Development of a Management App for Postviral Fibromyalgia-Like Symptoms: Patient Preference-Guided Approach.

BACKGROUND: Persistent fibromyalgia-like symptoms have been increasingly reported following viral infections, including SARS-CoV-2. About 30% of patients with post-COVID-19 syndrome fulfill the fibromyalgia criteria. This complex condition presents significant challenges in terms of self-management. Digital health interventions offer a viable means to assist patients in managing their health conditions. However, the challenge of ensuring their widespread adoption and adherence persists. This study responds to this need by developing a patient-centered digital health management app, incorporating patient preferences to enhance usability and effectiveness, ultimately aiming to improve patient outcomes and quality of life. OBJECTIVE: This research aims to develop a digital health self-management app specifically for patients experiencing postviral fibromyalgia-like symptoms. By prioritizing patient preferences and engagement through the app's design and functionality, the study intends to facilitate better self-management practices and improve adherence. METHODS: Using an exploratory study design, the research used patient preference surveys and usability testing as primary tools to inform the development process of the digital health solution. We gathered and analyzed patients' expectations regarding design features, content, and usability to steer the iterative app development. RESULTS: The study uncovered crucial insights from patient surveys and usability testing, which influenced the app's design and functionality. Key findings included a preference for a symptom list over an automated chatbot, a desire to report on a moderate range of symptoms and activities, and the importance of an intuitive onboarding process. While usability testing identified some challenges in the onboarding process, it also confirmed the importance of aligning the app with patient needs to enhance engagement and satisfaction. CONCLUSIONS: Incorporating patient feedback has been a significant factor in the development of the digital health app. Challenges encountered with user onboarding during usability testing have highlighted the importance of this process for user adoption. The study acknowledges the role of patient input in developing digital health technologies and suggests further research to improve onboarding procedures, aiming to enhance patient engagement and their ability to manage digital health resources effectively. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32193.

Patient and clinician priorities for information on treatment outcomes for advanced ovarian cancer: a Delphi exercise.

OBJECTIVE: Patients with advanced ovarian cancer face a range of treatment options, and there is unwarranted variation in treatment decision-making between UK providers. Decision support tools that produce data on treatment outcomes as a function of individual patient characteristics, would help both patients and clinicians to make informed, preference- and values-based choices. However, data on treatment outcomes to include in such tools are lacking. METHODS: Following a literature review, a questionnaire was designed for use in a Delphi process to establish which treatment outcomes are important to both patients and clinicians in decision-making for treatment for advanced ovarian cancer. Patient and clinician panels were established. RESULTS: Following 2 Delphi rounds, consensus was achieved for 7/11 items in the patient panel and 8/11 items in the clinician panel. Consensus across both panels was achieved for inclusion of both overall survival and progression free survival as important items in the decision-making process, although there remained differences of opinion as to whether these should be presented as relative or absolute values. CONCLUSION: Information needs for treatment decision-making in ovarian cancer differ between and within patient and clinician groups. Whilst overall survival and progression free survival are universally accepted as important data items, decision support tools will need to be nuanced to allow presentation of a range of outcomes and associated probabilities, and in a range of formats, that can be tailored to the preferences of clinician and patients.

Factor Analysis of Patients Who Find Tablets or Capsules Difficult to Swallow Due to Their Large Size: Using the Personal Health Record Infrastructure of Electronic Medication Notebooks.

