Engaging Community Stakeholders to Evaluate the Design, Usability, and Acceptability of a Chronic Obstructive Pulmonary Disease Social Media Resource Center

PubMed Central

Chaney, Beth; Chaney, Don; Paige, Samantha; Payne-Purvis, Caroline; Tennant, Bethany; Walsh-Childers, Kim; Sriram, PS; Alber, Julia

2015-01-01

Background Patients with chronic obstructive pulmonary disease (COPD) often report inadequate access to comprehensive patient education resources. Objective The purpose of this study was to incorporate community-engagement principles within a mixed-method research design to evaluate the usability and acceptability of a self-tailored social media resource center for medically underserved patients with COPD. Methods A multiphase sequential design (qual → QUANT → quant + QUAL) was incorporated into the current study, whereby a small-scale qualitative (qual) study informed the design of a social media website prototype that was tested with patients during a computer-based usability study (QUANT). To identify usability violations and determine whether or not patients found the website prototype acceptable for use, each patient was asked to complete an 18-item website usability and acceptability questionnaire, as well as a retrospective, in-depth, semistructured interview (quant + QUAL). Results The majority of medically underserved patients with COPD (n=8, mean 56 years, SD 7) found the social media website prototype to be easy to navigate and relevant to their self-management information needs. Mean responses on the 18-item website usability and acceptability questionnaire were very high on a scale of 1 (strongly disagree) to 5 (strongly agree) (mean 4.72, SD 0.33). However, the majority of patients identified several usability violations related to the prototype’s information design, interactive capabilities, and navigational structure. Specifically, 6 out of 8 (75%) patients struggled to create a log-in account to access the prototype, and 7 out of 8 patients (88%) experienced difficulty posting and replying to comments on an interactive discussion forum. Conclusions Patient perceptions of most social media website prototype features (eg, clickable picture-based screenshots of videos, comment tools) were largely positive. Mixed-method stakeholder feedback was used to make design recommendations, categorize usability violations, and prioritize potential solutions for improving the usability of a social media resource center for COPD patient education. PMID:25630449

Effectiveness of Different Bristle Designs of Toothbrushes and Periodontal Status among Fixed Orthodontic Patients: A Double-blind Crossover Design.

PubMed

Naik, Sandhya P; Punathil, Sameer; Shetty, Praveena; Jayanti, Ipsita; Jalaluddin, Md; Avijeeta, Anisha

2018-02-01

The aim of the present study was to evaluate the effectiveness of different bristle designs of toothbrushes and the periodontal status among patients undergoing fixed orthodontic treatment. This randomized controlled trial (RCT) consisted of 45 adolescents (comprising 20 males and 25 females) undergoing fixed orthodontic treatment. The study participants were randomly allocated to three groups, each group being assigned a locally available toothbrush with a particular design of toothbrush bristle. In the first test phase, group I study participants were allocated to toothbrush with flat bristles, group II study subjects were allocated to toothbrush with zigzag bristles, and group III study participants were allocated to toothbrush with crisscross bristles. The study participants were recalled after 4 weeks to check the effectiveness of the allocated toothbrushes. A washout period of 1 week was maintained to ensure that there was no carryover effect of the different bristle designs. In the second test phase, each patient used the opposite toothbrush bristle design (group I: toothbrush with zigzag bristles, group II: toothbrush with crisscross bristles, and group III: toothbrush with flat bristles). Plaque scores were measured using Turesky-Gilmore-Glickman modification of Quigley-Hein plaque index (PI). In both phase 1 and 2 of this RCT, toothbrush with crisscross bristles exhibited maximum plaque reduction among the three different bristle design toothbrushes following 30 days (p = 0.312 ± 0.102 and 0.280 ± 0.110, respectively), which was statistically significant. It was concluded that all the three designs of toothbrushes were effective in removing plaque in patients with fixed orthodontic appliances. But among the three different toothbrushes, toothbrush with crisscross bristles showed the highest mean plaque reduction. Plaque accumulation around the orthodontic brackets and gingival margins is quite common among the fixed orthodontic patients, who encounter difficulty in maintaining good oral hygiene. Specially designed toothbrushes are very essential for effective plaque removal among the patients undergoing fixed orthodontic treatment.

Study design for a hepatitis B vaccine trial.

PubMed Central

Lustbader, E D; London, W T; Blumberg, B S

1976-01-01

A short-time trial of small sample size for an evaluation of the hepatitis B vaccine is proposed and designed. The vaccine is based on the premise that antibody to the surface antigen of the hepatitis B virus is protective against viral infection. This premise is verified by using the presence of the surface antigen as the marker of infection and comparing infection rates in renal dialysis patients who had naturally acquired antibody to patients without antibody. Patients with antibody have an extremely low risk of infection. The probability of remaining uninfected decreases at an exponential rate for patients without antibody, implying a constant risk of infection at any point in time. The study design described makes use of this time independence and the observed infection rates to formulate a clinical trial which can be accomplished with a relatively small number of patients. This design might be useful if, in preliminary studies, it is shown that the vaccine produces antibody in the patients and that protection against hepatitis B virus would be beneficial to the patients. PMID:1062809

Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies.

PubMed

Franklin, Jessica M; Rassen, Jeremy A; Bartels, Dorothee B; Schneeweiss, Sebastian

2014-01-01

Nonrandomized safety and effectiveness studies are often initiated immediately after the approval of a new medication, but patients prescribed the new medication during this period may be substantially different from those receiving an existing comparator treatment. Restricting the study to comparable patients after data have been collected is inefficient in prospective studies with primary collection of outcomes. We discuss design and methods for evaluating covariate data to assess the comparability of treatment groups, identify patient subgroups that are not comparable, and decide when to transition to a large-scale comparative study. We demonstrate methods in an example study comparing Cox-2 inhibitors during their postmarketing period (1999-2005) with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Graphical checks of propensity score distributions in each treatment group showed substantial problems with overlap in the initial cohorts. In the first half of 1999, >40% of patients were in the region of nonoverlap on the propensity score, and across the study period this fraction never dropped below 10% (the a priori decision threshold for transitioning to the large-scale study). After restricting to patients with no prior NSAID use, <1% of patients were in the region of nonoverlap, indicating that a large-scale study could be initiated in this subgroup and few patients would need to be trimmed from analysis. A sequential study design that uses pilot data to evaluate treatment selection can guide the efficient design of large-scale outcome studies with primary data collection by focusing on comparable patients.

Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study.

PubMed

Schulz, Constanze; Timm, Jürgen; Cordes, Joachim; Gründer, Gerhard; Mühlbauer, Bernd; Rüther, Eckart; Heinze, Martin

2016-06-01

The 'gold standard' for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design. It is widely accepted that second-generation antipsychotics are the therapy of choice in the treatment of schizophrenia. However, their general superiority over first-generation antipsychotics could not be demonstrated in recent randomised controlled trials. Furthermore, we are becoming increasingly aware that the experimental conditions of randomised controlled trials, as in the European First Episode Schizophrenia Trial and Clinical Antipsychotic Trials of Intervention Effectiveness Phase 1 studies, may be inappropriate for psychiatric treatments. The high heterogeneity in the patient population produces discrepancies between daily clinical perception and randomised controlled trials results. The patient-oriented approach in the Cost Utility of the Latest Antipsychotic drugs in Schizophrenia Study reflects everyday clinical practice. The results, however, are highly dependent on the physicians' preferences. The goal of the design described here is to take an intermediate path between randomised controlled trials and clinical studies such as Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study, combining the advantages of both study types. The idea is to randomise two treatment pairs each consisting of one first-generation antipsychotic and one second-generation antipsychotic in a first step and subsequently, to involve the investigators in deciding for a pair most appropriate to the patients' needs and then to randomise the allocation to one drug (first-generation antipsychotic or second-generation antipsychotic) of that chosen pair. This idea was first implemented in the clinical trial, the Neuroleptic Strategy Study, with a randomised design comparing efficacy and safety of two different strategies: either to use first-generation antipsychotics (haloperidol and flupentixol) or second-generation antipsychotics (olanzapine, aripiprazole and quetiapine) in patients suffering from schizophrenia. In the course of the Neuroleptic Strategy Study, feasibility of this design was demonstrated. All aspects of the new design were implemented: randomisation process, documentation of responses from investigators as well as patients and drug logistic experience. In implementing the design, furthermore, we could investigate its theoretical properties. The physicians' preferences for specific drugs used for the respective patients were analysed. The idea of patient-oriented randomisation can be generalised. In light of the heterogeneity and complexity of patient-drug interaction, this design should prove particularly useful. © The Author(s) 2016.

Lessons for Successful Study Enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study

PubMed Central

Crowley, Susan T.; Chertow, Glenn M.; Vitale, Joseph; O'Connor, Theresa; Zhang, Jane; Schein, Roland M.H.; Choudhury, Devasmita; Finkel, Kevin; Vijayan, Anitha; Paganini, Emil; Palevsky, Paul M.

2008-01-01

Background and objectives: Design elements of clinical trials can introduce recruitment bias and reduce study efficiency. Trials involving the critically ill may be particularly prone to design-related inefficiencies. Design, setting, participants, & measurements: Enrollment into the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was systematically monitored. Reasons for nonenrollment into this study comparing strategies of renal replacement therapy in critically ill patients with acute kidney injury were categorized as modifiable or nonmodifiable. Results: 4339 patients were screened; 2744 fulfilled inclusion criteria. Of these, 1034 were ineligible by exclusion criteria. Of the remaining 1710 patients, 1124 (65.7%) enrolled. Impediments to informed consent excluded 21.4% of potentially eligible patients. Delayed identification of potential patients, physician refusal, and involvement in competing trials accounted for 4.4, 2.7, and 2.3% of exclusions. Comfort measures only status, chronic illness, chronic kidney disease, and obesity excluded 11.8, 7.8, 7.6, and 5.9% of potential patients. Modification of an enrollment window reduced the loss of patients from 6.6 to 2.3%. Conclusions: The Acute Renal Failure Trial Network Study's enrollment efficiency compared favorably with previous intensive care unit intervention trials and supports the representativeness of its enrolled population. Impediments to informed consent highlight the need for nontraditional acquisition methods. Restrictive enrollment windows may hamper recruitment but can be effectively modified. The low rate of physician refusal acknowledges clinical equipoise in the study design. Underlying comorbidities are important design considerations for future trials that involve the critically ill with acute kidney injury. PMID:18385390

Identifying Facilitators and Barriers for Patient Safety in a Medicine Label Design System Using Patient Simulation and Interviews.

PubMed

Dieckmann, Peter; Clemmensen, Marianne Hald; Sørensen, Trine Kart; Kunstek, Pina; Hellebek, Annemarie

2016-12-01

Medicine label design plays an important role in improving patient safety. This study aimed at identifying facilitators and barriers in a medicine label system to prevent medication errors in clinical use by health care professionals. The study design is qualitative and exploratory, with a convenience sample of 10 nurses and 10 physicians from different acute care specialties working in hospitals in the Capital Region of Denmark. In 2 patient simulation scenarios and a sorting task, the participants selected the medicines from a range of ampules, vials, and infusion bags. After each scenario and in the end of the study, the participants were interviewed. Notes were validated with the participants, and content was analyzed. The label design benefited from the standardized construction of the labels, the clear layout and font, and some warning signs. The complexity of the system and some inconsistencies (different meaning of colors) posed challenges, when considered with the actual application context, in which there is little time to get familiar with the design features. For optimizing medicine labels and obtaining the full benefit of label design features on patient safety, it is necessary to consider the context in which they are used.

The incident user design in comparative effectiveness research.

PubMed

Johnson, Eric S; Bartman, Barbara A; Briesacher, Becky A; Fleming, Neil S; Gerhard, Tobias; Kornegay, Cynthia J; Nourjah, Parivash; Sauer, Brian; Schumock, Glen T; Sedrakyan, Art; Stürmer, Til; West, Suzanne L; Schneeweiss, Sebastian

2013-01-01

Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

The Role of Hospital Design in Reducing Anxiety for Pediatric Patients.

PubMed

Cartland, Jenifer; Ruch-Ross, Holly S; Carr, Lauren; Hall, Audrey; Olsen, Richard; Rosendale, Ellen; Ruohonen, Susan

2018-01-01

To study the impact of hospital design on patient and family experiences during and after hospitalization. Hospitalization can be psychologically traumatic for children. Few research studies have studied the role of the design of the hospital environment in mitigating that traumatic experience. The study employs a two-group posttest and follow-up design to compare the impact of hospitalization on child anxiety and parent stress. It compares the experiences of children (ages 3-17) hospitalized at a new facility designed to support child-centered care and with family-friendly features with an older facility that did not have these features. The new facility was a replacement of the old one, so that many challenges to comparison are addressed. Controlling for the facts of hospitalization, patient demographics, and the child's typical anxiety level, children in the new facility experienced less anxiety than in the old facility. The study does not provide evidence that the hospital design reduced the psychological sequelae of hospitalization. Parents and children found different features of the hospital to be restorative. The study supports the use of Ulrich's theory of supportive design to children's healthcare environments, though what is experienced as supportive design will vary by the developmental stage of the child.

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

PubMed Central

Ayres, J G; Frost, C D; Holmes, W F; Williams, D R R; Ward, S M

1998-01-01

Objective To evaluate the safety of a non-chlorofluorocarbon metered dose salbutamol inhaler. Design This was a postmarketing surveillance study, conducted under formal guidelines for company sponsored safety assessment of marketed medicines (SAMM). A non-randomised, non-interventional, observational design compared patients prescribed metered doses of salbutamol delivered by inhalers using either hydrofluoroalkane or chlorofluorocarbon as the propellant. Follow up was three months. Setting 646 general practices throughout the United Kingdom. Subjects 6614 patients with obstructive airways disease (1667 patient years of exposure). Main outcome measures Proportions of patients who were: admitted to hospital for respiratory diseases, reported adverse side effects, or withdrew because of adverse affects. Results There were no significant differences between the hydrofluoroalkane (HFA 134a) and chlorofluorocarbon inhaler groups in relation to the proportions of patients admitted to hospital for respiratory diseases (odds ratio 0.75; 95% confidence interval 0.51 to 1.08) or the proportions who reported adverse events (1.01; 0.88 to 1.17). However, more patients using the hydrofluoroalkane inhaler than the chlorofluorocarbon inhaler withdrew because of adverse events (3.8% and 0.9% respectively). Conclusion The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies. Key messagesCredibility of postmarketing surveillance studies is expected to increase after the introduction of guidelines covering their conduct The study design successfully fulfilled the requirements of these guidelines in terms of the number, rate, and geographical spread of patients recruitedSafety of salbutamol inhalers using hydrofluoroalkane and chlorofluorocarbon as propellants is similarImportant differences in study design/conduct and outcome between a postmarketing surveillance study and a randomised clinical trial merit further consideration. PMID:9756813

Interactive tools for inpatient medication tracking: a multi-phase study with cardiothoracic surgery patients

PubMed Central

Woollen, Janet; Prey, Jennifer; Restaino, Susan; Bakken, Suzanne; Feiner, Steven; Sackeim, Alexander; Vawdrey, David K

2016-01-01

Objective Prior studies of computing applications that support patients’ medication knowledge and self-management offer valuable insights into effective application design, but do not address inpatient settings. This study is the first to explore the design and usefulness of patient-facing tools supporting inpatient medication management and tracking. Materials and Methods We designed myNYP Inpatient, a custom personal health record application, through an iterative, user-centered approach. Medication-tracking tools in myNYP Inpatient include interactive views of home and hospital medication data and features for commenting on these data. In a two-phase pilot study, patients used the tools during cardiothoracic postoperative care at Columbia University Medical Center. In Phase One, we provided 20 patients with the application for 24–48 h and conducted a closing interview after this period. In Phase Two, we conducted semi-structured interviews with 12 patients and 5 clinical pharmacists who evaluated refinements to the tools based on the feedback received during Phase One. Results Patients reported that the medication-tracking tools were useful. During Phase One, 14 of the 20 participants used the tools actively, to review medication lists and log comments and questions about their medications. Patients’ interview responses and audit logs revealed that they made frequent use of the hospital medications feature and found electronic reporting of questions and comments useful. We also uncovered important considerations for subsequent design of such tools. In Phase Two, the patients and pharmacists participating in the study confirmed the usability and usefulness of the refined tools. Conclusions Inpatient medication-tracking tools, when designed to meet patients’ needs, can play an important role in fostering patient participation in their own care and patient-provider communication during a hospital stay. PMID:26744489

Interactive tools for inpatient medication tracking: a multi-phase study with cardiothoracic surgery patients.

PubMed

Wilcox, Lauren; Woollen, Janet; Prey, Jennifer; Restaino, Susan; Bakken, Suzanne; Feiner, Steven; Sackeim, Alexander; Vawdrey, David K

2016-01-01

Prior studies of computing applications that support patients' medication knowledge and self-management offer valuable insights into effective application design, but do not address inpatient settings. This study is the first to explore the design and usefulness of patient-facing tools supporting inpatient medication management and tracking. We designed myNYP Inpatient, a custom personal health record application, through an iterative, user-centered approach. Medication-tracking tools in myNYP Inpatient include interactive views of home and hospital medication data and features for commenting on these data. In a two-phase pilot study, patients used the tools during cardiothoracic postoperative care at Columbia University Medical Center. In Phase One, we provided 20 patients with the application for 24-48 h and conducted a closing interview after this period. In Phase Two, we conducted semi-structured interviews with 12 patients and 5 clinical pharmacists who evaluated refinements to the tools based on the feedback received during Phase One. Patients reported that the medication-tracking tools were useful. During Phase One, 14 of the 20 participants used the tools actively, to review medication lists and log comments and questions about their medications. Patients' interview responses and audit logs revealed that they made frequent use of the hospital medications feature and found electronic reporting of questions and comments useful. We also uncovered important considerations for subsequent design of such tools. In Phase Two, the patients and pharmacists participating in the study confirmed the usability and usefulness of the refined tools. Inpatient medication-tracking tools, when designed to meet patients' needs, can play an important role in fostering patient participation in their own care and patient-provider communication during a hospital stay. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Trends in Publications in Radiology Journals Designated as Relating to Patient-Centered Care.

PubMed

Rosenkrantz, Andrew B; Rawson, James V

2017-05-01

To assess trends in publications in radiology journals designated as dealing with patient-centered care. PubMed was searched for articles in radiology journals for which the article's record referenced patient-centered/patient-centric care. Among these, original research articles were identified and assigned major themes. Trends were assessed descriptively. A total of 115 articles in radiology journals designated as dealing with patient-centered care were identified, including 40 original research articles. The number of articles annually ranged from 0 to 4 in 2000-2008, 5 to 9 in 2010-2012, 14 to 15 in 2013-2014, and 25 in 2015. Only four radiology journals had published more than one of the original research articles. Original research articles' most common themes were: optimization of patients' access to reports and images (n=7); patients' examination experience (5); image evaluation (n=4); radiologists meeting with patients (n=4); improving patients' knowledge of imaging (n=3); examination wait times/efficiency (n=3); examination utilization/appropriateness (n=3); and IT enhancements (n=3). A total of 13 of 40 original research articles solicited opinions from patients. One study involved patients in educating trainees regarding patient-centered care. No study involved patients in system-level decisions regarding health care design and delivery. Articles dealing with patient-centered care in radiology are increasing, though they remain concentrated in a limited number of journals. Though major themes included image/report access, patient experiences, and radiologists meeting with patients, many studies dealt with less clearly patient-centric topics such as examination interpretation, while inclusion of patients in systems design was lacking. Further research in radiology is encouraged to target a broader range of ideals of patient-centered care, such as diversity, autonomy, and compassion, and to incorporate greater patient engagement. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Rationale of Cruciate Retaining Design in Rheumatoid Arthritis: A Review of Clinical Analysis and its Role in Rheumatoid Arthritis

PubMed Central

Ashraf, Munis; Sharma, Om Prakash; Priyavadhana, Sruthi; Sambandam, Senthil Nathan; Mounasamy, Varatharaj

2017-01-01

Background: Over the years, proponents of total knee designs (cruciate retaining and posterior stabilised) have conducted several long-term studies to claim the potential of these designs in several subsets of patients. Total knee arthroplasty (TKA) in patients with rheumatoid arthritis has also been one such domain where numerous studies were conducted in the past. A general perception among majority of arthroplasty surgeons is that, posterior stabilised (PS) is the implanted design of choice among patients with Rheumatoid arthritis (RA). However, with the available literature there is a significant disparity related to the selection of implants in patients with rheumatoid RA. In this review of literature, an attempt is made to identify the clinical performance and role of one such implant design, the cruciate retaining (CR) prosthesis in rheumatoid arthritis. Method: The review was conducted after a series of advanced search in the following medical databases; Pub med, Biomed central, Cochrane and Google scholar for articles related to long term follow up studies of cruciate retaining total knee arthroplasty in rheumatoid arthritis using the keywords cruciate retaining prosthesis, total knee arthroplasty, rheumatoid arthritis. Results: The available data demonstrate that the CR design is attributed with an excellent long term survivorship and functional outcome even in follow up studies up to twenty-five years. Conclusion: The advantages of using a CR design are long term survivorship, controlled femoral roll back and preservation of bone stock. Thus, the data gathered in this review lead to a consideration that the CR design is an implant design on par with PS design in patients with RA. PMID:29114338

Hyperactivity of the default-mode network in first-episode, drug-naive schizophrenia at rest revealed by family-based case-control and traditional case-control designs.

PubMed

Guo, Wenbin; Liu, Feng; Chen, Jindong; Wu, Renrong; Li, Lehua; Zhang, Zhikun; Chen, Huafu; Zhao, Jingping

2017-03-01

Abnormal regional activity and functional connectivity of the default-mode network (DMN) have been reported in schizophrenia. However, previous studies may have been biased by unmatched case-control design. To limit such bias, the present study used both the family-based case-control design and the traditional case-control design to investigate abnormal regional activity of the DMN in patients with schizophrenia at rest.Twenty-eight first-episode, drug-naive patients with schizophrenia, 28 age-, sex-matched unaffected siblings of the patients (family-based controls, FBC), and 40 healthy controls (HC) underwent resting-state functional magnetic resonance imaging (fMRI) scans. The group-independent component analysis and fractional amplitude of low-frequency fluctuation (fALFF) methods were used to analyze the data.Patients with schizophrenia show increased fALFF in an overlapped region of the right superior medial prefrontal cortex (MPFC) relative to the FBC and the HC. Compared with the HC, the patients and the FBC exhibit increased fALFF in an overlapped region of the left posterior cingulate cortex/precuneus (PCC/PCu). Furthermore, the z values of the 2 overlapped regions can separate the patients from the FBC/HC, and separate the patients/FBC from the HC with relatively high sensitivity and specificity.Both the family-based case-control and traditional case-control designs reveal hyperactivity of the DMN in first-episode, drug-naive patients with paranoid schizophrenia, which highlights the importance of the DMN in the neurobiology of schizophrenia. Family-based case-control design can limit the confounding effects of environmental factors in schizophrenia. Combination of the family-based case-control and traditional case-control designs may be a viable option for the neuroimaging studies.

Patients with heart failure as co-designers of an educational website: implications for medical education

PubMed Central

Svanholm, Jette R.; Schjødt, Inge; Mølgaard Jensen, Karsten; Silén, Charlotte; Karlgren, Klas

2017-01-01

Objectives To identify the learning needs of patients with heart failure between outpatients follow-up visits from their perspective and to ascertain what they emphasize as being important in the design of an educational website for them. Methods We conducted a two-step qualitative study at Aarhus University Hospital, Denmark. Twenty patients with heart failure participated either in focus group interviews, diary writing, or video-recorded design sessions. Data on learning needs were collected in step 1 and analyses, therefore, helped develop the preliminary prototypes of a website. In step 2, patients worked on the prototypes in video-recorded design sessions, employing a think-aloud method. The interviews were transcribed and a content analysis was performed on the text and video data. Results Patients’ learning needs were multifaceted, driven by anxiety, arising from, and often influenced by, such daily situations and contexts as the medical condition, medication, challenges in daily life, and where to get support and how to manage their self-care. They emphasized different ways of adapting the design to the patient group to enable interaction with peers and professionals and specific interface issues. Conclusions This study provided insights into the different learning needs of patients with heart failure, how managing daily situations is the starting point for these needs and how emotions play a part in patients’ learning. Moreover, it showed how patient co-designers proved to be useful for understanding how to design a website that supports patients’ learning: insights, which may become important in designing online learning tools for patients. PMID:28237976

Development of a Web-Based Health Care Intervention for Patients With Heart Disease: Lessons Learned From a Participatory Design Study

PubMed Central

2017-01-01

Background The use of telemedicine technologies in health care has increased substantially, together with a growing interest in participatory design methods when developing telemedicine approaches. Objective We present lessons learned from a case study involving patients with heart disease and health care professionals in the development of a personalized Web-based health care intervention. Methods We used a participatory design approach inspired by the method for feasibility studies in software development. We collected qualitative data using multiple methods in 3 workshops and analyzed the data using thematic analysis. Participants were 7 patients with diagnosis of heart disease, 2 nurses, 1 physician, 2 systems architects, 3 moderators, and 3 observers. Results We present findings in 2 parts. (1) Outcomes of the participatory design process: users gave valuable feedback on ease of use of the platforms’ tracking tools, platform design, terminology, and insights into patients’ monitoring needs, information and communication technologies skills, and preferences for self-management tools. (2) Experiences from the participatory design process: patients and health care professionals contributed different perspectives, with the patients using an experience-based approach and the health care professionals using a more attitude-based approach. Conclusions The essential lessons learned concern planning and organization of workshops, including the finding that patients engaged actively and willingly in a participatory design process, whereas it was more challenging to include and engage health care professionals. PMID:28526674

Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a prospective randomized controlled clinical trial

PubMed Central

van den Boom, Lennard GH; Brouwer, Reinoud W; van den Akker-Scheek, Inge; Bulstra, Sjoerd K; van Raaij, Jos JAM

2009-01-01

Background Prosthetic design for the use in primary total knee arthroplasty has evolved into designs that preserve the posterior cruciate ligament (PCL) and those in which the ligament is routinely sacrificed (posterior stabilized). In patients with a functional PCL the decision which design is chosen depends largely on the favour and training of the surgeon. The objective of this study is to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty. Methods/Design A randomized controlled trial will be conducted. Patients who are admitted for primary unilateral TKA due to primary osteoarthrosis are included when the following inclusion criteria are met: non-fixed fixed varus or valgus deformity less than 10 degrees, age between 55 and 85 years, body mass index less than 35 kg/m2 and ASA score (American Society of Anaesthesiologists) I or II. Patients are randomized in 2 groups. Patients in the posterior cruciate retaining group will receive a prosthesis with a posterior cut-out for the posterior cruciate ligament and relatively flat topography. In patients allocated to the posterior stabilized group, in which the posterior cruciate ligament is excised, the design may substitute for this function by an intercondylar tibial prominence that articulates with the femur in flexion. Measurements will take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. At all measurement points patient's perceived outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures are quality of life (SF-36) and physician reported functional status and range of motion as determined with the Knee Society Clinical Rating System (KSS). Discussion In the current practice both posterior cruciate retaining and posterior stabilized designs for total knee arthroplasty are being used. To date no studies have been performed determining whether there is a difference in patient's perceived outcome between the two designs. Additionally, there is a lack of studies determining the speed of recovery in both designs as most studies only determine the final outcome. This randomised controlled study has been designed to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty. Trial Registration The trial is registered in the Netherlands Trial Registry (NTR1673). PMID:19793397

Theoretical Basis of the Test-Negative Study Design for Assessment of Influenza Vaccine Effectiveness

PubMed Central

Sullivan, Sheena G.; Tchetgen Tchetgen, Eric J.; Cowling, Benjamin J.

2016-01-01

Influenza viruses undergo frequent antigenic changes. As a result, the viruses circulating change within and between seasons, and the composition of the influenza vaccine is updated annually. Thus, estimation of the vaccine's effectiveness is not constant across seasons. In order to provide annual estimates of the influenza vaccine's effectiveness, health departments have increasingly adopted the “test-negative design,” using enhanced data from routine surveillance systems. In this design, patients presenting to participating general practitioners with influenza-like illness are swabbed for laboratory testing; those testing positive for influenza virus are defined as cases, and those testing negative form the comparison group. Data on patients' vaccination histories and confounder profiles are also collected. Vaccine effectiveness is estimated from the odds ratio comparing the odds of testing positive for influenza among vaccinated patients and unvaccinated patients, adjusting for confounders. The test-negative design is purported to reduce bias associated with confounding by health-care-seeking behavior and misclassification of cases. In this paper, we use directed acyclic graphs to characterize potential biases in studies of influenza vaccine effectiveness using the test-negative design. We show how studies using this design can avoid or minimize bias and where bias may be introduced with particular study design variations. PMID:27587721

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Understanding coping with cancer: how can qualitative research help?

PubMed

Chittem, Mahati

2014-01-01

Research in psycho-oncology investigates the psycho-social and emotional aspects of cancer and how this is related to health, well-being and overall patient care. Coping with cancer is a prime focus for researchers owing to its impact on patients' psychological processing and life in general. Research so far has focused mainly on quantitative study designs such as questionnaires to examine the coping strategies used by cancer patients. However, in order to gain a rich and deep understanding of the reasons, processes and types of strategies that patients use to deal with cancer, qualitative study designs are necessary. Few studies have used qualitative designs such as semi-structured interviews to explore coping with cancer. The current paper aims to review the suitability and benefits of using qualitative research designs to understand coping with cancer with the help of some key literature in psycho-oncology research.

Traumatic Brain Injury Practice-Based Evidence Study: Design and Patients, Centers, Treatments, and Outcomes

PubMed Central

Horn, Susan D.; Corrigan, John D.; Bogner, Jennifer; Hammond, Flora M.; Seel, Ronald T.; Smout, Randall J.; Barrett, Ryan S.; Dijkers, Marcel P.; Whiteneck, Gale G.

2015-01-01

Objective To describe study design, patients, centers, treatments, and outcomes of a traumatic brain injury (TBI) practice-based evidence (PBE) study and to evaluate the generalizability of the findings to the US TBI inpatient rehabilitation population. Design Prospective, longitudinal observational study Setting 10 inpatient rehabilitation centers (9 US, 1 Canada) Participants Patients (n=2130) enrolled between October 2008 and Sept 2011, and admitted for inpatient rehabilitation after an index TBI injury Interventions Not applicable Main Outcome Measures Return to acute care during rehabilitation, rehabilitation length of stay, Functional Independence Measure (FIM) at discharge, residence at discharge, and 9 months post-discharge rehospitalization, FIM, participation, and subjective wellbeing. Results Level of admission FIM Cognitive score was found to create relatively homogeneous subgroups for subsequent analysis of best treatment combinations. There were significant differences in patient and injury characteristics, treatments, rehabilitation course, and outcomes by admission FIM Cognitive subgroups. TBI-PBE study patients overall were similar to US national TBI inpatient rehabilitation populations. Conclusions This TBI-PBE study succeeded in capturing naturally occurring variation within patients and treatments, offering opportunities to study best treatments for specific patient deficits. Subsequent papers in this issue report differences between patients and treatments and associations with outcomes in greater detail. PMID:26212396

Impact of Molecular Diagnostics for Tuberculosis on Patient-Important Outcomes: A Systematic Review of Study Methodologies

PubMed Central

Schumacher, Samuel G.; Sohn, Hojoon; Qin, Zhi Zhen; Gore, Genevieve; Davis, J. Lucian; Denkinger, Claudia M.; Pai, Madhukar

2016-01-01

Background Several reviews on the accuracy of Tuberculosis (TB) Nucleic Acid Amplification Tests (NAATs) have been performed but the evidence on their impact on patient-important outcomes has not been systematically reviewed. Given the recent increase in research evaluating such outcomes and the growing list of TB NAATs that will reach the market over the coming years, there is a need to bring together the existing evidence on impact, rather than accuracy. We aimed to assess the approaches that have been employed to measure the impact of TB NAATs on patient-important outcomes in adults with possible pulmonary TB and/or drug-resistant TB. Methods We first develop a conceptual framework to clarify through which mechanisms the improved technical performance of a novel TB test may lead to improved patient outcomes and outline which designs may be used to measure them. We then systematically review the literature on studies attempting to assess the impact of molecular TB diagnostics on such outcomes and provide a narrative synthesis of designs used, outcomes assessed and risk of bias across different study designs. Results We found 25 eligible studies that assessed a wide range of outcomes and utilized a variety of experimental and observational study designs. Many potentially strong design options have never been used. We found that much of the available evidence on patient-important outcomes comes from a small number of settings with particular epidemiological and operational context and that confounding, time trends and incomplete outcome data receive insufficient attention. Conclusions A broader range of designs should be considered when designing studies to assess the impact of TB diagnostics on patient outcomes and more attention needs to be paid to the analysis as concerns about confounding and selection bias become relevant in addition to those on measurement that are of greatest concern in accuracy studies. PMID:26954678

Three lessons from a randomized trial of massage and meditation at end of life: patient benefit, outcome measure selection, and design of trials with terminally ill patients.

PubMed

Downey, Lois; Engelberg, Ruth A; Standish, Leanna J; Kozak, Leila; Lafferty, William E

2009-01-01

Improving end-of-life care is a priority in the United States, but assigning priorities for standard care services requires evaluations using appropriate study design and appropriate outcome indicators. A recent randomized controlled trial with terminally ill patients produced no evidence of benefit from massage or guided meditation, when evaluated with measures of global quality of life or pain distress over the course of patient participation. However, reanalysis using a more targeted outcome, surrogates' assessment of patients' benefit from the study intervention, suggested significant gains from massage-the treatment patients gave their highest preassignment preference ratings. The authors conclude that adding a menu of complementary therapies as part of standard end-of-life care may yield significant benefit, that patient preference is an important predictor of outcome, and that modifications in trial design may be appropriate for end-of-life studies.

Optimal designs for population pharmacokinetic studies of the partner drugs co-administered with artemisinin derivatives in patients with uncomplicated falciparum malaria.

PubMed

Jamsen, Kris M; Duffull, Stephen B; Tarning, Joel; Lindegardh, Niklas; White, Nicholas J; Simpson, Julie A

2012-07-11

Artemisinin-based combination therapy (ACT) is currently recommended as first-line treatment for uncomplicated malaria, but of concern, it has been observed that the effectiveness of the main artemisinin derivative, artesunate, has been diminished due to parasite resistance. This reduction in effect highlights the importance of the partner drugs in ACT and provides motivation to gain more knowledge of their pharmacokinetic (PK) properties via population PK studies. Optimal design methodology has been developed for population PK studies, which analytically determines a sampling schedule that is clinically feasible and yields precise estimation of model parameters. In this work, optimal design methodology was used to determine sampling designs for typical future population PK studies of the partner drugs (mefloquine, lumefantrine, piperaquine and amodiaquine) co-administered with artemisinin derivatives. The optimal designs were determined using freely available software and were based on structural PK models from the literature and the key specifications of 100 patients with five samples per patient, with one sample taken on the seventh day of treatment. The derived optimal designs were then evaluated via a simulation-estimation procedure. For all partner drugs, designs consisting of two sampling schedules (50 patients per schedule) with five samples per patient resulted in acceptable precision of the model parameter estimates. The sampling schedules proposed in this paper should be considered in future population pharmacokinetic studies where intensive sampling over many days or weeks of follow-up is not possible due to either ethical, logistic or economical reasons.

Patient engagement in research: a systematic review.

PubMed

Domecq, Juan Pablo; Prutsky, Gabriela; Elraiyah, Tarig; Wang, Zhen; Nabhan, Mohammed; Shippee, Nathan; Brito, Juan Pablo; Boehmer, Kasey; Hasan, Rim; Firwana, Belal; Erwin, Patricia; Eton, David; Sloan, Jeff; Montori, Victor; Asi, Noor; Dabrh, Abd Moain Abu; Murad, Mohammad Hassan

2014-02-26

A compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients' concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are the best ways to identify patient representatives? How to engage them in designing and conducting research? What are the observed benefits of patient engagement? What are the harms and barriers of patient engagement? We searched MEDLINE, EMBASE, PsycInfo, Cochrane, EBSCO, CINAHL, SCOPUS, Web of Science, Business Search Premier, Academic Search Premier and Google Scholar. Included studies were published in English, of any size or design that described engaging patients or their surrogates in research design. We conducted an environmental scan of the grey literature and consulted with experts and patients. Data were analyzed using a non-quantitative, meta-narrative approach. We included 142 studies that described a spectrum of engagement. In general, engagement was feasible in most settings and most commonly done in the beginning of research (agenda setting and protocol development) and less commonly during the execution and translation of research. We found no comparative analytic studies to recommend a particular method. Patient engagement increased study enrollment rates and aided researchers in securing funding, designing study protocols and choosing relevant outcomes. The most commonly cited challenges were related to logistics (extra time and funding needed for engagement) and to an overarching worry of a tokenistic engagement. Patient engagement in healthcare research is likely feasible in many settings. However, this engagement comes at a cost and can become tokenistic. Research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed.

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies.

PubMed

Kramer, C Bradley; LeRoy, Lisa; Donahue, Sara; Apter, Andrea J; Bryant-Stephens, Tyra; Elder, John P; Hamilton, Winifred J; Krishnan, Jerry A; Shelef, Deborah Q; Stout, James W; Sumino, Kaharu; Teach, Stephen J; Federman, Alex D

2016-12-01

African-American and Latino patients are often difficult to recruit for asthma studies. This challenge is a barrier to improving asthma care and outcomes for these populations. We sought to examine the recruitment experiences of 8 asthma comparative effectiveness studies that specifically targeted African-American and Latino patients, and identify the solutions they developed to improve recruitment. Case report methodology was used to gather and evaluate information on study design, recruitment procedures and outcomes from study protocols and annual reports, and in-depth interviews with each research team. Data were analyzed for themes, commonalities, and differences. There were 4 domains of recruitment challenges: individual participant, institutional, research team, and study intervention. Participants had competing demands for time and some did not believe they had asthma. Institutional challenges included organizational policies governing monetary incentives and staff hiring. Research team challenges included ongoing training needs of recruitment staff, and intervention designs often were unappealing to participants because of inconveniences. Teams identified a host of strategies to address these challenges, most importantly engagement of patients and other stakeholders in study design and troubleshooting, and flexibility in data collection and intervention application to meet the varied needs of patients. Asthma researchers may have greater success with recruitment by addressing uncertainty among patients about asthma diagnosis, engaging stakeholders in all aspects of study design and implementation, and maximizing flexibility of study and intervention protocols. However, even with such efforts, engagement of African-American and Latino patients in asthma research may remain low. Greater investment in research on engaging these populations in asthma research may ultimately be needed to improve their asthma care and outcomes. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Multi-Reader ROC studies with Split-Plot Designs: A Comparison of Statistical Methods

PubMed Central

Obuchowski, Nancy A.; Gallas, Brandon D.; Hillis, Stephen L.

2012-01-01

Rationale and Objectives Multi-reader imaging trials often use a factorial design, where study patients undergo testing with all imaging modalities and readers interpret the results of all tests for all patients. A drawback of the design is the large number of interpretations required of each reader. Split-plot designs have been proposed as an alternative, in which one or a subset of readers interprets all images of a sample of patients, while other readers interpret the images of other samples of patients. In this paper we compare three methods of analysis for the split-plot design. Materials and Methods Three statistical methods are presented: Obuchowski-Rockette method modified for the split-plot design, a newly proposed marginal-mean ANOVA approach, and an extension of the three-sample U-statistic method. A simulation study using the Roe-Metz model was performed to compare the type I error rate, power and confidence interval coverage of the three test statistics. Results The type I error rates for all three methods are close to the nominal level but tend to be slightly conservative. The statistical power is nearly identical for the three methods. The coverage of 95% CIs fall close to the nominal coverage for small and large sample sizes. Conclusions The split-plot MRMC study design can be statistically efficient compared with the factorial design, reducing the number of interpretations required per reader. Three methods of analysis, shown to have nominal type I error rate, similar power, and nominal CI coverage, are available for this study design. PMID:23122570

Multi-reader ROC studies with split-plot designs: a comparison of statistical methods.

PubMed

Obuchowski, Nancy A; Gallas, Brandon D; Hillis, Stephen L

2012-12-01

Multireader imaging trials often use a factorial design, in which study patients undergo testing with all imaging modalities and readers interpret the results of all tests for all patients. A drawback of this design is the large number of interpretations required of each reader. Split-plot designs have been proposed as an alternative, in which one or a subset of readers interprets all images of a sample of patients, while other readers interpret the images of other samples of patients. In this paper, the authors compare three methods of analysis for the split-plot design. Three statistical methods are presented: the Obuchowski-Rockette method modified for the split-plot design, a newly proposed marginal-mean analysis-of-variance approach, and an extension of the three-sample U-statistic method. A simulation study using the Roe-Metz model was performed to compare the type I error rate, power, and confidence interval coverage of the three test statistics. The type I error rates for all three methods are close to the nominal level but tend to be slightly conservative. The statistical power is nearly identical for the three methods. The coverage of 95% confidence intervals falls close to the nominal coverage for small and large sample sizes. The split-plot multireader, multicase study design can be statistically efficient compared to the factorial design, reducing the number of interpretations required per reader. Three methods of analysis, shown to have nominal type I error rates, similar power, and nominal confidence interval coverage, are available for this study design. Copyright © 2012 AUR. All rights reserved.

Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design.

PubMed

Mathe, Nonsikelelo; Johnson, Steven T; Wozniak, Lisa A; Majumdar, Sumit R; Johnson, Jeffrey A

2015-08-25

Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters. We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design. The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process. Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial. Health Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380. Date registered: 7 October 2009. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011.

Additive-manufactured patient-specific titanium templates for thoracic pedicle screw placement: novel design with reduced contact area.

PubMed

Takemoto, Mitsuru; Fujibayashi, Shunsuke; Ota, Eigo; Otsuki, Bungo; Kimura, Hiroaki; Sakamoto, Takeshi; Kawai, Toshiyuki; Futami, Tohru; Sasaki, Kiyoyuki; Matsushita, Tomiharu; Nakamura, Takashi; Neo, Masashi; Matsuda, Shuich

2016-06-01

Image-based navigational patient-specific templates (PSTs) for pedicle screw (PS) placement have been described. With recent advances in three-dimensional computer-aided designs and additive manufacturing technology, various PST designs have been reported, although the template designs were not optimized. We have developed a novel PST design that reduces the contact area without sacrificing stability. It avoids susceptibility to intervening soft tissue, template geometric inaccuracy, and difficulty during template fitting. Fourteen candidate locations on the posterior aspect of the vertebra were evaluated. Among them, locations that had high reproducibility on computed tomography (CT) images and facilitated accurate PS placement were selected for the final PST design. An additive manufacturing machine (EOSINT M270) fabricated the PSTs using commercially pure titanium powder. For the clinical study, 36 scoliosis patients and 4 patients with ossification of the posterior longitudinal ligament (OPLL) were treated with thoracic PSs using our newly developed PSTs. We intraoperatively and postoperatively evaluated the accuracy of the PS hole created by the PST. Based on the segmentation reproducibility and stability analyses, we selected seven small, round contact points for our PST: bilateral superior and inferior points on the transverse process base, bilateral inferior points on the laminar, and a superior point on the spinous process. Clinically, the success rates of PS placement using this PST design were 98.6 % (414/420) for scoliosis patients and 100 % (46/46) for OPLL patients. This study provides a useful design concept for the development and introduction of patient-specific navigational templates for placing PSs.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

PubMed

Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan

2016-10-01

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Design to Improve Visibility: Impact of Corridor Width and Unit Shape.

PubMed

Hadi, Khatereh; Zimring, Craig

2016-07-01

This study analyzes 10 intensive care units (ICUs) to understand the associations between design features of space layout and nurse-to-patient visibility parameters. Previous studies have explored how different hospital units vary in their visibility relations and how such varied visibility relations result in different nurse behaviors toward patients. However, more limited research has examined the specific design attributes of the layouts that determine the varied visibility relations in the unit. Changes in size, geometry, or other attributes of design elements in nursing units, which might affect patient observation opportunities, require more research. This article reviews the literature to indicate evidence for the impact of hospital unit design on nurse/patient visibility relations and to identify design parameters shown to affect visibility. It further focuses on 10 ICUs to investigate how different layouts diverge regarding their visibility relations using a set of metrics developed by other researchers. Shape geometry and corridor width, as two selected design features, are compared. Corridor width and shape characteristics of ICUs are positively correlated with visibility. Results suggest that floor plans, which are repeatedly broken down into smaller convex (higher convex fragmentation values), or units, which have longer distances between their rooms or between their two opposite ends (longer relative grid distances), might have lower visibility levels across the unit. The findings of this study also suggest that wider corridors positively affect visibility of patient rooms. Changes in overall shape configuration and corridor width of nursing units may have important effects on patient observation and monitoring opportunities. © The Author(s) 2016.

75 FR 23775 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-04

... for research entitled ``Experimental Study of Patient Information Prototypes.'' This study is designed..., the working group refined several prototypes and designed a study to investigate the usefulness of... Design and Protocol The study is experimental and will have two independent variables in a 3 x 2 design...

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

A new partially covered metal stent for palliation of malignant dysphagia: a prospective follow-up study.

PubMed

van Boeckel, Petra G; Siersema, Peter D; Sturgess, Richard; Dwyer, Laura; Raijman, Isaac; Hirdes, Meike M; Vleggaar, Frank P

2010-12-01

Metal stents are frequently used for palliation of malignant dysphagia. Recently, a new stent design, the partially covered Wallflex stent (Boston Scientific, Natick, Mass), has been introduced. To determine clinical effectiveness and safety of the esophageal Wallflex stent for the palliation of dysphagia. A prospective follow-up study evaluating a new stent design. Three tertiary-care referral centers. This study involved 37 patients with cancer of the esophagus or gastric cardia. Stent placement. Data were collected regarding technical and clinical outcome, complications, recurrent dysphagia, and survival. A total of 37 patients (median age, 67 years; range, 48-84 years; 22 men [59%]) had a Wallflex stent placed. Stent placement was technically successful in all but 1 patient. Dysphagia improved from a median dysphagia score of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 3 patients (8%; pneumonia in 1, severe pain in 2), and 1 patient (3%) died from a complication (pneumonia). Minor complications included mild retrosternal pain in 10 patients (27%) and regurgitation in 7 patients (19%). In total, 8 patients (22%) developed recurrent dysphagia because of stent migration (n = 2 [6%]), food impaction (n = 2 [6%]), or tissue ingrowth or overgrowth (n = 4 [10%]). Nonrandomized study design. Placement of a partially covered Wallflex stent is safe and effective for the palliation of malignant dysphagia, with migration and tissue in- and overgrowth rates comparable to those of similarly designed stents. Retrosternal pain may occur more often with this stent than with other stent designs. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study.

PubMed

Crowley, Susan T; Chertow, Glenn M; Vitale, Joseph; O'Connor, Theresa; Zhang, Jane; Schein, Roland M H; Choudhury, Devasmita; Finkel, Kevin; Vijayan, Anitha; Paganini, Emil; Palevsky, Paul M

2008-07-01

Design elements of clinical trials can introduce recruitment bias and reduce study efficiency. Trials involving the critically ill may be particularly prone to design-related inefficiencies. Enrollment into the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was systematically monitored. Reasons for nonenrollment into this study comparing strategies of renal replacement therapy in critically ill patients with acute kidney injury were categorized as modifiable or nonmodifiable. 4339 patients were screened; 2744 fulfilled inclusion criteria. Of these, 1034 were ineligible by exclusion criteria. Of the remaining 1710 patients, 1124 (65.7%) enrolled. Impediments to informed consent excluded 21.4% of potentially eligible patients. Delayed identification of potential patients, physician refusal, and involvement in competing trials accounted for 4.4, 2.7, and 2.3% of exclusions. Comfort measures only status, chronic illness, chronic kidney disease, and obesity excluded 11.8, 7.8, 7.6, and 5.9% of potential patients. Modification of an enrollment window reduced the loss of patients from 6.6 to 2.3%. The Acute Renal Failure Trial Network Study's enrollment efficiency compared favorably with previous intensive care unit intervention trials and supports the representativeness of its enrolled population. Impediments to informed consent highlight the need for nontraditional acquisition methods. Restrictive enrollment windows may hamper recruitment but can be effectively modified. The low rate of physician refusal acknowledges clinical equipoise in the study design. Underlying comorbidities are important design considerations for future trials that involve the critically ill with acute kidney injury.

Systematic Review of the Literature on Pain in Patients with Polytrauma Including Traumatic Brain Injury

PubMed Central

Dobscha, Steven K.; Clark, Michael E.; Morasco, Benjamin J.; Freeman, Michele; Campbell, Rose; Helfand, Mark

2010-01-01

Objective To review the literature addressing the assessment and management of pain in patients with polytraumatic injuries including traumatic brain injury (TBI) and blast-related headache, and to identify patient, clinician and systems factors associated with pain-related outcomes. Design Systematic review. Methods We conducted searches in MEDLINE of literature published from 1950 through July 2008. Due to a limited number of studies using controls or comparators, we included observational and rigorous qualitative studies. We systematically rated the quality of systematic reviews, cohort, and case-control design studies. Results One systematic review, 93 observational studies, and one qualitative research study met inclusion criteria. The literature search yielded no published studies that assessed measures of pain intensity or pain-related functional interference among patients with cognitive deficits due to TBI, that compared patients with blast-related headache with patients with other types of headache, or that assessed treatments for blast-related headache pain. Studies on the association between TBI severity and pain reported mixed findings. There was limited evidence that the following factors are associated with pain among TBI patients: severity, location, and multiplicity of injuries; insomnia; fatigue; depression; and post-traumatic stress disorder. Conclusions Very little evidence is currently available to guide pain assessment and treatment approaches in patients with polytrauma. Further research employing systematic observational as well as controlled intervention designs is clearly indicated. PMID:19818031

Psychogeriatric inpatient unit design: a literature review.

PubMed

Dobrohotoff, John T; Llewellyn-Jones, Robert H

2011-03-01

In many parts of the world the provision of psychogeriatric inpatient units (PGUs) remains limited. More units will be required over coming decades given rapid population aging. Medline (1950-2010), psycINFO (1806-2009), EMBASE (1980-2009) and CINAHL (1982-2009) were searched for papers about PGU design. Selected non-peer reviewed literature such as government reports and unpublished academic dissertations were also reviewed. Data were also obtained from the literature related to general adult psychiatry inpatient units where there was limited information from studies of units designed for older people. Over 200 papers were reviewed and 130 were included. There are few good quality studies to guide the design of acute PGUs and much of the existing literature is based on opinion and anecdote or, at best, based on observational studies. Randomized controlled studies comparing different designs and assessing outcomes are virtually non-existent. Several studies have identified violence and trauma resulting from hospitalization as significant problems with current acute PGU care. Despite its limitations the available literature provides useful guidance on how PGU design can optimize patient and staff safety and improve clinical outcomes. There are significant problems with current acute PGUs, and patient mix on existing units is an important issue. Future research should examine patient and staff perceptions of different PGU ward environments, the relationship between ward design and clinical outcomes, the effects of segregating patients with challenging behaviors in dementia and the benefits or otherwise of gender segregation.

A knee monitoring device and the preferences of patients living with osteoarthritis: a qualitative study

PubMed Central

Papi, Enrica; Belsi, Athina; McGregor, Alison H

2015-01-01

Objectives To identify perspective of patients with osteoarthritis, in particular design requirements and mode of use, of wearable technology to support the rehabilitation pathway. This study is part of a user-centred design approach adopted to develop a rehabilitation tool for patients with osteoarthritis. Design Qualitative study using a focus group approach; data management via a thematic analysis of patients’ responses. Participants 21 patients with osteoarthritis (age range 45–65 years) participated in 1 of the 4 focus groups. Recruitment continued until data saturation. Setting The study was conducted in a university setting. Results Main determinants of user acceptance of a wearable technology were appearance and comfort during use. Patients were supportive of the use of wearable technologies during rehabilitation and could recognise their benefit as monitors for their progress, incentives to adhere to exercise, and tools for more informed interaction with clinicians. Conclusions This paper should encourage adoption and development of wearable technology to support rehabilitation of patients with osteoarthritis. It is pivotal that technological development takes into account patients’ views in that it should be small, light, discrete, not ‘appear medical’ or challenge the identity of the user. Derived data should be available to patients and clinicians. Furthermore, wearable technologies should be developed to operate in two modes: for exercise guidance and assessment only, and for unobtrusive everyday monitoring. The information obtained from this study should guide the design of new technologies and support their use in clinical practice. PMID:26346873

Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies.

PubMed

Domańska, Barbara; Stumpp, Oliver; Poon, Steven; Oray, Serkan; Mountian, Irina; Pichon, Clovis

2018-01-01

We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava ® , an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP). Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling. Validation HFS (one EU study and one US study) assessed the safe and effective setup and use of the e-Device using 22 predefined critical tasks. Task outcomes were categorized as "failures" if participants did not succeed within three attempts. Two hundred eighty-three participants entered formative (163) and validation (120) HFS; 260 participants performed one or more simulated e-Device self-injections. Design changes following formative HFS included alterations to buttons and the graphical user interface screen. All validation HFS participants completed critical tasks necessary for CZP dose delivery, with minimal critical task failures (12 of 572 critical tasks, 2.1%, in the EU study, and 2 of 5310 critical tasks, less than 0.1%, in the US study). CZP e-Device development was guided by intended user feedback through HFS, ensuring the final design addressed patients' needs. In both validation studies, participants successfully performed all critical tasks, demonstrating safe and effective e-Device self-injections. UCB Pharma. Plain language summary available on the journal website.

Patient perspectives on engagement in shared decision-making for asthma care.

PubMed

Tapp, Hazel; Derkowski, Diane; Calvert, Melissa; Welch, Madelyn; Spencer, Sara

2017-06-01

Engagement of patient and advocacy group stakeholders is increasingly considered essential to meaningful outcomes research. Patient-centred research benefits from partnership formation between patients, clinicians and research team members. Here, we describe the rationale for engaging patients on a research team and a case study of patient engagement on an asthma shared decision-making study. Here, we describe a case study of patient engagement in outcomes research and examine the variety of roles patients are engaged in and the associated impact on the study. Patients assisted the project at various levels and were integrated into the research team by (i) advising on study development; (ii) assisting with design and usability of study materials, including the toolkit, patient surveys and dissemination strategies; and (iii) advocacy via membership in external disease-specific organizations and participating in outcomes research conferences. Patients were engaged both individually and as members of a patient advisory board. Primary lessons learned were the importance of building a trusting partnership with patients through understanding perspectives, being aware of clearly explaining patients' roles, research methods and jargon, providing training, listening to patients' needs and understanding what the partnership means from a patient perspective. For the case study described, patient engagement directly influenced multiple aspects of the study, including study design, implementation, data analysis and dissemination through incorporation of the patients' and caregivers' input and concerns. © The Author 2016. Published by Oxford University Press.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Health literacy and the clozapine patient.

PubMed

Brosnan, Susan; Barron, Elizabeth; Sahm, L J

2012-01-01

To estimate the prevalence of limited health literacy in patients receiving clozapine for schizophrenia. To develop and produce a pharmacist-designed clozapine patient information leaflet (PIL) which has a higher readability score than the company-produced PIL. This was a cross sectional prevalence study. Ethical approval for the study was granted by the local ethics committee. Patients, over 18 years, attending the Clozapine Clinic of a Cork urban teaching hospital, were asked to participate in the study. Demographics such as gender, age, employment and smoking status, were gathered from all participants. The total daily clozapine dose, duration of clozapine treatment, and information regarding the clozapine DVD was also noted. The Rapid Estimate of Adult Literacy in Medicine (REALM) health literacy (HL) screening tool was then administered to each patient. A user-friendly PIL on clozapine was designed by the pharmacist, which was assessed for readability and compared to the company-produced PIL using the FRES and FKGL. Data were analysed using SPSS Version 15. Forty patients (65% male, 95% unemployed and 70% smokers) of average age 38.0 years (+/- 11.2) completed the REALM. The average score was 60.6 (+/- 8.7). Twenty-nine patients (72.5%) were found to have "adequate" health literacy. The remaining eleven patients were found to have either "marginal" or "low" health literacy. The pharmacist-designed PIL would have been readable by 95% of the study population, in contrast to 72.5% with the company-designed PIL. More than a quarter of the population were found to have marginal or low health literacy. Patient information should be matched to the health literacy level of the target population.

Using stakeholder engagement to develop a patient-centered pediatric asthma intervention.

PubMed

Shelef, Deborah Q; Rand, Cynthia; Streisand, Randi; Horn, Ivor B; Yadav, Kabir; Stewart, Lisa; Fousheé, Naja; Waters, Damian; Teach, Stephen J

2016-12-01

Stakeholder engagement has the potential to develop research interventions that are responsive to patient and provider preferences. This approach contrasts with traditional models of clinical research in which researchers determine the study's design. This article describes the effect of stakeholder engagement on the design of a randomized trial of an intervention designed to improve child asthma outcomes by reducing parental stress. The study team developed and implemented a stakeholder engagement process that provided iterative feedback regarding the study design, patient-centered outcomes, and intervention. Stakeholder engagement incorporated the perspectives of parents of children with asthma; local providers of community-based medical, legal, and social services; and national experts in asthma research methodology and implementation. Through a year-long process of multidimensional stakeholder engagement, the research team successfully refined and implemented a patient-centered study protocol. Key stakeholder contributions included selection of patient-centered outcome measures, refinement of intervention content and format, and language framing the study in a culturally appropriate manner. Stakeholder engagement was a useful framework for developing an intervention that was acceptable and relevant to our target population. This approach might have unique benefits in underserved populations, leading to sustainable improvement in health outcomes and reduced disparities. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Optimization of an idealized Y-Shaped Extracardiac Fontan Baffle

NASA Astrophysics Data System (ADS)

Yang, Weiguang; Feinstein, Jeffrey; Mohan Reddy, V.; Marsden, Alison

2008-11-01

Research has showed that vascular geometries can significantly impact hemodynamic performance, particularly in pediatric cardiology, where anatomy varies from one patient to another. In this study we optimize a newly proposed design for the Fontan procedure, a surgery used to treat single ventricle heart patients. The current Fontan procedure connects the inferior vena cava (IVC) to the pulmonary arteries (PA's) via a straight Gore-Tex tube, forming a T-shaped junction. In the Y-graft design, the IVC is connected to the left and right PAs by two branches. Initial studies on the Y-graft design showed an increase in efficiency and improvement in flow distribution compared to traditional designs in a single patient-specific model. We now optimize an idealized Y-graft model to refine the design prior to patient testing. A derivate-free optimization algorithm using Kriging surrogate functions and mesh adaptive direct search is coupled to a 3-D finite element Navier-Stokes solver. We will present optimization results for rest and exercise conditions and examine the influence of energy efficiency, wall shear stress, pulsatile flow, and flow distribution on the optimal design.

Personalized ovarian stimulation for assisted reproductive technology: study design considerations to move from hype to added value for patients.

