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Objectives: To prospectively investigate patient-reported outcomes and clinical performance of implant supported overdentures in edentulous Sjögren's disease (SjD) patients compared to subjects without SjD., Methods: 51 implants were placed in 12 patients with SjD and 50 implants in 12 non-SjD patients to support overdentures. Clinical performance, marginal bone-level changes, patient satisfaction and oral health related quality of life (OHRQoL) were assessed at 1 (T1), 6 (T6), 12 (T12) and 18 (T18) months after placement of the overdenture. Patient satisfaction, ability to chew and OHRQoL were assessed with validated questionnaires. Marginal bone-level changes were measured on standardised dental radiographs. Clinical parameters included implant and overdenture survival, plaque, bleeding and gingival indices, and probing depth., Results: OHRQoL in patients with SjD improved significantly after placement of implant supported overdentures at all measuring moments compared to baseline (p<0.05). Nevertheless, ability to chew tough and hard food was significantly better for non-SjD patients at all timepoints after placement of an implant supported overdenture (p<0.05). Implant survival at T18 was 100% in the patients with SjD and 98% in the non-SS group. Mean marginal bone loss at T18 did not differ between patients with SjD and non-SS patients, 1.12±0.74 mm and 1.43±1.66 mm, respectively (p=0.58). Clinical performance was good with no differences between the groups for all outcome measures (p>0.05)., Conclusions: Implant-supported overdentures have a positive effect on OHRQoL and dental implants can be successfully applied in edentulous patients with SjD with nearly similar outcomes as in non-SjD subjects.