BACKGROUND: Understanding patient preference regarding taking tablet or capsule formulations plays a pivotal role in treatment efficacy and adherence. Therefore, these preferences should be taken into account when designing formulations and prescriptions. OBJECTIVE: This study investigates the factors affecting patient preference in patients who have difficulties swallowing large tablets or capsules and aims to identify appropriate sizes for tablets and capsules. METHODS: A robust data set was developed based on a questionnaire survey conducted from December 1, 2022, to December 7, 2022, using the harmo smartphone app operated by harmo Co, Ltd. The data set included patient input regarding their tablet and capsule preferences, personal health records (including dispensing history), and drug formulation information (available from package inserts). Based on the medication formulation information, 6 indices were set for each of the tablets or capsules that were considered difficult to swallow owing to their large size and concomitant tablets or capsules (used as controls). Receiver operating characteristic (ROC) analysis was used to evaluate the performance of each index. The index demonstrating the highest area under the curve of the ROC was selected as the best index to determine the tablet or capsule size that leads to swallowing difficulties. From the generated ROCs, the point with the highest discriminative performance that maximized the Youden index was identified, and the optimal threshold for each index was calculated. Multivariate logistic regression analysis was performed to identify the risk factors contributing to difficulty in swallowing oversized tablets or capsules. Additionally, decision tree analysis was performed to estimate the combined risk from several factors, using risk factors that were significant in the multivariate logistic regression analysis. RESULTS: This study analyzed 147 large tablets or capsules and 624 control tablets or capsules. The "long diameter + short diameter + thickness" index (with a 21.5 mm threshold) was identified as the best indicator for causing swallowing difficulties in patients. The multivariate logistic regression analysis (including 132 patients with swallowing difficulties and 1283 patients without) results identified the following contributory risk factors: aged <50 years (odds ratio [OR] 1.59, 95% CI 1.03-2.44), female (OR 2.54, 95% CI 1.70-3.78), dysphagia (OR 3.54, 95% CI 2.22-5.65), and taking large tablets or capsules (OR 9.74, 95% CI 5.19-18.29). The decision tree analysis results suggested an elevated risk of swallowing difficulties for patients with taking large tablets or capsules. CONCLUSIONS: This study identified the most appropriate index and threshold for indicating that a given tablet or capsule size will cause swallowing difficulties, as well as the contributory risk factors. Although some sampling biases (eg, only including smartphone users) may exist, our results can guide the design of patient-friendly formulations and prescriptions, promoting better medication adherence.

Patient Preference of Apalutamide Versus Enzalutamide for Recurrent or Metastatic Hormone-sensitive Prostate Cancer: An Open-label, Randomized, Crossover Trial.

BACKGROUND AND OBJECTIVE: Treatment preference regarding apalutamide versus enzalutamide in prostate cancer (PCa) and the factors influencing decisions are largely unknown. Our aim was to investigate the preference for apalutamide versus enzalutamide among prostate cancer patients and their physicians and caregivers, and factors influencing their decision. METHODS: This was a prospective, open-label, randomized, crossover trial. Patients with recurrence of localized PCa or with metastatic disease not considered as high-risk or high-volume and on continued androgen deprivation therapy were recruited. All subjects received a trial of two agents, apalutamide (A) and enzalutamide (E), for 12 wk each, with a 5-wk washout period in between. The sequencing of the drugs was randomized. The primary outcome was patient preference for one the drugs, assessed at the end of the study. Other outcomes included factors influencing patient preference, a comparison of side-effect profiles, and patients' quality of life (QoL). Physician and caregiver preferences for the drugs and factors affecting their choice were also assessed. KEY FINDINGS AND LIMITATIONS: A total of 74 patients met the eligibility criteria and were randomized to the A â†’ E or E â†’ A arm. Of these, 66 patients (89.1%; 32 A â†’ E, 34 E â†’ A) completed the study. Baseline characteristics were comparable between the two groups, and ∼90% of the patients had low-volume metastatic disease. After completion of both treatments for 12 wk each, the difference in preference for A over E was 17.8%, with similar trends for preference of A over E among physicians (18.2%) and caregivers (22.4%). Fewer side effect was the most critical factor influencing the preference of patients. Among the side effects, less fatigue was the benefit of A over E most frequently reported. No notable difference in QoL was observed between the two drugs. However, the study was terminated on interim analysis and the results might not be conclusive. CONCLUSIONS: There was a trend for preference of A over E among patients with predominantly low-volume recurrent or metastatic PCa and their physicians and caregivers. Fewer side effects was the most critical factor influencing their choice. PATIENT SUMMARY: Patients with low-volume recurrent or metastatic prostate cancer tended to prefer treatment with apalutamide over enzalutamide. Side effects were the most critical factor influencing treatment preference.

Outcome prioritization and preferences among older adults with cancer starting chemotherapy in a randomized clinical trial.

