Facilitators and barriers in the implementation and adoption of Patient Reported Outcomes Measurements in daily practice.

OBJECTIVES: At the Erasmus MC, Patient Reported Outcome Measures (PROMs) are implemented on a hospital-wide scale. However, less than half of the patients and healthcare professionals (HCP) utilize these PROMs. Therefore, this study aimed to investigate facilitators and barriers for adoption of PROMs to develop guidance around implementation. METHODS: A mixed-methods study with a combination of interviews and focus groups, and questionnaires was conducted, involving patients, both PROM non-responders and PROM responders, HCPs, and medicine students and nurse specialists in training (hereafter 'students'). (Group)interview transcripts were subjected to thematic content analysis. Subsequently, questionnaires were developed and presented to all stakeholders to validate the findings. Last, identified themes and implementation recommendations were presented in a final questionnaire to the Value Based Healthcare Erasmus MC expert group to prioritize findings. RESULTS: Interviews were conducted with 15 patients, 14 HCPs and 4 students, and 2 focus groups with 5 students. The questionnaire was completed by 370/999 responders (37.0%), 173/1395 non-responders (12.5%), 44/194 HCPs (22.7%) and 40 students were reached via an open link. The identified facilitators and barriers were grouped into four overarching themes; training on PROMs at different levels in the education of (future) HCPS, motivate and reduce the burden for the HCP, implement generic and disease-specific PROMs simultaneously and motivate, activate and reduce the patient burden. CONCLUSIONS: Providing end-users with digital tools, implementation support and a clear hospital-wide vision are important, yet this does not guarantee successful adoption of PROMs. Successful adoption necessitates ongoing efforts to engage, motivate and train end-users.

Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial.

AIMS/HYPOTHESIS: Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design. METHODS: We included 158 obese adults (median BMI 36.3 [IQR 32.5-40.0] kg/m2) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC, the Netherlands, who achieved ≥5% weight loss on an 8 week very low calorie diet. Participants were randomised (stratified by weight loss) to usual care or usual care plus group-CBT (17 group sessions). The primary outcomes were the between-group differences after 2 years in: (1) body weight; and (2) weight regain. Secondary outcomes were HbA1c levels, insulin dose, plasma lipid levels, depression, anxiety, self-esteem, quality of life, fatigue, physical activity, eating disorders and related cognitions. Data were analysed using linear mixed modelling. RESULTS: During the initial 8 week dieting phase, the control group (n = 75) lost a mean of 10.0 (95% CI 9.1, 10.9) kg and the intervention group (n = 83) lost 9.2 (95% CI 8.4, 10.0) kg (p = 0.206 for the between-group difference). During 2 years of follow-up, mean weight regain was 4.7 (95% CI 3.0, 6.3) kg for the control group and 4.0 (95% CI 2.3, 5.6) kg for the intervention group, with a between-group difference of -0.7 (95% CI -3.1, 1.6) kg (p = 0.6). The mean difference in body weight at 2 years was -1.2 (95% CI -7.7, 5.3) kg (p = 0.7). None of the secondary outcomes differed between the two groups. CONCLUSIONS/INTERPRETATION: Despite increased treatment contact, a group-CBT programme for long-term weight maintenance after an initial ≥5% weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone. TRIAL REGISTRATION: Trialregister.nl NTR2264 FUNDING: The study was funded by the Erasmus MC funding programme 'Zorgonderzoek' (grant 2008-8303).

Focus group interviews reveal reasons for differences in the perception of disease activity in rheumatoid arthritis.

