Integrative development of a short screening questionnaire of highly processed food consumption (sQ-HPF).

BACKGROUND: Recent lifestyle changes include increased consumption of highly processed foods (HPF), which has been associated with an increased risk of non-communicable diseases (NCDs). However, nutritional information relies on the estimation of HPF consumption from food-frequency questionnaires (FFQ) that are not explicitly developed for this purpose. We aimed to develop a short screening questionnaire of HPF consumption (sQ-HPF) that integrates criteria from the existing food classification systems. METHODS: Data from 4400 participants (48.1% female and 51.9% male, 64.9 ± 4.9 years) of the Spanish PREDIMED-Plus ("PREvention with MEDiterranean DIet") trial were used for this analysis. Items from the FFQ were classified according to four main food processing-based classification systems (NOVA, IARC, IFIC and UNC). Participants were classified into tertiles of HPF consumption according to each system. Using binomial logistic regression, food groups associated with agreement in the highest tertile for at least two classification systems were chosen as items for the questionnaire. ROC analysis was used to determine cut-off points for the frequency of consumption of each item, from which a score was calculated. Internal consistency of the questionnaire was assessed through exploratory factor analysis (EFA) and Cronbach's analysis, and agreement with the four classifications was assessed with weighted kappa coefficients. RESULTS: Regression analysis identified 14 food groups (items) associated with high HPF consumption for at least two classification systems. EFA showed that items were representative contributors of a single underlying factor, the "HPF dietary pattern" (factor loadings around 0.2). We constructed a questionnaire asking about the frequency of consumption of those items. The threshold frequency of consumption was selected using ROC analysis. Comparison of the four classification systems and the sQ-HPF showed a fair to high agreement. Significant changes in lifestyle characteristics were detected across tertiles of the sQ-HPF score. Longitudinal changes in HPF consumption were also detected by the sQ-HPF, concordantly with existing classification systems. CONCLUSIONS: We developed a practical tool to measure HPF consumption, the sQ-HPF. This may be a valuable instrument to study its relationship with NCDs. TRIAL REGISTRATION: Retrospectively registered at the International Standard Randomized Controlled Trial Registry ( ISRCTN89898870 ) on July 24, 2014.

Pro-vegetarian food patterns and cardiometabolic risk in the PREDIMED-Plus study: a cross-sectional baseline analysis.

PURPOSE: We explored the cross-sectional association between the adherence to three different provegetarian (PVG) food patterns defined as general (gPVG), healthful (hPVG) and unhealthful (uPVG), and the cardiometabolic risk in adults with metabolic syndrome (MetS) of the PREDIMED-Plus randomized intervention study. METHODS: We performed a cross-sectional analysis of baseline data from 6439 participants of the PREDIMED-Plus randomized intervention study. The gPVG food pattern was built by positively scoring plant foods (vegetables/fruits/legumes/grains/potatoes/nuts/olive oil) and negatively scoring, animal foods (meat and meat products/animal fats/eggs/fish and seafood/dairy products). The hPVG and uPVG were generated from the gPVG by adding four new food groups (tea and coffee/fruit juices/sugar-sweetened beverages/sweets and desserts), splitting grains and potatoes and scoring them differently. Multivariable-adjusted robust linear regression using MM-type estimator was used to assess the association between PVG food patterns and the standardized Metabolic Syndrome score (MetS z-score), a composed index that has been previously used to ascertain the cardiometabolic risk, adjusting for potential confounders. RESULTS: A higher adherence to the gPVG and hPVG was associated with lower cardiometabolic risk in multivariable models. The regression coefficients for 5th vs. 1st quintile were - 0.16 (95% CI: - 0.33 to 0.01) for gPVG (p trend: 0.015), and - 0.23 (95% CI: - 0.41 to - 0.05) for hPVG (p trend: 0.016). In contrast, a higher adherence to the uPVG was associated with higher cardiometabolic risk, 0.21 (95% CI: 0.04 to 0.38) (p trend: 0.019). CONCLUSION: Higher adherence to gPVG and hPVG food patterns was generally associated with lower cardiovascular risk, whereas higher adherence to uPVG was associated to higher cardiovascular risk.