PubMed

Mol, Ben W; Bossuyt, Patrick M; Sunkara, Sesh K; Garcia Velasco, Juan A; Venetis, Christos; Sakkas, Denny; Lundin, Kersti; Simón, Carlos; Taylor, Hugh S; Wan, Robert; Longobardi, Salvatore; Cottell, Evelyn; D'Hooghe, Thomas

2018-06-01

Although most medical treatments are designed for the average patient with a one-size-fits-all-approach, they may not benefit all. Better understanding of the function of genes, proteins, and metabolite, and of personal and environmental factors has led to a call for personalized medicine. Personalized reproductive medicine is still in its infancy, without clear guidance on treatment aspects that could be personalized and on trial design to evaluate personalized treatment effect and benefit-harm balance. While the rationale for a personalized approach often relies on retrospective analyses of large observational studies or real-world data, solid evidence of superiority of a personalized approach will come from randomized trials comparing outcomes and safety between a personalized and one-size-fits-all strategy. A more efficient, targeted randomized trial design may recruit only patients or couples for which the personalized approach would differ from the previous, standard approach. Multiple monocenter studies using the same study protocol (allowing future meta-analysis) might reduce the major center effect associated with multicenter studies. In certain cases, single-arm observational studies can generate the necessary evidence for a personalized approach. This review describes each of the main segments of patient care in assisted reproductive technologies treatment, addressing which aspects could be personalized, emphasizing current evidence and relevant study design. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

[Systematic Review of the Application of Complementary and Alternative Medicine and their Potential Therapeutic Benefits in the Treatment of Ophthalmology Patients].

PubMed

Welte, A K; Hahn, U; Büssing, A; Krummenauer, F

2017-05-01

Purpose A systematic review was carried out of the reported therapeutic effects of complementary and alternative medicine methods as supplementary or primary treatments for patients suffering from glaucoma, cataract or age-related macular degeneration (AMD). Material and Methods For the years 1990 to 2013, the following databases were screened for reports of the application of complementary and alternative treatments: PubMed, Cochrane Library, EMBASE, CAMbase and AMED. Both randomised and prospective non-randomised patient trials were included in the review; results were evaluated in the following classes: "phytotherapy", "acupuncture/acupressure", "biofeedback" and "other alternative treatments". The studies were evaluated by measures of clinical effect, statistical significance (p value and/or confidence interval) and the underlying trial design. Results 30 clinical trials were included, including 13 on glaucoma, 5 on cataract and 12 on AMD patients. These trials were based on patient numbers of 6 - 332, 27 - 157 and 6 - 328 patients, respectively. Phytotherapy was applied in 14 trials, including 6 on glaucoma patients (all 6 with a controlled design, and 3 of which reporting statistically significant results); 5 trials were on cataract patients (3 with a controlled design and 2 with a significant result) and 3 on AMD patients (only 1 with a controlled design, with a significant result). Acupuncture/acupressure was investigated in 9 trials, 5 on glaucoma patients (3 with a controlled design, 1 with a significant result); no acupuncture/acupressure trial was found in cataract patients, but 4 trials in AMD patients (none with a controlled design). Biofeedback was studied in 4 trials, all on AMD patients (only one with a controlled design, without statistically significant findings). Conclusion Despite its rigorous inclusion criteria, this review identified several clinical trials on complementary and alternative medicine in ophthalmological patients. Phytotherapeutic methods gave significant results in half of the reported controlled trials, whereas there were few significant benefits with acupuncture or acupressure. Georg Thieme Verlag KG Stuttgart · New York.

Life Satisfaction Questionnaire (Lisat-9): Reliability and Validity for Patients with Acquired Brain Injury

ERIC Educational Resources Information Center

Boonstra, Anne M.; Reneman, Michiel F.; Stewart, Roy E.; Balk, Gerlof A.

2012-01-01

The aim of this study was to determine the reliability and discriminant validity of the Dutch version of the life satisfaction questionnaire (Lisat-9 DV) to assess patients with an acquired brain injury. The reliability study used a test-retest design, and the validity study used a cross-sectional design. The setting was the general rehabilitation…

The Effects of Organization Design and Patient Perceptions of Care on Switching Behavior and Reliance on a Health Care System Across Time.

PubMed

Labonte, Alan J; Benzer, Justin K; Burgess, James F; Cramer, Irene E; Meterko, Mark; Pogoda, Terri K; Charns, Martin P

2016-04-01

Sustaining ongoing relationships with patients is a strategic, clinically relevant goal of health care systems. This study develops and tests a conceptual model that aims to account for the influence of organization design, perceptions of quality of patient care, and other patient-level factors on the extent to which patients sustain reliance on a health care system. We use a longitudinal survey design and structural equation modeling to predict increases or decreases in patient reliance on the Department of Veterans Affairs health care system across a 4-year period for Veterans with Parkinson's Disease. Our findings show that specialized and integrated clinical practices have a positive association with the quality of patient care. Health care systems may be able to foster long-term relations with patients and improve service quality by allocating resources to form integrated, specialized, disease-specific centers of care designed for patients with chronic illnesses. © The Author(s) 2016.

The physical environment and patients' activities and care: A comparative case study at three newly built stroke units.

PubMed

Anåker, Anna; von Koch, Lena; Sjöstrand, Christina; Heylighen, Ann; Elf, Marie

2018-04-20

To explore and compare the impact of the physical environment on patients' activities and care at three newly built stroke units. Receiving care in a stroke unit instead of in a general ward reduces the odds of death, dependency and institutionalized care. In stroke units, the design of the physical environment should support evidence-based care. Studies on patients' activities in relation to the design of the physical environment of stroke units are scarce. This work is a comparative descriptive case study. Patients (N = 55) who had a confirmed diagnosis of stroke were recruited from three newly built stroke units in Sweden. The units were examined by non-participant observation using two types of data collection: behavioural mapping analysed with descriptive statistics and field note taking analysed with deductive content analysis. Data were collected from April 2013 - December 2015. The units differed in the patients' levels of physical activity, the proportion of the day that patients spent with health professionals and family presence. Patients were more physically active in a unit with a combination of single and multi-bed room designs than in a unit with an entirely single-room design. Stroke units that were easy to navigate and offered variations in the physical environment had an impact on patients' activities and care. Patients' activity levels and interactions appeared to vary with the design of the physical environments of stroke units. Stroke guidelines focused on health status assessments, avoidance of bed-rest and early rehabilitation require a supportive physical environment. © 2018 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.

PubMed

Khan, Arif; Kolts, Russell L; Thase, Michael E; Krishnan, K Ranga Rama; Brown, Walter

2004-11-01

The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials. Clinical trial data were reviewed for nine antidepressants approved by the Food and Drug Administration between 1985 and 2000. From the antidepressant research programs on these medications, 52 clinical trials were included in the study. The authors evaluated trial design features, patient characteristics, and difference in response between placebo and antidepressant. Nine trial design features and patient characteristics were present in the research programs for all nine of the antidepressants. The severity of depressive symptoms before patient randomization, the dosing schedule (flexible versus fixed), the number of treatment arms, and the percentage of female patients were significantly associated with the difference in response to antidepressant and placebo. The duration of the antidepressant trial, number of patients per treatment arm, number of sites, and mean age of the patients were similar in successful trials (with a greater antidepressant-placebo difference) and less successful trials (with a smaller antidepressant-placebo difference). These findings may help in the design of future antidepressant trials.

The China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Retrospective Study of Acute Myocardial Infarction: Study Design China PEACE-Retrospective AMI Study Design

PubMed Central

Dharmarajan, Kumar; Li, Jing; Li, Xi; Lin, Zhenqiu; Krumholz, Harlan; Jiang, Lixin

2014-01-01

Background Cardiovascular diseases are rising as a cause of death and disability in China. To improve outcomes for patients with these conditions, the Chinese government, academic researchers, clinicians, and more than 200 hospitals have created China Patient-centered Evaluative Assessment of Cardiac Events (China-PEACE), a national network for research and performance improvement. The first study from China PEACE, the Retrospective Study of Acute Myocardial Infarction (China PEACE-Retrospective AMI Study), is designed to promote improvements in AMI quality of care by generating knowledge about the characteristics, treatments, and outcomes of patients hospitalized with acute myocardial infarction (AMI) across a representative sample of Chinese hospitals over the last decade. Methods and Results The China PEACE-Retrospective AMI Study will examine more than 18,000 patient records from 162 hospitals identified using a 2-stage cluster sampling design within economic-geographic regions. Records were chosen from 2001, 2006, and 2011 to identify temporal trends. Data quality will be monitored by a central coordinating center and will, in particular, address case ascertainment, data abstraction, and data management. Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results by time and site of care. In addition to publications, data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement. Conclusions The China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and over the last decade in China. The China PEACE collaboration between government, academicians, clinicians and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients. PMID:24221838

Staff Nurse Perceptions of Open-Pod and Single Family Room NICU Designs on Work Environment and Patient Care.

PubMed

Winner-Stoltz, Regina; Lengerich, Alexander; Hench, Anna Jeanine; OʼMalley, Janet; Kjelland, Kimberly; Teal, Melissa

2018-06-01

Neonatal intensive care units have historically been constructed as open units or multiple-bed bays, but since the 1990s, the trend has been toward single family room (SFR) units. The SFR design has been found to promote family-centered care and to improve patient outcomes and safety. The impact of the SFR design NICU on staff, however, has been mixed. The purposes of this study were to compare staff nurse perceptions of their work environments in an open-pod versus an SFR NICU and to compare staff nurse perceptions of the impact of 2 NICU designs on the care they provide for patients/families. A prospective cohort study was conducted. Questionnaires were completed at 6 months premove and again at 3, 9, and 15 months postmove. A series of 1-way analyses of variance were conducted to compare each group in each of the 8 domains. Open-ended questions were evaluated using thematic analysis. The SFR design is favorable in relation to environmental quality and control of primary workspace, privacy and interruption, unit features supporting individual work, and unit features supporting teamwork; the open-pod design is preferable in relation to walking. Incorporating design features that decrease staff isolation and walking and ensuring both patient and staff safety and security are important considerations. Further study is needed on unit design at a microlevel including headwall design and human milk mixing areas, as well as on workflow processes.

Developmental Therapeutics Consortium report on study design effects on trial outcomes in chronic myeloid leukaemia.

PubMed

Giles, Francis; Mahon, François-Xavier; Gjertsen, Bjorn; Swords, Ronan; Labar, Boris; Turkina, Anna; Rosti, Gianantonio

2012-09-01

Tyrosine kinase inhibitors (TKIs) have dramatically changed the treatment of chronic myeloid leukaemia (CML). Results from ongoing phase 3 trials with nilotinib [Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd)] and dasatinib [Dasatinib Versus Imatinib Study in Treatment-Naive CML-CP Patients (DASISION)] in newly diagnosed patients with CML in chronic phase have demonstrated that these TKIs resulted in significant improvements in responses vs. imatinib. The Developmental Therapeutics Consortium (DTC) systematically reviewed the published literature to provide a comparative analysis of the ENESTnd and DASISION trial designs and data reported on each study. The recent approval of nilotinib and dasatinib based on these two pivotal studies offers physicians the option to optimise frontline treatment based on a patient's comorbidities, risk factors and tolerability profiles. Although nilotinib and dasatinib provide effective therapeutic options for the frontline treatment of CML, the lack of an evidenced-based, side-by-side comparison makes it difficult to directly compare these agents. Despite potential bias from differences in patient populations and study design, indirect cross-trial comparisons to determine the relative effectiveness of these agents will be performed by physicians. This DTC report provides a comprehensive summary of the study designs, protocols and results of the ENESTnd and DASISION trials, which will assist physicians in making informed decisions on the best treatment approach for their patients. © 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.

Study design and "evidence" in patient-oriented research.

PubMed

Concato, John

2013-06-01

Individual studies in patient-oriented research, whether described as "comparative effectiveness" or using other terms, are based on underlying methodological designs. A simple taxonomy of study designs includes randomized controlled trials on the one hand, and observational studies (such as case series, cohort studies, and case-control studies) on the other. A rigid hierarchy of these design types is a fairly recent phenomenon, promoted as a tenet of "evidence-based medicine," with randomized controlled trials receiving gold-standard status in terms of producing valid results. Although randomized trials have many strengths, and contribute substantially to the evidence base in clinical care, making presumptions about the quality of a study based solely on category of research design is unscientific. Both the limitations of randomized trials as well as the strengths of observational studies tend to be overlooked when a priori assumptions are made. This essay presents an argument in support of a more balanced approach to evaluating evidence, and discusses representative examples from the general medical as well as pulmonary and critical care literature. The simultaneous consideration of validity (whether results are correct "internally") and generalizability (how well results apply to "external" populations) is warranted in assessing whether a study's results are accurate for patients likely to receive the intervention-examining the intersection of clinical and methodological issues in what can be called a medicine-based evidence approach. Examination of cause-effect associations in patient-oriented research should recognize both the strengths and limitations of randomized trials as well as observational studies.

Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

PubMed

Ho, M W; Pick, A S; Sutton, D N; Dyker, K; Cardale, K; Gilbert, K; Johnson, J; Quantrill, J; McCaul, J A

2018-05-01

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Patient-physician interaction in general practice and health inequalities in a multidisciplinary study: design, methods and feasibility in the French INTERMEDE study.

PubMed

Kelly-Irving, Michelle; Rolland, Christine; Afrite, Anissa; Cases, Chantal; Dourgnon, Paul; Lombrail, Pierre; Pascal, Jean; Lang, Thierry

2009-04-22

The way in which patients and their doctors interact is a potentially important factor in optimal communication during consultations as well as treatment, compliance and follow-up care. The aim of this multidisciplinary study is to use both qualitative and quantitative methods to explore the 'black box' that is the interaction between the two parties during a general practice consultation, and to identify factors therein that may contribute to producing health inequalities. This paper outlines the original multidisciplinary methodology used, and the feasibility of this type of study. The study design combines methodologies on two separate samples in two phases. Firstly, a qualitative phase collected ethnographical and sociological data during consultation, followed by in-depth interviews with both patients and doctors independently. Secondly, a quantitative phase on a different sample of patients and physicians collected data via several questionnaires given to patients and doctors consisting of specific 'mirrored' questions asked post-consultation, as well as collecting information on patient and physician characteristics. The design and methodology used in this study were both successfully implemented, and readily accepted by doctors and patients alike. This type of multidisciplinary study shows great potential in providing further knowledge into the role of patient/physician interaction and its influence on maintaining or producing health inequalities. The next challenge in this study will be implementing the multidisciplinary approach during the data analysis.

Effectiveness and feasibility of Socratic feedback to increase awareness of deficits in patients with acquired brain injury: Four single-case experimental design (SCED) studies.

PubMed

Schrijnemaekers, Anne-Claire M C; Winkens, Ieke; Rasquin, Sascha M C; Verhaeg, Annette; Ponds, Rudolf W H M; van Heugten, Caroline M

2018-06-29

To investigate the effectiveness and feasibility of a Socratic feedback programme to improve awareness of deficits in patients with acquired brain injury (ABI). Rehabilitation centre. Four patients with ABI with awareness problems. A series of single-case experimental design studies with random intervention starting points (A-B + maintenance design). Rate of trainer-feedback and self-control behaviour on everyday tasks, patient competency rating scale (PCRS), self-regulating skills interview (SRSI), hospital anxiety and depression scale. All patients needed less trainer feedback, the change was significant in 3 out of 4. One patient increased in overt self-corrective behaviour. SRSI performance increased in all patients (medium to strong effect size), and PCRS performance increased in two patients (medium and strong effect size). Mood and anxiety levels were elevated in one patient at the beginning of the training and decreased to normal levels at the end of the training. The feasibility of the programme was scored 9 out of 10. The Socratic feedback method is a promising intervention for improving awareness of deficits in patients with ABI. Controlled studies with larger populations are needed to draw more solid conclusions about the effect of this method.

Theoretical Basis of the Test-Negative Study Design for Assessment of Influenza Vaccine Effectiveness.

PubMed

Sullivan, Sheena G; Tchetgen Tchetgen, Eric J; Cowling, Benjamin J

2016-09-01

Influenza viruses undergo frequent antigenic changes. As a result, the viruses circulating change within and between seasons, and the composition of the influenza vaccine is updated annually. Thus, estimation of the vaccine's effectiveness is not constant across seasons. In order to provide annual estimates of the influenza vaccine's effectiveness, health departments have increasingly adopted the "test-negative design," using enhanced data from routine surveillance systems. In this design, patients presenting to participating general practitioners with influenza-like illness are swabbed for laboratory testing; those testing positive for influenza virus are defined as cases, and those testing negative form the comparison group. Data on patients' vaccination histories and confounder profiles are also collected. Vaccine effectiveness is estimated from the odds ratio comparing the odds of testing positive for influenza among vaccinated patients and unvaccinated patients, adjusting for confounders. The test-negative design is purported to reduce bias associated with confounding by health-care-seeking behavior and misclassification of cases. In this paper, we use directed acyclic graphs to characterize potential biases in studies of influenza vaccine effectiveness using the test-negative design. We show how studies using this design can avoid or minimize bias and where bias may be introduced with particular study design variations. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Modelling elderly cardiac patients decision making using Cognitive Work Analysis: identifying requirements for patient decision aids.

PubMed

Dhukaram, Anandhi Vivekanandan; Baber, Chris

2015-06-01

Patients make various healthcare decisions on a daily basis. Such day-to-day decision making can have significant consequences on their own health, treatment, care, and costs. While decision aids (DAs) provide effective support in enhancing patient's decision making, to date there have been few studies examining patient's decision making process or exploring how the understanding of such decision processes can aid in extracting requirements for the design of DAs. This paper applies Cognitive Work Analysis (CWA) to analyse patient's decision making in order to inform requirements for supporting self-care decision making. This study uses focus groups to elicit information from elderly cardiovascular disease (CVD) patients concerning a range of decision situations they face on a daily basis. Specifically, the focus groups addressed issues related to the decision making of CVD in terms of medication compliance, pain, diet and exercise. The results of these focus groups are used to develop high level views using CWA. CWA framework decomposes the complex decision making problem to inform three approaches to DA design: one design based on high level requirements; one based on a normative model of decision-making for patients; and the third based on a range of heuristics that patients seem to use. CWA helps in extracting and synthesising decision making from different perspectives: decision processes, work organisation, patient competencies and strategies used in decision making. As decision making can be influenced by human behaviour like skills, rules and knowledge, it is argued that patients require support to different types of decision making. This paper also provides insights for designers in using CWA framework for the design of effective DAs to support patients in self-management. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Public Interest in Medical Research Participation: Does It Matter if Patients or Community Members Have Helped Design the Study?

PubMed

Cobb, Enesha M; Gebremariam, Achamyeleh; Singer, Dianne; Davis, Matthew M

2015-10-01

We determined national levels of public participation in medical research study design. We compared public interest in medical research participation (MRP) in studies overall, versus studies explicitly designed with public involvement. Cross-sectional household survey of US population in June 2013. Descriptive statistics estimated participation in medical research study design. Chi-square test compared levels of interest in MRP if respondent knew patients or community members helped design the study. Of 2,048 respondents (participation rate 60%), 5% knew someone who had helped design a medical research study. There was no association between having known someone or personal participation in study design and willingness to engage in MRP. Although the overall proportion of respondents who would consider MRP initially (51%) was similar to the proportion who would consider MRP with community member involvement in study design (49%), the changes in respondents' views across the different scenarios were significantly greater than what would have been expected by chance. We found similar levels of interest in MRP whether or not the public is involved in medical research study design. This finding may indicate that public involvement in study design, like community-based participatory research, may not affect overall rates of MRP. © 2015 Wiley Periodicals, Inc.

Turning challenges into design principles: Telemonitoring systems for patients with multiple chronic conditions.

PubMed

Sultan, Mehwish; Kuluski, Kerry; McIsaac, Warren J; Cafazzo, Joseph A; Seto, Emily

2018-01-01

People with multiple chronic conditions often struggle with managing their health. The purpose of this research was to identify specific challenges of patients with multiple chronic conditions and to use the findings to form design principles for a telemonitoring system tailored for these patients. Semi-structured interviews with 15 patients with multiple chronic conditions and 10 clinicians were conducted to gain an understanding of their needs and preferences for a smartphone-based telemonitoring system. The interviews were analyzed using a conventional content analysis technique, resulting in six themes. Design principles developed from the themes included that the system must be modular to accommodate various combinations of conditions, reinforce a routine, consolidate record keeping, as well as provide actionable feedback to the patients. Designing an application for multiple chronic conditions is complex due to variability in patient conditions, and therefore, design principles developed in this study can help with future innovations aimed to help manage this population.

Building patient-centeredness: hospital design as an interpretive act.

PubMed

Bromley, Elizabeth

2012-09-01

Hospital designs reflect the sociocultural, economic, professional, and aesthetic priorities prevalent at a given time. As such, hospital buildings concretize assumptions about illness, care and healing, patienthood, and medical providers' roles. Trends in hospital design have been attributed to the increasing influence of consumerism on healthcare, the influx of business-oriented managers, and technological changes. This paper describes the impact of the concept of patient-centeredness on the design of a new hospital in the USA. Data come from 35 interviews with planners, administrators, and designers of the new hospital, as well as from public documents about the hospital design. Thematic content analysis was used to identify salient design principles and intents. For these designers, administrators, and planners, an interpretation of patient-centeredness served as a heuristic, guiding the most basic decisions about space, people, and processes in the hospital. I detail the particular interpretation of patient-centeredness used to build and manage the new hospital space and the roles and responsibilities of providers working within it. Three strategies were central to the implementation of patient-centeredness: an onstage/offstage layout; a concierge approach to patients; and the scripting of communication. I discuss that this interpretation of patient-centeredness may challenge medical professionals' roles, may construct medical care as a product that should sate the patient's desire, and may distance patients from the realities of medical care. By describing the ways in which hospital designs reflect and reinforce contemporary concepts of patienthood and caring, this paper raises questions about the implementation of patient-centeredness that deserve further empirical study by medical social scientists. Copyright © 2012 Elsevier Ltd. All rights reserved.

Co-designing technologies in the context of hypertension care: Negotiating participation and technology use in design meetings.

PubMed

Lundin, Mona; Mäkitalo, Åsa

2017-01-01

Research Interest: In this article, we take an interest in the new kind of relation that has been claimed to be urgently required between health services and patients. Co-production of health services implies fundamental changes in the ways medical care is organized and delivered. Usually, technologies are put forth as potential solutions to problems that might occur when establishing such new relations. The aim of this study is to scrutinize how different perspectives were brought into the discussions as the concrete design and use of a mobile phone application were introduced, and how participants anticipated and negotiated their own participation in the design project. This article reports results from an explorative study of a co-design project in hypertension care wherein health professionals and patients were invited to co-design some features of the application they were later to use. The study shows that new practices of self-treatment are not likely to take place without the cooperation of patients, since they are to provide the observational data necessary for the professionals' work. The negotiations are needed to balance patients' concerns of being monitored by technology and their needs of being in control of their everyday lives and activities.

Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers

PubMed Central

2013-01-01

Background Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers. Methods/design The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years. Discussion The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes). Trial registration Clinical Trials Identifier: NCT01485627 PMID:23570278

The Elimination of Transfer Distances Is an Important Part of Hospital Design.

PubMed

Karvonen, Sauli; Nordback, Isto; Elo, Jussi; Havulinna, Jouni; Laine, Heikki-Jussi

2017-04-01

The objective of the present study was to describe how a specific patient flow analysis with from-to charts can be used in hospital design and layout planning. As part of a large renewal project at a university hospital, a detailed patient flow analysis was applied to planning the musculoskeletal surgery unit (orthopedics and traumatology, hand surgery, and plastic surgery). First, the main activities of the unit were determined. Next, the routes of all patients treated over the course of 1 year were studied, and their physical movements in the current hospital were calculated. An ideal layout of the new hospital was then generated to minimize transfer distances by placing the main activities with close to each other, according to the patient flow analysis. The actual architectural design was based on the ideal layout plan. Finally, we compared the current transfer distances to the distances patients will move in the new hospital. The methods enabled us to estimate an approximate 50% reduction in transfer distances for inpatients (from 3,100 km/year to 1,600 km/year) and 30% reduction for outpatients (from 2,100 km/year to 1,400 km/year). Patient transfers are nonvalue-added activities. This study demonstrates that a detailed patient flow analysis with from-to charts can substantially shorten transfer distances, thereby minimizing extraneous patient and personnel movements. This reduction supports productivity improvement, cross-professional teamwork, and patient safety by placing all patient flow activities close to each other. Thus, this method is a valuable additional tool in hospital design.

What is the best?: simple versus visitor restricted rest period.

PubMed

Silvius-Byron, Stephanie A; Florimonte, Christine; Panganiban, Elizabeth G; Ulmer, Janice Fitzgerald

2014-05-01

The aim of this study was to compare a highly structured planned rest protocol that includes visitor and healthcare personnel restrictions with a simple planned rest period that encourages patients to rest during a designated time without restriction of visitors and healthcare personnel. Many hospitals acute care have begun to restrict visitors and nonessential health team interventions during specific times despite the lack of experimentally designed studies. Using a convenience sample of 52 intermediate care unit patients, a randomized experimental design study compared a highly structured planned rest protocol with restriction of visitors/healthcare personnel to a simple planned rest period without restrictions. The primary outcome variable was the patient's perceived quality of rest after a 2-hour rest period. Intermediate care patients' perception of rest and sleep during a designated rest period was similar whether elaborate rest strategies were used, including visitor and healthcare personnel restrictions, or if it was only suggested they rest and the door to their room closed. The restriction of visitors and healthcare personnel during a 2-hour rest period did not improve the patient's perception of rest or how long it took them to go to sleep.

Do managed care plans' tiered networks lead to inequities in care for minority patients?

PubMed

Brennan, Troyen A; Spettell, Claire M; Fernandes, Joaquim; Downey, Roberta L; Carrara, Lisa M

2008-01-01

This study examined whether specialists designated as meeting efficiency thresholds in an insurance company's performance network were less likely than non-designated specialists to treat minority patients insured by that company. Claims data were used to identify patients treated by specialists. Claimants' race/ethnicity status was self-reported to the insurer at enrollment. In large part, minority patients appeared to be evenly distributed across the performance network, with the exception of Asian/Pacific Islanders, who appeared to be more likely to be treated by nondesignated physicians than by designated "good-performing" specialists.

A Novel Computer-Aided Approach for Parametric Investigation of Custom Design of Fracture Fixation Plates.

PubMed

Chen, Xiaozhong; He, Kunjin; Chen, Zhengming

2017-01-01

The present study proposes an integrated computer-aided approach combining femur surface modeling, fracture evidence recover plate creation, and plate modification in order to conduct a parametric investigation of the design of custom plate for a specific patient. The study allows for improving the design efficiency of specific plates on the patients' femur parameters and the fracture information. Furthermore, the present approach will lead to exploration of plate modification and optimization. The three-dimensional (3D) surface model of a detailed femur and the corresponding fixation plate were represented with high-level feature parameters, and the shape of the specific plate was recursively modified in order to obtain the optimal plate for a specific patient. The proposed approach was tested and verified on a case study, and it could be helpful for orthopedic surgeons to design and modify the plate in order to fit the specific femur anatomy and the fracture information.

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.

PubMed

Mauri, Laura; Kario, Kazuomi; Basile, Jan; Daemen, Joost; Davies, Justin; Kirtane, Ajay J; Mahfoud, Felix; Schmieder, Roland E; Weber, Michael; Nanto, Shinsuke; Azizi, Michel

2018-01-01

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient engagement and the design of digital health

PubMed Central

Birnbaum, Faith; Lewis, Dana M.; Rosen, Rochelle; Ranney, Megan L.

2015-01-01

Digital health is an area of growing interest for physicians, patients, and technology companies alike. It promises the ability to engage patients in their care, before, during, and after an emergency department visit. Current efforts to create, study, and disseminate digital health have been limited by lack of user engagement. In this commentary, we outline the imperative for engaging end-users in each phase of digital health design, as well as a few techniques to facilitate better digital health design and implementation. PMID:25997375

Design considerations to enhance the safety of patient compartments in ambulance transporters.

PubMed

Byran, Eyal; Gilad, Issachar

2012-01-01

The safety of the interior of ambulances is dubious and, in the event of sudden impact during emergency transport, potentially perilous to patients they carry. The workplace ergonomics of the interior of the passenger cabin is lacking. This article discusses an improved ergonomic interior design based on study findings, observations and subjective perception. It suggests design aspects and safety concepts aimed at increasing the safety of patients and paramedic staff inside the ambulance as a mobile workstation.

Placement of a Newly Designed Y-Configured Bilateral Self-Expanding Metallic Stent for Hilar Biliary Obstruction: A Pilot Study.

PubMed

Jiao, Dechao; Huang, Kai; Zhu, Ming; Wu, Gang; Ren, Jianzhuang; Wang, Yanli; Han, Xinwei

2017-01-01

Whether unilateral or bilateral drainage should be performed for malignant hilar biliary obstruction remains a matter of debate. Although a Y-stent with a central wide-open mesh facilitates bilateral stent placement, it has its own limitations. This study aims to evaluate the feasibility and efficacy of a newly designed Y-configured bilateral self-expanding metallic stent (SEMS) for the treatment of hilar biliary obstruction. In this retrospective study, 14 consecutive patients with unresectable malignant hilar biliary obstruction (Bismuth type II or higher), who underwent placement of a newly designed Y-configured bilateral SEMS for hilar biliary obstruction from April 2013 to March 2015, were included into this study. Data on technical success, clinical success, stent patency, complications and patient survival were collected. Technical and clinical success was 100 and 92.9 %, respectively. Mean serum bilirubin level was significantly decreased 1 month after stent placement (P < 0.01). Furthermore, two patients (14.3 %) had early complications (one patient had severe hemobilia and one patient had cholangitis), and two patients (14.3 %) had late complications (one patient had cholangitis and one patient had cholecystitis). During the mean follow-up period of 298 days (range 89-465 days), six patients (42.9 %) developed stent occlusion caused by tumor ingrowth or overgrowth (n = 5) and sludge (n = 1). Median stent patency and overall survival times were 281 days (95 % CI 175.9-386.1 days) and 381 days (95 % CI 291.4-470.6 days), respectively. The use of the newly designed Y-configured bilateral SEMS is feasible and effective for hilar biliary obstruction using port docking deployment.

Patient Perceptions of Electronic Health Records

ERIC Educational Resources Information Center

Lulejian, Armine

2011-01-01

Research objective. Electronic Health Records (EHR) are expected to transform the way medicine is delivered with patients/consumers being the intended beneficiaries. However, little is known regarding patient knowledge and attitudes about EHRs. This study examined patient perceptions about EHR. Study design. Surveys were administered following…

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

PubMed

Bauhofer, A; Lorenz, W; Stinner, B; Rothmund, M; Koller, M; Sitter, H; Celik, I; Farndon, J R; Fingerhut, A; Hay, J M; Lefering, R; Lorijn, R; Nyström, P O; Schäfer, H; Schein, M; Solomkin, J; Troidl, H; Volk, H D; Wittmann, D H; Wyatt, J

2001-04-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Evidence-based design in an intensive care unit: end-user perceptions.

PubMed

Ferri, Mauricio; Zygun, David A; Harrison, Alexandra; Stelfox, Henry T

2015-04-25

The objective of this study was to describe end-user impressions and experiences in a new intensive care unit built using evidence-based design. This qualitative study was comprised of early (2-3 months after opening) and late (12-15 months after opening) phase individual interviews with end-users (healthcare providers, support staff, and patient family members) of the newly constructed Foothills Medical Centre intensive care unit in Calgary, Canada. The study unit was the recipient of the Society of Critical Care Medicine Design Citation award in 2012. We conducted interviews with thirty-nine ICU end-users, twenty-four in the early phase and fifteen in the late phase. We identified four themes (eleven sub-themes): atmosphere (abundant natural light and low noise levels), physical spaces (single occupancy rooms, rooms clustered into clinical pods, medication rooms, and tradeoffs of larger spaces), family participation in care (family support areas and social networks), and equipment (usability, storage, and providers connectivity). Abundant natural light was the design feature most frequently associated with a pleasant atmosphere. Participants emphasized the tradeoffs of size and space, and reported that the benefits of additional space (e.g., fewer interruptions due to less noise) out-weighed the disadvantages (e.g., greater distances between patients, families and providers). End-users advised that local patient care policies (e.g., number of visitors allowed at a time) and staffing needed to be updated to reflect the characteristics of the new facility design. End-users identified design elements for creating a pleasant atmosphere, attention to the tradeoffs of space and size, designing family support areas to encourage family participation in care, and updating patient care policies and staffing to reflect the new physical space as important aspects to consider when building intensive care units. Evidence-based design may optimize ICU structure for patients, patient families and providers.

Online continuing medical education (CME) for GPs: does it work? A systematic review.

PubMed

Thepwongsa, Isaraporn; Kirby, Catherine N; Schattner, Peter; Piterman, Leon

2014-10-01

Numerous studies have assessed the effectiveness of online continuing medical education (CME) designed to improve healthcare professionals' care of patients. The effects of online educational interventions targeted at general practitioners (GP), however, have not been systematically reviewed. A computer search was conducted through seven databases for studies assessing changes in GPs' knowledge and practice, or patient outcomes following an online educational intervention. Eleven studies met the eligibility criteria. Most studies (8/11, 72.7%) found a significant improvement in at least one of the following outcomes: satisfaction, knowledge or practice change. There was little evidence for the impact of online CME on patient outcomes. Variability in study design, characteristics of online and outcome measures limited conclusions on the effects of online CME. Online CME could improve GP satisfaction, knowledge and practices but there are very few well-designed studies that focus on this delivery method of GP education.

Pharmacists and patients feedback on empirically designed prescription warning labels: a qualitative study.

PubMed

Shiyanbola, Olayinka O; Smith, Paul D; Huang, Yen-Ming; Mansukhani, Sonal Ghura

2017-02-01

Background Recommendations call for the inclusion of both patient and provider input in the redesign of prescription labels. Pharmacist opinions on prescription warning labels are important because they are the health providers who would eventually distribute and explain the revised labels during medication counseling. They may be the first health provider to notice a patient's misunderstanding on how to safely use their prescription medications. Objectives To explore the perspectives of patients and pharmacists on five newly designed PWLs, and examine if there were similarities and differences between patients' and pharmacists' perspectives. Setting Private room in Wisconsin. Methods A descriptive study using semi-structured 60-min face-to-face individual interviews with patients and pharmacists explored patients and pharmacists' feedback on five newly designed PWLs. Patients who were 18 years and older, spoke English, and took a prescription medication and pharmacists who filled prescriptions in an ambulatory setting participated in the study. The patient and pharmacist perspectives on the words (content), picture and color (cosmetic appearance), and placement of warning instructions on the pill bottle (convenience) was based on a label redesign framework. Qualitative content analysis was done. Main outcome measure Patient and pharmacist perspectives on the newly designed PWLs. Results Twenty-one patients and eight pharmacists practicing in an academic medical center outpatient setting (n = 5) or retail pharmacy (n = 3) participated. All patients and pharmacists wanted the PWLs positioned on the front of the pill bottle but not the side of the bottle or warning instructions embedded into the main prescription label. Other similarities included participants preferring: (1) pictures closely depicting the instructions and (2) the use of yellow highlighting on the PWL to draw attention to it. There were differences in patient and pharmacist perspectives regarding the addition of 'Warning' to the instruction on the PWL with the patient preference to include the word 'Warning'. Pharmacists thought some PWL pictures had racial stereotypes, but this feedback was never mentioned by patients. Conclusions Patients and pharmacists had different preferences for PWL design changes to improve understandability. Pharmacist preferences did not always correspond with patient preferences. However, patients and pharmacists generally agreed on the preferred location of the PWL on the pill bottle and the use of color for drawing patients' attention.

Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach

PubMed Central

Webster, Fiona; Christian, Jennifer; Mansfield, Elizabeth; Bhattacharyya, Onil; Hawker, Gillian; Levinson, Wendy; Naglie, Gary; Pham, Thuy-Nga; Rose, Louise; Schull, Michael; Sinha, Samir; Stergiopoulos, Vicky; Upshur, Ross; Wilson, Lynn

2015-01-01

Objectives The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. Setting Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. Participants We included 62 interviews from 44 patients and 18 non-clinical caregivers. Intervention Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. Outcome measures This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. Results We identified 5 broad themes that capture the patients’ experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients’ experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. Conclusions Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and modification. PMID:26351182

Advancing cognitive engineering methods to support user interface design for electronic health records.

PubMed

Thyvalikakath, Thankam P; Dziabiak, Michael P; Johnson, Raymond; Torres-Urquidy, Miguel Humberto; Acharya, Amit; Yabes, Jonathan; Schleyer, Titus K

2014-04-01

Despite many decades of research on the effective development of clinical systems in medicine, the adoption of health information technology to improve patient care continues to be slow, especially in ambulatory settings. This applies to dentistry as well, a primary care discipline with approximately 137,000 practitioners in the United States. A critical reason for slow adoption is the poor usability of clinical systems, which makes it difficult for providers to navigate through the information and obtain an integrated view of patient data. In this study, we documented the cognitive processes and information management strategies used by dentists during a typical patient examination. The results will inform the design of a novel electronic dental record interface. We conducted a cognitive task analysis (CTA) study to observe ten general dentists (five general dentists and five general dental faculty members, each with more than two years of clinical experience) examining three simulated patient cases using a think-aloud protocol. Dentists first reviewed the patient's demographics, chief complaint, medical history and dental history to determine the general status of the patient. Subsequently, they proceeded to examine the patient's intraoral status using radiographs, intraoral images, hard tissue and periodontal tissue information. The results also identified dentists' patterns of navigation through patient's information and additional information needs during a typical clinician-patient encounter. This study reinforced the significance of applying cognitive engineering methods to inform the design of a clinical system. Second, applying CTA to a scenario closely simulating an actual patient encounter helped with capturing participants' knowledge states and decision-making when diagnosing and treating a patient. The resultant knowledge of dentists' patterns of information retrieval and review will significantly contribute to designing flexible and task-appropriate information presentation in electronic dental records. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Comparisons on Efficacy of Elcatonin and Limaprost Alfadex in Patients with Lumbar Spinal Stenosis and Concurrent Osteoporosis: A Preliminary Study Using a Crossover Design

PubMed Central

Imajo, Yasuaki; Suzuki, Hidenori; Yoshida, Yuichiro; Taguchi, Toshihiko; Tominaga, Toshikatsu; Toyoda, Koichiro

2014-01-01

Study Design Multicenter prospective study with a crossover design. Purpose The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. Overview of Literature It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. Methods A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. Results There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. Conclusions Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks. PMID:25187864

The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

PubMed

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2015-06-18

Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

Self-Report of Depressive Symptoms in Low Back Pain Patients.

ERIC Educational Resources Information Center

Crisson, James; And Others

1986-01-01

Presents two studies designed to examine the self-report of depressive symptoms in low back pain patients (N=134). Both studies found that patients were more likely to report somatic than cognitive symptoms of depression. Patients with multiple physical findings were not more likely to report somatic symptoms than patients with few physical…

A Pilot Project to Develop and Assess a Health Education Programme for Type 2 Diabetes Mellitus Patients

ERIC Educational Resources Information Center

Atak, Nazli; Arslan, Umit

2005-01-01

Objective: The current research was designed to develop a health education programme for type 2 diabetes mellitus based on the Taba-Tyler model and to evaluate its effect. Design: The study was quasi-experimental in design. Setting: Fifty-five patients from the Endocrinology and Metabolism Unit, University Hospital of Ankara. Method: An education…

Optimal color design of psychological counseling room by design of experiments and response surface methodology.

PubMed

Liu, Wenjuan; Ji, Jianlin; Chen, Hua; Ye, Chenyu

2014-01-01

Color is one of the most powerful aspects of a psychological counseling environment. Little scientific research has been conducted on color design and much of the existing literature is based on observational studies. Using design of experiments and response surface methodology, this paper proposes an optimal color design approach for transforming patients' perception into color elements. Six indices, pleasant-unpleasant, interesting-uninteresting, exciting-boring, relaxing-distressing, safe-fearful, and active-inactive, were used to assess patients' impression. A total of 75 patients participated, including 42 for Experiment 1 and 33 for Experiment 2. 27 representative color samples were designed in Experiment 1, and the color sample (L = 75, a = 0, b = -60) was the most preferred one. In Experiment 2, this color sample was set as the 'central point', and three color attributes were optimized to maximize the patients' satisfaction. The experimental results show that the proposed method can get the optimal solution for color design of a counseling room.

Do Alzheimer's Disease Patients Want to Participate in a Treatment Decision, and Would Their Caregivers Let Them?

ERIC Educational Resources Information Center

Hirschman, Karen B.; Joyce, Colette M.; James, Bryan D.; Xie, Sharon X.; Karlawish, Jason H.T.

2005-01-01

Purpose: This study was designed to examine the factors associated with the preferences of Alzheimer's disease patients to participate in a decision to use an Alzheimer's disease-slowing medication and how involved their caregivers would let them be in this decision. Design and Methods: Interviews were conducted with 48 patients in the…

Patient engagement in the design and execution of urologic oncology research.

PubMed

Lee, Daniel J; Avulova, Svetlana; Conwill, Ralph; Barocas, Daniel A

2017-09-01

There have been significant effort and financial support to engage patients in the design and execution of medical research. However, little is known about the relative benefits or potential impact of involving patients in research, most efficient practices and systems to enhance their involvement, and potential barriers and challenges that are involved with engaging patients. In this review, we will discuss the value of patient centered research, review the challenges that many of these studies faced, and highlight potential future opportunities to enhance patient involvement in urologic research. An English-language literature search was performed in the electronic databases of Medline (PubMed), EMBASE, Web of Science, Google Scholar, the Cochrane Library, and on the Patient Centered Outcomes Research Institute (PCORI) website. Search items included "patient-centered research," "patient-reported outcomes" and "patient engagement" in various combinations. Although PCORI has funded almost 600 projects with $1.6 billion to improve patient centered research, the search revealed 3 studies of patient engagement in the development, management, and execution of urologic oncology research. Patient engagement in the design and execution of medical research can help align research topics to match patient priorities, improve survey and data collection tools, increase patient recruitment and participation in studies, and improve accessibility and dissemination of clinically relevant results from medical research. However, engagement patients in research requires significant investment of time, financial support, and energy from the patients, stakeholders, and researchers to provide mutual benefit. In the three studies in urologic oncology that involved patients, the patients provided a significant impact on the structure of the studies and helped improve the ability of patients to apply the results from the research studies. The benefits to involving patients in research to improve the access, understanding, and application of clinical evidence can be significant. Patient engagement in urologic oncology research is limited currently, but is expected to grow as the funding agencies incentivize the practice and the culture shifts toward a greater emphasis on patient centered outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

PubMed

Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662 patients will be enrolled to reach a total of 1,028 patients for evaluation of the secondary end-point of pump replacement at 2 years. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Speaking Up: How Patient and Physician Voices Shaped a Trial to Improve Goals-of-Care Discussions.

PubMed

Solomon, Rachel; Smith, Cardinale; Kallio, Jay; Fenollosa, Amy; Benerofe, Barbara; Jones, Laurence; Adelson, Kerin; Gonsky, Jason P; Messner, Carolyn; Bickell, Nina A

2017-08-01

Patients with advanced cancer benefit from early goals-of-care (GoC) conversations, but few facilitators are known. We describe the process and outcomes of involving patient and physician stakeholders in the design and development of a trial, funded by the Patient-Centered Outcomes Research Institute (PCORI), to enhance oncologists' communication skills and their propensity to facilitate productive, meaningful GoC discussions with patients with advanced cancer. We recruited oncologists, palliative care physicians, and patient stakeholders to participate in proposal development, intervention design and modification, identification of outcome measures, and refinement of study tools. Formats for exchange included 1:1 structured interviews, workshops, and stakeholder meetings. Patient and physician voices helped craft and implement a study of an intervention to enhance oncologists' ability to facilitate GoC discussions with patients with advanced cancer. Physician inputs guided the creation of an oncologist and palliative care physician "joint visit" intervention at a turning point in disease management. Patient inputs impacted on the language used, outcome measures assessed, and approaches used to introduce patients to the intervention visit. Stakeholder input informed the development of a novel intervention that physicians seemed to find both valuable and in sync with their needs and their practice schedules. Where communication about difficult subjects and shared decision making are involved, including multiple stakeholder groups in study design, implementation, and outcomes measurement may have far-reaching effects.

Reducing psychological distress in patients undergoing chemotherapy.

PubMed

Milanti, Ariesta; Metsälä, Eija; Hannula, Leena

Psychological distress is a common problem among patients with cancer, yet it mostly goes unreported and untreated. This study examined the association of a psycho-educational intervention with the psychological distress levels of breast cancer and cervical cancer patients undergoing chemotherapy. The design of the study was quasi-experimental, pretest-posttest design with a comparison group. One hundred patients at a cancer hospital in Jakarta, Indonesia, completed Distress Thermometer screening before and after chemotherapy. Fifty patients in the intervention group were given a psycho-educational video with positive reappraisal, education and relaxation contents, while receiving chemotherapy. Patients who received the psycho-educational intervention had significantly lower distress levels compared with those in the control group. Routine distress screening, followed by distress management and outcome assessment, is needed to improve the wellbeing of cancer patients.

Remote health monitoring: predicting outcome success based on contextual features for cardiovascular disease.

PubMed

Alshurafa, Nabil; Eastwood, Jo-Ann; Pourhomayoun, Mohammad; Liu, Jason J; Sarrafzadeh, Majid

2014-01-01

Current studies have produced a plethora of remote health monitoring (RHM) systems designed to enhance the care of patients with chronic diseases. Many RHM systems are designed to improve patient risk factors for cardiovascular disease, including physiological parameters such as body mass index (BMI) and waist circumference, and lipid profiles such as low density lipoprotein (LDL) and high density lipoprotein (HDL). There are several patient characteristics that could be determining factors for a patient's RHM outcome success, but these characteristics have been largely unidentified. In this paper, we analyze results from an RHM system deployed in a six month Women's Heart Health study of 90 patients, and apply advanced feature selection and machine learning algorithms to identify patients' key baseline contextual features and build effective prediction models that help determine RHM outcome success. We introduce Wanda-CVD, a smartphone-based RHM system designed to help participants with cardiovascular disease risk factors by motivating participants through wireless coaching using feedback and prompts as social support. We analyze key contextual features that secure positive patient outcomes in both physiological parameters and lipid profiles. Results from the Women's Heart Health study show that health threat of heart disease, quality of life, family history, stress factors, social support, and anxiety at baseline all help predict patient RHM outcome success.

Nonmedical influences on medical decision making: an experimental technique using videotapes, factorial design, and survey sampling.

PubMed Central

Feldman, H A; McKinlay, J B; Potter, D A; Freund, K M; Burns, R B; Moskowitz, M A; Kasten, L E

1997-01-01

OBJECTIVE: To study nonmedical influences on the doctor-patient interaction. A technique using simulated patients and "real" doctors is described. DATA SOURCES: A random sample of physicians, stratified on such characteristics as demographics, specialty, or experience, and selected from commercial and professional listings. STUDY DESIGN: A medical appointment is depicted on videotape by professional actors. The patient's presenting complaint (e.g., chest pain) allows a range of valid interpretation. Several alternative versions are taped, featuring the same script with patient-actors of different age, sex, race, or other characteristics. Fractional factorial design is used to select a balanced subset of patient characteristics, reducing costs without biasing the outcome. DATA COLLECTION: Each physician is shown one version of the videotape appointment and is asked to describe how he or she would diagnose or treat such a patient. PRINCIPAL FINDINGS: Two studies using this technique have been completed to date, one involving chest pain and dyspnea and the other involving breast cancer. The factorial design provided sufficient power, despite limited sample size, to demonstrate with statistical significance various influences of the experimental and stratification variables, including the patient's gender and age and the physician's experience. Persistent recruitment produced a high response rate, minimizing selection bias and enhancing validity. CONCLUSION: These techniques permit us to determine, with a degree of control unattainable in observational studies, whether medical decisions as described by actual physicians and drawn from a demographic or professional group of interest, are influenced by a prescribed set of nonmedical factors. PMID:9240285

Hospital Nurses' Work Environment Characteristics and Patient Safety Outcomes: A Literature Review.

PubMed

Lee, Seung Eun; Scott, Linda D

2018-01-01

This integrative literature review assesses the relationship between hospital nurses' work environment characteristics and patient safety outcomes and recommends directions for future research based on examination of the literature. Using an electronic search of five databases, 18 studies published in English between 1999 and 2016 were identified for review. All but one study used a cross-sectional design, and only four used a conceptual/theoretical framework to guide the research. No definition of work environment was provided in most studies. Differing variables and instruments were used to measure patient outcomes, and findings regarding the effects of work environment on patient outcomes were inconsistent. To clarify the relationship between nurses' work environment characteristics and patient safety outcomes, researchers should consider using a longitudinal study design, using a theoretical foundation, and providing clear operational definitions of concepts. Moreover, given the inconsistent findings of previous studies, they should choose their measurement methodologies with care.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Exploring Patient Activation in the Clinic: Measurement from Three Perspectives

ERIC Educational Resources Information Center

Ledford, Christy J. W.; Ledford, Christopher C.; Childress, Marc A.

2013-01-01

Objective. To further conceptualize and operationalize patient activation (PA), using measures from patient, physician, and researcher perspectives. Data Source/Study Setting. Multimethod observation in 2010 within a family medicine clinic. Study Design. Part of an intervention with 130 patients with type 2 diabetes, this observational study…

[IBEAS design: adverse events prevalence in Latin American hospitals].

PubMed

Aranaz-Andrés, J M; Aibar-Remón, C; Limón-Ramírez, R; Amarilla, A; Restrepo, F R; Urroz, O; Sarabia, O; Inga, R; Santivañez, A; Gonseth-García, J; Larizgoitia-Jauregui, I; Agra-Varela, Y; Terol-García, E

2011-01-01

To describe the methodological characteristics of the IBEAS study: adverse events prevalence in Latin American hospitals, with the aim of analysing the magnitude, significance and impact of adverse events (AE); to identify the main problems associated with patient safety AE; to increase the capacity of professionals involved in patient safety; and the setting up of patient safety agendas in the participating countries. A patient safety study launched in 35 Latin American hospitals through the analysis of AE in 5 countries: Argentina, Colombia, Costa Rica, Mexico and Peru, using a cross-sectional study using a review of clinical records as the main method. The implications of using a cross-sectional design when studying AE are described, in terms of resources required, internal validity and usefulness related to risk management. The cross-sectional design seems an efficient methodology in terms of time and resources spent, as well as being easy to carry out. Although the cross-sectional design does not review the all hospital episodes, it is able to provide a reliable estimate of prevalence and to support a surveillance system. Because of a possible survival bias, it is likely that the AE which led to hospital admissions will be overestimated, as well as the health related infections or those adverse events which are difficult to identify if the patient is not examined (e.g. contusions). Communication with the ward staff (if the patient is still hospitalised) help in finding the causality and their prevention. Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.

Designing clinical trials for age-related geographic atrophy of the macula: enrollment data from the geographic atrophy natural history study.

PubMed

Sunness, Janet S; Applegate, Carol A; Bressler, Neil M; Hawkins, Barbara S

2007-02-01

To derive information from the Geographic Atrophy (GA) Natural History Study that is relevant to recruiting patients and designing clinical trials for GA. A prospective natural history study with annual follow-up enrolled patients with GA and no choroidal neovascularization (CNV) in at least one eye. Characteristics of recruited and enrolled patients are analyzed, in the context of progression data from the study. The data show that GA from age-related macular degeneration (AMD) was seen in 82% of the referred patients, there was an attrition rate of 14%, and 60% of the patients with GA from AMD had bilateral GA without CNV. Within the 83 patients in the bilateral GA group with follow-up, 50 patients (60%) met both the proposed visual acuity and the proposed GA area criteria for a treatment trial in one or both eyes. These data should be helpful in planning future treatment trials for GA.

Safety assessment for the postictal confusional phase following complex partial seizure.

PubMed

Tucker, C

1985-06-01

Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

Shifting Landscapes: The Impact of Centralized and Decentralized Nursing Station Models on the Efficiency of Care.

PubMed

Fay, Lindsey; Carll-White, Allison; Schadler, Aric; Isaacs, Kathy B; Real, Kevin

2017-10-01

The focus of this research was to analyze the impact of decentralized and centralized hospital design layouts on the delivery of efficient care and the resultant level of caregiver satisfaction. An interdisciplinary team conducted a multiphased pre- and postoccupancy evaluation of a cardiovascular service line in an academic hospital that moved from a centralized to decentralized model. This study examined the impact of walkability, room usage, allocation of time, and visibility to better understand efficiency in the care environment. A mixed-methods data collection approach was utilized, which included pedometer measurements of staff walking distances, room usage data, time studies in patient rooms and nurses' stations, visibility counts, and staff questionnaires yielding qualitative and quantitative results. Overall, the data comparing the centralized and decentralized models yielded mixed results. This study's centralized design was rated significantly higher in its ability to support teamwork and efficient patient care with decreased staff walking distances. The decentralized unit design was found to positively influence proximity to patients in a larger design footprint and contribute to increased visits to and time spent in patient rooms. Among the factors contributing to caregiver efficiency and satisfaction are nursing station design, an integrated team approach, and the overall physical layout of the space on walkability, allocation of caregiver time, and visibility. However, unit design alone does not solely impact efficiency, suggesting that designers must consider the broader implications of a culture of care and processes.

An adaptive drug delivery design using neural networks for effective treatment of infectious diseases: a simulation study.

PubMed

Padhi, Radhakant; Bhardhwaj, Jayender R

2009-06-01

An adaptive drug delivery design is presented in this paper using neural networks for effective treatment of infectious diseases. The generic mathematical model used describes the coupled evolution of concentration of pathogens, plasma cells, antibodies and a numerical value that indicates the relative characteristic of a damaged organ due to the disease under the influence of external drugs. From a system theoretic point of view, the external drugs can be interpreted as control inputs, which can be designed based on control theoretic concepts. In this study, assuming a set of nominal parameters in the mathematical model, first a nonlinear controller (drug administration) is designed based on the principle of dynamic inversion. This nominal drug administration plan was found to be effective in curing "nominal model patients" (patients whose immunological dynamics conform to the mathematical model used for the control design exactly. However, it was found to be ineffective in curing "realistic model patients" (patients whose immunological dynamics may have off-nominal parameter values and possibly unwanted inputs) in general. Hence, to make the drug delivery dosage design more effective for realistic model patients, a model-following adaptive control design is carried out next by taking the help of neural networks, that are trained online. Simulation studies indicate that the adaptive controller proposed in this paper holds promise in killing the invading pathogens and healing the damaged organ even in the presence of parameter uncertainties and continued pathogen attack. Note that the computational requirements for computing the control are very minimal and all associated computations (including the training of neural networks) can be carried out online. However it assumes that the required diagnosis process can be carried out at a sufficient faster rate so that all the states are available for control computation.

Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols

PubMed Central

2010-01-01

Background and Objective Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more efficacious than placebo in patients who receive either laparotomy or thoracotomy. Design and Methods The study is a 2 × 2 factorial armed, double blinded, bicentric, randomised placebo-controlled trial comparing (a) etoricoxib and (b) placebo in a pre- and postoperative setting. The total observation period is 6 months. According to a power analysis, 120 patients scheduled for abdominal or thoracic surgery will randomly be allocated to either the preemptive or the postoperative treatment group. These two groups are each divided into two arms. Preemptive group patients receive etoricoxib prior to surgery and either etoricoxib again or placebo postoperatively. Postoperative group patients receive placebo prior to surgery and either placebo again or etoricoxib after surgery (2 × 2 factorial study design). The Main Outcome Measure is the cumulative use of morphine within the first 48 hours after surgery (measured by patient controlled analgesia PCA). Secondary outcome parameters include a broad range of tests including sensoric perception and genetic polymorphisms. Discussion The results of this study will provide information on the analgesic effectiveness of etoricoxib in preemptive analgesia and will give hints on possible preventive effects of persistent pain. Trial registration NCT00716833 PMID:20504378

Telemanagement of hypertension: A qualitative assessment of patient and physician preferences

PubMed Central

Halifax, Nancy VD; Cafazzo, Joseph A; Irvine, M Jane; Hamill, Melinda; Rizo, Carlos A; McIsaac, Warren J; Rossos, Peter G; Logan, Alexander G

2007-01-01

BACKGROUND: Prevalence surveys have consistently found that the blood pressure control rate among people with hypertension is less than 25%. Studies of telemedicine as a means of providing care to hypertensive patients have shown that this approach is effective in lowering blood pressure. Major design flaws and high operating costs, however, have hindered its adoption by physicians and patients. OBJECTIVES: In the present commentary, the field of telemedicine, as it pertains to hypertension management, is reviewed, and the investigators’ experiences in developing a new telemedicine system are outlined. METHODS: An applied qualitative case study approach was used to determine the information needs for the design of a telemedicine system. Opinions were elicited separately from type 2 diabetic patients with hypertension (n=24) and family practitioners in active clinical practice (n=18). RESULTS: Physician and patient focus group meetings provided key information that led to changes in the prototype system. The low level of computer and Internet use by patients in everyday life and by physicians in practice-related activities precluded their inclusion in the design of the system for information retrieval and receiving clinical alerts. For patients, the mobile phone appeared to be an acceptable alternative. The only practical, automated means to disseminate reports and alerts to physicians was by fax, which was the most universally available device in a doctor’s office. CONCLUSION: This tightly focused qualitative study led to the development of design principles for a prototype system, increasing the likelihood of user acceptance and improving its effectiveness. PMID:17534469

A comparative study of patients' activities and interactions in a stroke unit before and after reconstruction-The significance of the built environment.

PubMed

Anåker, Anna; von Koch, Lena; Sjöstrand, Christina; Bernhardt, Julie; Elf, Marie

2017-01-01

Early mobilization and rehabilitation, multidisciplinary stroke expertise and comprehensive therapies are fundamental in a stroke unit. To achieve effective and safe stroke care, the physical environment in modern stroke units should facilitate the delivery of evidence-based care. Therefore, the purpose of this study was to explore patients' activities and interactions in a stroke unit before the reconstruction of the physical environment, while in a temporary location and after reconstruction. This case study examined a stroke unit as an integrated whole. The data were collected using a behavioral mapping technique at three different time points: in the original unit, in the temporary unit and in the new unit. A total of 59 patients were included. The analysis included field notes from observations of the physical environment and examples from planning and design documents. The findings indicated that in the new unit, the patients spent more time in their rooms, were less active, and had fewer interactions with staff and family than the patients in the original unit. The reconstruction involved a change from a primarily multi-bed room design to single-room accommodations. In the new unit, the patients' lounge was located in a far corner of the unit with a smaller entrance than the patients' lounge in the old unit, which was located at the end of a corridor with a noticeable entrance. Changes in the design of the stroke unit may have influenced the patients' activities and interactions. This study raises the question of how the physical environment should be designed in the future to facilitate the delivery of health care and improve outcomes for stroke patients. This research is based on a case study, and although the results should be interpreted with caution, we strongly recommend that environmental considerations be included in future stroke guidelines.

