Centers For Patients Research Articles

A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research

BackgroundTraditional medical research infrastructures relying on the Centers of Excellence (CoE) model (an infrastructure or shared facility providing high standards of research excellence and resources to advance scientific knowledge) are often limited by geographic reach regarding patient accessibility, presenting challenges for study recruitment and accrual. Thus, the development of novel, patient-centered (PC) strategies (e.g., the use of online technologies) to support recruitment and streamline study procedures are necessary. This research focused on an implementation evaluation of a design innovation with implementation outcomes as communicated by study staff and patients for CoE and PC approaches for a randomized controlled trial (RCT) for patients with vasculitis.MethodsIn-depth qualitative interviews were conducted with 32 individuals (17 study team members, 15 patients). Transcripts were coded using the Consolidated Framework for Implementation Research (CFIR).ResultsThe following CFIR elements emerged: characteristics of the intervention, inner setting, characteristics of individuals, and process. From the staff perspective, the communication of the PC approach was a major challenge, but should have been used as an opportunity to identify one “point person” in charge of all communicative elements among the study team. Study staff from both arms were highly supportive of the PC approach and saw its promise, particularly regarding online consent procedures. Patients reported high self-efficacy in reference to the PC approach and utilization of online technologies. Local physicians were integral for making patients feel comfortable about participation in research studies.ConclusionsThe complexity of replicating the interpersonal nature of the CoE model in the virtual setting is substantial, meaning the PC approach should be viewed as a hybrid strategy that integrates online and face-to-face practices.Trial registrations1) Name: The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach (TAPIR).Trial registration number: ClinicalTrials.gov NCT01940094.Date of registration: September 10, 2013.2) Name: The Assessment of Prednisone In Remission Trial – Patient Centric Approach (TAPIR).Trial registration number: Clinical Trials.gov NCT01933724.Date of registration: September 2, 2013.

Real-World Experiences of Parkinson's Disease OFF Time and Role of Demographics.

OFF periods are episodes when Parkinson's disease (PD) medications work suboptimally, with symptoms returning and impacting quality of life. We aimed to characterize OFF periods using patient-reported frequency, severity, and duration, as well as determine these characteristics' associations with demographics. A retrospective cohort study using Fox Insight Data Exploration Network (Fox DEN) database was conducted. Eligible patients had PD and were >18 years. The experience of OFF periods was characterized by frequency (number of episodes/day), duration (duration/episode), and severity (impact on activities). Significance level was Bonferroni-corrected for multivariate analyses. From a population of 6,757 persons with PD, 88% were non-Hispanic Whites (mean age: 66 ± 8.8 years); 52.7% were males versus 47.3% females; mean PD duration was 5.7 ± 5.2; and 51% experienced OFF periods. Subsequent analyses were limited to non-Hispanic Whites, as they constituted a large majority of the participants and were the subgroup that had the sample size to derive reliable inferences. The analyses showed that 67% experienced 1-2 episodes/day, 90% experienced >15-minute episodes, and 55% reported slight-mild severity/episode. Lower age was associated with a higher frequency (incidence rate ratio [IRR]: 0.992; P<0.001) and severity (odds ratio [OR]: 0.985; P=0.001) of OFF episodes. Income of <$35,000 was associated with 15.1% more episodes/day (IRR: 1.15, p<0.001) and 66.5% higher odds of a severe episode (OR: 1.66; P<0.001). Females experienced 7.5% more episodes compared to males (IRR: 1.075; P=0.003). Longer PD duration was associated with 1.3% more episodes/day (IRR: 1.013; P<0.001) and 10% higher odds of a severe episode (OR: 1.10; P<0.001). Lower age, income <$35,000, longer PD duration, female gender, and being unemployed are associated with a higher frequency and severity of OFF periods with no associations for duration/episode among non-Hispanic Whites with PD. In time-constrained clinic environments, clinicians should tailor OFF periods management counseling to vulnerable demographic groups to enhance care delivery.(J Patient Cent Res Rev. 2024;11:8-17.).

Patient-centred pathology reporting improves patient experience and understanding of disease in prostate cancer care.