INTRODUCTION: Older adults with cancer facing competing treatments must prioritize between various outcomes. This study assessed health outcome prioritization among older adults with cancer starting chemotherapy. METHODS: Secondary analysis of a randomized trial addressing vulnerabilities in older adults with cancer. Patients completed three validated outcome prioritization tools: 1) Health Outcomes Tool: prioritizes outcomes (survival, independence, symptoms) using a visual analog scale; 2) Now vs. Later Tool: rates the importance of quality of life at three times-today versus 1 or 5 years in the future; and 3) Attitude Scale: rates agreement with outcome-related statements. The authors measured the proportion of patients prioritizing various outcomes and evaluated their characteristics. RESULTS: A total of 219 patients (median [range] age 71 [65-88], 68% with metastatic disease) were included. On the Health Outcomes Tool, 60.7% prioritized survival over other outcomes. Having localized disease was associated with choosing survival as top priority. On the Now vs. Later Tool, 50% gave equal importance to current versus future quality of life. On the Attitude Scale, 53.4% disagreed with the statement "the most important thing to me is living as long as I can, no matter what my quality of life is"; and 82.2% agreed with the statement "it is more important to me to maintain my thinking ability than to live as long as possible". CONCLUSION: Although survival was the top priority for most participants, some older individuals with cancer prioritize other outcomes, such as cognition and function. Clinicians should elicit patient-defined priorities and include them in decision-making.

Real-world evidence and patient preference for subcutaneous versus intravenous natalizumab in the treatment of relapsing-remitting multiple sclerosis - initial results from the observational SISTER study.

Background: The consideration of patient preference for a certain drug route of administration (RoA) plays an important role in promoting patient adherence in chronic diseases. Natalizumab is an established treatment for relapsing-remitting multiple sclerosis (RRMS) and can be administered as intravenous (IV) infusion or subcutaneous (SC) injection developed to enable a shorter and easier administration versus IV RoA. Study objectives: Primary objective is to compare patients' preference for RoA and satisfaction with SC versus IV natalizumab at baseline and subsequent visits up to 12 months. Secondary objectives include drug utilization, clinical outcomes, safety, and treatment satisfaction in a usual care setting. Design and methods: SISTER (Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience from Real World) is an ongoing, prospective, observational study where natalizumab is utilized according to local label. RRMS patients are included in three natalizumab cohorts: Patients switching from current IV to SC administration (switcher) and patients newly starting natalizumab on either SC or IV route (starter SC/IV). This interim analysis includes 262 patients (184 switchers, 39 SC starters, and 39 IV starters), median observation period was 9 months. Results: 80.8% IV starters and 93.9% SC starters reported at baseline that they prefer the assigned RoA. Although initial satisfaction with chosen RoA was maintained over time from baseline through Month 12 in all three cohorts, the wish for change of the current RoA after 6 and 12 months was more frequently expressed among IV starters than in either SC cohort. Consistently, six patients (23.1%) starting with IV changed their RoA from IV to SC route.Mean global treatment satisfaction according to TSQM-II score at baseline remained high in the switcher group and increased through Month 12 in both IV and SC starter cohorts. Conclusion: Based on current data, there is a trend toward patients' preference for the natalizumab SC route over the IV route, which provides valuable insights into patients' preference for natalizumab RoA in routine care and complements available data from clinical studies with real-world data on SC natalizumab. Trial registration: This observational (non-interventional) study was registered in the local German PEI register for non-interventional studies (NIS-No. 611) and in the international CTgov register (NCT05304520).

Patient Preference for Surgical Methods for Ipsilateral Breast Tumor Recurrence.

BACKGROUND: Mastectomy has been the standard surgical treatment for ipsilateral breast tumor recurrence (IBTR). Recently, there has been growing interest in repeat breast-conserving surgery (rBCS) for IBTR among breast surgeons; however, there is currently little information regarding patient preferences for surgical procedure for IBTR. The purpose of this study was to evaluate preference for surgical procedure (mastectomy vs. rBCS) among breast cancer patients who had undergone salvage surgery for IBTR. METHODS: Overall, 100 breast cancer patients who had undergone salvage surgery for IBTR were asked about their preferred surgical methods for IBTR and the reason. The association of patient preference and the reasons related to various clinical and pathological factors were assessed. RESULTS: Of the 100 respondents, only 11 patients (11%) preferred rBCS. Patients who had undergone rBCS and radiotherapy for IBTR were significantly more likely to prefer to undergo rBCS than other groups (p = 0.030). The most frequent reason for choosing rBCS was the patient's desire to minimize breast deformity and surgical wounds. CONCLUSIONS: Our study revealed that there is a low rate of patients who opt to undergo rBCS among patients who had undergone salvage surgery for IBTR. Discrepancies in perceptions regarding the surgical procedure for IBTR between patients and their surgeons may exist.

Feasibility of a novel exercise program for patients with breast cancer offering different modalities and based on patient preference.