A systematic review of studies of web portals for patients with diabetes mellitus.

PubMed

Coughlin, Steven S; Williams, Lovoria B; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control.

A systematic review of studies of web portals for patients with diabetes mellitus

PubMed Central

Williams, Lovoria B.; Hatzigeorgiou, Christos

2017-01-01

Patient web portals are password-protected online websites that offer patients 24-hour access to personal health information from anywhere with an Internet connection. Due to advances in health information technologies, there has been increasing interest among providers and researchers in patient web portals for use by patients with diabetes and other chronic conditions. This article, which is based upon bibliographic searches in PubMed, reviews web portals for patients with diabetes mellitus including patient web portals tethered to electronic medical records and web portals developed specifically for patients with diabetes. Twelve studies of the impact of patient web portals on the management of diabetes patients were identified. Three had a cross-sectional design, 1 employed mixed-methods, one had a matched-control design, 3 had a retrospective cohort design, and 5 were randomized controlled trials. Six (50%) of the studies examined web portals tethered to electronic medical records and the remainder were web portals developed specifically for diabetes patients. The results of this review suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control. However, results from observational studies indicate that many diabetic patients do not take advantage of web portal features such as secure messaging, perhaps because of a lack of internet access or lack of experience in navigating web portal resources. Although results from randomized controlled trials provide stronger evidence of the efficacy of web portal use in improving glycemic control among diabetic patients, the number of trials is small and results from the trials have been mixed. Studies suggest that secure messaging between adult diabetic patients and their clinician is associated with improved glycemic control, but negative findings have also been reported. The number of randomized controlled trials that have examined the efficacy of web portal use in improving glycemic control among diabetic patients is still small. Additional research is needed to identify specific portal features that may impact quality of care or improve glycemic control. PMID:28736732

Exploring educational needs and design aspects of internet-enabled patient education for persons with diabetes: a qualitative interview study

PubMed Central

Jafari, Javad; Karimi Moonaghi, Hosein; Zary, Nabil; Masiello, Italo

2016-01-01

Objective The objective of this article is to explore the educational needs and design aspects of personalised internet-enabled education for patients with diabetes in Iran. Design Data were collected using semistructured interviews and then qualitatively analysed using inductive content analysis. Participants 9 patients with type 2 diabetes were included. Inclusion criteria were access to and knowledge on how to use the internet. The selection ensured representation based on gender, age, occupation and educational background. Setting The sample population was patients with diabetes who were admitted to an outpatient diabetes clinic in Mashhad, a large city of Iran with about 3 million inhabitants. Results 4 core categories emerged from the data: (1) seeking knowledge about diabetes, including specific knowledge acquisition, patient's interactions and learning requirements; (2) teaching and learning, including using different teaching methods and different ways to learn about the disease; (3) facilitators, including internet and mobile phone use to learn about the disease; and (4) barriers, including lack of internet access, uncertainty of access to the internet and lack of website in the local language and also perceived cultural barriers, such as patients' fears of the internet, lack of time and awareness. Conclusions This study provides a better understanding of the patient's educational expectations and technical needs in relation to internet-enabled education. This knowledge will inform the development of functional mock-ups in the next research phase using a design-based research approach in order to design internet-enabled patient education for self-management of diabetes. PMID:27799245

Virtual 3D planning of tracheostomy placement and clinical applicability of 3D cannula design: a three-step study.

PubMed

de Kleijn, Bertram J; Kraeima, Joep; Wachters, Jasper E; van der Laan, Bernard F A M; Wedman, Jan; Witjes, M J H; Halmos, Gyorgy B

2018-02-01

We aimed to investigate the potential of 3D virtual planning of tracheostomy tube placement and 3D cannula design to prevent tracheostomy complications due to inadequate cannula position. 3D models of commercially available cannula were positioned in 3D models of the airway. In study (1), a cohort that underwent tracheostomy between 2013 and 2015 was selected (n = 26). The cannula was virtually placed in the airway in the pre-operative CT scan and its position was compared to the cannula position on post-operative CT scans. In study (2), a cohort with neuromuscular disease (n = 14) was analyzed. Virtual cannula placing was performed in CT scans and tested if problems could be anticipated. Finally (3), for a patient with Duchenne muscular dystrophy and complications of conventional tracheostomy cannula, a patient-specific cannula was 3D designed, fabricated, and placed. (1) The 3D planned and post-operative tracheostomy position differed significantly. (2) Three groups of patients were identified: (A) normal anatomy; (B) abnormal anatomy, commercially available cannula fits; and (C) abnormal anatomy, custom-made cannula, may be necessary. (3) The position of the custom-designed cannula was optimal and the trachea healed. Virtual planning of the tracheostomy did not correlate with actual cannula position. Identifying patients with abnormal airway anatomy in whom commercially available cannula cannot be optimally positioned is advantageous. Patient-specific cannula design based on 3D virtualization of the airway was beneficial in a patient with abnormal airway anatomy.

Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach.

PubMed

Webster, Fiona; Christian, Jennifer; Mansfield, Elizabeth; Bhattacharyya, Onil; Hawker, Gillian; Levinson, Wendy; Naglie, Gary; Pham, Thuy-Nga; Rose, Louise; Schull, Michael; Sinha, Samir; Stergiopoulos, Vicky; Upshur, Ross; Wilson, Lynn

2015-09-08

The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. We included 62 interviews from 44 patients and 18 non-clinical caregivers. Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. We identified 5 broad themes that capture the patients' experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients' experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and modification. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Health Care Needs and Support for Patients Undergoing Treatment for Prosthetic Joint Infection following Hip or Knee Arthroplasty: A Systematic Review.

PubMed

Kunutsor, Setor K; Beswick, Andrew D; Peters, Tim J; Gooberman-Hill, Rachael; Whitehouse, Michael R; Blom, Ashley W; Moore, Andrew J

2017-01-01

Hip and knee arthroplasty are common interventions for the treatment of joint conditions, most notably osteoarthritis. Although many patients benefit from surgery, approximately 1% of patients develop infection afterwards known as deep prosthetic joint infection (PJI), which often requires further major surgery. To assess support needs of patients undergoing treatment for PJI following hip or knee arthroplasty and to identify and evaluate what interventions are routinely offered to support such patients. Systematic review. MEDLINE, EMBASE, Web of Science, PsycINFO, Cinahl, Social Science Citation Index, The Cochrane Library, and reference lists of relevant studies from January 01, 1980 to October 05, 2016. Observational (prospective or retrospective cohort, nested case-control or case-control) studies, qualitative studies, or clinical trials conducted in patients treated for PJI and/or other major adverse occurrences following hip or knee arthroplasty. Data were extracted by two independent investigators and consensus was reached with involvement of a third. Given the heterogeneous nature of study designs, methods, and limited number of studies, a narrative synthesis is presented. Of 4,213 potentially relevant citations, we identified one case-control, one prospective cohort and two qualitative studies for inclusion in the synthesis. Patients report that PJI and treatment had a profoundly negative impact affecting physical, emotional, social and economic aspects of their lives. No study evaluated support interventions. The findings demonstrate that patients undergoing treatment for PJI have extensive physical, psychological, social and economic support needs. The interpretation of study results is limited by variation in study design, outcome measures and the small number of relevant eligible studies. However, our review highlights a lack of evidence about support strategies for patients undergoing treatment for PJI and other adverse occurrences following hip or knee arthroplasty. There is a need to design, implement and evaluate interventions to support these patients. PROSPERO 2015: CRD42015027175.

Digital mobile technology facilitates HIPAA-sensitive perioperative messaging, improves physician-patient communication, and streamlines patient care.

PubMed

Gordon, Chad R; Rezzadeh, Kameron S; Li, Andrew; Vardanian, Andrew; Zelken, Jonathan; Shores, Jamie T; Sacks, Justin M; Segovia, Andres L; Jarrahy, Reza

2015-01-01

Mobile device technology has revolutionized interpersonal communication, but the application of this technology to the physician-patient relationship remains limited due to concerns over patient confidentiality and the security of digital information. Nevertheless, there is a continued focus on improving communication between doctors and patients in all fields of medicine as a means of improving patient care. In this study, we implement a novel communications platform to demonstrate that instantaneously sharing perioperative information with surgical patients and members of their support networks can improve patient care and strengthen the physician-patient relationship. 423 consecutive patients scheduled to undergo elective surgical procedures were offered complimentary registration to a secure, web-based service designed to distribute perioperative updates to a group of recipients designated by each patient via Short Message Service (SMS) and/or email. Messages were created by attending surgeons and delivered instantaneously through the web-based platform. In the postoperative period, patients and their designated message recipients, as well as participating healthcare providers, were asked to complete a survey designed to assess their experience with the messaging system. Survey results were statistically analyzed to determine satisfaction rates. Of the qualifying 423 patients, 313 opted to enroll in the study. On average, patients selected a total of 3.5 recipients to receive perioperative updates. A total of 1,195 electronic messages were generated for distribution to designated recipients during the study period and delivered to recipients located around the world. There were no documented errors or failures in message delivery. Satisfaction surveys were completed by 190 users of the service (73 %). Respondents identified themselves as either patients (n = 48, 25.5 %), family/friends (n = 120, 63.8 %), or healthcare providers (n = 15, 12 %). Satisfaction with the service was high: 94.2 % of users "enjoyed this software" and and 94.2 % of family/friends "felt more connected to their loved ones during surgery." 92.5 % would "recommend their loved ones sign up for this service". Ninety percent of patients who completed the survey reported "an improved hospital experience". Digital communications platforms can facilitate the immediate transfer of HIPAA-compliant data to patients and their designees. Such systems can greatly improve the level of communication between physicians, patients, and patients' families and caregivers. All types of users, including healthcare professionals, patients, and their loved ones, recorded high levels of satisfaction. Based on these observations, we conclude that mobile digital communications platforms represent a way to harness the power of social media to enhance patient care.

The impact of cannabis and cannabinoids for medical conditions on health-related quality of life: A systematic review and meta-analysis.

PubMed

Goldenberg, Matthew; Reid, Mark William; IsHak, Waguih William; Danovitch, Itai

2017-05-01

The use of cannabis or cannabinoids to treat medical conditions and/or alleviate symptoms is increasingly common. However, the impact of this use on patient reported outcomes, such as health-related quality of life (HRQoL), remains unclear. We conducted a systematic review and meta-analysis, employing guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We categorized studies based on design, targeted disease condition, and type of cannabis or cannabinoid used. We scored studies based on quality and risk of bias. After eliminating some studies because of poor quality or insufficient data, we conducted meta-analyses of remaining studies based on design. Twenty studies met our pre-defined selection criteria. Eleven studies were randomized controlled trials (RCTs; 2322 participants); the remaining studies were of cohort and cross-sectional design. Studies of cannabinoids were mostly RCTs of higher design quality than studies of cannabis, which utilized smaller self-selected samples in observational studies. Although we did not uncover a significant association between cannabis and cannabinoids for medical conditions and HRQoL, some patients who used them to treat pain, multiple sclerosis, and inflammatory bower disorders have reported small improvements in HRQoL, whereas some HIV patients have reported reduced HRQoL. The relationship between HRQoL and the use of cannabis or cannabinoids for medical conditions is inconclusive. Some patient populations report improvements whereas others report reductions in HRQoL. In order to inform users, practitioners, and policymakers more clearly, future studies should adhere to stricter research quality guidelines and more clearly report patient outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

Color Perception in Pediatric Patient Room Design: American versus Korean Pediatric Patients.

PubMed

Phillip Park, Jin Gyu; Park, Changbae

2013-01-01

This study simultaneously addresses the issues of the scarcity of information about pediatric patient color preferences, conflicting findings about the impact of culture on color preferences, and limitations of previous research instruments. Effects of culture and gender on color preferences were investigated using American and Korean pediatric patients. Much of the existing research in environmental design has focused on environments for healthy children and adults, but those findings cannot be confidently applied to environments for pediatric patients. In previous studies, the impact of culture on color preferences has been suggested, though the effects appear to vary. Moreover, the results of previous studies were typically based on perceptions of small color chips, which are different from seeing a color on wall surfaces. Previous studies also failed to control for confounding variables such as color attributes and light sources. Instead of using color chips, this study used physical model simulation to investigate environmental color preferences in real contexts. Cultural difference was found in white. Other than white, no significant cultural difference was found. Gender differences were found across both of the groups. Korean pediatric patients showed significantly higher preference scores for white than Americans did. Other than white, both groups reported blue and green as their most preferred colors; white was the least preferred. Both groups reported similar gender effects. Overall, male patients reported significantly lower preference scores for red and purple than female patients did. These results can help healthcare providers and professionals better understand appropriate colors for pediatric populations. Evidence-based design, healing environment, patients, pediatric, satisfaction.

Conceptualizing and measuring pharmacist-patient communication: a review of published studies.

PubMed

Shah, Bupendra; Chewning, Betty

2006-06-01

Pharmacist-patient communication in community pharmacies has been studied for over 25 years with little effort to evaluate this research comprehensively. The main objective of this review is to examine and summarize how researchers have conceptualized, defined, and measured pharmacist-patient communication across studies and identify gaps in the literature. Articles were compiled from a search of (1) Medline, IPA, CINAHL, and PubMed databases using the keywords, "counseling", "patient communication", "patient counseling", "patient education", "patient consult( *)", and/or "pharmacists", (2) bibliographies of selected articles. The search generated 56 studies on community pharmacy, of which 39 studies met the inclusion criteria. Most studies (72%) have used the term patient counseling, although pharmacist-patient communication and patient education were also used. The definition of patient counseling varies across studies. Almost half of the studies (49%) conceptualized pharmacist-patient communication solely as a pharmacist information provision activity. A total of 16 studies (41%) also focused on pharmacists' interpersonal behavior in addition to the information provision activity of the pharmacist. In contrast, patient communication behavior and the exchange process between both parties has been understudied. A total of 16 studies (41%) used a retrospective design. All studies used a cross-sectional design, with varying modes of data collection such as mail surveys, telephone interviews, nonparticipant observation, and shopper studies. Taped encounters are rare. SUMMARY/IMPLICATIONS: This review revealed that most studies have focused on a one way communication of pharmacists to patients. A need for examining the patient-pharmacist dyad is apparent. Future research could explore a greater use of taped encounters to analyze the interactive communication process, affective components of communication such as collaborative problem solving, interpersonal relationship development, and the expertise that patients bring into the encounter.

Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions.

PubMed

Ameling, Jessica M; Auguste, Priscilla; Ephraim, Patti L; Lewis-Boyer, LaPricia; DePasquale, Nicole; Greer, Raquel C; Crews, Deidra C; Powe, Neil R; Rabb, Hamid; Boulware, L Ebony

2012-12-01

Few educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in "stages." For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals' testimonials regarding various considerations that might influence patients' and families' treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

The outcome of trauma patients with do-not-resuscitate orders.

PubMed

Matsushima, Kazuhide; Schaefer, Eric W; Won, Eugene J; Armen, Scott B

2016-02-01

Institutional variation in outcome of patients with do-not-resuscitate (DNR) orders has not been well described in the setting of trauma. The purpose of this study was to assess the impact of trauma center designation on outcome of patients with DNR orders. A statewide trauma database (Pennsylvania Trauma Outcome Study) was used for the analysis. Characteristics of patients with DNR orders were compared between state-designated level 1 and 2 trauma centers. Inhospital mortality and major complication rates were compared using hierarchical logistic regression models that included a random effect for trauma centers. We adjusted for a number of potential confounders and allowed for nonlinearity in injury severity score and age in these models. A total of 106,291 patients (14 level 1 and 11 level 2 trauma centers) were identified in the Pennsylvania Trauma Outcome Study database between 2007 and 2011. We included 5953 patients with DNR orders (5.6%). Although more severely injured patients with comorbid disease were made DNR in level 1 trauma centers, trauma center designation level was not a significant factor for inhospital mortality of patients with DNR orders (odds ratio, 1.33; 95% confidence interval, 0.81-2.18; P = 0.26). Level 1 trauma centers were significantly associated with a higher rate of major complications (odds ratio, 1.75; 95% confidence interval, 1.11-2.75; P = 0.016). Inhospital mortality of patients with DNR orders was not significantly associated with trauma designation level after adjusting for case mix. More aggressive treatment or other unknown factors may have resulted in a significantly higher complication rate at level 1 trauma centers. Copyright © 2016 Elsevier Inc. All rights reserved.

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

Improving the governance of patient safety in emergency care: a systematic review of interventions

PubMed Central

Hesselink, Gijs; Berben, Sivera; Beune, Thimpe

2016-01-01

Objectives To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. Design A systematic review of the literature. Methods PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Results Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Conclusions Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures to strengthen the evidence base. PMID:26826151

Work engagement in Magnet(®)-designated hospitals: Exploring social and institutional demographics of RNs to optimize improvement efforts.

PubMed

Wonder, Amy Hagedorn

2013-12-01

This study analyzed and evaluated relationships between work engagement (WE) and social/institutional demographic variables of RNs in Magnet(®)-designated hospitals. Organizational structures of Magnet-designated hospitals are recognized to promote engagement of RNs. Because little is known about relationships between WE and the social/institutional demographics of nurses, this study focused on age (generation), gender, education, shift, hours worked per week, percentage of time in direct patient care, and nursing unit. A convenience sample of hospital RNs (n = 220) completed 2 surveys to measure WE and demographic variables in this descriptive correlational study. Shift was significantly related to RN engagement; however, age, gender, education, hours worked per week, percentage of time in direct patient care, and nursing unit were not. This study provides empirical evidence about the relationships between WE and social/institutional characteristics of RNs. The findings are relevant to patients, nurses, nurse leaders, and organizations.

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

Post-approval Studies for Rare Disease Treatments and Orphan Drugs.

PubMed

Maier, William C; Christensen, Ronald A; Anderson, Patricia

2017-01-01

Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications. The US FDA published guidance in 2011 and the European Medicines Agency in 2015.Post-approval studies for rare diseases include observational studies, pragmatic trials and randomized controlled studies. Observational studies include both original data collection studies and the use of secondary data (retrospective studies). Original data collection can address limitations of retrospective studies resulting from incomplete information in secondary data sources. Disease registries focus on detail about a broad range of patients with a rare disease while product-related registries focus on specific health care outcomes associated with a single product and may incorporate a comparator of an alternative therapy or therapies.Rare disease patients can be difficult to find and enroll in a registry using conventional physician based driven recruitment. The study process also needs to recognize changes in the patient's disease and lifestyle and adapt both the study design and methods over time. Many rare diseases have strong patient advocacy groups that can in aid the design and execution of rare disease registries.

Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

PubMed

Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

2015-08-07

Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one's condition and time poorness may have been barriers to engagement. Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound.

Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

PubMed Central

Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

2015-01-01

Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one’s condition and time poorness may have been barriers to engagement. Conclusions Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound. PMID:26254245

Computer-Assisted Telephone Screening: A New System for Patient Evaluation and Recruitment

PubMed Central

Radcliffe, Jeanne M.; Latham, Georgia S.; Sunderland, Trey; Lawlor, Brian A.

1990-01-01

Recruitment of subjects for research studies is a time consuming process for any research coordinator. This paper introduces three computerized databases designed to help screen potential research candidates by telephone. The three programs discussed are designed to evaluate specific populations: geriatric patients (i.e. Alzheimer's patients), patients with affective disorders and normal volunteers. The interview content, software development, and the utility of these programs is discussed with particular focus on how they can be helpful in the research setting.

A wearable exoskeleton suit for motion assistance to paralysed patients.

PubMed

Chen, Bing; Zhong, Chun-Hao; Zhao, Xuan; Ma, Hao; Guan, Xiao; Li, Xi; Liang, Feng-Yan; Cheng, Jack Chun Yiu; Qin, Ling; Law, Sheung-Wai; Liao, Wei-Hsin

2017-10-01

The number of patients paralysed due to stroke, spinal cord injury, or other related diseases is increasing. In order to improve the physical and mental health of these patients, robotic devices that can help them to regain the mobility to stand and walk are highly desirable. The aim of this study is to develop a wearable exoskeleton suit to help paralysed patients regain the ability to stand up/sit down (STS) and walk. A lower extremity exoskeleton named CUHK-EXO was developed with considerations of ergonomics, user-friendly interface, safety, and comfort. The mechanical structure, human-machine interface, reference trajectories of the exoskeleton hip and knee joints, and control architecture of CUHK-EXO were designed. Clinical trials with a paralysed patient were performed to validate the effectiveness of the whole system design. With the assistance provided by CUHK-EXO, the paralysed patient was able to STS and walk. As designed, the actual joint angles of the exoskeleton well followed the designed reference trajectories, and assistive torques generated from the exoskeleton actuators were able to support the patient's STS and walking motions. The whole system design of CUHK-EXO is effective and can be optimised for clinical application. The exoskeleton can provide proper assistance in enabling paralysed patients to STS and walk.

Culturally Competent Care for Sexual and Gender Minority Patients at National Cancer Institute-Designated Comprehensive Cancer Centers

PubMed Central

Wheldon, Christopher W.; Schabath, Matthew B.; Hudson, Janella; Bowman Curci, Meghan; Kanetsky, Peter A.; Vadaparampil, Susan T.; Simmons, Vani N.; Sanchez, Julian A.; Sutton, Steven K.

2018-01-01

Abstract Purpose: This study sought to identify the policies and guidelines regarding culturally competent care of sexual and gender minority (SGM) cancer patients and survivors at National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers. Methods: This study used an in-depth interview qualitative approach. Semistructured interviews were conducted via telephone with representatives from 21 of the 45 NCI-Designated Comprehensive Cancer Centers in 2015. Verbatim transcripts were created from the audiotapes for content analysis. Results: Two main themes were identified as follows: (1) patient-focused experiences and support and (2) organization-focused development activities. Most of the cancer centers in this study had an advisory committee to assist with SGM policies and guidelines. Despite the existence of these committees, the majority of centers did not have explicit policies, guidelines, or routine practices addressing the following issues: the collection and integration of sexual orientation and gender identity information in the medical record, gender-neutral language on patient forms, patient educational materials with SGM-specific health concerns, SGM-specific support for cancer survivors, or required SGM-specific cultural competency trainings for medical and nonmedical staff. Conclusion: In general, the cancer centers in this study lacked institutional policies, guidelines, and practices focused on patient-centered cancer care for SGM populations. Coordinated efforts are needed to systemically improve patient-centered cancer care for these populations. PMID:29641317

Strategy for Instructional Systems Design and Formative Evaluation.

DTIC Science & Technology

1976-07-01

The overall purpose of the study was to deal with the elements of a systems model for designing patient education modules in eight areas...staff evaluation. Examples are given for each of the eight patient education areas, in addition to the enlisted health educator’s functions, system

Design and implementation of the canadian kidney disease cohort study (CKDCS): A prospective observational study of incident hemodialysis patients

PubMed Central

2011-01-01

Background Many nephrology observational studies use renal registries, which have well known limitations. The Canadian Kidney Disease Cohort Study (CKDCS) is a large prospective observational study of patients commencing hemodialysis in five Canadian centers. This study focuses on delineating potentially reversible determinants of adverse outcomes that occur in patients receiving dialysis for end-stage renal disease (ESRD). Methods/Design The CKDCS collects information on risk factors and outcomes, and stores specimens (blood, dialysate, hair and fingernails) at baseline and in long-term follow-up. Such specimens will permit measurements of biochemical markers, proteomic and genetic parameters (proteins and DNA) not measured in routine care. To avoid selection bias, all consenting incident hemodialysis patients at participating centers are enrolled, the large sample size (target of 1500 patients), large number of exposures, and high event rates will permit the exploration of multiple potential research questions. Preliminary Results Data on the baseline characteristics from the first 1074 subjects showed that the average age of patients was 62 (range; 50-73) years. The leading cause of ESRD was diabetic nephropathy (41.9%), and the majority of the patients were white (80.0%). Only 18.7% of the subjects received dialysis in a satellite unit, and over 80% lived within a 50 km radius of the nearest nephrologist's practice. Discussion The prospective design, detailed clinical information, and stored biological specimens provide a wealth of information with potential to greatly enhance our understanding of risk factors for adverse outcomes in dialysis patients. The scientific value of the stored patient tissue will grow as new genetic and biochemical markers are discovered in the future. PMID:21324196

Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies.

PubMed

Place, Andrew E; Goldsmith, Kelly; Bourquin, Jean-Pierre; Loh, Mignon L; Gore, Lia; Morgenstern, Daniel A; Sanzgiri, Yeshwant; Hoffman, David; Zhou, Ying; Ross, Jeremy A; Prine, Betty; Shebley, Mohamad; McNamee, Megan; Farazi, Thalia; Kim, Su Young; Verdugo, Maria; Lash-Fleming, Leanne; Zwaan, C Michel; Vormoor, Josef

2018-03-29

Venetoclax is a highly selective, potent BCL-2 inhibitor that is approved for some patients previously treated for chronic lymphocytic leukemia, and has shown promising activity in adult studies across several hematologic malignancies. Preclinical studies have demonstrated venetoclax activity in pediatric patient-derived xenograft models and cell lines; however, clinical studies in pediatric patients have yet to be conducted. The prognosis is poor for children with most relapsed/refractory malignancies, and limited treatment options result in unmet clinical need. Herein, we describe the rationale and design of the first study of venetoclax in pediatric patients with relapsed/refractory malignancies: a Phase I trial investigating the safety and pharmacokinetics of venetoclax monotherapy followed by the addition of chemotherapy (Trial registration: EudraCT 2017-000439-14; NCT03236857).

Patient engagement in research with older adults with cancer.

PubMed

Puts, Martine T E; Sattar, Schroder; Ghodraty-Jabloo, Vida; Hsu, Tina; Fitch, Marg; Szumacher, Ewa; Ayala, Ana Patricia; Alibhai, Shabbir M H

2017-11-01

Cancer is a disease that mostly affects older adults. Older adults have been under-represented in clinical cancer research. Around the world there is a push for patient engagement on study teams as it is anticipated to improve study design, recruitment and dissemination of findings. In the current overview we examined the evidence with regard to: 1) the history of patient engagement in research and frameworks developed; 2) impact of patient engagement on patient and research outcomes; 3) use of patient engagement in geriatrics and oncology, 4) recommendations for successful engagement; and 5) gaps in the literature that should be studied further. A narrative review was conducted. Articles published in English were searched in Medline with the help of a librarian. Patient engagement has been shown to improve the conduct of studies by making the study design more relevant and feasible, and improving recruitment rates and uptake of research findings by patients. However, the best way to engage patients is not clear yet. Several resources have been developed to support researchers engaging older adults with cancer in research. While patient engagement in research seems promising to improve study outcomes, little evidence is available thus far in geriatric oncology settings. Several gaps in the literature are identified that should be further studied to determine the value of, and best approaches to, patient engagement with older adults with cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study.

PubMed

Seo, Woo-Keun; Kim, Yong Jae; Lee, Juneyoung; Kwon, Sun U

2017-09-01

Atherosclerosis is one of the main mechanisms of stroke and cardiovascular diseases and is associated with increased risk of recurrent stroke and cardiovascular events. Intima-medial thickness (IMT) is a well-known surrogate marker of atherosclerosis and has been used to predict stroke and cardiovascular events. However, the clinical significance of IMT and IMT change in stroke has not been investigated in well-designed studies. The PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage-Intima-Media Thickness (PICASSO-IMT) sub-study is designed to investigate the effects of cilostazol, probucol, or both on IMT in patients with stroke. PICASSO-IMT is a prospective sub-study of the PICASSO study designed to measure IMT and plaque score at 1, 13, 25, 37, and 49 months after randomization. The primary outcome is the change in mean carotid IMT, which is defined as the mean of the far-wall IMTs of the right and left common carotid arteries, between baseline and 13 months after randomization. PICASSO-IMT will provide the largest IMT data set in a stroke population and will provide valuable information about the clinical significance of IMT in patients with ischemic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Preparation, validation and user-testing of pictogram-based patient information leaflets for hemodialysis patients.

PubMed

Mateti, Uday Venkat; Nagappa, Anantha Naik; Attur, Ravindra Prabhu; Bairy, Manohar; Nagaraju, Shankar Prasad; Mallayasamy, Surulivelrajan; Vilakkathala, Rajesh; Guddattu, Vasudev; Balkrishnan, Rajesh

2015-11-01

Patient information leaflets are universally-accepted resources to educate the patients/users about their medications, disease and lifestyle modification. The objective of the study was to prepare, validate and perform user-testing of pictogram-based patient information leaflets (P-PILs) among hemodialysis (HD) patients. The P-PILs are prepared by referring to the primary, secondary and tertiary resources. The content and pictograms of the leaflet have been validated by an expert committee consisting of three nephrologists and two academic pharmacists. The Baker Able Leaflet Design has been applied to develop the layout and design of the P-PILs. Quasi-experimental pre- and post-test design without control group was conducted on 81 HD patients for user-testing of P-PILs. The mean Baker Able Leaflet Design assessment score for English version of the leaflet was 28, and 26 for Kannada version. The overall user-testing knowledge assessment mean scores were observed to have significantly improved from 44.25 to 69.62 with p value <0.001. The overall user opinion of content and legibility of the leaflets was good. Pictogram-based patient information leaflets can be considered an effective educational tool for HD patients.

Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Goulart, Bernardo H.L., E-mail: bhg@uw.edu; University of Washington, Seattle, Washington; Ramsey, Scott D.

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H and N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H and N RCTs, which limits the validity of their results to the broader H and N cancer patient population seenmore » in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H and N cancer, including treatment comparisons for rare types of H and N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H and N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H and N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design.« less

Observational study designs for comparative effectiveness research: an alternative approach to close evidence gaps in head-and-neck cancer.

PubMed

Goulart, Bernardo H L; Ramsey, Scott D; Parvathaneni, Upendra

2014-01-01

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H&N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H&N RCTs, which limits the validity of their results to the broader H&N cancer patient population seen in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H&N cancer, including treatment comparisons for rare types of H&N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H&N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H&N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design. Copyright © 2014 Elsevier Inc. All rights reserved.

Optimizing trial design in pharmacogenetics research: comparing a fixed parallel group, group sequential, and adaptive selection design on sample size requirements.

PubMed

Boessen, Ruud; van der Baan, Frederieke; Groenwold, Rolf; Egberts, Antoine; Klungel, Olaf; Grobbee, Diederick; Knol, Mirjam; Roes, Kit

2013-01-01

Two-stage clinical trial designs may be efficient in pharmacogenetics research when there is some but inconclusive evidence of effect modification by a genomic marker. Two-stage designs allow to stop early for efficacy or futility and can offer the additional opportunity to enrich the study population to a specific patient subgroup after an interim analysis. This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family-wise type I error rate. The designs were evaluated across scenarios that defined the effect sizes in the marker positive and marker negative subgroups and the prevalence of marker positive patients in the overall study population. Effect sizes were chosen to reflect realistic planning scenarios, where at least some effect is present in the marker negative subgroup. In addition, scenarios were considered in which the assumed 'true' subgroup effects (i.e., the postulated effects) differed from those hypothesized at the planning stage. As expected, both two-stage designs generally required fewer patients than a fixed parallel group design, and the advantage increased as the difference between subgroups increased. The adaptive selection design added little further reduction in sample size, as compared with the group sequential design, when the postulated effect sizes were equal to those hypothesized at the planning stage. However, when the postulated effects deviated strongly in favor of enrichment, the comparative advantage of the adaptive selection design increased, which precisely reflects the adaptive nature of the design. Copyright © 2013 John Wiley & Sons, Ltd.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

A utility-based design for randomized comparative trials with ordinal outcomes and prognostic subgroups.

PubMed

Murray, Thomas A; Yuan, Ying; Thall, Peter F; Elizondo, Joan H; Hofstetter, Wayne L

2018-01-22

A design is proposed for randomized comparative trials with ordinal outcomes and prognostic subgroups. The design accounts for patient heterogeneity by allowing possibly different comparative conclusions within subgroups. The comparative testing criterion is based on utilities for the levels of the ordinal outcome and a Bayesian probability model. Designs based on two alternative models that include treatment-subgroup interactions are considered, the proportional odds model and a non-proportional odds model with a hierarchical prior that shrinks toward the proportional odds model. A third design that assumes homogeneity and ignores possible treatment-subgroup interactions also is considered. The three approaches are applied to construct group sequential designs for a trial of nutritional prehabilitation versus standard of care for esophageal cancer patients undergoing chemoradiation and surgery, including both untreated patients and salvage patients whose disease has recurred following previous therapy. A simulation study is presented that compares the three designs, including evaluation of within-subgroup type I and II error probabilities under a variety of scenarios including different combinations of treatment-subgroup interactions. © 2018, The International Biometric Society.

A Phase I Dose-Finding Study of Silybin Phosphatidylcholine (Milk Thistle) in Patients With Advanced Hepatocellular Carcinoma

PubMed Central

Siegel, Abby B.; Narayan, Rupa; Rodriguez, Rosa; Goyal, Abhishek; Jacobson, Judith S.; Kelly, Kara; Ladas, Elena; Lunghofer, Paul J.; Hansen, Ryan J.; Gustafson, Daniel L.; Flaig, Thomas W.; Tsai, Wei Yann; Wu, David P. H.; Lee, Valerie; Greenlee, Heather

2013-01-01

Purpose To determine the maximum tolerated dose per day of silybin phosphatidylcholine (Siliphos) in patients with advanced hepatocellular carcinoma (HCC) and hepatic dysfunction. Experimental Design Patients with advanced HCC not eligible for other therapies based on poor hepatic function were enrolled in a phase I study of silybin phosphatidylcholine. A standard phase I design was used with 4 planned cohorts, dose escalating from 2, 4, 8, to 12 g per day in divided doses for 12 weeks. Results Three participants enrolled in this single institution trial. All enrolled subjects consumed 2 g per day of study agent in divided doses. Serum concentrations of silibinin and silibinin glucuronide increased within 1 to 3 weeks. In all 3 patients, liver function abnormalities and tumor marker α-fetoprotein progressed, but after day 56 the third patient showed some improvement in liver function abnormalities and inflammatory biomarkers. All 3 participants died within 23 to 69 days of enrolling into the trial, likely from hepatic failure, but it could not be ruled out that deaths were possibly due to the study drug. Conclusion Short-term administration of silybin phosphatidylcholine in patients with advanced HCC resulted in detectable increases in silibinin and its metabolite, silibinin glucuronide. The maximum tolerated dose could not be established. Since patients died soon after enrollment, this patient population may have been too ill to benefit from an intervention designed to improve liver function tests. PMID:23757319

Quantification of hepatic flow distribution using particle tracking for patient specific virtual Fontan surgery

NASA Astrophysics Data System (ADS)

Yang, Weiguang; Vignon-Clementel, Irene; Troianowski, Guillaume; Shadden, Shawn; Mohhan Reddy, V.; Feinstein, Jeffrey; Marsden, Alison

2010-11-01

The Fontan surgery is the third and final stage in a palliative series to treat children with single ventricle heart defects. In the extracardiac Fontan procedure, the inferior vena cava (IVC) is connected to the pulmonary arteries via a tube-shaped Gore-tex graft. Clinical observations have shown that the absence of a hepatic factor, carried in the IVC flow, can cause pulmonary arteriovenous malformations. Although it is clear that hepatic flow distribution is an important determinant of Fontan performance, few studies have quantified its relation to Fontan design. In this study, we virtually implanted three types of grafts (T-junction, offset and Y-graft) into 5 patient specific models of the Glenn (stage 2) anatomy. We then performed 3D time-dependent simulations and systematically compared the IVC flow distribution, energy loss, and pressure levels in different surgical designs. A robustness test is performed to evaluate the sensitivity of hepatic distribution to pulmonary flow split. Results show that the Y-graft design effectively improves the IVC flow distribution, compared to traditional designs and that surgical designs could be customized on a patient-by-patient basis.

“Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients”

PubMed Central

2014-01-01

Background Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA). Methods/Design CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced). Discussion The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA. PMID:24690143

An Open-Structure Treadmill Gait Trainer: From Research to Application.

PubMed

Li, Jian; Chen, Diansheng; Fan, Yubo

2017-01-01

Lower limb rehabilitation robots are designed to enhance gait function in individuals with motor impairments. Although numerous rehabilitation robots have been developed, only few of these robots have been used in practical health care, particularly in China. The objective of this study is to construct a lower limb rehabilitation robot and bridge the gap between research and application. Open structure to facilitate practical application was created for the whole robot. Three typical movement patterns of a single leg were adopted in designing the exoskeletons, and force models for patient training were established and analyzed under three different conditions, respectively, and then a control system and security strategy were introduced. After establishing the robot, a preliminary experiment on the actual use of a prototype by patients was conducted to validate the functionality of the robot. The experiment showed that different patients and stages displayed different performances, and results on the trend variations across patients and across stages confirmed the validity of the robot and suggested that the design may lead to a system that could be successful in the treatment of patients with walking disorders in China. Furthermore, this study could provide a reference for a similar application design.

A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

PubMed Central

2012-01-01

Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

Methodological issues in a before-after study design to evaluate the Liverpool Care Pathway for the Dying Patient in hospital.

PubMed

Costantini, Massimo; Di Leo, Silvia; Beccaro, Monica

2011-12-01

In 2006, as the first step of a 3-year research programme to assess the Liverpool Care Pathway for the Dying Patient (LCP) in hospital, the original LCP documentation was translated and piloted in four Italian hospital wards in Genoa. The primary aim was to evaluate the feasibility of LCP implementation in the Italian context. The secondary aim of the study was to evaluate the effectiveness of the LCP with an uncontrolled before-after design. The aim of the study was to discuss and critically evaluate the methodological issues in designing and interpreting the results of the before-after study design. All cancer deaths which occurred in four hospital wards (three general medicine and one respiratory disease) 4 months before and 4 months after LCP implementation (2 months for the respiratory disease ward) were registered. Caregivers were interviewed after the patient's death using the Toolkit After-Death Bereaved Family Member Interview. A total of 111 cancer deaths were identified (63 before and 48 after) and 79 caregivers (71.2%) were interviewed (46 before and 33 after). The analyses on number and characteristics of the patients, interviewed caregivers, compliance and modality of assessment showed significant differences before and after. A remarkable internal correlation coefficient for all of the Toolkit scales within the four hospital wards was observed. This analysis confirms the high risk of selection and information bias inherent the uncontrolled before- after study design. The high internal correlation strongly suggests that clustering should be taken into account in this kind of study.

Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations.

PubMed

Conti, Michele; Van Loo, Denis; Auricchio, Ferdinando; De Beule, Matthieu; De Santis, Gianluca; Verhegghe, Benedict; Pirrelli, Stefano; Odero, Attilio

2011-06-01

To quantitatively evaluate the impact of carotid stent cell design on vessel scaffolding by using patient-specific finite element analysis of carotid artery stenting (CAS). The study was organized in 2 parts: (1) validation of a patient-specific finite element analysis of CAS and (2) evaluation of vessel scaffolding. Micro-computed tomography (CT) images of an open-cell stent deployed in a patient-specific silicone mock artery were compared with the corresponding finite element analysis results. This simulation was repeated for the closed-cell counterpart. In the second part, the stent strut distribution, as reflected by the inter-strut angles, was evaluated for both cell types in different vessel cross sections as a measure of scaffolding. The results of the patient-specific finite element analysis of CAS matched well with experimental stent deployment both qualitatively and quantitatively, demonstrating the reliability of the numerical approach. The measured inter-strut angles suggested that the closed-cell design provided superior vessel scaffolding compared to the open-cell counterpart. However, the full strut interconnection of the closed-cell design reduced the stent's ability to accommodate to the irregular eccentric profile of the vessel cross section, leading to a gap between the stent surface and the vessel wall. Even though this study was limited to a single stent design and one vascular anatomy, the study confirmed the capability of dedicated computer simulations to predict differences in scaffolding by open- and closed-cell carotid artery stents. These simulations have the potential to be used in the design of novel carotid stents or for procedure planning.

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

PubMed Central

Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

2018-01-01

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients. PMID:21681382

The dialysis outcomes and practice patterns study phase 5 in the Gulf Cooperation Council countries: Design and study methods.

PubMed

Pisoni, Ronald L; Bieber, Brian A; Al Wakeel, Jamal; Al Arrayed, Sameer; Alkandari, Naser; Hassan, Mohamed; Karkar, Ayman; Al Lawati, Nabil M; Al Ali, Fadwa; Albert, Justin M; Robinson, Bruce M

2016-11-01

The Dialysis Outcomes and Practice Patterns Study (DOPPS) is an international prospective cohort study of the relationships between hemodialysis (HD) care practices and HD patient outcomes. The DOPPS began in 1996, in the United States, and has since expanded to 21 countries, collecting detailed data from >75,000 HD patients, with >200 scientific publications, focused on describing HD practices associated with improved HD patient outcomes. The goal of DOPPS is to help HD patients "live better and live longer." Starting in 2012, the DOPPS was able to expand to all six of the Gulf Cooperation Council (GCC) countries, namely, Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. The DOPPS study design consists of selecting HD facilities for study participation in each country to represent the different types of HD facilities and geographic regions within each GCC country. Within each study site, HD patients were randomly selected for detailed data collection to represent the HD practices within each participating HD facility. Altogether, 41 HD facilities have participated in the GCC-DOPPS Phase 5 study including 20 facilities from Saudi Arabia, nine from the United Arab Emirates, four each from Kuwait and Oman, two from Qatar, and one from Bahrain. Herein, we provide a detailed description of the study design and methods, data collection, study management, scientific investigator oversight and guidance, and study governance and support for the GCCDOPPS Phase 5 study.

Assessing barriers to a rational chemoprevention trial design in young patients with familial adenomatous polyposis.

PubMed

Wood, Joanna P; Howells, Lynne M; Brown, Karen; Thomas, Anne L

2017-07-01

Familial adenomatous polyposis coli (FAP) is an autosomal dominant condition caused by a germline mutation in the adenomatous polyposis coli gene. Colonic adenomas form and almost all patients will develop colorectal cancer if they are not managed at an early stage. The safest preventive strategy is surgical resection of the colon, most commonly performed in late teenage years. There is a paucity of trials investigating the use of primary chemoprevention to delay polyp formation in paediatric FAP. There are extensive preclinical and early clinical data demonstrating that curcumin may be a safe and effective chemotherapeutic agent in reducing the polyp burden in this disease. We ultimately proposed to design and conduct a clinical study to assess whether curcumin treatment delays the need for surgery and/or prevents cancer in young patients with FAP. Research into clinical trial protocols has demonstrated that assessing patients' perceptions at the initial stage leads to better outcomes. We therefore conducted a questionnaire study of patients and parents of children affected by FAP to gain information to aid the protocol design. Results demonstrated that there are some FAP patients for whom this study is relevant and desirable. Those with a personal history of curcumin use reported that it was well tolerated. However, the response rate was poor (25%), indicating that there are potential difficulties ensuring adequate recruitment to the proposed trial. This report draws on lessons learnt from prior trials and the findings from the questionnaire to outline the challenges faced in designing such a study.

Firefighting to Innovation: Using Human Factors and Ergonomics to Tackle Slip, Trip, and Fall Risks in Hospitals.

PubMed

Hignett, Sue; Wolf, Laurie; Taylor, Ellen; Griffiths, Paula

2015-11-01

The aim of this study was to use a theoretical model (bench) for human factors and ergonomics (HFE) and a comparison with occupational slips, trips, and falls (STFs) risk management to discuss patient STF interventions (bedside). Risk factors for patient STFs have been identified and reported since the 1950s and are mostly unchanged in the 2010s. The prevailing clinical view has been that STF events indicate underlying frailty or illness, and so many of the interventions over the past 60 years have focused on assessing and treating physiological factors (dizziness, illness, vision/hearing, medicines) rather than designing interventions to reduce risk factors at the time of the STF. Three case studies are used to discuss how HFE has been, or could be, applied to STF risk management as (a) a design-based (building) approach to embed safety into the built environment, (b) a staff- (and organization-) based approach, and (c) a patient behavior-based approach to explore and understand patient perspectives of STF events. The results from the case studies suggest taking a similar HFE integration approach to other industries, that is, a sustainable design intervention for the person who experiences the STF event-the patient. This paper offers a proactive problem-solving approach to reduce STFs by patients in acute hospitals. Authors of the three case studies use HFE principles (bench/book) to understand the complex systems for facility and equipment design and include the perspective of all stakeholders (bedside). © 2015, Human Factors and Ergonomics Society.

Novel Arch Bar Fabricated With a Computer-Aided Design and Three-Dimensional Printing: A Feasibility Study.

PubMed

He, Wei; Sun, Yuchun; Tian, Kaiyue; Xie, Xiaoyan; Wang, Xiaoxia; Li, Zili

2015-11-01

The aim of the present study was to evaluate the feasibility of the design and fabrication of a novel arch bar using 3-dimensional printing. Furthermore, the study assessed its use in a preliminary clinical study of intermaxillary fixation. Seven patients who met the inclusion criteria were enrolled in the present study. Plaster dental casts were created of each patient and scanned using cone-beam computed tomography to obtain digital casts. Computer-aided design software was then used to complete the virtual building of the arch bars, which were manufactured using 3-dimensional printing and a cobalt-chrome alloy. The clinical results were observed after the arch bars were fixed to the dentition with steel wires. The arch bar contacted the dentition with a "surface-to-surface" pattern. The utility of these novel arch bars was verified by successfully fitting them to the dental arches of the patients. All the patients achieved their desired occlusion. The results of the present study have illustrated that this digital method is feasible for constructing a novel arch bar, showing promise for clinical use. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

National Urea Cycle Disorders Foundation

MedlinePlus

... questions, NUCDF has collaborated with clinical investigators to design a patient-centered research study to gather evidence- ... UCDC). The UCDC will be assist in study design as well as protocol review. Pre-clinical research ...

A descriptive study of the readability of patient information leaflets designed by nurses.

PubMed

Mumford, M E

1997-11-01

Written patient information materials can be valuable communication tools for teaching and reinforcing the verbal message, especially in the present climate of today's health service where patients are in hospital for such short times. They are only useful if the patient is able to read and understand them, otherwise they become an expensive waste of resources. Various studies have shown that many healthcare information leaflets are written at university or postgraduate level and would cause problems with understanding for many people reading them. This study set out to examine the readability of nurse-designed written information leaflets using the Flesch Reading Ease score and the FOG and SMOG readability formulae. This descriptive study used a sample of 24 leaflets designed by trained nurses in a large teaching hospital. The results produced a mean grade of 11.3 with a range of 8.9 to 14.8. This was similar to the results of other studies and meant that patients may have difficulty comprehending the information. It would appear that little progress has been made in 40 years in this area and potential reasons are discussed. Advantages and disadvantages of readability formulae and other guidelines available for developing information leaflets are explored. Recommendations for further research are made.

Exploring health navigating design: momentary contentment in a cancer context

PubMed Central

Sandén, Ulrika; Harrysson, Lars; Thulesius, Hans; Nilsson, Fredrik

2017-01-01

ABSTRACT Purpose: The technocratic and medicalized model of healthcare is rarely optimal for patients. By connecting two different studies we explore the possibilities of increasing quality of life in cancer care. Methods: The first study captures survival strategies in a historically isolated Arctic village in Norway resulting in Momentary contentment theory, which emerged from analysing four years of participant observation and interview data. The second study conceptualizes everyday life of cancer patients based on in-depth interviews with 19 cancer patients; this was conceptualized as Navigating a new life situation. Both studies used classic grounded theory methodology. The connection between the studies is based on a health design approach. Results: We found a fit between cancer patients challenging life conditions and harsh everyday life in an Arctic village. Death, treatments and dependence have become natural parts of life where the importance of creating spaces-of-moments and a Sense of Safety is imminent to well-being. While the cancer patients are in a new life situation, the Arctic people show a natural ability to handle uncertainties. Conclusion: By innovation theories connected to design thinking, Momentary contentment theory modified to fit cancer care would eventually be a way to improve cancer patients’ quality of life. PMID:28911272

Health literacy and patient web portals.

PubMed

Coughlin, Steven S; Stewart, Jessica L; Young, Lufei; Heboyan, Vahé; De Leo, Gianluca

2018-05-01

There is limited evidence about the association between health literacy and use of patient web portals in patients with chronic illnesses. The objective of this review was to learn more about health literacy and use of patient web portals. Bibliographic searches were conducted in PubMed and CINAHL using relevant MeSH search terms and Boolean algebra commands. Qualitative studies and studies with a cross-sectional, cohort, or pre-/post-test design have shown that persons with limited health literacy are less likely to use patient web portals, although there is inconsistency in the association across studies. The conflicting findings may be partially due to racial and ethnic differences in health literacy or level of comfort in sharing private health information using mobile technologies. Several opportunities exist to improve the usability and acceptability of web portals for patients with limited health literacy including enhancements in the design of the portals, patient and provider education and training, and engagement of proxies such as caregivers and close family members. Copyright © 2018 Elsevier B.V. All rights reserved.

The Role of the Built Environment: How Decentralized Nurse Stations Shape Communication, Patient Care Processes, and Patient Outcomes.

PubMed

Real, Kevin; Bardach, Shoshana H; Bardach, David R

2017-12-01

Increasingly, health communication scholars are attending to how hospital built environments shape communication, patient care processes, and patient outcomes. This multimethod study was conducted on two floors of a newly designed urban hospital. Nine focus groups interviews were conducted with 35 health care professionals from 10 provider groups. Seven of the groups were homogeneous by profession or level: nursing (three groups), nurse managers (two groups), and one group each of nurse care technicians ("techs") and physicians. Two mixed groups were comprised of staff from pharmacy, occupational therapy, patient care facilitators, physical therapy, social work, and pastoral care. Systematic qualitative analysis was conducted using a conceptual framework based on systems theory and prior health care design and communication research. Additionally, quantitative modeling was employed to assess walking distances in two different hospital designs. Results indicate nurses walked significantly more in the new hospital environment. Qualitative analysis revealed three insights developed in relationship to system structures, processes, and outcomes. First, decentralized nurse stations changed system interdependencies by reducing nurse-to-nurse interactions and teamwork while heightening nurse interdependencies and teamwork with other health care occupations. Second, many nursing-related processes remained centralized while nurse stations were decentralized, creating systems-based problems for nursing care. Third, nursing communities of practices were adversely affected by the new design. Implications of this study suggest that nurse station design shapes communication, patient care processes, and patient outcomes. Further, it is important to understand how the built environment, often treated as invisible in communication research, is crucial to understanding communication within complex health care systems.

Feasibility of using routinely collected inpatient data to monitor quality and inform choice: a case study using the UK inflammatory bowel disease audit

PubMed Central

Roberts, Stephen E; Williams, John G; Cohen, David R; Akbari, Ashley; Groves, Sam; Button, Lori A

2011-01-01

Objective To assess the utility and cost of using routinely collected inpatient data for large-scale audit. Design Comparison of audit data items collected nationally in a designed audit of inflammatory bowel disease (UK IBD audit) with routinely collected inpatient data; surveys of audit sites to compare costs. Setting National Health Service hospitals across England, Wales and Northern Ireland that participated in the UK IBD audit. Patients Patients in the UK IBD audit. Interventions None. Main outcome measures Percentage agreement between designed audit data items collected for the UK IBD audit and routine inpatient data items; costs of conducting the designed UK IBD audit and the routine data audit. Results There were very high matching rates between the designed audit data and routine data for a small subset of basic important information collected in the UK IBD audit, including mortality; major surgery; dates of admission, surgery, discharge and death; principal diagnoses; and sociodemographic patient characteristics. There were lower matching rates for other items, including source of admission, primary reason for admission, most comorbidities, colonoscopy and sigmoidoscopy. Routine data did not cover most detailed information collected in the UK IBD audit. Using routine data was much less costly than collecting designed audit data. Conclusion Although valuable for large population-based studies, and less costly than designed data, routine inpatient data are not suitable for the evaluation of individual patient care within a designed audit. PMID:28839601

An Estimation for Availability of Battery less LF Band RFID Tag to Identify Patients in Operation Room from Viewpoint of Engineering

NASA Astrophysics Data System (ADS)

Hosaka, Ryosuke

Nowadays, medical accidents increase in Japanese patient environment. Especially, misidentification of the patients occurred in operation room of higher level hospitals. It is considered that the great deals of accidents are due to mistakes by nurse. However, the accidents are prevented by management of patients. If a suitable patient identification system is developed, the accidents are prevented. In this study, new patient identification system using battery less LF band RFID(Radio Frequency Identification) is proposed. In the method, battery less RFID tag is attached to patient. In operation room, patient is identified before operation using the proposed system. However, identification distance of RFID is small. It is important that extension of the distance. In this study, antennas of RFID tag and sensor are designed. Two types of tag are proposed. One of them is set on wristband. An antenna for the tag is designed as a circular shape with 30mm in diameter. The other one is shaped like a necklace. The antenna is also designed 220mm, 240mm and 260mm in diameter. Using necklace type new antenna, sufficient identification distance for detection of the tag in the operation room is realized. The patient identification is realized using the proposed system

Utility of a Newly Designed Film Holder for Premolar Bitewing Radiography.

PubMed

Safi, Yaser; Esmaeelinejad, Mohammad; Vasegh, Zahra; Valizadeh, Solmaz; Aghdasi, Mohammad Mehdi; Sarani, Omid; Afsahi, Mahmoud

2015-11-01

Bitewing radiography is a valuable technique for assessment of proximal caries, alveolar crest and periodontal status. Technical errors during radiography result in erroneous radiographic interpretation, misdiagnosis, possible mistreatment or unnecessary exposure of patient for taking a repeat radiograph. In this study, we aimed to evaluate the efficacy of a film holder modified from the conventional one and compared it with that of conventional film holder. Our study population comprised of 70 patients who were referred to the Radiology Department for bilateral premolar bitewing radiographs as requested by their attending clinician. Bitewing radiographs in each patient were taken using the newly designed holder in one side and the conventional holder in the other side. The acceptability of the two holders from the perspectives of the technician and patients was determined using a 0-20 point scale. The frequency of overlap and film positioning errors was calculated for each method. The conventional holder had greater acceptability among patients compared to the newly designed holder (mean score of 16.59 versus 13.37). From the technicians' point of view, the newly designed holder was superior to the conventional holder (mean score of 17.33 versus 16.44). The frequency of overlap was lower using the newly designed holder (p<0.001) and it allowed more accurate film positioning (p=0.005). The newly designed holder may facilitate the process of radiography for technicians and may be associated with less frequency of radiographic errors compared to the conventional holder.

Real-time feedback on nonverbal clinical communication. Theoretical framework and clinician acceptance of ambient visual design.

PubMed

Hartzler, A L; Patel, R A; Czerwinski, M; Pratt, W; Roseway, A; Chandrasekaran, N; Back, A

2014-01-01

This article is part of the focus theme of Methods of Information in Medicine on "Pervasive Intelligent Technologies for Health". Effective nonverbal communication between patients and clinicians fosters both the delivery of empathic patient-centered care and positive patient outcomes. Although nonverbal skill training is a recognized need, few efforts to enhance patient-clinician communication provide visual feedback on nonverbal aspects of the clinical encounter. We describe a novel approach that uses social signal processing technology (SSP) to capture nonverbal cues in real time and to display ambient visual feedback on control and affiliation--two primary, yet distinct dimensions of interpersonal nonverbal communication. To examine the design and clinician acceptance of ambient visual feedback on nonverbal communication, we 1) formulated a model of relational communication to ground SSP and 2) conducted a formative user study using mixed methods to explore the design of visual feedback. Based on a model of relational communication, we reviewed interpersonal communication research to map nonverbal cues to signals of affiliation and control evidenced in patient-clinician interaction. Corresponding with our formulation of this theoretical framework, we designed ambient real-time visualizations that reflect variations of affiliation and control. To explore clinicians' acceptance of this visual feedback, we conducted a lab study using the Wizard-of-Oz technique to simulate system use with 16 healthcare professionals. We followed up with seven of those participants through interviews to iterate on the design with a revised visualization that addressed emergent design considerations. Ambient visual feedback on non- verbal communication provides a theoretically grounded and acceptable way to provide clinicians with awareness of their nonverbal communication style. We provide implications for the design of such visual feedback that encourages empathic patient-centered communication and include considerations of metaphor, color, size, position, and timing of feedback. Ambient visual feedback from SSP holds promise as an acceptable means for facilitating empathic patient-centered nonverbal communication.

Using a patient-centered approach to develop a fertility preservation brochure for pediatric oncology patients: a pilot study.

PubMed

Murphy, Devin; Sawczyn, Kelly K; Quinn, Gwendolyn P

2012-04-01

Most pediatric education materials are designed for a parent audience. Social marketing techniques rely on the principles called the "4 P's": product, price, place, and promotion. The objective of this study was to test the design, readability, likelihood to read, and overall opinion of a pediatric fertility preservation brochure with patients, parents, and providers. Qualitative face-to-face interviews. The Children's Cancer Center in Tampa, FL, and All Children's Hospital in St. Petersburg, FL. Male and female cancer patients and survivors aged 12-21 (N = 7), their parents (N = 11), and healthcare providers (N = 6). Patients, survivors, parents, and healthcare providers were given two versions of gender concordant brochures on fertility preservation designed for both pediatric oncology patients and their parents. Design, readability, likelihood to read, and overall opinion from interviews in order to identify facilitators of involving patients in fertility preservation discussions. Parents and teens differed on the design, readability, and likelihood to read, the highest discord being preferences for medical terminology used in the brochures. While parents remarked that much of the language was 'too advanced,' the majority of teens explained that they understood the terminology and preferred it remained on the brochure. Overall feedback from all three groups was utilized to revise the brochures into final versions to increase the likelihood of reading. Information about the development of the 4 P's of social marketing highlights needs from the intended audience. Barriers to patient education in pediatrics can be ameliorated when using the social marketing approach. Copyright © 2012 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

The cost effectiveness of an early transition from hospital to nursing home for stroke patients: design of a comparative study

PubMed Central

2010-01-01

Background As the incidence of stroke has increased, its impact on society has increased accordingly, while it continues to have a major impact on the individual. New strategies to further improve the quality, efficiency and logistics of stroke services are necessary. Early discharge from hospital to a nursing home with an adequate rehabilitation programme could help to optimise integrated care for stroke patients. The objective is to describe the design of a non-randomised comparative study evaluating early admission to a nursing home, with multidisciplinary assessment, for stroke patients. The study is comprised of an effect evaluation, an economic evaluation and a process evaluation. Methods/design The design involves a non-randomised comparative trial for two groups. Participants are followed for 6 months from the time of stroke. The intervention consists of a redesigned care pathway for stroke patients. In this care pathway, patients are discharged from hospital to a nursing home within 5 days, in comparison with 12 days in the usual situation. In the nursing home a structured assessment takes place, aimed at planning adequate rehabilitation. People in the control group receive the usual care. The main outcome measures of the effect evaluation are quality of life and daily functioning. In addition, an economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention as well as the experiences and opinions of patients and professionals. Discussion The results of this study will provide information about the cost effectiveness of the intervention and its effects on clinical outcomes and quality of life. Relevant strengths and weaknesses of the study are addressed in this article. Trial registration Current Controlled Trails ISRCTN58135104 PMID:20504313

Design Thinking for mHealth Application Co-Design to Support Heart Failure Self-Management.

