Assessment of the Effectiveness, Socio-Economic Impact and Implementation of a Digital Solution for Patients with Advanced Chronic Diseases: The ADLIFE Study Protocol.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

Effects of a Brief E-Learning Resource on Sexual Attitudes and Beliefs of Healthcare Professionals Working in Prostate Cancer Care: A Pilot Study.

Sexual issues and treatment side effects are not routinely discussed with men receiving treatment for prostate cancer, and support to address these concerns is not consistent across settings. This study evaluates a brief e-learning resource designed to improve sexual wellbeing support and examine its effects on healthcare professionals' sexual attitudes and beliefs. Healthcare professionals (n = 44) completed an online questionnaire at baseline which included a modified 12-item sexual attitudes and beliefs survey (SABS). Follow-up questionnaires were completed immediately after the e-learning and at 4 weeks. Data were analysed using one-way, repeat measures ANOVAs to assess change in attitudes and beliefs over time. Significant improvements were observed at follow-up for a number of survey statements including 'knowledge and understanding', 'confidence in discussing sexual wellbeing' and the extent to which participants felt 'equipped with the language to initiate conversations'. The resource was seen as concise, relevant to practice and as providing useful information on potential side effects of treatment. In brief, e-learning has potential to address barriers to sexual wellbeing communication and promote delivery of support for prostate cancer survivors. Practical methods and resources should be included with these interventions to support implementation of learning and long-term changes in clinical behaviour.

Efficacy, Use, and Acceptability of a Web-Based Self-management Intervention Designed to Maximize Sexual Well-being in Men Living With Prostate Cancer: Single-Arm Experimental Study.

BACKGROUND: Sexual dysfunction is a frequent side effect associated with different prostate cancer treatment approaches. It can have a substantial impact on men and their partners and is associated with increased psychological morbidity. Despite this, sexual concerns are often not adequately addressed in routine practice. Evidence-based web-based interventions have the potential to provide ongoing information and sexual well-being support throughout all stages of care. OBJECTIVE: The aim of this study is to examine the efficacy of a web-based self-management intervention designed to maximize sexual well-being in men living with prostate cancer and explore user perspectives on usability and acceptability. METHODS: We used a single-arm study design, and participants were provided with access to the 5-step intervention for a period of 3 months. The intervention content was tailored based on responses to brief screening questions on treatment type, relationship status, and sexual orientation. Efficacy was assessed by using two-tailed, paired sample t tests for comparing the mean differences between pre- and postintervention measurements for exploring the participants' self-reported knowledge and understanding, sexual satisfaction, and comfort in discussing sexual issues. Usability and acceptability were determined based on the program use data and a postintervention survey for exploring perceived usefulness. RESULTS: A total of 109 participants were recruited for this study. Significant postintervention improvements at follow-up were observed in the total scores (out of 20) from the survey (mean 12.23/20 points, SD 2.46 vs mean 13.62/20, SD 2.31; t88=9.570; P=.001) as well as in individual item scores on the extent to which the participants agreed that they had sufficient information to manage the impact that prostate cancer had on their sex life (mean 2.31/4 points, SD 0.86 vs mean 2.57/4, SD 0.85; t88=3.660; P=.001) and had the potential to have a satisfying sex life following treatment (mean 2.38/4 points, SD 0.79 vs mean 3.17/4, SD 0.78; t88=7.643; P=.001). The median number of intervention sessions was 3 (range 1-11), and intervention sessions had a median duration of 22 minutes (range 8-77). Acceptable usability scores were reported, with the highest result observed for the question on the extent to which the intervention provided relevant information. CONCLUSIONS: This study provides evidence on the efficacy of a tailored web-based intervention for maximizing sexual well-being in men living with prostate cancer. The results indicate that the intervention may improve one's self-perceived knowledge and understanding of how to manage sexual issues and increase self-efficacy or the belief that a satisfactory sex life could be achieved following treatment. The findings will be used to refine the intervention content before testing as part of a larger longitudinal study for examining its effectiveness.

The Tablet-Based, Engagement, Assessment, Support, and Sign-Posting (EASSi) Tool for Facilitating and Structuring Sexual Well-Being Conversations in Routine Prostate Cancer Care: Mixed-Methods Study.