PURPOSE: Exercise improves quality of life and reduces the side effects of cancer therapies. Nevertheless, attendance to exercise programs remains a challenge for patients. This study explored the feasibility of an exercise program in which women with breast cancer may be allowed to choose among three exercise delivery modalities. METHODS: Forty-seven patients with breast cancer (stage I-IV) participated in a 12-week combined aerobic and resistance training program. The exercise modality was chosen by patients according to their preferences and needs among three options: the personal training program, the home-based program, or the group-based program. Exercise prescription was similar between the three modalities. Whereas the primary endpoint was feasibility, assessed through recruitment rate, attendance, adherence, dropout rate, tolerability, and safety, secondary endpoints included health-related skills and quality of life. RESULTS: Out of 47 recruited patients, 24 chose the home-based program, 19 the personal training program, and four the group-based program. Six dropouts (13%) were registered, and no severe adverse events were recorded. The median program attendance was 98% for personal training programs, 96% for home-based programs, and 100% for group-based programs, whereas compliance resulted in more than 90% in each modality. At postintervention, a significant increase in cardiorespiratory fitness, lower body flexibility, and body weight was observed. Different quality-of-life domains were improved following the intervention, including physical and social functioning, fatigue, and appetite loss. No significant changes in other parameters were detected. CONCLUSIONS: An exercise prescription based on a patient-preferred delivery modality showed high feasibility in women with breast cancer.

An Assessment of Individual Preference for a Novel Capillary Blood Collection System.

Purpose: Typical barriers to venous blood collection for wellness testing include discomfort, time spent, and collection site accessibility. This study assessed individuals' experience, satisfaction, and preference associated with a FDA-cleared blood-collection device, the BD MiniDraw™ Capillary Blood Collection System (BD MiniDraw), in retail locations. Patients and Methods: A total of 113 individuals (≥18 years) with venous blood collection experience were enrolled; 107 completed the study. A pre-collection survey gathered information on demographics and past experiences with healthcare and venous blood collection settings. BD MiniDraw collection was conducted at three retail sites (two pharmacies and one grocery store) by trained healthcare workers using the Babson BetterWay blood testing service model. A follow up survey was performed two weeks later to determine experience with, and preference for, BD MiniDraw in terms of staff professionalism, blood collection location, blood collection time, and staff trustworthiness. Results: Among the 107 participants, 74 (69%) were female and 33 (31%) were male; the mean age was 49 years (range=18-71 years). Sixty-six (62%) participants viewed their prior venipuncture experience as "somewhat" or "very" positive. Following capillary collection, 96 (90%) participants expressed a "somewhat" or "very" positive experience with BD MiniDraw at a retail location. In particular, "very satisfied" responses were given for location (87/107; 81%) and collection time (78/1407; 73%). In a subset of respondents (n=89), those reasons (location and time savings) were most frequent for likelihood of future use. Ninety-nine participants (92%) rated the retail blood collection team as "very" or "extremely" trustworthy. Overall, 90 participants (84%) "strongly preferred" (56/107; 52%), "somewhat preferred" (14/107; 13%), or had "no preference" (20/107; 19%) for BD MiniDraw, compared to traditional venous blood collection. Conclusion: Most participants conveyed a preference for BD MiniDraw, primarily based on the blood collection retail location, perceived time savings, and professionalism and trustworthiness of the staff.

Clinical Investigation of Large Volume Subcutaneous Delivery up to 25 mL for Lean and Non-Lean Subjects.

PURPOSE: To evaluate the clinical feasibility and tolerability of large volume subcutaneous delivery at different injection depths for lean and non-lean subjects. METHODS: A single-center, randomized, subject-blinded, crossover study in 62 healthy subjects was conducted to evaluate delivery of a 10-cP solution containing hyaluronic acid. Subjects were separated into lean and non-lean cohort by SC thickness. A syringe pump was used to study the effect of different volumes (5, 12, 25 mL) of a viscous placebo solution and needle lengths (6, 9 and 12 mm) delivered at 0.5 mL/min. RESULTS: Across all treatments, injection sites were observed to have negligible leakage, ~34 kPa of back pressure, and VAS of mild pain with higher pain from needle insertion than during injection. While mild to moderate erythema was the most frequently reported ISR and edema was most prominent for 25 mL injections, all ISRs were resolved within 4 hours post injection. Subjects were unbothered by ISRs across all treatments and rated them as low distress scores (average 1.0-1.5 out of 6). CONCLUSION: SC injection of 25 mL is feasible and tolerable using a low-pain formulation for abdomen injection irrespective of subcutaneous thickness and injection depths at a delivery rate of 0.5 mL/min.