The influence of symptom severity of palliative care patients on their family caregivers.

BACKGROUND: This study anlyzed whether family caregivers of patients with advanced cancer suffer impaired sleep quality, increased strain, reduced quality of life or increased care burden due to the presence and heightened intensity of symptoms in the person being cared for. METHOD: A total of 41 patient-caregiver dyads (41 caregivers and 41 patients with advanced cancer) were recruited at six primary care centres in this cross-sectional study. Data were obtained over a seven-month period. Caregiver's quality of sleep (Pittsburgh Sleep Quality Index), caregiver's quality of life (Quality of Life Family Version), caregiver strain (Caregiver Strain Index), patients' symptoms and their intensity (Edmonton Symptom Assessment System), and sociodemographic, clinical and care-related data variables were assessed. The associations were determined using non-parametric Spearman correlation. RESULTS: Total Edmonton Symptom Assessment System was significantly related to overall score of the Pittsburgh Sleep Quality Index (r = 0.365, p = 0.028), the Caregiver Strain Index (r = 0.45, p = 0.005) and total Quality of Life Family Version (r = 0.432, p = 0.009), but not to the duration of daily care (r = -0.152, p = 0.377). CONCLUSIONS: Family caregivers for patients with advanced cancer suffer negative consequences from the presence and intensity of these patients' symptoms. Therefore, optimising the control of symptoms would benefit not only the patients but also their caregivers. Thus, interventions should be designed to improve the outcomes of patient-caregiver dyads in such cases.

Neighbourhood walkability and physical activity: moderating role of a physical activity intervention in overweight and obese older adults with metabolic syndrome.

BACKGROUND: While urban built environments might promote active ageing, an infrequently studied question is how the neighbourhood walkability modulates physical activity changes during a physical activity intervention programme in older adults. We assessed the influence of objectively assessed neighbourhood walkability on the change in physical activity during the intervention programme used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial. METHOD: The present study involved 228 PREDIMED-Plus senior participants aged between 55 and 75, recruited in Palma de Mallorca (Spain). Overweight/obese older adults with metabolic syndrome were randomised to an intensive weight-loss lifestyle intervention or a control group. A walkability index (residential density, land use mix, intersections density) was calculated using geographic information systems (1 km sausage-network buffer). Physical activity was assessed using accelerometer and a validated questionnaire, at baseline and two follow-up visits (6-months and 1-year later). Generalised additive mixed models were fitted to estimate the association between the neighbourhood walkability index and changes in physical activity during follow-up. RESULTS: Higher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (ß = 3.44; 95% CI = 0.52; 6.36 min/day). When analyses were stratified by intervention arm, the association was only observed in the intervention group (ß = 6.357; 95% CI = 2.07;10.64 min/day) (P for interaction = 0.055). CONCLUSIONS: The results indicate that the walkability of the neighbourhood could support a physical activity intervention, helping to maintain or increase older adults' physical activity.

Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.

BACKGROUND: Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment. METHOD: A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation. DISCUSSION: This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system. TRIAL REGISTRATION: The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.

Intervention to improve quality of sleep of palliative patient carers in the community: protocol for a multicentre randomised controlled trial.