OBJECTIVE: Doctors frequently see patients who have difficulties coping with their disease and rate their disease activity high, despite the fact that according to the doctors, the disease activity is low. This study explored the patients' perspectives on this discordance that may help to understand why for some patients, usual care seems to be insufficient. METHODS: In our qualitative study we conducted focus group interviews where questions were used as a guideline. Transcripts were analyzed using inductive thematic analysis. FINDINGS: Twenty-nine patients participated in four focus groups. Participants could not put their finger exactly on why doctors estimated that their disease activity was low, while they experienced high levels of disease activity. During the in-depth focus interviews, seven themes emerged that appeared related to high experienced disease activity: (1) perceived stress, (2) balancing activities and rest, (3) medication intake, (4) social stress, (5) relationship with professionals, (6) comorbidity, and (7) physical fitness. CONCLUSION: When patients were asked why their view of their disease activity was different from that of their physician, seven themes emerged. The way participants coped with these themes seemed to be the predominant concept. Specific interventions that focus on one or more of the reported themes and on coping may improve not only the quality of life of these patients but also the satisfaction with the patient-doctor relationship for both parties.

Problem-Solving Therapy During Outpatient Stroke Rehabilitation Improves Coping and Health-Related Quality of Life: Randomized Controlled Trial.

BACKGROUND AND PURPOSE: This study investigated whether problem-solving therapy (PST) is an effective group intervention for improving coping strategy and health-related quality of life (HRQoL) in patients with stroke. METHODS: In this multicenter randomized controlled trial, the intervention group received PST as add-on to standard outpatient rehabilitation, the control group received outpatient rehabilitation only. Measurements were performed at baseline, directly after the intervention, and 6 and 12 months later. Data were analyzed using linear-mixed models. Primary outcomes were task-oriented coping as measured by the Coping Inventory for Stressful Situations and psychosocial HRQoL as measured by the Stroke-Specific Quality of Life Scale. Secondary outcomes were the EuroQol EQ-5D-5L utility score, emotion-oriented and avoidant coping as measured by the Coping Inventory for Stressful Situations, problem-solving skills as measured by the Social Problem Solving Inventory-Revised, and depression as measured by the Center for Epidemiological Studies Depression Scale. RESULTS: Included were 166 patients with stroke, mean age 53.06 years (SD, 10.19), 53% men, median time poststroke 7.29 months (interquartile range, 4.90-10.61 months). Six months post intervention, the PST group showed significant improvement when compared with the control group in task-oriented coping (P=0.008), but not stroke-specific psychosocial HRQoL. Furthermore, avoidant coping (P=0.039) and the utility value for general HRQoL (P=0.034) improved more in the PST group than in the control after 6 months. CONCLUSIONS: PST seems to improve task-oriented coping but not disease-specific psychosocial HRQoL after stroke >6-month follow-up. Furthermore, we found indications that PST may improve generic HRQoL recovery and avoidant coping. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2509. Unique identifier: CNTR2509.

Nonadherence to disease modifying antirheumatic drugs in the first year after diagnosis: comparing three adherence measures in early arthritis patients.

OBJECTIVES: The aim of this study was to compare three measurement methods for non-adherence to DMARDs in early arthritis patients: the Compliance Questionnaire Rheumatology (CQR), the intracellular uptake of MTX in the form of MTX-polyglutamates (MTX-PGs) and electronic measurement with Medication Event Monitoring Systems (MEMS). METHODS: DMARD naïve early arthritis patients were included in an ongoing cohort study. MEMS were used to measure adherence continuously, while every 3 months MTX-PGs were collected together with the CQR. The associations between the measures were estimated with Spearman rank correlations. Sensitivity and specificity of the CQR against a MEMS cut-off was compared at 3, 6, 9 and 12 months. The same applied to MTX-PGs against a MEMS cut-off and MTX-PGs against a CQR cut-off. For the association between MEMS, the CQR and MTX-PGs, a multilevel linear regression model was performed with age, gender, weeks of treatment and MTX dosage as covariates. RESULTS: We included 206 patients. Non-adherence measured with MEMS varied over time and between DMARDs. The CQR score was not associated with MEMS non-adherence at 3, 9 and 12 months. At 9 months, MTX-PGs was associated with MEMS non-adherence, as well as with the CQR. All correlations were below 0.30. CONCLUSION: Associations between the three measures are weak. Explanations are individual differences in the uptake of MTX, and little variance in adherence between patients. Moreover, the measurement domains differ: perceptions (CQR), behaviour (MEMS) and pharmacokinetics (MTX).

