The effect of comorbidity on health-related quality of life for injury patients in the first year following injury: comparison of three comorbidity adjustment approaches

Background: Three approaches exist to deal with the impact of comorbidity in burden of disease studies - the maximum limit approach, the additive approach, and the multiplicative approach. The aim of this study was to compare the three comorbidity approaches in patients with temporary injury consequences as well as comorbid chronic conditions with nontrivial health impacts.Methods: Disability weights were assessed using data from the EQ-5D instrument developed by the EuroQol Group and derived from a postal survey among 2,295 injury patients at 2.5 and 9 months after being treated at an emergency department. We compared the observed and predicted EQ-5D disability weights in comorbid case

The relationship between change in subjective outcome and change in disease: a potential paradox

Contains fulltext : 87756.pdf (publisher's version ) (Closed access)BACKGROUND: Response shift theory suggests that improvements in health lead patients to change their internal standards and re-assess former health states as worse than initially rated when using retrospective ratings via the then-test. The predictions of response shift theory can be illustrated using prospect theory, whereby a change in current health causes a change in reference frame. Therefore, if health deteriorates, the former health state will receive a better rating, whereas if it improves, the former health state will receive a worse rating. OBJECTIVE: To explore the predictions of response shift and prospect theory by relating subjective change to objective change. METHODS: Baseline and 3-month follow-up data from a cohort of rheumatoid arthritis patients (N = 197) starting on TNFalpha-blocking agents were used. Objective disease change was classified according to a disease-specific clinical outcome measure (DAS28). Visual analogue scales (VAS) for general health (GH) and pain were used as self-reported measures. Three months after starting on anti-TNFalpha, patients used the then-test to re-rate their baseline health with regard to general health and pain. Differences between then-test value and baseline values were calculated and tested between improved, non-improved and deteriorated patients by the Student t-test. RESULTS: At 3 months, 51 (25.9%) patients had good improvement in health, 83 (42.1%) had moderate improvement, and 63 (32.0%) had no improvement or deteriorated in health. All patients no matter whether they improved, did not improve, or even became worse rated their health as worse retrospectively. The difference between the then-test rating and the baseline value was similarly sized in all groups. CONCLUSION: More positive ratings of retrospective health are independent of disease change. This suggests that patients do not necessarily change their standards in line with their disease change, and therefore it is inappropriate to use the then-test to correct for such a change. If a then-test is used to correct for shifts in internal standards, it might lead to the paradoxical result that patients who do not improve or even deteriorate increase significantly on self-reported health and pain. An alternative explanation for differences in retrospective and prospective ratings of health is the implicit theory of change which is more successful in explaining our results than prospect theory.1 september 201

Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

Contains fulltext : 81435.pdf (publisher's version ) (Open Access)BACKGROUND: Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD). The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. METHODS AND DESIGN: In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. DISCUSSION: A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient. TRIAL REGISTRATION: NCT00147693

Impact of a comprehensive cardiac rehabilitation programme versus coronary revascularisation in patients with stable angina pectoris: study protocol for the PRO-FIT randomised controlled trial

Background: Currently, in the majority of patients with stable angina pectoris (SAP) treatment consists of optimal medical treatment, potentially followed by coronary angiography and subsequent coronary revascularisation if necessary”. Recent work questioned the effectiveness of these invasive procedures in reducing re-events and improving prognosis. The potential of exercise-based cardiac rehabilitation on clinical outcomes in patients with coronary artery disease is well-known. However, in the modern era, no studies compared the effects of cardiac rehabilitation versus coronary revascularisation in patients with SAP. Methods: In this multicentre randomised controlled trial, 216 patients with stable angina pectoris and residual anginal complaints under optimal medical treatment will be randomised to: 1) usual care (i.e., coronary revascularisation), or 2) a 12-month cardiac rehabilitation (CR) programme. CR consists of a multidisciplinary intervention, including education, exercise training, lifestyle coaching and a dietary intervention with a stepped decline in supervision. The primary outcome will be anginal complaints (Seattle Angina Questionnaire-7) following the 12-month intervention. Secondary outcomes include cost-effectiveness, ischemic threshold during exercise, cardiovascular events, exercise capacity, quality of life and psychosocial wellbeing. Discussion: In this study, we will examine the hypothesis that multidisciplinary CR is at least equally effective in reducing anginal complaints as the contemporary invasive approach at 12-months follow-up for patients with SAP. If proven successful, this study will have significant impact on the treatment of patients with SAP as multidisciplinary CR is a less invasive and potentially less costly and better sustainable treatment than coronary revascularisations. Trial registration: Netherlands Trial Register, NL9537. Registered 14 June 2021

Efficacy of community-based physiotherapy networks for patients with Parkinson's disease:a cluster-randomised trial

\u3cp\u3eBACKGROUND: Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes.\u3c/p\u3e\u3cp\u3eMETHODS: Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694.\u3c/p\u3e\u3cp\u3eFINDINGS: We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399).\u3c/p\u3e\u3cp\u3eINTERPRETATION: Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters.\u3c/p\u3e\u3cp\u3eFUNDING: ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust.\u3c/p\u3

Micrometastases and isolated tumor cells: relevant and robust or rubbish? (MIRROR): preliminary results of the MIRROR study from the Dutch breast cancer trialists' group (BOOG).

