Self-reported health, function, and use of health care services in older prostate cancer survivors compared to matched controls: a cross-sectional study.

PURPOSE: Information about outcomes of particular relevance to older prostate cancer survivors is limited. This study aimed to compare health, activities of daily living (ADL), and use of health care services between survivors and matched controls. METHODS: A single-centre study on men treated for prostate cancer with curative intent at the age ≥ 70 years 2 to 7 years earlier. Controls matched on age and education were drawn (1:3) from the Trøndelag Health Study (HUNT) in Norway. Self-reported general health, independence in ADL and instrumental activities of daily living (IADL), hospital admissions and emergency room visits were compared by estimating non-adjusted and adjusted (age, education, comorbidity, cohabitant status and pack years of smoking) regression models. RESULTS: The majority of both survivors (N = 233) and controls (N = 699) reported good (58.7% vs. 62.7%) or very good (11.2% vs. 6.8%) health and independence in ADL (95.6% vs. 96.3%) and IADL (82.7% vs. 81.9%). Hospital admission was reported by 17.3% vs. 18.2% and emergency room visit by 23.6% vs. 26.7%. Regression models showed no significant differences between survivors and controls. CONCLUSIONS: Older prostate cancer survivors reported similar health, independence in ADL and use of emergency room and hospital admissions as matched controls. IMPLICATIONS FOR CANCER SURVIVORS: This study shows that survivors after curatively intended treatment of prostate cancer have as good health as matched controls, indicating that many patients tolerate such treatment well despite being of old age and that current practice for selection of patients offered such treatment is appropriate.

Health literacy in patients participating in cardiac rehabilitation: A prospective cohort study with pre-post-test design.

Background and aims: Adherence to recommendations regarding medical treatment and healthy behaviour serve as a significant challenge for patients experiencing a cardiac event. Optimizing the patients' health literacy (HL) may be crucial to meet this challenge and has gained increased focus the last decade. Despite cardiac rehabilitation (CR) being a central part of the treatment of patients experiencing a cardiac event, such programs have not been evaluated regarding HL. Therefore, the aim of this study was to describe and evaluate HL in patients participating in CR. Methods: A prospective cohort study with pre-post-test design of patients participating in CR. Data were collected at program admission and completion (August 2017-June 2018). Patients from three different CR-programs were included. Descriptive and inferential statistics were applied to describe and evaluate HL and change in HL across categories of demographical variables and type of rehabilitation. Results: In total, 113 patients attending CR were included. A statistically significant increase in HL was observed from pre-to post-CR (mean change: 2.24 ± 3.68 (p < 0.001)). Patients attending 12-weeks outpatients CR-program had statistically significant higher HL, both at pre- and post-CR, compared to those attending one-week residential CR. Conclusions: Participation in CR statistically significantly improves HL. Overall, judging health information was found as the most difficult aspect of HL, both at pre- and post-CR. This should be emphasized in secondary prevention to overcome barriers related to adherence to medical treatment and healthy behaviour.

Validity of dietary intake methods in cancer cachexia.

PURPOSE OF REVIEW: Accurate assessment of dietary intake, especially energy and protein intake, is crucial for optimizing nutritional care and outcomes in patients with cancer. Validation of dietary assessment methods is necessary to ensure accuracy, but the validity of these methods in patients with cancer, and especially in those with cancer cachexia, is uncertain. Validating nutritional intake is complex because of the variety of dietary methods, lack of a gold standard method, and diverse validation measures. Here, we review the literature on validations of dietary intake methods in patients with cancer, including those with cachexia, and highlight the gap between current validation efforts and the need for accurate dietary assessment methods in this population. RECENT FINDINGS: We analyzed eight studies involving 1479 patients with cancer to evaluate the accuracy and reliability of 24-hour recalls, food records, and food frequency questionnaires in estimating energy and protein intake. We discuss validation methods, including comparison with biomarkers, indirect calorimetry, and relative validation of dietary intake methods. SUMMARY: Few have validated dietary intake methods against objective markers in patients with cancer. While food records and 24-hour recalls show potential accuracy for energy and protein intake, this may be compromised in hypermetabolic patients. Additionally, under- and overreporting of intake may be less frequent, and the reliability of urinary nitrogen as a protein intake marker in patients with cachexia needs further investigation. Accurate dietary assessment is important for enhancing nutritional care outcomes in cachexia trials, requiring validation at multiple time points throughout the cancer trajectory.

