Key Factors Relevant for Healthcare Decisions of Patients with Type 1 and Type 2 Diabetes in Secondary Care According to Healthcare Professionals.

Purpose: Understanding which factors are important for healthcare decisions of patients with diabetes in clinical practice is important to personalise diabetes care strategies and tailor care plans to the individual. The main drivers for these healthcare decisions remain unclear. This study assessed which key factors are relevant for healthcare decisions during clinical consultations for patients with type 1 diabetes (T1DM) and type 2 diabetes (T2DM), according to healthcare professionals. Materials and Methods: Annual diabetes reviews were performed as part of a trial assessing the impact of a consultation model facilitating person-centred diabetes care in six hospital outpatient clinics. After each consultation, we asked healthcare professionals to choose a maximum of three out of 20 factors that were most relevant for healthcare decisions about treatment goals and the professional support needed during the upcoming year. Factors were characterised as either person or disease-related. Percentages reflect the number of annual diabetes reviews in which the key factor was reported. Results: Seventeen physicians and eight diabetes specialist nurses reported the key factors relevant for healthcare decisions in 285 annual diabetes reviews (T1DM n = 119, T2DM n = 166). Healthcare professionals most often reported quality of life (31.9%), motivation (27.0%) and diabetes self-management (25.6%), and to a lesser extent glycaemic control (24.2%), to be important for decisions about treatment goals. For decisions about the professional support needed during the upcoming year patient's preferences (33.7%), diabetes self-management (33.3%), quality of life (27.0%) and motivation (25.6%) were most often considered relevant by healthcare professionals. Conclusion: According to healthcare professionals, person-related factors such as quality of life, diabetes self-management and motivation are predominantly relevant for healthcare decisions about treatment goals and the professional support needed during the upcoming year.

Association between person and disease related factors and the planned diabetes care in people who receive person-centered type 2 diabetes care: An implementation study.

AIMS: To assess the planned diabetes care for the coming year and its associated factors in patients with Type 2 diabetes who have a person-centered annual consultation. METHODS: Implementation study of a new consultation model in 47 general practices (primary care) and 6 outpatient clinics (secondary care); 1200 patients from primary and 166 from secondary care participated. Data collection took place between November 2015 and February 2017. Outcomes: preferred monitoring frequency; referral to other health care provider(s); medication change. One measurement at the end of the consultation. We performed logistic regression analyses. Differences between primary and secondary care were analyzed. RESULTS: Many patients arranged a monitoring frequency <4 times per year (general practices 19.5%, outpatient clinics 40%, p < .001). Type of provider (physician/nurse, OR 3.83, p < .001), baseline HbA1c (OR 1.02, p = .017), glucose lowering medication; and setting treatment goals (OR .65, p = .048) were associated with the chosen frequency. Independently associated with a referral were age (OR .99, p = .039), baseline glucose lowering medication and patients' goal setting (OR 1.52, p = .016). Medication change was associated with type of provider, baseline HbA1c, blood glucose lowering medication, quality of life (OR .80, p = .037) and setting treatment goals (OR 2.64, p = .001). CONCLUSIONS: Not only disease but also person related factors, especially setting treatment goals, are independently associated with planned care use in person-centered diabetes care.

Patient activation in individuals with type 2 diabetes mellitus: associated factors and the role of insulin.

AIM: This study explored the relationship between insulin use and patient activation (a person's internal readiness and capabilities to undertake health-promoting actions) in individuals with type 2 diabetes mellitus and aimed to identify demographic, clinical and psychosocial factors involved in patient activation. METHODS: In this cross-sectional study, baseline data from a Dutch nationwide study were analyzed. Patient activation was assessed with the Patient Activation Measure 13. A linear mixed model was used to take clustering into account. RESULTS: In total, 1,189 persons were included (310 of whom were on insulin), enrolled via 47 general practices and six hospitals. Their mean Patient Activation Measure 13 score was 59±12. We found no association between insulin therapy and patient activation. In the multivariable analysis, individuals with a better health status, very good or very poor social support (vs good social support), individuals who felt they had greater control over their illness and those with a better subjective understanding of their illness showed higher patient activation. Individuals with a lower educational level and those who expected their illness to continue showed a lower activation level. CONCLUSION: Patient activation does not differ between individuals with type 2 diabetes mellitus on insulin therapy and those on other therapies.