Objective: To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS)., Methods: We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6-12 sessions delivered by specialised exercise- and physiotherapists., Primary Outcome Measure: patient's level of functioning., Secondary Outcomes: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts., Results: Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference - 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference - 1.93 [95% CI -3.81 to -0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference - 0.91 [95% CI -1.78 to -0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups., Conclusion: We only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study., Trial Registration: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356., Competing Interests: Declaration of Competing Interest The authors have declared no competing interests., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Being engaged in work and social activities is associated with a better quality of life. However, little evidence is available on the relationship between different categories of social participation and quality of life in people with severe mental illnesses. Furthermore, longitudinal studies considering this relationship in people with severe mental illnesses (SMI) are scarce. This study attempts to fill this gap by exploring whether and how different categories of social participation and quality of life were associated over a period of 4 years., Method: The association between social participation activities and quality of life was analyzed with linear mixed models, using data from a Dutch national panel of people with SMI. Four annual waves including self-reported measures were used. Three categories of participation were assessed: paid employment, voluntary work, outside social activities., Results: From 2015 to 2018, 1.682 panel members (18-75 years old) participated in the survey. All three participation variables show a unique significant positive association with quality of life. Controlling for covariates (age, sex, and mental health) comparable regression coefficients were found: paid employment, .208, 95% CI [.090-.326], voluntary work, .210, 95% CI [.120-.300], and outside social activities, .239, 95% CI [.154-.324]., Conclusions and Implications for Practice: The value of participation for people with SMI seems to be not restricted to competitive employment. Engagement in paid employment, voluntary work, and performing outside social activities each have a comparable and additional positive association with quality of life. Therefore, rehabilitation professionals should pay attention to social participation activities in a broad range. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Background: A survival benefit was demonstrated for patients with low-volume metastatic prostate cancer (mPCa) when local radiotherapy was added to androgen deprivation therapy (ADT)., Objective: To determine the effect of ADT combined with external beam radiotherapy (EBRT) to the prostate on health-related quality of life (HRQoL) of patients with primary bone mPCa., Design, Setting, and Participants: The HORRAD trial is a multicentre randomised controlled trial recruiting 432patients with primary bone mPCa between 2004 and 2014., Intervention: Patients were randomised to ADT with EBRT or to ADT alone., Outcome Measurements and Statistical Analysis: Patients completed two validated HRQoL questionnaires (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core Module (QLQ-C30) and EORTC Quality of Life Questionnaire Prostate Module [QLQ-PR25]) at baseline and at 3, 6, 12, and24 mo after the initiation of treatment. The effect of both treatments was evaluated based on mixed-effect models., Results and Limitations: Patient characteristics and HRQoL scores at baseline were similar in both arms. At baseline, 98% of patients completed the questionnaires, compared with 58% at 24 mo. Patients reported significantly more diarrhoea (difference between the groups 10.8; 95% confidence interval [CI] 7.3-14.2), bowel symptoms (4.5; 95% CI 2.1-6.8), and urinary symptoms (11.9; 95% CI 8.9-14.8) after EBRT and ADT compared with ADT alone (all between-arm difference p <  0.001). Urinary complaints levelled at 6 mo. At 2 yr, only bowel symptom scores were significantly different (8.0; 95% CI 4.8-11.1, p ≤  0.001), but 68% of patients in the radiotherapy group did not report clinically relevant worsening of their bowel symptom scores., Conclusions: Patients with bone mPCa reported temporary modest urinary and bowel symptoms after combined treatment with EBRT of the prostate and ADT compared with ADT alone. For some patients (22%), deterioration of bowel functions remains at 2 yr, whereas general HRQoL does not deteriorate.., Patient Summary: This study investigated the effect of radiotherapy to the prostate added to hormonal therapy on patient-reported health-related quality of life (HRQoL) in patients with primary bone metastatic prostate cancer. Most patients reported only temporary urinary and bowel symptoms. In 22% of patients, bowel symptoms remained at 2 yr, whereas general HRQoL did not deteriorate., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objectives: Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs)., Design: A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group., Setting and Participants: A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week., Methods: All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD., Secondary Outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences., Results: Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P = .007; and Trail Making Test part A (TMT-A): r = -28.98, 95% CI: -54.89, -3.08, P = .029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = -1.86, 95% CI: -3.56, -0.17, P = .031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = -3.30, 95% CI: -6.57, -0.03, P = .048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P = .005)., Conclusions and Implications: Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation., (Copyright © 2020 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: In this study, longitudinal associations between sports participation and health-related quality of life (HRQoL) were explored. Sports participation was operationalized as membership of a sports club, frequency of sports participation, performing individual versus team sports and performing indoor versus outdoor sports. The concept of HRQoL referred to the self-perceived enjoyment and satisfaction with one's personal health situation., Methods: Data from 618 fourth-grade primary school children were included at baseline; 10-13 months later, 417 children (response rate 67.5%) were retained. At both time points, children reported on sports participation (Move and Sports Monitor Questionnaire-youth aged 8-12 years) and health-related quality of life (KIDSCREEN-52). Because of the clustering of children in schools, data were analysed using linear mixed models. Analyses were adjusted for sex, age, BMI, household composition, SES and frequency of sports participation., Results: The questionnaires were fully completed by 417 children. High sports-active children showed better scores on almost all dimensions of HRQoL than moderate [difference (B) = - 1.82 (p = 0.05) to - 1.51 (p = 0.05)] or low ports-active children [difference (B) = - 3.67 (p < 0.001) to - 1.95 (p = 0.03)] and non-sports club members [difference (B) = - 5.58 (p < 0.001) to - 2.65 (p = 0.02)]. Unlike frequency, the other examined characteristics of sports participation were only to a limited extent longitudinal associated with HRQoL., Conclusion: As frequency is more relevant than the form of sports participation, children should be encouraged to perform any kind of sports activity on a very regular base.