Patient-centred (PC) and holistic care improves patient satisfaction and health outcomes. We sought to investigate the benefit of utilising a PC pathology report in patients undergoing radical prostatectomy (RP) for prostate cancer (PCa). Our study aimed to evaluate and compare patient understanding of their PCa diagnosis after RP, upon receiving either a standard histopathology report or a personalised and PC report (PCR). Moreover, we evaluated knowledge retention at 4 weeks after the initial consultation. We invited patients undergoing RP at three metropolitan Urology clinics to participate in our randomised controlled study. Patients were randomised to receive either a PCR or standard pathology report. Patient satisfaction questionnaires (Perceived Efficacy in Patient-Physician Interactions [PEPPI], Consultation and Relational Empathy [CARE] and Communication Assessment Tool [CAT]) and a knowledge test were conducted within 72 h of the initial appointment and again at 4 weeks. Accurate recollection of Gleason grade group (GGG) and extracapsular extension (ECE) were classified as 'correct'. Baseline demographic data included age, education, marital and employment status, pre-op prostate specific antigen (PSA) and clinical stage. Baseline data were tested for differences between groups using the Student's t test, chi-squared test or Fisher's exact test depending on whether data were continuous, categorical or sparse. Comparison of correctly answered 'knowledge' questions was analysed using chi-squared test. A significance level of p ≤ 0.05 was used. Data from 62 patients were analysed (30 standard vs. 32 PCR). No significant differences in baseline demographics were found between groups. Both groups reported high levels of satisfaction with their healthcare experiences in all domains of patient-physician rapport, empathy and communication. There were no significant differences between groups in PEPPI (p = 0.68), CAT (p = 0.39) and CARE (p = 0.66) scores, at baseline and 4 weeks. Ninety-three per cent of patients who received the PCR understood the report while 90% felt the report added to their understanding of their PCa. Regarding patient knowledge, the PCR group had significantly more correct answers on GGG and ECE as compared with the standard report group at baseline and 4 weeks (p < 0.001 and 0.001, respectively). Our findings demonstrate that PC pathology reports improve patient knowledge and understanding of their PCa that is retained for at least 4 weeks after initial receipt of results.

A Study to Demonstrate Impact of Active Referral of Acute Leukemia Patients and Families to Patient Organization at Diagnosis

Introduction and background Key factors that relate to worse quality of life (QoL) in acute leukemia patients were identified in a global survey conducted by the Acute Leukemia Advocates Network (ALAN) such as age, gender, socioeconomic state, social functioning (e.g., worries about family and friends, feeling isolated, finances, etc.[ Pemberton-Whiteley et al, 2023]). These factors should be taken into consideration by healthcare professionals caring for acute leukemia patients to enable a robust support system. The role of patient organizations (PO) in the care of the patient and family is becoming increasingly important, however, patients are often not aware of the existence of POs and physicians and providers are often unsure of the role and benefits of PO, which then leads to a delay in patients reaching out to POs (for information, education resources, support resources [support groups, online chat, peer-to-peer support, financial support, psychological support, carer support], etc.). To date, there is limited evidence showing the importance of support offered to patients and their families. The ALAN, the Mayo Clinic and a national PO, are conducting a study that aims to assess both retrospectively and prospectively the benefits of active referrals to PO for patients with acute leukemia. Hypothesis We hypothesize that active referrals of adult patients with acute leukemia to PO at diagnosis has a positive impact on patient-reported outcomes and patient experience. Methods Here we present the study methodology that uses a quantitative method via administration of surveys at different timepoints. We plan to do both a retrospective and prospective evaluation of patients (target N=200) previously referred and new patients with a diagnosis of acute leukemia. There are 4 scenarios which are presented in Figure 1. For patients already diagnosed and evaluated at Mayo Clinic (scenarios 3 and 4), we will contact them either via email or portal message to see if they are interested in the study. A study consent form will be sent to them. If they indicate interest and consent, they will be contacted to understand whether they were referred to or sought help from PO around the time of their diagnosis or subsequently, and a questionnaire will be sent to them to assess if PO services helped them in their disease or treatment course. For newly diagnosed patients (scenarios 1 and 2), active referral to PO using PO referral online form will be provided and they will receive study consent form during their first visit at Mayo Clinic. A questionnaire will be sent to them to understand if they used the services from PO after the referral and if yes, to assess if PO services helped them in their disease or treatment course. In addition, every month from diagnosis up to 6 months, all patients who consented to take part in the study will be asked to complete the validated HM-PRO QoL assessment tool (an instrument designed to measure patient-reported outcomes in those with hematological malignancies), to assess QoL and symptoms and change over time. Conclusion This is a pilot study aiming at building evidence on the importance of support offered to patients and their families and demonstrating the impact of an active referral at diagnosis. 1 Pemberton-Whiteley Z, Nier S, Geissler J, Wintrich S, Verhoeven B, Christensen RO, Salek S, Oliva EN, Ionova T, Bradley J. Understanding quality of life in patients with acute leukemia, a global survey. J Patient Cent Res Rev. 2023;10:21-30

Treatment outcomes of graded dose of empagliflozin in type-2 diabetes: A real world study.

