Assessing the validity of a Parkinson's care evaluation: the PRIME-NL study.

INTRODUCTION: The PRIME-NL study prospectively evaluates a new integrated and personalized care model for people with parkinsonism, including Parkinson's disease, in a selected region (PRIME) in the Netherlands. We address the generalizability and sources of selection and confounding bias of the PRIME-NL study by examining baseline and 1-year compliance data. METHODS: First, we assessed regional baseline differences between the PRIME and the usual care (UC) region using healthcare claims data of almost all people with Parkinson's disease in the Netherlands (the source population). Second, we compared our questionnaire sample to the source population to determine generalizability. Third, we investigated sources of bias by comparing the PRIME and UC questionnaire sample on baseline characteristics and 1-year compliance. RESULTS: Baseline characteristics were similar in the PRIME (n = 1430) and UC (n = 26,250) source populations. The combined questionnaire sample (n = 920) was somewhat younger and had a slightly longer disease duration than the combined source population. Compared to the questionnaire sample in the PRIME region, the UC questionnaire sample was slightly younger, had better cognition, had a longer disease duration, had a higher educational attainment and consumed more alcohol. 1-year compliance of the questionnaire sample was higher in the UC region (96%) than in the PRIME region (92%). CONCLUSION: The generalizability of the PRIME-NL study seems to be good, yet we found evidence of some selection bias. This selection bias necessitates the use of advanced statistical methods for the final evaluation of PRIME-NL, such as inverse probability weighting or propensity score matching. The PRIME-NL study provides a unique window into the validity of a large-scale care evaluation for people with a chronic disease, in this case parkinsonism.

Rationale and design to evaluate the PRIME Parkinson care model: a prospective observational evaluation of proactive, integrated and patient-centred Parkinson care in The Netherlands (PRIME-NL).

BACKGROUND: Culminating evidence shows that current care does not optimally meet the needs of persons with parkinsonism, their carers and healthcare professionals. Recently, a new model of care was developed to address the limitations of usual care: Proactive and Integrated Management and Empowerment in Parkinson's Disease (PRIME Parkinson). From 2021 onwards, PRIME Parkinson care will replace usual care in a well-defined region in The Netherlands. The utility of PRIME Parkinson care will be evaluated on a single primary endpoint (parkinsonism-related complications), which reflects the health of people with parkinsonism. Furthermore, several secondary endpoints will be measured for four dimensions: health, patient and carer experience, healthcare professional experience, and cost of healthcare. The reference will be usual care, which will be continued in other regions in The Netherlands. METHODS: This is a prospective observational study which will run from January 1, 2020 until December 31, 2023. Before the new model of care will replace the usual care in the PRIME Parkinson care region all baseline assessments will take place. Outcomes will be informed by two data sources. We will use healthcare claims-based data to evaluate the primary endpoint, and costs of healthcare, in all persons with parkinsonism receiving PRIME Parkinson care (estimated number: 2,000) and all persons with parkinsonism receiving usual care in the other parts of The Netherlands (estimated number: 48,000). We will also evaluate secondary endpoints by performing annual questionnaire-based assessments. These assessments will be administered to a subsample across both regions (estimated numbers: 1,200 persons with parkinsonism, 600 carers and 250 healthcare professionals). DISCUSSION: This prospective cohort study will evaluate the utility of a novel integrated model of care for persons with parkinsonism in The Netherlands. We anticipate that the results of this study will also provide insight for the delivery of care to persons with parkinsonism in other regions and may inform the design of a similar model for other chronic health conditions.

Non-surgical care in patients with hip or knee osteoarthritis is modestly consistent with a stepped care strategy after its implementation.