Primary Palliative Care in Urology: Quality Improvement Summit 2021-2022.

INTRODUCTION: The AUA convened a 2021-2022 Quality Improvement Summit to bring together interdisciplinary providers to inform the current state and to discuss potential strategies for integrating primary palliative care into urology practice. We hypothesized that the Summit findings would inform a scalable primary palliative care model for urology. METHODS: The 3-part summit reached a total of 160 interdisciplinary health care professionals. Webinar 1, "Building a Primary Palliative Care Model for Urology," focused on a urologist's role in palliative care. Webinar 2, "Perspectives on Increasing the Use of Palliative Care in Advanced Urologic Disease," addressed barriers to possible implementation of a primary palliative care model. The in-person Summit, "Laying the Foundation for Primary Palliative Care in Urology," focused on operationalization of primary palliative care, clinical innovations needed, and relevant metrics. RESULTS: Participants agreed that palliative care is needed early in the disease course for patients with advanced disease, including those with benign and malignant conditions. The group agreed about the important domains that should be addressed as well as the interdisciplinary providers who are best suited to address each domain. There was consensus that a primary "quarterback" was needed, encapsulated in a conceptual model-UroPal-with a urologist at the hub of care. CONCLUSIONS: The Summit provides the field of urology with a framework and specific steps that can be taken to move urology-palliative care integration forward. Urologists are uniquely positioned to provide primary palliative care for their many patients with serious illness, both in the surgical and chronic care contexts.

Women's preference for a vaginal birth in Brazilian private hospitals: effects of a quality improvement project.

BACKGROUND: In 2015, a quality improvement project called "Adequate Childbirth Project" (PPA) was implemented in Brazilian private hospitals in order to reduce cesarean sections without clinical indication. The PPA is structured in four components, one of which is directed at women and families. The objective of this study is to evaluate the effects of PPA on women's preference for vaginal birth (VB) at the end of pregnancy. METHODS: Evaluative research conducted in 12 private hospitals participating in the PPA. Interviews were carried out in the immediate postpartum period and medical record data were collected at hospital discharge. The implementation of PPA activities and women's preference for type of birth at the beginning and end of pregnancy were compared in women assisted in the PPA model of care and in the standard of care model, using a chi-square statistical test. To estimate the effect of PPA on women's preference for VB at the end of pregnancy, multiple logistic regression was performed with selection of variables using a causal diagram. RESULTS: Four thousand seven hundred ninety-eight women were interviewed. The implementation of the planned activities of PPA was less than 50%, but were significantly more frequent among women assisted in the PPA model of care. Women in this group also showed a greater preference for VB at the beginning and end of pregnancy. The PPA showed an association with greater preference for VB at the end of pregnancy in primiparous (OR 2.54 95% CI 1.99-3.24) and multiparous women (OR 1.44 95% CI 0.97-2.12), although in multiparous this association was not significant. The main factor associated with the preference for VB at the end of pregnancy was the preference for this type of birth at the beginning of pregnancy, both in primiparous (OR 18.67 95% CI 14.22-24.50) and in multiparous women (OR 53.11 95% CI 37.31-75.60). CONCLUSIONS: The PPA had a positive effect on women's preference for VB at the end of pregnancy. It is plausible that more intense effects are observed with the expansion of the implementation of the planned activities. Special attention should be given to information on the benefits of VB in early pregnancy.

Cesarean rates have been increasing worldwide and constitute the most frequent type of childbirth in Brazil since 2009. In 2015, a quality improvement project was implemented in Brazilian private hospitals, with the objective of reducing medically unnecessary cesarean sections and increasing the number of vaginal births. This project, called "Adequate Childbirth Project" (PPA), has four components, one of which is directed at women and families, aiming to increase their participation in decision-making processes related to childbirth. In this study, we assessed whether this program contributed to increased preference for vaginal birth at the end of pregnancy. In previous studies in Brazil, we saw that women who maintained preference for vaginal birth throughout pregnancy were those who had the lowest proportion of cesarean sections. We found that the PPA increased preference for vaginal birth by almost three times in primiparous women. Among women with previous births, this increase was smaller. In this group of women, having a previous cesarean section was an important factor for not wanting a vaginal birth, and this is a very common condition in Brazil. For all women, having preference for vaginal birth at the beginning of pregnancy was the main factor in wanting this type of birth at the end of pregnancy. The results demonstrate the importance of educational activities that disseminate information about the benefits of vaginal birth, increasing the preference of women for this type of childbirth, in addition to supporting them throughout pregnancy, so that they feel empowered in their choice.

Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis: the EASI-SWITCH RCT.

Background: Neutropenic sepsis is a common complication of systemic anticancer treatment. There is variation in practice in timing of switch to oral antibiotics after commencement of empirical intravenous antibiotic therapy. Objectives: To establish the clinical and cost effectiveness of early switch to oral antibiotics in patients with neutropenic sepsis at low risk of infective complications. Design: A randomised, multicentre, open-label, allocation concealed, non-inferiority trial to establish the clinical and cost effectiveness of early oral switch in comparison to standard care. Setting: Nineteen UK oncology centres. Participants: Patients aged 16 years and over receiving systemic anticancer therapy with fever (≥ 38°C), or symptoms and signs of sepsis, and neutropenia (≤ 1.0 × 109/l) within 24 hours of randomisation, with a Multinational Association for Supportive Care in Cancer score of ≥ 21 and receiving intravenous piperacillin/tazobactam or meropenem for < 24 hours were eligible. Patients with acute leukaemia or stem cell transplant were excluded. Intervention: Early switch to oral ciprofloxacin (750 mg twice daily) and co-amoxiclav (625 mg three times daily) within 12-24 hours of starting intravenous antibiotics to complete 5 days treatment in total. Control was standard care, that is, continuation of intravenous antibiotics for at least 48 hours with ongoing treatment at physician discretion. Main outcome measures: Treatment failure, a composite measure assessed at day 14 based on the following criteria: fever persistence or recurrence within 72 hours of starting intravenous antibiotics; escalation from protocolised antibiotics; critical care support or death. Results: The study was closed early due to under-recruitment with 129 patients recruited; hence, a definitive conclusion regarding non-inferiority cannot be made. Sixty-five patients were randomised to the early switch arm and 64 to the standard care arm with subsequent intention-to-treat and per-protocol analyses including 125 (intervention n = 61 and control n = 64) and 113 (intervention n = 53 and control n = 60) patients, respectively. In the intention-to-treat population the treatment failure rates were 14.1% in the control group and 24.6% in the intervention group, difference = 10.5% (95% confidence interval 0.11 to 0.22). In the per-protocol population the treatment failure rates were 13.3% and 17.7% in control and intervention groups, respectively; difference = 3.7% (95% confidence interval 0.04 to 0.148). Treatment failure predominantly consisted of persistence or recurrence of fever and/or physician-directed escalation from protocolised antibiotics with no critical care admissions or deaths. The median length of stay was shorter in the intervention group and adverse events reported were similar in both groups. Patients, particularly those with care-giving responsibilities, expressed a preference for early switch. However, differences in health-related quality of life and health resource use were small and not statistically significant. Conclusions: Non-inferiority for early oral switch could not be proven due to trial under-recruitment. The findings suggest this may be an acceptable treatment strategy for some patients who can adhere to such a treatment regimen and would prefer a potentially reduced duration of hospitalisation while accepting increased risk of treatment failure resulting in re-admission. Further research should explore tools for patient stratification for low-risk de-escalation or ambulatory pathways including use of biomarkers and/or point-of-care rapid microbiological testing as an adjunct to clinical decision-making tools. This could include application to shorter-duration antimicrobial therapy in line with other antimicrobial stewardship studies. Trial registration: This trial is registered as ISRCTN84288963. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/140/05) and is published in full in Health Technology Assessment; Vol. 28, No. 14. See the NIHR Funding and Awards website for further award information.