Background:Costs are important cause of therapeutic noncompliance in type-2 diabetes mellitus (T2DM). Half-tablet empagliflozin (EMPA)-25 mg has lowest monthly cost among all EMPA preparations; data is unavailable on efficacy of half EMPA-25. This study compared real world weight loss and glycaemic outcomes of 10 mg versus 12.5 mg versus 25 mg of EMPA.Methods:Data, retrospectively captured from records of 2 different centresfor patients > 35 years-age having T2DM on EMPA as part of standard pharmacotherapy for T2DM, having > 6 months follow-up data available was analysed. Patients were in 3-groups depending on EMPA dosage: Group 1 on EMPA 10 mg/day (1-tablet EMPA-10), Group-2 on EMPA 12.5 mg/day (half-tablet EMPA-25), and Group 3 on EMPA 25 mg/day (1-tablet EMPA-25). Primary endpoints were glycaemic efficacy and weight-loss.Results:Of 3601 records screened, data from 599 patients (184, 239 and 176 in Group-1, 2 and 3 respectively) was analysed. All 3 groups were comparable with regards to sex, blood pressure, haemoglobin, renal function, medications use. Group-3 were significantly older, had longest diabetes duration, highest HbA1c and lowest body mass index. Glycaemic efficacy was comparable among groups (ΔHbA1c Groups 1-3: −0.9 (−1.9 – 0.0), −1.0 (−1.8 – 0.5) and − 1.0 (−1.5 – 0.22], respectively; P = 0.363). Patients on EMPA 12.5 or 25 mg/d had significantly higher total (−1.4 [−3.0 –0.2] vs. −0.3 [−2.4 – 1.32] kg; P = 0.028) and percent weight-loss (−1.75% [−4.15 – 0.26] vs. −0.44% [−3.11 – 1.39]; P = 0.039), and significantly higherfraction achieving HbA1c < 5.7% (12% vs. 0; P = 0.021), compared to EMPA-10.Conclusion:Half EMPA-25 is the most cost effective way of using EMPA in clinical practice.

Transcultural Nurse Views on Culture-Sensitive/Patient-Centered Assessment and Care Planning: A Descriptive Study.

Culture-sensitive (CS) and patient-centered (PC) care are considered essential to achieve high-quality equitable care. The purpose of this study was to determine how expert nurses incorporate CS/PC care into their assessment and care planning practices, especially for culturally diverse and marginalized patients. Using a qualitative, descriptive design, we conducted a focus group at the October 2019 Transcultural Nursing Society Conference. Participants (n = 9) discussed how they instilled cultural sensitivity and patient-centeredness into their assessment and care planning skills. Participants revealed attitudes, knowledge, and skills associated with CS/PC assessment and care planning. They also identified specific strategies for translating CS/PC theory into assessment and care planning practices. Three principles and many pragmatic strategies for incorporating CS/PC care into daily practice emerged from the data. Nurses may find these principles and strategies helpful in integrating CS/PC care into their daily care of patients in busy clinical settings.

Patient-centered approaches applied in inpatient and outpatient TB services in Armenia