OBJECTIVE: To improve the management of hip or knee osteoarthritis (OA), a stepped care strategy (SCS) has been developed that presents the optimal sequence for care in three steps. This study evaluates the extent to which clinical practice is consistent with the strategy after implementation and identifies determinants of SCS-consistent care. DESIGN: A 2-year observational prospective cohort study. SETTING: General practices in the region of Nijmegen in the Netherlands. PARTICIPANTS: Three hundred and thirteen patients with hip or knee OA and their general practitioner (GP). INTERVENTIONS: Multifaceted interventions were developed to implement the strategy. MAIN OUTCOME MEASURES: Consistency between clinical practice and the strategy was examined regarding three aspects of care: (i) timing of radiological assessment, (ii) sequence of non-surgical treatment options and (iii) making follow-up appointments. RESULTS: Out of the 212 patients who reported to have had an X-ray, 92 (44%) received it in line with the SCS. The sequence of treatment was inconsistent with the SCS in 58% of the patients, which was mainly caused by the underuse of lifestyle advice and dietary therapy. In 57% of the consultations, the patient reported to have been advised to make a follow-up appointment. No determinants that influenced all three aspects of care were identified. CONCLUSIONS: Consistency with the SCS was found in about half of the patients for each of the three aspects of care. Health care can be further optimized by encouraging GP s to use X-rays more appropriately and to make more use of lifestyle advice, dietary therapy and follow-up appointments.

Agreement of general practitioners with the guideline-based stepped-care strategy for patients with osteoarthritis of the hip or knee: a cross-sectional study.

BACKGROUND: To improve the management of hip or knee osteoarthritis (OA), a multidisciplinary guideline-based stepped-care strategy (SCS) with recommendations regarding the appropriate non-surgical treatment modalities and optimal sequence for care has been developed. Implementation of this SCS in the general practice may be hampered by the negative attitude of general practitioners (GPs) towards the strategy. In order to develop a tailored implementation plan, we assessed the GPs' views regarding specific recommendations in the SCS and their working procedures with regard to OA. METHODS: A survey was conducted among a random sample of Dutch GPs. Questions included the GP's demographical characteristics and the practice setting as well as how the management of OA was organized and whether the GPs supported the SCS recommendations. In particular, we assessed GP's views regarding the effectiveness of 14 recommended and non-recommended treatment modalities. Furthermore, we calculated their agreement with 7 statements based on the SCS recommendations regarding the sequence for care. With a linear regression model, we identified factors that seemed to influence the GPs' agreement with the SCS recommendations. RESULTS: Four hundred fifty-six GPs (37%) aged 30-65 years, of whom 278 males (61%), responded. Seven of the 11 recommended modalities (i.e. oral Non-Steroidal Anti-Inflammatory Drugs, physical therapy, glucocorticoid intra-articular injections, education, lifestyle advice, acetaminophen, and tramadol) were considered effective by the majority of the GPs (varying between 95-60%). The mean agreement score, based on a 5-point scale, with the recommendations regarding the sequence for care was 2.8 (SD = 0.5). Ten percent of the variance in GPs' agreement could be explained by the GPs' attitudes regarding the effectiveness of the recommended and non-recommended non-surgical treatment modalities and the type of practice. CONCLUSION: In general, GPs support the recommendations in the SCS. Therefore, we expect that their attitudes will not impede a successful implementation in general practice. Our results provide several starting points on which to focus implementation activities for specific SCS recommendations; those related to the prescription of pain medication and the use of X-rays. We could not identify factors that contribute substantially to GPs' attitudes regarding the SCS recommendations regarding the sequence for care.

Patient reported barriers and facilitators to using a self-management booklet for hip and knee osteoarthritis in primary care: results of a qualitative interview study.