PubMed

Woods, Leanna; Cummings, Elizabeth; Duff, Jed; Walker, Kim

2017-01-01

Heart failure is a prevalent, progressive chronic disease costing in excess of $1billion per year in Australia alone. Disease self-management has positive implications for the patient and decreases healthcare usage. However, adherence to recommended guidelines is challenging and existing literature reports sub-optimal adherence. mHealth applications in chronic disease education have the potential to facilitate patient enablement for disease self-management. To the best of our knowledge no heart failure self-management application is available for safe use by our patients. In this paper, we present the process established to co-design a mHealth application in support of heart-failure self-management. For this development, an interdisciplinary team systematically proceeds through the phases of Stanford University's Design Thinking process; empathise, define, ideate, prototype and test with a user-centred philosophy. Using this clinician-led heart failure app research as a case study, we describe a sequence of procedures to engage with local patients, carers, software developers, eHealth experts and clinical colleagues to foster rigorously developed and locally relevant patient-facing mHealth solutions. Importantly, patients are engaged in each stage with ethnographic interviews, a series of workshops and multiple re-design iterations.

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination.

PubMed

Shi, Meng; An, Qian; Ainslie, Kylie E C; Haber, Michael; Orenstein, Walter A

2017-12-08

As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational studies are being increasingly used to estimate VE. We developed a probability model for comparing the bias and the precision of VE estimates from two case-control designs: the traditional case-control (TCC) design and the test-negative (TN) design. In both study designs, acute respiratory illness (ARI) patients seeking medical care testing positive for influenza infection are considered cases. In the TN design, ARI patients seeking medical care who test negative serve as controls, while in the TCC design, controls are randomly selected individuals from the community who did not contract an ARI. Our model assigns each study participant a covariate corresponding to the person's health status. The probabilities of vaccination and of contracting influenza and non-influenza ARI depend on health status. Hence, our model allows non-random vaccination and confounding. In addition, the probability of seeking care for ARI may depend on vaccination and health status. We consider two outcomes of interest: symptomatic influenza (SI) and medically-attended influenza (MAI). If vaccination does not affect the probability of non-influenza ARI, then VE estimates from TN studies usually have smaller bias than estimates from TCC studies. We also found that if vaccinated influenza ARI patients are less likely to seek medical care than unvaccinated patients because the vaccine reduces symptoms' severity, then estimates of VE from both types of studies may be severely biased when the outcome of interest is SI. The bias is not present when the outcome of interest is MAI. The TN design produces valid estimates of VE if (a) vaccination does not affect the probabilities of non-influenza ARI and of seeking care against influenza ARI, and (b) the confounding effects resulting from non-random vaccination are similar for influenza and non-influenza ARI. Since the bias of VE estimates depends on the outcome against which the vaccine is supposed to protect, it is important to specify the outcome of interest when evaluating the bias.

Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.

PubMed

Thayabaranathan, Tharshanah; Cadilhac, Dominique A; Srikanth, Velandai K; Fitzgerald, Sharyn M; Evans, Roger G; Kim, Joosup; Gerraty, Richard P; Phan, Thanh G; Bladin, Christopher F; Nelson, Mark R; Frayne, Judith H; Thrift, Amanda G

2016-06-01

Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Advancing Virtual Patient Simulations through Design Research and InterPLAY: Part I--Design and Development

ERIC Educational Resources Information Center

Hirumi, Atsusi; Kleinsmith, Andrea; Johnsen, Kyle; Kubovec, Stacey; Eakins, Michael; Bogert, Kenneth; Rivera-Gutierrez, Diego J.; Reyes, Ramsamooj Javier; Lok, Benjamin; Cendan, Juan

2016-01-01

Systematic reviews and meta-analyses of randomized controlled studies conclude that virtual patient simulations are consistently associated with higher learning outcomes compared to other educational methods. However, we cannot assume that students will learn from simply exposing students to the simulations. The instructional features that are…

Esophageal cancer: 5-year survival rate at south-east of Caspian sea of northern Iran.

PubMed

Taziki, Mohammad Hussin; Rajaee, Siamak; Behnampour, Naser; Tadrisee, Massoud; Mansourian, Azad Reza

2011-01-01

Locating at southern margin of Caspian sea and Asian esophagus cancer cordon Golestan state is one of the most common sites of this cancer. This study designed to evaluate the 5-years survival rate of esophagus cancer. 55 patients with esophagus cancer diagnosed by pathologic examination, age, gender, type of tumor, clinical manifestation on the time of tumor metastases, treatment and patient survival time studied. The collecting data were analyzed by SPSS 11.5, and life table and Kaplan Meier methods were applied. 55 patients studied included 11 females and 44 males respectively with average survival life time of 12.8 months for the 5-year survival rate for patients diagnosed at early stage was 0.025, patients with systemic symptoms such as weight loss was 0.00. Far metastases adverse effect on highest survivals was observed among patients who underwent surgery; the survival rate for such patients was about 0.014. Esophageal cancer is high in southern margin of Caspian Sea, it is suggested to design studies to find the probable risk factors and the screening tests for on-time diagnosis.

Rooftop hospital gardens for physical therapy: a post-occupancy evaluation.

PubMed

Davis, Brad E

2011-01-01

The goal of this study was to understand successes and weaknesses of a rooftop hospital garden used primarily for physical therapy. Literature on the healing benefits of nature and designed outdoor spaces in healthcare contexts continues to become more focused on specific patient populations. This study contributes to the knowledge of rooftop hospital gardens and gardens for physical rehabilitation. A post-occupancy evaluation was conducted using interviews with a lead therapist and landscape architect, behavior mapping, a staff survey, and a patient questionnaire. The designer and administrative staff perceived high accessibility while patients and staff reported low accessibility. Patients reported high satisfaction with the garden while staff reported little time for garden use. Poor maintenance decisions resulted in decreased functional and aesthetic value. Garden elements take on added layers of meaning and value to users seeking to escape the indoor environment, placing increased importance on evidence-based site design. Multiple perspectives must be considered in facility and garden master planning. Finally, designers and horticultural therapists must be retained in garden management to preserve and enhance garden functionality.

A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.

PubMed

Walter, Daisy; Laleman, Wim; Jansen, Jeroen M; van Milligen de Wit, A W M; Weusten, Bas L; van Boeckel, Petra G; Hirdes, Meike M; Vleggaar, Frank P; Siersema, Peter D

2015-05-01

Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent. To evaluate the efficacy of a novel FCSEMS with antimigration features. Prospective cohort study. Five hospitals in the Netherlands and Belgium. Consecutive patients with BBS. FCSEMS placement for 3 months. Initial and long term clinical success, stent migration rate and safety. Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common. Nonrandomized study design. Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Discrete Event Simulation Models for CT Examination Queuing in West China Hospital.

PubMed

Luo, Li; Liu, Hangjiang; Liao, Huchang; Tang, Shijun; Shi, Yingkang; Guo, Huili

2016-01-01

In CT examination, the emergency patients (EPs) have highest priorities in the queuing system and thus the general patients (GPs) have to wait for a long time. This leads to a low degree of satisfaction of the whole patients. The aim of this study is to improve the patients' satisfaction by designing new queuing strategies for CT examination. We divide the EPs into urgent type and emergency type and then design two queuing strategies: one is that the urgent patients (UPs) wedge into the GPs' queue with fixed interval (fixed priority model) and the other is that the patients have dynamic priorities for queuing (dynamic priority model). Based on the data from Radiology Information Database (RID) of West China Hospital (WCH), we develop some discrete event simulation models for CT examination according to the designed strategies. We compare the performance of different strategies on the basis of the simulation results. The strategy that patients have dynamic priorities for queuing makes the waiting time of GPs decrease by 13 minutes and the degree of satisfaction increase by 40.6%. We design a more reasonable CT examination queuing strategy to decrease patients' waiting time and increase their satisfaction degrees.

Discrete Event Simulation Models for CT Examination Queuing in West China Hospital

PubMed Central

Luo, Li; Tang, Shijun; Shi, Yingkang; Guo, Huili

2016-01-01

In CT examination, the emergency patients (EPs) have highest priorities in the queuing system and thus the general patients (GPs) have to wait for a long time. This leads to a low degree of satisfaction of the whole patients. The aim of this study is to improve the patients' satisfaction by designing new queuing strategies for CT examination. We divide the EPs into urgent type and emergency type and then design two queuing strategies: one is that the urgent patients (UPs) wedge into the GPs' queue with fixed interval (fixed priority model) and the other is that the patients have dynamic priorities for queuing (dynamic priority model). Based on the data from Radiology Information Database (RID) of West China Hospital (WCH), we develop some discrete event simulation models for CT examination according to the designed strategies. We compare the performance of different strategies on the basis of the simulation results. The strategy that patients have dynamic priorities for queuing makes the waiting time of GPs decrease by 13 minutes and the degree of satisfaction increase by 40.6%. We design a more reasonable CT examination queuing strategy to decrease patients' waiting time and increase their satisfaction degrees. PMID:27547237

[Cancer treatment situation in Japan with regard to the type of medical facility using medical claim data of Health Insurance Societies].

PubMed

Tanaka, Hirokazu; Nakamura, Fumiaki; Higashi, Takahiro; Kobayashi, Yasuki

2015-01-01

Analyzing the cancer treatment situation in Japan is an important public health issue, especially because of increasing crude cancer morbidity in a rapidly aging society. This study aimed to examine where cancer patients received treatment, with special attention to designated regional cancer hospitals, and the treatment modality they received. Using health insurance claim data (1,064,875 subjects on December 2011) managed by the Japan Medical Data Center, we included patients that received treatments for stomach, colon, liver, lung, or breast cancer, the most common cancers in Japan, between 2005 and 2011. We divided the medical facilities where they were treated into five groups: prefectural designated regional cancer hospitals, local designated regional cancer hospitals, large/medium hospitals (≥100 beds), small hospitals (20-99 beds), and clinics (0-19 beds). We calculated the percentage of patients treated at each type of medical facility with different treatment modalities. The study included 2,901 patients. In total, 43.9% patients were treated at designated regional cancer hospitals (prefectural or local). This percentage was the highest for lung cancer (60.0%) and the lowest for colon cancer (31.3%). Surgeries for liver cancer (67.6%) and lung cancer (61.9%) were performed more at designated regional cancer hospitals (prefectural or local) than surgeries for stomach cancer (45.5%), colon cancer (40.1%), and breast cancer (49.8%). Some procedures were performed at small hospitals or clinics (surgery for stomach cancer [9.4%], surgery for breast cancer [9.3%], endoscopic procedures for stomach cancer [14.1%] and colon cancer [40.6%], and chemotherapy for breast cancer [11.4%]). Colon and breast cancer patients treated at prefectural designated regional cancer hospitals or clinics were younger than those treated at other types of facilities. The distribution of facilities at which cancer patients received treatment differed significantly according to cancer site, treatment modality, and patient age.

Evolution of design considerations in complex craniofacial reconstruction using patient-specific implants.

PubMed

Peel, Sean; Bhatia, Satyajeet; Eggbeer, Dominic; Morris, Daniel S; Hayhurst, Caroline

2017-06-01

Previously published evidence has established major clinical benefits from using computer-aided design, computer-aided manufacturing, and additive manufacturing to produce patient-specific devices. These include cutting guides, drilling guides, positioning guides, and implants. However, custom devices produced using these methods are still not in routine use, particularly by the UK National Health Service. Oft-cited reasons for this slow uptake include the following: a higher up-front cost than conventionally fabricated devices, material-choice uncertainty, and a lack of long-term follow-up due to their relatively recent introduction. This article identifies a further gap in current knowledge - that of design rules, or key specification considerations for complex computer-aided design/computer-aided manufacturing/additive manufacturing devices. This research begins to address the gap by combining a detailed review of the literature with first-hand experience of interdisciplinary collaboration on five craniofacial patient case studies. In each patient case, bony lesions in the orbito-temporal region were segmented, excised, and reconstructed in the virtual environment. Three cases translated these digital plans into theatre via polymer surgical guides. Four cases utilised additive manufacturing to fabricate titanium implants. One implant was machined from polyether ether ketone. From the literature, articles with relevant abstracts were analysed to extract design considerations. In all, 19 frequently recurring design considerations were extracted from previous publications. Nine new design considerations were extracted from the case studies - on the basis of subjective clinical evaluation. These were synthesised to produce a design considerations framework to assist clinicians with prescribing and design engineers with modelling. Promising avenues for further research are proposed.

Rationale and design of the SERVE-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure.

PubMed

Cowie, Martin R; Woehrle, Holger; Wegscheider, Karl; Angermann, Christiane; d'Ortho, Marie-Pia; Erdmann, Erland; Levy, Patrick; Simonds, Anita; Somers, Virend K; Zannad, Faiez; Teschler, Helmut

2013-08-01

Central sleep apnoea/Cheyne-Stokes respiration (CSA/CSR) is a risk factor for increased mortality and morbidity in heart failure (HF). Adaptive servo-ventilation (ASV) is a non-invasive ventilation modality for the treatment of CSA/CSR in patients with HF. SERVE-HF is a multinational, multicentre, randomized, parallel trial designed to assess the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone (control group) in patients with symptomatic chronic HF, LVEF ≤45%, and predominant CSA. The trial is based on an event-driven group sequential design, and the final analysis will be performed when 651 events have been observed or the study is terminated at one of the two interim analyses. The aim is to randomize ∼1200 patients to be followed for a minimum of 2 years. Patients are to stay in the trial up to study termination. The first patient was randomized in February 2008 and the study is expected to end mid 2015. The primary combined endpoint is the time to first event of all-cause death, unplanned hospitalization (or unplanned prolongation of a planned hospitalization) for worsening (chronic) HF, cardiac transplantation, resuscitation of sudden cardiac arrest, or appropriate life-saving shock for ventricular fibrillation or fast ventricular tachycardia in implantable cardioverter defibrillator patients. The SERVE-HF study is a randomized study that will provide important data on the effect of treatment with ASV on morbidity and mortality, as well as the cost-effectiveness of this therapy, in patients with chronic HF and predominantly CSA/CSR. ISRCTN19572887.

Service design attributes affecting diabetic patient preferences of telemedicine in South Korea.

PubMed

Park, Hayoung; Chon, Yucheong; Lee, Jongsu; Choi, Ie-Jung; Yoon, Kun-Ho

2011-01-01

Attempts to introduce telemedicine in South Korea have failed mostly, leaving critical questions for service developers and providers about whether patients would be willing to pay for the service and how the service should be designed to encourage patient buy-in. In this study, we explore patients' valuations and preferences for each attribute of telemedicine service for diabetes management and evaluate patient willingness to pay for specific service attributes. We conducted a conjoint survey to collect data on patients' stated preferences among telemedicine service alternatives. The alternatives for diabetes-related service differed in 10 attributes, including those related to price, type of service provider, and service scope. To estimate the relative importance of attributes, patients' willingness to pay for each attribute, and their probable choice of specific alternatives, we used a rank-ordered logit model. A total of 118 respondents participated in the survey. All 10 attributes significantly affected patients' valuations and preferences, and demographic and disease characteristics, such as existence of complications and comorbidities, significantly affected patients' valuations of the attributes. Price was the most important attribute, followed by comprehensive scope of service, the availability of mobile phone-based delivery, and large general-hospital provided services. The study findings have significant implications for adoption policy and strategy of telemedicine in diabetes management care. Further, the methodology presented in this study can be used to draw knowledge needed to formulate effective policy for adoption of the necessary technology and for the design of services that attract potential beneficiaries.

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

PubMed

Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

2005-12-01

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

Methodological and ethical challenges in studying patients' perceptions of coercion: a systematic mixed studies review.

PubMed

Soininen, Päivi; Putkonen, Hanna; Joffe, Grigori; Korkeila, Jyrki; Välimäki, Maritta

2014-06-04

Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients' perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Systematic mixed studies review was the study method. Studies reporting patients' perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient's refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). The use of different study designs made comparison methodologically challenging. The timing of data collection (considering bias and confounding factors) and the reasons for non-participation of eligible participants are likewise methodological challenges, e.g. recommended flow charts could aid the information. Other challenges identified were the recruitment of large and representative samples. Ethical challenges included requesting participants' informed consent and respecting ethical procedures.

Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis.

PubMed

Miller, Frank; Björnsson, Marcus; Svensson, Ola; Karlsten, Rolf

2014-03-01

Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase IIa study followed by a Phase IIb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach. Copyright © 2014 Elsevier Inc. All rights reserved.

Peyronie's disease intervention trials: methodological challenges and issues.

PubMed

Müller, Alexander; Mulhall, John P

2009-03-01

Peyronie's Disease (PD) has been studied for more than 260 years since Francois de la Peyronie's description in 1743. Based on the current literature, the prevalence of PD seems 3-9% with an average age of onset in the fifth life decade. Much effort has been spent on developing nonsurgical treatment options to cure or at least prevent disease progression. The recent examination of drug trials for erectile dysfunction has led us to assess PD trial methodology more closely. An Iinternet search on PubMed was performed using MeSH words PD, clinical trials, oral, transdermal, intralesional and shock wave therapy focusing on 26 representing studies published over the last 15 years. Mean Outcome Measures. A comprehensive review of the current literature on nonsurgical treatment options for PD was conducted to address methodological issues and challenges in PD trials highlighting trial design, patient population, and symptom and sign assessment. The majority of the reviewed studies are underpowered and the heterogeneity in the methodological approach and patient assessment between the studies is one of the remarkable findings from our review. Studies should use a uniform means of defining the degree and type of penile deformity and a large enough cohort of patients should be studied for adequate study power. An ideally designed PD intervention trial should comprise: (i) a randomized, placebo-controlled design; (ii) with a PD patient set representative of the general PD population; and (iii) a comprehensive symptom and sign assessment before and at the end of treatment which includes an assessment of at least deformity, pain, and sexual function. A number of challenges exist for the design of PD intervention trials and deciphering the data generated from them. The field would benefit greatly from a consensus statement or guidelines development on the design and conduct of such trials.

Effects of auditing patient safety in hospital care: design of a mixed-method evaluation

PubMed Central

2013-01-01

Background Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects. Methods and design Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects. Discussion We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously. Trial registration Netherlands Trial Register (NTR): NTR3343 PMID:23800253

Design and evaluation of a patient website to reduce crowding in emergency departments: a preliminary study.

PubMed

Schiro, Jessica; Marcilly, Romaric; Leroy, Nicolas; Wawrzyniak, Clément; Martinot, Alain; Pelayo, Sylvia

2015-01-01

The study aims to identify the information useful to support a patients' EDs' choice in order to design a patient Web-based system. For that purpose, a focus group and a formative user test have been performed. The results show that five types of information can be relevant. The spontaneous favored information is the "distance" to EDs. The "Wait time", that is sanctified in literature, is only used in a second time. A larger summative evaluation should be planned to evaluate and validate the befits of this kind of tool.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

Trauma systems and the costs of trauma care.

PubMed Central

Goldfarb, M G; Bazzoli, G J; Coffey, R M

1996-01-01

OBJECTIVE. This study examines the cost of providing trauma services in trauma centers organized by publicly administered trauma systems, compared to hospitals not part of a formal trauma system. DATA SOURCES AND STUDY SETTING. Secondary administrative discharge abstracts for a national sample of severely injured trauma patients in 44 trauma centers and 60 matched control hospitals for the year 1987 were used. STUDY DESIGN. Retrospective univariate and multivariate analyses were conducted to examine the impact of formal trauma systems and trauma center designation on the costs of treating trauma patients. Key dependent variables included length of stay, charge per day per patient, and charge per hospital stay. Key impact variables were type of trauma system and level of trauma designation. Control variables included patient, hospital, and community characteristics. DATA COLLECTION/EXTRACTION METHODS. Data were selected for hospitals based on (1) a large national hospital discharge database, the Hospital Cost and Utilization Project, 1980-1987 (HCUP-2) and (2) a special survey of trauma systems and trauma designation undertaken by the Hospital Research and Educational Trust of the American Hospital Association. PRINCIPAL FINDINGS. The results show that publicly designated Level I trauma centers, which are the focal point of most trauma systems, have the highest charge per case, the highest average charge per day, and similar or longer average lengths of stay than other hospitals. These findings persist after controlling for patient injury and health status, and for demographic characteristics and hospital and community characteristics. CONCLUSIONS. Prior research shows that severely injured trauma patients have greater chances of survival when treated in specialized trauma centers. However, findings here should be of concern to the many states developing trauma systems since the high costs of Level I centers support limiting the number of centers designated at this level and/or reconsidering the requirements placed on these centers. PMID:8617611

Efficiency of a Care Coordination Model: A Randomized Study with Stroke Patients

ERIC Educational Resources Information Center

Claiborne, Nancy

2006-01-01

Objectives: This study investigated the efficiency of a social work care coordination model for stroke patients. Care coordination addresses patient care and treatment resources across the health care system to reduce risk, improve clinical outcomes, and maximize efficiency. Method: A randomly assigned, pre-post experimental design measured…

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Methods/design Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. Discussion The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an ‘effectiveness trial’ to support broader implementation in the healthcare system if it is successful. Trial registration Unique identifier: NCT00461513 PMID:23837415

Nursing staff's experiences of working in an evidence-based designed ICU patient room-An interview study.

PubMed

Sundberg, Fredrika; Olausson, Sepideh; Fridh, Isabell; Lindahl, Berit

2017-12-01

It has been known for centuries that environment in healthcare has an impact, but despite this, environment has been overshadowed by technological and medical progress, especially in intensive care. Evidence-based design is a concept concerning integrating knowledge from various research disciplines and its application to healing environments. The aim was to explore the experiences of nursing staff of working in an evidence-based designed ICU patient room. Interviews were carried out with eight critical care nurses and five assistant nurses and then subjected to qualitative content analysis. The experience of working in an evidence-based designed intensive care unit patient room was that the room stimulates alertness and promotes wellbeing in the nursing staff, fostering their caring activities but also that the interior design of the medical and technical equipment challenges nursing actions. The room explored in this study had been rebuilt in order to create and evaluate a healing environment. This study showed that the new environment had a great impact on the caring staffs' wellbeing and their caring behaviour. At a time when turnover in nurses is high and sick leave is increasing, these findings show the importance of interior design ofintensive care units. Copyright © 2017 Elsevier Ltd. All rights reserved.

The design and implementation of a ubiquitous personal health record system for South Africa.

PubMed

Kyazze, Michael; Wesson, Janet; Naude, Kevin

2014-01-01

Doctors can experience difficulty in accessing medical information of new patients. One reason for this is that, the management of medical records is mostly institution-centred. The lack of access to medical information may affect patients in several ways, such as: new medical tests may be carried out at a cost to the patient, and doctors may prescribe drugs to which the patient is allergic. This paper presents the design and implementation of a ubiquitous Personal Health Record system for South Africa. The design was informed by a literature review of existing personal health record standards, applications and the need to ensure patient privacy. Three medical practices in Port Elizabeth were interviewed with the aim of contextualizing the personal health record standards from the literature study. The findings of this research provide an insight as to how patients can bridge the gap created by institution-centred management of medical records.

The role of lymphadenectomy in endometrial cancer: was the ASTEC trial doomed by design and are we destined to repeat that mistake?

PubMed

Naumann, R Wendel

2012-07-01

This study examines the design of previous and future trials of lymph node dissection in endometrial cancer. Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject. Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%. This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference. Copyright © 2012 Elsevier Inc. All rights reserved.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Effects of Patient Care Unit Design and Technology on Nurse and Patient Care Technician Communication.

PubMed

Beck, Mary S; Doscher, Mindy

2018-04-01

The current study described RN and patient care technician (PCT) communication in centralized and hybrid decentralized workstation designs using hands-free communication technology and infrared locator badge technology to facilitate communication. New construction of an oncology unit provided the opportunity to compare staff communication in two different workstation designs. Observations and questionnaires compared nurse and PCT communication in the two-unit designs. Descriptive statistics were used to analyze the differences. The hybrid decentralized unit had increased use of hands-free communication technology and hallway communication by nurses and PCTs, and increased patient room communication by nurses. Perceptions of communication between nurses and PCTs and congruency of priorities for care were similar for both units. The locator badge technology had limited adoption. Replacement of nurse workstations with new construction or remodeling impact staff communication patterns, necessitating that nurse leaders understand the impact of design and technology on communication. [Journal of Gerontological Nursing, 44(4), 17-22.]. Copyright 2018, SLACK Incorporated.

An Educational Intervention to Train Professional Nurses in Promoting Patient Engagement: A Pilot Feasibility Study.

PubMed

Barello, Serena; Graffigna, Guendalina; Pitacco, Giuliana; Mislej, Maila; Cortale, Maurizio; Provenzi, Livio

2016-01-01

Introduction: Growing evidence recognizes that patients who are motivated to take an active role in their care can experience a range of health benefits and reduced healthcare costs. Nurses play a critical role in the effort to make patients fully engaged in their disease management. Trainings devoted to increase nurses' skills and knowledge to assess and promote patient engagement are today a medical education priority. To address this goal, we developed a program of nurse education training in patient engagement strategies (NET-PES). This paper presents pilot feasibility study and preliminary participants outcomes for NET-PES. Methods: This is a pilot feasibility study of a 2-session program on patient engagement designed to improve professional nurses' ability to engage chronic patients in their medical journey; the training mainly focused on passing patient engagement assessment skills to clinicians as a crucial mean to improve care experience. A pre-post pilot evaluation of NET-PES included 46 nurses working with chronic conditions. A course specific competence test has been developed and validated to measure patient engagement skills. The design included self-report questionnaire completed before and after the training for evaluation purposes. Participants met in a large group for didactic presentations and then they were split into small groups in which they used role-play and case discussion to reflect upon the value of patient engagement measurement in relation to difficult cases from own practice. Results: Forty-six nurses participated in the training program. The satisfaction questionnaire showed that the program met the educational objectives and was considered to be useful and relevant by the participants. Results demonstrated changes on clinicians' attitudes and skills in promoting engagement. Moreover, practitioners demonstrated increases on confidence regarding their ability to support their patients' engagement in the care process. Conclusions: Learning programs teaching nurses about patient engagement strategies and assessment measures in clinical practice are key in supporting the realization of patient engagement in healthcare. Training nurses in this area is feasible and accepted and might have an impact on their ability to engage patients in the chronic care journey. Due to the limitation of the research design, further research is needed to assess the effectiveness of such a program and to verify if the benefits envisaged in this pilot are maintained on a long-term perspective and to test results by employing a randomized control study design.

The development and validation of three videos designed to psychologically prepare patients for coronary bypass surgery.

PubMed

Mahler, H I; Kulik, J A

1995-02-01

The purpose of this study was to demonstrate the validation of videotape interventions that were designed to prepare patients for coronary artery bypass graft (CABG) surgery. First, three videotapes were developed. Two of the tapes featured the experiences of three actual CABG patients and were constructed to present either an optimistic portrayal of the recovery period (mastery tape) or a portrayal designed to inoculate patients against potential problems (coping tape). The third videotape contained the more general nurse scenes and narration used in the other two tapes, but did not include the experiences of particular patients. We then conducted a study to establish the convergent and discriminant validity of the three tapes. That is, we sought to demonstrate both that the tapes did differ along the mastery-coping dimension, and that they did not differ in other respects (such as in the degree of information provided or the perceived credibility of the narrator). The validation study, conducted with 42 males who had previously undergone CABG, demonstrated that the intended equivalences and differences between the tapes were achieved. The importance of establishing the validity of health-related interventions is discussed.

Modeling hospital surgical delivery process design using system simulation: optimizing patient flow and bed capacity as an illustration.

PubMed

Kumar, Sameer

2011-01-01

It is increasingly recognized that hospital operation is an intricate system with limited resources and many interacting sources of both positive and negative feedback. The purpose of this study is to design a surgical delivery process in a county hospital in the U.S where patient flow through a surgical ward is optimized. The system simulation modeling is used to address questions of capacity planning, throughput management and interacting resources which constitute the constantly changing complexity that characterizes designing a contemporary surgical delivery process in a hospital. The steps in building a system simulation model is demonstrated using an example of building a county hospital in a small city in the US. It is used to illustrate a modular system simulation modeling of patient surgery process flows. The system simulation model development will enable planners and designers how they can build in overall efficiencies in a healthcare facility through optimal bed capacity for peak patient flow of emergency and routine patients.

Design of a randomized trial of diabetes genetic risk testing to motivate behavior change: the Genetic Counseling/lifestyle Change (GC/LC) Study for Diabetes Prevention.

PubMed

Grant, Richard W; Meigs, James B; Florez, Jose C; Park, Elyse R; Green, Robert C; Waxler, Jessica L; Delahanty, Linda M; O'Brien, Kelsey E

2011-10-01

The efficacy of diabetes genetic risk testing to motivate behavior change for diabetes prevention is currently unknown. This paper presents key issues in the design and implementation of one of the first randomized trials (The Genetic Counseling/Lifestyle Change (GC/LC) Study for Diabetes Prevention) to test whether knowledge of diabetes genetic risk can motivate patients to adopt healthier behaviors. Because individuals may react differently to receiving 'higher' vs 'lower' genetic risk results, we designed a 3-arm parallel group study to separately test the hypotheses that: (1) patients receiving 'higher' diabetes genetic risk results will increase healthy behaviors compared to untested controls, and (2) patients receiving 'lower' diabetes genetic risk results will decrease healthy behaviors compared to untested controls. In this paper we describe several challenges to implementing this study, including: (1) the application of a novel diabetes risk score derived from genetic epidemiology studies to a clinical population, (2) the use of the principle of Mendelian randomization to efficiently exclude 'average' diabetes genetic risk patients from the intervention, and (3) the development of a diabetes genetic risk counseling intervention that maintained the ethical need to motivate behavior change in both 'higher' and 'lower' diabetes genetic risk result recipients. Diabetes genetic risk scores were developed by aggregating the results of 36 diabetes-associated single nucleotide polymorphisms. Relative risk for type 2 diabetes was calculated using Framingham Offspring Study outcomes, grouped by quartiles into 'higher', 'average' (middle two quartiles) and 'lower' genetic risk. From these relative risks, revised absolute risks were estimated using the overall absolute risk for the study group. For study efficiency, we excluded all patients receiving 'average' diabetes risk results from the subsequent intervention. This post-randomization allocation strategy was justified because genotype represents a random allocation of parental alleles ('Mendelian randomization'). Finally, because it would be unethical to discourage participants to participate in diabetes prevention behaviors, we designed our two diabetes genetic risk counseling interventions (for 'higher' and 'lower' result recipients) so that both groups would be motivated despite receiving opposing results. For this initial assessment of the clinical implementation of genetic risk testing we assessed intermediate outcomes of attendance at a 12-week diabetes prevention course and changes in self-reported motivation. If effective, longer term studies with larger sample sizes will be needed to assess whether knowledge of diabetes genetic risk can help patients prevent diabetes. We designed a randomized clinical trial designed to explore the motivational impact of disclosing both higher than average and lower than average genetic risk for type 2 diabetes. This design allowed exploration of both increased risk and false reassurance, and has implications for future studies in translational genomics.

A comparative study of occupancy and patient care quality in four different types of intensive care units in a children's hospital.

PubMed

Smith, Thomas J

2012-01-01

This paper reports a comparative study of occupancy and patient care quality in four types of intensive care units in a children's hospital,: an Infant Care Center (ICC), a Medical/Surgical (Med/Surg) unit, a Neonatal Intensive Care Unit (NICU), and a Pediatric Intensive Care Unit (PICU), each featuring a mix of multi-bed and private room (PR) patient care environments. The project is prompted by interest by the project sponsor in a pre-occupancy analysis, before the units are upgraded to exclusive PR designs. Methods comprised, for each unit: (1) observations of ergonomic design features; (2) task activity analyses of job performance of selected staff; and (3) use of a survey to collect perceptions by unit nursing and house staff (HS) of indicators of occupancy and patient care quality. (1) the five most common task activities are interaction with patients, charting, and interaction with equipment, co-workers and family members; (2) job satisfaction, patient care, work environment, job, patient care team interaction, and general occupancy quality rankings by ICC and/or NICU respondents are significantly higher than those by other staff respondents; and (3) ergonomic design shortcomings noted are excess noise, problems with equipment, and work environment, job-related health, and patient care quality issues.

Posterior stabilized versus cruciate retaining total knee arthroplasty designs: conformity affects the performance reliability of the design over the patient population.

PubMed

Ardestani, Marzieh M; Moazen, Mehran; Maniei, Ehsan; Jin, Zhongmin

2015-04-01

Commercially available fixed bearing knee prostheses are mainly divided into two groups: posterior stabilized (PS) versus cruciate retaining (CR). Despite the widespread comparative studies, the debate continues regarding the superiority of one type over the other. This study used a combined finite element (FE) simulation and principal component analysis (PCA) to evaluate "reliability" and "sensitivity" of two PS designs versus two CR designs over a patient population. Four fixed bearing implants were chosen: PFC (DePuy), PFC Sigma (DePuy), NexGen (Zimmer) and Genesis II (Smith & Nephew). Using PCA, a large probabilistic knee joint motion and loading database was generated based on the available experimental data from literature. The probabilistic knee joint data were applied to each implant in a FE simulation to calculate the potential envelopes of kinematics (i.e. anterior-posterior [AP] displacement and internal-external [IE] rotation) and contact mechanics. The performance envelopes were considered as an indicator of performance reliability. For each implant, PCA was used to highlight how much the implant performance was influenced by changes in each input parameter (sensitivity). Results showed that (1) conformity directly affected the reliability of the knee implant over a patient population such that lesser conformity designs (PS or CR), had higher kinematic variability and were more influenced by AP force and IE torque, (2) contact reliability did not differ noticeably among different designs and (3) CR or PS designs affected the relative rank of critical factors that influenced the reliability of each design. Such investigations enlighten the underlying biomechanics of various implant designs and can be utilized to estimate the potential performance of an implant design over a patient population. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

Does Improving Patient-Practitioner Communication Improve Clinical Outcomes in Patients with Cardiovascular Diseases? A Systematic Review of the Evidence

PubMed Central

Schoenthaler, Antoinette; Kalet, Adina; Nicholson, Joseph; Lipkin, Mack

2014-01-01

Objective To conduct a systematic literature review appraising the effects of interventions to improve patient-practitioner communication on cardiovascular-related clinical outcomes. Methods Databases were searched up to March 27, 2013 to identify eligible studies that included interventions to improve patient and/or practitioner communication skills and assessment of a cardiovascular-related clinical outcome in adults ≥ 18 years of age. Results Fifteen papers were reviewed: The primary focus in seven studies was the patient; seven included a practitioner-focused intervention and one targeted both. Two patient-focused and two practitioner-focused studies demonstrated a beneficial effect of the intervention compared to a control group. Patient-focused studies were designed to improve patients’ information-seeking and question-asking skills with their practitioner. Practitioner-focused studies were designed to either improve practitioner’s general patient-centered communication or risk communication skills. Conclusions Few interventions targeting patient-practitioner communication have assessed the impact on cardiovascular-related clinical outcomes, limiting the ability to determine effectiveness. Additional rigorous research supported by theoretical frameworks and validated measurement is needed to understand the potential of patient-practitioner communication to improve cardiovascular-related clinical outcomes. Practice Implications Investments in communication skills trainings in medical education and practice are needed in order to attain the full potential of patient-centered care on cardiovascular-related clinical outcomes. Systematic Review Protocol Registration CRD42013006302 PMID:24795073

[Prevalence of the Diabetic Retinopathy and Genetic Factors Significance in the Development of Diabetic Retinopathy in Patients with Diabetes Mellitus type I and II in Slovakia (DIARET SK study). Overview of Actual Findings and Design of the Epidemiological DIARET SK Study].

PubMed

Krásnik, V; Štefaničková, J; Fabková, J; Bucková, D; Helbich, M

2015-09-01

Diabetic retinopathy (DR) is the second most common microvascular complication and the most common cause of blindness in patients with diabetes mellitus (DM). Despite the ongoing research, the findings of diabetic retinopathy epidemiological and risk factors are, until now, not consistent. More finding may be revealed by epidemiological studies, consistently mapping DR epidemiology under the current possibilities of investigations and treatment of the DM. DIARET SK Study, with 5 000 enrolled patients with diabetes mellitus in the Slovak Republic, is, until now, the largest epidemiological study to set the prevalence of diabetic retinopathy. The primary aim is to establish the prevalence of diabetic retinopathy in patients with diabetes mellitus type I and II, according to the duration of the disease. The secondary aim is to establish prevalence of the different stages of the DR and diabetic macular edema (DME) and analysis of the risk factors influence. Included are patients with DM type I and II regardless to the ocular complications history and the period of DM duration. Each enrolled patient has both complex diabetic and ophthalmic examinations.Projects to establish DR prevalence: Tens of projects concerned with diabetic retinopathy epidemiology with different approaches to establish the prevalence and with different patients population. Results from different studies vary significantly (from 12.3 % to 66.9 %). The results depend on the design of the study and the patients recruitment, used examination methods, specific patients population with regard to the geography, prevalence of risk factors, period of diabetes duration, glycated hemoglobin (HbA1C) level, blood pressure, and is higher in type I diabetic patients. The most accurate results are from population epidemiological studies with well-controlled patient recruitment and uniform complex examination that are similar to the DIARET SK study. The DIARET SK study represents the largest epidemiological study to establish the prevalence of the diabetic retinopathy in patients with DM type I and II. Thanks to the quality design, similar to the already published studies, but with larger number of patients and newest examinations methods, the DIARET SK study has the aspiration to obtain the most accurate up to date data of diabetic retinopathy prevalence and risk factors influence to its outbreak. The patients recruitment started in February 2015. The expected date of patients recruitment termination is in the end of the year 2015, and the data analysis in 2016.

From the nurses' station to the health team hub: how can design promote interprofessional collaboration?

PubMed

Gum, Lyn Frances; Prideaux, David; Sweet, Linda; Greenhill, Jennene

2012-01-01

Interprofessional practice implies that health professionals are able to contribute patient care in a collaborative environment. In this paper, it is argued that in a hospital the nurses' station is a form of symbolic power. The term could be reframed as a "health team hub," which fosters a place for communication and interprofessional working. Studies have found that design of the Nurses' Station can impact on the walking distance of hospital staff, privacy for patients and staff, jeopardize patient confidentiality and access to resources. However, no studies have explored the implications of nurses' station design on interprofessional practice. A multi-site collective case study of three rural hospitals in South Australia explored the collaborative working culture of each hospital. Of the cultural concepts being studied, the physical design of nurses' stations and the general physical environment were found to have a major influence on an effective collaborative practice. Communication barriers were related to poor design, lack of space, frequent interruptions and a lack of privacy; the name "nurses' station" denotes the space as the primary domain of nurses rather than a workspace for the healthcare team. Immersive work spaces could encourage all members of the healthcare team to communicate more readily with one another to promote interprofessional collaboration.

Electromagnetic compatibility and safety design of a patient compliance-free, inductive implant charger.

PubMed

Theodoridis, Michael P; Mollov, Stefan V

2014-10-01

This article presents the design of a domestic, radiofrequency induction charger for implants toward compliance with the Federal Communications Commission safety and electromagnetic compatibility regulations. The suggested arrangement does not impose any patient compliance requirements other than the use of a designated bed for night sleep, and therefore can find a domestic use. The method can be applied to a number of applications; a rechargeable pacemaker is considered as a case study. The presented work has proven that it is possible to realize a fully compliant inductive charging system with minimal patient interaction, and has generated important information for consideration by the designers of inductive charging systems. Experimental results have verified the validity of the theoretical findings.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

The China Patient-Centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective study of acute myocardial infarction: study design.

PubMed

Dharmarajan, Kumar; Li, Jing; Li, Xi; Lin, Zhenqiu; Krumholz, Harlan M; Jiang, Lixin

2013-11-01

Cardiovascular diseases are rising as a cause of death and disability in China. To improve outcomes for patients with these conditions, the Chinese government, academic researchers, clinicians, and >200 hospitals have created China Patient-Centered Evaluative Assessment of Cardiac Events (China PEACE), a national network for research and performance improvement. The first study from China PEACE, the Retrospective Study of Acute Myocardial Infarction (China PEACE-Retrospective AMI Study), is designed to promote improvements in acute myocardial infarction (AMI) quality of care by generating knowledge about the characteristics, treatments, and outcomes of patients hospitalized with AMI across a representative sample of Chinese hospitals during the past decade. The China PEACE-Retrospective AMI Study will examine >18 000 patient records from 162 hospitals identified using a 2-stage cluster sampling design within economic-geographic regions. Records were chosen from 2001, 2006, and 2011 to identify temporal trends. Data quality will be monitored by a central coordinating center and will, in particular, address case ascertainment, data abstraction, and data management. Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results by time and site of care. In addition to publications, data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement. The China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and during the past decade in China. The China PEACE collaboration among government, academicians, clinicians, and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01624883.

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.

PubMed

Lal, Rohit; Bourayou, Nawel; Hillerdal, Gunnar; Nicolson, Marianne; Vikstrom, Anders; Lorenzo, Maria; D'yachkova, Yulia; Barriga, Susana; Visseren-Grul, Carla

2013-10-03

Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment. ClinicalTrials.gov: NCT01473563.

What outcomes are associated with developing and implementing co-produced interventions in acute healthcare settings? A rapid evidence synthesis

PubMed Central

Clarke, David; Jones, Fiona; Harris, Ruth; Robert, Glenn

2017-01-01

Background Co-production is defined as the voluntary or involuntary involvement of users in the design, management, delivery and/or evaluation of services. Interest in co-production as an intervention for improving healthcare quality is increasing. In the acute healthcare context, co-production is promoted as harnessing the knowledge of patients, carers and staff to make changes about which they care most. However, little is known regarding the impact of co-production on patient, staff or organisational outcomes in these settings. Aims To identify and appraise reported outcomes of co-production as an intervention to improve quality of services in acute healthcare settings. Design Rapid evidence synthesis. Data sources Medline, Cinahl, Web of Science, Embase, HMIC, Cochrane Database of Systematic Reviews, SCIE, Proquest Dissertation and Theses, EThOS, OpenGrey; CoDesign; The Design Journal; Design Issues. Study selection Studies reporting patient, staff or organisational outcomes associated with using co-production in an acute healthcare setting. Findings 712 titles and abstracts were screened; 24 papers underwent full-text review, and 11 papers were included in the evidence synthesis. One study was a feasibility randomised controlled trial, three were process evaluations and seven used descriptive qualitative approaches. Reported outcomes related to (a) the value of patient and staff involvement in co-production processes; (b) the generation of ideas for changes to processes, practices and clinical environments; and (c) tangible service changes and impacts on patient experiences. Only one study included cost analysis; none reported an economic evaluation. No studies assessed the sustainability of any changes made. Conclusions Despite increasing interest in and advocacy for co-production, there is a lack of rigorous evaluation in acute healthcare settings. Future studies should evaluate clinical and service outcomes as well as the cost-effectiveness of co-production relative to other forms of quality improvement. Potentially broader impacts on the values and behaviours of participants should also be considered. PMID:28701409

Evaluating the impact of patients' online access to doctors' visit notes: designing and executing the OpenNotes project

PubMed Central

2012-01-01

Background Providers and policymakers are pursuing strategies to increase patient engagement in health care. Increasingly, online sections of medical records are viewable by patients though seldom are clinicians' visit notes included. We designed a one-year multi-site trial of online patient accessible office visit notes, OpenNotes. We hypothesized that patients and primary care physicians (PCPs) would want it to continue and that OpenNotes would not lead to significant disruptions to doctors' practices. Methods/Design Using a mixed methods approach, we designed a quasi-experimental study in 3 diverse healthcare systems in Boston, Pennsylvania, and Seattle. Two sites had existing patient internet portals; the third used an experimental portal. We targeted 3 key areas where we hypothesized the greatest impacts: beliefs and attitudes about OpenNotes, use of the patient internet portals, and patient-doctor communication. PCPs in the 3 sites were invited to participate in the intervention. Patients who were registered portal users of participating PCPs were given access to their PCPs' visit notes for one year. PCPs who declined participation in the intervention and their patients served as the comparison groups for the study. We applied the RE-AIM framework to our design in order to capture as comprehensive a picture as possible of the impact of OpenNotes. We developed pre- and post-intervention surveys for online administration addressing attitudes and experiences based on interviews and focus groups with patients and doctors. In addition, we tracked use of the internet portals before and during the intervention. Results PCP participation varied from 19% to 87% across the 3 sites; a total of 114 PCPs enrolled in the intervention with their 22,000 patients who were registered portal users. Approximately 40% of intervention and non-intervention patients at the 3 sites responded to the online survey, yielding a total of approximately 38,000 patient surveys. Discussion Many primary care physicians were willing to participate in this "real world" experiment testing the impact of OpenNotes on their patients and their practices. Results from this trial will inform providers, policy makers, and patients who contemplate such changes at a time of exploding interest in transparency, patient safety, and improving the quality of care. PMID:22500560

Predictive model for survival in patients with gastric cancer.

PubMed

Goshayeshi, Ladan; Hoseini, Benyamin; Yousefli, Zahra; Khooie, Alireza; Etminani, Kobra; Esmaeilzadeh, Abbas; Golabpour, Amin

2017-12-01

Gastric cancer is one of the most prevalent cancers in the world. Characterized by poor prognosis, it is a frequent cause of cancer in Iran. The aim of the study was to design a predictive model of survival time for patients suffering from gastric cancer. This was a historical cohort conducted between 2011 and 2016. Study population were 277 patients suffering from gastric cancer. Data were gathered from the Iranian Cancer Registry and the laboratory of Emam Reza Hospital in Mashhad, Iran. Patients or their relatives underwent interviews where it was needed. Missing values were imputed by data mining techniques. Fifteen factors were analyzed. Survival was addressed as a dependent variable. Then, the predictive model was designed by combining both genetic algorithm and logistic regression. Matlab 2014 software was used to combine them. Of the 277 patients, only survival of 80 patients was available whose data were used for designing the predictive model. Mean ?SD of missing values for each patient was 4.43?.41 combined predictive model achieved 72.57% accuracy. Sex, birth year, age at diagnosis time, age at diagnosis time of patients' family, family history of gastric cancer, and family history of other gastrointestinal cancers were six parameters associated with patient survival. The study revealed that imputing missing values by data mining techniques have a good accuracy. And it also revealed six parameters extracted by genetic algorithm effect on the survival of patients with gastric cancer. Our combined predictive model, with a good accuracy, is appropriate to forecast the survival of patients suffering from Gastric cancer. So, we suggest policy makers and specialists to apply it for prediction of patients' survival.

Virtual surgical planning, flow simulation, and 3-dimensional electrospinning of patient-specific grafts to optimize Fontan hemodynamics.

PubMed

Siallagan, Dominik; Loke, Yue-Hin; Olivieri, Laura; Opfermann, Justin; Ong, Chin Siang; de Zélicourt, Diane; Petrou, Anastasios; Daners, Marianne Schmid; Kurtcuoglu, Vartan; Meboldt, Mirko; Nelson, Kevin; Vricella, Luca; Johnson, Jed; Hibino, Narutoshi; Krieger, Axel

2018-04-01

Despite advances in the Fontan procedure, there is an unmet clinical need for patient-specific graft designs that are optimized for variations in patient anatomy. The objective of this study is to design and produce patient-specific Fontan geometries, with the goal of improving hepatic flow distribution (HFD) and reducing power loss (P loss ), and manufacturing these designs by electrospinning. Cardiac magnetic resonance imaging data from patients who previously underwent a Fontan procedure (n = 2) was used to create 3-dimensional models of their native Fontan geometry using standard image segmentation and geometry reconstruction software. For each patient, alternative designs were explored in silico, including tube-shaped and bifurcated conduits, and their performance in terms of P loss and HFD probed by computational fluid dynamic (CFD) simulations. The best-performing options were then fabricated using electrospinning. CFD simulations showed that the bifurcated conduit improved HFD between the left and right pulmonary arteries, whereas both types of conduits reduced P loss . In vitro testing with a flow-loop chamber supported the CFD results. The proposed designs were then successfully electrospun into tissue-engineered vascular grafts. Our unique virtual cardiac surgery approach has the potential to improve the quality of surgery by manufacturing patient-specific designs before surgery, that are also optimized with balanced HFD and minimal P loss , based on refinement of commercially available options for image segmentation, computer-aided design, and flow simulations. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke.

PubMed

Pei, Yu-Cheng; Chen, Jean-Lon; Wong, Alice M K; Tseng, Kevin C

2017-01-01

Case series. IV (case series). Robot-assisted therapy for upper limb rehabilitation is an emerging research topic and its design process must integrate engineering, neurological pathophysiology, and clinical needs. This study developed/evaluated the usefulness of a novel rehabilitation device, the MirrorPath , designed for the upper limb rehabilitation of patients with hemiplegic stroke. The process follows Tseng's methodology for innovative product design and development, namely two stages, device development and usability assessment. During the development process, the design was guided by patients' rehabilitation needs as defined by patients and their therapists. The design applied synchronic movement of the bilateral upper limbs, an approach that is compatible with the bilateral movement therapy and proprioceptive neuromuscular facilitation theories. MirrorPath consists of a robotic device that guides upper limb movement linked to a control module containing software controlling the robotic movement. Five healthy subjects were recruited in the pretest, and 4 patients, 4 caregivers, and 4 therapists were recruited in the formal test for usability. All recruited subjects were allocated to the test group, completed the evaluation, and their data were all analyzed. The total system usability scale score obtained from the patients, caregivers, and therapists was 71.8 ± 11.9, indicating a high level of usability and product acceptance. Following a standard development process, we could yield a design that meets clinical needs. This low-cost device provides a feasible platform for carrying out robot-assisted bilateral movement therapy of patients with hemiplegic stroke. identifier NCT02698605.

Do Bedside Visual Tools Improve Patient and Caregiver Satisfaction? A Systematic Review of the Literature.

PubMed

Goyal, Anupama A; Tur, Komalpreet; Mann, Jason; Townsend, Whitney; Flanders, Scott A; Chopra, Vineet

2017-11-01

Although common, the impact of low-cost bedside visual tools, such as whiteboards, on patient care is unclear. To systematically review the literature and assess the influence of bedside visual tools on patient satisfaction. Medline, Embase, SCOPUS, Web of Science, CINAHL, and CENTRAL. Studies of adult or pediatric hospitalized patients reporting physician identification, understanding of provider roles, patient-provider communication, and satisfaction with care from the use of visual tools were included. Outcomes were categorized as positive, negative, or neutral based on survey responses for identification, communication, and satisfaction. Two reviewers screened studies, extracted data, and assessed the risk of study bias. Sixteen studies met the inclusion criteria. Visual tools included whiteboards (n = 4), physician pictures (n = 7), whiteboard and picture (n = 1), electronic medical record-based patient portals (n = 3), and formatted notepads (n = 1). Tools improved patients' identification of providers (13/13 studies). The impact on understanding the providers' roles was largely positive (8/10 studies). Visual tools improved patient-provider communication (4/5 studies) and satisfaction (6/8 studies). In adults, satisfaction varied between positive with the use of whiteboards (2/5 studies) and neutral with pictures (1/5 studies). Satisfaction related to pictures in pediatric patients was either positive (1/3 studies) or neutral (1/3 studies). Differences in tool format (individual pictures vs handouts with pictures of all providers) and study design (randomized vs cohort) may explain variable outcomes. The use of bedside visual tools appears to improve patient recognition of providers and patient-provider communication. Future studies that include better design and outcome assessment are necessary before widespread use can be recommended. © 2017 Society of Hospital Medicine

Background and design of the symptom burden in end-stage liver disease patient-caregiver dyad study.

PubMed

Hansen, Lissi; Lyons, Karen S; Dieckmann, Nathan F; Chang, Michael F; Hiatt, Shirin; Solanki, Emma; Lee, Christopher S

2017-10-01

Over half a million Americans are affected by cirrhosis, the cause of end-stage liver disease (ESLD). Little is known about how symptom burden changes over time in adults with ESLD and their informal caregivers, which limits our ability to develop palliative care interventions that can optimize symptom management and quality of life in different patient-caregiver dyads. The purpose of this article is to describe the background and design of a prospective, longitudinal descriptive study, "Symptom Burden in End-Stage Liver Disease Patient-Caregiver Dyads," which is currently in progress. The study is designed to (i) identify trajectories of change in physical and psychological symptom burden in adults with ESLD; (ii) identify trajectories of change in physical and psychological symptom burden in caregivers of adults with ESLD; and (iii) determine predictors of types of patient-caregiver dyads that would benefit from tailored palliative care interventions. We aim for a final sample of 200 patients and 200 caregivers who will be followed over 12 months. Integrated multilevel and latent growth mixture modeling will be used to identify trajectories of change in symptom burden, linking those changes to clinical events, and quality of life outcomes and characterizing types of patient-caregiver dyads based on patient-, caregiver-, and dyad-level factors. Challenges we have encountered include unexpected attrition of study participants, participants not returning their baseline questionnaires, and hiring and training of research staff. The study will lay the foundation for future research and innovation in ESLD, end-of-life and palliative care, and caregiving. © 2017 Wiley Periodicals, Inc.

Comparisons on efficacy of elcatonin and limaprost alfadex in patients with lumbar spinal stenosis and concurrent osteoporosis: a preliminary study using a crossover design.

PubMed

Kanchiku, Tsukasa; Imajo, Yasuaki; Suzuki, Hidenori; Yoshida, Yuichiro; Taguchi, Toshihiko; Tominaga, Toshikatsu; Toyoda, Koichiro

2014-08-01

Multicenter prospective study with a crossover design. The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks.

Design of the Blood Pressure Goals in Dialysis pilot study.

PubMed

Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer; Harford, Antonia; Horowitz, Bruce; Chen, Joline; Paine, Susan; Bedrick, Edward; Kusek, John W; Unruh, Mark; Zager, Philip

2014-02-01

Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

Design Features for Internet-Based Quality of Life Instrument in Inflammatory Bowel Disease

PubMed Central

Jonsson, Jens

1999-01-01

The idea of enabling user interaction in an Internet-based quality of life application comes with intention to solve problems common for conventional ways of communicating with patients. Here we are presenting results of the feasibility study, which regarded design and introduction of new forms to acquire patient information. Imagesp1092-a

Improvements in Limb Kinetic Apraxia by Repetition of a Newly Designed Facilitation Exercise in a Patient with Corticobasal Degeneration

ERIC Educational Resources Information Center

Kawahira, Kazumi; Noma, Tomokazu; Iiyama, Junichi; Etoh, Seiji; Ogata, Atsuko; Shimodozono, Megumi

2009-01-01

Corticobasal degeneration is a progressive neurological disorder characterized by a combination of parkinsonism and cortical dysfunction such as limb kinetic apraxia, alien limb phenomenon, and dementia. To study the effect of repetitive facilitation exercise (RFE) in a patient with corticobasal degeneration, we used a newly designed facilitation…

Novel antireflux covered metal stent for recurrent occlusion of biliary metal stents: a pilot study.

PubMed

Hamada, Tsuyoshi; Isayama, Hiroyuki; Nakai, Yousuke; Kogure, Hirofumi; Togawa, Osamu; Kawakubo, Kazumichi; Yamamoto, Natsuyo; Ito, Yukiko; Sasaki, Takashi; Tsujino, Takeshi; Sasahira, Naoki; Hirano, Kenji; Tada, Minoru; Koike, Kazuhiko

2014-03-01

Feasibility of antireflux metal stent (ARMS), designed to prevent duodenobiliary reflux, was reported in patients with distal malignant biliary obstruction. In this prospective pilot study, we aimed to evaluate a newly designed ARMS as a reintervention for self-expandable metallic stent (SEMS) occlusion believed to be caused by duodenobiliary reflux. Patients with non-resectable distal malignant biliary obstruction were included in whom a prior SEMS was occluded as a result of sludge or food impaction between March 2010 and January 2012 at two Japanese tertiary referral centers. The occluded SEMS were endoscopically removed, if possible, and subsequently replaced by a newly designed ARMS. We evaluated the technical success rate and complications of ARMS and compared the time to occlusion of ARMS with that of prior SEMS. A total of 13 patients were included. ARMS was successfully placed in all patients in a single procedure. No procedure-related complications were identified. ARMS occlusion occurred in two patients (15%), the causes of which were sludge in one patient and unknown in the other. ARMS migration occurred in four patients (31%). ARMS patency time was significantly longer than that of prior SEMS (median, not available vs 58 days; P = 0.039). This newly designed ARMS is a technically feasible, safe, and effective reintervention for SEMS occlusion as a result of sludge or food impaction. An anti-migration mechanism to improve the outcomes of ARMS should be considered. © 2013 The Authors. Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society.

Quality of Life and Functional Outcome After Transanal Abdominal Transanal Proctectomy for Low Rectal Cancer

PubMed Central

Marks, John H.; Salem, Jean F.; Valsdottir, Elsa B.; Yarandi, Shadi S.; Marks, Gerald J.

2018-01-01

BACKGROUND Transanal abdominal transanal proctectomy is a sphincter-preserving procedure designed to avoid colostomy in patients with cancer in the distal third of the rectum. Oncologic outcomes of this procedure have been established. However, data regarding patient satisfaction and quality of life are scant. OBJECTIVE The purpose of this study was to evaluate the quality of life and functional outcomes of patients after transanal abdominal transanal proctectomy. DESIGN This is a cross-sectional study. SETTINGS The study was conducted at a tertiary referral colorectal center. PATIENTS Patients who underwent transanal abdominal transanal proctectomy were included and surveyed using the Fecal Incontinence Quality of Life Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, the Quality of Life Questionnaire CR38 module, and a questionnaire designed by the authors to assess satisfaction with quality of life. MAIN OUTCOME MEASURES Quality of life, functional outcomes, and patient satisfaction were measured and compared by age, tumor level, and stage of the disease. RESULTS A total of 133 surveys were mailed, and 90 patients responded and were included in the study. Patient quality of life was not significantly different after surgery. Patients with more proximal tumors had better lifestyle, physical, and emotional scores. Older patients performed better on multiple levels, including coping, emotional, body image, future perspective, and digestive. Stage of disease had no impact on quality of life. Compared with reference values, patients who underwent transanal abdominal transanal proctectomy performed better on most of the components. All of patients preferred transanal abdominal transanal proctectomy over having a stoma based on their current anal sphincter function, and >97% of patients preferred transanal abdominal transanal proctectomy based on their current quality of life, sexual function, and level of activities. LIMITATIONS This study is limited by the lack of a comparison group and a potential selection bias. CONCLUSIONS Satisfaction with quality of life and functional outcomes is high after transanal abdominal transanal proctectomy. Older patients and those with more proximal tumors performed better. This patient population clearly preferred a sphincter-preserving option for treatment of their rectal cancer. PMID:28177987

A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design

PubMed Central

Zheng, Hua; Rosal, Milagros C; Li, Wenjun; Borg, Amy; Yang, Wenyun; Ayers, David C

2018-01-01

Background Data-driven surgical decisions will ensure proper use and timing of surgical care. We developed a Web-based patient-centered treatment decision and assessment tool to guide treatment decisions among patients with advanced knee osteoarthritis who are considering total knee replacement surgery. Objective The aim of this study was to examine user experience and acceptance of the Web-based treatment decision support tool among older adults. Methods User-centered formative and summative evaluations were conducted for the tool. A sample of 28 patients who were considering total knee replacement participated in the study. Participants’ responses to the user interface design, the clarity of information, as well as usefulness, satisfaction, and acceptance of the tool were collected through qualitative (ie, individual patient interviews) and quantitative (ie, standardized Computer System Usability Questionnaire) methods. Results Participants were older adults with a mean age of 63 (SD 11) years. Three-quarters of them had no technical questions using the tool. User interface design recommendations included larger fonts, bigger buttons, less colors, simpler navigation without extra “next page” click, less mouse movement, and clearer illustrations with simple graphs. Color-coded bar charts and outcome-specific graphs with positive action were easiest for them to understand the outcomes data. Questionnaire data revealed high satisfaction with the tool usefulness and interface quality, and also showed ease of use of the tool, regardless of age or educational status. Conclusions We evaluated the usability of a patient-centered decision support tool designed for advanced knee arthritis patients to facilitate their knee osteoarthritis treatment decision making. The lessons learned can inform other decision support tools to improve interface and content design for older patients’ use. PMID:29712620

Results of a diabetic retinopathy screening. Risk markers analysis.