Background: In children physical activity has been shown to be associated with health-related quality of life (HRQoL). This study further explores this association for specific characteristics of sports participation, namely membership of a sports club, frequency of sports participation, performing individual versus team sports, performing indoor versus outdoor sports, while differentiating between specific dimensions in the physical, psychological and social domain of HRQoL., Methods: Cross-sectional data were collected from Dutch primary school children aged 10 to 12 years. They completed the Movement and Sports Monitor Questionnaire Youth aged 8 to 12 years (MSMQ) and the KIDSCREEN-52, an HRQoL questionnaire for children and adolescents. The data were examined using linear multilevel analyses because of the clustering of children in schools., Results: The questionnaires were completed by 1876 children (response rate 81.3%). Membership of a sports club, moderate or high frequency of sports participation, and performing outdoor sports were all significantly associated with better HRQoL. These associations were largely found in the physical domain of HRQoL, to a lesser degree in the social domain, and to a limited extent in the psychological domain., Conclusion: The association between sports participation and HRQoL in children depends on both characteristics of sports participation and the domain of life that is concerned. These differences offer starting points for developing tailor-made sports programs for children.

Background: In Parkinson's disease (PD) patients, fluctuations in symptoms commonly occur after many years of dopamine replacement therapy. The so-called wearing-off phenomenon exists of both motor and non-motor symptoms, such as rigidity and anxiety. Current treatment options are limited and an integrated approach is needed to address the complex interactions between motor and non-motor symptoms. Since wearing-off is eventually inevitable, treatment needs to focus on coping, acceptance and self-efficacy. We developed the body awareness training, named BEWARE, combining physical therapy with acceptance and commitment therapy to help PD patients deal better with wearing-off related anxiety (WRA)., Methods: This was an investigator-blinded randomized controlled trial. Forty PD patients with WRA were randomly assigned to the BEWARE or to the treatment as usual (TAU) condition. Assessments were performed prior to and immediately after the treatment period, and at 3-months follow up. The primary outcome was self-efficacy, secondary outcomes focused on mobility, daily functioning, anxiety, depression and quality of life., Results: There was no significant improvement in self-efficacy in the BEWARE treatment condition when compared to TAU. However, standing balance and emotional wellbeing showed a significant improvement, and feelings of stigmatization showed a trend-significant decrease in the BEWARE condition., Conclusions: We consider the BEWARE training to be a promising therapeutic approach to address WRA. Improvement points from the participants included 1) less frequent but longer therapy sessions; 2) active involvement of caregivers; and 3) the development of a supportive workbook. The optimized treatment protocol needs further evaluation in a phase III RCT., Trial Registration: ClinicalTrials.gov identifier: NCT02054845., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Primary care-based comprehensive care programs have the potential to improve outcomes in frail older adults. We evaluated the impact of the Geriatric Care Model (GCM) on the quality of life of community-dwelling frail older adults., Methods: A 24-month stepped wedge cluster randomized controlled trial was conducted between May 2010 and March 2013 in 35 primary care practices in the Netherlands, and included 1147 frail older adults. The intervention consisted of a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Reassessment occurred every six months. Nurses worked together with primary care physicians and were supervised and trained by geriatric expert teams. Complex patients were reviewed in multidisciplinary consultations. The primary outcome was quality of life (SF-12). Secondary outcomes were health-related quality of life, functional limitations, self-rated health, psychological wellbeing, social functioning and hospitalizations., Results: Intention-to-treat analyses based on multilevel modeling showed no significant differences between the intervention group and usual care regarding SF-12 and most secondary outcomes. Only for IADL limitations we found a small intervention effect in patients who received the intervention for 18months (B=-0.25, 95%CI=-0.43 to -0.06, p=0.007), but this effect was not statistically significant after correction for multiple comparisons., Conclusion: The GCM did not show beneficial effects on quality of life in frail older adults in primary care, compared to usual care. This study strengthens the idea that comprehensive care programs add very little to usual primary care for this population., Trial Registration: The Netherlands National Trial Register NTR2160., (Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