BACKGROUND: Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will assess the influence of specific variables that could modify these effects, analyse the correlates related to nocturnal wakefulness and consider the diurnal consequences according to the sleep characteristics identified. METHODS: This single-blind, multicentre, randomised clinical trial will focus on informal providers of care for cancer patients. Two samples of 40 caregivers will be recruited. The first, intervention, group will receive seven music-based sessions. The control group will be masked with seven sessions of therapeutic education (reinforcing previous sessions). Outcomes will be evaluated using the Pittsburgh Sleep Quality Index, a triaxial accelerometer, EuroQol-5D-5L, the Caregiver Strain Index, the Epworth Sleepiness Scale and the Client Satisfaction Questionnaire. The caregivers' satisfaction with the intervention performed will also be examined. DISCUSSION: This study is expected to extend our understanding of the efficacy of music therapy in enhancing the sleep quality of caregivers for patients receiving home palliative care. To our knowledge, no reliable scientific investigations of this subject have previously been undertaken. Music is believed to benefit certain aspects of sleep, but this has yet to be proven and, according to a Cochrane review, high-quality research in this field is necessary. One of the main strengths of our study, which heightens the quality of the randomised clinical trial design, is the objective assessment of physical activity by accelerometry and the use of both objective and subjective measures of sleep in caregivers. Music therapy for the caregivers addressed in this study is complementary, readily applicable, provokes no harmful side effects and may produce significant benefits. TRIAL REGISTRATION: The IMECA study is registered at Clinical Trials.gov, ClinicalTrials.gov Identifier: NCT04491110 . Registered 29 July, 2020.

Validation of a modified version of the Spanish Geriatric Oral Health Assessment Index (GOHAI-SP) for adults and elder people.

BACKGROUND: The Geriatric Oral Health Assessment Index (GOHAI) was developed and validated in 1990 and translated into Spanish in 1999. Since then, the original version has been used in numerous studies, but it has not been re-evaluated in terms of language in the new generations of older adults. The purpose of this study is to confirm the validity of the Spanish version of the Geriatric Oral Health Assessment Index (GOHAI-SP) after three decades to be used as part of an ongoing field trial. METHODS: The GOHAI-SP was pilot tested in a focus group to confirm linguistic comprehension. A version with minor language changes was administered to individuals with metabolic syndrome aged 55-75 years from one health care district in southern Spain as part of an ongoing field trial (PREDIMED-Plus). Clinical evaluation included assessment of dental and periodontal status. The psychometric properties of the GOHAI-SP were evaluated through stability and internal consistency measures, and concurrent and discriminant validity were assessed. RESULTS: The new version of the GOHAI-SP was administered to 100 individuals. The application time was reduced by 7 min. The alpha value for reliability was 0.87. The item-scale correlation coefficients ranged from 0.54 to 0.75, and the test-re-test correlation for the total score was 0.75. There were inverse correlations between GOHAI-SP scores and the number of lost teeth and the decayed-missing-filled teeth index (p < 0.001). CONCLUSIONS: The GOHAI-SP questionnaire remains a valid and useful tool to assess oral health-related quality of life in primary health care settings. A linguistic update of the questionnaire brought improvements to the instrument application. TRIAL REGISTRATION: The PREDIMED-Plus trial is registered in the ISRCTN registry with reference number ISRCTN89898870. Registration date: 4th July 2014.

Evidence of Benefit of Telerehabitation After Orthopedic Surgery: A Systematic Review.

