninety percent of patients (n=917) received prescribed medication for their diabetes (51.2% [n=518] were treated with oral medication only, 15.3% [n=155] with injectable treatment alone, and 24.1% [n=244] received both oral and injected medications).

Participant physicians had a mean age of 52.4 (SD: 7.8) years, being 66.3% (n=646) male. Overall, 39% (n=380) of physicians reported seeing one to 50 T2DM patients per month, 36% (n=351) indicated 51 to 100, and 25% (n=243) estimated more than 100 visits per month. Patients’ and physicians’ socio-demographic and clinical variables are described in .

Table 2 Sociodemographic and clinical characteristics of the T2DM patients and physicians

Questionnaire scores

Statistically significant differences between patients’ and physicians’ scores were found in all the included questions (P<0.001).

Health status questions

The questionnaire scores showed that T2DM patients perceived a worse health status compared with physicians’ perceptions. Seventy-seven percent of physicians answered that their patients had a “good” health status, while most patients considered their health status was “good” (40%) or “neither good nor bad” (38%).

On the other hand, patients thought that T2DM had a lower impact on their current health status compared with physicians, since most patients answered that T2DM affected their health status “neither too much nor too little” (38%), while 74% of physicians thought that T2DM affected patients’ health status “a lot”.

PROs questions

reflects the relative importance given by both patients and physicians to PROs assessment (HRQoL and treatment persistence, adherence, satisfaction, and preferences) and the relative importance given by physicians to the impact of PROs on T2DM treatment and management.

In general, most patients reported that their doctors assessed PROs “sometimes” or “often”. However, physicians mainly indicated that they “often” or “very often” asked their patients about PROs. The estimated percentage of patients responding that physicians evaluated their treatment persistence “very often” was 18%, compared to the 36% of physicians who considered they assessed patients’ treatment persistence “very often”. Interestingly, almost half of the physicians (46%) thought they assessed treatment adherence “very often”, while only 17% of patients agreed with this statement.

Added to this, both patients and physicians agreed on the importance of PROs for T2DM management; nevertheless, the proportion of physicians who considered their assessment “important” or “very important” was statistically significantly higher for all comparisons. As an example, most physicians (63%) answered that treatment adherence was very important in order to achieve optimal clinical outcomes, while only 25% of patients considered this attribute of great importance for doctors. Moreover, 51% of the physicians included reported that they “often” changed treatment, aiming at improving treatment adherence, while only a quarter of patients (25%) perceived that physicians changed treatment to improve their medication adherence.

In general, the majority of physicians reported that they “often” changed treatment in order to improve PROs, while most patients perceived that physicians only changed treatments “sometimes” in order to improve their PROs. Finally, although most participants answered that the patient–physician relationship was “good”, while more physicians had a similar opinion about it (68%) compared with patients (53%).

T2DM management and treatment questions Information provided

Regarding the information about treatment techniques and self-management provided to patients by nurses, the results in show that the majority of patients answered that they received information about T2DM, self-monitoring of blood glucose (SMBG), and treatment administration techniques from nurses “sometimes” or “frequently”, whereas physicians indicated that this information was given “frequently” or “always” to the patients. A high percentage of physicians perceived that nurses “always” assessed patients’ abilities to check blood glucose levels (38%) or trained them how to administrate their treatments (40%), compared to 14% of patients who answered that they were “always” taught how to perform SMBG or received information regarding treatment dosage and administration (13%).

Table 4 T2DM management and treatment questionsTable Footnote*

In addition, most patients answered that they were “satisfied” or “neither satisfied nor unsatisfied” with the given information; however, patients’ satisfaction was higher according to physicians, who considered that patients were “satisfied” or “very satisfied” with the information for SMBG and treatment administration.

Recommendations

reports the frequency with which patients followed physicians’ recommendations about routine SMBG or medical visits, diet, exercise, and oral treatments and the degree of satisfaction with these recommendations.

Table 5 Physician recommendations*

In general, patients perceived that they “frequently” or “always” followed physicians’ recommendations about routine SMBG, routine medical visits, diet, exercise, and oral treatments, while physicians’ answers indicated a lower frequency than patients’ opinions. As an example, almost a quarter of patients thought they “always” followed physicians’ diet (23%) and exercise recommendations (20%), while only 3% and 2% of physicians believed patients accomplished doctors’ suggestions regarding diet and exercise, respectively. Regarding patients’ satisfaction with routine SMBG recommendations, the results showed that most patients were “satisfied” or “very satisfied” with them, while the majority of physicians indicated that patients were “satisfied” or “neither satisfied nor unsatisfied”. Interestingly, physicians perceived lower patient satisfaction with diet (5%) and exercise (4%) recommendations compared with the patients (17%) themselves. Concerning routine medical visits and oral and injectable treatment, the proportion of patients “satisfied” was lower than the patients satisfaction that physicians perceived.

On the other hand, although most patients and physicians reported that following medical recommendations allowed “quite a lot” of control of T2DM, the proportion was generally higher for physicians. Regarding patients’ perceptions about the importance of medical recommendations, most patients (57%) reported that it was “important”, while most physicians considered it as “very important” (58%).