Nutrition impact symptom monitoring and weight loss outcomes: a longitudinal radiotherapy study.

OBJECTIVES: Nutrition impact symptoms (NIS) are associated with weight loss (WL), and decreased energy intake in cross-sectional studies. We aimed to ascertain associations between changes in NIS burden, energy intake and WL over time in patients with advanced cancer. METHODS: Adult patients from an observational radiotherapy study for painful bone metastases self-reported NIS and WL using the Patient-Generated Subjective Global Assessment tool (PG-SGA) at baseline and week eight (W8). NIS burden, the sum of NIS per patient, categorised as 0, 1-2 and ≥3 with changes defined as 2-point differences from baseline to W8 were used. Energy intake was assessed by 24-hour recall interviews. RESULTS: 111 patients (72.1%) were analysed and grouped by NIS burden; 0 NIS (44.1%), 1-2 NIS (30.6%) and ≥3 NIS (25.2%). Patients with NIS burden of ≥3 reported higher baseline WL compared with those with 1-2 or 0 NIS (46.4% vs 18.2% vs 10.2%, respectively, p=0.002). At W8, 21 patients (19%) reported improved NIS burden, accompanied by a lower proportion of severe (≥5%) new-onset WL (19% vs 42.1%) and higher energy intake (median 29.6 vs 21.2 kcal/kg) than those with worsened NIS burden (17.1%). CONCLUSIONS: NIS management may improve energy intake and prevent WL, emphasising the importance of systematic follow-up and interventions. CLINICALTRIALSGOV REGISTRATION: NCT02107664.

Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study.

BACKGROUND: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting. METHODS: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137. RESULTS: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period. CONCLUSIONS: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.

The incidence and mortality of refeeding syndrome in older hospitalized patients, based on three different diagnostic criteria: A longitudinal study.

BACKGROUND & AIMS: Refeeding syndrome (RFS) lacks both a global definition and diagnostic criteria. Different diagnostic criteria are used; serum phosphate (traditional criterion (TC)), the Friedli consensus recommendations, and the ASPEN. We investigated the incidence of RFS in older hospitalized patients and the mortality rates in patients with or without RFS using these three different diagnostic criteria. METHODS: This is a longitudinal study with data originating from a randomized controlled trial conducted between March 2017 and August 2019. A total of 85 malnourished hospitalized patients at risk of RFS according to the National Institute for Health and Clinical Excellence tool for detecting patients at risk of RFS, were included. All patients were provided with enteral tube feeding, and electrolytes were measured daily during the intervention period. Friedli and ASPEN included phosphate, magnesium, and potassium in their definitions, but used different cut-off values. Incidences were recorded, and Kaplan-Meier estimates were used to determine whether mortality was more prevalent in patients with RFS. Regression analysis was used to test for confounders regarding the association between RFS and death, and Kappa was used to test for agreement between the three diagnostic criteria. RESULTS: The mean (SD) age of the patients was 79.8 (7.4) years, and the mean (SD) BMI was 18.5 (3.4) kg/m2. The mean (SD) kcal/kg/day was 19 (11) on day one and 26 (15) on day seven. The incidences of RFS differed with the criteria used; 12.9% (TC), 31.8% (Friedli), and 65.9% (ASPEN). Mortality was high, with 36.5% (n = 31) and 56.5% (n = 48) of patients dead at three-month and one-year follow-up, respectively. In the TC, 8/11 (72.7%) with RFS vs. 40/74 (54.1%) without RFS died within one-year, in Friedli 15/27 (55.5%) with RFS vs. 33/58 (56.9%) without RFS died, and in ASPEN 32/56 (65.9%) with RFS, vs. 16/29 (55.2%) without RFS died within one-year. There was no statistically significant difference in mortality between patients with or without RFS regardless of which criteria were used. Age was the only variable associated with death at one-year. The Kappa analysis showed very low agreement between the categories. CONCLUSION: Our results show that using different diagnostic criteria significantly impacts incidence rates. However, regardless of criteria used, the mortality was not significantly higher in the group of patients with RFS compared to the patients without RFS. Furthermore, none of the criteria showed a significant association with death at one-year. This supports the need for a global unified diagnostic criterion for RFS. This study was registered in ClinicalTrials.gov (identifier NCT03141489).