BACKGROUND: Long-term side-effects associated with different prostate cancer treatment approaches are common. Sexual challenges are the most frequently occurring issues and can result in increased psychological morbidity. It is recognized that barriers to communication can make initiating discussions around sexual concerns in routine practice difficult. Health care professionals need to routinely initiate conversations, effectively engage with patients, and assess needs in order to provide essential support. One proposed method that could support health care professionals to do this involves the use of prompts or structured frameworks to guide conversations. OBJECTIVE: This study aimed to assess feasibility, acceptability, and satisfaction with the tablet-based Engagement, Assessment, Support, and Sign-posting (EASSi) tool designed to facilitate and structure sexual well-being discussions in routine prostate cancer care. METHODS: Health care professionals (n=8) used the EASSi tool during 89 posttreatment appointments. Quantitative data were recorded based on program usage and surveys completed by health care professionals and patients. Qualitative data exploring perceptions on use of the tool were gathered using semistructured interviews with all health care professionals (n=8) and a sample of patients (n=10). RESULTS: Surveys were completed by health care professionals immediately following each appointment (n=89, 100%). Postal surveys were returned by 59 patients (66%). Health care professionals and patients reported that the tool helped facilitate discussions (81/89, 91% and 50/59, 85%, respectively) and that information provided was relevant (82/89, 92% and 50/59, 85%, respectively). The mean conversation duration was 6.01 minutes (SD 2.91). Qualitative synthesis identified the tool's ability to initiate and structure discussions, improve the "depth" of conversations, and normalize sexual concerns. CONCLUSIONS: The EASSi tool was appropriate and acceptable for use in practice and provided a flexible approach to facilitate routine brief conversations and deliver essential sexual well-being support. Further work will be conducted to evaluate the effectiveness of using the tablet-based tool in prostate cancer care settings.

Advanced Symptom Management System for Patients with Malignant Pleural Mesothelioma (ASyMSmeso): Mixed Methods Study.

BACKGROUND: Patients with malignant pleural mesothelioma (MPM) have a life-limiting illness and short prognosis and experience many debilitating symptoms from early in the illness. Innovations such as remote symptom monitoring are needed to enable patients to maintain wellbeing and manage symptoms in a proactive and timely manner. The Advanced Symptom Management System (ASyMS) has been successfully used to monitor symptoms associated with cancer. OBJECTIVE: This study aimed to determine the feasibility and acceptability of using an ASyMS adapted for use by patients with MPM, called ASyMSmeso, enabling the remote monitoring of symptoms using a smartphone. METHODS: This was a convergent mixed methods study using patient-reported outcome measures (PROMs) at key time points over a period of 2-3 months with 18 patients. The Sheffield Profile for Assessment and Referral for Care (SPARC), Technology Acceptance Model (TAM) measure for eHealth, and Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) were the PROMs used in the study. Patients were also asked to complete a daily symptom questionnaire on a smartphone throughout the study. At the end of the study, semistructured interviews with 11 health professionals, 8 patients, and 3 carers were conducted to collect their experience with using ASyMSmeso. RESULTS: Eighteen patients with MPM agreed to participate in the study (33.3% response rate). The completion rates of study PROMs were high (97.2%-100%), and completion rates of the daily symptom questionnaire were also high, at 88.5%. There were no significant changes in quality of life, as measured by LCSS-Meso. There were statistically significant improvements in the SPARC psychological need domain (P=.049) and in the "Usefulness" domain of the TAM (P=.022). End-of-study interviews identified that both patients and clinicians found the system quick and easy to use. For patients, in particular, the system provided reassurance about symptom experience and the feeling of being listened to. The clinicians largely viewed the system as feasible and acceptable, and areas that were mentioned included the early management of symptoms and connectivity between patients and clinicians, leading to enhanced communication. CONCLUSIONS: This study demonstrates that remote monitoring and management of symptoms of people with MPM using a mobile phone are feasible and acceptable. The evidence supports future trials using remote symptom monitoring to support patients with MPM at home.

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery.