The Cost-Effectiveness of Cognitive-Behavioral Group Training for Patients with Unexplained Physical Symptoms.

OBJECTIVE: The aim of the study was to evaluate the cost-effectiveness of a cognitive-behavioral group training compared with a wait-list control for patients with unexplained physical symptoms (UPS). METHODS: A probabilistic decision-analytic Markov model was developed with three health states (poor health, average health, and death) based on a cutoff score of the Physical Component Summary of the short-form 36 health survey. To assess the cost-effectiveness in terms of cost per quality-adjusted life-year (QALY), a societal perspective was adopted. The model consisted of cycles of 3 months and a time horizon of 4 years. Data for the model were derived from a randomized controlled trial, in which 162 patients with UPS were randomized either to cognitive-behavioral group training or to the wait-list control. Data were assessed at baseline and after the training of 3 months or after a wait-list period of 3 months. In addition, the training group was followed in an uncontrolled phase and assessed at 3 months and 1 year after the training. RESULTS: After 4 years, the group training was in terms of cost-effectiveness "dominant" compared with the wait-list control; there was a positive effect of 0.06 QALYs and a €828 reduction in costs. The cost-effectiveness improved with a longer time horizon. A threshold of €30,000/QALY was passed after 18 months. The group training was cost saving after 33 months. CONCLUSIONS: Cognitive-behavioral group training is a cost-effective treatment compared with the wait-list control for patients with UPS.

Fatigue management in patients with IBD: a randomised controlled trial.

OBJECTIVE: To assess the effectiveness of solution-focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD). DESIGN: Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength--Fatigue (CIS--fatigue) score of ≥ 35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality. RESULTS: Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS-fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed. CONCLUSIONS: SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up.

The effectiveness of problem solving therapy for stroke patients: study protocol for a pragmatic randomized controlled trial.

BACKGROUND: Coping style is one of the determinants of health-related quality of life after stroke. Stroke patients make less use of active problem-oriented coping styles than other brain damaged patients. Coping styles can be influenced by means of intervention. The primary aim of this study is to investigate if Problem Solving Therapy is an effective group intervention for improving coping style and health-related quality of life in stroke patients. The secondary aim is to determine the effect of Problem Solving Therapy on depression, social participation, health care consumption, and to determine the cost-effectiveness of the intervention. METHODS/DESIGN: We strive to include 200 stroke patients in the outpatient phase of rehabilitation treatment, using a multicenter pragmatic randomized controlled trial with one year follow-up. Patients in the intervention group will receive Problem Solving Therapy in addition to the standard rehabilitation program. The intervention will be provided in an open group design, with a continuous flow of patients. Primary outcome measures are coping style and health-related quality of life. Secondary outcome measures are depression, social participation, health care consumption, and the cost-effectiveness of the intervention. DISCUSSION: We designed our study as close to the implementation in practice as possible, using a pragmatic randomized trial and open group design, to represent a realistic estimate of the effectiveness of the intervention. If effective, Problem Solving Therapy is an inexpensive, deliverable and sustainable group intervention for stroke rehabilitation programs. TRIAL REGISTRATION: Nederlands Trial Register, NTR2509.

Patients with unexplained physical symptoms have poorer quality of life and higher costs than other patient groups: a cross-sectional study on burden.