Treatment

Thirty-nine percent of patients reported that physicians “always” take into account comorbidities when they choose a T2DM treatment, while doctors had a more favorable perception, as 70% of them indicated the same assertion.

The majority of patients (53%) perceived that their current T2DM treatment suited their preferences “quite a lot”, which was a lower proportion than among the physicians (69%). Additionally, fewer patients (53%) than physicians (79%) believed that their treatment improved their HRQoL “quite a lot”. Finally, 46% of physicians considered new technologies were very important for T2DM management, while only 29% of patients agreed with this statement.

Discussion

The findings in this study show that PC physicians and T2DM patients have different perceptions regarding their health status, PROs evaluation, and T2DM management and treatment in routine clinical practice in Spain.

The perceived health status of T2DM patients was worse compared with physicians’ opinions; nevertheless, physicians considered that T2DM had a higher impact on patients’ health statuses than the patients themselves. This fact is consistent with a previous study showing that health care professionals perceived T2DM as more serious and having a higher negative psychosocial impact than patients did.Citation19 In addition, it has been shown that a poor understanding of the disease due to low health care quality may affect patients’ perceptions of seriousness, which consequently may influence self-management and treatment adherence;Citation16,Citation19 nevertheless, patients’ T2DM knowledge was not directly explored in this study and should be considered in future designs.

Regarding PROs, it should be noted that, despite patients and physicians considering PROs assessment important or very important, most patients perceived a low frequency of patient-centeredness in diabetes management and treatment compared with physicians’ opinions. In this sense, current guidelinesCitation10,Citation13 recommend patient-centered care in which patients’ needs and preferences regarding treatment should be strongly considered by physicians for clinical decision making. Added to this, PROs assessment is increasingly being used in clinical trials and accepted as a measure of health and well-being in clinical practice.Citation20 Nevertheless, results in this study show that the majority of physicians’ decisions related to diabetes management and treatment are not completely aligned with patients’ opinions and perspectives. On the other hand, it should be remarked that most patients in our study reported lower satisfaction and frequency regarding the information about T2DM, SMBG, and treatment administration techniques provided by the nurses compared with physicians’ perceptions. A good interaction between health care professionals (especially nurses) and patients has been shown to be paramount for appropriate patient-centered careCitation15 and is related to better disease understanding and patient self-management.Citation16 In this regard, the majority of diabetes patients included in this study perceived that they followed medical recommendations regarding routine SMBG, routine medical visits, diet and exercise, and treatment to a greater degree than physicians thought they did.

Given the complexity of diabetes management, T2DM patients need to develop the competency to achieve disease control and improve their outcomes, which requires education, a dietary intervention, exercise management, medication adjustment, and glucose monitoring.Citation10 In the Spanish NHS, PC health care professionals, including nurses and physicians, are considered to have the main responsibility for providing information and recommendations to patients about the therapy and self-management of T2DM.Citation21 It has been shown that self-management support interventions or programs are effective,Citation22 but health care professionals report several limiting factors to providing better health care quality, such as lack of time and resources, inadequate training, or health system problems,Citation21,Citation23 that may influence the frequency and quality of education and information interventions.

The study has some limitations inherent to the observational design, including susceptibility to bias and confounding, restricting the ability to define causality,Citation24 and the lack of objective outcomes (such as glycemic control) which could allow describing of the patient population in more detail. Additional studies, including data from medical records, such as glycemic control and weight variables, could reveal if diabetes could be treated well if patients gave less importance to its management. Moreover, it could be interesting to investigate further how patients’ diabetes durations can affect patients’ perceptions on diabetes management. In addition, in this study, professionals with at least 5 years’ post-residency experience were included, given that the authors wanted to reflect the perspectives of physicians with enough experience in the control of diabetic patients; however, it could be interesting to assess if physicians’ experience modifies their perceptions on diabetes management. Although the sample size was calculated to be representative of both sets of participants and the recruitment was performed with the support of independent and unbiased organizations (FEDE and RedGDPs), generalization of results should be performed with caution since participants might not represent the whole Spanish diabetes patient and PC physician population. Finally, considering that the administered questionnaire was not previously validated and that the included patients were from 47 Spanish provinces and the physicians were from 52, the results must be interpreted with caution. The possibility that different perceptions were due to misinterpretation of questions or because of the different perceptions were due to misinterpretation of questions or because of sociodemographics differences between patients and physicians cannot be ruled out.

Despite the described limitations, this study has several strengths, including the large sample of PC physicians and T2DM patients included, which provides relevant information regarding perceptions and views in daily clinical practice of an heterogeneous patients’ and physicians’ population. These results are evidence of the need of modifying some components of the routine clinical practice in the NHS, such as understanding the patient and physician perspective and specifically incorporating greater patient-centeredness that may lead to the patients’ better understanding of the illness and consequently encourage better self-management behaviors.