Study Question: Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety?, Methods: 265 people aged ≥50 were randomly assigned to a stepped care programme plus usual care (n=131) or usual care only (n=134). Supervised occupational therapists, social workers, and psychologists from low vision rehabilitation organisations delivered the stepped care programme, which comprised watchful waiting, guided self help based on cognitive behavioural therapy, problem solving treatment, and referral to a general practitioner. The primary outcome was the 24 month cumulative incidence (seven measurements) of major depressive dysthymic and/or anxiety disorders (panic disorder, agoraphobia, social phobia, and generalised anxiety disorder). Secondary outcomes were change in symptoms of depression and anxiety, vision related quality of life, health related quality of life, and adaptation to vision loss over time up to 24 months' follow-up., Study Answer and Limitations: 62 participants (46%) in the usual care group and 38 participants (29%) from the stepped care group developed a disorder. The intervention was associated with a significantly reduced incidence (relative risk 0.63, 95% confidence interval 0.45 to 0.87; P=0.01), even if time to the event was taken into account (adjusted hazard ratio 0.57, 0.35 to 0.93; P=0.02). The number needed to treat was 5.8 (3.5 to 17.3). The dropout rate was fairly high (34.3%), but rates were not significantly different for the two groups, indicating that the intervention was as acceptable as usual care. Participants who volunteered and were selected for this study might not be representative of visually impaired older adults in general (responders were significantly younger than non-responders), thereby reducing the generalisability of the outcomes., What This Study Adds: Stepped care seems to be a promising way to deal with depression and anxiety in visually impaired older adults. This approach could lead to standardised strategies for the screening, monitoring, treatment, and referral of visually impaired older adults with depression and anxiety., Funding, Competing Interests, Data Sharing: Funded by ZonMw InZicht, the Dutch Organisation for Health Research and Development-InSight Society. There are no competing interests. Full dataset and statistical code are available from the corresponding author.Study registration www.trialregister.nl NTR3296., (© van der Aa et al 2015.)

Background: In 1992 a cargo aircraft crashed into apartment buildings in Amsterdam. In the troublesome aftermath rumours emerged on potential toxic exposures and health consequences. The aim of this study is to assess the long-term impact of this disaster on the health-related quality of life (HRQoL) of professional assistance workers., Methods: Historic cohort study, using questionnaires to assess occupational disaster exposure, HRQoL (SF36), and background variables, at on average 8.5 years post-disaster. Participating were the exposed professional firefighters (n = 334) and police officers (n = 834) who reported disaster-related task(s), and their non-exposed colleagues who did not report such tasks (n = 194, and n = 634, respectively)., Results: Multivariate logistic regression analysis showed that exposed workers reported a significantly lower physical HRQoL and vitality than non-exposed workers. Exposed police officers also reported a lower mental HRQoL. Among exposed workers, a lower HRQoL was reported significantly more often by workers who had a close one affected by the disaster; by firefighters who rescued people, cleaned-up, or witnessed the immediate disaster scene; and by police officers who supported the injured. Exposed police officers who perceived the disaster as 'not bad' reported a lower HRQoL less often than those to whom it was 'the worst ever'., Conclusions: This study demonstrates that professional disaster assistance workers are at risk for a lower HRQoL, even after years.