OBJECTIVE: To design and develop a digital monitoring application to support and improve the care of patients in the first 30 post-operative days following colorectal cancer surgery. DATA SOURCES: Patient interviews, health professional focus groups, patient co-creation activities, and health professional prioritization discussions. CONCLUSION: The structured and iterative co-design activities adopted in this study with key stakeholders, including patients and health professionals, lead to the development of a prototype application (app) to support patients at home during the first 30 days following surgery for colorectal cancer. A similar approach could be implemented to develop comparable apps for patients with other cancer diagnoses requiring different surgical procedures. Further research should focus on the continued development and testing of this app in relation to patient care and outcomes as well as the app's affect on nursing and other health services. IMPLICATIONS FOR NURSING PRACTICE: Clinical implementation of remote monitoring following discharge home after surgery for colorectal cancer gives patients the opportunity to report issues of concern to relevant health professionals. This could facilitate the early identification of concerning signs and symptoms, ensuring appropriate and timely interventions to minimize readmission rates. Patients' experiences during the recovery period could also be improved through the provision of reliable and relevant online information. More specifically, health professionals could easily identify those patients requiring additional support to manage their recovery, for example, those with more severe symptoms or problems, facilitating the direction of appropriate health services to those most in need of their expertise.

Development of a conceptual framework to improve sexual wellbeing communication in routine prostate cancer care.

OBJECTIVE: To systematically develop a framework to improve sexual wellbeing communication in routine prostate cancer care. METHODS: The Theoretical Domains Framework was used to guide a multi-phase process used to identify components of the framework based on evidence reviews, semi-structured interviews and stakeholder workshops. 'Think-aloud' testing was used to explore usability, potential barriers and other factors relevant to implementation. RESULTS: A conceptual communication framework consisting of 'Engagement' (E), 'Assessment' (A), information and 'Support' (S) and 'Sign-posting' (Si) sections was developed. The framework emphasises routine engagement to normalise sexual concerns, brief, non-sensitive assessment, personalised advice based on treatment type and relationship status, and a mechanism for referral to additional support or self-management resources in the form of a patient and partner handout. Usability testing identified strategies to promote implementation. CONCLUSIONS: The proposed framework is appropriate for use in routine practice and appears to be acceptable to patients, partners and healthcare professionals. Its use may help address gaps in sexual wellbeing support for men and partners living with prostate cancer. Further work will be conducted evaluating an online engagement tool, modelled on the framework. PRACTICE IMPLICATIONS: The EASSi framework can facilitate and structure sexual wellbeing conversations and ensure fundamental but individualised support is provided routinely in prostate cancer care.

Healthcare professional perceived barriers and facilitators to discussing sexual wellbeing with patients after diagnosis of chronic illness: A mixed-methods evidence synthesis.

OBJECTIVES: To explore healthcare professional perceived barriers and facilitators to discussing sexual health and wellbeing with patients after diagnosis of chronic illness. METHODS: Five databases were searched and included data were synthesised using a meta-ethnographic approach. Confidence in findings was assessed using the GRADE-CERQual framework. Searches, extraction and quality assessment procedures were conducted independently by at least two authors. RESULTS: Concepts extracted from 30 included studies were used to develop a conceptual framework based on five overarching themes. These were [1] individual and societal attitudes to sex and sexual wellbeing [2], patient specific factors [3], organizational and professional factors [4], strategies to overcome barriers in practice and [5] perceived training needs. Healthcare professionals acknowledged the importance of discussing and providing support for sexual wellbeing needs, but recognized it is not routinely provided. CONCLUSIONS: While patient specific factors and organizational issues such as lack of time were frequently identified as barriers, intra-personal and social perceptions appear to have the strongest influence on healthcare professional perspectives. PRACTICE IMPLICATIONS: Brief education and tools to support healthcare professionals to have effective conversations with patients are required. These should address social barriers, normalise sexual issues, and support healthcare professionals to initiate discussions around sexual concerns.

Development and preliminary testing of a brief clinical tool to enable daily monitoring of chemotherapy toxicity: The Daily Chemotherapy Toxicity self-Assessment Questionnaire.