Abstract Background Healthcare system performance indicators are common instruments measuring and facilitating quality improvement. The End-TB strategy urges provision of integrated patient-centered (PC) care for all forms of tuberculosis (TB). This study aimed to assess and compare quality of inpatient and outpatient TB services using international standards on specific PC indicators to identify potential targets for improvement. Methods Joint Commission International (JCI) accreditation standards, adapted to local needs and context, were used as a basic instrument for qualitative and quantitative data collection. We utilized Patient and Family Right (PFR) and Patient and Family Education (PFE) 15 standards with 49 measurable elements as PC indicators for the nationwide assessment of TB services. A scoring system and a scaling approach were used to convert all-source-data and present the overall performance of services. Results We reviewed and analyzed data from 10 legal documents, 34 medical records and 155 interviews and focus group discussions with TB healthcare providers, patients and family members from inpatient and outpatient TB services to define the degree of compliance of their practices and treatment experiences to JCI standards. Outpatient TB services met the PFR and PFE standards at the 51%-level receiving a grading of partially performed and requiring improvements. The inpatient services met the PFR and PFE standards at 39%- and 26%-level respectively, receiving a grading of minimally performed for the JCI standards, showing statistically significantly less patient centeredness compared to the outpatient services (p = 0.007, CI 0.234; 0.4234), and requiring major improvements. Conclusions Strengthening interventions towards patient-centeredness are essential in both inpatient and outpatient services, but Armenia needs to put more emphasis on inpatient care to bridge the gap between the existing and recommended practices.

Assessing Patients' Perceptions of Clinician Communication: Acceptability of Brief Point-of-Care Surveys in Primary Care.

Improving patient-centered (PC) communication is a priority in many healthcare organizations. Most PC communication metrics are distal to the care encounter and lack clear attribution, thereby reducing relevance for leaders and clinicians. We assessed the acceptability of measuring PC communication at the point-of-care. A brief patient survey was conducted immediately post-primary care appointments at one Veterans Affairs Medical Center. Audit-feedback reports were created for clinicians and discussed in qualitative interviews. A total of 485 patients completed the survey. Thirteen interviews were conducted with clinicians and hospital leaders. Measures included collaboRATE (a 3-item tool measuring PC communication), a question about how well needs were met, and overall visit satisfaction. Data were analyzed using descriptive statistics to characterize the mean and distribution of collaboRATE scores and determine the proportion of patients giving clinicians a "top score" on each item. Associations among responses were examined. Interviews focused on the value of measuring PC communication and were analyzed using a framework approach. The proportion of patients giving PC communication "top scores" ranged from 41 to 92% for 16 clinicians who had ≥ 25 completed surveys. Among patients who gave "top scores" for PC communication, the odds of reporting that needs were "completely met" were 10.8 times higher (p < .001) and the odds of reporting being "very satisfied" with their care were 13.3 times higher (p < .001) compared with patients who did not give "top scores." Interviewees found clinician-specific feedback useful; concerns included prioritizing this data when other measures are used to evaluate clinicians' performance. Difficulties improving PC communication given organizational structures were noted. Recommendations for interventions included peer-to-peer education and mentoring by top-scoring clinicians. Assessing provider communication at the point-of-care is acceptable and useful to clinicians. Challenges remain to properly incentivize and support the use of this data for improving PC communication.

The technological, organizational and environmental determinants of adoption of mobile health applications (m-health) by hospitals in Kenya.

IntroductionSub-Saharan Africa lags in adoption of mobile health (m-health) applications and in leveraging m-health for sustainable development goals. There is a need for a comprehensive investigation of determinants of hospitals’ adoption of m-health in Sub-Saharan Africa to inform policies, practices and investments.MethodsThis investigation used a logit regression model to analyze the determinants of m-health adoption in Kenyan hospitals applying the Technological, Organizational and Environmental (TOE) framework and the Diffusion of Innovation (DOI) theory. A representative sample of 211 executives of Level 4–6 hospitals in 24 counties provided primary data on Patient-Centered (PC) and Facility-Centered (FC) m-health applications.ResultsBoth PC and FC m-health adoption were predicted by competition for patients (PC p = 0.041, FC p = 0.021), IT human resource capacity (PC p = 0.048, FC p = 0.037), and hospital pursuit of market growth through technological leadership (PC p = 0.010, FC p = 0.020). Further determinants of PC m-health adoption included hospital access to slack financial resources (p = 0.006), acquisition strategy (p = 0.011), compatibility with the hospital systems (p = 0.015), trialability (p = 0.019), medical insurance company support (p = 0.025),patient pressure (p = 0.036), and perceived effect of global medical tourism (p = 0.039). FC m-health adoption was predicted by hospital size (p = 0.008), ICT infrastructure capacity (p = 0.041), and government support (p = 0.013).ConclusionA differentiated approach is required to scale up m-health adoption. PC m-health requires emphasis on establishing national and regional compatibility and interoperability, developing trialability processes and validation mechanisms, incentivizing patient competition and mobility, establishing innovative and cost-effective acquisition strategies, and ensuring integration of digital services within national insurance schemes and policies. These policies require support from patients and communities to drive demand and spur investment in adequate IT human resources to maintain reliability. Pilot PC m-health projects should prioritize hospitals with slack financial resources, while FC m-health should target large facility size. FC m-health applications are more complex and costly than PC, requiring government incentives to trigger hospital investments and national investment in ICT infrastructure. Investors and hospital managers should integrate m-health into market growth strategies for sustainable m-health scale-up in Kenya and beyond.