Implementation of a Structured Diabetes Consultation Model to Facilitate a Person-Centered Approach: Results From a Nationwide Dutch Study.

OBJECTIVE: We assessed both from a patient and provider perspective the usefulness and added value of a consultation model that facilitates person-centered diabetes care. RESEARCH DESIGN AND METHODS: The model consists of 1) inventory of disease and patient-related factors; 2) setting personal goals; 3) choosing treatment; and 4) determination of required care. It was implemented in 47 general practices and 6 hospital outpatient clinics. Providers were trained, and patients were recommended to prepare their visit. All filled out a questionnaire after every consultation. Differences between primary and secondary care practices and between physician-led and nurse-led consultations were analyzed. RESULTS: Seventy-four physicians and thirty-one nurses participated, reporting on 1,366 consultations with type 2 diabetes patients. According to providers, the model was applicable in 72.4% (nurses 79.3% vs. physicians 68.5%, P < 0.001). Physicians more often had a consultation time <25 min (80.4% vs. 56.9%, P < 0.001). According to providers, two of three patients spoke more than half of the consultation time (outpatient clinics 75.2% vs. general practices 66.6%, P = 0.002; nurses 73.2% vs. physicians 64.4%, P = 0.001). Providers stated that person-related factors often determined treatment goals. Almost all patients (94.4%) reported that they made shared decisions; they felt more involved than before (with physicians 45.1% vs. with nurses 33.6%, P < 0.001) and rated the consultation 8.6 of 10. After physician-led consultations, 52.5% reported that the consultation was better than before (nurse visit 33.7%, P < 0.001). CONCLUSIONS: A consultation model to facilitate person-centered care seems well applicable and results in more patient involvement, including shared decision making, and is appreciated by a substantial number of patients.

Prospective validation of a risk calculator which calculates the probability of a positive prostate biopsy in a contemporary clinical cohort.

BACKGROUND: Prediction models need validation to assess their value outside the development setting. OBJECTIVE: To assess the external validity of the European Randomised study of Screening for Prostate Cancer (ERSPC) Risk Calculator (RC) in a contemporary clinical cohort. METHODS: The RC calculates the probability of a positive sextant prostate biopsy (P(posb)) using serum prostate-specific antigen (PSA), results of digital rectal examination, transrectal ultrasound (TRUS) and ultrasound assessed prostate volume. We prospectively validated the RC in 320 biopsied men (55-75 years), with no previous prostate biopsy, included in five Dutch hospitals in 2008-2011. If the P(posb) was ≥ 20% a biopsy was recommended. The performance of the RC was tested by comparing the observed outcomes to predicted probabilities, using the area under the curve (AUC) and decision curves analyses. RESULTS: Compared to the screening cohort, men in the clinical cohort differed. They had higher PSA levels (median 6.8 versus 4.3 ng/ml, p<0.01), less TRUS-lesions (27% versus 34%, p = 0.01) and more prostate cancer (PCa) at biopsy (43% versus 25%, p<0.01). Mainly eight biopsy cores were taken. Despite the differences between these cohorts, the mean observed probability agreed with the mean predicted probability (43% versus 40%). The RC predicted P(posb) better than a model with PSA and digital rectal examination, AUC 0.77 (95% confidence interval (CI) 0.72-0.83) and 0.71 (95%CI 0.65-0.76, p<0.01), respectively. This was confirmed by the decision curves analysis. Under the 20% threshold, 17% (11/63) of the biopsied men were diagnosed with PCa. Two of 11 men had an important cancer (Gleason 3+4). CONCLUSIONS: The ERSPC RC performs well in a Dutch clinical cohort in men with previous PSA tests and contemporary biopsy schemes, and outperforms a PSA and DRE-based approach in the decision to perform a biopsy.