Biomarker endpoints in cancer cachexia clinical trials: Systematic Review 5 of the cachexia endpoint series.

Regulatory agencies require evidence that endpoints correlate with clinical benefit before they can be used to approve drugs. Biomarkers are often considered surrogate endpoints. In cancer cachexia trials, the measurement of biomarkers features frequently. The aim of this systematic review was to assess the frequency and diversity of biomarker endpoints in cancer cachexia trials. A comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2023) was completed. Eligible trials met the following criteria: adults (≥18 years), prospective design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a biomarker(s) as an endpoint. Biomarkers were defined as any objective measure that was assayed from a body fluid, including scoring systems based on these assays. Routine haematology and biochemistry to monitor intervention toxicity were not considered. Data extraction was performed using Covidence, and reporting followed PRISMA guidance (PROSPERO: CRD42022276710). A total of 5975 studies were assessed, of which 52 trials (total participants = 6522) included biomarkers as endpoints. Most studies (n = 29, 55.7%) included a variety of cancer types. Pharmacological interventions (n = 27, 51.9%) were most evaluated, followed by nutritional interventions (n = 20, 38.4%). Ninety-nine different biomarkers were used across the trials, and of these, 96 were assayed from blood. Albumin (n = 29, 55.8%) was assessed most often, followed by C-reactive protein (n = 22, 42.3%), interleukin-6 (n = 16, 30.8%) and tumour necrosis factor-α (n = 14, 26.9%), the latter being the only biomarker that was used to guide sample size calculations. Biomarkers were explicitly listed as a primary outcome in six trials. In total, 12 biomarkers (12.1% of 99) were used in six trials or more. Insulin-like growth factor binding protein 3 (IGFBP-3) and insulin-like growth factor 1 (IGF-1) levels both increased significantly in all three trials in which they were both used. This corresponded with a primary outcome, lean body mass, and was related to the pharmacological mechanism. Biomarkers were predominately used as exploratory rather than primary endpoints. The most commonly used biomarker, albumin, was limited by its lack of responsiveness to nutritional intervention. For a biomarker to be responsive to change, it must be related to the mechanism of action of the intervention and/or the underlying cachexia process that is modified by the intervention, as seen with IGFBP-3, IGF-1 and anamorelin. To reach regulatory approval as an endpoint, the relationship between the biomarker and clinical benefit must be clarified.

Body weight and composition endpoints in cancer cachexia clinical trials: Systematic Review 4 of the cachexia endpoints series.

Significant variation exists in the outcomes used in cancer cachexia trials, including measures of body composition, which are often selected as primary or secondary endpoints. To date, there has been no review of the most commonly selected measures or their potential sensitivity to detect changes resulting from the interventions being examined. The aim of this systematic review is to assess the frequency and diversity of body composition measures that have been used in cancer cachexia trials. MEDLINE, Embase and Cochrane Library databases were systematically searched between January 1990 and June 2021. Eligible trials examined adults (≥18 years) who had received an intervention aiming to treat or attenuate the effects of cancer cachexia for >14 days. Trials were also of a prospective controlled design and included body weight or at least one anthropometric, bioelectrical or radiological endpoint pertaining to body composition, irrespective of the modality of intervention (e.g., pharmacological, nutritional, physical exercise and behavioural) or comparator. Trials with a sample size of <40 patients were excluded. Data extraction used Covidence software, and reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance. This review was prospectively registered (PROSPERO: CRD42022276710). A total of 84 clinical trials, comprising 13 016 patients, were eligible for inclusion. Non-small-cell lung cancer and pancreatic cancer were studied most frequently. The majority of trial interventions were pharmacological (52%) or nutritional (34%) in nature. The most frequently reported endpoints were assessments of body weight (68 trials, n = 11 561) followed by bioimpedance analysis (BIA)-based estimates (23 trials, n = 3140). Sixteen trials (n = 3052) included dual-energy X-ray absorptiometry (DEXA)-based endpoints, and computed tomography (CT) body composition was included in eight trials (n = 841). Discrepancies were evident when comparing the efficacy of interventions using BIA-based estimates of lean tissue mass against radiological assessment modalities. Body weight, BIA and DEXA-based endpoints have been most frequently used in cancer cachexia trials. Although the optimal endpoints cannot be determined from this review, body weight, alongside measurements from radiological body composition analysis, would seem appropriate. The choice of radiological modality is likely to be dependent on the trial setting, population and intervention in question. CT and magnetic resonance imaging, which have the ability to accurately discriminate tissue types, are likely to be more sensitive and provide greater detail. Endpoints are of particular importance when aligned with the intervention's mechanism of action and/or intended patient benefit.