The Moderating Role Of Top Executives' Sex, Level Of Education And Knowledge On Adoption Of Mobile Health Applications By Hospitals In Kenya.

BackgroundKenya lags behind other countries in adoption of mobile health (m-health) applications. Understanding factors affecting adoption of m-health by hospitals is required to inform strategic scale up and leverage m-health for sustainable development goals. This study investigated the moderating effects of Top Executives’ (TEs) traits, namely sex, level of education and knowledge of m-health, on adoption of Patient Centered (PC) and Facility-Centered (FC) m-health applications.MethodsThis study applied the Technological, Organizational and Environmental (TOE) framework and the Diffusion of Innovation (DOI) theory to test hypotheses that TEs' traits individually or combined had no statistically significant moderating effect on adoption of PC and FC m-health applications. Primary data were collected through a self-administered questionnaire from a representative sample size of 211 TEs from level 4 to 6 hospitals. The Logit Regression Model was used to determine the significance of each predictor.ResultsMost TEs of hospitals are predominantly male (75.3%). Most TEs (65%) rated their knowledge of m-health at medium level. Most TEs reported having completed undergraduate (46%) or post-graduate (38.4%) degrees. At 5% level of significance, the study found that being a male TE (p=0.041) and having higher level of knowledge of m-health (p=0.009) were statistically significant moderators of adoption of PC m-health applications by hospitals in Kenya. However, all TEs' traits combined or individually were not statistically significant moderators of FC m-health applications. The moderating effect of TEs' traits is thus affected by the focus, level of complexity of the technology, and by the required organizational change management. For PC scale-up, there is an urgent need to integrate digital health training in the medical education curricula and in the professional development programs and to develop policy incentives that remove any gender-related barriers to adoption of m-health. However, scale up of FC m-health may require other strategies such as pre-existence of systems and infrastructure and a cohesive change management strategy.ConclusionThis study recommends a differentiated approach to introduction, scale up, and investigation of PC and FC m-health applications.

Clinical performance of minimally invasive periodontal surgery in the treatment of infrabony defects: Systematic review and meta-analysis.

To assess the effectiveness, in terms of clinical performance and patient perception, of minimally invasive periodontal surgeries (MIPSs), and to compare MIPSs to traditional surgery in the treatment of periodontal infrabony defects. An electronic search and a manual search were carried out to identify studies investigating clinical (CAL, PPD, REC), radiographic (bone fill) and patient's centred (VAS) outcomes at least 6months after MIPSs. A linear mixed-effect model was used for meta-analysis. Subgroup analyses were performed according to the study quality (RCT or case series). A meta-analysis assessing differences in clinical parameters between MIPSs and traditional flaps was also performed. Meta-analysis from the 18 included studies revealed a PPD reduction of 4.24mm (95% CI=3.79-4.69mm), a CAL gain of 3.89mm (95% CI=3.42-4.35mm), a REC increase of 0.44mm (95% CI=0.11-0.77mm), a radiographic bone fill gain of 58.25% (95% CI=42.30%-74.21%) and a VAS value of 1.16 (95% CI=0.78-1.54). Based on 2 RCTs, MIPSs are more effective than traditional surgery for PPD reduction (0.93mm, 95% CI=1.71-0.15) and CAL gain (1mm, 95% CI=1.75-.24). Minimally invasive periodontal surgeries may be considered for the treatment of periodontal infrabony defects. However, the real effect cannot be systematically evaluated due to the paucity of studies comparing MIPSs to traditional flap for periodontal reconstructive surgery.