BACKGROUND: In addition to traditional physiotherapy, studies based on telerehabilitation programs have published the results of effectiveness, validity, noninferiority, and important advantages in some neurological, cognitive, and musculoskeletal disorders, providing an opportunity to define new social policies and interventions. OBJECTIVES: The aim of this systematic review is to investigate the effects of telerehabilitation after surgical procedures on orthopedic conditions as well as to describe how interventions are designed and to determine whether telerehabilitation is comparable with conventional methods of delivery. This systematic review summarizes the levels of evidence and grades of recommendation regarding telerehabilitation intervention (synchronous or asynchronous provided via the telerehabilitation medium, either in conjunction with, or in isolation of, other treatment interventions) after surgical procedures on orthopedic conditions. METHODS: Study quality was assessed using the Physiotherapy Evidence Database (PEDro) scores and grade of recommendation following the recommendation of the Oxford Centre for Evidence-Based Medicine. RESULTS: We found 3 studies with PEDro scores between 6 and 8, which is considered as level 1 evidence (good; 20% [3/15]), 4 studies with a score of 5, which is considered as level 2 evidence (acceptable; 27% [4/15]), and the remaining 8 studies had scores of 4 or less, which is considered (poor; 53% [8/15]). A total of 1316 participants received telerehabilitation intervention in the selected studies, where knee and hip replacement were 75% of all the studies. Strong and moderate grades of evidence (grade of recommendation A-B) were found in knee and hip replacement interventions. Studies on the upper limb were 25% of the studies, but only 1 study presented a moderate grade of evidence (grade of recommendation B) and the rest were of poor methodological quality with weak evidence (grade of recommendation C). CONCLUSIONS: Conclusive evidence on the efficacy of telerehabilitation for treatment after an orthopedic surgery, regardless of pathology, was not obtained. We found strong evidence in favor of telerehabilitation in patients following total knee and hip arthroplasty and limited evidence in the upper limb interventions (moderate and weak evidence). Future research needs to be more extensive and conclusive. To the best of the authors' knowledge, this is the first attempt at evaluating the quality of telerehabilitation intervention research after surgical procedures on orthopedic conditions in a systematic review. Clinical messages and future research recommendations are included in the review.

[Validation of the knowledge and attitudes of health professionals in the Living Will Declaration process]. / Validación del cuestionario de conocimientos y actitudes de los profesionales sanitarios en el proceso de declaración de voluntades vitales anticipadas.

OBJECTIVE: Evaluate the validity and reliability of the knowledge and attitudes of health professionals questionnaire on the Living Will Declaration (LWD) process. DESIGN: Cross-sectional study structured into 3 phases: (i)pilot questionnaire administered with paper to assess losses and adjustment problems; (ii)assessment of the validity and internal reliability, and (iii)assessment of the pre-filtering questionnaire stability (test-retest). LOCATION: Costa del Sol (Malaga) Health Area. January 2014 to April 2015. PARTICIPANTS: Healthcare professionals of the Costa del Sol Primary Care District and the Costa del Sol Health Agency. There were 391 (23.6%) responses, and 100 participated in the stability assessment (83 responses). MAIN MEASUREMENTS: The questionnaire consisted of 2 parts: (i)Knowledge (5 dimensions and 41 items), and (ii)Attitudes (2 dimensions and 17 items). RESULTS: In the pilot study, none of the items lost over 10%. In the evaluation phase of validity and reliability, the questionnaire was reduced to 41 items (29 of knowledge, and 12 of attitudes). In the stability evaluation phase, all items evaluated met the requirement of a kappa higher than 0.2, or had a percentage of absolute agreement exceeding 75%. CONCLUSIONS: The questionnaire will identify the status and areas for improvement in the health care setting, and then will allow an improved culture of LWD process in general population.

Effectiveness of the Nursing Methodology in Pain Management after Major Ambulatory Surgery.

Patients undergoing a surgical intervention for the first time are unfamiliar with the perioperative context, and they usually have no knowledge of postoperative pain management. In the preoperative circuit, there is no time to educate the patient in these terms. The professional profile of nurses allows this need to be addressed, and provides a regulated language to evaluate their effectiveness. This study evaluates the effectiveness of nursing counseling during a preoperative consultation for the management of postoperative pain and its effects on patient satisfaction at hospital discharge. This quasi-experimental study assesses the efficacy of preoperative nursing intervention in two groups, control (n = 185) and intervention (n = 195). Those in the intervention group attended a preoperative session during which they received information from nursing staff and took part in activities to learn about postoperative pain management and the perioperative circuit. Control group patients underwent the standard preoperative protocol. Data were compiled from January to December 2009. Statistically significant differences existed between the two groups regarding postoperative pain (visual analogue scale >3, 20.5% versus 11.5%; p = .023), patient satisfaction (87.1% versus 78.7%; p = .041), and surgical wound complications (13.9% versus 5.5%; p = .010). The results confirm the benefits of applying the nursing methodology in preoperative clinics.