Quality of life endpoints in cancer cachexia clinical trials: Systematic review 3 of the cachexia endpoints series.

The use of patient-reported outcomes (PROMs) of quality of life (QOL) is common in cachexia trials. Patients' self-report on health, functioning, wellbeing, and perceptions of care, represent important measures of efficacy. This review describes the frequency, variety, and reporting of QOL endpoints used in cancer cachexia clinical trials. Electronic literature searches were performed in Medline, Embase, and Cochrane (1990-2023). Seven thousand four hundred thirty-five papers were retained for evaluation. Eligibility criteria included QOL as a study endpoint using validated measures, controlled design, adults (>18 years), ≥40 participants randomized, and intervention exceeding 2 weeks. The Covidence software was used for review procedures and data extractions. Four independent authors screened all records for consensus. Papers were screened by titles and abstracts, prior to full-text reading. PRISMA guidance for systematic reviews was followed. The protocol was prospectively registered via PROSPERO (CRD42022276710). Fifty papers focused on QOL. Twenty-four (48%) were double-blind randomized controlled trials. Sample sizes varied considerably (n = 42 to 469). Thirty-nine trials (78%) included multiple cancer types. Twenty-seven trials (54%) featured multimodal interventions with various drugs and dietary supplements, 11 (22%) used nutritional interventions alone and 12 (24%) used a single pharmacological intervention only. The median duration of the interventions was 12 weeks (4-96). The most frequent QOL measure was the EORTC QLQ-C30 (60%), followed by different FACIT questionnaires (34%). QOL was a primary, secondary, or exploratory endpoint in 15, 31 and 4 trials respectively, being the single primary in six. Statistically significant results on one or more QOL items favouring the intervention group were found in 18 trials. Eleven of these used a complete multidimensional measure. Adjustments for multiple testing when using multicomponent QOL measures were not reported. Nine trials (18%) defined a statistically or clinically significant difference for QOL, five with QOL as a primary outcome, and four with QOL as a secondary outcome. Correlation statistics with other study outcomes were rarely performed. PROMs including QOL are important endpoints in cachexia trials. We recommend using well-validated QOL measures, including cachexia-specific items such as weight history, appetite loss, and nutritional intake. Appropriate statistical methods with definitions of clinical significance, adjustment for multiple testing and few co-primary endpoints are encouraged, as is an understanding of how interventions may relate to changes in QOL endpoints. A strategic and scientific-based approach to PROM research in cachexia trials is warranted, to improve the research base in this field and avoid the use of QOL as supplementary measures.

The association between age and long-term quality of life after curative treatment for prostate cancer: a cross-sectional study.

OBJECTIVE: We aimed to investigate the associations between age at radical prostate cancer treatment and long-term global quality of life (QoL), physical function (PF), and treatment-related side effects. MATERIAL AND METHODS: This single-center, cross-sectional study included men treated for localized prostate cancer with robotic-assisted radical prostatectomy (RARP) or external beam radiotherapy (EBRT) in 2014-2018. Global QoL and PF were assessed by the European Organisation of Research and Treatment in Cancer Quality of life Questionnaire-C30 (QLQ-C30), side effects by the Expanded Prostate Cancer Index Composite (EPIC-26). Adjusted linear regression models were estimated to assess associations between age (continuous variable) at treatment and outcomes. QLQ-C30 scores were compared to normative data after dividing the cohort in two groups, <70 years and ≥70 years at treatment. RESULTS: Of 654 men included, 516 (79%) had undergone RARP, and 138 (21%) had undergone EBRT combined with androgen deprivation therapy for 93%. Mean time since treatment was 57 months. Median age at treatment was 68 (min-max 44-84) years. We found no statistically significant independent association between age at treatment and global QoL, PF or side effects, except for sexual function (regression coefficient [RC] -0.77; p < 0.001) and hormonal/vitality (RC 0.30; p = 0.006) function. Mean QLQ-C30 scores were slightly poorer than age-adjusted normative scores, for men <70 years (n = 411) as well as for men ≥70 years (n = 243) at treatment, but the differences were not beyond clinical significance. CONCLUSIONS: In this cohort of prostate cancer survivors, age at treatment had little impact on long-term QoL and function. Due to the cross-sectional design, short term impact or variation over time cannot be ruled out.

Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.

There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40-628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge's g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.

Older adults' perceptions and experiences of interprofessional communication as part of the delivery of integrated care in the primary healthcare sector: a meta-ethnography of qualitative studies.

BACKGROUND: Communication between patients and healthcare providers, and effective interprofessional communication, are essential to the provision of high-quality care. Implementing a patient-centred approach may lead to patients experiencing a sense of comfort, validation, and active participation in own healthcare. However, home-dwelling older adults' perspectives on interprofessional communication (IPC) are lacking. The aim is therefore to explore how home-dwelling older adults experience communication in connection with the delivery of integrated care. METHODS: The meta-synthesis was conducted in line with Noblit and Hare's seven phases of meta-ethnography. A systematic literature search was conducted by two university librarians in seven databases using the search terms 'older adults', 'communication', 'integrated care' and 'primary care'. All articles were reviewed by two authors independently. 11 studies were included for analysis. RESULTS: Older adults are aware of IPC and have preferences regarding how it is conducted. Three main themes were identified in the reciprocal analysis: (1) Inconsistent care perceived as lack of IPC, (2) individual preferences regarding involvement and awareness of IPC and (3) lack of IPC may trigger negative feelings. CONCLUSIONS: This meta-ethnography shows the perspective of older adults on IPC as part of integrated care. Our study shows that older adults are concerned about whether healthcare personnel talk to each other or not and recognise IPC as fundamental in providing consistent care. The perspectives of older adults are relevant for clinicians and politicians, as well as researchers, when developing and implementing future integrated care services for home-dwelling older adults.

Food for Soul-Older Immigrants' Food Habits and Meal Preferences After Immigration: A Systematic Literature Review.

There are few primary studies that focused on the older immigrants' food habits and meal preferences after immigration and settlement in a new country. A comprehensive database search for literature was conducted in May 2021 and upgraded in September 2021. Ten databases (Medline (Ovid), EMBASE (Ovid), PsycInfo (Ovid), Cinahl (EBSCOhost), Food Science Source (EBSCOhost), SocIndex (EBSCOhost), Social Care Online, Applied Social Sciences Index & Abstracts (ASSIA), Web of Science and Google Scholar), were scanned for original, peer-reviewed papers published in English. The review was conducted and reported in accordance with the PRISMA 2020 guidelines and SWiM items. Out of 3069 records, 10 papers were included for thematic synthesis. A data synthesis across all studies resulted in three main findings: (i) the significance of food in maintaining cultural identity, (ii) the continuity of traditional food culture and (iii) adapting to the host country's food culture. Although different forms of dietary acculturation occur throughout life, older immigrants often want to maintain their traditional food habits and meal preferences. For them, traditional eating habits offer comfort and security by serving as a means of identifying who they are and reminding them where they have come from. Public health and social services play an important role in providing cultural nutritional care to older immigrants; therefore, this issue should be carefully addressed by professionals and future research.Registration: The review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on 27 September 2022 with registration number CRD42022358235.

Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series.

In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.

The effect of nutritional interventions in acute radiation-induced diarrhoea in patients with primary pelvic cancer: A systematic review.

Acute radiation-induced diarrhoea (RID) is a well-known side effect of external radiation therapy for pelvic cancer. Acute RID is an unresolved clinical problem in approximately 80% of patients. We investigated the effect of nutritional interventions on acute RID in patients with pelvic cancer treated with curative radiotherapy. A search was conducted using PubMed, Embase.com, CINAHL, and Cochrane Library, from 1 January 2005 until 10 October 2022. We included randomised controlled trials or prospective observational studies. Eleven of the 21 identified studies had low quality of evidence, mainly because of low patient numbers distributed among several cancer diagnoses, and non-systematic assessment of acute RID. Interventions included probiotics (n = 6), prebiotics (n = 6), glutamine (n = 4), and others (n = 5). Five studies, of which two provided high quality evidence, showed that probiotics improved acute RID. Future well-designed studies investigating the effects of probiotics on acute RID are warranted. PROSPERO ID: CRD42020209499).