Neutropenic sepsis, or infection with a low white blood cell count, can occur following cancer treatment. Usually patients receive treatment with intravenous antibiotics (antibiotics delivered into a vein) for two or more days. Patients at low risk of complications from their infection may be able to have a shorter period of intravenous antibiotics benefitting both patients and the NHS. The trial compared whether changing from intravenous to oral antibiotics (antibiotics taken by mouth as tablets or liquid) 12­24 hours after starting antibiotic treatment ('early switch') is as effective as usual care. Patients could take part if they had started intravenous antibiotics for low-risk neutropenic sepsis. Patients were randomly allocated to 'early switch' or to usual care. The main outcome measured was treatment failure. Treatment failure happened if fever persisted or recurred despite antibiotics, if patients needed to change antibiotics, if they needed to be re-admitted to hospital or needed to be admitted to intensive care within 14 days or died. We had originally intended that 628 patients would take part, but after review of the design of the study the number needed to take part was revised to 230. We were not able to complete the trial as planned as unfortunately only 129 patients took part. As the trial was smaller than expected we were not able to draw conclusions as to whether 'early switch' is no less effective than usual care. Our findings suggest that 'early switch' might result in a shorter time in hospital initially; however, treatment failure was more likely to occur, meaning some patients had to return to hospital for further antibiotics. There were no differences in side effects and no serious complications from treatment or treatment failure (such as intensive care admission or death) among the 65 patients in the 'early switch' group. Patients were satisfied with 'early switch'. Early switch may be a treatment option for some patients with low-risk neutropenic sepsis who would prefer a shorter duration of hospital admission but accept a risk of needing hospital re-admission.

Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

Patient Preferences for Lifestyle Management in a Multi-site Randomized Lifestyle Trial for Remission of the Metabolic Syndrome.

BACKGROUND: Randomized behavioral clinical trials are the gold standard for evaluating efficacy of a behavioral treatment. However, because participants are generally unblinded to treatment, preference for a specific treatment option can lead to biased results and/or reduced treatment efficacy. The purpose was to describe the relative frequency and correlates of existence of a preference and patient preference for either an in-person group-based or a remote self-directed, lifestyle treatment prior to randomization to one of these treatments. METHODS: The Enhanced Lifestyles for Metabolic Syndrome (ELM) trial is a multi-site behavioral clinical trial that compares efficacy of a group-based vs. a self-directed approach to lifestyle change on 2-year remission of the metabolic syndrome. Prior to randomization, participants were asked whether they had a preference for a particular treatment and, if so, which approach they preferred. Baseline data were used for a series of logistic regression models to determine behavioral correlates of treatment preference, independent of socioeconomic factors. RESULTS: Of the 331 participants, 131 (39.6%) had no preference for either treatment. Among the 200 with a preference, 56 (28.0%) preferred the self-directed program. Strength of a pre-existing habit of eating vegetables on most days was an independent correlate of no preference (adjusted OR, 1.27; 95% CI, 1.01-1.61; p = 0.03) and preference for a self-directed program (adjusted OR, 1.55; 95% CI, 1.09-2.22; p = 0.01). CONCLUSION: A pre-existing habit of eating vegetables was associated with no preference and preference for a less intensive lifestyle treatment. Post-treatment follow-up of the trial results will determine if concordance between preference and treatment assignment influences outcomes.

Advances in Human-Centered Care to Address Contemporary Unmet Needs in Chronic Dialysis.

Advances in the treatment of kidney failure with chronic dialysis have stagnated over the past three decades, with over 50% of patients still managed by conventional in-hospital haemodialysis. In parallel, the demands of chronic dialysis medical care have changed and evolved due to a growing population that has higher frailty and multimorbidity. Thus, the gap between the needs of kidney failure patients and the healthcare capability to provide effective overall management has widened. To address this problem, healthcare policy has increasingly aligned towards a human-centred approach. The paradigm shift of human-centred approach places patients at the forefront of decision-making processes, ensuring that specific needs are understood and prioritised. Integration of human-centred approaches with patient care has been shown to improve satisfaction and quality of life. The aim of this narrative is to evaluate the current clinical challenges for managing kidney failure for dialysis providers; summarise current experiences and unmet needs of chronic dialysis patients; and finally emphasise how human-centred care has advanced chronic dialysis care. Specific incremental advances include implementation of renal supportive care; home-assisted dialysis; hybrid dialysis; refinements to dialysis methods; whereas emerging advances include portable and wearable dialysis devices and the potential for the integration of artificial intelligence in clinical practice.