Objective: To determine the level of diabetes-related symptom distress and its association with negative mood in subjects participating in a targeted population-screening program, comparing those identified as having type 2 diabetes vs. those who did not., Research Design and Methods: This study was conducted within the framework of a targeted screening project for type 2 diabetes in a general Dutch population (age 50-75 years). The study sample consisted of 246 subjects, pre-selected on the basis of a high-risk profile; 116 of whom were subsequently identified as having type 2 diabetes, and 130 who were non-diabetic subjects. Diabetes-related symptom distress and negative mood was assessed approximately 2 weeks, 6 months, and 12 months after the diagnosis of type 2 diabetes, with the Type 2 Diabetes Symptom Checklist and the Negative well-being sub scale of the Well-being Questionnaire (W-BQ12), respectively., Results: Screening-detected diabetic patients reported significantly greater burden of hyperglycemic (F = 6.0, df = 1, p = 0.015) and of fatigue (F = 5.3, df = 1, p = 0.023) symptoms in the first year following diagnosis type 2 diabetes compared to non-diabetic subjects. These outcomes did not change over time. The total symptom distress (range 0-4) was relatively low for both screening-detected diabetic patients (median at approximately 2 weeks, 6 months, and 12 months; 0.24, 0.24, 0.29) and non-diabetic subjects (0.15, 0.15, 0.18), and not significantly different. No average difference and change over time in negative well-being was found between screening-detected diabetic patients and non-diabetic subjects. Negative well-being was significantly positive related with the total symptom distress score (regression coefficient beta = 2.86, 95% CI 2.15-3.58)., Conclusions: The screening-detected diabetic patients were bothered more by symptoms of hyperglycemia and fatigue in the first year following diagnosis type 2 diabetes than non-diabetic subjects. More symptom distress is associated with increased negative mood in both screening-detected diabetic patients and non-diabetic subjects.

Objectives: To prospectively assess the clinical performance and patient‐reported outcomes of dental implants in dentate patients with primary and secondary Sjögren's syndrome (pSS and sSS, respectively) compared to patients without SS. Materials and Methods: Thirty‐seven implants were placed in 17 patients with pSS/sSS and 26 implants in 17 non‐SS patients to replace missing (pre)molars. Clinical performance, marginal bone‐level changes, patient satisfaction, and oral health‐related quality of life (OHRQoL) were assessed at 1 (T1), 6 (T6), 12 (T12), and 18 (T18) months after placement of the superstructure. Marginal bone‐level changes were measured on standardized dental radiographs. Clinical parameters included implant and crown survival, plaque, bleeding and gingival indices, and probing depth. Patient satisfaction and OHRQoL were assessed with validated questionnaires. Results: Implant survival at T18 was 100% in the patients with pSS/sSS and 96.2% in the non‐SS group. Mean marginal bone loss at T18 did not differ between patients with pSS/sSS and non‐SS patients, 1.10 ± 1.04 and 1.04 ± 0.75 mm, respectively (p =.87). Clinical performance was good with no differences between the groups for all outcome measures (p >.05). OHRQoL in patients with pSS/sSS had improved significantly after placement of implant supported crowns at all measuring moments compared to baseline (p <.05). Nevertheless, patient satisfaction and OHRQoL remained significantly higher for patients without SS at all measuring moments (p <.05). Conclusion: Dental implants can be successfully applied in dentate patients with pSS/sSS and have a positive effect on OHRQoL. [ABSTRACT FROM AUTHOR]

Purpose: Vincristine (VCR) is a chemotherapeutic agent used in the treatment of pediatric oncology patients, but its main toxicity is VCR‐induced peripheral neuropathy (VIPN). However, whether VIPN has an effect on health‐related quality of life (HR‐QoL) in children during treatment is unknown. Therefore, the aim of our study was to investigate the association between VIPN and HR‐QoL in children starting treatment for cancer. Methods: Measurements of VIPN were performed using two tools: Common Terminology Criteria for Adverse Events (CTCAE) and pediatric‐modified Total Neuropathy Score (ped‐mTNS). Assessment of HR‐QoL was done with self‐ and proxy assessment of the Cancer and Generic module of the Pediatric Cancer Quality of Life Inventory™ (PedsQL). Results: In total, N = 86 children were included. HR‐QoL of children with VIPN (n = 67%, 76%) was significantly lower in comparison with children without VIPN: estimated Total score of PedsQL Generic (proxy) 84.57; β = −8.96 and 95% confidence interval (CI) −14.48 to −3.43; p = 0.002, estimated PedsQL Generic Total score (self‐reported): 85.16, β = −8.38 (95% CI: −13.76 to −3.00); p = 0.003. Similar results were found in the Pain and Hurt domain of the PedsQL Cancer (pain: estimated score [proxy]: 85.28, β = −9.94 [95%CI: −16.44 to −3.45], p = 0.003; hurt: estimated score [self‐report] 97.57, β = −19.15 [95%CI: −26.82 to −11.48], p < 0.001). Conclusion: VIPN results in a significant reduction of HR‐QoL in children under treatment for a malignancy, which means that VIPN is important for the well‐being of pediatric oncology patients. Therefore, this study underlines the importance of optimizing treatment with VCR, thereby aiming to reduce VIPN while maintaining efficacy. [ABSTRACT FROM AUTHOR]