Mobile health technology, exercise adherence and optimal nutrition post rehabilitation among people with Parkinson's Disease (mHEXANUT) - a randomized controlled trial protocol.

BACKGROUND: Although it is well known that regular physical activity and exercise, as well as maintaining adequate nutritional status is important to delaying symptom development and maintaining physical capacity and function in people with Parkinson's Disease (PD), many are unable to follow self-management recommendations. Active interventions have shown short-term effects, but there is a need for interventions that facilitate self-management over the course of the disease. Until now, no studies have combined exercise and nutritional interventions with an individual self-management approach in PD. Thus, we aim to examine the effect of a six-month mobile health technology(m-health)-based follow-up programme, focusing on self-management in exercise and nutrition, after an in-service interdisciplinary rehabilitation programme. METHODS: A single-blinded, two-group randomised controlled trial. Participants are Adults aged 40 or older, with idiopathic PD, Hoehn and Yahr 1-3, living at home. The intervention group receives a monthly, individualized, digital conversation with a PT, combined with use of an activity tracker. People at nutritional risk get additional digital-follow-up from a nutritional specialist. The control group receives usual care. The primary outcome is physical capacity, measured by 6-min walk test (6MWT). Secondary outcomes are nutritional status, Health related quality of life (HRQOL), physical function and exercise adherence. All measurements are performed at baseline, after 3 months and after 6 months. Sample size, based on primary outcome, is set at 100 participants randomized into the two arms, including an estimated 20% drop out. DISCUSSION: The increasing prevalence of PD globally makes it even more important to develop evidence-based interventions that can increase motivation to stay active, promote adequate nutritional status and improve self-management in people with PD. The individually tailored digital follow-up programme, based on evidence-based practice, has the potential to promote evidence-based decision-making and to empower people with PD to implement exercise and optimal nutrition in their daily lives and, hopefully, increase adherence to exercise and nutritional recommendations. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04945876). First registration 01.03.2021.

Nutrition impact symptoms and the risk of malnutrition in people with Parkinson's disease: A cross-sectional study.

BACKGROUND: People with Parkinson's disease (PD) often experience symptoms that affect their ability to eat. This may contribute to weight loss and increased risk of malnutrition. The present study aimed to quantify the extent of nutrition impact symptoms (NIS) in the population and a scoring system of NIS was incorporated in the tool used to identify malnutrition. METHODS: In this cross-sectional study, members of the Norwegian Parkinson's Association, with any PD diagnosis and stage of illness, were invited to respond to an online 24-item questionnaire. Questions from two validated questionnaires, comprising the abridged Patient-Generated Subjective Global Assessment (aPG-SGA) and the Radboud Oral Motor Inventory for Parkinson's disease (ROMP), were adapted to an online format. RESULTS: The questionnaire was sent to 3047 members, of which 508 persons (17%) responded (61% men). In total, 59% were categorised as well-nourished, 34% at risk of malnutrition and 6.5% as malnourished. One quarter of all participants reported symptoms that affected food intake. The most frequent symptoms were constipation (14.2%) and dry mouth (13.4%). Malnourished participants reported a mean ± SD of 3.4 ± 1.4 symptoms versus 0.1 ± 0.3 per well-nourished participant. Malnourished participants had more swallowing problems than well-nourished participants, with a mean ± SD total ROMP score of 15.5 ± 6.0 versus 9.0 ± 2.9 (p < 0.001). As the number of points in the ROMP score increased by one, the points in the aPG-SGA score increased with 37% (95% confidence interval = 0.309-0.428). CONCLUSIONS: Risk of malnutrition was largely related to NIS, especially dysphagia in people with PD. Symptoms affecting food intake should be systematically mapped and treated in conjunction with PD to prevent malnutrition.

Geriatric impairments are associated with reduced quality of life and physical function in older patients with cancer receiving radiotherapy - A prospective observational study.