Patient Preferences and Their Effects on Rehabilitation Outcomes: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To assess the effect of aligning patients' preferences with specific rehabilitation delivery modes on rehabilitation outcomes. DESIGN: A secondary analysis of a randomized controlled trial (RCT). METHODS: The study cohort comprised 208 patients referred for physiotherapy rehabilitation after non-surgical or surgical interventions for rotator cuff injury, shoulder impingement, or acromioclavicular osteoarthritis. Participants were randomly assigned to one of three rehabilitation modalities: 1) group-based exercise, 2) individual exercise, or 3) home exercise. In this study, participants were categorized into two groups: "matched preference" (MP) and "unmatched preference" (UP). The primary outcome measure was change in function, measured with the shortened Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary outcome measures were change in pain, assessed using the Numeric Rating Scale (NRS), mental well-being measured with the World Health Organization Well-Being Index (WHO-5), health-related quality of life assessed using the EuroQol-5Domain questionnaire (EQ-5D), fear avoidance assessed using the Örebro Musculoskeletal Pain Questionnaire (ÖMPQ), and overall treatment satisfaction. Outcomes were assessed at 3 and 6 months. RESULTS: The primary outcome measure, QuickDASH, showed no significant differences between groups at either 3 months (-3.0 [-8.2 to 2.3]) or 6 months (0.5 [-5.7 to 6.7]). Additionally, no significant differences were observed in the secondary outcome measures. CONCLUSION: Matching patients' preferences for specific rehabilitation delivery modes did not seem to effect rehabilitation outcomes.

Patient Comfort with Before and After Photography at Plastic Surgery Offices.

BACKGROUND: Before and after (B&A) photographs are a sensitive part of patients' medical records, and the use of smartphones may pose risks to confidentiality and comfort. The purpose of this study was to assess patient comfort depending on the circumstances under which these photographs being taken. METHODS: Amazon's Mechanical Turk crowdsourcing service and REDCap's survey manager were used to recruit survey participants. An anonymous survey was distributed to ascertain demographics and comfort in various B&A scenarios using a five-point Likert scale. T tests and ANOVA testing were used to compare groups. RESULTS: There were 411 respondents with an average age of 36.1 years old. Of them, 46% were female and the majority were White (90%) and non-Hispanic (64%). Nearly one-third had previously undergone plastic surgery, with 80% receiving B&A photography. Surgeons took these photographs 51% of the time with similar rates of smartphone cameras use (47%) versus professional cameras (52%). The public had similar levels of comfort when a nurse or a surgeon took the clinical photographs (p = 0.08). Patients were significantly less comfortable when non-medically trained office staff captured their photographs (p = 0.0041). The public had similar comfort levels with the use of smartphones and professional cameras when dressed but were significantly less comfortable with the use of a smartphone when unclothed (p = < 0.001). CONCLUSION: To ensure the best patient experience, B&A photography should be taken by a medical professional. If photographs are to be taken when the patient is unclothed, the use of a professional-grade camera may help ease patient discomfort. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Patient Preferences for Treatment Attributes in Inflammatory Bowel Disease: Results From a Large Survey Across Seven European Countries Using a Discrete Choice Experiment.

BACKGROUND: Inflammatory bowel disease requires long-term treatment; therefore, understanding patient preferences is important in aiding informed treatment decision making. This study explored patients' preferences for treatment attributes of available inflammatory bowel disease therapies. METHODS: Adult patients from 7 European countries who self-reported previous/current treatment for Crohn's disease (CD) or ulcerative colitis (UC) participated in an online survey via the Carenity platform. In a discrete choice experiment, the relative importance of treatment attributes for CD and UC was estimated using conditional logit models. Latent class analysis was conducted to estimate heterogeneous treatment preferences based on patient profiles. Patients' perspectives and preferences regarding their quality of life were assessed. RESULTS: Across 686 completed survey responses (CD, n = 360; UC, n = 326), the mean patient age was 48 and 50 years, respectively. Patients with CD ranked route of administration as the most important attribute (attribute importance: 32%), preferring subcutaneous over intravenous treatment (P < .001). Patients with UC ranked route of administration and frequency of serious adverse events as the most important attributes (attribute importance: 31% and 23%, respectively), preferring oral (P < .001) and subcutaneous (P < .001) over intravenous treatment and treatment that minimized the risk of serious adverse events (P < .001) or mild adverse events (P < .01). Latent class analyses confirmed the impact of patients' sociodemographic profile on their preferences. All patients prioritized general well-being, energy level, and daily activities as the most important aspects for improvement through treatment. CONCLUSIONS: Patient preferences for treatment attributes varied among patients with CD or UC, highlighting the importance of personalized care and shared decision making to maximize treatment benefits.

This study explored patients' preferences for treatment attributes in Crohn's disease or ulcerative colitis, such as subcutaneous/intravenous drug administration and adverse effects. Patients' preferences highlighted the importance of personalized care and shared decision making to maximize treatment benefits.