Moderating role of transformational leadership styles of hospital management boards on adoption of mobile health innovations by hospitals in Kenya

Sub-Saharan Africa lags other regions in the adoption of both Patient-Centered (PC) and Facility Centered (FC) mobile health (m-health) applications. Transformational Leadership Style (TLS) of Hospital Management Boards (HMBs) is catalytic for the adoption of disruptive technologies such as m-health by hospitals. There is limited evidence on the effect of TLS of HMBs in the adoption of innovations in Low- and Middle-Income Countries (LMICS). This study investigated the moderating role of TLS of HMBs on the adoption of PC and FC m-health by hospitals in Kenya. It used the Logit Regression Model to test null hypotheses that the four constructs of TLS (Idealized Influence (II), Individualized Consideration (IC), Inspirational Motivation (IM), Intellectual Stimulation (IS)) individually or combined had no significant moderating effect on adoption of PC and FC m-health applications. Primary data was collected from a representative sample size of 211 Top Executives (TEs) of level 4 to 6 hospitals who evaluated the TLS of their HMBs on m-health adoption. At a 5% level of significance, the study found that only the combined application of the four constructs (II, IC, IM, IS) significantly moderated the adoption of PC m-health (p=0.046) but did not moderate FC m-health (p=0.345). Each incremental application of TLS would increase the odds of adopting PC m-health by 1.002 but not for FC. Therefore, this study recommends the capacity strengthening of HMBs in TLS to scale up PC m-health adoption in Kenya and other LMICs. It also recommends a differentiated approach to policies, practices, and theories of adoption of innovations using the PC-FC models.

Evaluating organizational change in health care: the patient-centered hospital model

BackgroundAn increasing number of hospitals react to recent demographic, epidemiological and managerial challenges moving from a traditional organizational model to a Patient-Centered (PC) hospital model. Although the theoretical managerial literature on the PC hospital model is vast, quantitative evaluations of the performance of hospitals that moved from the traditional to the PC organizational structure is scarce. However, quantitative analysis of effects of managerial changes is important and can provide additional argument in support of innovation.MethodsWe take advantage of a quasi-experimental setting and of a unique administrative data set on the population of hospital discharge charts (HDCs) over a period of 9 years of Lombardy, the richest and one of the most populated region of Italy. During this period three important hospitals switched to the PC model in 2010, whereas all the others remained with the functional organizational model. This allowed us to develop a difference-in-difference analysis of some selected measures of efficiency and effectiveness for PC hospitals focusing on the “between-variability” of the 25 major diagnostic categories (MDCs) in each hospital and estimating a difference-in-difference model.ResultsWe contribute to the literature that addresses the evaluation of healthcare and hospital change by providing a quantitative estimation of efficiency and effectiveness changes following to the implementation of the PC hospital model. Results show that both efficiency and effectiveness have significantly increased in the average MDC of PC hospitals, thus confirming the need for policy makers to invest in new organizational models close to the principles of PC hospital structures.ConclusionsAlthough an organizational change towards the PC model can be a costly process, implying a rebalancing of responsibilities and power among hospital personnel (e.g. medical and nursing staff), our results suggest that changing towards a PC model can be worthwhile in terms of both efficacy and efficiency. This evidence can be used to inform and sustain hospital managers and policy makers in their hospital design efforts and to communicate the innovation advantages within the hospital organizations, among the personnel and in the public debate.

Patient-centred dietetic care from the perspectives of older malnourished patients.

Governing organisations for health services currently recommend a patient-centred (PC) approach to practice for all health professions, including dietetics. For the vulnerable older malnourished patient, this approach needs to be prioritised to improve outcomes. The paucity of patient experience data likely limits evidence-based, patient-centred care (PCC) from being implemented effectively. The present study aimed to identify quality indicators of dietetic services from the perspectives of older malnourished patients to inform evidence-based PC dietetic care. Surveys were completed by a sample of 28 females and 28 males (mean age 81 years) who had been seen by a dietitian for malnutrition assessment. In-depth, face-to-face, semi-structured interviews were undertaken with a sub-sample of four females and six males (mean age 81 years). Interviews were transcribed verbatim. Thematic analysis of transcripts and open-ended survey responses was conducted to determine patient-identified quality indicators. Three structure indicators (continuity of care through regular contact and post-discharge dietetic follow-up; interdisciplinary coordination and collaboration; and high-quality hospital food services), five process indicators (addressing a patient's primary medical concern; involving the patient's family; providing clear and simple dietetic information; providing expert dietary knowledge; utilising interpersonal communication skills) and three outcome indicators (improvement in health status; improvement or maintenance of independence; weight gain) were identified. The experiences of older malnourished patients with dietetic services, as described in the present study, reinforce the importance of ensuring high-quality and tailored dietetic care as a key element of PC dietetic services. The quality indicators of dietetic services identified in the present study may facilitate dietitians to provide evidence-based PCC for older malnourished patients.