Reliability and criterion-related validity with a smartphone used in timed-up-and-go test.

BACKGROUND: The capacity to diagnosys, quantify and evaluate movement beyond the general confines of a clinical environment under effectiveness conditions may alleviate rampant strain on limited, expensive and highly specialized medical resources. An iPhone 4® mounted a three dimensional accelerometer subsystem with highly robust software applications. The present study aimed to evaluate the reliability and concurrent criterion-related validity of the accelerations with an iPhone 4® in an Extended Timed Get Up and Go test. Extended Timed Get Up and Go is a clinical test with that the patient get up from the chair and walking ten meters, turn and coming back to the chair. METHODS: A repeated measure, cross-sectional, analytical study. Test-retest reliability of the kinematic measurements of the iPhone 4® compared with a standard validated laboratory device. We calculated the Coefficient of Multiple Correlation between the two sensors acceleration signal of each subject, in each sub-stage, in each of the three Extended Timed Get Up and Go test trials. To investigate statistical agreement between the two sensors we used the Bland-Altman method. RESULTS: With respect to the analysis of the correlation data in the present work, the Coefficient of Multiple Correlation of the five subjects in their triplicated trials were as follows: in sub-phase Sit to Stand the ranged between r = 0.991 to 0.842; in Gait Go, r = 0.967 to 0.852; in Turn, 0.979 to 0.798; in Gait Come, 0.964 to 0.887; and in Turn to Stand to Sit, 0.992 to 0.877. All the correlations between the sensors were significant (p < 0.001). The Bland-Altman plots obtained showed a solid tendency to stay at close to zero, especially on the y and x-axes, during the five phases of the Extended Timed Get Up and Go test. CONCLUSIONS: The inertial sensor mounted in the iPhone 4® is sufficiently reliable and accurate to evaluate and identify the kinematic patterns in an Extended Timed Get and Go test. While analysis and interpretation of 3D kinematics data continue to be dauntingly complex, the iPhone 4® makes the task of acquiring the data relatively inexpensive and easy to use.

Adherence to the WHO recommendation of three weekly days of vigorous intensity activities in children: an accelerometry study of vigorous physical activity bouts.

Background: The World Health Organization (WHO) recommends that children and adolescents incorporate vigorous intensity activities (VIAs) at least three days a week. This recommendation has not been sufficiently studied using objective methods, such as accelerometry. Physical education classes and extracurricular sports activities are optimal opportunities for compliance with this recommendation. Objective: To identify VIAs through bouts of vigorous physical activity (VPA-Bouts) evaluated with accelerometry and, with this, to know the compliance with the recommendation on VIAs. Methods: A cross-sectional study of the habitual physical activity of 353 children (8-9 years old) was carried out using accelerometry and participation in organized extracurricular sports activities was asked through a questionnaire. School days with and without physical education class, weekends, and the average weekly day were identified, as well as school time and out-of-school time. A VPA-Bout was defined as an interval of at least 60 minutes with a proportion of VPA of at least 16.7% in boys and 12.5% in girls (10.0 and 7.5 minutes/hour of VPA, respectively). Results: The average daily time in organized extracurricular sports activities declared by questionnaire and the average daily duration of the VPA-Bouts evaluated with accelerometers in the extracurricular period was 21.3 (SD 19.8) and 23.9 (SD 31.2) minutes, respectively, in boys, whereas, in girls it was 20.2 (SD 17.4) and 11.0 (SD 16.9) minutes, respectively. In school time including a physical education class, there was a higher proportion of VPA-Bouts than without these classes (with: 28.6%, without: 2.1%, p < 0.001). Children who reported at least three weekly hours of organized extracurricular sports activities accumulated a higher proportion of school afternoons with VPA-Bouts than those with fewer weekly hours of this type of activities (≥3 hours/week: 27.5%, <3 hours/week: 9.3%, p < 0.001). On the weekend, boys who reported at least three weekly hours of organized extracurricular sports activities performed more VPA-Bouts than those participating in less weekly hours, while in girls no significant differences were observed (weekend; boys, ≥3 hours/week: 26.0%, <3 hours/week: 9.0%, p < 0.001; girls: 8.3%, 8.0%, p = 0.917). Compliance with the recommendation to incorporate VIAs at least three days a week was 23.8%. Children who reported at least three weekly hours of extracurricular sports activities achieved higher compliance than those who reported fewer extracurricular activities (≥3 hours/week: 35.1%, <3 hours/week: 12.7%, p < 0.001). Additionally, boys showed higher compliance rates than girls (boys: 32.9%, girls: 15.3%, p < 0.001). Conclusion: One in every four children met the WHO recommendation to incorporate VIAs at least three days a week, as evaluated by accelerometry. Physical education classes and extracurricular organized sports activities contributed to compliance with this recommendation.