Prediction of prostate cancer risk: the role of prostate volume and digital rectal examination in the ERSPC risk calculators.

BACKGROUND: The European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculators (RCs) are validated tools for prostate cancer (PCa) risk assessment and include prostate volume (PV) data from transrectal ultrasound (TRUS). OBJECTIVE: Develop and validate an RC based on digital rectal examination (DRE) that circumvents the need for TRUS but still includes information on PV. DESIGN, SETTING, AND PARTICIPANTS: For development of the DRE-based RC, we studied the original ERSPC Rotterdam RC population including 3624 men (885 PCa cases) and 2896 men (547 PCa cases) detected at first and repeat screening 4 yr later, respectively. A validation cohort consisted of 322 men, screened in 2010-2011 as participants in ERSPC Rotterdam. MEASUREMENTS: Data on TRUS-assessed PV in the development cohorts were re-coded into three categories (25, 40, and 60 cm3) to assess the loss of information by categorization of volume information. New RCs including PSA, DRE, and PV categories (DRE-based RC) were developed for men with and without a previous negative biopsy to predict overall and clinically significant PCa (high-grade [HG] PCa) defined as T stage>T2b and/or Gleason score≥7. Predictive accuracy was quantified by the area under the receiver operating curve. We compared performance with the Prostate Cancer Prevention Trial (PCPT) RC in the validation study. RESULTS AND LIMITATIONS: Areas under the curve (AUC) of prostate-specific antigen (PSA) alone, PSA and DRE, the DRE-based RC, and the original ERSPC RC to predict PCa at initial biopsy were 0.69, 0.73, 0.77, and 0.79, respectively. The corresponding AUCs for predicting HG PCa were higher (0.74, 0.82, 0.85, and 0.86). Similar results were seen in men previously biopsied and in the validation cohort. The DRE-based RC outperformed the PCPT RC (AUC 0.69 vs 0.59; p=0.0001) and a model based on PSA and DRE only (AUC 0.69 vs 0.63; p=0.0075) in the relatively small validation cohort. Further validation is required. CONCLUSIONS: An RC should contain volume estimates based either on TRUS or DRE. Replacing TRUS measurements by DRE estimates may enhance implementation in the daily practice of urologists and general practitioners.

Selecting men diagnosed with prostate cancer for active surveillance using a risk calculator: a prospective impact study.

UNLABELLED: Study Type - Prognosis (cohort series). Level of Evidence 2a. What's known on the subject? and What does the study add? The present study is one of the first to investigate urologists' and patients' compliance with recommendations based on a risk calculator that calculates the probability of indolent prostate cancer. A threshold was set for a recommendation of active surveillance vs active treatment. Active surveillance recommendations based on a prostate cancer risk calculator were followed by most patients, but 30% with active treatment recommendations chose active surveillance instead. This indicates that the threshold may be too high for urologists and patients. OBJECTIVES: • To assess urologists' and patients' compliance with treatment recommendations based on a prostate cancer risk calculator (RC) and the reasons for non-compliance. • To assess the difference between patients who were compliant and non-compliant with recommendations based on this RC. PATIENTS AND METHODS: • Eight urologists from five Dutch hospitals included 240 patients with prostate cancer (PCa), aged 55-75 years, from December 2008 to February 2011. • The urologists used the European Randomized Study of Screening for Prostate Cancer RC which predicts the probability of potentially indolent PCa (P[indolent]), using serum prostate-specific antigen (PSA), prostate volume and pathological findings on biopsy. • Inclusion criteria were PSA <20 ng/mL, clinical stage T1 or T2a-c disease, <50% positive sextant biopsy cores, ≤ 20 mm cancer tissue, ≥ 40 mm benign tissue and Gleason ≤ 3 + 3. If the P(indolent) was >70%, active surveillance (AS) was recommended, and active treatment (AT) otherwise. • After the treatment decision, patients completed a questionnaire about their treatment choice, related (dis)advantages, and validated measurements of other factors, e.g. anxiety. RESULTS: • Most patients (45/55, 82%) were compliant with an AS recommendation. Another 54 chose AS despite an AT recommendation (54/185, 29%). • The most common reason for non-compliance with AT recommendations by urologists was the patient's preference for AS (n= 30). These patients most often reported the delay of physical side effects of AT as the main advantage (n= 19). • Those who complied with AT recommendations had higher mean PSA levels (8 vs 7 ng/mL, P= 0.02), higher mean amount of cancer tissue (7 vs 3 mm, P < 0.001), lower mean P(indolent) (36% vs 55%, P < 0.001), and higher mean generic anxiety scores (42 vs 38, P= 0.03) than those who did not comply. CONCLUSIONS: • AS recommendations were followed by most patients, while 29% with AT recommendations chose AS instead. • Although further research is needed to validate the RC threshold, the current version is already useful in treatment decision-making in men with localized PCa.