64Cu-PSMA-617 PET/CT Imaging of Prostate Adenocarcinoma: First In-Human Studies.

The prostate-specific membrane antigen (PSMA) is a cell surface protein, which is overexpressed in nearly all cases of prostate cancer (PCa). PET imaging with 68Ga-PSMA-HBED-CC has recently found widespread application in the diagnosis of recurrent PCa. In this study, the diagnostic potential of 64Cu-labeled PSMA ligand (PSMA-617) PET in patients with PCa has been investigated. The study was conducted simultaneously at two nuclear medicine centers, Austria (Vienna, Center 1) and Germany (Bad Berka, Center 2). The patients (n = 29) included in this study were referred for PET (Center 1, 21 patients) or PET/CT (Center 2, 8 patients) imaging with either a high suspicion of recurrent disease or for possible surgical or PSMA radioligand therapy planning. PET images of the whole body were performed at 1 hour p.i. and additional images of the pelvis at 2 hours p.i. In 23 of 29 patients, at least one focus of pathological tracer uptake suspicious for primary disease in the prostate lobe or recurrent disease was detected. Among healthy organs, the salivary glands, kidneys, and liver showed the highest radiotracer uptake. Lesions suspicious for PCa were detected with excellent contrast as early as 1 hour p.i. with high detection rates even at low prostate-specific antigen (PSA) levels. The preliminary results of this study demonstrate the high potential of 64Cu-PSMA ligand PET/CT imaging in patients with recurrent disease and in the primary staging of selected patients with progressive local disease. The acquired PET images showed an excellent resolution of the detected lesions with very high lesion-to- background contrast. Furthermore, the long half-life of 64Cu allows distribution of the tracer to clinical PET centers that lack radiochemistry facilities for the preparation of 68Ga-PSMA ligand (satellite concept).

A Pilot Study of Circulating Tumor Cells in Stage IV Non-Small Cell Lung Carcinoma

Purpose Measurement of the number of circulating tumor cells (CTCs) in the bloodstream has been shown to have prognostic significance in treating breast carcinoma. This pilot study was formulated to determine if stage IV non-small cell lung carcinomas similarly shed malignant cells into the circulation and if their presence has prognostic significance. Methods Patients with stage IV non-small cell lung carcinomas were tested once for CTCs in 7.5 ml of their blood prior to receiving any treatments. A proprietary blood collection kit produced by Veridex LLC (Raritan, NJ), which manufactures the instrument that performs the immunomagnetic CELLSEARCH ® CTC assay, was used. Tumor measurements were determined in three dimensions by the same radiologist using computerized axial tomography. The three-dimensional sum was used to represent tumor size. Survival from the date of the pretreatment CTC assay was monitored and recorded. Data were analyzed statistically using NCSS8 statistical software (NCSS LLC, Kaysville, UT). Results Of 19 evaluable patients, 10 had no detectable CTCs. There was no relation between intrapulmonary primary tumor size and the number of CTCs, nor between tumor size and survival. Survival was not affected by gender or age at entry into the trial. The mean survival of those with no detectable CTCs was 536 ± 91.1 days versus 239 ± 96.0 days for those with 1 or more detectable CTCs, a statistically significant advantage (P=0.034) favoring those without CTCs. Conclusions Patients with a CTC score of 0 survived significantly longer than those with a CTC score of ≥ 1. Survival was not correlated with gender, age or primary tumor size. Recovery of CTCs potentially provides a noninvasive source of tumor cells for genomic profiling, which may enable development of a custom treatment plan for the individual patient. Further investigations are warranted and needed. (J Patient Cent Res Rev. 2016;3:136-141.)

Comparative effectiveness of a patient centered pathology report for bladder cancer care.