BACKGROUND: To enhance guideline-based non-surgical management of hip or knee osteoarthritis (OA), a multidisciplinary, stepped-care strategy has been implemented in primary care in a region of the Netherlands. To facilitate this implementation, the self-management booklet "Care for Osteoarthritis" was developed and introduced. The aim of the booklet was to educate patients about OA, to enhance the patient's active role in the treatment course, and to improve the communication with health care providers. To successfully introduce the booklet on a large scale we assessed barriers and facilitators for patients to using this booklet. METHODS: Seventeen primary care patients with hip or knee OA who received the self-management booklet participated in this qualitative study using semi-structured interviews. Purposive sampling was used to ensure diversity of the patients' view about the booklet. The interviews were transcribed verbatim and analysed using a thematic analysis approach. RESULTS: Three core themes with patient perceived barriers and facilitators to use the booklet emerged from the interviews: 1) the role of health care providers, 2) the patient's perceptions about OA and its manageability, and 3) the patient's perceptions about the usefulness of the booklet and patient's information needs. Regarding the first theme, a barrier was the lack of encouragement from health care providers to use the booklet in the treatment course of OA. Moreover, patients had doubts concerning the health care providers' endorsement of non-surgical treatment for OA. Barriers from the second theme were: thinking that OA is not treatable or that being pro-active during the treatment course is not important. In contrast, being convinced about the importance of an active participation in the treatment course was a facilitator. Third, patients' perceptions about the usefulness of the booklet and patients' information needs were both identified as barriers as well as facilitators for booklet use. CONCLUSIONS: This study contributes to the understanding of patient perceived barriers and facilitators to use a self-management booklet in the treatment course of OA. The results offer practical starting points to tailor the implementation activities of the booklet nationwide and to introduce comparable educational tools in OA primary care or in other chronic diseases.

Proactive and Integrated Management and Empowerment in Parkinson's Disease protocol for a randomised controlled trial (PRIME-UK) to evaluate a new model of care.

BACKGROUND: People living with Parkinson's disease experience progressive motor and non-motor symptoms, which negatively impact on health-related quality of life and can lead to an increased risk of hospitalisation. It is increasingly recognised that the current care models are not suitable for the needs of people with parkinsonism whose care needs evolve and change as the disease progresses. This trial aims to evaluate whether a complex and innovative model of integrated care will increase an individual's ability to achieve their personal goals, have a positive impact on health and symptom burden and be more cost-effective when compared with usual care. METHODS: This is a single-centre, randomised controlled trial where people with parkinsonism and their informal caregivers are randomised into one of two groups: either PRIME Parkinson multi-component model of care or usual care. Adults ≥18 years with a diagnosis of parkinsonism, able to provide informed consent or the availability of a close friend or relative to act as a personal consultee if capacity to do so is absent and living in the trial geographical area are eligible. Up to three caregivers per patient can also take part, must be ≥18 years, provide informal, unpaid care and able to give informed consent. The primary outcome measure is goal attainment, as measured using the Bangor Goal Setting Interview. The duration of enrolment is 24 months. The total recruitment target is n=214, and the main analyses will be intention to treat. DISCUSSION: This trial tests whether a novel model of care improves health and disease-related metrics including goal attainment and decreases hospitalisations whilst being more cost-effective than the current usual care. Subject to successful implementation of this intervention within one centre, the PRIME Parkinson model of care could then be evaluated within a cluster-randomised trial at multiple centres.

Proactive and Integrated Management and Empowerment in Parkinson's Disease: Designing a New Model of Care.

Parkinson's disease is the second most common neurodegenerative condition after Alzheimer's disease. The number of patients will rise dramatically due to ageing of the population and possibly also due to environmental issues. It is widely recognised that the current models of care for people with Parkinson's disease or a form of atypical parkinsonism lack continuity, are reactive to problems rather than proactive, and do not adequately support individuals to self-manage. Integrated models of care have been developed for other chronic conditions, with a range of positive effects. A multidisciplinary team of professionals in the United Kingdom and the Netherlands, all with a long history of caring for patients with movement disorders, used knowledge of deficiencies with the current model of care, an understanding of integrated care in chronic disease and the process of logic modelling, to develop a novel approach to the care of patients with Parkinson's disease. We propose a new model, termed PRIME Parkinson (Proactive and Integrated Management and Empowerment in Parkinson's Disease), which is designed to manage problems proactively, deliver integrated, multidisciplinary care, and empower patients and their carers. It has five main components: (1) personalised care management, (2) education and empowerment of patients and carers, (3) empowerment of healthcare professionals, (4) a population health approach, and (5) support of the previous four components by patient- and professional-friendly technology. Having mapped the processes required for the success of this initiative, there is now a requirement to assess its effect on health-related and quality of life outcomes as well as determining its cost-effectiveness. In the next phase of the project, we will implement PRIME Parkinson in selected areas of the United Kingdom and the Netherlands.