Accelerometry-assessed daily physical activity and compliance with recommendations in Spanish children: importance of physical education classes and vigorous intensity.

Background: Physical activity (PA) is associated with numerous health benefits. Vigorous PA (VPA) may have a greater impact on public health than lower-intensity PA. The incorporation of a specific recommendation on VPA could complement and improve existing recommendations for average daily moderate-vigorous PA (MVPA). Physical education classes could have a positive impact on children's adherence to average daily physical activity recommendations. The aim was to investigate the association between MVPA and VPA in children, as well as adherence to recommendations, and obesity and the presence of physical education classes. Methods: A cross-sectional study of physical activity was conducted in a sample of 8 and 9-year-old children in Andalusia (Spain). GENEActiv accelerometers were used, placed on the non-dominant wrist for at least eight consecutive days (24-h protocol). School days with and without physical education class, and weekend days were defined. ROC curves were used to calculate the threshold associated with obesity for average daily MVPA and VPA for recommendations. Results: A total of 360 schoolchildren were included in the analyses (184 girls). An average of 7.7 (SD 1.4) valid days per participant were evaluated, with 19.9 (SD 10.5) and 11.4 (SD 5.1) minutes of VPA performed by boys and girls respectively. 25.8% of the participants were classified with central obesity. The optimal threshold determined with ROC analysis was 12.5 and 9.5 minutes of average daily VPA for boys and girls, respectively (RecVPA), and 75 minutes of average daily MVPA for both sexes (RecMVPA). The RecVPA showed stronger association with obesity. On school days with physical education class, compared to days without this class, children showed increased VPA and MVPA engagement and better compliance with recommendations, with smaller differences in adherence according to sex or obesity. Conclusions: On days with physical education class, more physical activity was accumulated at all intensities and greater adherence to the recommendations than on days without this class. VPA had a stronger correlation with the absence of obesity than lower-intensity activity. It was also observed that boys were physically more active and had higher adherence to the recommendations than girls.

Effects of Music on the Quality of Life of Family Caregivers of Terminal Cancer Patients: A Randomised Controlled Trial.

The aim of this study was to investigate the effects of listening to self-chosen music on the quality of life of family caregivers of cancer patients receiving palliative home care. A total of 82 family caregivers were assigned either to the intervention group (n = 41) or to the control group (n = 41) in this double-blind, multicentre, randomised controlled clinical trial. The recruitment period was between July 2020 and September 2021. The intervention group received individualised pre-recorded music in daily 30 min sessions for 7 consecutive days. The control group was given a recorded repetition of the basic therapeutic training education also in 30 min sessions for 7 consecutive days. The primary endpoint assessed was the caregivers' quality of life (Quality of Life Family Version and European Quality of Life visual analogue scale) before and after the intervention. The secondary endpoint was their perceived satisfaction with the intervention (Client Satisfaction Questionnaire). The music intervention was successful, producing a tangible improvement in the caregivers' quality of life (p < 0.01) and satisfaction with the care provided (p = 0.002). The intervention was not only effective but produced no adverse effects. This study encourages the use of self-chosen music as a complementary intervention in nursing care for family caregivers of palliative cancer patients.