BACKGROUND: To determine whether healthcare resources are allocated fairly, it is helpful to have information on the quality of life (QoL) of patients with Unexplained Physical Symptoms (UPS) and on the costs associated with them, and on how these relate to corresponding data in other patient groups. As studies to date have been limited to specific patient populations with UPS, the objective of this study was to assess QoL and costs in a general sample of patients with UPS using generic measures. METHODS: In a cross-sectional study, 162 patients with UPS reported on their QoL, use of healthcare resources and lost productivity in paid and unpaid work. To assess QoL, the generic SF-36 questionnaire was used, from which multidimensional quality-of-life scores and a one-dimensional score (utility) using the SF-6D scorings algorithm were derived. To assess costs, the TiC-P questionnaire was used. RESULTS: Patients with UPS reported a poor QoL. Their QoL was mostly decreased by limitations in functioning due to physical health, and the least by limitations in functioning due to emotional problems. The median of utilities was 0.57, and the mean was 0.58 (SD = .09).The cost for the use of healthcare services was estimated to be €3,123 (SD = €2,952) per patient per year. This cost was enlarged by work-related costs: absence from work (absenteeism), lower on-the-job productivity (presenteeism), and paid substitution of domestic tasks. The resulting mean total cost was estimated to be €6,815 per patient per year. CONCLUSIONS: These findings suggest that patients with UPS have a high burden of disease and use a considerable amount of healthcare resources. In comparison with other patient groups, the QoL values of patients with UPS were among the poorest and their costs were among the highest of all patient groups. The burden for both patients and society helps to justify the allocation of sufficient resources to effective treatment for patients with UPS.

The Prevention Of WEight Regain in diabetes type 2 (POWER) study: the effectiveness of adding a combined psychological intervention to a very low calorie diet, design and pilot data of a randomized controlled trial.

BACKGROUND: Obesity is of major pathogenetic importance to type 2 diabetes, it contributes to poor glycemic control and increases the risk of cardiovascular disease. Over 80% of patients with diabetes type 2 are overweight. To achieve a more favourable risk profile, changes in diet and lifestyle are needed. However, current treatment programs for obese DM type 2 patients are not effective in the long term. In this RCT, we compare the effectiveness of a Combined Psychological Intervention (CPI) and usual care in maintaining the favourable effects on weight and risk profile during 2 years of follow-up after a Very Low Calorie Diet (VLCD). METHODS AND DESIGN: In a randomised parallel group intervention study, 140 patients with type 2 diabetes and overweight (BMI>27 kg/m2) will be recruited from the outpatient department of the Erasmus Medical Centre.After obtaining ≥5% of weight loss with a VLCD, participants will be randomly assigned to CPI or usual care for 10 weeks. CPI consists of cognitive behaviour therapy, problem solving therapy and proactive coping.Primary outcome measure is weight change (kg).Other outcome measures are Body Mass Index (BMI = weight (kg)/length (m)2), waist circumference (cm), systolic blood pressure (mmHg), HbA1c (mmol/mol), lipid levels (LDL, HDL, TG (mmol/l) and chol/HDL-ratio), antidiabetic agents and doses, cardiovascular risk profile (UKPDS), lifestyle and quality of life (EuroQol EQ-5D). Psychosocial parameters are also studied, as secondary outcomes as well as determinants for weight loss.When successful, we want to conduct an analysis of the cost effectiveness of the intervention as compared to usual care. DISCUSSION: We expect that a CPI after a VLCD will be effective in maintaining weight loss and improving cardiovascular risk and glycaemic control, while being cost-effective and improving quality of life in patients with type 2 diabetes. CLINICAL TRIALS REGISTRATION: trialregister.nl NTR2264.

Predicting the outcome of a cognitive-behavioral group training for patients with unexplained physical symptoms: a one-year follow-up study.