PubMed

Ancochea, G; Martín Sánchez, M D

2016-01-01

To identify risk markers for retinopathy in patients from our geographic area, and to compare them with those published in other studies. To design a screening interval strategy, taking into account these results, and compare it with intervals suggested in published studies. Cross-sectional observational study on 383 diabetic patients with no previous retinopathy diagnosis, who were screened for diabetic retinopathy. An analysis was made on the possible association between patient factors and presence of retinopathy. A greater probability for finding retinopathy in diabetic patients was associated to insulin treatment in our study, with a statistical significance level of 95%. In patients with less than 10year onset of their diabetes, only mild retinopathy without macular oedema was found. Insulin treatment and time of onset of diabetes should be taken into account when designing efficient screening strategies for diabetic retinopathy. Copyright © 2015 Sociedad Española de Oftalmología. Published by Elsevier España, S.L.U. All rights reserved.

Patient safety and patient assessment in pre-hospital care: a study protocol.

PubMed

Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

2016-02-12

Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

Human patient simulators and interactive case studies: a comparative analysis of learning outcomes and student perceptions.

PubMed

Howard, Valerie Michele; Ross, Carl; Mitchell, Ann M; Nelson, Glenn M

2010-01-01

Although human patient simulators provide an innovative teaching method for nursing students, they are quite expensive. To investigate the value of this expenditure, a quantitative, quasi-experimental, two-group pretest and posttest design was used to compare two educational interventions: human patient simulators and interactive case studies. The sample (N = 49) consisted of students from baccalaureate, accelerated baccalaureate, and diploma nursing programs. Custom-designed Health Education Systems, Inc examinations were used to measure knowledge before and after the implementation of the two educational interventions. Students in the human patient simulation group scored significantly higher than did those in the interactive case study group on the posttest Health Education Systems, Inc examination, and no significant difference was found in student scores among the three types of nursing programs that participated in the study. Data obtained from a questionnaire administered to participants indicated that students responded favorably to the use of human patient simulators as a teaching method.

Design of the rivaroxaban for heparin-induced thrombocytopenia study.

PubMed

Linkins, Lori-Ann; Warkentin, Theodore E; Pai, Menaka; Shivakumar, Sudeep; Manji, Rizwan A; Wells, Philip S; Crowther, Mark A

2014-11-01

Rivaroxaban is an ideal potential candidate for treatment of heparin-induced thrombocytopenia (HIT) because it is administered orally by fixed dosing, requires no laboratory monitoring and is effective in the treatment of venous and arterial thromboembolism in other settings. The Rivaroxaban for HIT study is a prospective, multicentre, single-arm, cohort study evaluating the incidence of new symptomatic venous and arterial thromboembolism in patients with suspected or confirmed HIT who are treated with rivaroxaban. Methodological challenges faced in the design of this study include heterogeneity of the patient population, differences in the baseline risk of thrombosis and bleeding dependent on whether HIT is confirmed or just suspected, and heterogeneity in laboratory confirmation of HIT. The rationale for how these challenges were addressed and the final design of the Rivaroxaban for HIT study is reviewed.

Design and fabrication of facial prostheses for cancer patient applying computer aided method and manufacturing (CADCAM)

NASA Astrophysics Data System (ADS)

Din, Tengku Noor Daimah Tengku; Jamayet, Nafij; Rajion, Zainul Ahmad; Luddin, Norhayati; Abdullah, Johari Yap; Abdullah, Abdul Manaf; Yahya, Suzana

2016-12-01

Facial defects are either congenital or caused by trauma or cancer where most of them affect the person appearance. The emotional pressure and low self-esteem are problems commonly related to patient with facial defect. To overcome this problem, silicone prosthesis was designed to cover the defect part. This study describes the techniques in designing and fabrication for facial prosthesis applying computer aided method and manufacturing (CADCAM). The steps of fabricating the facial prosthesis were based on a patient case. The patient was diagnosed for Gorlin Gotz syndrome and came to Hospital Universiti Sains Malaysia (HUSM) for prosthesis. The 3D image of the patient was reconstructed from CT data using MIMICS software. Based on the 3D image, the intercanthal and zygomatic measurements of the patient were compared with available data in the database to find the suitable nose shape. The normal nose shape for the patient was retrieved from the nasal digital library. Mirror imaging technique was used to mirror the facial part. The final design of facial prosthesis including eye, nose and cheek was superimposed to see the result virtually. After the final design was confirmed, the mould design was created. The mould of nasal prosthesis was printed using Objet 3D printer. Silicone casting was done using the 3D print mould. The final prosthesis produced from the computer aided method was acceptable to be used for facial rehabilitation to provide better quality of life.

Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial: Rationale and Design.

PubMed

Sheth, Kevin N; Elm, Jordan J; Beslow, Lauren A; Sze, Gordon K; Kimberly, W Taylor

2016-02-01

Patients with large territory infarction are at high risk of cerebral edema and neurological deterioration, including death. Preclinical studies have shown that a continuous infusion of glyburide blocks edema formation and improves outcome. We hypothesize that treatment with RP-1127 (Glyburide for Injection) reduces formation of brain edema in patients after large anterior circulation infarction. GAMES-RP is a prospective, randomized, double-blind, multicenter trial designed to evaluate RP-1127 in patients at high risk for the development of malignant cerebral edema. The study population consisted of subjects with a clinical diagnosis of acute severe anterior circulation ischemic stroke with a baseline diffusion-weighted image lesion between 82 and 300 cm(3) who are 18-80 years of age. The target time from symptom onset to start of study infusion was ≤10 h. Subjects were randomized to RP-1127 (glyburide for injection) or placebo and treated with a continuous infusion for 72 h. The primary efficacy outcome was a composite of the modified Rankin Scale and the incidence of decompressive craniectomy, assessed at 90 days. Safety outcomes were the frequency and severity of adverse events, with a focus on cardiac- and glucose-related serious adverse events. GAMES-RP was designed to provide critical information regarding glyburide for injection in patients with large hemispheric stroke and will inform the design of future studies.

Using Experience-based Co-design with older patients, their families and staff to improve palliative care experiences in the Emergency Department: A reflective critique on the process and outcomes.

PubMed

Blackwell, Rebecca Wright Née; Lowton, Karen; Robert, Glenn; Grudzen, Corita; Grocott, Patricia

2017-03-01

Increasing use of emergency departments among older patients with palliative needs has led to the development of several service-level interventions intended to improve care quality. There is little evidence of patient and family involvement in developmental processes, and little is known about the experiences of - and preferences for - palliative care delivery in this setting. Participatory action research seeking to enable collaborative working between patients and staff should enhance the impact of local quality improvement work but has not been widely implemented in such a complex setting. To critique the feasibility of this methodology as a quality improvement intervention in complex healthcare settings, laying a foundation for future work. an Emergency Department in a large teaching hospital in the United Kingdom. Experience-based Co-design incorporating: 150h of nonparticipant observation; semi-structured interviews with 15 staff members about their experiences of palliative care delivery; 5 focus groups with 64 staff members to explore challenges in delivering palliative care; 10 filmed semi-structured interviews with palliative care patients or their family members; a co-design event involving staff, patients and family members. the study successfully identified quality improvement priorities leading to changes in Emergency Department-palliative care processes. Further outputs were the creation of a patient-family-staff experience training DVD to encourage reflective discussion and the identification and application of generic design principles for improving palliative care in the Emergency Department. There were benefits and challenges associated with using Experience-based Co-design in this setting. Benefits included the flexibility of the approach, the high levels of engagement and responsiveness of patients, families and staff, and the impact of using filmed narrative interviews to enhance the 'voice' of seldom heard patients and families. Challenges included high levels of staff turnover during the 19 month project, significant time constraints in the Emergency Department and the ability of older patients and their families to fully participate in the co-design process. Experience-based Co-design is a useful approach for encouraging collaborative working between vulnerable patients, family and staff in complex healthcare environments. The flexibility of the approach allows the specific needs of participants to be accounted for, enabling fuller engagement with those who typically may not be invited to contribute to quality improvement work. Recommendations for future studies in this and similar settings include testing the 'accelerated' form of the approach and experimenting with alternative ways of increasing involvement of patients/families in the co-design phase. Copyright © 2017 Elsevier Ltd. All rights reserved.

Partners in Care: Design Considerations for Caregivers and Patients During a Hospital Stay

PubMed Central

Miller, Andrew D.; Mishra, Sonali R.; Kendall, Logan; Haldar, Shefali; Pollack, Ari H.; Pratt, Wanda

2016-01-01

Informal caregivers, such as close friends and family, play an important role in a hospital patient’s care. Although CSCW researchers have shown the potential for social computing technologies to help patients and their caregivers manage chronic conditions and support health behavior change, few studies focus on caregivers’ role during a multi-day hospital stay. To explore this space, we conducted an interview and observation study of patients and caregivers in the inpatient setting. In this paper, we describe how caregivers and patients coordinate and collaborate to manage patients’ care and wellbeing during a hospital stay. We define and describe five roles caregivers adopt: companion, assistant, representative, navigator, and planner, and show how patients and caregivers negotiate these roles and responsibilities throughout a hospital stay. Finally, we identify key design considerations for technology to support patients and caregivers during a hospital stay. PMID:27148596

Health Care Professionals' Views about Supporting Patients' Self-Management

ERIC Educational Resources Information Center

Mikkonen, Irma; Hynynen, Marja-Anneli

2012-01-01

Purpose: The aim of this study was to describe nurses' and other health care professionals' views about their patient education skills and how to develop them. Design/methodology/approach: The data for the study were collected from the participants of the online education course on patient education. The data were analyzed using qualitative…

Effect of asthma management education program on stress and compliance of patients with allergic asthma to house dust mite.

PubMed

Yoo, Yang Sook; Cho, Ok Hee; Kim, Eun Sin; Jeong, Hye Sun

2005-06-01

This study was designed to examine the effect of asthma management education program applied to allergic asthma patients receiving immunotherapy due to house dust mite on their stress and compliance with health care regimens. A quasi experimental design with non-equivalent control group and non-synchronized design was used. The subjects of this study were 61 patients who were receiving immunotherapy at intervals of a week after their symptoms were diagnosed as house dust mite allergic asthma at the pulmonary department of a university hospital in Seoul. They were divided into an experimental group of 29 patients who received asthma management education and a control group of 32 patients. The asthma management education program was composed of group education (once) and reinforcement education (three times) with environmental therapy and immunotherapy to house dust mite. Stress significantly decreased in the experimental group compared to that in the control group. Compliance with health care regimens significantly increased in the experimental group compared to that in the control group. The results suggested that the asthma management education program is effective for the management of stress and the improvement of compliance in patients with allergic asthma to house dust mite.

Macroergonomic factors in the patient work system: examining the context of patients with chronic illness.

PubMed

Holden, Richard J; Valdez, Rupa S; Schubert, Christiane C; Thompson, Morgan J; Hundt, Ann S

2017-01-01

Human factors/ergonomics recognises work as embedded in and shaped by levels of social, physical and organisational context. This study investigates the contextual or macroergonomic factors present in the health-related work performed by patients. We performed a secondary content analysis of findings from three studies of the work of chronically ill patients and their informal caregivers. Our resulting consolidated macroergonomic patient work system model identified 17 factors across physical, social and organisational domains and household and community levels. These factors are illustrated with examples from the three studies and discussed as having positive, negative or varying effects on health and health behaviour. We present three brief case studies to illustrate how macroergonomic factors combine across domains and levels to shape performance in expected and unexpected ways. Findings demonstrate not only the importance of context for patients' health-related activities but also specific factors to consider in future research, design and policy efforts. Practitioner Summary: Health-related activities of patients are embedded in and shaped by levels of social, physical and organisational context. This paper combined findings from three studies to specify 17 contextual or macroergonomic factors in home- and community-based work systems of chronically ill patients. These factors have research, design and policy implications.

The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome

PubMed Central

Dietrich, Johannes W; Stachon, Axel; Antic, Biljana; Klein, Harald H; Hering, Steffen

2008-01-01

Background Non-thyroidal illness syndrome (NTIS) is a characteristic functional constellation of thyrotropic feedback control that frequently occurs in critically ill patients. Although this condition is associated with significantly increased morbidity and mortality, there is still controversy on whether NTIS is caused by artefacts, is a form of beneficial adaptation, or is a disorder requiring treatment. Trials investigating substitution therapy of NTIS revealed contradictory results. The comparison of heterogeneous patient cohorts may be the cause for those inconsistencies. Objectives Primary objective of this study is the identification and differentiation of different functional states of thyrotropic feedback control in order to define relevant evaluation criteria for the prognosis of affected patients. Furthermore, we intend to assess the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent (so-called "sub-clinical") thyrotoxicosis. Secondary objective is observation of variables that quantify distinct components of NTIS in the context of independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication. Design The approach to a quantitative follow-up of non-thyroidal illness syndrome (AQUA FONTIS study) is designed as both a cross-sectional and prospective longitudinal observation trial in critically ill patients. Patients are observed in at least two evaluation points with consecutive assessments of thyroid status, physiological and clinical data in additional weekly observations up to discharge. A second part of the study investigates the neuropsychological impact of NTIS and medium-term outcomes. The study design incorporates a two-module structure that covers a reduced protocol in form of an observation trial before patients give informed consent. Additional investigations are performed if and after patients agree in participation. Trial Registration ClinicalTrials.gov NCT00591032 PMID:18851740

Innovative research methods for studying treatments for rare diseases: methodological review.

PubMed

Gagne, Joshua J; Thompson, Lauren; O'Keefe, Kelly; Kesselheim, Aaron S

2014-11-24

To examine methods for generating evidence on health outcomes in patients with rare diseases. Methodological review of existing literature. PubMed, Embase, and Academic Search Premier searched for articles describing innovative approaches to randomized trial design and analysis methods and methods for conducting observational research in patients with rare diseases. We assessed information related to the proposed methods, the specific rare disease being studied, and outcomes from the application of the methods. We summarize methods with respect to their advantages in studying health outcomes in rare diseases and provide examples of their application. We identified 46 articles that proposed or described methods for studying patient health outcomes in rare diseases. Articles covered a wide range of rare diseases and most (72%) were published in 2008 or later. We identified 16 research strategies for studying rare disease. Innovative clinical trial methods minimize sample size requirements (n=4) and maximize the proportion of patients who receive active treatment (n=2), strategies crucial to studying small populations of patients with limited treatment choices. No studies describing unique methods for conducting observational studies in patients with rare diseases were identified. Though numerous studies apply unique clinical trial designs and considerations to assess patient health outcomes in rare diseases, less attention has been paid to innovative methods for studying rare diseases using observational data. © Gagne et al 2014.

Identifying Personal Goals of Patients With Long Term Condition: A Service Design Thinking Approach.

PubMed

Lee, Eunji; Gammon, Deede

2017-01-01

Care for patients with long term conditions is often characterized as fragmented and ineffective, and fails to engage the resources of patients and their families in the care process. Information and communication technology can potentially help bridge the gap between patients' lives and resources and services provided by professionals. However, there is little attention on how to identify and incorporate the patients' individual needs, values, preferences and care goals into the digitally driven care settings. We conducted a case study with healthcare professionals and patients participated applying a service design thinking approach. The participants could elaborate some personal goals of patients with long term condition which can potentially be incorporated in digitally driven care plans using examples from their own experiences.

Implementation of tuberculosis infection control measures in designated hospitals in Zhejiang Province, China: are we doing enough to prevent nosocomial tuberculosis infections?

PubMed Central

Chen, Bin; Liu, Min; Gu, Hua; Wang, Xiaomeng; Qiu, Wei; Shen, Jian; Jiang, Jianmin

2016-01-01

Objectives Tuberculosis (TB) infection control measures are very important to prevent nosocomial transmission and protect healthcare workers (HCWs) in hospitals. The TB infection control situation in TB treatment institutions in southeastern China has not been studied previously. Therefore, the aim of this study was to investigate the implementation of TB infection control measures in TB-designated hospitals in Zhejiang Province, China. Design Cross-sectional survey using observation and interviews. Setting All TB-designated hospitals (n=88) in Zhejiang Province, China in 2014. Primary and secondary outcome measures Managerial, administrative, environmental and personal infection control measures were assessed using descriptive analyses and univariate logistic regression analysis. Results The TB-designated hospitals treated a median of 3030 outpatients (IQR 764–7094) and 279 patients with confirmed TB (IQR 154–459) annually, and 160 patients with TB (IQR 79–426) were hospitalised in the TB wards. Most infection control measures were performed by the TB-designated hospitals. Measures including regular monitoring of TB infection control in high-risk areas (49%), shortening the wait times (42%), and providing a separate waiting area for patients with suspected TB (46%) were sometimes neglected. N95 respirators were available in 85 (97%) hospitals, although only 44 (50%) hospitals checked that they fit. Hospitals with more TB staff and higher admission rates of patients with TB were more likely to set a dedicated sputum collection area and to conduct annual respirator fit testing. Conclusions TB infection control measures were generally implemented by the TB-designated hospitals. Measures including separation of suspected patients, regular monitoring of infection control practices, and regular fit testing of respirators should be strengthened. Infection measures for sputum collection and respirator fit testing should be improved in hospitals with lower admission rates of patients with TB. PMID:26940111

SU-C-19A-05: Treatment Chairs for Modern Radiation Therapy Treatments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Court, L; Fullen, D; Tharp, K

2014-06-15

Purpose: Treating patients in a seated position has potential advantages including improved comfort, increased lung volume, and reduced respiratory motion. We compared chair designs for head and neck, thoracic and breast patients for use with either IGRT linacs or a proposed low-cost fixed horizontal beam-line machine. Methods: Three treatment chairs were designed and constructed. Two of the chairs are based on a massage-chair, with the patient angled slightly forwards and knee rests used to minimize intra-fraction slouch. The third chair design is more conventional; the patient is angled backwards, with indexed positioning devices and the ability to attach thermoplastic masks.more » Patient geometries, including PTV location and patient sizes, were extracted from 137 CTs of past patients were used to model the probability of collision between the patient and the linac for various seated positions. All chairs were designed around the weight limits for couches on our linacs. At the time of writing we have just received IRB approval for imaging studies to evaluate comfort, and intra- and interfraction reproducibility. Results: The geometric analysis showed that head and neck patients and thoracic patients could be treated without collision. However, there is very limited space between the patient and the treatment/imaging devices, so careful design of the chair is essential. The position of the treatment target and extended arm positioning means that this is a particular concern for thoracic and breast patients. This was demonstrated for one of the prototype chairs designed for breast treatment where the arm holders would collide with the kV detector. The extra clearance of a dedicated fixed-beam linac would overcome these difficulties. Intra- and inter-fraction reproducibility results will be presented at the meeting. Conclusion: To take advantage of the clinical advantages of seated treatments, appropriate treatment chairs are needed. A dedicate fixed-beam linac may enable more options. This work was partially funded by Varian Medical Systems.« less

Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes?

PubMed

Waliszewski, Matthias; Rittger, Harald

2016-10-01

Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value. Moreover, we intend to describe the statistical limitations in order to demonstrate differences between potential treatment groups. Furthermore, careful endpoint recommendations for a given patient number are offered for future study designs. The number of patients per treatment group was estimated for various study designs such as noninferiority test hypotheses with hard clinical endpoints and various surrogate endpoints. To test for differences in various surrogate endpoint scenarios, the corresponding patient group sizes were explored. To evaluate these endpoints in terms of their reimbursement impact, preferred endpoints for technical appraisals in interventional cardiology at the National Institute of Health and Care Excellence (NICE) were used. Even with the most stringent experimental control to reduce bias-introducing factors, studies with hard primary clinical endpoints such as the occurrence of major adverse cardiac events (MACE) or target-lesion revascularization (TLR) rates remain the gold standard, with numbers reaching into the 300-700 patient range per group. Study designs using loss in fractional-flow reserve (FFR) or stent-strut-coverage rates can be statistically formulated; however, the clinical ramifications for the patient remain to be discussed. Nonrandomized study designs with intrapatient angiographic controls in nontarget vessels may merit further thoughts and explorations. From a reimbursement impact, the primary endpoints MACE and TLR are the best choices for a moderately sized study population of 500 patients per group. Angiographic endpoints, in particular minimal lumen diameter (MLD), are not useful in this context. The emerging endpoints such as loss in FFR or stent coverage require smaller patient populations. However, their impact on reimbursement-related decisions is limited. © The Author(s), 2016.

Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes?

PubMed Central

Waliszewski, Matthias; Rittger, Harald

2016-01-01

Background: Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value. Moreover, we intend to describe the statistical limitations in order to demonstrate differences between potential treatment groups. Furthermore, careful endpoint recommendations for a given patient number are offered for future study designs. Methods: The number of patients per treatment group was estimated for various study designs such as noninferiority test hypotheses with hard clinical endpoints and various surrogate endpoints. To test for differences in various surrogate endpoint scenarios, the corresponding patient group sizes were explored. To evaluate these endpoints in terms of their reimbursement impact, preferred endpoints for technical appraisals in interventional cardiology at the National Institute of Health and Care Excellence (NICE) were used. Results: Even with the most stringent experimental control to reduce bias-introducing factors, studies with hard primary clinical endpoints such as the occurrence of major adverse cardiac events (MACE) or target-lesion revascularization (TLR) rates remain the gold standard, with numbers reaching into the 300–700 patient range per group. Study designs using loss in fractional-flow reserve (FFR) or stent-strut-coverage rates can be statistically formulated; however, the clinical ramifications for the patient remain to be discussed. Nonrandomized study designs with intrapatient angiographic controls in nontarget vessels may merit further thoughts and explorations. Conclusions: From a reimbursement impact, the primary endpoints MACE and TLR are the best choices for a moderately sized study population of 500 patients per group. Angiographic endpoints, in particular minimal lumen diameter (MLD), are not useful in this context. The emerging endpoints such as loss in FFR or stent coverage require smaller patient populations. However, their impact on reimbursement-related decisions is limited. PMID:27378486

Patient-Staff Interactions and Mental Health in Chronic Dialysis Patients

ERIC Educational Resources Information Center

Swartz, Richard D.; Perry, Erica; Brown, Stephanie; Swartz, June; Vinokur, Amiram

2008-01-01

Chronic dialysis imposes ongoing stress on patients and staff and engenders recurring contact and long-term relationships. Thus, chronic dialysis units are opportune settings in which to investigate the impact of patients' relationships with staff on patient well-being. The authors designed the present study to examine the degree to which…

Service Design Attributes Affecting Diabetic Patient Preferences of Telemedicine in South Korea

PubMed Central

Chon, YuCheong; Lee, Jongsu; Choi, Ie-Jung; Yoon, Kun-Ho

2011-01-01

Abstract Objective Attempts to introduce telemedicine in South Korea have failed mostly, leaving critical questions for service developers and providers about whether patients would be willing to pay for the service and how the service should be designed to encourage patient buy-in. In this study, we explore patients' valuations and preferences for each attribute of telemedicine service for diabetes management and evaluate patient willingness to pay for specific service attributes. Materials and Methods We conducted a conjoint survey to collect data on patients' stated preferences among telemedicine service alternatives. The alternatives for diabetes-related service differed in 10 attributes, including those related to price, type of service provider, and service scope. To estimate the relative importance of attributes, patients' willingness to pay for each attribute, and their probable choice of specific alternatives, we used a rank-ordered logit model. A total of 118 respondents participated in the survey. Results All 10 attributes significantly affected patients' valuations and preferences, and demographic and disease characteristics, such as existence of complications and comorbidities, significantly affected patients' valuations of the attributes. Price was the most important attribute, followed by comprehensive scope of service, the availability of mobile phone-based delivery, and large general-hospital provided services. Conclusions The study findings have significant implications for adoption policy and strategy of telemedicine in diabetes management care. Further, the methodology presented in this study can be used to draw knowledge needed to formulate effective policy for adoption of the necessary technology and for the design of services that attract potential beneficiaries. PMID:21631382

Clinical studies in restorative dentistry: New directions and new demands.

PubMed

Opdam, N J M; Collares, K; Hickel, R; Bayne, S C; Loomans, B A; Cenci, M S; Lynch, C D; Correa, M B; Demarco, F; Schwendicke, F; Wilson, N H F

2018-01-01

Clinical research of restorative materials is confounded by problems of study designs, length of trials, type of information collected, and costs for trials, despite increasing numbers and considerable development of trials during the past 50 years. This opinion paper aims to discuss advantages and disadvantages of different study designs and outcomes for evaluating survival of dental restorations and to make recommendations for future study designs. Advantages and disadvantages of randomized trials, prospective and retrospective longitudinal studies, practice-based, pragmatic and cohort studies are addressed and discussed. The recommendations of the paper are that clinical trials should have rational control groups, include confounders such as patient risk factors in the data and analysis and should use outcome parameters relevant for profession and patients. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Using technology to engage hospitalised patients in their care: a realist review.

PubMed

Roberts, Shelley; Chaboyer, Wendy; Gonzalez, Ruben; Marshall, Andrea

2017-06-06

Patient participation in health care is associated with improved outcomes for patients and hospitals. New technologies are creating vast potential for patients to participate in care at the bedside. Several studies have explored patient use, satisfaction and perceptions of health information technology (HIT) interventions in hospital. Understanding what works for whom, under what conditions, is important when considering interventions successfully engaging patients in care. This realist review aimed to determine key features of interventions using bedside technology to engage hospital patients in their care and analyse these in terms of context, mechanisms and outcomes. A realist review was chosen to explain how and why complex HIT interventions work or fail within certain contexts. The review was guided by Pawson's realist review methodology, involving: clarifying review scope; searching for evidence; data extraction and evidence appraisal; synthesising evidence and drawing conclusions. Author experience and an initial literature scope provided insight and review questions and theories (propositions) around why interventions worked were developed and iteratively refined. A purposive search was conducted to find evidence to support, refute or identify further propositions, which formed an explanatory model. Each study was 'mined' for evidence to further develop the propositions and model. Interactive learning was the overarching theme of studies using technology to engage patients in their care. Several propositions underpinned this, which were labelled: information sharing; self-assessment and feedback; tailored education; user-centred design; and support in use of HIT. As studies were mostly feasibility or usability studies, they reported patient-centred outcomes including patient acceptability, satisfaction and actual use of HIT interventions. For each proposition, outcomes were proposed to come about by mechanisms including improved communication, shared decision-making, empowerment and self-efficacy; which acted as facilitators to patient participation in care. Overall, there was a stronger representation of health than IT disciplines in studies reviewed, with a lack of IT input in terms of theoretical underpinning, methodological design and reporting of outcomes. HIT interventions have great potential for engaging hospitalised patients in their care. However, stronger interdisciplinary collaboration between health and IT researchers is needed for effective design and evaluation of HIT interventions.

Do participation and personalization matter? A model-driven evaluation of an Internet-based patient education intervention for fibromyalgia patients.

PubMed

Camerini, Luca; Camerini, Anne-Linda; Schulz, Peter J

2013-08-01

To evaluate the effectiveness of an Internet-based patient education intervention, which was designed upon principles of personalization and participatory design. Fifteen months after the first release of the website, 209 fibromyalgia patients recruited through health professionals completed an online questionnaire to assess patients' use of the website, health knowledge, self-management behavior, and health outcomes. These constructs were combined into an a-priory model that was tested using a structural equation modeling approach. Results show that the usage of certain tools of the website - designed and personalized involving the end users - impacts patients' health knowledge, which in turn impacts self-management. Improvements in self-management ultimately lower the impact of Fibromyalgia Syndrome leading to better health outcomes. This study empirically confirmed that the adoption of a participatory approach to the design of eHealth interventions and the use of personalized contents enhance the overall effectiveness of systems. More time and effort should be invested in involving patients in the preliminary phases of the development of Internet-based patient education interventions and in the definition of models that can guide the systems' evaluation beyond technology-related variables such as usability, accessibility or adoption. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Observational methods in comparative effectiveness research.

PubMed

Concato, John; Lawler, Elizabeth V; Lew, Robert A; Gaziano, J Michael; Aslan, Mihaela; Huang, Grant D

2010-12-01

Comparative effectiveness research (CER) may be defined informally as an assessment of available options for treating specific medical conditions in selected groups of patients. In this context, the most prominent features of CER are the various patient populations, medical ailments, and treatment options involved in any particular project. Yet, each research investigation also has a corresponding study design or "architecture," and in patient-oriented research a common distinction used to describe such designs are randomized controlled trials (RCTs) versus observational studies. The purposes of this overview, with regard to CER, are to (1) understand how observational studies can provide accurate results, comparable to RCTs; (2) recognize strategies used in selected newer methods for conducting observational studies; (3) review selected observational studies from the Veterans Health Administration; and (4) appreciate the importance of fundamental methodological principles when conducting or evaluating individual studies. Published by Elsevier Inc.

Design and validation of a critical pathway for hospital management of patients with severe traumatic brain injury.

PubMed

Espinosa-Aguilar, Amilcar; Reyes-Morales, Hortensia; Huerta-Posada, Carlos E; de León, Itzcoatl Limón-Pérez; López-López, Fernando; Mejía-Hernández, Margarita; Mondragón-Martínez, María A; Calderón-Téllez, Ligia M; Amezcua-Cuevas, Rosa L; Rebollar-González, Jorge A

2008-05-01

Critical pathways for the management of patients with severe traumatic brain injury (STBI) may contribute to reducing the incidence of hospital complications, length of hospitalization stay, and cost of care. Such pathways have previously been developed for departments with significant resource availability. In Mexico, STBI is the most important cause of complications and length of stay in neurotrauma services at public hospitals. Although current treatment is designed basically in accordance with the Brain Trauma Foundation guidelines, shortfalls in the availability of local resources make it difficult to comply with these standards, and no critical pathway is available that accords with the resources of public hospitals. The purpose of the present study was to design and to validate a critical pathway for managing STBI patients that would be suitable for implementation in neurotrauma departments of middle-income level countries. The study comprised two phases: design (through literature review and design plan) and validation (content, construct, and appearance) of the critical pathway. The validated critical pathway for managing STBI patients entails four sequential subprocesses summarizing the hospital's care procedures, and includes three components: (1) nodes and criteria (in some cases, indicators are also included); (2) health team members in charge of the patient; (3) maximum estimated time for compliance with recommendations. This validated critical pathway is based on the current scientific evidence and accords with the availability of resources of middle-income countries.

The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

PubMed

Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

2018-03-01

Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P < 0.001) and more likely to be working (OR 5.04; 95%CI 1.96-12.98, P < 0.001) than non-participants. In the present study, recruitment of CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study.

PubMed

Biondi-Zoccai, Giuseppe G L; Sangiorgi, Giuseppe M; Antoniucci, David; Grube, Eberhard; Di Mario, Carlo; Reimers, Bernard; Tamburino, Corrado; Agostoni, Pierfrancesco; Cosgrave, John; Colombo, Antonio

2007-05-02

Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. STUDY DESIGN, PATIENT CHARACTERISTICS AND IN-HOSPITAL OUTCOMES: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrollment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5+/-0.6 vessels and 2.0+/-1.0 lesions were treated per patient, with 2.0+/-1.2 PES implanted per patient, and a 46+/-30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk-benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context.

The Design, Prototyping, and Formative Evaluation of an Assistive Robotic Table (ART) for Stroke Patients.

PubMed

Threatt, Anthony L; Merino, Jessica; Brooks, Johnell O; Healy, Stan; Truesdail, Constance; Manganelli, Joseph; Walker, Ian; Green, Keith Evan

2017-04-01

This article presents the results of an exploratory study in which 14 healthcare subject matter experts (H-SMEs) in addition to four research and design subject matter experts (RD-SMEs) at a regional rehabilitation hospital engaged in a series of complementary, participatory activities in order to design an assistive robotic table (ART). As designers, human factor experts, and healthcare professionals continue to work to integrate assistive human-robot technologies in healthcare, it is imperative to understand how the technology affects patient care from clinicians' perspectives. Fourteen clinical H-SMEs rated a subset of conceptual ART design ideas; participated in the iterative design process of ART; and evaluated a final cardboard prototype, the rehabilitation hospital's current over-the-bed table (OBT), an ART built with true materials, and two therapy surface prototypes. Four RD-SMEs conducted a heuristic evaluation on the ART built with true materials. Data were analyzed by frequency and content analysis. The results include a design and prototype for the next generation ART and a pneumatically controlled therapy surface, a broadened list of specifications for the future design and implementation of assistive robotic furniture, and final observations. When compared to the rehabilitation hospital's current OBT, the developed ART in this study was successful. Designing novel features is dependent upon ensuring patient safety. The inclusion of clinicians in the participatory iterative design and evaluation process and the use of personas provided a broadened list of specifications for the successful implementation of assistive robotic furniture.

Using archetypes to design services for high users of healthcare.

PubMed

Vaillancourt, Samuel; Shahin, Ilan; Aggarwal, Payal; Pomedli, Steve; Hayden, Leigh; Pus, Laura; Bhattacharyya, Onil

2014-01-01

A subset of people with complex health and social needs account for the majority of healthcare costs in Ontario. There is broad agreement that better solutions for these patients could lead to better health outcomes and lower costs, but we have few tools to design services around their diverse needs. Predictive modelling may help determine numbers of high users, but design methods such as user archetypes may offer important ways of understanding how to meet their needs. We studied a range of patient profiles and interviews with frequent emergency department users to develop four archetypes of patients with complex needs to orient the service design process. These can be refined and adapted for use within initiatives like Health Links to help provide more appropriate cost-effective care.

The HRQoL of Chinese patients undergoing haemodialysis.

PubMed

Yu, Hui-Dan; Petrini, Marcia A

2010-03-01

With the transition from infectious disease and acute illness to chronic disease and degenerative illness as leading causes of death, health-related quality of life has become an important aspect in assessing the burden of chronic disease. The quality of life of haemodialysis patients has been studied extensively; however, very limited research using exploratory descriptive design has been carried out in this area in China. The aim of this study was to explore health-related quality of life of end-stage renal disease patients undergoing haemodialysis in China. This study used the qualitative research design approach. A semi-structured, in-depth interview was conducted with 16 haemodialysis patients in two hospitals using Colaizzi's phenomenological method to transcribe and analyse the data. The results of this study showed that dialysis patients show improvement in physical competence, but they also experienced emotional instability and psychological distress, financial burdens, inadequate disease knowledge and less social support which influenced their quality of life. To optimise the patients undergoing dialysis health-related quality of life, support of psycho-social-economical aspects should be enhanced. Health care providers should give haemodialysis patients thorough health education, individualised psychological and emotional intervention and adequate social support to optimise health-related quality of life.

Patient positioning and ventilator-associated pneumonia.

PubMed

Hess, Dean R

2005-07-01

Rotational beds, prone position, and semi-recumbent position have been proposed as procedures to prevent ventilator-associated pneumonia (VAP). Rotational therapy uses a special bed designed to turn continuously, or nearly continuously, the patient from side to side; specific designs include kinetic therapy and continuous lateral rotation therapy. A meta-analysis of studies evaluating the effect of rotational bed therapy shows a decrease in the risk of pneumonia but no effect on mortality. Two studies reported a lower risk of VAP in patients placed in a prone position, with no effect on mortality. Studies using radiolabeled enteral feeding solutions in mechanically ventilated patients have reported that aspiration of gastric contents occurs to a greater degree when patients are in the supine position, compared with the semirecumbent position. One study reported a lower rate of VAP in patients randomized to semi-recumbent compared to supine position. Although each of the techniques discussed in this paper has been shown to reduce the risk of VAP, none has been shown to affect mortality. The available evidence suggests that semi-recumbent position should be used routinely, rotational therapy should be considered in selected patients, and prone position should not be used as a technique to reduce the risk of VAP.

Benefit design innovations: implications for consumer-directed health care.

PubMed

Tu, Ha T; Ginsburg, Paul B

2007-02-01

Current health insurance benefit designs that simply rely on higher, one-size-fits-all patient cost sharing have limited potential to curb rapidly rising costs, but innovations in benefit design can potentially make cost sharing a more effective tool, according to a new study by the Center for Studying Health System Change (HSC). Innovative benefit designs include incentives to encourage healthy behaviors; incentives that vary by service type, patient condition or enrollee income; and incentives to use efficient providers. But most applications of these innovative designs are not widespread, suggesting that any significant cost impact is many years off. Moreover, regulations governing high-deductible, consumer-directed health plans eligible for health savings accounts (HSAs) preclude some promising benefit design innovations and dilute the incentives in others. A movement away from a one-size-fits-all HSA benefit structure toward a more flexible design might broaden the appeal of HSA plans and enable them to incorporate features that promote cost-effective care.

Pentoxifylline for Anemia in Chronic Kidney Disease: A Systematic Review and Meta-Analysis

PubMed Central

Bolignano, Davide; D’Arrigo, Graziella; Pisano, Anna; Coppolino, Giuseppe

2015-01-01

Background Pentoxifylline (PTX) is a promising therapeutic approach for reducing inflammation and improving anemia associated to various systemic disorders. However, whether this agent may be helpful for anemia management also in CKD patients is still object of debate. Study Design Systematic review and meta-analysis. Population Adults with CKD (any KDOQI stage, including ESKD patients on regular dialysis) and anemia (Hb<13 g/dL in men or < 12 g/dL in women). Search Strategy and Sources Cochrane CENTRAL, EMBASE, Ovid-MEDLINE and PubMed were searched for studies providing data on the effects of PTX on anemia parameters in CKD patients without design or follow-up restriction. Intervention PTX derivatives at any dose regimen. Outcomes Hemoglobin, hematocrit, ESAs dosage and resistance (ERI), iron indexes (ferritin, serum iron, TIBC, transferrin and serum hepcidin) and adverse events. Results We retrieved 11 studies (377 patients) including seven randomized controlled trials (all comparing PTX to placebo or standard therapy) one retrospective case-control study and three prospective uncontrolled studies. Overall, PTX increased hemoglobin in three uncontrolled studies but such improvement was not confirmed in a meta-analysis of seven studies (299 patients) (MD 0.12 g/dL, 95% CI -0.22 to 0.47). Similarly, there were no conclusive effects of PTX on hematocrit, ESAs dose, ferritin and TSAT in pooled analyses. Data on serum iron, ERI, TIBC and hepcidin were based on single studies. No evidence of increased rate of adverse events was also noticed. Limitations Small sample size and limited number of studies. High heterogeneity among studies with respect to CKD and anemia severity, duration of intervention and responsiveness/current therapy with iron or ESAs. Conclusions There is currently no conclusive evidence supporting the utility of pentoxifylline for improving anemia control in CKD patients. Future trials designed on hard, patient-centered outcomes with larger sample size and longer follow-up are advocated. PMID:26237421

Hospital Patient Room Design: The Issues Facing 23 Occupational Groups Who Work in Medical/Surgical Patient Rooms.

PubMed

Lavender, Steven A; Sommerich, Carolyn M; Patterson, Emily S; Sanders, Elizabeth B-N; Evans, Kevin D; Park, Sanghyun; Umar, Radin Zaid Radin; Li, Jing

2015-01-01

The aim of this study was to learn from a wide range of hospital staff members about how the design of the patient room in which they work adversely affects their ergonomics or hinders their job performance. In addition to providing a healing space for patients, hospital patient rooms need to serve as functional workplaces for the people who provide clinical care, to clean, or to maintain room functions. Therefore, from a design perspective, it is important to understand the needs of all the users of hospital patient rooms with regard to room design. One hundred forty-seven people, representing 23 different occupational stakeholder groups, participated in either focus groups or interviews in which they were asked to identify room design issues that affect the performance of their work tasks. Key issues shared across multiple stakeholder groups included an inability to have eye contact with the patient when entering the room, inadequate space around the bed for the equipment used by stakeholders, the physical demands experienced as stakeholders move furnishings to accomplish their activities or access equipment, and a lack of available horizontal surfaces. Unique issues were also identified for a number of stakeholder groups. There are a number of issues that should be addressed in the next generation of hospital patient rooms, or when refurbishing existing facilities, so that all occupational stakeholder groups can work effectively, efficiently, and without undue physical stress. © The Author(s) 2015.

Patients' and practitioners' views on health behaviour change: a qualitative study.

PubMed

Elwell, Laura; Povey, Rachel; Grogan, Sarah; Allen, Candia; Prestwich, Andrew

2013-01-01

This study was designed to examine patients' and health professionals' perspectives on lifestyle behaviour change and to inform the development of a lifestyle behaviour change intervention to be used in primary care. Focus groups were conducted with seven patients and 13 health professionals where they were asked to discuss lifestyle behaviour change in relation to the design and development phase of a tailored lifestyle behaviour change intervention package. An inductive thematic analysis of transcripts suggested a range of issues that are relevant to the development and implementation of lifestyle change interventions such as time, lack of resources and starting interventions too late, as well as personal circumstances and the continuous effort that behaviour change requires. They were interpreted as two superordinate themes of 'internal and external influences on behaviour change' and 'behaviour change initiation and maintenance'. The results are discussed in relation to the implications they may have for researchers and health service commissioners designing interventions and practitioners implementing lifestyle change interventions in primary care. Many factors are involved in patients' and health care professionals' understanding of interventions and lifestyle behaviour change. These should be taken into consideration when designing interventions based on behaviour change theories.

Objective and subjective evaluation of a redesigned corridor environment in a psychiatric hospital.

PubMed

Edgerton, Edward; Ritchie, Louise; McKechnie, Jim

2010-05-01

This study examined the impact of redesigning a corridor space within a psychiatric hospital on the behaviour of patients with dementia. In addition, patient and staff perceptions of the redesigned corridor were assessed. Data were collected through an observational tool (behavioural mapping) and a specifically design questionnaire. The findings suggest a positive impact of the redesigned corridor on patient behaviour and that patients and staff perceived the change to the environment differentially. These results are discussed in relation to theoretical explanations of the importance of the health care environment and design for dementia.

The role and benefits of accessing primary care patient records during unscheduled care: a systematic review.

PubMed

Bowden, Tom; Coiera, Enrico

2017-09-22

The purpose of this study was to assess the impact of accessing primary care records on unscheduled care. Unscheduled care is typically delivered in hospital Emergency Departments. Studies published to December 2014 reporting on primary care record access during unscheduled care were retrieved. Twenty-two articles met inclusion criteria from a pool of 192. Many shared electronic health records (SEHRs) were large in scale, servicing many millions of patients. Reported utilization rates by clinicians was variable, with rates >20% amongst health management organizations but much lower in nation-scale systems. No study reported on clinical outcomes or patient safety, and no economic studies of SEHR access during unscheduled care were available. Design factors that may affect utilization included consent and access models, SEHR content, and system usability and reliability. Despite their size and expense, SEHRs designed to support unscheduled care have been poorly evaluated, and it is not possible to draw conclusions about any likely benefits associated with their use. Heterogeneity across the systems and the populations they serve make generalization about system design or performance difficult. None of the reviewed studies used a theoretical model to guide evaluation. Value of Information models may be a useful theoretical approach to design evaluation metrics, facilitating comparison across systems in future studies. Well-designed SEHRs should in principle be capable of improving the efficiency, quality and safety of unscheduled care, but at present the evidence for such benefits is weak, largely because it has not been sought.

A mobile phone based remote patient monitoring system for chronic disease management.

PubMed

Trudel, Mathieu; Cafazzo, Joseph A; Hamill, Melinda; Igharas, Walter; Tallevi, Kevin; Picton, Peter; Lam, Jack; Rossos, Peter G; Easty, Anthony C; Logan, Alexander

2007-01-01

Rising concern over the poor state of chronic disease management led to the user-informed design and development of a home tele-monitoring system. Focus groups with patients and primary care providers guided the research team towards a design that would accommodate the workflow and concerns of the healthcare providers and the low use and comfort with technology found among the patient population. The system was trialed in a before-and-after pilot study of 34 patients with diabetes and hypertension. Findings demonstrate a significant improvement in systolic and diastolic blood pressure. An RCT beginning in 2007 is being conducted to confirm these findings. It is hypothesized that this user-centred approach, utilizing focus groups, iterative design and human factors methods of evaluation, will lead to the next-generation of home tele-monitoring applications that are more intuitive, less cumbersome, and ultimately bring about greater patient compliance and better physician management.

The Legacy of Florence Nightingale's Environmental Theory: Nursing Research Focusing on the Impact of Healthcare Environments.

PubMed

Zborowsky, Terri

2014-01-01

The purpose of this paper is to explore nursing research that is focused on the impact of healthcare environments and that has resonance with the aspects of Florence Nightingale's environmental theory. Nurses have a unique ability to apply their observational skills to understand the role of the designed environment to enable healing in their patients. This affords nurses the opportunity to engage in research studies that have immediate impact on the act of nursing. Descriptive statistics were performed on 67 healthcare design-related research articles from 25 nursing journals to discover the topical areas of interest of nursing research today. Data were also analyzed to reveal the research designs, research methods, and research settings. These data are part of an ongoing study. Descriptive statistics reveal that topics and settings most frequently cited are in keeping with the current healthcare foci of patient care quality and safety in acute and intensive care environments. Research designs and methods most frequently cited are in keeping with the early progression of a knowledge area. A few assertions can be made as a result of this study. First, education is important to continue the knowledge development in this area. Second, multiple method research studies should continue to be considered as important to healthcare research. Finally, bedside nurses are in the best position possible to begin to help us all, through research, understand how the design environment impacts patients during the act of nursing. Evidence-based design, literature review, nursing.

Applying User-Centered Design Methods to the Development of an mHealth Application for Use in the Hospital Setting by Patients and Care Partners.

PubMed

Couture, Brittany; Lilley, Elizabeth; Chang, Frank; DeBord Smith, Ann; Cleveland, Jessica; Ergai, Awatef; Katsulis, Zachary; Benneyan, James; Gershanik, Esteban; Bates, David W; Collins, Sarah A

2018-04-01

 Developing an optimized and user-friendly mHealth application for patients and family members in the hospital environment presents unique challenges given the diverse patient population and patients' various states of well-being.  This article describes user-centered design methods and results for developing the patient and family facing user interface and functionality of MySafeCare, a safety reporting tool for hospitalized patients and their family members.  Individual and group usability sessions were conducted with specific testing scenarios for participants to follow to test the usability and functionality of the tool. Participants included patients, family members, and Patient and Family Advisory Council (PFAC) members. Engagement rounds were also conducted on study units and lessons learned provided additional information to the usability work. Usability results were aligned with Nielsen's Usability Heuristics.  Eleven patients and family members and 25 PFAC members participated in usability testing and over 250 patients and family members were engaged during research team rounding. Specific themes resulting from the usability testing sessions influenced the changes made to the user interface design, workflow functionality, and terminology.  User-centered design should focus on workflow functionality, terminology, and user interface issues for mHealth applications. These themes illustrated issues aligned with four of Nielsen's Usability Heuristics: match between system and the real world, consistency and standards, flexibility and efficiency of use, and aesthetic and minimalist design. We identified workflow and terminology issues that may be specific to the use of an mHealth application focused on safety and used by hospitalized patients and their families. Schattauer GmbH Stuttgart.

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

PubMed

Chen, Ronald C; Carpenter, William R; Kim, Mimi; Hendrix, Laura H; Agans, Robert P; Meyer, Anne-Marie; Hoffmeyer, Anna; Reeve, Bryce B; Nielsen, Matthew E; Usinger, Deborah S; Strigo, Tara S; Jackman, Anne M; Anderson, Mary; Godley, Paul A

2015-01-01

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Factors Influencing Patient Selection of a Foot and Ankle Surgeon.

PubMed

Manning, Blaine T; Bohl, Daniel D; Wang, Kevin C; Hamid, Kamran S; Holmes, George B; Lee, Simon

2017-09-01

An increasingly consumer-centric health insurance market has empowered patients to select the providers of their choice. There is a lack of studies investigating the rationale by which patients select a foot and ankle surgeon. In the present study, 824 consecutive new patients seeking treatment from 3 foot-ankle surgeons were consecutively administered an anonymous questionnaire prior to their first appointment. It included rating the importance of 15 factors regarding specialist selection on a 1 to 10 scale, with 10 designated " Very important" and 1 designated " Not important at all." The remaining questions were multiple choice regarding patient perspectives on other surgeon aspects (appointment availability, waiting room times, clinic proximity, etc). Of 824 consecutive patients administered the survey, 305 (37%) responded. Patients rated board certification (9.24 ± 1.87) and on-site imaging availability (8.48 ± 2.37)-on a 1 to 10 scale, with 10 designated "Very important- as the 2 most important criteria in choosing a foot and ankle surgeon. Patients rated advertisements as least important. Among the patients, 91% responded that a maximum of 30 minutes should elapse between clinic check-in and seeing their physician; 61% responded that a maximum of 20 minutes should elapse between clinic check-in and seeing their physician. In the context of an increasingly consumer-driven paradigm of health care delivery and reimbursement, it is important to understand patients' preferences in specialist selection. Level III: Prospective questionnaire.

Understanding Design Vulnerabilities in the Physical Environment Relating to Patient Fall Patterns in a Psychiatric Hospital: Seven Years of Sentinel Events.

PubMed

Bayramzadeh, Sara; Portillo, Margaret; Carmel-Gilfilen, Candy

2018-05-01

The influence of the physical environment on patient falls has not been fully explored in psychiatric units, despite this patient population's vulnerability and the critical role of the physical environment in patient safety. The research objective is to describe the spatial and temporal pattern of falls occurrences and their location in relation to the levels of safety continuum model. This article presents an exploratory case study design. Seven years of retrospective data on patient falls, yielding 818 sentinel events, in an 81-bed psychiatric hospital in the United States were collected and analyzed. Data focused on extrinsic factors for falls, emphasizing the physical environment. Through a content analysis of the sentinel event narratives, recorded by the hospital staff, this study explored patient falls related to location and elements of the physical environment. The analysis revealed that 15% of recorded falls were attributed to some aspect of or element within the physical environment. The most typical locations of falls were patient rooms (39%), patient bathrooms (22%), and dayrooms (20%). Also, the results identified patterns of environmental factors that appeared linked to increasing patients' susceptibility to falls. Risk factors included poor nighttime lighting, flooring surfaces that were uneven, and spaces that inadvertently limited visual access and supervision. The physical environment plays an often-unexamined role in fall events and specific locations. These results are deserving of further research on design strategies and applications to reduce patient falls in psychiatric hospital settings.

Bayesian adaptive phase II screening design for combination trials.

PubMed

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial.

Perceived service quality's effect on patient satisfaction and behavioural compliance.

PubMed

Mohamed, Bahari; Azizan, Noor Azlinna

2015-01-01

The purpose of this paper is to advance healthcare service quality research using hierarchical component models. This study used a quantitative approach with cross-sectional design as a survey method, combining cluster and convenience sampling and partial least square structural equation modelling (PLS-SEM) to validate the research model and test the hypotheses. The study extends health service quality literature by showing that: patient satisfaction (PS) is dominant, significant and indirect determinant of behavioural compliance (BC); perceived service quality has the strongest effect on BC via PS. Only one hospital was evaluated. The study provides managers with a service quality model for conducting integrated service delivery systems analysis and design. Overall, the study makes a significant contribution to healthcare organizations, better health outcomes for patients and better quality of life for the community.

Design and methods of a strategic outcome study for chronic kidney disease: Frontier of Renal Outcome Modifications in Japan.

PubMed

Yamagata, Kunihiro; Makino, Hirofumi; Akizawa, Tadao; Iseki, Kunitoshi; Itoh, Sadayoshi; Kimura, Kenjiro; Koya, Daisuke; Narita, Ichiei; Mitarai, Tetsuya; Miyazaki, Masanobu; Tsubakihara, Yoshiharu; Watanabe, Tsuyoshi; Wada, Takashi; Sakai, Osamu

2010-04-01

The continuous increase in the number of people requiring dialysis is a major clinical and socioeconomical issue in Japan and other countries. This study was designed to encourage chronic kidney disease (CKD) patients to consult a physician, enhance cooperation between nephrologists and general practices, and prevent the progression of kidney disease. Subjects comprise CKD patients aged between 40 and 74 years consulting a general physician, and patients in CKD stage 3 with proteinuria and diabetes or hypertension. This trial is a stratified open cluster-randomized study with two intervention groups: group A (weak intervention) and group B (strong intervention). We have recruited 49 local medical associations (clusters) in 15 different prefectures, which were classified into four regions (strata) based on the level of increase rate of dialysis patients. The patients in group A clusters were instructed initially to undergo treatment in accordance with the current CKD treatment guide, whereas patients in group B clusters were not only instructed in the same fashion but also received support from an information technology (IT)-based system designed to help achieve the goals of CKD treatment, consultation support centers, and consultations by dietitians visiting the local general practice offices. We assessed the rates of continued consultation, collaboration between general practitioners and nephrologists, and progression of CKD (as expressed by CKD stage). Through this study, filling the evidence-practice gap by facilitating effective communication and supporting general physicians and nephrologists, we will establish a CKD care system and decrease the number of advanced-stage CKD patients.

Progressive addition lenses--measurements and ratings.

PubMed

Sheedy, Jim; Hardy, Raymond F; Hayes, John R

2006-01-01

This study is a followup to a previous study in which the optics of several progressive addition lens (PALs) designs were measured and analyzed. The objective was to provide information about various PAL designs to enable eye care practitioners to select designs based on the particular viewing requirements of the patient. The optical properties of 12 lenses of the same power for each of 23 different PAL designs were measured with a Rotlex Class Plus lens analyzer. Lenses were ordered through optical laboratories and specified to be plano with a +2.00 diopters add. Measurements were normalized to plano at the manufacturer-assigned location for the distance power to eliminate laboratory tolerance errors. The magnitude of unwanted astigmatism and the widths and areas of the distance, intermediate, and near viewing zones were calculated from the measured data according to the same criteria used in a previous study. The optical characteristics of the different PAL designs were significantly different from one another. The differences were significant in terms of the sizes and widths of the viewing zones, the amount of unwanted astigmatism, and the minimum fitting height. Ratings of the distance, intermediate, and near viewing areas were calculated for each PAL design based on the widths and sizes of those zones. Ratings for unwanted astigmatism and recommended minimum fitting heights were also determined. Ratings based on combinations of viewing zone ratings are also reported. The ratings are intended to be used to select a PAL design that matches the particular visual needs of the patient and to evaluate the success and performance of currently worn PALs. Reasoning and task analyses suggest that these differences can be used to select a PAL design to meet the individual visual needs of the patient; clinical trials studies are required to test this hypothesis.

Designing and validation of a yoga-based intervention for schizophrenia.

PubMed

Govindaraj, Ramajayam; Varambally, Shivarama; Sharma, Manjunath; Gangadhar, Bangalore Nanjundaiah

2016-06-01

Schizophrenia is a chronic mental illness which causes significant distress and dysfunction. Yoga has been found to be effective as an add-on therapy in schizophrenia. Modules of yoga used in previous studies were based on individual researcher's experience. This study aimed to develop and validate a specific generic yoga-based intervention module for patients with schizophrenia. The study was conducted at NIMHANS Integrated Centre for Yoga (NICY). A yoga module was designed based on traditional and contemporary yoga literature as well as published studies. The yoga module along with three case vignettes of adult patients with schizophrenia was sent to 10 yoga experts for their validation. Experts (n = 10) gave their opinion on the usefulness of a yoga module for patients with schizophrenia with some modifications. In total, 87% (13 of 15 items) of the items in the initial module were retained, with modification in the remainder as suggested by the experts. A specific yoga-based module for schizophrenia was designed and validated by experts. Further studies are needed to confirm efficacy and clinical utility of the module. Additional clinical validation is suggested.

Design simplicity influences patient portal use: the role of aesthetic evaluations for technology acceptance

PubMed Central

Watkins, Ivan; Mackert, Michael S; Xie, Bo; Stephens, Keri K; Shalev, Heidi

2016-01-01

Objective This study focused on patient portal use and investigated whether aesthetic evaluations of patient portals function are antecedent variables to variables in the Technology Acceptance Model. Methods A cross-sectional survey of current patient portals users (N = 333) was conducted online. Participants completed the Visual Aesthetics of Website Inventory, along with items measuring perceived ease of use (PEU), perceived usefulness (PU), and behavioral intentions (BIs) to use the patient portal. Results The hypothesized model accounted for 29% of the variance in BIs to use the portal, 46% of the variance in the PU of the portal, and 29% of the variance in the portal’s PEU. Additionally, one dimension of the aesthetic evaluations functions as a predictor in the model – simplicity evaluations had a significant positive effect on PEU. Conclusion This study provides evidence that aesthetic evaluations – specifically regarding simplicity – function as a significant antecedent variable to patients’ use of patient portals and should influence patient portal design strategies. PMID:26635314

Surrogate decision making: do we have to trade off accuracy and procedural satisfaction?

PubMed

Frey, Renato; Hertwig, Ralph; Herzog, Stefan M

2014-02-01

Making surrogate decisions on behalf of incapacitated patients can raise difficult questions for relatives, physicians, and society. Previous research has focused on the accuracy of surrogate decisions (i.e., the proportion of correctly inferred preferences). Less attention has been paid to the procedural satisfaction that patients' surrogates and patients attribute to specific approaches to making surrogate decisions. The objective was to investigate hypothetical patients' and surrogates' procedural satisfaction with specific approaches to making surrogate decisions and whether implementing these preferences would lead to tradeoffs between procedural satisfaction and accuracy. Study 1 investigated procedural satisfaction by assigning participants (618 in a mixed-age but relatively young online sample and 50 in an older offline sample) to the roles of hypothetical surrogates or patients. Study 2 (involving 64 real multigenerational families with a total of 253 participants) investigated accuracy using 24 medical scenarios. Hypothetical patients and surrogates had closely aligned preferences: Procedural satisfaction was highest with a patient-designated surrogate, followed by shared surrogate decision-making approaches and legally assigned surrogates. These approaches did not differ substantially in accuracy. Limitations are that participants' preferences regarding existing and novel approaches to making surrogate decisions can only be elicited under hypothetical conditions. Next to decision making by patient-designated surrogates, shared surrogate decision making is the preferred approach among patients and surrogates alike. This approach appears to impose no tradeoff between procedural satisfaction and accuracy. Therefore, shared decision making should be further studied in representative samples of the general population, and if people's preferences prove to be robust, they deserve to be weighted more strongly in legal frameworks in addition to patient-designated surrogates.