Compliance with biopsy recommendations of a prostate cancer risk calculator.

UNLABELLED: Study Type - Diagnostic (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? So far, few publications have shown that a prediction model influences the behaviour of both physicians and patients. To our knowledge, it was unknown whether urologists and patients are compliant with the recommendations of a prostate cancer risk calculator and their reasons for non-compliance. Recommendations of the European Randomized study of Screening for Prostate Cancer risk calculator (ERSPC RC) about the need of a prostate biopsy were followed in most patients. In most cases of non-compliance with 'no biopsy' recommendations, a PSA level ≥ 3 ng/mL was decisive to opt for biopsy. Before implementation of the ERSPC RC in urological practices at a large scale, it is important to obtain insight into the use of guidelines that might counteract the adoption of the use of the RC as a result of opposing recommendations. OBJECTIVES: To assess both urologist and patient compliance with a 'no biopsy' or 'biopsy' recommendation of the European Randomized study of Screening for Prostate Cancer (ERSPC) Risk Calculator (RC), as well as their reasons for non-compliance. To assess determinants of patient compliance. PATIENTS AND METHODS: The ERSPC RC calculates the probability on a positive sextant prostate biopsy (P(posb) ) using serum prostate-specific antigen (PSA) level, outcomes of digital rectal examination and transrectal ultrasonography, and ultrasonographically assessed prostate volume. A biopsy was recommended if P(posb) ≥20%. Between 2008 and 2011, eight urologists from five Dutch hospitals included 443 patients (aged 55-75 years) after a PSA test with no previous biopsy. Urologists calculated the P(posb) using the RC in the presence of patients and completed a questionnaire about compliance. Patients completed a questionnaire about prostate cancer knowledge, attitude towards prostate biopsy, self-rated health (12-Item Short Form Health Survey), anxiety (State Trait Anxiety Inventory-6, Memorial Anxiety Scale for Prostate Cancer) and decision-making measures (Decisional Conflict Scale). RESULTS: Both urologists and patients complied with the RC recommendation in 368 of 443 (83%) cases. If a biopsy was recommended, almost all patients (96%; 257/269) complied, although 63 of the 174 (36%) patients were biopsied against the recommendation of the RC. Compliers with a 'no biopsy' recommendation had a lower mean P(posb) than non-compliers (9% vs 14%; P < 0.001). Urologists opted for biopsies against the recommendations of the RC because of an elevated PSA level (≥ 3 ng/mL) (78%; 49/63) and patients because they wanted certainty (60%; 38/63). CONCLUSIONS: Recommendations of the ERSPC RC on prostate biopsy were followed in most patients. The RC hence may be a promising tool for supporting clinical decision-making.