Background: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.Methods: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.Discussion: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.Trial Registration: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018. [ABSTRACT FROM AUTHOR]

Patient's quality of life should be included in clinical decision making regarding the administration of adjuvant chemotherapy (ACT) in stage II/III colon cancer. Therefore, quality of life, summarized as health utility (HU), was evaluated for patients treated with and without ACT. Furthermore, the role of chemotherapy–induced peripheral neuropathy (CIPN) on HU was evaluated. Patients diagnosed with stage II/III colon cancer between 2011 and 2019 and participating in the Prospective Dutch ColoRectal Cancer cohort were included (n = 914). HU scores were assessed with the EQ‐5D‐5L at baseline, 3, 6, 12, 18, and 24 months. Patients treated with ACT received mainly capecitabine and oxaliplatin (57%) or capecitabine monotherapy (40%) (average duration: 3.5 months). HU 3 to 18 months after diagnosis (potential ACT period + 12 months follow‐up) was compared between patients treated with and without ACT using a mixed model adjusted for age, sex and education level. Subsequently, the CIPN sensory, motor and autonomy scales, measured using the EORTC QLQ‐CIPN20, were independently included in the model to evaluate the impact of neuropathy. Using a mixed model, a significant difference of −0.039 (95% confidence interval: −0.062; −0.015) in HU was found between patients treated with and without ACT. Including the CIPN sensory, motor and autonomy scales decreased the difference with 0.019, 0.015 and 0.02, respectively. HU 3 to 18 months after diagnosis is significantly lower in patients treated with ACT vs without ACT. This difference is on the boundary of clinical relevance and appears to be partly related to the sensory and motor neuropathy‐related side effects of ACT. What's new? Given its potentially serious side effects, patient quality of life should be included in clinical decision‐making regarding the administration of adjuvant chemotherapy in stage II/III colon cancer. Using a mixed model which was corrected for relevant covariates, here the authors found a statistically‐significant but small decrease in HU of −0.039 during chemotherapy and the following 12 months for patients treated with adjuvant chemotherapy compared to patients without adjuvant chemotherapy. The decrease in HU, which is on the boundary of clinical relevance, appears to be partly related to sensory and motor neuropathy side effects of adjuvant chemotherapy. [ABSTRACT FROM AUTHOR]

Background: Few studies have investigated which patients with obsessive-compulsive disorder (OCD) do not recover through regular cognitive behavior therapy or pharmacotherapy and subsequently end up in intensive treatment like day treatment or inpatient treatment. Knowing the predictors of intensive treatment in these patients is significant because it could prevent intensive treatment. This study has identified predictors of intensive treatment in patients with OCD. Methods: Using 6-year longitudinal data of the Netherlands Obsessive Compulsive Disorder Association (NOCDA), potential predictors of intensive treatment were assessed in patients with OCD (n = 419). Intensive treatment was assessed using the Treatment Inventory Costs in Patients with Psychiatric Disorders (TIC-P). Examined potential predictors were: sociodemographics, and clinical and psychosocial characteristics. Logistic Generalized Estimating Equations was used to estimate to what extent the various characteristics (at baseline, 2- and 4-year assessment) predicted intensive treatment in the following 2 years, averaged over the three assessment periods. Results: Being single, more severe comorbid depression, use of psychotropic medication, and a low quality of life predicted intensive treatment in the following 2 years. Conclusions: Therapists should be aware that patients with OCD who are single, who have more severe comorbid depression, who use psychotropic medication, and who have a low quality of life or a drop in quality of life are at risk for intensive treatment. Intensive treatment might be prevented by focusing regular treatment not only on OCD symptoms but also on comorbid depression and on quality of life. Intensive treatment might be improved by providing extra support in treatment or by adjusting treatment to impairments due to comorbid depressive symptoms or a low quality of life. [ABSTRACT FROM AUTHOR]