Close monitoring of chemotherapy toxicity can be instrumental in ensuring prompt symptom management and quality care. Our aim was to develop a brief clinical tool to enable daily assessment of chemotherapy toxicity and investigate/establish its content validity, feasibility/applicability, internal consistency and stability. Development of the Daily Chemotherapy Toxicity self-Assessment Questionnaire (DCTAQ) was based on an initial item pool created from two scoping reviews. Expert panel review (n = 15) and cognitive debriefing with patients with cancer (n = 7) were used to establish content validity. Feasibility/acceptability, applicability (self-report vs. interview-like administration), internal consistency (KR-20) and test-retest reliability (at 1-hr intervals) of the DCTAQ were field-tested with 82 patients with breast or colorectal cancer receiving active chemotherapy at eight hospitals. Initial development/content validity stages enabled item revisions and re-wording that led to a final, 11-item DCTAQ version with 10 core symptom items plus one open-ended "any other symptom" item. Feasibility and acceptability were demonstrated through the absence of participant withdrawals, absence of missing data and no complaints about tool length. The DCTAQ was found to have modest internal consistency (KR-20 = 0.56), but very good test-retest reliability. The DCTAQ is a brief clinical tool that allows for rapid and accurate daily assessments of chemotherapy toxicity in clinical practice.

Employing patient-reported outcome (PRO) measures to support newly diagnosed patients with melanoma: Feasibility and acceptability of a holistic needs assessment intervention.

PURPOSE: Living with a melanoma diagnosis can be challenging. We aimed to assess the feasibility, acceptability, and perceived value of a nurse-led intervention that utilised patient-reported outcome (PRO) measures to identify and address the supportive care needs of newly diagnosed patients with Stage I/II melanoma over the first 4 months post-diagnosis. METHODS: We conducted an exploratory, repeated-measures, single-arm, feasibility trial. One baseline (4 weeks post-diagnosis; T1) and one follow-up intervention session (4 weeks after wide local excision; T3) took place, two months apart. Patient survey data were collected monthly, at four assessment points (T1-T4), followed by exit interviews. RESULTS: A recruitment rate of 55% (10/18) was achieved. The skin cancer nurse specialist (CNS) performed 19 in-clinic patient assessments within 6 months. One patient missed their follow-up intervention session (90% retention rate). Three participants (30%) were lost to follow-up at T4. Patients endorsed the standardised use of easy-to-use PRO measures as a means to help them shortlist, report and prioritise their needs. The CNS viewed the intervention as a highly structured activity that allowed tailoring support priority needs. A sizeable reduction in information needs was found from T1 to T4 (Standardised Response Mean [SRM] change = -0.99; p < 0.05). From T1 to T2, significant reductions in psychological (SRM change = -1.18; p < 0.001), practical (SRM change = -0.67; p < 0.05) and sexuality needs (SRM change = -0.78; p < 0.05) were observed. CONCLUSIONS: The intervention appears to be feasible in clinical practice and acceptable to both patients with newly diagnosed melanoma and clinicians. Future research is warranted to test its effectiveness against standard care.

Development of a novel remote patient monitoring system: the advanced symptom management system for radiotherapy to improve the symptom experience of patients with lung cancer receiving radiotherapy.

BACKGROUND: The use of technology-enhanced patient-reported outcome measures to monitor the symptoms experienced by people with cancer is an effective way to offer timely care. OBJECTIVE: This study aimed to (a) explore the feasibility and acceptability of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy and clinicians involved in their care and (b) assess changes in patient outcomes during implementation of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy in clinical practice. METHODS: A repeated-measures, single-arm, mixed-methods study design was used involving poststudy interviews and completion of patient-reported outcome measures at baseline and end of treatment with 16 patients with lung cancer and 13 clinicians who used this mobile phone-based symptom monitoring system. RESULTS: Only rarely did patients report problems in using the handset and they felt that the system covered all relevant symptoms and helped them to manage their symptoms and effectively communicate with clinicians. Clinical improvements in patient anxiety, drowsiness, and self-care self-efficacy were also observed. Clinicians perceived the use of "real-time" risk algorithms and automated self-care advice provided to patients as positively contributing to clinical care. Reducing the complexity of the system was seen as important to promote its utility. CONCLUSIONS: Although preliminary, these results suggest that monitoring patient symptoms using mobile technology in the context of radiotherapy for lung cancer is feasible and acceptable in clinical practice. IMPLICATIONS FOR PRACTICE: Future research would be most beneficial if the use of this technology was focused on the postradiotherapy phase and expanded the scope of the system to encompass a wider range of supportive care needs.

Patients' perceptions of and emotional outcome after intensive care: results from a multicentre study.