Updating the prostate cancer risk indicator for contemporary biopsy schemes.

INTRODUCTION AND OBJECTIVE: The prostate cancer risk indicator is a validated tool for predicting the chance of a screen detected prostate cancer to be classified as indolent, partially based on lateralized sextant biopsies. Our objective is to extract correction factors for adjustment of the model, addressing contemporary extended biopsy schemes. MATERIALS AND METHODS: Post-mortem 18-core biopsy results of men who died of unrelated causes, but were diagnosed with prostate cancer post-mortem were used to provide details on prostate biopsies and whole mount specimens. For each of the 18-core biopsies showing cancer, Gleason score, number of positive cores, location in the gland and percentage of cancer involvement were determined and correlated to final pathology. Total length of cancer tissue in a 6-core scheme was related to the length in 12 and 18-core schemes to compute correction factors. Furthermore, upgrading on extended biopsies and final pathology was evaluated. RESULTS: Data from 33 autopsied men were included. The 18 and 12-core biopsies showed 192.72 mm and 143.76 mm of prostate cancer, compared to 70.80 mm with lateralized sextant biopsy, resulting in correction factors of 2.72 and 2.03 for 18 and 12-core schemes respectively. Upgrading in Gleason score on extended biopsy regimens compared to lateralized sextant biopsy occurred in 33% (11/33) of the cases. CONCLUSION: Based on autopsy data, the present correction factors provide a support in the adjustment of the prostate cancer risk indicator towards more extended contemporary biopsy schemes, eventually leading to a more accurate prediction of the probability of indolent cancers and assisting patients and clinicians to make appropriate choices in daily practice.

Prediction of prostate cancer in unscreened men: external validation of a risk calculator.

BACKGROUND: Prediction models need external validation to assess their value beyond the setting where the model was derived from. OBJECTIVE: To assess the external validity of the European Randomized study of Screening for Prostate Cancer (ERSPC) risk calculator (www.prostatecancer-riskcalculator.com) for the probability of having a positive prostate biopsy (P(posb)). DESIGN, SETTING AND PARTICIPANTS: The ERSPC risk calculator was based on data of the initial screening round of the ERSPC section Rotterdam and validated in 1825 and 531 men biopsied at the initial screening round in the Finnish and Swedish sections of the ERSPC respectively. P(posb) was calculated using serum prostate specific antigen (PSA), outcome of digital rectal examination (DRE), transrectal ultrasound and ultrasound assessed prostate volume. MEASUREMENTS: The external validity was assessed for the presence of cancer at biopsy by calibration (agreement between observed and predicted outcomes), discrimination (separation of those with and without cancer), and decision curves (for clinical usefulness). RESULTS AND LIMITATIONS: Prostate cancer was detected in 469 men (26%) of the Finnish cohort and in 124 men (23%) of the Swedish cohort. Systematic miscalibration was present in both cohorts (mean predicted probability 34% versus 26% observed, and 29% versus 23% observed, both p<0.001). The areas under the curves were 0.76 and 0.78, and substantially lower for the model with PSA only (0.64 and 0.68 respectively). The model proved clinically useful for any decision threshold compared with a model with PSA only, PSA and DRE, or biopsying all men. A limitation is that the model is based on sextant biopsies results. CONCLUSIONS: The ERSPC risk calculator discriminated well between those with and without prostate cancer among initially screened men, but overestimated the risk of a positive biopsy. Further research is necessary to assess the performance and applicability of the ERSPC risk calculator when a clinical setting is considered rather than a screening setting.

Should prostate-specific antigen screening be offered to asymptomatic men?