BACKGROUND: Although Cognitive-Behavioral Therapy (CBT) is effective for Unexplained Physical Symptoms (UPS), some therapists in clinical practice seem to believe that CBT outcome will diminish if psychiatric comorbidity is present. The result is that patients with a psychiatric comorbidity are redirected from treatment for UPS into treatment for mental health problems. To explore whether this selection and allocation are appropriate, we explored whether CBT outcomes in UPS could be predicted by variables assessed at baseline and used in routine-practice assessments. METHODS: Patients (n=162) with UPS classified as undifferentiated somatoform disorder or chronic pain disorder were followed up until one year after they had attended a CBT group training. The time-points of the follow-up were at the end of CBT (immediate outcome), three months after CBT (short-term outcome), and one year after CBT (long-term outcome).CBT outcome was measured using the Physical Component Summary of the SF-36, which was the primary outcome measure in the randomized controlled trial that studied effectiveness of the CBT group training. Predictors were: 1.) psychological symptoms (global severity score of SCL-90), 2.) personality-disorder characteristics (sum of DSM-IV axis II criteria confirmed), 3.) psychiatric history (past presence of DSM-IV axis I disorders), and 4.) health-related quality of life in the mental domain (mental component summary of SF-36). The effect of this predictor set was explored using hierarchical multiple regression analyses into which these predictors had been entered simultaneously, after control for: a.) pretreatment primary outcome scores, b.) age, c.) gender, d.) marital status, and e.) employment. RESULTS: The predictor set was significant only for short-term CBT outcome, where it explained 15% of the variance. A better outcome was predicted by more psychological symptoms, fewer personality-disorder characteristics, the presence of a psychiatric history, and a better quality of life in the mental domain. CONCLUSIONS: As the predictors do not seem to predict CBT outcome consistently over time, the need for selection and allocation of patients for CBT is doubtful. It seems that this would unnecessarily deprive patients of effective treatment. TRIAL REGISTRATION: Nederlands Trial Register, NTR1609.

Discussing prognosis and the end of life with patients with advanced cancer or COPD: A qualitative study.

OBJECTIVES: To explore patients' experiences and recommendations for discussions about their prognosis and end of life with their physicians. METHODS: Patients with advanced cancer or advanced chronic obstructive pulmonary disease (COPD) were enrolled in qualitative interviews, which were analyzed with a phenomenological and thematic approach. RESULTS: During interviews with fourteen patients (median age 64 years), we identified the following themes for discussion about prognosis and the end of life: topics discussed, the timing, the setting, physician-patient relationship, responsibilities for clinicians, and recommendations. Patients preferred the physician to initiate such discussion, but wanted to decide about its continuation and content. The discussions were facilitated by an established physician-patient relationship or attendance of relatives. Patients with cancer had had discussions about prognosis at rather clear-cut moments of deterioration than patients with COPD. Patients with COPD did not consider end-of-life discussions a responsibility of the pulmonologist. Patients recommended an understandable message, involvement of relatives or other clinicians, sufficient time, and sensitive non-verbal communication. CONCLUSIONS: Patients appreciated open, sensitive, and negotiable discussions about prognosis and the end of life. PRACTICE IMPLICATIONS: Patients' recommendations could be used for communication training. Possible differences in the need for such discussions between patients with cancer or COPD warrant further research.

Tailoring a cognitive behavioural model for unexplained physical symptoms to patient's perspective: a bottom-up approach.

The prevalence of unexplained physical symptoms (UPS) in primary care is at least 33%. Cognitive behavioural therapy has shown to be effective. Within cognitive behavioural therapy, three models can be distinguished: reattribution model, coping model and consequences model. The consequences model, labelling psychosocial stress in terms of consequences rather than as causes of UPS, has high acceptance among patients and is effective in academic medical care. This acceptance is lost when applied in primary care. To increase acceptance of the consequences model among patients in primary care, we tailor this model to patient's perspective by approaching the model from bottom-up instead of top-down. Subsequently, we use this tailored model in an easily accessible group training. We illustrate our approach using two illustrative cases.

The effectiveness of a training for patients with unexplained physical symptoms: protocol of a cognitive behavioral group training and randomized controlled trial.

BACKGROUND: In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training. METHODS AND DESIGN: A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial. DISCUSSION: If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group in the daily practice of a mental healthcare institution, its transfer to practice should be relatively easy. TRIAL REGISTRATION: Nederlands Trial Register, NTR1609.