Factors Associated With Referral to Secondary Care in Patients With Osteoarthritis of the Hip or Knee After Implementation of a Stepped-Care Strategy.

OBJECTIVE: We introduced a stepped-care strategy (SCS) for hip and knee osteoarthritis, focusing on delivery of high-quality stepped care. In this study, we aimed to identify factors associated with various steps of the SCS. METHODS: We used data from a 2-year observational prospective cohort study, including 313 patients visiting their general practitioner (GP) with a new episode of hip/knee osteoarthritis. We used logistic multilevel analyses to identify factors at the level of the patient, the GP, and the general practice, related to treatment limited to primary care, referral to nonsurgical secondary care, or surgical procedures. RESULTS: Patients whose treatment had been limited to primary care tended to function physically better (odds ratio [OR] 1.03). Furthermore, they less often received exercise therapy (OR 0.46), intraarticular injections (OR 0.08), and radiologic assessments (OR 0.06). Continuation of nonsurgical care after referral was more likely in employed patients (OR 2.90) and patients who had no exercise therapy (OR 0.19) or nonsteroidal antiinflammatory drugs (OR 0.35). Surgically treated patients more often received exercise therapy (OR 7.42). Referral and surgical treatment depended only to a limited extent on the GP or the general practice. CONCLUSION: After implementation of the SCS in primary care, the performance of exercise therapy, rather than disease severity or psychologic factors, seems to play a key role in the decision whether or not to refer for surgical or nonsurgical treatment in secondary care. To optimize patient-tailored treatment, future research should be adressed to determine the optimal moment of switching from primary to secondary care in patients with hip/knee osteoarthritis.

Effect of stepped care on health outcomes in patients with osteoarthritis: an observational study in Dutch general practice.

BACKGROUND: A stepped care strategy (SCS) to improve adequate healthcare use in patients with osteoarthritis was developed and implemented in a primary care region in the Netherlands. AIM: To assess the association between care that is in line with the SCS recommendations and health outcomes. DESIGN AND SETTING: Data were used from a 2-year observational study of 313 patients who had consulted their GP because of osteoarthritis. METHOD: Care was considered 'SCS-consistent' if all advised modalities of the previous steps of the SCS were offered before more advanced modalities of subsequent steps. Pain and physical function were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (range 0-100); active pain coping with the Pain Coping Inventory (range 10-40); and self-efficacy with the Dutch General Self-Efficacy Scale (range 12-48). Crude and adjusted associations between SCS-consistent care and outcomes were estimated with generalised estimating equations. RESULTS: No statistically significant differences were found in changes over a 2-year period in pain and physical function between patients who received SCS-inconsistent care (n = 163) and patients who received SCS-consistent care (n = 117). This was also the case after adjusting for possible confounders, that is, -4.3 (95% confidence interval [CI] = -10.3 to 1.7) and -1.9 (95% CI = -7.0 to 3.1), respectively. Furthermore, no differences were found in changes over time between groups in self-efficacy and pain coping. CONCLUSION: The results raised several important issues that need to be considered regarding the value of the SCS, such as the reasons that GPs provide SCS-inconsistent care, the long-term effects of the SCS, and the effects on costs and side effects.

Health care use of patients with osteoarthritis of the hip or knee after implementation of a stepped-care strategy: an observational study.