420 Background: We compared the effectiveness of a patient-centered (PC) version of bladder biopsy pathology reports derived from PC outcomes research methods with standard pathology reports. Methods: Local bladder cancer experts provided consensus on the important elements of a bladder biopsy pathology. Patient focus groups reviewed these elements and identified PC formats and language. Candidate reports were iterated with patients to arrive at a pilot PC bladder biopsy report. We enrolled 40 patients undergoing bladder biopsy for suspicion of initial or recurrent bladder cancer. Block randomization was performed to the standard report or the standard report and the pilot patient-centered pathology report (PCPR). Through web-based surveys, we assessed self-efficacy with the PEPPI (Perceived Efficacy in Patient-Physician Interactions), physician communication with the CAT (Communication Assessment Tool), knowledge based on comprehension of report elements prioritized by experts, and format preferences at pathology disclosure and one month later. We compared study groups with descriptive statistics. Results: The 26-member expert clinician panel identified stage, grade, and histology as the most important elements of a pathology report. Patients prioritized data expressed in a narrative format, an illustration of tumor stage, and risk stratification for future recurrence. From July 2014 to 2015, 39 patients completed initial and follow-up assessments. Patients that received the PCPR had an improved ability to identify their cancer stage (initial 58% vs 20%, p = 0.02; follow-up 47% vs 15%, p = 0.03) and trended toward improved identification of cancer grade (initial 74% vs 50%, p = 0.12) compared with patients that only received standard reports. Ratings of patient self-efficacy did not differ by report format and communication trended toward improved communication for patients exposed to PCPR. Conclusions: PCPR are associated with greater patient knowledge about their new cancer diagnosis and may aid patient-provider communication around a new cancer diagnosis. While these results require validation in larger cohorts, this pilot may serve as a model for the development of PCPR for other cancers.

Information security requirements in patient-centred healthcare support systems.

Enabling Patient-Centred (PC) care in modern healthcare requires the flow of medical information with the patient between different healthcare providers as they follow the patient's treatment plan. However, PC care threatens the stability of the balance of information security in the support systems since legacy systems fall short of attaining a security balance when sharing their information due to compromises made between its availability, integrity, and confidentiality. Results show that the main reason for this is that information security implementation in discrete legacy systems focused mainly on information confidentiality and integrity leaving availability a challenge in collaboration. Through an empirical study using domain analysis, observations, and interviews, this paper identifies a need for six information security requirements in legacy systems to cope with this situation in order to attain the security balance in systems supporting PC care implementation in modern healthcare.

1541 – Influence of discarnated people in mental diseases and its respective approach

The incidence and prevalence of mental diseases are growing throughout the world and their causes are not yet clearly established in spite of the recent advances in modern psychiatry. By using mediumnistic techniques, or the human ability to enter spiritual reality in an objective manner, we have come into contact with spirits and spiritual contexts that have a well defined relationship with each patient. This has happened in healing sessions in Spiritist Centers for patients with different mental diseases, such as depression, autism, schizophrenia and panic disorder. The diagnostic approach to uncover the spiritual aspects of each case happened with the aid of a team of doctors-mediums. In all cases the spirits were of human beings who had lived their lives in the past such as we live ours in the present. They were now in a spiritual reality that is a world parallel to ours. They interfered psychically in the lives of the patients, causing harm and maintaining the symptoms of specific mental diseases. The ties between these spirits and the patients were established in previous lives and old reincarnations. In a non-controlled prospective study of 48 patients with the mental diseases mentioned above, we were able to perceive them and to act in a psychotherapeutic manner with them such that we were able to undo the spiritual ties of each case. This resulted in an evident improvement of a significant percentage of the cases and even resulted in the complete and sustained recovery of many of them.

Dynamic posturography for staging of patients with Ménière's disease

In recent years, techniques such as computerised dynamic posturography have facilitated objective evaluation of patients with balance disorders. In this study, we used computerised dynamic posturography for clinical staging of Ménière's disease. We applied a computerised dynamic posturography sensory organisation test to 53 patients with American Academy of Otolaryngology criteria of Ménière's disease. The following parameters were considered in data analysis: computerised dynamic posturography scores for testing the patient's centre of gravity with a mobile surface, immobile visual surroundings and eyes closed, scores for testing with a mobile surface, mobile visual surroundings and eyes open, and vestibular ratio. We used four hearing threshold stages (although we had no patients at stage four). This study did not observe a statistically significant correlation between audiometric hearing thresholds and computerised dynamic posturography scores. Computerised dynamic posturography scores showed statistically significant variation with time elapsed since the last vertigo attack. Although our results showed an increasing trend in computerised dynamic posturography scores as Ménière's disease activity level decreased from recent post-attack (i.e. less than one week since last attack) through late post-attack (i.e. one week to 60 days since last attack) to inactive (i.e. more than 60 days since last attack), these differences were not statistically significant.