[Influence of different multifocal intraocular lens concepts on retinal stray light parameters].

PubMed

Ehmer, A; Rabsilber, T M; Mannsfeld, A; Sanchez, M J; Holzer, M P; Auffarth, G U

2011-10-01

Multifocal intraocular lenses (MIOL) are known to induce various photic phenomena depending on the optical principle. The aim of this study was to investigate the correlation between stray light measurements performed with the C-Quant (Oculus, Germany) and the results of a subjective patient questionnaire. In this study three different MIOLs were compared: AMO ReZoom (refractive design, n=10), AMO ZM900 (diffractive design, n=10) and Oculentis Mplus (near segment design, n=10). Cataract and refractive patients were enrolled in the study. Functional results were evaluated at least 3 months postoperatively followed by stray light measurements and a subjective questionnaire. Surgery was performed for all patients without complications. The three groups were matched for age, IOL power and corrected distance visual acuity (CDVA). Significantly different stray light (median) values log(s) were found (Kruskal-Wallis test, p<0.05): 1.12 log (refractive), 1.13 log (segment) and 1.28 log (diffractive). The subjective questionnaire did not show differences in glare perception but refractive MIOL patients noticed more halos surrounding light sources than the diffractive and segment MIOL patients. Stray light and subjective photopic phenomena do not show any basic correlation. Measurements in patients with refractive MIOLs showed less stray light than near segment or diffractive MIOLs. However, refractive MIOLs induced more halos compared to the other groups analyzed.

Comparison of effect between group discussion and educational booklet on Iranian nursing students' attitude and practice toward patient privacy.

PubMed

Adib-Hajbaghery, Mohsen; Faraji, Mona

2016-01-01

This study aimed to compare the effects between group discussion and educational booklet on nursing students' attitude and practice toward patient privacy in Iran. A two-group, pre-test and post-test design study was conducted in 2015. The study was conducted on 60 nursing students in Kashan, Iran who were randomly allocated into two groups to be trained on patient privacy either through group discussion or by an educational booklet. The students' attitude and practice was assessed before and after the education using a questionnaire and a checklist. Data analysis was performed through paired t-test, Wilcoxon signed ranks test, and independent samples t-tests. Before the intervention, no significant difference was found between the group designated to group discussion and that designated to the educational booklet in the mean overall score of attitude (P=0.303) and practice (P=0.493) toward patient privacy. After the intervention, the mean attitude score significantly increased in the two groups (P=0.001). Moreover, the students' practice score increased in the discussion group while it did not significantly change in the booklet group (P=0.001). Both methods were effective on the students' attitude; however, the educational booklet did not affect their practice toward patient privacy. Group discussion can effectively improve the students' attitude and practice toward patient privacy.

Improving self-efficacy in spinal cord injury patients through "design thinking" rehabilitation workshops.

PubMed

Wolstenholme, Daniel; Downes, Tom; Leaver, Jackie; Partridge, Rebecca; Langley, Joseph

2014-01-01

Advances in surgical and medical management have significantly reduced the length of time that patients with spinal cord injury (SCI) have to stay in hospital, but has left patients with potentially less time to psychologically adjust. Following a pilot in 2012, this project was designed to test the effect of "design thinking" workshops on the self-efficacy of people undergoing rehabilitation following spinal injuries. Design thinking is about understanding the approaches and methods that designers use and then applying these to think creatively about problems and suggest ways to solve them. In this instance, design thinking is not about designing new products (although the approaches can be used to do this) but about developing a long term creative and explorative mind-set through skills such as lateral thinking, prototyping and verbal and visual communication. The principles of "design thinking" have underpinned design education and practice for many years, it is also recognised in business and innovation for example, but a literature review indicated that there was no evidence of it being used in rehabilitation or spinal injury settings. Twenty participants took part in the study; 13 (65%) were male and the average age was 37 years (range 16 to 72). Statistically significant improvements were seen for EQ-5D score (t = -3.13, p = 0.007) and Patient Activation Measure score (t = -3.85, p = 0.001). Other outcome measures improved but not statistically. There were no statistical effects on length of stay or readmission rates, but qualitative interviews indicated improved patient experience.

The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy.

PubMed

Ulbrich-Zürni, Susanne; Teut, Michael; Roll, Stephanie; Mathie, Robert T

2018-02-01

 The randomised controlled trial (RCT) is considered the 'gold standard' for establishing treatment efficacy or effectiveness of an intervention, but its data do not infer response in an individual patient. Individualised clinical care, a fundamental principle in complementary and alternative medicine (CAM), including homeopathy, seems well disposed in principle to being researched by single-patient (N-of-1) study design. Guidelines for reporting N-of-1 trials have recently been developed.  To overview the current status in the literature of the N-of-1 method and its application in medicine, including CAM. To consider whether the N-of-1 trial design offers an opportunity for novel research in homeopathy. N-OF-1 TRIAL DESIGN:  The N-of-1 trial applies the principles of the conventional crossover, blinded, RCT design. The treatment under study and the comparator are repeated in a randomised order, and with suitable washout time, over a defined period. N-of-1 design is constrained for use in chronic stable conditions, and for interventions that have quick onset and cessation of effect, with modest or negligible carryover. Outcome data can be aggregated and interpreted for the individual subject; they can also be pooled with data from several similar N-of-1 trials, enabling more generalisable conclusions. THE N-OF-1 TRIAL IN CAM: The typical individualisation of patient care can be accommodated in N-of-1 study design if the patient and the specific therapeutic intervention are selected within the constraints of the method. Application of the N-of-1 method in CAM has been advocated but has been mainly limited, in practice, to a small number of studies in herbal and traditional Chinese medicine. THE N-OF-1 TRIAL IN HOMEOPATHY:  Individualised homeopathy can be accommodated for investigation within the same methodological constraints; less in-depth homeopathic approaches to prescribing are also amendable to investigation using the N-of-1 method. No such studies have been published. We identify three main targets in its ready applicability to homeopathy: (1) to optimise clinical care in an individual patient; (2) to investigate whether the outcomes of treatment using homeopathy differ from those of placebo; (3) to aggregate data from a series of N-of-1 trials to enable broader conclusions about a group of patients or intervention.  The N-of-1 trial design offers important new investigative possibilities in homeopathy and should be explored as a means to optimise individualised health care or investigate effectiveness of the homeopathic intervention compared with placebo in individual subjects. The Faculty of Homeopathy.

Development of a Bayesian response-adaptive trial design for the Dexamethasone for Excessive Menstruation study.

PubMed

Holm Hansen, Christian; Warner, Pamela; Parker, Richard A; Walker, Brian R; Critchley, Hilary Od; Weir, Christopher J

2017-12-01

It is often unclear what specific adaptive trial design features lead to an efficient design which is also feasible to implement. This article describes the preparatory simulation study for a Bayesian response-adaptive dose-finding trial design. Dexamethasone for Excessive Menstruation aims to assess the efficacy of Dexamethasone in reducing excessive menstrual bleeding and to determine the best dose for further study. To maximise learning about the dose response, patients receive placebo or an active dose with randomisation probabilities adapting based on evidence from patients already recruited. The dose-response relationship is estimated using a flexible Bayesian Normal Dynamic Linear Model. Several competing design options were considered including: number of doses, proportion assigned to placebo, adaptation criterion, and number and timing of adaptations. We performed a fractional factorial study using SAS software to simulate virtual trial data for candidate adaptive designs under a variety of scenarios and to invoke WinBUGS for Bayesian model estimation. We analysed the simulated trial results using Normal linear models to estimate the effects of each design feature on empirical type I error and statistical power. Our readily-implemented approach using widely available statistical software identified a final design which performed robustly across a range of potential trial scenarios.

Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results

PubMed Central

Smeltzer, Matthew P.; Rugless, Fedoria E.; Jackson, Bianca M.; Berryman, Courtney L.; Faris, Nicholas R.; Ray, Meredith A.; Meadows, Meghan; Patel, Anita A.; Roark, Kristina S.; Kedia, Satish K.; DeBon, Margaret M.; Crossley, Fayre J.; Oliver, Georgia; McHugh, Laura M.; Hastings, Willeen; Osborne, Orion; Osborne, Jackie; Ill, Toni; Ill, Mark; Jones, Wynett; Lee, Hyo K.; Signore, Raymond S.; Fox, Roy C.; Li, Jingshan; Robbins, Edward T.; Ward, Kenneth D.; Klesges, Lisa M.

2018-01-01

Background Responsible for 25% of all US cancer deaths, lung cancer presents complex care-delivery challenges. Adoption of the highly recommended multidisciplinary care model suffers from a dearth of good quality evidence. Leading up to a prospective comparative-effectiveness study of multidisciplinary vs. serial care, we studied the implementation of a rigorously benchmarked multidisciplinary lung cancer clinic. Methods We used a mixed-methods approach to conduct a patient-centered, combined implementation and effectiveness study of a multidisciplinary model of lung cancer care. We established a co-located multidisciplinary clinic to study the implementation of this care-delivery model. We identified and engaged key stakeholders from the onset, used their input to develop the program structure, processes, performance benchmarks, and study endpoints (outcome-related process measures, patient- and caregiver-reported outcomes, survival). In this report, we describe the study design, process of implementation, comparative populations, and how they contrast with patients within the local and regional healthcare system. Trial Registration: ClinicalTrials.gov Identifier: NCT02123797. Results Implementation: the multidisciplinary clinic obtained an overall treatment concordance rate of 90% (target >85%). Satisfaction scores were high, with >95% of patients and caregivers rating themselves as being “very satisfied” with all aspects of care from the multidisciplinary team (patient/caregiver response rate >90%). The Reach of the multidisciplinary clinic included a higher proportion of minority patients, more women, and younger patients than the regional population. Comparative effectiveness: The comparative effectiveness trial conducted in the last phase of the study met the planned enrollment per statistical design, with 178 patients in the multidisciplinary arm and 348 in the serial care arm. The multidisciplinary cohort had older age and a higher percentage of racial minorities, with a higher proportion of stage IV patients in the serial care arm. Conclusions This study demonstrates a comprehensive implementation of a multidisciplinary model of lung cancer care, which will advance the science behind implementing this much-advocated clinical care model. PMID:29535915

Just-in-Time Evidence-Based E-mail “Reminders” in Home Health Care: Impact on Nurse Practices

PubMed Central

Murtaugh, Christopher M; Pezzin, Liliana E; McDonald, Margaret V; Feldman, Penny H; Peng, Timothy R

2005-01-01

Objective To test the effectiveness of two interventions designed to improve the adoption of evidence-based practices by home health nurses caring for heart failure (HF) patients. Data Sources/Study Setting Information on nurse practices was abstracted from the clinical records of patients admitted between June 2000 and November 2001 to the care of 354 study nurses at a large, urban, nonprofit home care agency. Study Design The study employed a randomized design with nurses assigned to usual care or one of two intervention groups upon identification of an eligible patient. The basic intervention was a one-time e-mail reminder highlighting six HF-specific clinical recommendations. The augmented intervention consisted of the initial e-mail reminder supplemented by provider prompts, patient education material, and clinical nurse specialist outreach. Data Collection At each home health visit provided by a study nurse to an eligible HF patient during the 45-day follow-up period, a structured chart abstraction tool was used to collect information on whether the nurse provided the care practices highlighted in the e-mail reminder. Principal Findings Both the basic and the augmented interventions greatly increased the practice of evidence-based care, according to patient records, in the areas of patient assessment and instructions about HF disease management. While not all results were statistically significant at conventional levels, intervention effects were positive in virtually all cases and effect magnitudes frequently were large. Conclusions The results of this randomized trial strongly support the efficacy of just-in-time evidence-based reminders as a means of changing clinical practice among home health nurses who are geographically dispersed and spend much of their time in the field. PMID:15960694

XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation

PubMed Central

Camm, A John; Amarenco, Pierre; Haas, Sylvia; Hess, Susanne; Kirchhof, Paulus; van Eickels, Martin; Turpie, Alexander GG

2014-01-01

Atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke. The Phase III ROCKET AF (Rivaroxaban Once-Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial showed that rivaroxaban, an oral, direct Factor Xa inhibitor, was noninferior to warfarin for the reduction of stroke or systemic embolism in patients with AF. Compared with warfarin, rivaroxaban significantly reduced rates of intracranial and fatal hemorrhages, although not rates of bleeding overall. XANTUS (Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation) is a prospective, international, observational, postauthorization, noninterventional study designed to collect safety and efficacy data on the use of rivaroxaban for stroke prevention in AF in routine clinical practice. The key goal is to determine whether the safety profile of rivaroxaban established in ROCKET AF is also observed in routine clinical practice. XANTUS is designed as a single-arm cohort study to minimize selection bias, and will enroll approximately 6,000 patients (mostly from Europe) with nonvalvular AF prescribed rivaroxaban, irrespective of their level of stroke risk. Overall duration of follow-up will be 1 year; the first patient was enrolled in June 2012. Similar studies (XANTUS-EL [Xarelto® for Prevention of Stroke in Patients with Nonvalvular Atrial Fibrillation, Eastern Europe, Middle East, Africa and Latin America] and XANAP [Xarelto® for Prevention of Stroke in Patients with Atrial Fibrillation in Asia-Pacific]) are ongoing in Latin America and Asia-Pacific. Data from these studies will supplement those from ROCKET AF and provide practical information concerning the use of rivaroxaban for stroke prevention in AF. PMID:25083135

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Quasi-Experimental Designs.

PubMed

Schweizer, Marin L; Braun, Barbara I; Milstone, Aaron M

2016-10-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt, nonrandomized interventions. Quasi-experimental studies can be categorized into 3 major types: interrupted time-series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship, including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. Infect Control Hosp Epidemiol 2016;1-6.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship – Quasi-Experimental Designs

PubMed Central

Schweizer, Marin L.; Braun, Barbara I.; Milstone, Aaron M.

2016-01-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt non-randomized interventions. Quasi-experimental studies can be categorized into three major types: interrupted time series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. PMID:27267457

A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design.

PubMed

Zheng, Hua; Rosal, Milagros C; Li, Wenjun; Borg, Amy; Yang, Wenyun; Ayers, David C; Franklin, Patricia D

2018-04-30

Data-driven surgical decisions will ensure proper use and timing of surgical care. We developed a Web-based patient-centered treatment decision and assessment tool to guide treatment decisions among patients with advanced knee osteoarthritis who are considering total knee replacement surgery. The aim of this study was to examine user experience and acceptance of the Web-based treatment decision support tool among older adults. User-centered formative and summative evaluations were conducted for the tool. A sample of 28 patients who were considering total knee replacement participated in the study. Participants' responses to the user interface design, the clarity of information, as well as usefulness, satisfaction, and acceptance of the tool were collected through qualitative (ie, individual patient interviews) and quantitative (ie, standardized Computer System Usability Questionnaire) methods. Participants were older adults with a mean age of 63 (SD 11) years. Three-quarters of them had no technical questions using the tool. User interface design recommendations included larger fonts, bigger buttons, less colors, simpler navigation without extra "next page" click, less mouse movement, and clearer illustrations with simple graphs. Color-coded bar charts and outcome-specific graphs with positive action were easiest for them to understand the outcomes data. Questionnaire data revealed high satisfaction with the tool usefulness and interface quality, and also showed ease of use of the tool, regardless of age or educational status. We evaluated the usability of a patient-centered decision support tool designed for advanced knee arthritis patients to facilitate their knee osteoarthritis treatment decision making. The lessons learned can inform other decision support tools to improve interface and content design for older patients' use. ©Hua Zheng, Milagros C Rosal, Wenjun Li, Amy Borg, Wenyun Yang, David C Ayers, Patricia D Franklin. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 30.04.2018.

Mouth-opening device as a treatment modality in trismus patients with head and neck cancer and oral submucous fibrosis: a prospective study.

PubMed

Li, Yu-Hsuan; Chang, Wei-Chin; Chiang, Tien-En; Lin, Chiun-Shu; Chen, Yuan-Wu

2018-04-26

This study investigated the clinical effectiveness of intervention with an open-mouth exercise device designed to facilitate maximal interincisal opening (MIO) and improve quality of life in patients with head and neck (H&N) cancer and oral submucous fibrosis (OSF). Sixty patients with H&N cancer, OSF, and trismus (MIO < 35 mm) participated in the functional rehabilitation program. An open-mouth exercise device intervention group and conventional group, each consisting of 20 patients, underwent a 12-week training and exercising program and follow-up. For the control group, an additional 20 patients were randomly selected to match the demographic characteristics of the aforementioned two groups. The patients' MIO improvements in the aforementioned three groups were 14.0, 10.5, and 1.3 mm, respectively. Results of this study confirm the significant improvement in average mouth-opening range. In addition, according to patient feedback, significant improvements in health-related quality of life and reductions in trismus symptoms occurred in the open-mouth exercise device group. This newly designed open-mouth exercise device can facilitate trismus patients with H&N cancer and OSF and improve mouth-opening range and quality of life.

Clinical Evaluation of Kshara sutra Therapy in the management of Bhagandara( Fistula- in-Ano)- A prospective study

PubMed Central

Panigrahi, Hemanta Kumar; Rani, Rakesh; Padhi, M.M.; Lavekar, G.S.

2009-01-01

Study design: A prospective study of 50 patients suffering from Bhagandara(Fistula in Ano) (age ranging from 18-54years) treated by Kshara sutra therapy Place: Kshara sutra unit, Central research Unit, Punjabi bagh, New Delhi Duration: January 2007 to July 2008. Objectives: To determine the incidence of low or high anal fistula, recurrence rate following Kshara sutra therapy and effect of Ksharasutra therapy on the Bhagandara. Material and methods: The fifty patients (50) were selected randomly in the Out Patient Department. Study Design: Uncontrolled open level Study. Results: Patients were followed to see the incidence of recurrence, effect of Kshara Sutra Therapy on incontinence. Overall recurrence rate was only 5.88 %. Minor incontinence was observed only following Kshara sutra Therapy for high variety for which no treatment was given. No such complication occurred in low variety. Conclusion: Bhagandara (Fistula in Ano) can be treated by Kshara Sutra Therapy with minimal loss of sphincter muscle and low reoccurrence rate. PMID:22557318

An Information Technology Framework for Strengthening Telehealthcare Service Delivery

PubMed Central

Chen, Chi-Wen; Weng, Yung-Ching; Shang, Rung-Ji; Yu, Hui-Chu; Chung, Yufang; Lai, Feipei

2012-01-01

Abstract Objective: Telehealthcare has been used to provide healthcare service, and information technology infrastructure appears to be essential while providing telehealthcare service. Insufficiencies have been identified, such as lack of integration, need of accommodation of diverse biometric sensors, and accessing diverse networks as different houses have varying facilities, which challenge the promotion of telehealthcare. This study designs an information technology framework to strengthen telehealthcare delivery. Materials and Methods: The proposed framework consists of a system architecture design and a network transmission design. The aim of the framework is to integrate data from existing information systems, to adopt medical informatics standards, to integrate diverse biometric sensors, and to provide different data transmission networks to support a patient's house network despite the facilities. The proposed framework has been evaluated with a case study of two telehealthcare programs, with and without the adoption of the framework. Results: The proposed framework facilitates the functionality of the program and enables steady patient enrollments. The overall patient participations are increased, and the patient outcomes appear positive. The attitudes toward the service and self-improvement also are positive. Conclusions: The findings of this study add up to the construction of a telehealthcare system. Implementing the proposed framework further assists the functionality of the service and enhances the availability of the service and patient acceptances. PMID:23061641

An information technology framework for strengthening telehealthcare service delivery.

PubMed

Chen, Li-Chin; Chen, Chi-Wen; Weng, Yung-Ching; Shang, Rung-Ji; Yu, Hui-Chu; Chung, Yufang; Lai, Feipei

2012-10-01

Telehealthcare has been used to provide healthcare service, and information technology infrastructure appears to be essential while providing telehealthcare service. Insufficiencies have been identified, such as lack of integration, need of accommodation of diverse biometric sensors, and accessing diverse networks as different houses have varying facilities, which challenge the promotion of telehealthcare. This study designs an information technology framework to strengthen telehealthcare delivery. The proposed framework consists of a system architecture design and a network transmission design. The aim of the framework is to integrate data from existing information systems, to adopt medical informatics standards, to integrate diverse biometric sensors, and to provide different data transmission networks to support a patient's house network despite the facilities. The proposed framework has been evaluated with a case study of two telehealthcare programs, with and without the adoption of the framework. The proposed framework facilitates the functionality of the program and enables steady patient enrollments. The overall patient participations are increased, and the patient outcomes appear positive. The attitudes toward the service and self-improvement also are positive. The findings of this study add up to the construction of a telehealthcare system. Implementing the proposed framework further assists the functionality of the service and enhances the availability of the service and patient acceptances.

Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial.

PubMed

Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria

2018-03-22

Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.

Development of a Decision Aid for Cardiopulmonary Resuscitation Involving Intensive Care Unit Patients' and Health Professionals' Participation Using User-Centered Design and a Wiki Platform for Rapid Prototyping: A Research Protocol

PubMed Central

Heyland, Daren Keith; Ebell, Mark H; Dupuis, Audrey; Lavoie-Bérard, Carole-Anne; Légaré, France; Archambault, Patrick Michel

2016-01-01

Background Cardiopulmonary resuscitation (CPR) is an intervention used in cases of cardiac arrest to revive patients whose heart has stopped. Because cardiac arrest can have potentially devastating outcomes such as severe neurological deficits even if CPR is performed, patients must be involved in determining in advance if they want CPR in the case of an unexpected arrest. Shared decision making (SDM) facilitates discussions about goals of care regarding CPR in intensive care units (ICUs). Patient decision aids (DAs) are proven to support the implementation of SDM. Many patient DAs about CPR exist, but they are not universally implemented in ICUs in part due to lack of context and cultural adaptation. Adaptation to local context is an important phase of implementing any type of knowledge tool such as patient DAs. User-centered design supported by a wiki platform to perform rapid prototyping has previously been successful in creating knowledge tools adapted to the needs of patients and health professionals (eg, asthma action plans). This project aims to explore how user-centered design and a wiki platform can support the adaptation of an existing DA for CPR to the local context. Objective The primary objective is to use an existing DA about CPR to create a wiki-based DA that is adapted to the context of a single ICU and tailorable to individual patient’s risk factors while employing user-centered design. The secondary objective is to document the use of a wiki platform for the adaptation of patient DAs. Methods This study will be conducted in a mixed surgical and medical ICU at Hôtel-Dieu de Lévis, Quebec, Canada. We plan to involve all 5 intensivists and recruit at least 20 alert and oriented patients admitted to the ICU and their family members if available. In the first phase of this study, we will observe 3 weeks of daily interactions between patients, families, intensivists, and other allied health professionals. We will specifically observe 5 dyads of attending intensivists and alert and oriented patients discussing goals of care concerning CPR to understand how a patient DA could support this decision. We will also conduct individual interviews with the 5 intensivists to identify their needs concerning the implementation of a DA. In the second phase of the study, we will build a first prototype based on the needs identified in Phase I. We will start by translating an existing DA entitled “Cardiopulmonary resuscitation: a decision aid for patients and their families.” We will then adapt this tool to the needs we identified in Phase I and archive this first prototype in a wiki. Building on the wiki’s programming architecture, we intend to integrate the Good Outcome Following Attempted Resuscitation risk calculator into our DA to determine personal risks and benefits of CPR for each patient. We will then present the first prototype to 5 new patient-intensivist dyads. Feedback about content and visual presentation will be collected from the intensivists through short interviews while longer interviews will be conducted with patients and their family members to inform the visual design and content of the next prototype. After each rapid prototyping cycle, 2 researchers will perform qualitative content analysis of data collected through interviews and direct observations. We will attempt to solve all content and visual design issues identified before moving to the next round of prototyping. In all, we will conduct 3 prototyping cycles with a total of 15 patient-intensivist dyads. Results We expect to develop a multimedia wiki-based DA to support goals of care discussions about CPR adapted to the local needs of patients, their family members, and intensivists and tailorable to individual patient risk factors. The final version of the DA as well as the development process will be housed in an open-access wiki and free to be adapted and used in other contexts. Conclusions This study will shed new light on the development of DAs adapted to local context and tailorable to individual patient risk factors employing user-centered design and a wiki to support rapid prototyping of content and visual design issues. PMID:26869137

The Impact of Relationship Quality on Health-Related Outcomes in Heart Failure Patients and Informal Family Caregivers: An Integrative Review.

PubMed

Hooker, Stephanie A; Grigsby, Megan E; Riegel, Barbara; Bekelman, David B

2015-01-01

Relationships can have positive and negative impacts on health and well-being. Dyadic relationships between heart failure (HF) patients and their informal family caregivers may affect both patient and caregiver outcomes. The aim of this study is to synthesize the literature to date on the associations between HF patient-caregiver relationship quality and communication and patient and caregiver health outcomes. An integrative review of the literature was conducted. Computerized literature searches in Medline, PsycInfo, CINAHL, Web of Science, and EMBASE yielded 13 articles of HF patients and caregivers. Included articles were reviewed and double-coded by 2 independent coders. Included articles measured relationship quality or aspects of communication within an HF patient-caregiver dyad and used both cross-sectional and longitudinal designs. Results of the longest prospective study suggested that better relationship quality between HF patients and their informal family caregivers was related to a reduced risk for mortality in patients. Results of 11 of the 12 other studies were consistent to the reference study, suggesting that better relationship quality and communication were related to reduced mortality, increased health status, less distress, and lower caregiver burden. Relationship quality and communication seem to matter in the health and well-being of both HF patients and their informal family caregivers. More research is needed to elucidate mechanisms and to design effective relationship-focused interventions.

A System Design for Studying Geriatric Patients with Dementia and Hypertension Based on Daily Living Information

NASA Astrophysics Data System (ADS)

Xu, Weifeng; Betz, Willian R.; Frezza, Stephen T.; Liu, Yunkai

2011-08-01

Geriatric patients with dementia and hypertension (DAH) suffer both physically and financially. The needs of these patients mainly include improving the quality of daily living and reducing the cost of long-term care. Traditional treatment approaches are strained to meet these needs. The goal of the paper is to design an innovative system to provide cost-effective quality treatments for geriatric patients with DAH by collecting and analyzing the multi-dimensional personal information, such as observations in daily living (ODL) from a non-clinical environment. The proposed ODLs in paper include activities, cleanliness, blood pressure, medication compliance and mood changes. To complete the system design, an incremental user-centered strategy is exploited to assemble needs of patients, caregivers, and clinicians. A service-oriented architecture (SOA) is employed to make full use of existing devices, software systems, and platforms. This health-related knowledge can be interpreted and utilized to help patients with DAH remain in their homes safely and improve their life quality while reducing medical expenditures.

Evaluating Intention and Effect: The Impact of Healthcare Facility Design on Patient and Staff Well-Being.

PubMed

Alvaro, Celeste; Wilkinson, Andrea J; Gallant, Sara N; Kostovski, Deyan; Gardner, Paula

2016-01-01

This post occupancy evaluation (POE) assessed the impact of architectural design on psychosocial well-being among patients and staff in the context of a new complex continuing care and rehabilitation facility. Departing from typical POEs, the hospital design intentions formed the theoretical basis to assess outcomes. Intentions included creating an environment of wellness; enhancing connection to the community, the city, and nature; enhancing opportunities for social interaction; and inspiring activity. A pretest-posttest quasi experiment, including quantitative surveys, assessed the impact of the building design on well-being outcomes across three facilities-the new hospital, the former hospital, and a comparison facility with a similar population. With the exception of connection to neighborhood (for patients) and opportunities to visit with others (for staff) and wayfinding (for patients and staff), impressions of the new hospital mirrored the design intentions relative to the former hospital and the comparison facility among patients and staff. Perceptions of improvement in mental health, self-efficacy in mobility, satisfaction, and interprofessional interactions were enhanced at the new hospital relative to the former hospital, whereas optimism, depressive symptoms, general well-being, burnout, and intention to quit did not vary. Interestingly, patients and staff with favorable impressions of the building design fared better on most well-being-related outcomes relative to those with less favorable impressions. Beyond the value of assessing the impact of the design intentions on outcomes, the approach used in this study would benefit evaluation strategies across a diversity of health and other public and large-scale buildings. © The Author(s) 2015.

Website design: technical, social and medical issues for self-reporting by elderly patients.

PubMed

Taylor, Mark J; Stables, Rod; Matata, Bashir; Lisboa, Paulo J G; Laws, Andy; Almond, Peter

2014-06-01

There is growing interest in the use of the Internet for interacting with patients, both in terms of healthcare information provision and information gathering. In this article, we examine the issues in designing healthcare websites for elderly users. In particular, this article uses a year-long case study of the development of a web-based system for self-reporting of symptoms and quality of life with a view to examine the issues relating to website design for elderly users. The issues identified included the technical, social and medical aspects of website design for elderly users. The web-based system developed was based on the European Quality of Life 5-Dimensions health-status questionnaire, a commonly used tool for patient self-reporting of quality of life, and the more specific coronary revascularisation outcome questionnaire. Currently, self-reporting is generally administered in the form of paper-based questionnaires to be completed in the outpatient clinic or at home. There are a variety of issues relating to elderly users, which imply that websites for elderly patients may involve different design considerations to other types of websites.

Simultaneously optimizing dose and schedule of a new cytotoxic agent.

PubMed

Braun, Thomas M; Thall, Peter F; Nguyen, Hoang; de Lima, Marcos

2007-01-01

Traditionally, phase I clinical trial designs are based upon one predefined course of treatment while varying among patients the dose given at each administration. In actual medical practice, patients receive a schedule comprised of several courses of treatment, and some patients may receive one or more dose reductions or delays during treatment. Consequently, the overall risk of toxicity for each patient is a function of both actual schedule of treatment and the differing doses used at each adminstration. Our goal is to provide a practical phase I clinical trial design that more accurately reflects actual medical practice by accounting for both dose per administration and schedule. We propose an outcome-adaptive Bayesian design that simultaneously optimizes both dose and schedule in terms of the overall risk of toxicity, based on time-to-toxicity outcomes. We use computer simulation as a tool to calibrate design parameters. We describe a phase I trial in allogeneic bone marrow transplantation that was designed and is currently being conducted using our new method. Our computer simulations demonstrate that our method outperforms any method that searches for an optimal dose but does not allow schedule to vary, both in terms of the probability of identifying optimal (dose, schedule) combinations, and the numbers of patients assigned to those combinations in the trial. Our design requires greater sample sizes than those seen in traditional phase I studies due to the larger number of treatment combinations examined. Our design also assumes that the effects of multiple administrations are independent of each other and that the hazard of toxicity is the same for all administrations. Our design is the first for phase I clinical trials that is sufficiently flexible and practical to truly reflect clinical practice by varying both dose and the timing and number of administrations given to each patient.

A Comparison of Psychoanalytic Therapy and Cognitive Behavioral Therapy for Anxiety (Panic/Agoraphobia) and Personality Disorders (APD Study): Presentation of the RCT Study Design.

PubMed

Benecke, Cord; Huber, Dorothea; Staats, Hermann; Zimmermann, Johannes; Henkel, Miriam; Deserno, Heinrich; Wiegand-Grefe, Silke; Schauenburg, Henning

2016-09-01

Anxiety disorders, most notably panic disorders and agoraphobia, are common mental disorders, and there is a high comorbidity with personality disorders. Randomized controlled trails addressing this highly relevant group of patients are missing. The multicenter Anxiety and Personality Disorders (APD) study investigates 200 patients with panic disorder and/or agoraphobia with comorbid personality disorder in a randomized control-group comparison of psychoanalytic therapy (PT) and cognitive behavioral therapy (CBT), including 100 patients in each group. Each patient will be examined over a period of six years, regardless of the duration of the individual treatment. The main issues that are addressed in this study are the comparison of the efficacy of PT and CBT in this special patient population, the comparison of the sustainability of the effects of PT and CBT, the comparison of the long-term cost-benefit-ratios of PT and CBT as well as the investigation of prescriptive patient characteristics for individualized treatment recommendations (differential indication). The APD study compares efficacy, sustainability, and cost-benefit-ratios of CBT and PT for anxiety plus personality disorders in a randomized controlled trail. The study design meets the requirements for an efficacy study for PT, which were recently defined. Current Controlled Trials ISRCTN12449681.

Profiling Patients' Healthcare Needs to Support Integrated, Person-Centered Models for Long-Term Disease Management (Profile): Research Design.

PubMed

Elissen, Arianne Mj; Hertroijs, Dorijn Fl; Schaper, Nicolaas C; Vrijhoef, Hubertus Jm; Ruwaard, Dirk

2016-04-29

This article presents the design of PROFILe, a study investigating which (bio)medical and non-(bio)medical patient characteristics should guide more tailored chronic care. Based on this insight, the project aims to develop and validate 'patient profiles' that can be used in practice to determine optimal treatment strategies for subgroups of chronically ill with similar healthcare needs and preferences. PROFILe is a practice-based research comprising four phases. The project focuses on patients with type 2 diabetes. During the first study phase, patient profiles are drafted based on a systematic literature research, latent class growth modeling, and expert collaboration. In phase 2, the profiles are validated from a clinical, patient-related and statistical perspective. Phase 3 involves a discrete choice experiment to gain insight into the patient preferences that exist per profile. In phase 4, the results from all analyses are integrated and recommendations formulated on which patient characteristics should guide tailored chronic care. PROFILe is an innovative study which uses a uniquely holistic approach to assess the healthcare needs and preferences of chronically ill. The patient profiles resulting from this project must be tested in practice to investigate the effects of tailored management on patient experience, population health and costs.

Islam and the healthcare environment: designing patient rooms.

PubMed

Kopec, D A K; Han, Li

2008-01-01

Islam and the Muslim population are often the source of much misunderstanding and media-influenced misconceptions. Muslim patients who enter the healthcare environment are often weak and likely to experience feelings of vulnerability. Because of the complex and interwoven nature of culture and religion in a person's identity, it is important to consider patient belief systems and values when designing a patient's immediate environment. Through an exploration of literature related to culture and diversity and the beliefs and value system of the Muslim population, the authors were able to identify flexible design initiatives that could accommodate an array of cultural and spiritual practices. Islam and the Muslim population were chosen as the points of reference for this study because of the strong influence of the religion on the culture, and because of the many nuances that differ from the dominant culture within the United States. From these points of reference, a hypothetical design was developed for a patient room that considers differing notions of privacy, alternatives for cultural and religious practices, and ways to include symbolic meaning derived from attributes such as color.

Patient-specific surgical planning and hemodynamic computational fluid dynamics optimization through free-form haptic anatomy editing tool (SURGEM).

PubMed

Pekkan, Kerem; Whited, Brian; Kanter, Kirk; Sharma, Shiva; de Zelicourt, Diane; Sundareswaran, Kartik; Frakes, David; Rossignac, Jarek; Yoganathan, Ajit P

2008-11-01

The first version of an anatomy editing/surgical planning tool (SURGEM) targeting anatomical complexity and patient-specific computational fluid dynamics (CFD) analysis is presented. Novel three-dimensional (3D) shape editing concepts and human-shape interaction technologies have been integrated to facilitate interactive surgical morphology alterations, grid generation and CFD analysis. In order to implement "manual hemodynamic optimization" at the surgery planning phase for patients with congenital heart defects, these tools are applied to design and evaluate possible modifications of patient-specific anatomies. In this context, anatomies involve complex geometric topologies and tortuous 3D blood flow pathways with multiple inlets and outlets. These tools make it possible to freely deform the lumen surface and to bend and position baffles through real-time, direct manipulation of the 3D models with both hands, thus eliminating the tedious and time-consuming phase of entering the desired geometry using traditional computer-aided design (CAD) systems. The 3D models of the modified anatomies are seamlessly exported and meshed for patient-specific CFD analysis. Free-formed anatomical modifications are quantified using an in-house skeletization based cross-sectional geometry analysis tool. Hemodynamic performance of the systematically modified anatomies is compared with the original anatomy using CFD. CFD results showed the relative importance of the various surgically created features such as pouch size, vena cave to pulmonary artery (PA) flare and PA stenosis. An interactive surgical-patch size estimator is also introduced. The combined design/analysis cycle time is used for comparing and optimizing surgical plans and improvements are tabulated. The reduced cost of patient-specific shape design and analysis process, made it possible to envision large clinical studies to assess the validity of predictive patient-specific CFD simulations. In this paper, model anatomical design studies are performed on a total of eight different complex patient specific anatomies. Using SURGEM, more than 30 new anatomical designs (or candidate configurations) are created, and the corresponding user times presented. CFD performances for eight of these candidate configurations are also presented.

Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

PubMed

Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

2001-08-01

Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

Antioxidants and cancer therapy: a systematic review.

PubMed

Ladas, Elena J; Jacobson, Judith S; Kennedy, Deborah D; Teel, Katherine; Fleischauer, Aaron; Kelly, Kara M

2004-02-01

Many patients with cancer take antioxidant nutritional supplements during cancer treatment to alleviate treatment toxicities and to improve long-term outcomes, but little is known about the efficacy and safety of antioxidant use during cancer treatment. We reviewed English-language manuscripts published in the biomedical literature, reporting the results of observational studies of antioxidant status and cancer outcomes and of intervention trials of antioxidants among patients receiving chemotherapy with or without radiation for various malignancies. We searched the Medline database and the bibliographies of the retrieved manuscripts, reviews, and books on antioxidants and cancer. The retrieved studies are grouped by study design, malignancy, and end points. More than 100 citations were retrieved; 52 met our criteria, 31 were observational studies, and 21 were intervention trials. The studies varied in study design, timing of observation/intervention, intervention protocol, malignancy, and anticancer regimen. These inconsistencies preclude a definitive conclusion as to the effect of chemotherapy on antioxidant status in patients undergoing anticancer therapy. However, our review suggests that total antioxidant status (measured by total radical antioxidant parameter) declines during cancer treatment. Adequately powered trials or observational studies among patients with a specific cancer diagnosis receiving a specific treatment regimen are needed to address patients' and physicians' concerns regarding these associations.

Advancing cognitive engineering methods to support user interface design for electronic health records

PubMed Central

Thyvalikakath, Thankam P.; Dziabiak, Michael P.; Johnson, Raymond; Torres-Urquidy, Miguel Humberto; Acharya, Amit; Yabes, Jonathan; Schleyer, Titus K.

2014-01-01

Background Despite many decades of research on the effective development of clinical systems in medicine, the adoption of health information technology to improve patient care continues to be slow, especially in ambulatory settings. This applies to dentistry as well, a primary care discipline with approximately 137,000 practitioners in the United States. A critical reason for slow adoption is the poor usability of clinical systems, which makes it difficult for providers to navigate through the information and obtain an integrated view of patient data. Objective In this study, we documented the cognitive processes and information management strategies used by dentists during a typical patient examination. The results will inform the design of a novel electronic dental record interface. Methods We conducted a cognitive task analysis (CTA) study to observe ten general dentists (five general dentists and five general dental faculty members, each with more than two years of clinical experience) examining three simulated patient cases using a think-aloud protocol. Results Dentists first reviewed the patient’s demographics, chief complaint, medical history and dental history to determine the general status of the patient. Subsequently, they proceeded to examine the patient’s intraoral status using radiographs, intraoral images, hard tissue and periodontal tissue information. The results also identified dentists’ patterns of navigation through patient’s information and additional information needs during a typical clinician-patient encounter. Conclusion This study reinforced the significance of applying cognitive engineering methods to inform the design of a clinical system. Second, applying CTA to a scenario closely simulating an actual patient encounter helped with capturing participants’ knowledge states and decision-making when diagnosing and treating a patient. The resultant knowledge of dentists’ patterns of information retrieval and review will significantly contribute to designing flexible and task-appropriate information presentation in electronic dental records. PMID:24503391

Designation as “Unfit for Open Repair” Is Associated With Poor Outcomes After Endovascular Aortic Aneurysm Repair

PubMed Central

De Martino, Randall R.; Brooke, Benjamin S.; Robinson, William; Schanzer, Andres; Indes, Jeffrey E.; Wallaert, Jessica B.; Nolan, Brian W.; Cronenwett, Jack L.; Goodney, Philip P.

2014-01-01

Background Endovascular aortic aneurysm repair (EVAR) is often offered to patients with abdominal aortic aneurysms (AAAs) considered preoperatively to be unfit for open AAA repair (oAAA). This study describes the short- and long-term outcomes of patients undergoing EVAR with AAAs <6.5 cm who are considered unfit for oAAA. Methods and Results We analyzed elective EVARs for AAAs <6.5 cm diameter in the Vascular Study Group of New England (2003–2011). Patients were designated as fit or unfit for oAAA by the treating surgeon. End points included in-hospital major adverse events and long-term mortality. We identified patient characteristics associated with being unfit for open repair and predictors of survival using multivariable analyses. Of 1653 EVARs, 309 (18.7%) patients were deemed unfit for oAAA. These patients were more likely to have advanced age, cardiac disease, chronic obstructive pulmonary disease, and larger aneurysms at the time of repair (54 versus 56 mm, P=0.001). Patients unfit for oAAA had higher rates of cardiac (7.8% versus 3.1%, P<0.01) and pulmonary (3.6 versus 1.6, P<0.01) complications and worse survival rates at 5 years (61% versus 80%; log rank P<0.01) compared with those deemed fit for oAAA. Finally, patients designated as unfit for oAAA had worse survival, even adjusting for patient characteristics and aneurysm size (hazard ratio, 1.6; 95% confidence interval, 1.2–2.2; P<0.01). Conclusions In patients with AAAs <6.5 cm, designation by the operating surgeon as unfit for oAAA provides insight into both short- and long-term efficacy of EVAR. Patients unable to tolerate oAAA may not benefit from EVAR unless their risk of AAA rupture is very high. PMID:24046399

Applying health education theory to patient safety programs: three case studies.

PubMed

Gilkey, Melissa B; Earp, Jo Anne L; French, Elizabeth A

2008-04-01

Program planning for patient safety is challenging because intervention-oriented surveillance data are not yet widely available to those working in this nascent field. Even so, health educators are uniquely positioned to contribute to patient safety intervention efforts because their theoretical training provides them with a guide for designing and implementing prevention programs. This article demonstrates the utility of applying health education concepts from three prominent patient safety campaigns, including the concepts of risk perception, community participation, and social marketing. The application of these theoretical concepts to patient safety programs suggests that health educators possess a knowledge base and skill set highly relevant to patient safety and that their perspective should be increasingly brought to bear on the design and evaluation of interventions that aim to protect patients from preventable medical error.

User-centered Design Groups to Engage Patients and Caregivers with a Personalized Health IT Tool

PubMed Central

Maher, Molly; Kaziunas, Elizabeth; Ackerman, Mark; Derry, Holly; Forringer, Rachel; Miller, Kristen; O’Reilly, Dennis; An, Larry C.; Tewari, Muneesh; Hanauer, David A.; Choi, Sung Won

2015-01-01

Health information technology (IT) has opened exciting avenues for capturing, delivering and sharing data, and offers the potential to develop cost-effective, patient-focused applications. In recent years, there has been a proliferation of health IT applications such as outpatient portals. Rigorous evaluation is fundamental to ensure effectiveness and sustainability, as resistance to more widespread adoption of outpatient portals may be due to lack of user friendliness. Health IT applications that integrate with the existing electronic health record and present information in a condensed, user-friendly format could improve coordination of care and communication. Importantly, these applications should be developed systematically with appropriate methodological design and testing to ensure usefulness, adoption, and sustainability. Based on our prior work that identified numerous information needs and challenges of HCT, we developed an experimental prototype of a health IT tool, the BMT Roadmap. Our goal was to develop a tool that could be used in the real-world, daily practice of HCT patients and caregivers (users) in the inpatient setting. In the current study, we examined the views, needs, and wants of patients and caregivers in the design and development process of the BMT Roadmap through two user-centered Design Groups, conducted in March 2015 and April 2015, respectively: Design Group I utilized a low-fidelity paper-based prototype and Design Group II utilized a high-fidelity prototype presented to users as a web-app on Apple® iPads. There were 11 caregivers (median age 44, range 34–69 years) and 8 patients (median age 18 years, range 11–24 years) in the study population. The qualitative analyses revealed a wide range of responses helpful in guiding the iterative development of the system. Three important themes emerged from the Design Groups: 1) perception of core features as beneficial (views), 2) alerting the design team to potential issues with the user interface (needs); and 3) providing a deeper understanding of the user experience in terms of wider psychosocial requirements (wants). From the patient and caregiver perspectives, the BMT Roadmap system was considered useful. The findings from the Design Groups resulted in changes that led to an improved, functional BMT Roadmap product. This unique research process and the findings reported herein included data generated from patients, caregivers, providers, and researchers as partners. Collectively, the data informed the design and development of the tool, which will be tested as an intervention in the pediatric HCT population at our center in the fall of 2015 (ClinicalTrials.gov NCT02409121). PMID:26343948

An Educational Intervention to Train Professional Nurses in Promoting Patient Engagement: A Pilot Feasibility Study

PubMed Central

Barello, Serena; Graffigna, Guendalina; Pitacco, Giuliana; Mislej, Maila; Cortale, Maurizio; Provenzi, Livio

2017-01-01

Introduction: Growing evidence recognizes that patients who are motivated to take an active role in their care can experience a range of health benefits and reduced healthcare costs. Nurses play a critical role in the effort to make patients fully engaged in their disease management. Trainings devoted to increase nurses' skills and knowledge to assess and promote patient engagement are today a medical education priority. To address this goal, we developed a program of nurse education training in patient engagement strategies (NET-PES). This paper presents pilot feasibility study and preliminary participants outcomes for NET-PES. Methods: This is a pilot feasibility study of a 2-session program on patient engagement designed to improve professional nurses' ability to engage chronic patients in their medical journey; the training mainly focused on passing patient engagement assessment skills to clinicians as a crucial mean to improve care experience. A pre-post pilot evaluation of NET-PES included 46 nurses working with chronic conditions. A course specific competence test has been developed and validated to measure patient engagement skills. The design included self-report questionnaire completed before and after the training for evaluation purposes. Participants met in a large group for didactic presentations and then they were split into small groups in which they used role-play and case discussion to reflect upon the value of patient engagement measurement in relation to difficult cases from own practice. Results: Forty-six nurses participated in the training program. The satisfaction questionnaire showed that the program met the educational objectives and was considered to be useful and relevant by the participants. Results demonstrated changes on clinicians' attitudes and skills in promoting engagement. Moreover, practitioners demonstrated increases on confidence regarding their ability to support their patients' engagement in the care process. Conclusions: Learning programs teaching nurses about patient engagement strategies and assessment measures in clinical practice are key in supporting the realization of patient engagement in healthcare. Training nurses in this area is feasible and accepted and might have an impact on their ability to engage patients in the chronic care journey. Due to the limitation of the research design, further research is needed to assess the effectiveness of such a program and to verify if the benefits envisaged in this pilot are maintained on a long-term perspective and to test results by employing a randomized control study design. PMID:28119644

[Information for teenagers with cancer: current state in French pediatric oncology units].

PubMed

Toutenu, Pauline; Chauvin, Franck

2007-04-01

In France, teenagers with cancer are managed mainly in paediatric units, given that there are only few teenage cancer units. This situation leads to the following question: are teenagers with cancer provided with tailored patient education? The object of this study was to identify education programmes specifically designed for teenagers in French paediatric oncology units. This study was conducted first by questionnaires, second by interviews with health care providers in units where information programs had been implemented. Nine information programmes or projects were identified: 2 booklets, one log book, one Web chat, one video, one DVD, one educative muppet, one peer based education group project, one nursing education session project and one qualitative study project. Only 5 from these programmes or project were specifically designed for teenagers. Four approaches can be identified: conception of education materials, individual patient education, group patient education, informal patient education.

Designing a Mobile Health App for Patients With Dysphagia Following Head and Neck Cancer: A Qualitative Study

PubMed Central

Constantinescu, Gabriela; Loewen, Irene; King, Ben; Brodt, Chris; Hodgetts, William

2017-01-01

Background Adherence to swallowing rehabilitation exercises is important to develop and maintain functional improvement, yet more than half of head and neck cancer (HNC) patients report having difficulty adhering to prescribed regimens. Health apps with game elements have been used in other health domains to motivate and engage patients. Understanding the factors that impact adherence may allow for more effective gamified solutions. Objective The aim of our study was to (1) identify self-reported factors that influence adherence to conventional home therapy without a mobile device in HNC patients and (2) identify appealing biofeedback designs that could be used in a health app. Methods A total of 10 (4 females) HNC patients (mean=60.1 years) with experience completing home-based rehabilitation programs were recruited. Thematic analysis of semi-structured interviews was used to answer the first objective. Convergent interviews were used to obtain reactions to biofeedback designs. Results Facilitators and barriers of adherence to home therapy were described through 6 themes: patient perceptions on outcomes and progress, clinical appointments, cancer treatment, rehabilitation program, personal factors, and connection. App visuals that provide feedback on performance during swallowing exercises should offer an immediate representation of effort relative to a goal. Simple, intuitive graphics were preferred over complex, abstract ones. Continued engagement with the app could be facilitated by tracking progress and by using visuals that build structures with each use. Conclusions This is a detailed documentation of the initial steps in designing a health app for a specific patient group. Results revealed the importance of patient engagement in early stages of app development. PMID:28582245

Designing a Care Pathway Model - A Case Study of the Outpatient Total Hip Arthroplasty Care Pathway.

PubMed

Oosterholt, Robin I; Simonse, Lianne Wl; Boess, Stella U; Vehmeijer, Stephan Bw

2017-03-09

Although the clinical attributes of total hip arthroplasty (THA) care pathways have been thoroughly researched, a detailed understanding of the equally important organisational attributes is still lacking. The aim of this article is to contribute with a model of the outpatient THA care pathway that depicts how the care team should be organised to enable patient discharge on the day of surgery. The outpatient THA care pathway enables patients to be discharged on the day of surgery, shortening the length of stay and intensifying the provision and organisation of care. We utilise visual care modelling to construct a visual design of the organisation of the care pathway. An embedded case study was conducted of the outpatient THA care pathway at a teaching hospital in the Netherlands. The data were collected using a visual care modelling toolkit in 16 semi-structured interviews. Problems and inefficiencies in the care pathway were identified and addressed in the iterative design process. The results are two visual models of the most critical phases of the outpatient THA care pathway: diagnosis & preparation (1) and mobilisation & discharge (4). The results show the care team composition, critical value exchanges, and sequence that enable patient discharge on the day of surgery. The design addressed existing problems and is an optimisation of the case hospital's pathway. The network of actors consists of the patient (1), radiologist (1), anaesthetist (1), nurse specialist (1), pharmacist (1), orthopaedic surgeon (1,4), physiotherapist (1,4), nurse (4), doctor (4) and patient application (1,4). The critical value exchanges include patient preparation (mental and practical), patient education, aligned care team, efficient sequence of value exchanges, early patient mobilisation, flexible availability of the physiotherapist, functional discharge criteria, joint decision making and availability of the care team.

Exploring educational needs and design aspects of internet-enabled patient education for persons with diabetes: a qualitative interview study.

PubMed

Jafari, Javad; Karimi Moonaghi, Hosein; Zary, Nabil; Masiello, Italo

2016-10-31

The objective of this article is to explore the educational needs and design aspects of personalised internet-enabled education for patients with diabetes in Iran. Data were collected using semistructured interviews and then qualitatively analysed using inductive content analysis. 9 patients with type 2 diabetes were included. Inclusion criteria were access to and knowledge on how to use the internet. The selection ensured representation based on gender, age, occupation and educational background. The sample population was patients with diabetes who were admitted to an outpatient diabetes clinic in Mashhad, a large city of Iran with about 3 million inhabitants. 4 core categories emerged from the data: (1) seeking knowledge about diabetes, including specific knowledge acquisition, patient's interactions and learning requirements; (2) teaching and learning, including using different teaching methods and different ways to learn about the disease; (3) facilitators, including internet and mobile phone use to learn about the disease; and (4) barriers, including lack of internet access, uncertainty of access to the internet and lack of website in the local language and also perceived cultural barriers, such as patients' fears of the internet, lack of time and awareness. This study provides a better understanding of the patient's educational expectations and technical needs in relation to internet-enabled education. This knowledge will inform the development of functional mock-ups in the next research phase using a design-based research approach in order to design internet-enabled patient education for self-management of diabetes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study

PubMed Central

Koek, Mayke BG; Buskens, Erik; Steegmans, Paul HA; van Weelden, Huib; Bruijnzeel-Koomen, Carla AFM; Sigurdsson, Vigfús

2006-01-01

Background Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). Methods We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. Discussion In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy. Trial registration Current controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930 PMID:16882343

UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study.

PubMed

Koek, Mayke B G; Buskens, Erik; Steegmans, Paul H A; van Weelden, Huib; Bruijnzeel-Koomen, Carla A F M; Sigurdsson, Vigfús

2006-08-01

Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy. Current controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930.

Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

PubMed Central

2013-01-01

Background The current literature recognises that left ventricular hypertrophy makes a key contribution to the high rate of premature cardiovascular mortality in dialysis patients. Determining how we might intervene to ameliorate left ventricular hypertrophy in dialysis populations has become a research priority. Reducing sodium exposure through lower dialysate sodium may be a promising intervention in this regard. However there is clinical equipoise around this intervention because the benefit has not yet been demonstrated in a robust prospective clinical trial, and several observational studies have suggested sodium lowering interventions may be deleterious in some dialysis patients. Methods/design The Sodium Lowering in Dialysate (SoLID) study is funded by the Health Research Council of New Zealand. It is a multi-centre, prospective, randomised, single-blind (outcomes assessor), controlled parallel assignment 3-year clinical trial. The SoLID study is designed to study what impact low dialysate sodium has upon cardiovascular risk in dialysis patients. The study intends to enrol 118 home hemodialysis patients from 6 sites in New Zealand over 24 months and follow up each participant over 12 months. Key exclusion criteria are: patients who dialyse more frequently than 3.5 times per week, pre-dialysis serum sodium of <135 mM, and maintenance hemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials, which contraindicate the SoLID study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will be dialysed using dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure is left ventricular mass index, as measured by cardiac magnetic resonance imaging, after 12 months of intervention. Eleven or more secondary outcomes will be studied in an attempt to better understand the physiologic and clinical mechanisms by which lower dialysate sodium alters the primary end point. Discussion The SoLID study is designed to clarify the effect of low dialysate sodium upon the cardiovascular outcomes of dialysis patients. The study results will provide much needed information about the efficacy of a cost effective, economically sustainable solution to a condition which is curtailing the lives of so many dialysis patients. Trial registration Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998 PMID:23855560

[Fitting Monocurve and Bicurve (Soper-McGuire design) rigid gas-permeable contact lenses in keratoconus patients: a prospective randomized comparative clinical trial].

PubMed

Coral-Ghanem, Cleusa; Alves, Milton Ruiz

2008-01-01

To evaluate the clinical performance of Monocurve and Bicurve (Soper-McGuire design) rigid gas-permeable contact lens fitting in patients with keratoconus. A prospective and randomized comparative clinical trial was conducted with a minimum follow-up of six months in two groups of 63 patients. One group was fitted with Monocurve contact lenses and the other with Bicurve Soper-McGuire design. Study variables included fluoresceinic pattern of lens-to-cornea fitting relationship, location and morphology of the cone, presence and degree of punctate keratitis and other corneal surface alterations, topographic changes, visual acuity for distance corrected with contact lenses and survival analysis for remaining with the same contact lens design during the study. During the follow-up there was a decrease in the number of eyes with advanced and central cones fitted with Monocurve lenses, and an increase in those fitted with Soper-McGuire design. In the Monocurve group, a flattening of both the steepest and the flattest keratometric curve was observed. In the Soper-McGuire group, a steepening of the flattest keratometric curve and a flattening of the steepest keratometric curve were observed. There was a decrease in best-corrected visual acuity with contact lens in the Monocurve group. Survival analysis for the Monocurve lens was 60.32% and for the Soper-McGuire was 71.43% at a mean follow-up of six months. This study showed that due to the changes observed in corneal topography, the same contact lens design did not provide an ideal fitting for all patients during the follow-up period. The Soper-McGuire lenses had a better performance than the Monocurve lenses in advanced and central keratoconus.

Patient and public involvement in reducing health and care research waste.

PubMed

Minogue, Virginia; Cooke, Mary; Donskoy, Anne-Laure; Vicary, Penny; Wells, Bill

2018-01-01

As much as 85 % of health research is believed to be wasted because it is not published or reported, the design is poor or does not consider what is already known in the topic area. Although a great deal of work has been done in the UK to reduce research waste, the role of patients and the public has not been discussed.This paper describes a survey, on the role of patients in reducing research waste, which was carried out as part of a larger piece of work on reducing waste in healthcare. The study found that patients were interested in reducing research waste. The key roles they play in research, for example being co-applicants for funding, members of project teams, co-researchers, means they have some shared responsibility for making sure the quality of research is high. This includes finding out what is already known about a topic and getting the study design right before seeking funding, publishing and reporting the results when the study is finished. Recognising where waste happens is part of good management of a research study. Background Eighty five per cent of health research expenditure is potentially wasted due to failure to publish research, unclear reporting of research that is published, and the failure of new research studies to systematically review previous research in the same topic area, poor study design and conduct. A great deal of progress has been made to address this issue but the role of patients and the public has not been considered. Main A small survey was undertaken, as part of a larger programme of work on reducing health and care waste, to understand the role of patients in reducing research waste. The study showed that patients are interested in this issue particularly in relation to the prioritisation of research and patient and public involvement. Conclusions Patients undertake key roles in the research process including co-applicancy, project management, or as co-researchers. This brings responsibility for ensuring high quality research and value for money. Responsibility for recognition of the potential for wasteful practices is part of the conduct and operation of research studies.

A cross-sectional study to identify organisational processes associated with nurse-reported quality and patient safety

PubMed Central

Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

2012-01-01

Objectives The purpose of this study was to identify organisational processes and structures that are associated with nurse-reported patient safety and quality of nursing. Design This is an observational cross-sectional study using survey methods. Setting Respondents from 31 Norwegian hospitals with more than 85 beds were included in the survey. Participants All registered nurses working in direct patient care in a position of 20% or more were invited to answer the survey. In this study, 3618 nurses from surgical and medical wards responded (response rate 58.9). Nurses' practice environment was defined as organisational processes and measured by the Nursing Work Index Revised and items from Hospital Survey on Patient Safety Culture. Outcome measures Nurses' assessments of patient safety, quality of nursing, confidence in how their patients manage after discharge and frequency of adverse events were used as outcome measures. Results Quality system, nurse–physician relation, patient safety management and staff adequacy were process measures associated with nurse-reported work-related and patient-related outcomes, but we found no associations with nurse participation, education and career and ward leadership. Most organisational structures were non-significant in the multilevel model except for nurses’ affiliations to medical department and hospital type. Conclusions Organisational structures may have minor impact on how nurses perceive work-related and patient-related outcomes, but the findings in this study indicate that there is a considerable potential to address organisational design in improvement of patient safety and quality of care. PMID:23263021

The Family Value of Information, Community Support, and Experience Study: Rationale, Design, and Methods of a "Family-Centered" Research Study.