Psychosocial predictors of DMARD adherence in the first three months of treatment for early arthritis.

OBJECTIVES: To induce disease remission, early arthritis patients should adhere to their disease-modifying antirheumatic drugs (DMARD) in the first months after diagnosis. It remains unknown why some patients are non-adherent. We aimed to identify patients at risk for non-adherence in the first 3 months of treatment. METHODS: Adult DMARD-naive early arthritis patients starting synthetic DMARDs filled out items on potential adherence predictors at baseline. Adherence was measured continuously. Non-adherence was defined as not opening the electronically monitored pill bottle when it should have been. Items were reduced and clustered using principal component analysis. The most discriminating items were identified with latent trait models. We used a multivariable logistic regression model to find non-adherence predictors. RESULTS: 301 patients agreed to participate. Adherence was high and declined over time. Principal component analysis led to 7 dimensions, while subsequent latent trait models analyses led to 15 dimensions. Two dimensions were associated with adherence, one dimension was associated with non-adherence. CONCLUSIONS: Information seeking behavior and positive expectations about the course of the disease are associated with adherence. Patients who become passive because of pain are at risk for non-adherence. PRACTICE IMPLICATIONS: Rheumatologists have cues to identify non-adherence, and may intervene on non-adherence through implementing shared decision making techniques.

Does non-adherence to DMARDs influence hospital-related healthcare costs for early arthritis in the first year of treatment?

INTRODUCTION: Non-adherence to disease-modifying antirheumatic drugs (DMARDs) is suspected to relate to health care costs. In this study we investigated this relation in the first year of treatment. METHODS: In a multi-center cohort study with a one year follow up, non-adherence was continuously measured using electronic monitored medication jars. Non-adherence was defined as the number of days with a negative difference between expected and observed opening of the container. Cost measurement focused on hospital costs in the first year: consultations, emergency room visits, hospitalization, medical procedures, imaging modalities, medication costs, and laboratory tests. Cost volumes were registered from patient medical files. We applied multivariate regression analyses for the association between non-adherence and costs, and other variables (age, sex, center, baseline disease activity, diagnosis, socioeconomic status, anxiety and depression) and costs. RESULTS: Of the 275 invited patients, 206 were willing to participate. 74.2% had rheumatoid arthritis, 20.9% had psoriatic arthritis and 4.9% undifferentiated arthritis. 23.7% of the patients were more than 20% non-adherent over the follow-up period. Mean costs are € 2117.25 (SD € 3020.32). Non-adherence was positively related to costs in addition to baseline anxiety. CONCLUSION: Non-adherence is associated with health care costs in the first year of treatment for arthritis. This suggests that improving adherence is not only associated with better outcome, but also with savings.

Predictors of Diet-Induced Weight Loss in Overweight Adults with Type 2 Diabetes.