Cancer Patients' Satisfaction with In-Home Palliative Care and Its Impact on Disease Symptoms.

The aim of the study was to determine whether the satisfaction of cancer patients with in-home palliative care is associated with the impact of disease symptoms and with self-perceived quality of life. This was a cross-sectional descriptive study, conducted in the primary health care sector in six clinical management units, where 72 patients were recruited over a period of six months. The severity of symptoms was determined by the Edmonton Symptom Assessment System (ESAS). Quality of life was evaluated with the EORTC QLQ-C30 (version 3) questionnaire, and patients' satisfaction with the care received was evaluated by the Client Satisfaction Questionnaire (CSQ-8). The patients' satisfaction with the health care received was represented by an average score of 6, on a scale of 1-10; thus, there is room for improvement in patient satisfaction. Moreover, it was found that more intense symptoms and lower quality of life are associated with lower satisfaction with health care received (p = 0.001). Similarly, when symptoms are more severe, the quality of life is lower (p < 0.001). The identification of fatigue, reduced well-being, pain, drowsiness, and depression as the symptoms experienced with the highest intensity by our patients provides valuable information for health care providers in developing individualized symptom management plans for patients with advanced cancer.

Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial.

The experience of caregiver burden among family members of patients with advanced cancer is a common problem. The aim of this study was to determine whether the burden may be alleviated by means of a therapeutic approach based on self-chosen music. This randomised controlled trial (ClinicalTrials.gov, NCT04052074. Registered 9 August 2019) included 82 family caregivers of patients receiving home palliative care for advanced cancer. The intervention group (n = 41) listened to pre-recorded, self-chosen music for 30 min/day for seven consecutive days, while the control group (n = 41) listened to a recording of basic therapeutic education at the same frequency. The degree of burden was assessed by the Caregiver Strain Index (CSI), calculated before and after the seven-day intervention. According to this measure, caregiver burden fell significantly in the intervention group (CSI change: -0.56, SD 2.16) but increased in the control group (CSI change: +0.68, SD 1.47), with a significant group x moment interaction F(1, 80) = 9.30, p = 0.003, η2p = 0.11. These results suggest that, in the short term at least, the use of therapy based on self-chosen music alleviates the burden on family caregivers of palliative cancer patients. Moreover, this therapy is easy to administer at home and does not present any problems in practice.

Accelerometer-Measured Physical Activity, Inactivity, and Related Factors in Family Caregivers of Patients with Terminal Cancer.

The physical activity (PA) and inactivity of family caregivers of cancer patients were investigated and related to burden and quality of life through a cross-sectional multicentre study. A total of 75 caregivers were recruited from June 2020 to March 2021. The levels of PA and inactivity were estimated with a wrist accelerometer, 24 h a day, for 7 consecutive days. The Quality of Life Family Version, the Caregiver Strain Index, the total duration of care, the average number of hours spent in care, and the assistance received were registered. Our results showed that moderate-to-vigorous PA was 96.40 ± 46.93 min/day, with 90.7% of participants performing more than 150 min/week of physical activity, and this was significantly associated with age (r = −0.237). Daily inactivity was 665.78 ± 94.92 min, and inactivity for 20−30 min was significantly associated with caregiver burden (r = 0.232) and quality of life (r = −0.322). Compliance with the World Health Organization recommendations was significantly associated with a lower quality of life (r = −0.269). The strength of these associations was limited (r ~0.2). In conclusion, the PA performed by most caregivers met the established recommendations, although older caregivers (>65 years old) performed lower moderate-to-vigorous PA than younger ones. In addition, the mean inactive time was high (11 h/day), showing slight relationships with the burden and quality of life of caregivers.

Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity.

Background: The COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity. Methods: We assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown. Results: During the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants' follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60-0.91]) and after (0.72 cm [95% CI: 0.56-0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: -0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: -0.30 to -0.04]). Conclusion: Mitigating strategies to enforce the intervention and patient's follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity. Clinical trial registration: https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

Burden and quality of life in caregivers of cancer patients at the beginning of palliative care. CUIDPALCOSTASOL Study.

OBJECTIVES: To describe the quality of life and caregiver burden of family caregivers of cancer patients at the beginning of palliative care. METHOD: Cross-sectional descriptive study in the CUIDPACOSTASOL cohort of family caregivers of palliative phase cancer patients, included between February 2017 and December 2019 from health centres of the Costa del Sol and Malaga-Valle del Guadalhorce Primary Care District, and Cudeca Foundation. Sociodemographic data on caregivers and patients, specific questionnaires related to family caregiver burden as well as satisfaction (Zarit and FAMCARE), quality of life (SF-36) and nursing diagnoses (NANDA), and patient characteristics (PPI, PPSv2) were collected. RESULTS: 174 family caregivers were included, 86.8% were women with a mean age of 57 years. 60.6% perceived their health as good, and the mean score on the Zarit scale was 13.0. The most repeated nursing diagnosis (NANDA) was «Risk for caregiver role strain¼ (41.8%). The quality-of-life dimensions with the highest scores were «Physical function¼ (80.5), and «Physical role¼ (67.2). Of the people receiving care, 62.6% were men with a mean age of 73 years and required care for an average of 19 h per day. The mean score on the Palliative Performance Scale, PPSv2, was 44.9%, and 3.9% on the PPI Palliative Prognostic Index. CONCLUSIONS: Family caregivers in this study had moderate burden, high risk for caregiver role strain, and acceptable perceived health and quality of life. This is probably because they were at the beginning of palliative care.

Burden and quality of life in caregivers of cancer patients at the beginning of palliative care. CUIDPALCOSTASOL Study. / Sobrecarga y calidad de vida en cuidadoras de pacientes oncológicos al inicio de los cuidados paliativos. Estudio CUIDPALCOSTASOL.

OBJECTIVES: To describe the quality of life and caregiver burden of family caregivers of cancer patients at the beginning of palliative care. METHOD: Cross-sectional descriptive study in the CUIDPACOSTASOL cohort of family caregivers of palliative phase cancer patients, included between February 2017 and December 2019 from health centres of the Costa del Sol and Malaga-Valle del Guadalhorce Primary Care District, and Cudeca Foundation. Sociodemographic data on caregivers and patients, specific questionnaires related to family caregiver burden as well as satisfaction (Zarit and FAMCARE), quality of life (SF-36) and nursing diagnoses (NANDA), and patient characteristics (PPI, PPSv2) were collected. RESULTS: 174 family caregivers were included, 86.8% were women with a mean age of 57 years. 60.6% perceived their health as good, and the mean score on the Zarit scale was 13.0. The most repeated nursing diagnosis (NANDA) was «Risk for caregiver role strain¼ (41.8%). The quality-of-life dimensions with the highest scores were «Physical function¼ (80.5), and «Physical role¼ (67.2). Of the people receiving care, 62.6% were men with a mean age of 73 years and required care for an average of 19 hours per day. The mean score on the Palliative Performance Scale, PPSv2, was 44.9%, and 3.9% on the PPI Palliative Prognostic Index. CONCLUSIONS: Family caregivers in this study had moderate burden, high risk for caregiver role strain, and acceptable perceived health and quality of life. This is probably because they were at the beginning of palliative care.