OBJECTIVE: To enhance guideline-based nonsurgical management of osteoarthritis (OA), a multidisciplinary stepped-care strategy has been implemented in clinical practice. This study aimed to describe health care use after implementation of this strategy and to identify factors related to such use at multiple levels. METHODS: For this 2-year observational prospective cohort, patients with symptomatic hip or knee OA were included by their general practitioner. Activities aligned with patients and health care providers were executed to implement the strategy. Health care use was described as the cumulative percentage of "users" for each modality recommended in the strategy. Determinants were identified at the level of the patient, general practitioner, and practice using backward stepwise logistic multilevel regression models. RESULTS: Three hundred thirteen patients were included by 70 general practitioners of 38 practices. Their mean ± SD age was 64 ± 10 years and 120 (38%) were men. The most frequently used modalities were education, acetaminophen, lifestyle advice, and exercise therapy, which were used by 242 (82%), 250 (83%), 214 (73%), and 187 (63%) patients, respectively. Fourteen percent of the overweight patients reported being treated by a dietician. Being female, having an active coping style, using the booklet "Care for Osteoarthritis," and having limitations in functioning were recurrently identified as determinants of health care use. CONCLUSION: After implementation of the stepped-care strategy, most recommended nonsurgical modalities seem to be well used. Health care could be further improved by providing dietary therapy in overweight patients and making more efforts to encourage patients with a passive coping style to use nonsurgical modalities.

"Beating osteoARThritis": development of a stepped care strategy to optimize utilization and timing of non-surgical treatment modalities for patients with hip or knee osteoarthritis.

Inadequacies in health care practices have been reported despite existing guidelines to manage hip or knee osteoarthritis. To facilitate guideline implementation and improve utilization of non-surgical treatment options a care strategy should be developed. This study describes the development of an evidence-based, multidisciplinary, patient-centered, stepped care strategy. A national, multidisciplinary, steering group developed the strategy in three phases: (1) consensus among steering group members (first draft); (2) written consultation of 23 representatives of patient organizations and professional associations involved in osteoarthritis care (second draft); (3) consensus of the final draft after discussion in two rounds during a conference with representatives from the different disciplines. The final stepped care strategy presents, in three tiers, the optimal order for non-surgical treatment modalities. It recommends that more advanced options should only be considered if options listed in previous steps failed to produce satisfactory results. Hence, the first step treatment options can be offered to all patients but may also be provided through self care (education, life style advice, and acetaminophen). The second step (exercise therapy, dietary therapy, and non-steroidal anti-inflammatory drugs) and third step treatment options (multidisciplinary care, intra-articular injections, and transcutaneous electrical nerve stimulation) can be considered for people with persisting complaints. Trough a consensus procedure, we succeeded to develop a multidisciplinary, patient-centered, stepped care strategy based on national guidelines. This strategy provides a framework for health care providers and patients with hip or knee osteoarthritis to discuss the optimal timing of the various treatment options.

Exposure to hexachlorobenzene during pregnancy increases the risk of overweight in children aged 6 years.

AIM: To determine whether prenatal exposure to hexachlorobenzene (HCB) has potential adverse effects on child's weight and body mass index (BMI) in a general population with no local pollution sources. METHODS: Starting from mid 1997, all mothers presenting for antenatal exposure in Menorca were recruited. Subsequently, 482 children were enrolled. HCB was measured in cord blood. Weight and height were measured at birth and at age 6.5 years. RESULTS: Children with HCB levels higher than 1.03 ng/mL in cord blood were 1.14 kg (0.38) heavier and had a higher BMI (beta= 0.80 (0.34)) than children with HCB levels lower than 0.46 ng/mL. No statistically significant associations were found in height. Children in the higher exposure group of HCB had an increased risk of 2.5 and 3.0 of being overweight and obese. Children from normal weight mothers also presented an increased risk of having higher BMI with increasing concentrations of HCB in cord serum. CONCLUSION: Prenatal exposure to HCB is associated with an increase in BMI and weight at age 6.5 years. Further studies with larger samples and longer follow-up are needed to confirm these results.