The benefits of population-based prostate cancer screening are the detection of clinically important prostate cancers at an early, still curable, stage and the subsequent reduction of prostate cancer-specific mortality. However, a prostate-specific antigen (PSA)-based prostate cancer screening program is currently insufficient to warrant its introduction as a public health policy. The main reasons are insufficient knowledge regarding the optimal screening strategy and overdiagnosis and overtreatment of indolent prostate cancers that are unlikely to lead to complaints or death. In some countries, guidelines have been developed on screening for prostate cancer, but the diversity of recommendations illustrates the limited knowledge on the optimal strategy. Therefore, men should be well informed about the benefits and potential harms of PSA screening in order to enable them to make an informed decision. Although a mortality reduction can be achieved by early detection of prostate cancer, patients and physicians must be aware of the current side effects of screening. Algorithms that advise screening at a young age (<55 years), with screening intervals of less than 4 years and low PSA thresholds (<3 ng/ml) for prostate biopsy seem premature and are not supported by evidence.

Disease insight and treatment perception of men on active surveillance for early prostate cancer.

STUDY TYPE: Survey (prospective cohort). LEVEL OF EVIDENCE: 1b. OBJECTIVE: To investigate the levels of knowledge of prostate cancer and the perception of active surveillance (AS) in men on AS, as AS for early prostate cancer instead of radical treatment might partly solve the over-treatment dilemma in this disease, but might be experienced as a complex and contradictory strategy by patients. PATIENTS AND METHODS: In all, 150 Dutch men recently diagnosed with early prostate cancer participating in a prospective protocol-based AS programme (PRIAS study) received questionnaires, including a 15-item measure on their general knowledge of prostate cancer, and open-ended questions on the most important disadvantages and advantages of AS, and on the specific perception of AS. We assessed knowledge scores and explored potentially associated factors, the stated (dis)advantages and specific perceptions. RESULTS: The questionnaire response rate was 86% (129/150). Participants provided correct answers to a median (interquartile range) of 13 (12-14) of 15 (87%) knowledge items. Younger and higher educated men had higher knowledge scores. In line with a priori hypotheses, the most frequently reported advantage and disadvantage of AS were the delay of side-effects and the risk of disease progression, respectively. Specific negative experiences included the feeling of losing control over treatment decisions, distress at follow-up visits, and the desire for a more active participation in disease management. No conceptually wrong understandings or expectations of AS were identified. CONCLUSIONS: We found adequate knowledge of prostate cancer levels and realistic perceptions of the AS strategy in patients with early prostate cancer and on AS. These findings suggest adequate counselling by the physician or patient self-education.

Informed decision making on PSA testing for the detection of prostate cancer: an evaluation of a leaflet with risk indicator.

BACKGROUND: Population-based screening for prostate cancer (PCa) remains controversial. To help men making informed decisions about prostate specific antigen (PSA) screening a risk indicator (www.uroweb.org) was developed. This risk indicator is embedded in a leaflet that informs men about the pros and cons of PCa screening and enables calculation of the individual risk of having a biopsy detectable PCa. AIM: To assess the effect of providing a leaflet including individualized risk estimation on informed decision making of men, i.e. knowledge about PCa and PSA screening, attitude towards undergoing a PSA test and intention to have a PSA test. METHODS: An intervention study among 2000 men, aged 55-65 years, randomly selected from the population registry of the city of Dordrecht, the Netherlands, in 2008. Men were sent a questionnaire on knowledge of PCa, attitude and intention to have a PSA test. Men without a history of (screening for) PCa were sent the leaflet and Questionnaire 2 within 2 weeks after returning Questionnaire 1. Validated health and anxiety measures were used. RESULTS: One thousand and twenty seven of 2000 men completed Questionnaire 1 (51%), of whom 298 were excluded due to a history of (screening for) PCa. Of the 729 remaining men, 601 completed Questionnaire 2 as well. At the second assessment significantly more men met the requirements of informed decision making (15% versus 33%, p<0.001), more men had relevant knowledge (284/601, 50% versus 420/601, 77%, p<0.001) and the intention to have a PSA test had increased (p<0.001). CONCLUSIONS: Providing information on PCa screening combined with individualized risk estimation enhanced informed decision making and may be used for shared decision making on PSA screening of physicians and patients.