Background: Stating preferences about care beforehand using advance care planning and advance directives has become increasingly common in current medicine. There is still lack of clarity what happens over the course of time in relation to these preferences. We wanted to determine whether the preferences about end-of-life care of a person owning an advance directive stay stable after the experience of a life-event; how often advance directives are altered and discussed with family members and physicians over time. Design: A longitudinal cohort study with a population consisting of people owning the most common advance directives in the Netherlands, with a follow-up of 6-years from 2005 until 2011. Respondents were recruited using two associations that provided the advance directives, Right to Die-NL (n = 4463) and the Dutch Patient Organisation (n = 1263). Each 1.5 year a questionnaire was sent. We analyzed the relationship between variables using generalized estimated equations. Results: 96.9–98.1% of the respondents who had experienced a life-event had stable preferences. 89.9–93.7% of Right-to-Die-NL-members who had experienced a life-event didn’t make any alterations in their advance directives. During the 6-year course of our study, a minority of both groups didn’t discuss their advance directive with anyone (8.7–16.4%), while a majority didn’t discuss it with physicians (ranging 58.1–95.1%). Factors related to health, such as deterioration in experienced health, increased the odds to discuss advance directives. Conclusion: Our results largely dispute criticism concerning usability of advance directives due to lack of stability of preferences. Whereas a change in health status and the experience of other life-events were not related to instability in preferences, they did increase the odds of communication about advance directives. Because our results show that the possession of an advance directive does not necessarily result in frequent discussions between patients and caregivers, a more structured approach like advance care planning might be a solution. [ABSTRACT FROM AUTHOR]

Background: International evidence-based guidelines recommend physical exercise to form part of standard care for all cancer survivors. However, at present, the optimum exercise intensity is unclear. Therefore, we aimed to evaluate the effectiveness of a high intensity (HI) and low-to-moderate intensity (LMI) resistance and endurance exercise program compared with a wait list control (WLC) group on physical fitness and fatigue in a mixed group of cancer survivors who completed primary cancer treatment, including chemotherapy.Methods: Overall, 277 cancer survivors were randomized to 12 weeks of HI exercise (n = 91), LMI exercise (n = 95), or WLC (n = 91). Both interventions were identical with respect to exercise type, duration and frequency, and only differed in intensity. Measurements were performed at baseline (4-6 weeks after primary treatment) and post-intervention. The primary outcomes were cardiorespiratory fitness (peakVO2), muscle strength (grip strength and 30-second chair-stand test), and self-reported fatigue (Multidimensional Fatigue Inventory; MFI). Secondary outcomes included health-related quality of life, physical activity, daily functioning, body composition, mood, and sleep disturbances. Multilevel linear regression analyses were performed to estimate intervention effects using an intention-to-treat principle.Results: In the HI and LMI groups, 74 % and 70 % of the participants attended more than 80 % of the prescribed exercise sessions, respectively (P = 0.53). HI (β = 2.2; 95 % CI, 1.2-3.1) and LMI (β = 1.3; 95 % CI, 0.3-2.3) exercise showed significantly larger improvements in peakVO2 compared to WLC. Improvements in peakVO2 were larger for HI than LMI exercise (β = 0.9; 95 % CI, -0.1 to 1.9), but the difference was not statistically significant (P = 0.08). No intervention effects were found for grip strength and the 30-second chair-stand test. HI and LMI exercise significantly reduced general and physical fatigue and reduced activity (MFI subscales) compared to WLC, with no significant differences between both interventions. Finally, compared to WLC, we found benefits in global quality of life and anxiety after HI exercise, improved physical functioning after HI and LMI exercise, and less problems at work after LMI exercise.Conclusions: Shortly after completion of cancer treatment, both HI and LMI exercise were safe and effective. There may be a dose-response relationship between exercise intensity and peakVO2, favoring HI exercise. HI and LMI exercise were equally effective in reducing general and physical fatigue.Trial Registration: This study was registered at the Netherlands Trial Register [ NTR2153 ] on the 5th of January 2010. [ABSTRACT FROM AUTHOR]