INTRODUCTION: Quality of life (QoL) and function are important outcomes for older adults with cancer. We aimed to assess differences in trends in patient-reported outcomes (PROs) during radiotherapy (RT) between (1) groups with curative or palliative treatment intent and (2) groups defined according to the number of geriatric impairments. MATERIALS AND METHODS: A prospective observational study including patients aged ≥65 years receiving curative or palliative RT was conducted. Geriatric assessment (GA) was performed before RT, and cut-offs for impairments within each domain were defined. Patients were grouped according to the number of geriatric impairments: 0, 1, 2, 3, and ≥ 4. Our primary outcomes, global QoL and physical function (PF), were assessed by The European Organisation for Research and Treatment of Cancer Quality-of-Life Core Questionnaire (EORTC) (QLQ-C30) at baseline, RT completion, and two, eight, and sixteen weeks later. Differences in trends in outcomes between the groups were assessed by linear mixed models. RESULTS: 301 patients were enrolled, mean age was 73.6 years, 53.8% received curative RT. Patients receiving palliative RT reported significantly worse global QoL and PF compared to the curative group. The prevalence of 0, 1, 2, 3 and ≥ 4 geriatric impairments was 16.6%, 22.7%, 16.9%, 16.3% and 27.5%, respectively. Global QoL and PF gradually decreased with an increasing number of impairments. These group differences remained stable from baseline throughout follow-up without any clinically significant changes for any of the outcomes. DISCUSSION: Increasing number of geriatric impairments had a profound negative impact on global QoL and PF, but no further decline was observed for any group or outcome, indicating that RT was mainly well tolerated. Thus, geriatric impairments per se should not be reasons for withholding RT. GA is key to identifying vulnerable patients in need of supportive measures, which may have the potential to improve treatment tolerance. Registered at clinicaltrials.gov (NCT03071640).

The Norwegian Directorate of Health recommends malnutrition screening tool (MST) for all adults.

BACKGROUND & AIMS: Malnutrition is underdiagnosed and undertreated in Norway. In a revision of a national guideline on malnutrition, the Norwegian Directorate of Health aimed for a harmonization and standardization of the malnutrition screening practice, including a recommendation of one malnutrition screening tool to be used among all adults in Norwegian health and care services. METHODS: A working group was appointed by the Norwegian Directorate of Health. Evidence-based practice, a pragmatic decision-making process based on a literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE), and the DECIDE decision-making model was used as a guidance in order to convert evidence into recommendations. RESULTS: The criteria and properties of the four most frequently validated malnutrition screening tools were identified and ranked by the working group. The tools were prioritized in the following order: 1: Malnutrition Screening Tool (MST), 2: Malnutrition Universal Screening Tool (MUST), 3: Nutritional Risk Screening 2002 (NRS-2002), and 4: Mini-Nutritional Assessment short form (MNA). CONCLUSIONS: The Norwegian Directorate of Health recommends use of MST for screening for malnutrition among all adults (≥18 years), across all health care settings, and diagnoses or conditions in Norway.

Harmonization and standardization of malnutrition screening for all adults - A systematic review initiated by the Norwegian Directorate of Health.

BACKGROUND & AIMS: The Norwegian Directorate of Health has identified a need to harmonize and standardize the malnutrition screening practice in Norwegian hospitals and primary health care settings, in order to provide a seamless communication of malnutrition screening along the patient pathway. Our aim was to perform a systematic review of the validity and reliability of screening tools used to identify risk of malnutrition across health care settings, diagnoses or conditions and adult age groups, as a first step towards a national recommendation of one screening tool. METHODS: A systematic literature search for articles evaluating validity, agreement, and reliability of malnutrition screening tools, published up to August 2020, was conducted in: MEDLINE, Embase, APA PsycInfo, Cinahl, Cochrane Databases, Web of Science, Epistemonikos, SveMed+, and Norart. The systematic review was registered in PROSPERO (CRD42022300558). For critical appraisal of each included article, the Quality Criteria Checklist by The Academy of Nutrition and Dietetics was used. RESULTS: The review identified 105 articles that fulfilled the inclusion and exclusion criteria. The most frequently validated tools were Mini Nutritional Assessment short form (MNA), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool (MST), and Nutritional Risk Screening 2002 (NRS-2002). MNA, MST and NRS-2002 displayed overall moderate validity, and MUST low validity. All four tools displayed low agreement. MST and MUST were validated across health care settings and age groups. In general, data on reliability was limited. CONCLUSIONS: The screening tools MST and NRS-2002 displayed moderate validity for the identification of malnutrition in adults, of which MST is validated across health care settings. In addition, MNA has moderate validity for the identification of malnutrition in adults 65 years or older.