PubMed

Reeves, Gloria M; Wehring, Heidi J; Connors, Kathleen M; Bussell, Kristin; Schiffman, Jason; Medoff, Deborah R; Tsuji, Thomas; Walker, Jane; Brown, Alicia; Strobeck, Danielle; Clough, Tammy; Rush, Caitlin B; Riddle, Mark A; Love, Raymond C; Zachik, Albert; Hoagwood, Kimberly; Olin, S Serene; Stephan, Sharon; Okuzawa, Nana; Edwards, Sarah; Baquet, Claudia; dosReis, Susan

2015-12-01

The Patient Protection and Affordable Care Act focuses on improving consumer engagement and patient-centered care. This article describes the design and rationale of a study targeting family engagement in pediatric mental health services. The study is a 90-day randomized trial of a telephone-delivered Family Navigator services versus usual care for parents of Medicaid-insured youth younger than 13 years with serious mental illness. Youth are identified through a pediatric antipsychotic medication preauthorization program. Family Navigators offer peer support to empower and engage parents in their child's recovery. Outcomes include parent report of empowerment, social support, satisfaction with child mental health services, and child functioning as well as claims-based measures of psychotherapy service utilization and antipsychotic medication dosage. The focus on "family-centered" care in this study is strongly supported by the active role of consumers in study design and implementation.

An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions.

PubMed

Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J

2008-06-01

This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

Creating Conditions for Patients’ Values to Emerge in Clinical Conversations: Perspectives of Health Care Team Members

PubMed Central

Berry, Andrew B.L.; Lim, Catherine; Hartzler, Andrea L.; Hirsch, Tad; Ludman, Evette; Wagner, Edward H.; Ralston, James D.

2017-01-01

Eliciting, understanding, and honoring patients’ values— the things most important to them in daily life—is a cornerstone of patient-centered care. However, this rarely occurs explicitly as a routine part of clinical practice. This is particularly problematic for individuals with multiple chronic conditions (MCC) because they face difficult choices about how to balance competing demands for self-care in accordance with their values. In this study, we sought to inform the design of interventions to support conversations about patient values between patients with MCC and their health care providers. We conducted a field study that included observations of 21 clinic visits for patients who have MCC, and interviews with 16 care team members involved in those visits. This paper contributes a practice-based account of ways in which providers engage with patient values, and discusses how future work in interactive systems design might extend and enrich these engagements. PMID:28890950

User-Design: A Case Application in Health Care Training.

ERIC Educational Resources Information Center

Carr-Chellman, Alison; Cuyar, Craig; Breman, Jeroen

1998-01-01

Discussion of user-design as a theoretical process for creating training, software, and computer systems focuses on a case study that describes user-design methodology in home health care through the context of diffusing a new laptop patient-record-keeping system with home nurses. Research needs and implications for the design process are…

Clay and Anxiety Reduction: A One-Group, Pretest/Posttest Design with Patients on a Psychiatric Unit

ERIC Educational Resources Information Center

Kimport, Elizabeth R.; Hartzell, Elizabeth

2015-01-01

Little research exists on using clay as an anxiety-reducing intervention with patients in psychiatric hospitals. This article reports on a study that used a one-group, pretest/posttest design with 49 adults in a psychiatric facility who created a clay pinch pot. The State-Trait Anxiety Inventory (STAI) was used as a pre- and posttest measure.…

Visual interaction in recently admitted and chronic long-stay schizophrenic patients.

PubMed

Rutter, D R

1976-09-01

Several reports have suggested that schizophrenic patients engage in very little Looking and eye-contact. However, previous work, much of it methodologically unsatisfactory, has been based almost always on the clinical psychiatric interview, with the result that several important questions remain unanswered. In particular, we do not know how schizophrenic patients behave in free conversation, how their behaviour with another patient may differ from their behaviour with a psychiatrically normal partner, nor even whether they show individual consistency across encounters. The first study was designed to examine these questions, by observing recently admitted schizophrenic patients in two free dyadic conversations, one with a schizophrenic partner and one with a psychiatrically normal partner, and comparing them with three control groups: depressive patients; patients suffering from neurotic or personality disorders; and psychiatrically normal chest patients. The second study went on to test whether the early descriptions of gross abnormality may be more appropriate to chronic long-stay patients than to recently admitted patients, and the design consisted of a comparison between the two groups. The first study revealed a quite unexpected pattern of results. Consistently across their two encounters, schizophrenic subjects behaved similarly for the most part to all three control groups, normal and abnormal alike. Moreover, the few differences which did emerge conflicted sharply with previous findings, including the writer's, and were no more marked in patient-patient than patient-normal encounters. The second study revealed no differences between chronic long-stay and recently admitted schizophrenic patients. It is suggested that the differences in findings between the present two studies and previous reports are most likely to be attributable to differences in verbal content: schizophrenic patients show abnormalities of visual interaction when talking about personal matters, but behave quite normally when the topic is not of immediate personal relevance.

Randomised trials comparing different healthcare settings: an exploratory review of the impact of pre-trial preferences on participation, and discussion of other methodological challenges.

PubMed

Corbett, Mark S; Watson, Judith; Eastwood, Alison

2016-10-19

We recently published a systematic review of different healthcare settings (such as outpatient, community or home) for administering intravenous chemotherapy, and concluded that performing conventionally designed randomised trials was difficult. The main problems were achieving adequate trial accrual rates and recruiting a study population which adequately represented the target population of interest. These issues stemmed from the fact that potential participants may have had pre-trial perceptions about the trial settings they may be allocated; such preferences will sometimes be strong enough for patients to decline an invitation to participate in a trial. A patient preference trial design (in which patients can choose, or be randomised to, an intervention) may have obviated these recruitment issues, although none of the trials used such a design. In order to gain a better understanding of the broader prevalence and extent of these preference issues (and any other methodological challenges), we undertook an exploratory review of settings trials in any area of healthcare treatment research. We searched The Cochrane Library and Google Scholar and used snowballing methods to identify trials comparing different healthcare settings. Trial accrual was affected by patient preferences for a setting in 15 of the 16 identified studies; birth setting trials were the most markedly affected, with between 68 % and 85 % of eligible women declining to participate specifically because of preference for a particular healthcare setting. Recruitment into substance abuse and chemotherapy setting studies was also notably affected by preferences. Only four trials used a preference design: the proportion of eligible patients choosing to participate via a preference group ranged from between 33 % and 67 %. In trials of healthcare settings, accrual may be seriously affected by patient preferences. The use of trial designs which incorporate a preference component should therefore strongly be considered. When designing such trials, investigators should consider settings to be complex interventions, which are likely to have linked components which may be difficult to control for. Careful thought is also needed regarding the choice of comparator settings and the most appropriate outcome measures to be used.

My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology

PubMed Central

Shroff, Adhir; Groo, Vicki; Dickens, Carolyn; Field, Jerry; Baumann, Matthew; Welland, Betty; Gutowski, Gerry; Flores Jr, Jose D; Zhao, Zhongsheng; Bahroos, Neil; Hynes, Denise M; Wilkie, Diana J

2015-01-01

Background Patient adherence to medication regimens is critical in most chronic disease treatment plans. This study uses a patient-centered tablet app, “My Interventional Drug-Eluting Stent Educational App (MyIDEA).” This is an educational program designed to improve patient medication adherence. Objective Our goal is to describe the design, methodology, limitations, and results of the MyIDEA tablet app. We created a mobile technology-based patient education app to improve dual antiplatelet therapy adherence in patients who underwent a percutaneous coronary intervention and received a drug-eluting stent. Methods Patient advisers were involved in the development process of MyIDEA from the initial wireframe to the final launch of the product. The program was restructured and redesigned based on the patient advisers’ suggestions as well as those from multidisciplinary team members. To accommodate those with low health literacy, we modified the language and employed attractive color schemes to improve ease of use. We assumed that the target patient population may have little to no experience with electronic tablets, and therefore, we designed the interface to be as intuitive as possible. Results The MyIDEA app has been successfully deployed to a low-health-literate elderly patient population in the hospital setting. A total of 6 patients have interacted with MyIDEA for an average of 17.6 minutes/session. Conclusions Including patient advisers in the early phases of a mobile patient education development process is critical. A number of changes in text order, language, and color schemes occurred to improve ease of use. The MyIDEA program has been successfully deployed to a low-health-literate elderly patient population. Leveraging patient advisers throughout the development process helps to ensure implementation success. PMID:26139587

HEALTH PROFESSIONALS' USER EXPERIENCE OF THE INTELLIGENT BED IN PATIENTS' HOMES.

PubMed

Cai, Hao; Toft, Egon; Hejlesen, Ole; Hansen, John; Oestergaard, Claus; Dinesen, Birthe

2015-01-01

The intelligent bed is a medical bed with several home healthcare functions. It includes, among others, an "out of bed" detector, a moisture detector, and a catheter bag detector. The design purpose of the intelligent bed is to assist patients in their daily living, facilitate the work of clinical staff, and improves the quality of care. The aim of this sub-study of the iCare project was to explore how health professionals (HPs) experience and use the intelligent bed in patients' homes. The overall research design is inspired by case study methodology. A triangulation of data collection techniques has been used: log book, documentation study, participant observations (n = 45 hr), and qualitative interviews (n = 23). The data have been analyzed by means of Nvivo 9.0. We identified several themes: HP transformation from passive technology recipient to innovator; individualized care; work flow redesign; and sensor technology intruding on patient privacy. It is suggested that functions of the intelligent bed can result in more individualized care, workflow redesign, and time savings for the health professionals in caring for elderly patients. However, the technology intruded on patients' privacy.

Implantable Cardioverter Defibrillator

MedlinePlus

... patients will benefit from an ICD. Improving ICD design. Although high-energy shocks are effective therapy for ... patients with many stressful decisions, and this study tests the effectiveness of educational videos and handouts to ...

Enclosed versus open nursing stations in adult acute care psychiatric settings: does the design affect the therapeutic milieu?

PubMed

Southard, Kelly; Jarrell, Ashley; Shattell, Mona M; McCoy, Thomas P; Bartlett, Robin; Judge, Christine A

2012-05-01

Specific efforts by hospital accreditation organizations encourage renovation of nursing stations, so nurses can better see, attend, and care for their patients. The purpose of this study was to examine the effect of nursing station design on the therapeutic milieu in an adult acute care psychiatric unit. A repeated cross-sectional, pretest-posttest design was used. Data were collected from a convenience sample of 81 patients and 25 nursing staff members who completed the Ward Atmosphere Scale. Pretest data were collected when the unit had an enclosed nursing station, and posttest data were collected after renovations to the unit created an open nursing station. No statistically significant differences were found in patient or staff perceptions of the therapeutic milieu. No increase in aggression toward staff was found, given patients' ease of access to the nursing station. More research is needed about the impact of unit design in acute care psychiatric settings. Copyright 2012, SLACK Incorporated.

"Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients".

PubMed

Pappas, Dimitrios A; Kremer, Joel M; Reed, George; Greenberg, Jeffrey D; Curtis, Jeffrey R

2014-04-01

Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA). CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced). The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.

Study protocol: Improving patient choice in treating low back pain (IMPACT - LBP): A randomised controlled trial of a decision support package for use in physical therapy

PubMed Central

2011-01-01

Background Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. Methods/Design Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study. Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. Discussion Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. Trial registration Current Controlled Trials ISRCTN46035546 PMID:21352528

Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention 'ReumaUitgedaagd!' for Adults With a Rheumatic Disease: Results of a Usability Study and Design for a Randomized Control Trail.

PubMed

Ammerlaan, Judy W; Mulder, Olga K; de Boer-Nijhof, Nienke C; Maat, Bertha; Kruize, Aike A; van Laar, Jaap; van Os-Medendorp, Harmieke; Geenen, Rinie

2016-06-23

The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.

Refining Prescription Warning Labels Using Patient Feedback: A Qualitative Study

PubMed Central

Mansukhani, Sonal Ghura; Huang, Yen-Ming

2016-01-01

The complexity of written medication information hinders patients’ understanding and leads to patient misuse of prescribed medications. Incorporating patient feedback in designing prescription warning labels (PWLs) is crucial in enhancing patient comprehension of medication warning instructions. This qualitative study explored patient feedback on five newly designed PWLs. In-depth semi-structured face-to-face interviews were conducted with 21 patients, who were 18 years and older, spoke English, and took a prescription medication. These patients were shown different variations of the five most commonly used PWLs-Take with Food, Do not Drink Alcohol, Take with a Full glass of Water, Do not Chew or Break, and Protect from Sunlight. The 60-minute interviews explored feedback on patient comprehension of the PWL instructions and their suggestions for improving the clarity of the PWLs. At the end of the interview, patient self-reported socio-demographic information was collected with a 3-minute survey and a brief health literacy assessment was completed using the Newest Vital Sign. Twenty-one patients completed the interviews. Most patients were female (n = 15, 71.4%) with ages ranging from 23 to 66 years old (mean: 47.6 ± 13.3). The mean health literacy score was 2.4 on a scale of 0–6. Qualitative content analysis based on the text, pictures, and placement of the PWLs on the pill bottle showed preferences for including ‘WARNING’ on the PWL to create alertness, inclusion of a picture together with the text, yellow color highlighting behind the text, and placement of the PWL on the front of the pill bottle. Although patients had positive opinions of the redesigned PWLs, patients wanted further improvements to the content and design of the PWLs for enhanced clarity and understandability. PMID:27258026

The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications.

PubMed

Kandzari, David E; Kario, Kazuomi; Mahfoud, Felix; Cohen, Sidney A; Pilcher, Garrett; Pocock, Stuart; Townsend, Raymond; Weber, Michael A; Böhm, Michael

2016-01-01

Renal sympathetic activation plays a key role in the pathogenesis of hypertension, as demonstrated by high renal norepinephrine spillover into plasma of patients with essential hypertension. Renal denervation has demonstrated a significant reduction in blood pressure in unblinded studies of hypertensive patients. The SYMPLICITY HTN-3 trial, the first prospective, masked, randomized study of renal denervation versus sham control, failed its primary efficacy end point and raised important questions around potentially confounding factors, such as drug changes and adherence, study population, and procedural methods. The SPYRAL HTN Global Clinical Trial Program is designed to address limitations associated with predicate studies and provide insight into the impact of pharmacotherapy on renal denervation efficacy. The 2 initial trials of the program focus on the effect of renal denervation using the Symplicity Spyral multielectrode renal denervation catheter in hypertensive patients in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. The SPYRAL HTN ON-MED study requires patients to be treated with a consistent triple therapy antihypertensive regimen, whereas the SPYRAL HTN OFF-MED study includes a 3- to 4-week drug washout period followed by a 3-month efficacy and safety end point in the absence of antihypertensive medications. The studies will randomize patients with combined systolic-diastolic hypertension to renal denervation or sham procedure. Both studies allow renal denervation treatments in renal artery branches and accessories. These studies will inform the design of the second pivotal phase of the program, which will more definitively analyze the antihypertensive effect of renal denervation. Copyright © 2015 Elsevier Inc. All rights reserved.

Development of a decision aid to inform patients’ and families’ renal replacement therapy selection decisions

PubMed Central

2012-01-01

Background Few educational resources have been developed to inform patients’ renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients’ treatment and support patients’ decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. Methods We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in “stages.” For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. Results The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals’ testimonials regarding various considerations that might influence patients’ and families’ treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. Conclusions This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values. PMID:23198793

Learning and cognitive fatigue trajectories in multiple sclerosis defined using a burst measurement design.

PubMed

Holtzer, Roee; Foley, Frederick; D'Orio, Vanessa; Spat, Jessica; Shuman, Melissa; Wang, Cuiling

2013-10-01

Compromised learning and cognitive fatigue are critical clinical features in multiple sclerosis. This study was designed to determine the effect of repeated exposures within and across study visits on performance measures of learning and cognitive fatigue in relapsing-remitting multiple sclerosis (RRMS). Thirty patients with RRMS and 30 controls were recruited. Using a burst measurement design (i.e. repeated assessments within and across study visits) the oral version of the Symbol Digit Modalities Test (SDMT) was administered three times during the baseline and two consecutive monthly follow-up visits for a total of nine test administrations. Learning was assessed within and across study visits whereas cognitive fatigue was assessed during the course of each test administration that was divided into three 30-second intervals. Linear mixed-effect models revealed compromised learning within (95% CI: 2.6355 to 3.9867) and across (95% CI: 1.3250 to 3.1861) visits and worse cognitive fatigue (95% CI: -2.1761 to -0.1720) in patients with RRMS compared with controls. Among patients with RRMS, worse self-rated cognitive dysfunction predicted poor learning within (95% CI: -0.1112 to -0.0020) and across (95% CI: -0.0724 to -0.0106) visits. Burst design is optimal to study learning and cognitive fatigue. This methodology, using the SDMT or other time-efficient tests as outcome measures, can be successfully implemented in longitudinal studies and clinical trials.

Contributors to Suicidal Ideation among Bipolar Patients with and without a History of Suicide Attempts

ERIC Educational Resources Information Center

Allen, Michael H.; Chessick, Cheryl A.; Miklowitz, David J.; Goldberg, Joseph F.; Wisniewski, Stephen R.; Miyahara, Sachiko; Calabrese, Joseph R.; Marangell, Lauren; Bauer, Mark S.; Thomas, Marshall R.; Bowden, Charles L.; Sachs, Gary S.

2005-01-01

This study was designed to develop models for vulnerability to suicidal ideation in bipolar patients. Logistic regression models examined correlates of suicidal ideation in patients who had versus had not attempted suicide previously. Of 477 patients assessed, complete data on demographic, illness history, and personality variables were available…

Clinicians' and Patients' Assessment of Activity Overuse and Underuse and Its Relation to Physical Capacity

ERIC Educational Resources Information Center

de Jong, Annemieke Bonny; Preuper, Henrica R. Schiphorst; Reneman, Michiel F.

2012-01-01

To explore clinicians' and patients' (self)-assessment of activity overuse and underuse, and its relationship with physical capacity in patients with chronic musculoskeletal pain (CMP). Study design was cross-sectional. Participants included patients with CMP, admitted to a multidisciplinary outpatient pain rehabilitation program. The main…

Recall in Older Cancer Patients: Measuring Memory for Medical Information

ERIC Educational Resources Information Center

Jansen, Jesse; van Weert, Julia; van der Meulen, Nienke; van Dulmen, Sandra; Heeren, Thea; Bensing, Jozien

2008-01-01

Purpose: Remembering medical treatment information may be particularly taxing for older cancer patients, but to our knowledge this ability has never been assessed in this specific age group only. Our purpose in this study was to investigate older cancer patients' recall of information after patient education preceding chemotherapy. Design and…

Are Cancer Survivors/Patients Knowledgeable about Osteoporosis? Results from a Survey of 285 Chemotherapy-Treated Cancer Patients and Their Companions

ERIC Educational Resources Information Center

McKean, Heidi; Looker, Sherry; Hartmann, Lynn C.; Hayman, Suzanne R.; Kaur, Judith S.; McWilliams, Robert R.; Peethambaram, Prema P.; Stahl, Jean F.; Jatoi, Aminah

2008-01-01

Objective: This study assessed osteoporosis knowledge deficits among cancer patients and their spouses/partners. Design: Single-institution survey (modified version of the Osteoporosis Knowledge Assessment Tool). Setting: The Mayo Clinic in Rochester, Minnesota. Participants: Consecutive chemotherapy-treated cancer patients (n = 285) with their…

Tailored Prevention of Inpatient Falls

PubMed Central

ZUYEV, LYUBOV; BENOIT, ANGELA N.; CHANG, FRANK Y.; DYKES, PATRICIA C.

2011-01-01

Patient falls and fall-related injuries are serious problems in hospitals. The Fall TIPS application aims to prevent patient falls by translating routine nursing fall risk assessment into a decision support intervention that communicates fall risk status and creates a tailored evidence-based plan of care that is accessible to the care team, patients, and family members. In our design and implementation of the Fall TIPS toolkit, we used the Spiral Software Development Life Cycle model. Three output tools available to be generated from the toolkit are bed poster, plan of care, and patient education handout. A preliminary design of the application was based on initial requirements defined by project leaders and informed by focus groups with end users. Preliminary design partially simulated the paper version of the Morse Fall Scale currently used in hospitals involved in the research study. Strengths and weaknesses of the first prototype were identified by heuristic evaluation. Usability testing was performed at sites where research study is implemented. Suggestions mentioned by end users participating in usability studies were either directly incorporated into the toolkit and output tools, were slightly modified, or will be addressed during training. The next step is implementation of the fall prevention toolkit on the pilot testing units. PMID:20975543

Design simplicity influences patient portal use: the role of aesthetic evaluations for technology acceptance.

PubMed

Lazard, Allison J; Watkins, Ivan; Mackert, Michael S; Xie, Bo; Stephens, Keri K; Shalev, Heidi

2016-04-01

This study focused on patient portal use and investigated whether aesthetic evaluations of patient portals function are antecedent variables to variables in the Technology Acceptance Model. A cross-sectional survey of current patient portals users (N = 333) was conducted online. Participants completed the Visual Aesthetics of Website Inventory, along with items measuring perceived ease of use (PEU), perceived usefulness (PU), and behavioral intentions (BIs) to use the patient portal. The hypothesized model accounted for 29% of the variance in BIs to use the portal, 46% of the variance in the PU of the portal, and 29% of the variance in the portal's PEU. Additionally, one dimension of the aesthetic evaluations functions as a predictor in the model - simplicity evaluations had a significant positive effect on PEU. This study provides evidence that aesthetic evaluations - specifically regarding simplicity - function as a significant antecedent variable to patients' use of patient portals and should influence patient portal design strategies. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Patient-Perceived Usefulness of Online Electronic Medical Records: Employing Grounded Theory in the Development of Information and Communication Technologies for Use by Patients Living with Chronic Illness

PubMed Central

Winkelman, Warren J.; Leonard, Kevin J.; Rossos, Peter G.

2005-01-01

Objective: Patient use of online electronic medical records (EMR) holds the potential to improve health outcomes. The purpose of this study is to discover how patients living with chronic inflammatory bowel disease (IBD) value Internet-based patient access to electronic patient records. Design: This was a qualitative, exploratory, descriptive study using in-depth interviews and focus groups of a total of 12 patients with IBD of at least one-year duration at University Health Network, a tertiary care center in Toronto, Ontario. Results: Four themes have been elucidated that comprise a theoretical framework of patient-perceived information and communication technology usefulness: promotion of a sense of illness ownership, of patient-driven communication, of personalized support, and of mutual trust. Conclusions: For patients with chronic IBD, simply providing access to electronic medical records has little usefulness on its own. Useful technology for patients with IBD is multifaceted, self-care promoting, and integrated into the patient's already existing health and psychosocial support infrastructure. The four identified themes can serve as focal points for the evaluation of information technology designed for patient use, thus providing a patient-centered framework for developers seeking to adapt existing EMR systems to patient access and use for the purposes of improving health care quality and health outcomes. Further studies in other populations are needed to enhance generalizability of the emergent theory. PMID:15684128

[Design of a plan for patient safety in pediatric surgery service].

PubMed

Paredes Esteban, R M; Castillo Fernández, A L; Miñarro del Moral, R; Garrido Pérez, J I; Granero Cendón, R; Gómez Beltrán, O; Berenguer Garcia, M J; Tejedor Fernández, M

2014-10-01

Patient safety is a key priority in quality management for healthcare services providers. Every patient is entitled to receive safe and effective healthcare. The aim of this study was to design a patient safety plan for a Paediatric Surgery Department. We carried out a literature review and we established a work group that included healthcare professionals from the Paediatric Surgery Department and the Quality and Medical Records Department. The group identified potential adverse events, failures and causes and established a rating using Failure Mode Effects Analysis. Potential risks were mapped out and a plan was designed establishing actions to reduce risks. We designated leaders to ensure the effective implementation of the plan. A total of 58 adverse events were identified in the Paediatric Surgery Department. We detected 128 failures that were produced by 211 different causes. The group developed a proposal with 424 specific measures to carry out preventive and/or remedial actions that were then narrowed down to 322. The group designed a plan to apply the programme, which is currently being implemented. The methodology used enabled obtaining key information for improvement of patient safety and developing preventive and/or remedial actions. These measures are applicable in practice, as they were designed using proposals and agreements with professionals that take active part in the care of children with surgical conditions.

A pragmatic observational feasibility study on integrated treatment for musculoskeletal disorders: Design and protocol.

PubMed

Hu, Xiao-yang; Hughes, John; Fisher, Peter; Lorenc, Ava; Purtell, Rachel; Park, A-La; Robinson, Nicola

2016-02-01

Musculoskeletal disorders (MSD) comprise a wide range of conditions, associated with an enormous pain and impaired mobility, and are affecting people's lives and work. Management of musculoskeletal disorders typically involves a multidisciplinary team approach. Positive findings have been found in previous studies evaluating the effectiveness of complementary therapies, though little attention has been paid to evaluating of the effectiveness of integrated packages of care combining conventional and complementary approaches for musculoskeletal conditions in a National Health Service (NHS) setting. To determine the feasibility of all aspects of a pragmatic observational study designed: (1) to evaluate the effectiveness and cost effectiveness of integrated treatments for MSDs in an integrated NHS hospital in the UK; (2) to determine the acceptability of the study design and research process to patients; (3) to explore patients' expectation and experience of receiving integrated treatments. This is an observational feasibility study, with 1-year recruitment and 1-year follow-up, conducted in Royal London Hospital for Integrated Medicine, University College London Hospital Trust, UK. All eligible patients with MSDs newly referred to the hospital were included in the study. Interventions are integrated packages of care (conventional and complementary) as currently provided in the hospital. SF-36™ Health Survey, short form Brief Pain Inventory, Visual Analogue Scale, and modified Client Service Receipt Inventory will be assessed at 4/5 time points. Semi-structured interview/focus group will be carried out before treatment, and 1 year after commence of treatment. We intend to conduct a pragmatic observational study of integrated medical treatment of MSDs at a public sector hospital. It will inform the design of a future trial including recruitment, retention, suitability of the outcome measures and patients experiences.

Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

PubMed Central

Jenkins, Tim M; Smart, Trevor S; Hackman, Frances; Cooke, Carol; Tan, Keith KC

2012-01-01

Background: Detecting the efficacy of novel analgesic agents in neuropathic pain is challenging. There is a critical need for study designs with the desirable characteristics of assay sensitivity, low placebo response, reliable pain recordings, low cost, short duration of exposure to test drug and placebo, and relevant and recruitable population. Methods: We designed a proof-of-concept, double-blind, randomized, placebo-controlled, crossover study in patients with post-traumatic peripheral neuropathic pain (PTNP) to evaluate whether such a study design had the potential to detect efficacious agents. Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic. We also assessed physical activity throughout the study. Results: Twenty-five adults (20–70 years of age) with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences: (1) pregabalin followed by placebo or (2) placebo followed by pregabalin. These 2-week treatment periods were separated by a 2-week washout period. Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15). In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2-week washout period. Average daily pain scores (primary endpoint) were significantly reduced for pregabalin versus placebo, with a mean treatment difference of −0.81 (95% confidence interval: −1.45 to −0.17; P = 0.015). Conclusion: The efficacy of pregabalin was similar to that identified in a large, parallel group trial in PTNP. Therefore, this efficient crossover study design has potential utility for future proof-of-concept studies in neuropathic pain. PMID:22888270

[Congenital adrenal hyperplasia: a qualitative study on sex definition and redesignation dilation surgery and psychological support (part II)].

PubMed

Telles-Silveira, Mariana; Tonetto-Fernandes, Vânia F; Schiller, Paulo; Kater, Claudio E

2009-12-01

To identify relevant questions related to sex definition and re-designation and reconstructive surgery in patients with congenital adrenal hyperplasia (CAH), and to understand the role of the psychologist in providing care for these patients. We selected 21 subjects: 7 pediatric endocrinologists from 5 Brazilian Public Health System institutions, 9 parents and 6 patients with CAH, according to a qualitative research model. In this paper, 3 of the studied categories are analyzed: 'sex definition and re-designation', 'reconstructive surgery/vaginal dilation', and 'psychology'. Parents' main anguish relates to the situation of an unnamed sex at birth, whereas sex re-designation was distressful to physicians. A sense of loneliness when dealing with the disease and treatment was a common anguish among patients; dilation procedures were the major complaint. In general, physicians recommend that genital reconstructive surgery be performed early on to avoid future trauma. In such a complex scenario, it is remarkable that not all the reference service staff have a psychologist on duty. Difficulties to deal with questions involving sexuality were evident and dilation procedures are an additional source of trauma for these patients.

Implementation of tuberculosis infection control measures in designated hospitals in Zhejiang Province, China: are we doing enough to prevent nosocomial tuberculosis infections?

PubMed

Chen, Bin; Liu, Min; Gu, Hua; Wang, Xiaomeng; Qiu, Wei; Shen, Jian; Jiang, Jianmin

2016-03-03

Tuberculosis (TB) infection control measures are very important to prevent nosocomial transmission and protect healthcare workers (HCWs) in hospitals. The TB infection control situation in TB treatment institutions in southeastern China has not been studied previously. Therefore, the aim of this study was to investigate the implementation of TB infection control measures in TB-designated hospitals in Zhejiang Province, China. Cross-sectional survey using observation and interviews. All TB-designated hospitals (n=88) in Zhejiang Province, China in 2014. Managerial, administrative, environmental and personal infection control measures were assessed using descriptive analyses and univariate logistic regression analysis. The TB-designated hospitals treated a median of 3030 outpatients (IQR 764-7094) and 279 patients with confirmed TB (IQR 154-459) annually, and 160 patients with TB (IQR 79-426) were hospitalised in the TB wards. Most infection control measures were performed by the TB-designated hospitals. Measures including regular monitoring of TB infection control in high-risk areas (49%), shortening the wait times (42%), and providing a separate waiting area for patients with suspected TB (46%) were sometimes neglected. N95 respirators were available in 85 (97%) hospitals, although only 44 (50%) hospitals checked that they fit. Hospitals with more TB staff and higher admission rates of patients with TB were more likely to set a dedicated sputum collection area and to conduct annual respirator fit testing. TB infection control measures were generally implemented by the TB-designated hospitals. Measures including separation of suspected patients, regular monitoring of infection control practices, and regular fit testing of respirators should be strengthened. Infection measures for sputum collection and respirator fit testing should be improved in hospitals with lower admission rates of patients with TB. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Rationale and Design of the Lung Cancer Screening Implementation. Evaluation of Patient-Centered Care Study.

PubMed

Miranda, Leah S; Datta, Santanu; Melzer, Anne C; Wiener, Renda Soylemez; Davis, James M; Tong, Betty C; Golden, Sara E; Slatore, Christopher G

2017-10-01

Screening for lung cancer using low-dose computed tomography has been demonstrated to reduce lung cancer-related mortality and is being widely implemented. Further research in this area is needed to assess the impact of screening on patient-centered outcomes. Here, we describe the design and rationale for a new study entitled Lung Cancer Screening Implementation: Evaluation of Patient-Centered Care. The protocol is composed of an interconnected series of studies evaluating patients and clinicians who are engaged in lung cancer screening in real-world settings. The primary goal of this study is to evaluate communication processes that are being used in routine care and to identify best practices that can be readily scaled up for implementation in multiple settings. We hypothesize that higher overall quality of patient-clinician communication processes will be associated with lower levels of distress and decisional conflict as patients decide whether or not to participate in lung cancer screening. This work is a critical step toward identifying modifiable mechanisms that are associated with high quality of care for the millions of patients who will consider lung cancer screening. Given the enormous potential benefits and burdens of lung cancer screening on patients, clinicians, and the healthcare system, it is important to identify and then scale up quality communication practices that positively influence patient-centered care.

Relationship between Nursing Students' Views about Web-Based Patient Education Course and Anxiety in Turkey

ERIC Educational Resources Information Center

Tasocak, Gülsün; Kaya, Hülya; Senyuva, Emine; Isik, Burçin; Bodur, Gönül

2014-01-01

The study was designed as descriptive and cross-sectional to determine the relation between students' views about web-based Patient Education course and anxiety. The study group consisted of all students registered the web-based Patient Education course (N: 148) at 2010-2011 semester at a nursing school. Data were collected using "Information…

Making it work: health care provider perspectives on strategies to increase colorectal cancer screening in federally qualified health centers.

PubMed

Gwede, Clement K; Davis, Stacy N; Quinn, Gwendolyn P; Koskan, Alexis M; Ealey, Jamila; Abdulla, Rania; Vadaparampil, Susan T; Elliott, Gloria; Lopez, Diana; Shibata, David; Roetzheim, Richard G; Meade, Cathy D

2013-12-01

Colorectal cancer screening (CRCS) rates are low among men and women who seek health care at federally qualified health centers (FQHCs). This study explores health care providers' perspectives about their patient's motivators and impediments to CRCS and receptivity to preparatory education. A mixed methods design consisting of in-depth interviews, focus groups, and a short survey is used in this study. The participants of this study are 17 health care providers practicing in FQHCs in the Tampa Bay area. Test-specific patient impediments and motivations were identified including fear of abnormal findings, importance of offering less invasive fecal occult blood tests, and need for patient-centered test-specific educational materials in clinics. Opportunities to improve provider practices were identified including providers' reliance on patients' report of symptoms as a cue to recommend CRCS and overemphasis of clinic-based guaiac stool tests. This study adds to the literature on CRCS test-specific motivators and impediments. Providers offered unique approaches for motivating patients to follow through with recommended CRCS and were receptive to in-clinic patient education. Findings readily inform the design of educational materials and interventions to increase CRCS in FQHCs.

Promoting patient participation in healthcare interactions through communication skills training: A systematic review.

PubMed

D'Agostino, Thomas A; Atkinson, Thomas M; Latella, Lauren E; Rogers, Madeline; Morrissey, Dana; DeRosa, Antonio P; Parker, Patricia A

2017-07-01

To present literature on training patients in the use of effective communication skills. Systematic searches were conducted in six databases. References were screened for inclusion through several phases. Extracted data included intervention study design, sample characteristics, content and structure of training programs, outcomes assessed, and findings reported. A total of 32 unique intervention studies were included. Most targeted primary care or cancer patients and used a randomized controlled study design. Interventions used a variety of training formats and modes of delivering educational material. Reported findings suggest that communication training is an effective approach to increase patients' total level of active participation in healthcare interactions and that some communication behaviors may be more amenable to training (e.g., expressing concerns). Trained patients do not have longer visits and tend to receive more information from their providers. Most studies have found no relationship between communication training and improved health, psychosocial wellbeing, or treatment-related outcomes. Findings reinforce the importance and potential benefits of patient communication training. Additional research is warranted to determine the most efficacious training programs with the strongest potential for dissemination. Copyright © 2017 Elsevier B.V. All rights reserved.

Management Systems, Patient Quality Improvement, Resource Availability, and Substance Abuse Treatment Quality

PubMed Central

Fields, Dail; Roman, Paul M; Blum, Terry C

2012-01-01

Objective To examine the relationships among general management systems, patient-focused quality management/continuous process improvement (TQM/CPI) processes, resource availability, and multiple dimensions of substance use disorder (SUD) treatment. Data Sources/Study Setting Data are from a nationally representative sample of 221 SUD treatment centers through the National Treatment Center Study (NTCS). Study Design The design was a cross-sectional field study using latent variable structural equation models. The key variables are management practices, TQM/continuous quality improvement (CQI) practices, resource availability, and treatment center performance. Data Collection Interviews and questionnaires provided data from treatment center administrative directors and clinical directors in 2007–2008. Principal Findings Patient-focused TQM/CQI practices fully mediated the relationship between internal management practices and performance. The effects of TQM/CQI on performance are significantly larger for treatment centers with higher levels of staff per patient. Conclusions Internal management practices may create a setting that supports implementation of specific patient-focused practices and protocols inherent to TQM/CQI processes. However, the positive effects of internal management practices on treatment center performance occur through use of specific patient-focused TQM/CPI practices and have more impact when greater amounts of supporting resources are present. PMID:22098342

Administering the Sarcoidosis Health Questionnaire to sarcoidosis patients in Serbia.

PubMed

Mihailović-Vučinić, Violeta; Gvozdenović, Branislav; Stjepanović, Mihailo; Vuković, Mira; Marković-Denić, Ljiljana; Milovanović, Aleksandar; Videnović-Ivanov, Jelica; Žugić, Vladimir; Škodrić-Trifunović, Vesna; Filipović, Snežana; Omčikus, Maja

2016-04-01

The aim of this study was to use a Serbian-language version of the disease-specific, self-report Sarcoidosis Health Questionnaire (SHQ), which was designed and originally validated in the United States, to assess health status in sarcoidosis patients in Serbia, as well as validating the instrument for use in the country. This was a cross-sectional study of 346 patients with biopsy-confirmed sarcoidosis. To evaluate the health status of the patients, we used the SHQ, which was translated into Serbian for the purposes of this study. We compared SHQ scores by patient gender and age, as well as by disease duration and treatment. Lower SHQ scores indicate poorer health status. The SHQ scores demonstrated differences in health status among subgroups of the sarcoidosis patients evaluated. Health status was found to be significantly poorer among female patients and older patients, as well as among those with chronic sarcoidosis or extrapulmonary manifestations of the disease. Monotherapy with methotrexate was found to be associated with better health status than was monotherapy with prednisone or combination therapy with prednisone and methotrexate. The SHQ is a reliable, disease-specific, self-report instrument. Although originally designed for use in the United States, the SHQ could be a useful tool for the assessment of health status in various non-English-speaking populations of sarcoidosis patients.

Designing With Empathy: Humanizing Narratives for Inspired Healthcare Experiences.

PubMed

Carmel-Gilfilen, Candy; Portillo, Margaret

2016-01-01

Designers can and should play a critical role in shaping a holistic healthcare experience by creating empathetic design solutions that foster a culture of care for patients, families, and staff. Using narrative inquiry as a design tool, this case study shares strategies for promoting empathy. Designing for patient-centered care infuses empathy into the creative process. Narrative inquiry offers a methodology to think about and create empathetic design that enhances awareness, responsiveness, and accountability. This article shares discoveries from a studio on empathetic design within an outpatient cancer care center. The studio engaged students in narrative techniques throughout the design process by incorporating aural, visual, and written storytelling. Benchmarking, observations, and interviews were merged with data drawn from scholarly evidence-based design literature reviews. Using an empathy-focused design process not only motivated students to be more engaged in the project but facilitated the generation of fresh and original ideas. Design solutions were innovative and impactful in supporting the whole person. Similarities as well as differences defined empathetic cancer care across projects and embodied concepts of design empowerment, design for the whole person, and design for healing. By becoming more conscious of empathy, those who create healthcare environments can better connect holistically to the user to take an experiential approach to design. Explicitly developing a mind-set that raises empathy to the forefront of the design process offers a breakthrough in design thinking that bridges the gap between what might be defined as "good design" and patient-centered care. © The Author(s) 2015.

Optimum Design of Anti-Siphon Device used to Prevent Cerebrospinal Fluid from Overdraining

NASA Astrophysics Data System (ADS)

Jang, Jong Yun; Lee, Chong Sun; Suh, Chang Min

The present study investigated design parameters of an anti-siphon device used with shunt valves to treat patients with hydrocephalus. Structural analyses were performed to understand roles of design variables and optimize performance of the diaphragm-type anti-siphon device (hereafter referred to as the ASD). Experiments were performed on the lab-made product and showed good agreements with the numerical simulations. Using the simulations, we were able to design a more physiological ASD which gave equal opening pressures in both supine and upright postures. Tissue encapsulization phenomenon was also simulated and the results indicated underdrainage of CSF in the upright position of the patient.

Preoperative endoscopic versus percutaneous transhepatic biliary drainage in potentially resectable perihilar cholangiocarcinoma (DRAINAGE trial): design and rationale of a randomized controlled trial.

PubMed

Wiggers, Jimme K; Coelen, Robert J S; Rauws, Erik A J; van Delden, Otto M; van Eijck, Casper H J; de Jonge, Jeroen; Porte, Robert J; Buis, Carlijn I; Dejong, Cornelis H C; Molenaar, I Quintus; Besselink, Marc G H; Busch, Olivier R C; Dijkgraaf, Marcel G W; van Gulik, Thomas M

2015-02-14

Liver surgery in perihilar cholangiocarcinoma (PHC) is associated with high postoperative morbidity because the tumor typically causes biliary obstruction. Preoperative biliary drainage is used to create a safer environment prior to liver surgery, but biliary drainage may be harmful when severe drainage-related complications deteriorate the patients' condition or increase the risk of postoperative morbidity. Biliary drainage can cause cholangitis/cholecystitis, pancreatitis, hemorrhage, portal vein thrombosis, bowel wall perforation, or dehydration. Two methods of preoperative biliary drainage are mostly applied: endoscopic biliary drainage, which is currently used in most regional centers before referring patients for surgical treatment, and percutaneous transhepatic biliary drainage. Both methods are associated with severe drainage-related complications, but two small retrospective series found a lower incidence in the number of preoperative complications after percutaneous drainage compared to endoscopic drainage (18-25% versus 38-60%, respectively). The present study randomizes patients with potentially resectable PHC and biliary obstruction between preoperative endoscopic or percutaneous transhepatic biliary drainage. The study is a multi-center trial with an "all-comers" design, randomizing patients between endoscopic or percutaneous transhepatic biliary drainage. All patients selected to potentially undergo a major liver resection for presumed PHC are eligible for inclusion in the study provided that the biliary system in the future liver remnant is obstructed (even if they underwent previous inadequate endoscopic drainage). Primary outcome measure is the total number of severe preoperative complications between randomization and exploratory laparotomy. The study is designed to detect superiority of percutaneous drainage: a provisional sample size of 106 patients is required to detect a relative decrease of 50% in the number of severe preoperative complications (alpha = 0.95; beta = 0.8). Interim analysis after inclusion of 53 patients (50%) will provide the definitive sample size. Secondary outcome measures encompass the success of biliary drainage, quality of life, and postoperative morbidity and mortality. The DRAINAGE trial is designed to identify a difference in the number of severe drainage-related complications after endoscopic and percutaneous transhepatic biliary drainage in patients selected to undergo a major liver resection for perihilar cholangiocarcinoma. Netherlands Trial Register [ NTR4243 , 11 October 2013].

Lessons Learned During the Conduct of Clinical Studies in The Dental PBRN

PubMed Central

Gilbert, Gregg H.; Richman, Joshua S.; Gordan, Valeria V.; Rindal, D. Brad; Fellows, Jeffrey L.; Benjamin, Paul L.; Wallace-Dawson, Martha; Williams, O. Dale

2012-01-01

Effectively addressing challenges of conducting research in nonacademic settings is crucial to its success. A dental practice-based research network called The Dental Practice-Based Research Network (DPBRN) is comprised of practitioner-investigators in two health maintenance organizations, several universities, many U.S. states, and three Scandinavian countries. Our objective in this article is to describe lessons learned from conducting studies in this research context; the studies are conducted by clinicians in community settings who may be doing their first research study. To date, twenty-one studies have been completed or are in implementation. These include a broad range of topic areas, enrollment sizes, and study designs. A total of 1,126 practitioner-investigators have participated in at least one study. After excluding one study because it involved electronic records queries only, these studies included more than 70,000 patient/participant units. Because the DPBRN is committed to being both practitioner- and patient-driven, all studies must be approved by its Executive Committee and a formal study section of academic clinical scientists. As a result of interacting with a diverse range of institutional and regulatory entities, funding agencies, practitioners, clinic staff, patients, academic scientists, and geographic areas, twenty-three key lessons have been learned. Patients’ acceptance of these studies has been very high, judging from high participation rates and their completion of data forms. Early studies substantially informed later studies with regard to study design, practicality, forms design, informed consent process, and training and monitoring methods. Although time-intensive and complex, these solutions improved acceptability of practice-based research to patients, practitioners, and university researchers. PMID:21460266

A systematic review of reliable and valid tools for the measurement of patient participation in healthcare.

PubMed

Phillips, Nicole Margaret; Street, Maryann; Haesler, Emily

2016-02-01

Patient participation in healthcare is recognised internationally as essential for consumer-centric, high-quality healthcare delivery. Its measurement as part of continuous quality improvement requires development of agreed standards and measurable indicators. This systematic review sought to identify strategies to measure patient participation in healthcare and to report their reliability and validity. In the context of this review, patient participation was constructed as shared decision-making, acknowledging the patient as having critical knowledge regarding their own health and care needs and promoting self-care/autonomy. Following a comprehensive search, studies reporting reliability or validity of an instrument used in a healthcare setting to measure patient participation, published in English between January 2004 and March 2014 were eligible for inclusion. From an initial search, which identified 1582 studies, 156 studies were retrieved and screened against inclusion criteria. Thirty-three studies reporting 24 patient participation measurement tools met inclusion criteria, and were critically appraised. The majority of studies were descriptive psychometric studies using prospective, cross-sectional designs. Almost all the tools completed by patients, family caregivers, observers or more than one stakeholder focused on aspects of patient-professional communication. Few tools designed for completion by patients or family caregivers provided valid and reliable measures of patient participation. There was low correlation between many of the tools and other measures of patient satisfaction. Few reliable and valid tools for measurement of patient participation in healthcare have been recently developed. Of those reported in this review, the dyadic Observing Patient Involvement in Decision Making (dyadic-OPTION) tool presents the most promise for measuring core components of patient participation. There remains a need for further study into valid, reliable and feasible strategies for measuring patient participation as part of continuous quality improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effects of perceptions of care, medical advice, and hospital quality on patient satisfaction after primary total knee replacement: A cross-sectional study.

PubMed

Schaal, Tom; Schoenfelder, Tonio; Klewer, Joerg; Kugler, Joachim

2017-01-01

The increase in the number of patients presenting with osteoarthritis in the past decade has led to a 32% increase in knee replacement surgeries designed to reduce restrictions on patient movement and improve their quality of life. Patient satisfaction is becoming an increasingly important indicator of quality of care. This study was designed to identify predictors of various service components in the treatment process and hospital key performance indicators significantly associated with patient satisfaction. A multicenter cross-sectional study was conducted with 856 patients having their primary total knee replacements at 41 hospitals. Patient satisfaction was queried via a validated, multidimensional questionnaire mainly using a six-point scale. In addition to bivariate calculations, patient satisfaction was the dependent variable in a binary logistic regression model. The bivariate analysis showed a strong association between satisfaction and sex (male or female), the patients' health before admission, and the length of stay. The number of cases treated at each hospital did not reveal any impact on satisfaction. The multivariate analysis identified three predictors associated with overall satisfaction. The strongest factor was the treatment outcome and the weakest was the quality of food. It became apparent that the statutory procedure minimums were not being met. The relevant factors influencing patient satisfaction were partially the same as previous study results and allowed more detailed conclusions. The results provide suggestions across hospitals that could help health care providers better meet needs of patients after knee arthroplasties.

Finding a Middle Ground: Exploring the Impact of Patient- and Family-Centered Design on Nurse-Family Interactions in the Neuro ICU.

PubMed

Rippin, Allyn S; Zimring, Craig; Samuels, Owen; Denham, Megan E

2015-01-01

This comparative study of two adult neuro critical care units examined the impact of patient- and family-centered design on nurse-family interactions in a unit designed to increase family involvement. A growing evidence base suggests that the built environment can facilitate the delivery of patient- and family-centered care (PFCC). However, few studies examine how the PFCC model impacts the delivery of care, specifically the role of design in nurse-family interactions in the adult intensive care unit (ICU) from the perspective of the bedside nurse. Two neuro ICUs with the same patient population and staff, but with different layouts, were compared. Structured observations were conducted to assess changes in the frequency, location, and content of interactions between the two units. Discussions with staff provided additional insights into nurse attitudes, perceptions, and experiences caring for families. Nurses reported challenges balancing the needs of many stakeholders in a complex clinical environment, regardless of unit layout. However, differences in communication patterns between the clinician- and family-centered units were observed. More interactions were observed in nurse workstations in the PFCC unit, with most initiated by family. While the new unit was seen as more conducive to the delivery of PFCC, some nurses reported a loss of workspace control. Patient- and family-centered design created new spatial and temporal opportunities for nurse-family interactions in the adult ICU, thus supporting PFCC goals. However, greater exposure to unplanned family encounters may increase nurse stress without adequate spatial and organizational support. © The Author(s) 2015.

Southampton mealtime assistance study: design and methods

PubMed Central

2013-01-01

Background Malnutrition is common in older people in hospital and is associated with adverse clinical outcomes including increased mortality, morbidity and length of stay. This has raised concerns about the nutrition and diet of hospital in-patients. A number of factors may contribute to low dietary intakes in hospital, including acute illness and cognitive impairment among in-patients. The extent to which other factors influence intake such as a lack of help at mealtimes, for patients who require assistance with eating, is uncertain. This study aims to evaluate the effectiveness of using trained volunteer mealtime assistants to help patients on an acute medical ward for older people at mealtimes. Methods/design The study design is quasi-experimental with a before (year one) and after (year two) comparison of patients on the intervention ward and parallel comparison with patients on a control ward in the same department. The intervention in the second year was the provision of trained volunteer mealtime assistance to patients in the intervention ward. There were three components of data collection that were repeated in both years on both wards. The first (primary) outcome was patients’ dietary intake, collected as individual patient records and as ward-level balance data over 24 hour periods. The second was clinical outcome data assessed on admission and discharge from both wards, and 6 and 12 months after discharge. Finally qualitative data on the views and experience of patients, carers, staff and volunteers was collected through interviews and focus groups in both years to allow a mixed-method evaluation of the intervention. Discussion The study will describe the effect of provision of trained volunteer mealtime assistants on the dietary intake of older medical in-patients. The association between dietary intake and clinical outcomes including malnutrition risk, body composition, grip strength, length of hospital stay and mortality will also be determined. An important component of the study is the use of qualitative approaches to determine the views of patients, relatives, staff and volunteers on nutrition in hospital and the impact of mealtime assistance. Trial registration Trial registered with ClinicalTrials.gov NCTO1647204 PMID:23294981

Advances in Patellofemoral Arthroplasty.

PubMed

Strickland, Sabrina M; Bird, Mackenzie L; Christ, Alexander B

2018-06-01

To describe current indications, implants, economic benefits, comparison to TKA, and functional and patient-reported outcomes of patellofemoral arthroplasty. Modern onlay implants and improved patient selection have allowed for recent improvements in short- and long-term outcomes after patellofemoral joint replacement surgery. Patellofemoral arthroplasty has become an increasingly utilized technique for the successful treatment of isolated patellofemoral arthritis. Advances in patient selection, implant design, and surgical technique have resulted in improved performance and longevity of these implants. Although short- and mid-term data for modern patellofemoral arthroplasties appear promising, further long-term clinical studies are needed to evaluate how new designs and technologies will affect patient outcomes and long-term implant performance.

Integrating emotional and psychological support into the end-stage renal disease pathway: a protocol for mixed methods research to identify patients' lower-level support needs and how these can most effectively be addressed.

PubMed

Taylor, Francesca; Taylor, Celia; Baharani, Jyoti; Nicholas, Johann; Combes, Gill

2016-08-02

As a result of difficulties related to their illness, diagnosis and treatment, patients with end-stage renal disease experience significant emotional and psychological problems, which untreated can have considerable negative impact on their health and wellbeing. Despite evidence that patients desire improved support, management of their psychosocial problems, particularly at the lower-level, remains sub-optimal. There is limited understanding of the specific support that patients need and want, from whom, and when, and also a lack of data on what helps and hinders renal staff in identifying and responding to their patients' support needs, and how barriers to doing so might be overcome. Through this research we therefore seek to determine what, when, and how, support for patients with lower-level emotional and psychological problems should be integrated into the end-stage renal disease pathway. The research will involve two linked, multicentre studies, designed to identify and consider the perspectives of patients at five different stages of the end-stage renal disease pathway (Study 1), and renal staff working with them (Study 2). A convergent, parallel mixed methods design will be employed for both studies, with quantitative and qualitative data collected separately. For each study, the data sets will be analysed separately and the results then compared or combined using interpretive analysis. A further stage of synthesis will employ data-driven thematic analysis to identify: triangulation and frequency of themes across pathway stages; patterns and plausible explanations of effects. There is an important need for this research given the high frequency of lower-level distress experienced by end-stage renal disease patients and lack of progress to date in integrating support for their lower-level psychosocial needs into the care pathway. Use of a mixed methods design across the two studies will generate a holistic patient and healthcare professional perspective that is more likely to identify viable solutions to enable implementation of timely and integrated care. Based on the research outputs, appropriate support interventions will be developed, implemented and evaluated in a linked follow-on study.

A randomised controlled feasibility study investigating the use of eccentric and concentric strengthening exercises in the treatment of rotator cuff tendinopathy

PubMed Central

Adams, Nicola

2014-01-01

Objectives: To conduct a feasibility study to compare concentric and eccentric rotator cuff strengthening exercises for rotator cuff tendinopathy. Methods: A total of 11 patients with rotator cuff tendinopathy who were on the waiting list for arthroscopic subacromial decompression surgery were randomised to perform eccentric rotator cuff strengthening exercises, concentric strengthening exercises or no exercises. Patients were evaluated in terms of levels of pain and function using the Oxford Shoulder Score and a Visual Analogue Scale initially, at 4 weeks and at 8 weeks. Results: The study design was found to be acceptable to patients and achieved a high level of 86% compliance. The drop-out rate was 0%. Two patients performing eccentric strengthening exercises improved sufficiently to cancel their planned surgery. Conclusion: Further research in this area is recommended. The study design was feasible and power calculations have been conducted to aid future research planning. PMID:26770702

Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial.

PubMed

Schein, Aso; Correa, Aps; Casali, Karina Rabello; Schaan, Beatriz D

2016-01-20

Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes. This study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load). Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability. ClinicalTrials.gov NCT02292810 .

The Impact of Patient-to-Patient Interaction in Health Facility Waiting Rooms on Their Perception of Health Professionals.

PubMed

Willis, William Kent; Ozturk, Ahmet Ozzie; Chandra, Ashish

2015-01-01

Patients have to wait in waiting rooms prior to seeing the physician. But there are few studies that demonstrate what they are actually doing in the waiting room. This exploratory study was designed to investigate the types of discussions that patients in the waiting room typically engage in with other patients and how the conversations affected their opinion on general reputation of the clinic, injections/blocks as treatment procedures, waiting time, time spent with the caregiver, overall patient satisfaction, and the pain medication usage policy. The study demonstrates that patient interaction in the waiting room has a positive effect on patient opinion of the pain clinic and the caregivers.

Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care.

PubMed

Nordin, Karin; Rissanen, Ritva; Ahlgren, Johan; Burell, Gunilla; Fjällskog, Marie-Louise; Börjesson, Susanne; Arving, Cecilia

2012-05-04

A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients' quality of life and psychological well-being. ClinicalTrials.gov Identifier: NCT01555645.

Social support, gender and patient delay.

PubMed

Pedersen, A F; Olesen, F; Hansen, R P; Zachariae, R; Vedsted, P

2011-04-12

The purpose of this study was to examine the relationship between perceived social support and patient delay (PD) among female and male cancer patients. A population-based study with register-sampled cancer patients was designed. Patient delay was defined as the time interval between the patient's experience of the first symptom and the first contact with a health-care professional. Both dates were provided by the patients (n=910). The patients completed a purpose-designed questionnaire, which assessed the patient's perceptions of how the partner reacted ('Partner Avoidance' and 'Partner Support') and how others in the social network responded ('Other Avoidance' and 'Other Support') to the patient's worries about the symptoms. The associations between the social support subscales and PD were analysed separately for men and women. In female patients, Partner Support and Other Support were associated with shorter PD, whereas Other Avoidance was associated with longer PD. In the multivariate analysis, Other Avoidance remained associated with longer PD. Moreover, disclosure of symptoms to someone reduced the likelihood of a long PD in female patients. In male patients, none of the social support scales significantly increased or decreased the risk of a long PD in the univariate analysis, but Partner Support significantly decreased risk of a long PD in the multivariate analysis. The results of this study suggest that social support and avoidance from network members influence length of PD differently in male and female cancer patients. This gender difference may explain previous mixed findings obtained in this field.

Quality of Austrian and Dutch Falls-Prevention Information: A Comparative Descriptive Study

ERIC Educational Resources Information Center

Schoberer, Daniela; Mijnarends, Donja M.; Fliedner, Monica; Halfens, Ruud J. G.; Lohrmann, Christa

2016-01-01

Objectives: The aim of this study was to evaluate and compare the quality of written patient information material available in Austrian and Dutch hospitals and nursing homes pertaining to falls prevention. Design: Comparative descriptive study design Setting: Hospitals and nursing homes in Austria and the Netherlands. Method: Written patient…

A comparative analysis between fixed bearing total knee arthroplasty (PFC Sigma) and rotating platform total knee arthroplasty (PFC-RP) with minimum 3-year follow-up.

PubMed

Jawed, Akram; Kumar, Vijay; Malhotra, R; Yadav, C S; Bhan, S

2012-06-01

Since the introduction of mobile bearing total knee designs nearly 30 years back, many studies have been done to evaluate its long-term result. Comparison with fixed bearing designs has been done in the past, but the studies were confounded by variables such as disease, surgeon, bone quality, pain tolerance, etc. We attempt to eliminate these variables in this study. A total of 50 patients who had bilateral arthritis of the knee with similar deformity and pre-operative range of motion on both sides agreed to have one knee replaced with mobile bearing total knee design (PFC-RP) and the other with a fixed bearing design (PFC Sigma) were prospectively evaluated. Comparative analysis of both the designs was done at a mean follow-up of 40 months, minimizing patient, surgeon and observer related bias. Clinical and radiographic outcome, survival and complication rates were compared. At a mean follow-up of 40 months (range 36-47 months), no benefit of mobile bearing (PFC-RP) over fixed bearing design (PFC Sigma) could be demonstrated with respect to Knee Society scores, pain scores, range of flexion, subject preference or patello-femoral complication rates. Radiographs showed no difference in prosthetic alignment. No patient required a revision surgery till last follow-up. Our study demonstrated no advantage of the mobile-bearing arthroplasty over fixed bearing arthroplasty with regard to clinical results at short-term follow-up. However, longer follow-up is necessary to confirm whether these results are sustained.

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

PubMed

Malfait, Simon; Eeckloo, Kristof; Lust, Elisa; Van Biesen, Wim; Van Hecke, Ann

2017-02-01

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design. © 2016 John Wiley & Sons Ltd.

Systematic review: what interventions improve dignity for older patients in hospital?