Conclusion

The present study gives useful information about both physicians’ and T2DM patients’ views on PROs assessment, disease management, and treatment, providing useful insight into aspects that may influence medical decision making.

Acknowledgments

The authors acknowledge FEDE (Federación de Diabéticos Españoles [Spanish Diabetic Patients Federation]) and OUTCOMES’10 for their invaluable contribution to this study.

Disclosure

Mylan EPD funded the production of this manuscript, which has been read and approved by all named authors. The authors report no other conflicts of interest in this work.

References

  • International Diabetes Federation (IDF)IDF Diabetes Atlas6th edBrusselsIDF2013 Available from: http://www.idf.org/sites/default/files/EN_6E_Atlas_Full_0.pdfAccessed January 8, 2015
  • ShawJESicreeRAZimmetPZGlobal estimates of the prevalence of diabetes for 2010 and 2030Diabetes Res Clin Pract201087141419896746
  • SoriguerFGodayABosch-ComasAPrevalence of diabetes mellitus and impaired glucose regulation in Spain: the [email protected] StudyDiabetologia2012551889321987347
  • ValdésSBotasPDelgadoEDíaz CadórnigaFMortality risk in spanish adults with diagnosed diabetes, undiagnosed diabetes or pre-diabetes. The Asturias study 1998–2004Rev Esp Cardiol2009625528534 English, Spanish19406067
  • DECODE Study Group, European Diabetes Epidemiology GroupIs the current definition for diabetes relevant to mortality risk from all causes and cardiovascular and noncardiovascular diseases?Diabetes Care200326368869612610023
  • ValdésSRojo-MartínezGSoriguerFEvolution of prevalence of type 2 diabetes in adult Spanish populationMed Clin (Barc)20071299352355 Spanish17910853
  • GaedePVedelPLarsenNJensenGVParvingHHPedersenOMultifactorial intervention and cardiovascular disease in patients with type 2 diabetesN Engl J Med2003348538339312556541
  • CrespoCBrosaMSoria-JuanACostes directos de la diabetes mellitus y de sus complicaciones en España [Direct cost of diabetes mel-litus and its complications in Spain (SECCAID Study: Spain estimated cost Ciberdem-Cabimer in Diabetes)]Av Diabetol201329182189 Spanish
  • LuscombeFAHealth-related quality of life measurement in type 2 diabetesValue Health20003Suppl 1152816464206
  • American Diabetes AssociationStandards of medical care in diabetes – 2014Diabetes Care201437Suppl 1S14S8024357209
  • BolañosESarría-SantameraAPerspective of patients on type-2 diabetes and their relationship with primary care health professionals: a qualitative studyAten Primaria2003324195200 Spanish12975081
  • CooperHCBoothKGillGPatients’ perspectives on diabetes health care educationHealth Educ Res200318219120612729178
  • InzucchiSEBergenstalRMBuseJBManagement of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)Diabetologia20125561577159622526604
  • VinagreIMata-CasesMHermosillaEControl of glycemia and cardiovascular risk factors in patients with type 2 diabetes in primary care in Catalonia (Spain)Diabetes Care201235477477922344609
  • HobbsJLA dimensional analysis of patient-centered careNurs Res2009581526219092555
  • ThomasJ3rdIyerNNCollinsWBAssociations between perceived chronic care quality, perceived patient centeredness, and illness representations among persons with diabetesJ Healthc Qual2014365505925263955
  • Population figures at 1st January 2012 [webpage on the Internet]Instituto Nacionale de Estadística Available from: http://www.ine.es/dynt3/inebase/en/index.html?padre=517&dh=1Accessed January 8, 2015 Spanish, English
  • PerezPBLópez-ValcárcelBGVegaRSMinisterio de Sanidad, Política Social e IgualdadOferta y Necesidad de Especialistas Médicos en España (2010–2025) [Offer and need for medical specialists in Spain]2011 Available from: http://www.msssi.gob.es/profesionales/formacion/necesidadEspecialistas/doc/11-NecesidadesMEspecialistas(2010-2025).pdfAccessed January 8, 2015 Spanish
  • ClarkMHampsonSEComparison of patients’ and healthcare professionals’ beliefs about and attitudes towards type 2 diabetesDiabet Med200320215215412581267
  • VietaABadiaXSacristánJAA systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitusClin Ther20113391225124521856000
  • FonsecaMFleitasGTamboreroGBenejamMLeivaALifestyles of primary care physicians: perception and implications on cardiovascular preventionSemergen2013398421432 Spanish23583184
  • Salinero-FortMACarrillo-de Santa PauEArrieta-BlancoFJEffectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitusBMC Public Health20111126721524316
  • Tambo-LizaldeECarrasco-GimenoJMMayoral-BlascoSRabanaque-HernándezMJAbad-DíezJMPatient and health professional perceptions on the quality of care provided to diabetic patientsRev Calid Asist2013282124131 Spanish22999530
  • YangWZilovASoewondoPBechOMSekkalFHomePDObservational studies: going beyond the boundaries of randomized controlled trialsDiabetes Res Clin Pract201088Suppl 1S3S920466165