Background: Care for older adults is facing a number of challenges: health problems are not consistently identified at a timely stage, older adults report a lack of autonomy in their care process, and care systems are often confronted with the need for better coordination between health care professionals. We aim to address these challenges by introducing the geriatric care model, based on the chronic care model, and to evaluate its effects on the quality of life of community-dwelling frail older adults. Methods/design: In a 2-year stepped-wedge cluster randomised clinical trial with 6-monthly measurements, the chronic care model will be compared with usual care. The trial will be carried out among 35 primary care practices in two regions in the Netherlands. Per region, practices will be randomly allocated to four allocation arms designating the starting point of the intervention. Participants: 1200 community-dwelling older adults aged 65 or over and their primary informal caregivers. Primary care physicians will identify frail individuals based on a composite definition of frailty and a polypharmacy criterion. Final inclusion criterion: scoring 3 or more on a disability case-finding tool. Intervention: Every 6 months patients will receive a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Expert teams will manage and train practice nurses. Patients with complex care needs will be reviewed in interdisciplinary consultations. Evaluation: We will perform an effect evaluation, an economic evaluation, and a process evaluation. Primary outcome is quality of life as measured with the Short Form-12 questionnaire. Effect analyses will be based on the "intention-to-treat" principle, using multilevel regression analysis. Cost measurements will be administered continually during the study period. A cost-effectiveness analysis and cost-utility analysis will be conducted comparing mean total costs to functional status, care needs and QALYs. We will investigate the level of implementation, barriers and facilitators to successful implementation and the extent to which the intervention manages to achieve the transition necessary to overcome challenges in elderly care. Discussion: This is one of the first studies assessing the effectiveness, cost-effectiveness and implementation process of the chronic care model for frail community-dwelling older adults. Trial registration: The Netherlands National Trial Register NTR2160. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity may improve different aspects of wellbeing in older people, such as quality of life, vitality and depression. However, there is little experimental evidence to support this assumption. Therefore, we examined the effect of different training protocols on quality of life, vitality and depression of older adults living in long-term care facilities. Methods: Subjects (n = 173, aged 64 to 94 years, living in long-term care facilities), were randomized to six months of three different moderate-intensity group exercise training protocols, or to an 'educational' control condition. Exercise consisted of two 45--60-minute training sessions per week of 1) resistance training; 2) all-round, functional training; or 3) a combination of both. Perceived health, the Geriatric Depression Scale (GDS), the Vitality Plus Scale (VPS) and the Dementia Quality of Life questionnaire (DQoL) were administered at baseline and after six months. Results: In the combined training group a small but significant decline was seen in perceived health, DQoL and VPS score compared to the control group. Conclusions: We conclude that neither strength training nor all-round, functional training of moderate intensity is effective in improving quality of life, vitality or depression of older people living in long-term care facilities. [ABSTRACT FROM AUTHOR]

Background: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.Methods: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446.Findings: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups.Interpretation: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved.Funding: Pink Ribbon, Nuts-Ohra, and LifeCell. [ABSTRACT FROM AUTHOR]