AIMS: A very low calorie diet improves the metabolic regulation of obesity related type 2 diabetes, but not for all patients, which leads to frustration in patients and professionals alike. The aim of this study was to develop a prediction model of diet-induced weight loss in type 2 diabetes. METHODS: 192 patients with type 2 diabetes and BMI>27 kg/m2 from the outpatient diabetes clinic of the Erasmus Medical Center underwent an 8-week very low calorie diet. Baseline demographic, psychological and physiological parameters were measured and the C-index was calculated of the model with the largest explained variance of relative weight loss using backward linear regression analysis. The model was internally validated using bootstrapping techniques. RESULTS: Weight loss after the diet was 7.8±4.6 kg (95%CI 7.2-8.5; p<0.001) and was independently associated with the baseline variables fasting glucose (B = -0.33 (95%CI -0.49, -0.18), p = 0.001), anxiety (HADS; B = -0.22 (95%CI -0.34, -0.11), p = 0.001), numb feeling in extremities (B = 1.86 (95%CI 0.85, 2.87), p = 0.002), insulin dose (B = 0.01 (95%CI 0.00, 0.02), p = 0.014) and waist-to-hip ratio (B = 6.79 (95%CI 2.10, 11.78), p = 0.003). This model explained 25% of the variance in weight loss. The C-index of this model to predict successful (≥5%) weight loss was 0.74 (95%CI 0.67-0.82), with a sensitivity of 0.93 (95% CI 0.89-0.97) and specificity of 0.29 (95% CI 0.16-0.42). When only the obese T2D patients (BMI≥30 kg/m2; n = 181) were considered, age also contributed to the model (B = 0.06 (95%CI 0.02, 0.11), p = 0.008), whereas waist-to-hip ratio did not. CONCLUSIONS: Diet-induced weight loss in overweight adults with T2D was predicted by five baseline parameters, which were predominantly diabetes related. However, failure seems difficult to predict. We propose to test this prediction model in future prospective diet intervention studies in patients with type 2 diabetes.

Facilitators and barriers to adherence in the initiation phase of Disease-modifying Antirheumatic Drug (DMARD) use in patients with arthritis who recently started their first DMARD treatment.

OBJECTIVE: To explore themes associated with adherence in the initiation phase for first-time use of disease-modifying antirheumatic drugs (DMARD) in patients with inflammatory arthritis using focus groups and individual interviews. METHODS: Thirty-three patients were interviewed in focus groups and individual interviews. Interviews were transcribed verbatim and imported into ATLAS.ti software (Scientific Software Development GmbH). Responses that included reasons for adherence or nonadherence in the initiation phase were extracted and coded by 2 coders separately. The 2 coders conferred until consensus on the codes was achieved. Codes were classified into overarching themes. RESULTS: Five themes emerged: (1) symptom severity, (2) experiences with medication, (3) perceptions about medication and the illness, (4) information about medication, and (5) communication style and trust in the rheumatologist. CONCLUSION: Perceptions about medication and the communication style with, and trust in, the rheumatologist were mentioned the most in relation to starting DMARD. The rheumatologist plays a crucial role in influencing adherence behavior by addressing perceptions about medication, providing information, and establishing trust in the treatment plan.

Non-adherence to disease-modifying antirheumatic drugs is associated with higher disease activity in early arthritis patients in the first year of the disease.

INTRODUCTION: Non-adherence to disease-modifying antirheumatic drugs (DMARDs) hampers the targets of rheumatoid arthritis (RA) treatment, obtaining low disease activity and decreasing radiological progression. This study investigates if, and to what extent, non-adherence to treatment would lead to a higher 28-joint count disease activity score (DAS28) in the first year after diagnosis. METHODS: Adult patients from an ongoing cohort study on treatment adherence were selected if they fulfilled the EULAR/ACR2010 criteria for RA, and were to start with their first DMARDs. Clinical variables were assessed at baseline and every 3 months. Non-adherence was continuously electronically measured and was defined as the proportion of days with a negative difference between expected and observed openings of the medication container out of the 3-month period before DAS28 measurement. Generalized linear mixed models were used to investigate whether the DAS28 related to non-adherence. Covariates included were age, sex, baseline DAS28, rheumatoid factor positivity, anti-cyclic citrullinated peptide antibodies (ACPA) positivity, anxiety, depression, weeks of treatment, number of DMARDs used, education level, use of subcutaneous methotrexate and biological use. RESULTS: One hundred and twenty patients met the inclusion criteria for RA. During the study period 17 patients became lost to follow-up. There was a decline in adherence over time for all DMARDs except for prednisone. Non-adherence is a predictor of disease activity in the first 6 months of therapy, adjusted for weeks of treatment, baseline DAS28, and baseline anxiety. CONCLUSIONS: Non-adherence relates to disease activity. Therefore, interventions towards enhancing adherence can improve disease outcome.