BACKGROUND: Recovery from critical illness can be prolonged and can result in a number of significant short- and long-term psychological consequences. These may be associated with the patient's perception of the intensive care experience. AIM: The aims of the study were to assess patients' perceptions of their intensive care unit (ICU) experience and the effect of these on anxiety, depression and post-traumatic stress up to 6 months after discharge. METHOD: One hundred and three participants were recruited from six ICUs from one Critical Care Network in the United Kingdom. A prospective, longitudinal study was designed to assess anxiety, depression, post-traumatic stress symptomatology and patients' perceptions of their intensive care experience. Data were collected on three occasions: after intensive care discharge and before hospital discharge, and 2 months and 6 months later. Measures included the impact of events scale, hospital anxiety and depression scale and intensive care experience questionnaire. RESULTS: Anxiety, depression, avoidance and intrusion scores did not significantly reduce over time. At hospital discharge there was a significant association between patients' perceptions of their intensive care experience and anxiety, depression, avoidance and intrusion scores at hospital discharge. CONCLUSION: Standardised assessment of an intensive care experience is important. It provides information about the patient experience which can inform care practice within ICU, following discharge to the ward and, in the longer term, rehabilitation.

Pattern of declining blood pressure across replicate population surveys of the WHO MONICA project, mid-1980s to mid-1990s, and the role of medication.

OBJECTIVE: Declining mean systolic and diastolic blood pressures were observed in most populations of the World Health Organization MONICA (monitoring trends and determinants in cardiovascular disease) project from the mid-1980s to mid-1990s. We tested whether pooled results would show mean change associated with decline in high readings only, resulting from better antihypertensive medication, or with similar falls in low, middle, and high readings, implying other causes. DESIGN: Independent, random sample, cross sectional population surveys, each end of the MONICA decade. SETTING: 38 populations in 21 countries across four continents. PARTICIPANTS: Design target in each survey of 200 participants in each 10 year age and sex group from age 35 to 64 MAIN OUTCOME MEASURES: Changes in the population in mean systolic and diastolic blood pressure, and in low, middle, and high readings-the 20th, 50th, and 80th centiles-and the differences between these changes. RESULTS: Individual populations differed considerably, but pooling the 38 population results gave mean changes in systolic blood pressure of -2.2 mm Hg in men, -3.3 mm Hg in women, and in diastolic blood pressure of -1.4 mm Hg in men and -2.2 mm Hg in women (overall average -2.26 mm Hg, population median -1.55 mm Hg). Antihypertensive medication, associated with high readings, rose by 0.5% to 11.4%. However, average falls in low and middle blood pressure readings were so similar to those in high readings and in the mean that no effect from improving treatment of hypertension was detected. Results in contrasted subgroups were consistent. CONCLUSIONS: Blood pressure fell across 38 MONICA populations at all levels of readings, with no differential fall in high readings attributable to better control of hypertension. Despite the importance of medication to individuals, in that decade other determinants of blood pressure lowering must have been more pervasive and powerful in whole populations.

Secular and socio-economic trends in compliance with dietary targets in the north Glasgow MONICA population surveys 1986-1995: did social gradients widen?

OBJECTIVE: To compare trends in the consumption of key foods over 10 years in the most deprived and least deprived quarters in north Glasgow, Scotland as defined by the Carstairs deprivation index for their postcode of domicile. DESIGN: Four random, cross-sectional, age- and gender-stratified population surveys carried out in 1986, 1989, 1992 and 1995. After assigning a deprivation score, food-frequency questionnaires from 2883 men and 3127 women were examined for compliance with dietary targets, examining trends by gender and within the most and least deprived quarters of the population. SETTING: North Glasgow, Scotland. SUBJECTS: Over 600 men and 600 women (aged 25-64 years) in each of the four survey years who completed a lifestyle questionnaire including a food frequency section. RESULTS: Increasing trends in the reported consumption of fruit and vegetables and oil-rich fish were observed over the 10-year period. However, the trend to increased fruit and vegetable consumption in the most deprived groups was not significant, and in 1995 only 8% of men and 12% of women in this group claimed consumption of these foods 4 or more times a day. In general, a higher percentage of those in the least deprived group met the targets for the key foods. CONCLUSIONS: Trends to increasing consumption of fruit and vegetables and fish were in the right direction, but the targets for consumption of certain key foods were met by a minority of the population. The progress towards the target for fruit and vegetables showed widening social gradients with time.