Abstract Abstract #23 Background&amp;#x2028; The sentinel lymph node procedure (SNP) has largely replaced axillary lymph node dissection (ALND) in patients with early breast cancer (BC). Intensified examination of the sentinel node (SN) results in the detection of isolated tumor cells (ITCs) and micrometastases, whereas its relevance is still debated. This retrospective cohort study is the first study on this topic which includes only patients who underwent a SNP, with central review of all SN slides, and with separate analyses for the impact of administration of adjuvant systemic therapy.&amp;#x2028; Methods&amp;#x2028; Patients operated for BC in all Dutch hospitals in the years 1998-2005, having favourable tumor characteristics (&amp;gt; 35 year; tumor size 1-3 cm and differentiation grade I-II OR tumor size ≤ 1 cm irrespective of grade), having undergone a SNP with pN0(i-), pN0(i+), or pN1mi as final N-stage were selected. Patients were classified in cohort I in case of pN0(i-) and no adjuvant systemic therapy (AST), in cohort II in case of pN0(i+)/pN1mi and no AST, and in cohort III in case of pN0(i+)/pN1mi with AST. SNs were centrally reviewed and restaged according to 6th TNM classification. The 5-year disease-free survival (DFS) was analysed for the 3 different cohorts.&amp;#x2028; Results&amp;#x2028; So far, data are available for 1,744 of the 3,240 selected patients (cohort I n=935; cohort II n=340, cohort III n=469) with a median follow-up of 5.5 years. At diagnosis median age was 58, 56 and 56 years (p &amp;lt; 0.01) and median tumor size was 1.2, 1.4 and 1.5 cm (p &amp;lt; 0.0001). Differentiation grade and hormone receptor status were equally distributed among the three cohorts. Adjuvant systemic therapy in cohort III consisted of chemotherapy (10%), hormonal therapy (63%), or both (27%). The 5-yr DFS is 84% in cohort I, 73% in cohort II, and 86% in cohort III (p = 0.003 cohort I vs II; p &amp;lt; 0.0001 cohort II vs III). Correction for baseline characteristics did not lead to a relevant change in the results.&amp;#x2028; Conclusion&amp;#x2028; BC patients with ITCs or micrometastases as final N-stage after SNP have a significantly worse 5-yr DFS as compared to patients having no ITCs or micrometastases, independent of primary tumor characteristics. Adjuvant systemic therapy significantly improves the 5-yr DFS in the group of patients with ITCs or micrometastases in the lymph node(s). At the meeting, updated analyses will be available for the entire MIRROR study population.&amp;#x2028; Support: The Netherlands organization for health research and development (ZonMw) and all Dutch CCCs. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 23.</jats:p

Abstract PD06-04: Relevant Impact of Central Pathology Review on Nodal Classification, but Not on the Association of Small Nodal Metastases with Breast Cancer Outcome. Results from the Dutch MIRROR Study

Abstract Background: Previously, we reported that isolated tumor cells, pN0(i+), or micrometastases, pN1mi, were associated with a reduced 5-year disease-free survival (DFS) rate among patients with favorable early-stage breast cancer who did not receive adjuvant systemic therapy (AST) (de Boer et al, NEJM 2009). In patients with pN0(i+) or pN1mi who received AST, DFS was improved. Patients were classified by N-status as determined after central pathology review and restaged according to the 6th AJCC classification. In real life, however, treatment decisions are based on the pathology reports performed by local pathologists. Therefore, in the present study we addressed the role of the central pathology review. Methods: In the MIRROR study, a total of 2707 patients were included. Involved women were operated for breast cancer in a(ny) Dutch hospital in 1998-2005, had favorable characteristics (tumor size 1-3 cm and differentiation grade I-II OR tumor size 1 cm irrespective of grade) and had undergone a sentinel node procedure with pN0(i+) or pN1(mi) as final N-status. A control group with low-risk node-negative disease was randomly selected from the years 2000 and 2001. We assessed the difference between the original N-status and N-status after central review. Further, in patients who had not received AST (n=1712), 5-year DFS was assessed according to the original N-status as well as the review N-status. Results: Of 856 patients with pN0 after central review, 0.4% patients were originally staged as pN0(i+). Of 819 patients with reviewed pN0(i+), 24% patients originally had pN0 and 20% patients pN1 mi. And, of 1032 patients with pN1mi after review, 3% patients had originally pN0 and 15% patients pN0(i+). Overall, central review changed the N-classification thereby in 20% of patients. In patients who did not receive AST, the 5-year DFS rates of cohorts based on central pathology review were 86% for pN0, 77% for pN0(i+) and 76% for pN1mi (P&amp;lt;0.001, pN0(i+) and pN1mi compared with pN0). According to the original staging, the 5-years DFS rates were 85% for pN0, 73% for pN0(i+) and 72% for pN1mi (P&amp;lt;0.001; pN0(i+) and pN1mi compared with pN0). Conclusion: Central pathology review changed the N-classification in 20% of patients. On a population level the association of isolated tumor cells and micrometastases with breast cancer outcome remained unchanged. However, on an individual patient level, the upstaging of pN0 patients may be of clinical relevance. Quality control of pathology departments should therefore also include nodal staging of breast (and perhaps other) cancers. Support: The Netherlands organization for health research and development (ZonMw) and the Dutch Breast Cancer TrialistsGroup (BOOG) Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD06-04.</jats:p