PubMed

Zahran, Zainab; Tauber, Marcelle; Watson, Holly Howe; Coghlan, Phoebe; White, Sarah; Procter, Sue; Addis, Gulen; Norton, Christine

2016-02-01

To review the evidence for interventions to improve dignity for older patients in acute care. High profile cases have highlighted failure to provide dignified care for older people in hospitals. There is good evidence on what older people consider is important for dignified care and abundant recommendations on improving dignity, but it is unclear which interventions are effective. Narrative systematic review. The Cochrane library, MEDLINE, EMBASE, CINAHL, BNI and HMIC electronic databases were searched for intervention studies of any design aiming to improve inpatients' dignity. The main population of interest was older patients, but the search included all patients. Studies that focused on 'dignity therapy' were excluded. There were no intervention studies found in any country which aimed to improve patient dignity in hospitals which included evaluation of the effect. A narrative overview of papers that described implementing dignity interventions in practice but included no formal evaluation was, therefore, undertaken. Five papers were identified. Three themes were identified: knowing the person; partnership between older people and health care professionals; and, effective communication and clinical leadership. The effect on dignity of improving these is untested. There are currently no studies that have tested interventions to improve the dignity of older people (nor anyone else) in hospitals. Further research using well designed trials of interventions is needed. There is also a need to develop and validate outcome measures for interventions to improve dignity. At present nurses lack robust evidence on how to improve dignity. There is ample evidence on what undermines patients' dignity and there is a need to develop and test interventions designed to improve patient dignity. © 2016 John Wiley & Sons Ltd.

[Clinical characteristics and surgical treatment of idiopathic congenital nystagmus in 224 patients].

PubMed

Ding, J; Zhao, K X; Li, Y P; Ma, H Z; Chen, X; Guo, X; Zhu, L N; Li, N D; Zhang, W

2016-08-01

To study clinical characteristics and surgical treatment of idiopathic congenital nystagmus (ICN). A retrospective study was conducted in 224 patients with ICN in Tianjin eye hospital from July 2007 to February 2013. There were 224 patients, 158 (70.54%) males and 66 (29.5%) females, mean age was (11.6±8.4) years and (11.4±6.4) years separately. Horizontal nystgamus happened in 215 cases, 3 cases were vertical type and 6 cases were mixed. 214 cases were with no history of operation and 10 patients had ever underwent surgeries before. Furthermore, 151 patients combined with strabismus and refractive error, anterior segment or retinal disorders, which accounting for 67.4% of all the patients. 48 patients were associated myopia, 30 patients with hyperopia, 43 patients with strabismus. Among them, 153 cases of compensatory head position direction were horizontal with face turn, 43 cases (43/153, 28.1%) showed face turning to the left, 110 cases (110/153, 71.9%) showed face turning to the right. Surgeries were designed according to the compensatory head position and head retroversion angle. For 15 patients with double intermediate zones, the position which was often used with good visual function was chosen for operation design. As for the patients with nystagmus and strabismus, the transfer null zone to primary position for the dominant eye and strabismus surgery for the other eye was chosen. And for complicated patients with compensative head position, the dominant head posture were designed for surgery. ICN is dominated by male with variable clinical manifestations. Surgical choice for ICN depends on the direction of head position and if there is strabismus accompanying it.The aim of ocular muscle surgery is to transfer null zone to primary position. (Chin J Ophthalmol, 2016, 52: 574-578).

Myofascial treatment for patients with acetabular labral tears: a single-subject research design study.

PubMed

Cashman, Glenn E; Mortenson, W Ben; Gilbart, Michael K

2014-08-01

Single-subject research design using 4 consecutive patients. To assess whether treatment using soft tissue therapy (ART or Active Release Technique), stretching, and strengthening of the hip abductors, hip external rotators, and tensor fascia latae muscles reduces pain and improves self-reported hip function in patients with acetabular labral tears who also have posterolateral hip pain of suspected myofascial origin. Acetabular labral tears cause pain in some but not all patients. Pain commonly presents anteriorly but may also present posteriorly and laterally. The standard of care is arthroscopic repair, which helps many but not all patients. It is possible that these patients may present with extra-articular contributions to their pain, such as myofascial pain, making their clinical presentation more complex. No previous study has assessed soft tissue therapy as a treatment option for this subset of patients. This A-B-A design used repeated measures of the Hip Outcome Score and visual analog scale for pain. Four patients were treated for 6 to 8 weeks, using a combination of soft tissue therapy, stretching, and strengthening for the hip abductors, external rotators, and tensor fascia latae. Data were assessed visually, statistically, and by comparing mean differences before and after intervention. All 4 patients experienced both statistically significant and clinically meaningful improvement in posterolateral hip pain and hip-related function. Three patients also experienced reduction in anteromedial hip pain. Myofascial hip pain may contribute to hip-related symptoms and disability in patients with acetabular labral tears and posterolateral hip pain. These patients may benefit from soft tissue therapy combined with stretching and strengthening exercises targeting the hip abductors, tensor fascia latae, and hip external rotator muscles. Level of Evidence Therapy, level 4.

Mockup design of personal health diary app for patients with chronic kidney disease.

PubMed

Lin, Hsiu-Wen; Wang, Yu-Jen; Jing, Ling-Fang; Chang, Polun

2014-01-01

Health self-management is important in the care of patients with chronic kidney disease. It is possible to improve the efficiency of patient self-management through the use of mobile technology and related software. This study is divided into three stages: 1. analysis of need: through observation, interview and content analysis of the chronic kidney disease health management manual; 2. design of system prototype: establish interface and system function; 3. prototype evaluation: evaluate whether the prototype designed by this study meets user needs. The system prototype includes: daily record, laboratory examination results, trend graphs, information search, sharing, communications and settings. Prototyping is done with Pencil Project for interface design and linking. The prototype is then exported in PDF format for mock-up simulation. Evaluation results: overall score was 4.01±0.60 leaning towards "agree", the highest score was ease of use (4.25±0.6), followed by easy to learn (4.15±0.68), acceptance (4.01±0.61), reliability (3.87±0.6) and functionality (3.83±0.49). The results show positive attitude towards the system.

Differences in orthotic design for thumb osteoarthritis and its impact on functional outcomes: A scoping review.

PubMed

de Almeida, Pedro Henrique Tq; MacDermid, Joy; Pontes, Tatiana Barcelos; Dos Santos-Couto-Paz, Clarissa Cardoso; Matheus, João Paulo Chieregato

2017-08-01

Orthoses are a well-known intervention for the treatment of thumb osteoarthritis; however, there is a multitude of orthotic designs and not enough evidence to support the efficacy of specific models. To examine the influence of different orthoses on pain, hand strength, and hand function of patients with thumb osteoarthritis. Literature review. A scoping literature review of 14 publications reporting orthotic interventions for patients with thumb osteoarthritis was conducted. Functional outcomes and measures were extracted and analyzed. In total, 12 studies reported improvements in pain and hand strength after the use of thumb orthoses. Comparisons between different orthotic designs were inconclusive. The use of orthoses can decrease pain and improve hand function of patients with thumb osteoarthritis; however, the effectiveness of different orthoses still needs support through adequate evidence. Clinical relevance Multiple orthoses for thumb osteoarthritis are available. Although current studies support their use to improve pain and hand function, there is no evidence to support the efficacy of specific orthotic designs. Improved functional outcomes can be achieved through the use of short orthoses, providing thumb stabilization without immobilizing adjacent joints.

Optimal two-stage enrichment design correcting for biomarker misclassification.

PubMed

Zang, Yong; Guo, Beibei

2018-01-01

The enrichment design is an important clinical trial design to detect the treatment effect of the molecularly targeted agent (MTA) in personalized medicine. Under this design, patients are stratified into marker-positive and marker-negative subgroups based on their biomarker statuses and only the marker-positive patients are enrolled into the trial and randomized to receive either the MTA or a standard treatment. As the biomarker plays a key role in determining the enrollment of the trial, a misclassification of the biomarker can induce substantial bias, undermine the integrity of the trial, and seriously affect the treatment evaluation. In this paper, we propose a two-stage optimal enrichment design that utilizes the surrogate marker to correct for the biomarker misclassification. The proposed design is optimal in the sense that it maximizes the probability of correctly classifying each patient's biomarker status based on the surrogate marker information. In addition, after analytically deriving the bias caused by the biomarker misclassification, we develop a likelihood ratio test based on the EM algorithm to correct for such bias. We conduct comprehensive simulation studies to investigate the operating characteristics of the optimal design and the results confirm the desirable performance of the proposed design.

Design and Usability of a Heart Failure mHealth System: A Pilot Study

PubMed Central

Chatterjee, Samir; Alluhaidan, Ala; Lee, Edward; Houston Feenstra, Linda

2017-01-01

Background Despite the advances in mobile health (mHealth) systems, little is known about patients’ and providers’ experiences using a new mHealth system design. Objective This study aimed to understand challenges and provide design considerations for a personalized mHealth system that could effectively support heart failure (HF) patients after they transition into the home environment. Methods Following exploratory interviews with nurses and preventive care physicians, an mHealth system was developed. Patients were asked to measure their weight, blood pressure, and blood glucose (if they had diabetes). They were also instructed to enter symptoms, view notifications, and read messages on a mobile app that we developed. A Bluetooth-enabled weight scale, blood pressure monitor, glucometer, and mobile phone was provided after an introductory orientation and training session. HF nurses used a dashboard to view daily measurements for each patient and received text and email alerts when risk was indicated. Observations of usage, cases of deterioration, readmissions, and metrics related to system usability and quality of life outcomes were used to determine overall effectiveness of the system, whereas focus group sessions with patients were conducted to elicit participants’ feedback on the system’s design. Results A total of 8 patients with HF participated over a 6-month period. Overall, the mean users’ satisfaction with the system ranked 73%, which was above average. Quality of life improvement was 3.6. Patients and nurses used the system on a regular basis and were able to successfully identify and manage 8 health deteriorations, of which 5 were completely managed remotely. Focus groups revealed that, on one hand, the system was beneficial and helped patients with: recording and tracking readings; receiving encouragement and reassurance from nurses; spotting and solving problems; learning from past experiences; and communication. On the other hand, findings also highlighted design issues and recommendations for future systems such as the need to communicate via other media, personalize symptom questions and messages, integrate other health tracking technologies, and provide additional methods to analyze and visualize their data. Conclusions Understanding users’ experiences provides important design considerations that could complement existing design recommendations from the literature, and, when combined with physician and nurse requirements, have the potential to yield a feasible telehealth system that is effective in supporting HF self-care. Future studies will include these guidelines and use a larger sample size to validate the outcomes. PMID:28341615

Bayesian adaptive phase II screening design for combination trials

PubMed Central

Cai, Chunyan; Yuan, Ying; Johnson, Valen E

2013-01-01

Background Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Methods Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Results Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. Limitations The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. Conclusions The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial. PMID:23359875

Accessibility and Barriers to Oncology Appointments at 40 National Cancer Institute-Designated Comprehensive Cancer Centers: Results of a Mystery Shopper Project.

PubMed

Hamlyn, Geoffrey S; Hutchins, Kathryn E; Johnston, Abby L; Thomas, Rishonda T; Tian, James; Kamal, Arif H

2016-10-01

Patients turn to National Cancer Institute (NCI) -designated comprehensive cancer centers because of perceived better quality and more timely access to care. However, recent studies have found that patients at various institutions may struggle to gain access to an appointment or obtain consistent information from attendants. Our study employs a mystery shopper format to identify and quantify barriers faced by patients seeking to make a first consultation appointment across a homogenous sample of 40 NCI-designated comprehensive cancer centers. Five mystery shoppers used a standardized call script to inquire about first available appointment times and service offerings. When inquiring about a date for a first available appointment, 29% of callers were unable to secure an estimated date without registering into the center's database, 51% were able to secure an estimated date, and 20% were provided with an actual date. Of estimated or actual dates for a first available appointment, 74% were greater than 1 week away. There was no statistically significant variation between appointment availability across insurance type or US region. Our study highlights the difficulty of accessing information about appointment availability. Although not statistically significant, inquiries regarding first available appointments for Medicaid patients resulted in longer estimated or actual wait times than those for patients with private insurance, and Medicaid shoppers noted qualitative differences. Although our study was limited by small sample size and imperfect analytic methods, our results suggest the need for more efficient and accessible care for patients at our nation's top cancer centers.

How does the environment impact on the quality of life of advanced cancer patients? A qualitative study with implications for ward design.

PubMed

Rowlands, J; Noble, S

2008-09-01

It is well recognized that the ward environment has an effect on patients' quality of life and may, therefore, impact on the quality of end of life care. The body of evidence that informs ward design policy recommends single-bedded rooms on grounds of reduced infection risk, noise and versatility. Considering the majority of anticipated patient deaths occurring in hospitals, the quality of life aspects of ward design should also be considered. The aim of this study is to explore the views of patients with advanced cancer on the effect the ward environment has on their overall well-being. Semi-structured interviews exploring the experiences of 12 inpatients at a regional cancer centre were recorded and transcribed verbatim. Transcripts were analysed for emerging themes until theoretical saturation. Four major themes emerged: staff behaviours, the immediate environment, single vs. multi-bedded rooms and contact with the outside environment. The attitude, competence and helpfulness of the staff creates the atmosphere of the ward regardless of layout, furnishings, equipment and décor. The majority of the patients in this study expressed a strong preference for a multi-bedded room when they were well enough to interact and a single cubicle when they were very ill or dying, which opposes the current advice for building new hospitals with all single rooms. Although the current policy recommends the use of single-bedded rooms, this study suggests the need for a mix of multi-bedded wards and single rooms with respect to the impact of the environment on patient quality of life.

Assessment of the psychopathological effects of a horticultural therapy program in patients with schizophrenia.

PubMed

Oh, Yun-Ah; Park, Sin-Ae; Ahn, Byung-Eun

2018-02-01

This study assessed the psychopathological effects of participation in a 10-session horticultural therapy program in patients with schizophrenia. The study design was pre and post test design of experimental and control groups. Twenty-eight Korean patients with schizophrenia, recruited from a mental health clinic and two mental health rehabilitation centers in Suwon, South Korea, were voluntarily assigned to either a control group (average age: 33.4±9.4years) or a horticultural therapy group (average age: 42.1±13.0years). The participants in the horticultural therapy group participated in a 10-session horticultural therapy program designed around various plant cultivating activities. The horticultural therapy program involved sessions once a week from April 2017 to June 2017. A psychiatrist evaluated the psychopathological symptoms of schizophrenic patients in both groups. To assess the clinical psychopathological effects, the Korean version of the Positive and Negative Syndrome Scale (PANSS) and Brief Psychiatric Rating Scale (BPRS) were used. The horticultural therapy group significantly improved in terms of positive, negative, and general symptoms on the PANSS after the 10-session horticultural therapy program. Moreover, the horticultural therapy group significantly improved in terms of clinical symptoms of schizophrenia in BPRS after the 10-session horticultural therapy program. However, there was no change in the PANSS and BPRS scores in the control group. This study showed the potential of horticultural therapy in improving psychopathological symptoms in psychiatric patients. Future studies should investigate the effects of long-term horticultural therapy program on the chronic symptoms of patients with schizophrenia. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.

PubMed

Anderson, Robert M; Funnell, Martha M; Nwankwo, Robin; Gillard, Mary Lou; Oh, Mary; Fitzgerald, J Thomas

2005-01-01

The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes. The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation. Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values. We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.

Evaluating hospital design from an operations management perspective.

PubMed

Vos, Leti; Groothuis, Siebren; van Merode, Godefridus G

2007-12-01

This paper describes an evaluation method for the assessment of hospital building design from the viewpoint of operations management to assure that the building design supports the efficient and effective operating of care processes now and in the future. The different steps of the method are illustrated by a case study. In the case study an experimental design is applied to assess the effect of used logistical concepts, patient mix and technologies. The study shows that the evaluation method provides a valuable tool for the assessment of both functionality and the ability to meet future developments in operational control of a building design.

Using Human Factors Methods to Design a New Interface for an Electronic Medical Record

PubMed Central

Saleem, Jason J.; Patterson, Emily S.; Militello, Laura; Asch, Steven M.; Doebbeling, Bradley N.; Render, Marta L.

2007-01-01

The Veterans Health Administration (VHA) is a leader in development and use of electronic patient records and clinical decision support. The VHA is currently reengineering a somewhat dated platform for its Computerized Patient Record System (CPRS). This process affords a unique opportunity to implement major changes to the current design and function of the system. We report on two human factors studies designed to provide input and guidance during this reengineering process. One study involved a card sort to better understand how providers tend to cognitively organize clinical data, and how that understanding can help guide interface design. The other involved a simulation to assess the impact of redesign modifications on computerized clinical reminders, a form of clinical decision support in the CPRS, on the learnability of the system for first-time users. PMID:18693914

Overcoming obstacles in the design of cancer anorexia/weight loss trials.

PubMed

Le-Rademacher, Jennifer G; Crawford, Jeffrey; Evans, William J; Jatoi, Aminah

2017-09-01

Most advanced cancer patients suffer loss of appetite (anorexia) and loss of weight. Despite the fact that cancer anorexia and weight loss are associated with a poor prognosis and detract from quality of life, no interventions have been demonstrated to palliate this syndrome in its entirety, particularly in patients with treatment-refractory malignancies. Recently, two registration trials - one with anamorelin and another with enobosarm - failed to reach their primary endpoints, thus raising questions. Were both these agents ineffective? Alternatively, did study design issues compromise the ability of these trials to identify effective agents? Thus, this review is timely insofar it serves as an introduction to study design, offers guidance on how to test promising agents for cancer anorexia/weight loss, and provides advice for overcoming trial design obstacles. Copyright © 2017 Elsevier B.V. All rights reserved.

Haptic-based perception-empathy biofeedback system for balance rehabilitation in patients with chronic stroke: Concepts and initial feasibility study.

PubMed

Yasuda, Kazuhiro; Saichi, Kenta; Kaibuki, Naomi; Harashima, Hiroaki; Iwata, Hiroyasu

2018-05-01

Most individuals have sensory disturbances post stroke, and these deficits contribute to post-stroke balance impairment. The haptic-based biofeedback (BF) system appears to be one of the promising tools for balance rehabilitation in patients with stroke, and the BF system can increase the objectivity of feedback and encouragement than that provided by a therapist. Studies in skill science indicated that feedback or encouragement from a coach or trainer enhances motor learning effect. Nevertheless, the optimal BF system (or its concept) which would refine the interpersonal feedback between patients and therapist has not been proposed. Thus, the purpose of this study was to propose a haptic-based perception-empathy BF system which provides information regarding the patient's center-of-foot pressure (CoP) pattern to the patient and the physical therapist to enhance the motor learning effect and validate the feasibility of this balance-training regimen in patients with chronic stroke. This study used a pre-post design without control group. Nine chronic stroke patients (mean age: 64.4 ± 9.2 years) received a balance-training regimen using this BF system twice a week for 4 weeks. Testing comprised quantitative measures (i.e., CoP) and clinical balance scale (Berg Balance Scale, BBS; Functional Reach Test, FRT; and Timed-Up and Go test, TUG). Post training, patients demonstrated marginally reduced postural spatial variability (i.e., 95% confidence elliptical area), and clinical balance performance significantly improved at post-training. Although the changes in FRT and TUG exceeded the minimal detectable change (MDC), changes in BBS did not reach clinical significance (i.e., smaller than MDC). These results may provide initial knowledge (i.e., beneficial effects, utility and its limitation) of the proposed BF system in designing effective motor learning strategies for stroke rehabilitation. More studies are required addressing limitations due to research design and training method for future clinical use. Copyright © 2018 Elsevier B.V. All rights reserved.

Progressive addition spectacle lenses: Design preferences and head movements while reading

NASA Astrophysics Data System (ADS)

Preston, Julie Lynn

In a subjective preference study, two key progressive addition lens parameters, near zone width and corridor length, were varied in a double-masked, randomized, clinical trial of 49 patients. Each subject received a complete eye examination and a new frame. Each wore 6 pairs of lenses for one week at a time and completed questionnaires relating to vision, adaptation, and satisfaction. The preferred lens was identified from the three near zone width lenses and from the three corridor length lenses. Patient characteristics were analyzed for their effect on design preference. Satisfaction ratings following a brief experience with each design were compared to ratings after one week of wear in order to ascertain the predictability of initial impressions. One lens design appeared twice in the preference trial, providing an assessment of the repeatability of the rating instrument. The lens design with the widest near zone was rated significantly lower than the other near zone width designs for nearly every question relating to vision, adaptation, and satisfaction. This lens was also least preferred of all the designs. Preferences for corridor length were evenly distributed among the three designs. Of patient characteristics, years of progressive addition lens wear and gender significantly affected design preference in this population. Initial impressions were not predictive of satisfaction after a week of wear. The rating instrument was judged to have low repeatability. In the head movement portion of the study, 18 participants from the preference study wore the three near zone width designs while reading three paragraphs of varying print size. From a 20 second recording for each of three different paragraphs with each lens, measures of head rotation and posture were collected. The amplitude of head rotation was significantly affected by print size but not by lens design. The effective zone widths on the lenses scanned by the eyes and the locations of the reading levels were calculated from the head rotation and posture data. Effective zone widths were narrower than the contour plot widths for each condition.

Physician Interactions with Electronic Health Records in Primary Care

PubMed Central

Montague, Enid; Asan, Onur

2013-01-01

Objective It is essential to design technologies and systems that promote appropriate interactions between physicians and patients. This study explored how physicians interact with Electronic Health Records (EHRs) to understand the qualities of the interaction between the physician and the EHR that may contribute to positive physician-patient interactions. Study Design Video-taped observations of 100 medical consultations were used to evaluate interaction patterns between physicians and EHRs. Quantified observational methods were used to contribute to ecological validity. Methods Ten primary care physicians and 100 patients from five clinics participated in the study. Clinical encounters were recorded with video cameras and coded using a validated objective coding methodology in order to examine how physicians interact with electronic health records. Results Three distinct styles were identified that characterize physician interactions with the EHR: technology-centered, human-centered, and mixed. Physicians who used a technology-centered style spent more time typing and gazing at the computer during the visit. Physicians who used a mixed style shifted their attention and body language between their patients and the technology throughout the visit. Physicians who used the human-centered style spent the least amount of time typing and focused more on the patient. Conclusion A variety of EHR interaction styles may be effective in facilitating patient-centered care. However, potential drawbacks of each style exist and are discussed. Future research on this topic and design strategies for effective health information technology in primary care are also discussed. PMID:24009982

Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study.

PubMed

Wu, Li-Tzy; Brady, Kathleen T; Spratt, Susan E; Dunham, Ashley A; Heidenfelder, Brooke; Batch, Bryan C; Lindblad, Robert; VanVeldhuisen, Paul; Rusincovitch, Shelley A; Killeen, Therese K; Ghitza, Udi E

2016-01-01

The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs. We describe the study design, which explores the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. Our study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention. By capitalizing on an existing T2DM project that uses home-based primary care, our study results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

SMSaúde: Design, Development, and Implementation of a Remote/Mobile Patient Management System to Improve Retention in Care for HIV/AIDS and Tuberculosis Patients.

PubMed

Nhavoto, José António; Grönlund, Åke; Chaquilla, Walter Ponce

2015-03-09

The widespread and low cost of mobile phones and the convenience of short message service (SMS) text messaging suggest potential suitability for use with alternative strategies for supporting retention in care and adherence to the treatment of various chronic diseases, such as HIV and tuberculosis (TB). Despite the growing body of literature reporting positive outcomes of SMS text message-based communication with patients, there is yet very little research about the integration of communication technologies and electronic medical records or electronic patient tracking systems. To design, develop, and implement an integrated mobile phone text messaging system used to follow up with patients with HIV and TB in treatment in Mozambique. Following the design science research methodology, we developed a Web-based system that provides support to patients. A case study involving three health care sites in Mozambique was a basis for discussing design issues for this kind of system. We used brainstorming techniques to solicit usability requirements, focus group meetings to discuss and define system architecture, and prototyping to test in real environments and to improve the system. We found six sets of system requirements that need to be addressed for success: data collection, telecommunication costs, privacy and data security, text message content, connectivity, and system scalability. A text messaging system was designed and implemented in three health facilities. These sites feed data into a central data repository, which can be used for analysis of operations and decision support. Based on the treatment schedule, the system automatically sent SMS text message appointment reminders, medication reminders, as well as motivational and educational messages to patients enrolled in antiretroviral therapy and TB treatment programs. We successfully defined the requirements for, designed, and implemented a mobile phone text messaging system to support HIV and TB treatments. Implementation of this system could improve patients' self-management skills and strengthen communication between patients and health care providers.

Undertriage in older emergency department patients--tilting against windmills?

PubMed

Grossmann, Florian F; Zumbrunn, Thomas; Ciprian, Sandro; Stephan, Frank-Peter; Woy, Natascha; Bingisser, Roland; Nickel, Christian H

2014-01-01

The aim of this study was to investigate the long-term effect of a teaching intervention designed to reduce undertriage rates in older ED patients. Further, to test the hypothesis that non-adherence to the Emergency Severity Index (ESI) triage algorithm is associated with undertriage. Additionally, to detect patient related risk factors for undertriage. Pre-post-test design. The study sample consisted of all patients aged 65 years or older presenting to the ED of an urban tertiary and primary care center in the study periods. A teaching intervention designed to increase adherence to the triage algorithm. To assess, if the intervention resulted in an increase of factual knowledge, nurses took a test before and immediately after the teaching intervention. Undertriage rates were assessed one year after the intervention and compared to the pre-test period. In the pre-test group 519 patients were included, and 394 in the post-test-group. Factual knowledge among triage nurses was high already before the teaching intervention. Prevalence of undertriaged patients before (22.5%) and one year after the intervention (24.2%) was not significantly different (χ2 = 0.248, df = 1, p = 0.619). Sex, age, mode of arrival, and type of complaint were not identified as independent risk factors for undertriage. However, undertriage rates increased with advancing age. Adherence to the ESI algorithm is associated with correct triage decisions. Undertriage of older ED patients remained unchanged over time. Reasons for undertriage seem to be more complex than anticipated. Therefore, additional contributing factors should be addressed.

Three-Dimensional Planning in Maxillofacial Fracture Surgery: Computer-Aided Design/Computer-Aided Manufacture Surgical Splints by Integrating Cone Beam Computerized Tomography Images Into Multislice Computerized Tomography Images.

PubMed

Ren, Jiayin; Zhou, Zhongwei; Li, Peng; Tang, Wei; Guo, Jixiang; Wang, Hu; Tian, Weidong

2016-09-01

This study aimed to evaluate an innovative workflow for maxillofacial fracture surgery planning and surgical splint designing. The maxillofacial multislice computerized tomography (MSCT) data and dental cone beam computerized tomography (CBCT) data both were obtained from 40 normal adults and 58 adults who suffered fractures. The each part of the CBCT dentition image was registered into MSCT image by the use of the iterative closest point algorithm. Volume evaluation of the virtual splints that were designed by the registered MSCT images and MSCT images of the same object was performed. Eighteen patients (group 1) were operated without any splint. Twenty-one (group 2) and 19 patients (group 3) used the splints designed according to the MSCT images and registered MSCT images, respectively. The authors' results showed that the mean errors between the 2 models ranged from 0.53 to 0.92 mm and the RMS errors ranged from 0.38 to 0.69 mm in fracture patients. The mean errors between the 2 models ranged from 0.47 to 0.85 mm and the RMS errors ranged from 0.33 to 0.71 mm in normal adults. 72.22% patients in group 1 recovered occlusion. 85.71% patients in group 2, and 94.73% patients in group 3 reconstructed occlusion. There was a statistically significant difference between the MSCT images based splints' volume and the registered MSCT splints' volume in patients (P <0.05). The MSCT images based splints' volume was statistically significantly distinct from the registered MSCT splints' volume in normal adults (P <0.05). There was a statistically significant difference between the MSCT images based splints' volume and the registered MSCT splints' volume in patients and normal adults (P <0.05). The occlusion recovery rate of group 3 was better than that of group 1 and group 2. The way of integrating CBCT images into MSCT images for splints designing was feasible. The volume of the splints designed by MSCT images tended to be smaller than the splints designed by the integrated MSCT images. The patients operated with splints tended to regain occlusion. The patients who were operated with the splints which were designed according to registered MSCT images tended to get occlusal recovered.

Evaluating the Usability and Usefulness of a Mobile App for Atrial Fibrillation Using Qualitative Methods: Exploratory Pilot Study

PubMed Central

Mansour, Moussa; Sperber, Jodi; Agboola, Stephen; Kvedar, Joseph; Jethwani, Kamal

2018-01-01

Background Atrial fibrillation (AFib) is the most common form of heart arrhythmia and a potent risk factor for stroke. Nonvitamin K antagonist oral anticoagulants (NOACs) are routinely prescribed to manage AFib stroke risk; however, nonadherence to treatment is a concern. Additional tools that support self-care and medication adherence may benefit patients with AFib. Objective The aim of this study was to evaluate the perceived usability and usefulness of a mobile app designed to support self-care and treatment adherence for AFib patients who are prescribed NOACs. Methods A mobile app to support AFib patients was previously developed based on early stage interview and usability test data from clinicians and patients. An exploratory pilot study consisting of naturalistic app use, surveys, and semistructured interviews was then conducted to examine patients’ perceptions and everyday use of the app. Results A total of 12 individuals with an existing diagnosis of nonvalvular AFib completed the 4-week study. The average age of participants was 59 years. All participants somewhat or strongly agreed that the app was easy to use, and 92% (11/12) reported being satisfied or very satisfied with the app. Participant feedback identified changes that may improve app usability and usefulness for patients with AFib. Areas of usability improvement were organized by three themes: app navigation, clarity of app instructions and design intent, and software bugs. Perceptions of app usefulness were grouped by three key variables: core needs of the patient segment, patient workflow while managing AFib, and the app’s ability to support the patient’s evolving needs. Conclusions The results of this study suggest that mobile tools that target self-care and treatment adherence may be helpful to AFib patients, particularly those who are newly diagnosed. Additionally, participant feedback provided insight into the varied needs and health experiences of AFib patients, which may improve the design and targeting of the intervention. Pilot studies that qualitatively examine patient perceptions of usability and usefulness are a valuable and often underutilized method for assessing the real-world acceptability of an intervention. Additional research evaluating the AFib Connect mobile app over a longer period, and including a larger, more diverse sample of AFib patients, will be helpful for understanding whether the app is perceived more broadly to be useful and effective in supporting patient self-care and medication adherence. PMID:29549073

Health facilities humanisation: design guidelines supported by statistical evidence.

PubMed

Bosia, Daniela; Marino, Donatella; Peretti, Gabriella

2016-01-01

Healthcare building humanisation is currently a widely debated issue and the development of patient centered and evidence based design is growing worldwide. Many international health organizations and researchers understand the importance of Patient Centred Design and leading architects incorporate it into the design process. In Italy this design approach is still at an early stage. The article refers to research commissioned by the Italian Health Ministry and carried out by R. Del Nord (Università degli Studi di Firenze) and G. Peretti (Politecnico di Torino) with their collaborators. The scope of the research was the definition of design guidelines for healthcare facilities humanisation. The methodology framework adopted is the well established need and performance approach in architectural design. The article deals with the results of statistical investigations for the definition and ranking of users' needs and the consistent expression of their requirements. The investigations were carried out with the cooperation of psychologists of the Università degli Studi di Torino and researchers of the Università degli Studi di Cagliari. The proposed evaluation system allows ranking of health facilities according to the level of humanisation achieved. The statistical investigation evidence collected allowed the definition of humanisation design guidelines for health-care facilities and for the assessment of their specific level of humanisation.

The Relationship between Assessment and Alcohol Treatment.

ERIC Educational Resources Information Center

Maisto, Stephen A.; Nirenberg, Ted D.

The matching hypothesis, presented in this study, predicts that designing treatment according to patient characteristics leads to better outcomes. A study was conducted to collect data on current practices of patient-treatment matching in alcohol treatment. A questionnaire was completed by 70 directors of Veterans Administration inpatient alcohol…

Are patients open to elective re-sampling of their glioblastoma? A new way of assessing treatment innovations.

PubMed

Mir, Taskia; Dirks, Peter; Mason, Warren P; Bernstein, Mark

2014-10-01

This is a qualitative study designed to examine patient acceptability of re-sampling surgery for glioblastoma multiforme (GBM) electively post-therapy or at asymptomatic relapse. Thirty patients were selected using the convenience sampling method and interviewed. Patients were presented with hypothetical scenarios including a scenario in which the surgery was offered to them routinely and a scenario in which the surgery was in a clinical trial. The results of the study suggest that about two thirds of the patients offered the surgery on a routine basis would be interested, and half of the patients would agree to the surgery as part of a clinical trial. Several overarching themes emerged, some of which include: patients expressed ethical concerns about offering financial incentives or compensation to the patients or surgeons involved in the study; patients were concerned about appropriate communication and full disclosure about the procedures involved, the legalities of tumor ownership and the use of the tumor post-surgery; patients may feel alone or vulnerable when they are approached about the surgery; patients and their families expressed immense trust in their surgeon and indicated that this trust is a major determinant of their agreeing to surgery. The overall positive response to re-sampling surgery suggests that this procedure, if designed with all the ethical concerns attended to, would be welcomed by most patients. This approach of asking patients beforehand if a treatment innovation is acceptable would appear to be more practical and ethically desirable than previous practice.

Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function

PubMed Central

2010-01-01

Background The main hypothesis of this study is that neutral pH, low glucose degradation product (GDP) peritoneal dialysis (PD) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate. Methods/Design Inclusion criteria are adult PD patients (CAPD or APD) aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR ≥ 5 ml/min/1.73 m2, a urine output ≥ 400 ml/day and an ability to understand the nature and requirements of this trial. Pregnant or lactating patients or individuals with an active infection at the time of enrolment, a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded. Patients will be randomized 1:1 to receive either neutral pH, low GDP dialysis solution (Balance®) or conventional dialysis solution (Stay.safe®) for a period of 2 years. During this 2 year study period, urinary urea and clearance measurements will be performed at 0, 3, 6, 9, 12, 18 and 24 months. The primary outcome measure will be the slope of residual renal function decline, adjusted for centre and presence of diabetic nephropathy. Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria, peritoneal small solute clearance, peritoneal transport status, peritoneal ultrafiltration, technique survival, patient survival, peritonitis rates and adverse events. A total of 185 patients has been recruited into the trial. Discussion This investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients. Trial Registration Australian New Zealand Clinical Trials Registry Number: ACTRN12606000044527 PMID:20843375

Validation of a model to evaluate the role of radiographs in the diagnosis and treatment planning of periodontal diseases.

PubMed

Tugnait, A; Hirschmann, P N; Clerehugh, V

2006-08-01

The purposes of this study were (i) to see if an indirect method of design (paper patients) could be developed for study of change affected by radiographs on diagnostic outcome and planned treatment of periodontal patients and (ii) to investigate the effect of the nature of clinical examination on the value of radiographs in reaching a periodontal diagnosis. Paper cases could allow the design of examiner blind studies where repeatability could be assessed. 201 patients were assigned to one of four groups and clinically assessed according to group specifications. Radiographs were taken. Periodontal diagnoses and treatment plans were drawn up for each patient with and without radiographic information (real patient). Simulated paper transcriptions were made for each subject and diagnoses and treatment plans were again drawn up (paper patient). For many diagnoses and treatment options assessments were similar for real and paper patients. There was substantial agreement between periodontal diagnoses reached from real and paper assessments (kappa=0.68). Greater differences were seen for extractions and periodontal surgery. Paper assessments better replicated real assessments when more thorough clinical examinations were undertaken. The relatively time efficient Group 2 clinical assessment appeared to perform similarly to the extensive Group 4 clinical assessment. The model described may be useful for simulating real patients for studies of this nature. The Group 2 assessment appeared to give sufficient clinical information for patient management and may be an appropriate choice for initial diagnosis and treatment planning of periodontal patients.

Pre-Visit Prioritization for Complex Patients with Diabetes: Randomized Trial Design and Implementation within an Integrated Health Care System

PubMed Central

Grant, Richard W; Uratsu, Connie S; Hansen, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-01-01

Background/Aims Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. Methods We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. Results This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015 – 6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) Navigating research vs. quality improvement requirements; (2) Addressing informed consent considerations; and (3) Introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for “self-learning health system” research. Conclusions By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. PMID:26820612

Feasibility of a novel mHealth management system to capture and improve medication adherence among adolescents with asthma.

PubMed

Cushing, Anna; Manice, Melissa P; Ting, Andrew; Parides, Michael K

2016-01-01

Currently, 7.1 million children in the United States have asthma. Nonadherence to daily controller asthma medication is common, leading to more severe symptoms, overuse of rescue medication, and increased hospitalizations. The purpose of this study was to develop and evaluate the feasibility and acceptability of a novel mHealth management system composed of a sensored device, which is connected to mobile phone app that is designed to monitor and improve asthma medication adherence. The asthma management system was designed using well-established behavioral theory. Seven adolescents aged 11-18 years were enrolled and given an adherence sensor, and four of those also received a mobile phone app with game features and reminders. Five patients completed the study, and one was lost to follow-up in each group. Mobile app users and their parents participated in focus groups to assess patient preferences. Feasibility was assessed by the ability of sensors to capture real-time medication data. Acceptability was assessed by patient questionnaire and focus group analysis. Successful upload of real-time data from six of seven inhaler sensors to the HIPAA-compliant server demonstrates the feasibility of at-home patient monitoring using the sensor device. All three mobile app users who completed the study reported interest in continued use of the management system and would recommend the app to friends. Unstructured interviews and focus groups revealed that patients felt that the intervention helped their sense of asthma control. This study demonstrates the feasibility of using the sensor device to remotely monitor real-time medication usage, and user feedback demonstrates the acceptability of the intervention for patient use. The findings provide guidance for the improvement of study design and technology development. Further research is needed to assess the efficacy of the intervention.

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

PubMed

Grant, Richard W; Uratsu, Connie S; Estacio, Karen R; Altschuler, Andrea; Kim, Eileen; Fireman, Bruce; Adams, Alyce S; Schmittdiel, Julie A; Heisler, Michele

2016-03-01

Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations. Copyright © 2016 Elsevier Inc. All rights reserved.

Healing environments in cancer treatment and care. Relations of space and practice in hematological cancer treatment.

PubMed

Høybye, Mette Terp

2013-02-01

Given the growing attention to the importance of design in shaping healing hospital environments this study extends the understanding of healing environments, beyond causal links between environmental exposure and health outcome by elucidating how environments and practices interrelate. The study was conducted as an ethnographic fieldwork from March 2011 to September 2011 at the Department of Haematology at Odense University Hospital, Denmark, systematically using participant observation and interviews as research strategies. It included 20 patients, four of who were followed closely over an extended time period. Through thematic analysis five key concepts emerged about the social dynamics of hospital environments: practices of self; creating personal space; social recognition; negotiating space; and ambiguity of space and care. Through these concepts, the study demonstrates how the hospital environment is a flow of relations between space and practice that changes and challenges a structural idea of design and healing. Patients' sense of healing changes with the experience of progression in treatment and the capacity of the hospital space to incite an experience of homeliness and care. Furthermore, cancer patients continuously challenge the use and limits of space by individual objects and practices of privacy and home. Healing environments are complex relations between practices, space and care, where recognition of the individual patient's needs, values and experiences is key to developing the environment to support the patient quality of life. The present study holds implications for practice to inform design of future hospital environments for cancer treatment. The study points to the importance for being attentive to the need for flexible spaces in hospitals that recognize the dynamics of healing, by providing individualized care, relating to the particular and changing needs of patients supporting their potential and their challenged condition with the best care possible.

The cost effectiveness of an early transition from hospital to nursing home for stroke patients: design of a comparative study.

PubMed

Heijnen, Ron W H; Evers, Silvia M A A; van der Weijden, Trudy D E M; Limburg, Martien; Schols, Jos M G A

2010-05-26

As the incidence of stroke has increased, its impact on society has increased accordingly, while it continues to have a major impact on the individual. New strategies to further improve the quality, efficiency and logistics of stroke services are necessary. Early discharge from hospital to a nursing home with an adequate rehabilitation programme could help to optimise integrated care for stroke patients.The objective is to describe the design of a non-randomised comparative study evaluating early admission to a nursing home, with multidisciplinary assessment, for stroke patients. The study is comprised of an effect evaluation, an economic evaluation and a process evaluation. The design involves a non-randomised comparative trial for two groups. Participants are followed for 6 months from the time of stroke. The intervention consists of a redesigned care pathway for stroke patients. In this care pathway, patients are discharged from hospital to a nursing home within 5 days, in comparison with 12 days in the usual situation. In the nursing home a structured assessment takes place, aimed at planning adequate rehabilitation. People in the control group receive the usual care. The main outcome measures of the effect evaluation are quality of life and daily functioning. In addition, an economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention as well as the experiences and opinions of patients and professionals. The results of this study will provide information about the cost effectiveness of the intervention and its effects on clinical outcomes and quality of life. Relevant strengths and weaknesses of the study are addressed in this article. Current Controlled Trails ISRCTN58135104.

Evaluate the Feasibility of Using Frontal SSVEP to Implement an SSVEP-Based BCI in Young, Elderly and ALS Groups.

PubMed

Hsu, Hao-Teng; Lee, I-Hui; Tsai, Han-Ting; Chang, Hsiang-Chih; Shyu, Kuo-Kai; Hsu, Chuan-Chih; Chang, Hsiao-Huang; Yeh, Ting-Kuang; Chang, Chun-Yen; Lee, Po-Lei

2016-05-01

This paper studies the amplitude-frequency characteristic of frontal steady-state visual evoked potential (SSVEP) and its feasibility as a control signal for brain computer interface (BCI). SSVEPs induced by different stimulation frequencies, from 13 ~ 31 Hz in 2 Hz steps, were measured in eight young subjects, eight elders and seven ALS patients. Each subject was requested to participate in a calibration study and an application study. The calibration study was designed to find the amplitude-frequency characteristics of SSVEPs recorded from Oz and Fpz positions, while the application study was designed to test the feasibility of using frontal SSVEP to control a two-command SSVEP-based BCI. The SSVEP amplitude was detected by an epoch-average process which enables artifact-contaminated epochs can be removed. The seven ALS patients were severely impaired, and four patients, who were incapable of completing our BCI task, were excluded from calculation of BCI performance. The averaged accuracies, command transfer intervals and information transfer rates in operating frontal SSVEP-based BCI were 96.1%, 3.43 s/command, and 14.42 bits/min in young subjects; 91.8%, 6.22 s/command, and 6.16 bits/min in elders; 81.2%, 12.14 s/command, and 1.51 bits/min in ALS patients, respectively. The frontal SSVEP could be an alternative choice to design SSVEP-based BCI.

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study.

PubMed

Porzig, Ralf; Neugebauer, Sina; Heckmann, Thomas; Adolf, Daniela; Kaskel, Peter; Froster, Ursula G

2018-06-05

Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany. The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed. For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence. The study has been registered under DRKS00013199 in the German Clinical Trials Register.

The effectiveness of interventions to meet family needs of critically ill patients in an adult intensive care unit: a systematic review.

PubMed

Kynoch, Kate; Chang, Anne M; Coyer, Fiona

Background Attending to the needs of family members of critically ill patients is an important and necessary step in providing appropriate care for both the patient and the family. An initial search of the Cochrane and Joanna Briggs Institute Libraries did not reveal any published systematic reviews recommending effective interventions for addressing family needs of critically ill patients in an acute intensive care unit.Objectives This systematic review aims to establish best practice in addressing the needs of family members with a relative admitted to an adult critical care unit.Search strategy An extensive search of the major databases was conducted. Databases searched included: MEDLINE, CINAHL, psycINFO, Health source, Web of science, EMBASE, the Cochrane library and Database of abstracts of reviews of effects (DARE) as well as Pubmed. The search included published and unpublished studies and papers in English from 1980-2010.Selection criteria This review considered any randomised controlled trials that evaluated the effectiveness of interventions in addressing family needs of critically ill patients in an adult intensive care unit. In the absence of randomised controlled trials, other research designs such as quasi-experimental as well as before and after studies were considered for inclusion in the narrative summary to enable the identification of current approaches and possible future strategies for addressing family needs of critically ill patients.Assessment of quality Each included study was assessed by two independent reviewers using the appropriate appraisal checklist developed by the Joanna Briggs Institute.Data collection and analysis Data was extracted from the papers included in this review using standardised data extraction tools from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument package. The studies included in this review were not suitable for meta-analysis and therefore the results are presented in narrative form.Results Fourteen studies and one dissertation met the inclusion criteria and were included in the review. There were 12 quasi-experimental studies identified including 8 two or three group, pre-test/post-test studies; 1 one-way between subjects design; 1 interrupted time series and 1 two-group comparative design study. The dissertation was a quasi-experimental three group pre-test/post-test design. There were 3 prospective randomised trials included. The evidence identified includes: the use of support groups for family members of patients admitted to an intensive care unit, structured communication and/or education programs for family members, the use of leaflets or brochures to meet family information needs and open or more flexible visiting hours.Conclusion/Recommendations This review makes several recommendations for clinical practice to address family needs of patients admitted to a critical care unit, however this review highlights the need for significant further research in this area. Future intervention studies focusing on family needs could include: the use of technology such as DVD's and SMS for informing families and interventions specifically designed to improve family comfort.

Anti-Smoking Practice in Hospitals: An Intercept Survey among Patients in Hubei Province, China

ERIC Educational Resources Information Center

Zhou, Dunjin; Yan, Yaqiong; Yu, Huihong; Xia, Qinghua; Yang, Niannian; Zhang, Zhifeng; Zhu, Zhaoyang; Li, Fang; Gong, Jie

2012-01-01

Purpose: This study aims to examine whether, in the opinion of patients selected in 13 hospitals of Hubei province, China, hospitals are smoke free. Patients were also asked whether their physicians had inquired about their smoking status. Design/methodology/approach: Patients were recruited through an intercept method (i.e. stopped by the…

Up-and-down designs for phase I clinical trials

PubMed Central

Liu, Suyu; Cai, Chunyan; Ning, Jing

2014-01-01

Various up-and-down designs have been proposed to improve the operating characteristics of the traditional “3+3” design, but they have been of limited use in practice. A major impediment to the adoption of the improved up-and-down designs is a lack of general guidance and a comprehensive assessment of the operating characteristics of these designs under practical clinical settings. To fill this gap, we review six up-and-down designs: the “3+3” design, accelerated titration design, biased coin design, k-in-a-row design, group up-and-down design and cumulative group up-and-down design. We conduct comprehensive simulation studies to evaluate their operating characteristics under various practical settings, and compare their performance to a theoretical optimal bound of nonparametric designs. The results show that the cumulative group up-and-down design has the best overall performance in terms of selecting the maximum tolerated dose (MTD), assigning patients to the MTD and patient safety. Its performance is generally close to the upper bound of nonparametric designs, but improvement seems possible in some cases. PMID:23856381

Exploring patients' health information communication practices with social network members as a foundation for consumer health IT design.

PubMed

Valdez, Rupa Sheth; Brennan, Patricia Flatley

2015-05-01

There is a need to ensure that the growing number of consumer health information technologies designed to support patient engagement account for the larger social context in which health is managed. Basic research on how patients engage this larger social context is needed as a precursor to the development of patient-centered consumer health information technology (IT) solutions. The purpose of this study was to inform the broader design of consumer health IT by characterizing patients' existing health information communication practices with their social network members. This qualitative study took place between 2010 and 2012 in a Midwestern city. Eighteen patients with chronic conditions participated in a semi-structured interview that was analyzed using qualitative content analysis and descriptive statistics. Emphasis was placed on recruiting a sample representing diverse cultural groups and including participants of low socioeconomic status. Participants' social networks included a wide range of individuals, spanning biological relatives, divinities, and second-degree relationships. Participants' rationales for health information communication reflected seven themes: (1) characteristics and circumstances of the person, (2) characteristics and circumstances of the relationship, (3) structure and composition of the social network, (4) content of the message, (5) orientation of the goal, (6) dimensions of the context, and (7) adaptive practices. This study demonstrates that patients' health information communication practices are multidimensional, engaging individuals beyond formal and informal caregivers and driven by characteristics of their personal lives and larger social contexts in addition to their health problem. New models of consumer health IT must be created to better align with the realities of patients' communication routines. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)

PubMed Central

2010-01-01

Background More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients. Methods/Design Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA). Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI), a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis. Discussion ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy. PMID:20492672

Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) Trial: Design and Rationale

PubMed Central

Reeves, Gordon R.; Whellan, David J.; Duncan, Pamela; O’Connor, Christopher M.; Pastva, Amy M.; Eggebeen, Joel D; Hewston, Leigh Ann; Morgan, Timothy M.; Reed, Shelby D.; Rejeski, W. Jack; Mentz, Robert J.; Rosenberg, Paul B.; Kitzman, Dalane W.

2017-01-01

Background Acute decompensated heart failure (ADHF) is a leading cause of hospitalization in older persons in the United States. Reduced physical function and frailty are major determinants of adverse outcomes in older patients with hospitalized ADHF. However, these are not addressed by current heart failure (HF) management strategies and there has been little study of exercise training in older, frail HF patients with recent ADHF. Hypothesis Targeting physical frailty with a multi-domain structured physical rehabilitation intervention will improve physical function and reduce adverse outcomes among older patients experiencing a HF hospitalization. Study Design Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) is a multi-center clinical trial in which 360 patients ≥ 60 years hospitalized with ADHF will be randomized either to a novel 12-week multi-domain physical rehabilitation intervention or to attention control. The goal of the intervention is to improve balance, mobility, strength and endurance utilizing reproducible, targeted exercises administered by a multi-disciplinary team with specific milestones for progression. The primary study aim is to assess the efficacy of the REHAB-HF intervention on physical function measured by total Short Physical Performance Battery score. The secondary outcome is 6-month all-cause rehospitalization. Additional outcome measures include quality of life and costs. Conclusions REHAB-HF is the first randomized trial of a physical function intervention in older patients with hospitalized ADHF designed to determine if addressing deficits in balance, mobility, strength and endurance improves physical function and reduces rehospitalizations. It will address key evidence gaps concerning the role of physical rehabilitation in the care of older patients, those with ADHF, frailty, and multiple comorbidities. PMID:28267466

Comparative effectiveness studies to improve clinical outcomes in end stage renal disease: the DEcIDE patient outcomes in end stage renal disease study

PubMed Central

2012-01-01

Background Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD). Methods/design The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community. Discussion The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies’ impact on clinical care and patients’ outcomes. PMID:23217181

Improved satisfaction of preoperative patients after group video-teaching during interview at preanesthetic evaluation clinic: the experience of a medical center in Taiwan.

PubMed

Yang, Ya-Ling; Wang, Kuan-Jen; Chen, Wei-Hao; Chuang, Kuan-Chih; Tseng, Chia-Chih; Liu, Chien-Cheng

2007-09-01

Anesthesiologist-directed anesthetic preoperative evaluation clinic (APEC) is used to prepare patients to receive anesthesia for surgery. Studies have shown that APEC can reduce preoperative tests, consultations, surgery delays and cancellations. APEC with video-teaching has been purposed as a medium to provide comprehensive information about the process of anesthesia but it has not been practiced in small groups of patients. It is rational to assume that video-teaching in a small group patients can provide better information to patients to understand the process of anesthesia and in turn improve their satisfaction in anesthesia practice. This study was designed to evaluate the difference of satisfaction between patients who joined in small group video-teaching at APEC and patients who paid a traditional preoperative visit in the waiting area, using questionnaire for evaluation. Totally, 237 eligible patients were included in the study in a space of two months. Patients were divided in two groups; 145 patients joined the small group video-teaching designated as study group and 92 patients who were paid traditional preoperative visit at the waiting area served as control. All patients were requested to fill a special questionnaire after postoperative visit entrusted to two non-medical persons. There were significantly higher scores of satisfaction in anesthesia inclusive of waiting time for surgery in the operation room, attitude towards anesthetic staffs during postoperative visit and management of complications in patients who were offered small group video-teaching in comparison with patients of traditional preoperative visit. The results indicated that APEC with group video-teaching could not only make patients more satisfied with process of anesthesia in elective surgery but also reduce the expenditure of hospitalization and anesthetic manpower.

Some aspects of colour perception among patients with Alzheimer's disease.

PubMed

Wijk, H; Sivik, L

1995-01-01

The proportion of elderly people in western societies is on the increase. At the same time, demands are being heard for improvements in the quality of health care, including the design of the physical environment. The aim of this study was to call attention to some aspects of colour and the possibilities of using it as an orientational aid for institutionalized demented patients and thereby enhance the quality of their care. A pilot study was carried out to establish whether patients with Alzheimer's disease are different from non-demented patients regarding certain aspects of colour perception. Twelve hospitalized patients with Alzheimer's disease were compared with a matched control group of non-demented patients regarding colour naming, colour discrimination and colour preference. No significant differences were found between the groups. In an additional experiment to test short-term memory it was found that the patients with Alzheimer's disease gained substantial help from colour cues. It is concluded that colour should be taken into account in the designing of the health care environment, particularly geriatric wards.

The cognitive demands of standardized patients: understanding limitations in attention and working memory with the decoding of nonverbal behavior during improvisations.

PubMed

Newlin-Canzone, Elizabeth T; Scerbo, Mark W; Gliva-McConvey, Gayle; Wallace, Amelia M

2013-08-01

This study was designed to look at the challenges of standardized patients while in role and to use the findings to enhance training methods. The study investigated the effect of improvisations and multiple-task performance on the ability of standardized patients to observe and evaluate another's communication behaviors and its associated mental workload. Twenty standardized patients participated in a 2 types of interview (with and without improvisations)-by-2 types of observation (passive and active) within-groups design. The results indicated that both active observations and improvisations had a negative effect on the standardized patients' ability to observe the learner, missing more than 75% of nonverbal behaviors during active improvisational encounters. Moreover, standardized patients experienced the highest mental demand during active improvisational encounters. The findings suggest that the need to simultaneously portray a character and assess a learner may negatively affect the ability of standardized patients to provide accurate evaluations of a learner, particularly when they are required to improvise responses, underscoring the need for specific and targeted training.

Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

PubMed

Felker, G Michael; Ahmad, Tariq; Anstrom, Kevin J; Adams, Kirkwood F; Cooper, Lawton S; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Leifer, Eric S; Mark, Daniel B; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L; Whellan, David J; O'Connor, Christopher M

2014-10-01

The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of <1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure (HF). Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of <1,000 pg/ml. Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Patient safety in transitional care of the elderly: effects of a quasi-experimental interorganisational educational intervention

PubMed Central

Storm, Marianne; Schulz, Jörn; Aase, Karina

2018-01-01

Objective The study objective was to assess the effects of an interorganisational educational intervention called the ‘Meeting Point’ on patient safety culture among staff in hospital and nursing home wards. Design The study employs a quasi-experimental, non-randomised design with a hospital and nursing home intervention group and a hospital and nursing home control group. The study uses one preintervention and two postintervention survey measurements. The intervention group participated in an educational programme ‘The Meeting Point’ including interorganisational staff meetings combining educational sessions with a discussion platform focusing on quality and safety in transitional care of the elderly. Results The results show a stable development over time for the patient safety culture factor ‘Handoff and transitions’, and small improvements for ‘Overall perceptions of patient safety culture’ and ‘Organisational learning - continuous improvement’ for the hospital intervention group. No similar development was reported in the nursing home intervention group, which is most likely explained by ongoing organisational changes. Qualitative data show the existence of ongoing initiatives in the hospital to improve transitional care, but not all were connected to the ‘Meeting Point’. Conclusion The ‘Meeting Point’ has the potential to be a useful measure for healthcare professionals when aiming to improve patient safety culture in transitional care. Further refinement of the key components and testing with a more robust study design will be beneficial. PMID:29391363

Methylphenidate and emotional-motivational processing in attention-deficit/hyperactivity disorder.

PubMed

Conzelmann, Annette; Woidich, Eva; Mucha, Ronald F; Weyers, Peter; Müller, Mathias; Lesch, Klaus-Peter; Jacob, Christian P; Pauli, Paul

2016-08-01

In line with the assumption that emotional-motivational deficits are one core dysfunction in ADHD, in one of our previous studies we observed a reduced reactivity towards pleasant pictures in adult ADHD patients as compared to controls. This was indicated by a lack of attenuation of the startle reflex specifically during pleasant pictures in ADHD patients. The first choice medical agents in ADHD, methylphenidate (MPH), is discussed to normalize these dysfunctions. However, experimental evidence in the sense of double-blind placebo-controlled study designs is lacking. Therefore, we investigated 61 adult ADHD patients twice, one time with placebo and one time with MPH with the same experimental design as in our study previously and assessed emotion processing during the presentation of pleasant, neutral and unpleasant pictures. We obtained startle reflex data as well as valence and arousal ratings in association with the pictures. As previously shown, ADHD patients showed a diminished startle attenuation during pleasant pictures while startle potentiation during unpleasant pictures was normal. Valence and arousal ratings unsuspiciously increased with increasing pleasantness and arousal of the pictures, respectively. There were no significant influences of MPH. The study replicates that ADHD patients show a reduced reactivity towards pleasant stimuli. MPH did not normalize this dysfunction. Possibly, MPH only influences emotions during more complex behavioural tasks that involve executive functions in adults with ADHD. Our results emphasize the importance for the use of double-blind placebo-controlled designs in psychopharmacological research.

The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress.

PubMed

Antic, Nick A; Heeley, Emma; Anderson, Craig S; Luo, Yuanming; Wang, Jiguang; Neal, Bruce; Grunstein, Ron; Barbe, Ferran; Lorenzi-Filho, Geraldo; Huang, Shaoguang; Redline, Susan; Zhong, Nanshan; McEvoy, R Doug

2015-08-01

The Sleep Apnea cardioVascular Endpoints (SAVE) study is an ongoing investigator-initiated and conducted, international, multicenter, open, blinded endpoint, randomized controlled trial that was designed to determine whether treatment of obstructive sleep apnea (OSA) with continuous positive airways pressure (CPAP) can reduce the risk of serious cardiovascular (CV) events in patients with established CV disease (clinical trial registration NCT00738179). The results of this study will have important implications for the provision of health care to patients with sleep apnea around the world. The SAVE study has brought together respiratory, sleep, CV and stroke clinicians-scientists in an interdisciplinary collaboration with industry and government sponsorship to conduct an ambitious clinical trial. Following its launch in Australia and China in late 2008, the recruitment network expanded across 89 sites that included New Zealand, India, Spain, USA, and Brazil for a total of 2,717 patients randomized by December 2013. These patients are being followed until December 2015 so that the average length of follow-up of the cohort will be over 4 y. This article describes the rationale for the SAVE study, considerations given to the design including how various cultural and ethical challenges were addressed, and progress in establishing and maintaining the recruitment network, patient follow-up, and adherence to CPAP and procedures. The assumptions underlying the original trial sample size calculation and why this was revised downward in 2012 are also discussed. NCT00738179. ACTRN12608000409370. © 2015 Associated Professional Sleep Societies, LLC.

Evaluation of World Health Organization Multi-Professional Patient Safety Curriculum Topics in Nursing Education: Pre-test, post-test, none-experimental study.

PubMed

Mansour, Mansour; Skull, Alice; Parker, Michael

2015-01-01

The Multi-professional Patient Safety Curriculum Guide was launched by the World Health Organization to develop a patient safety-friendly curriculum in health education. The aim of this study was to evaluate the impact of teaching related to two topics from the Patient Safety Curriculum Guide on student nurses' knowledge and attitudes toward patient safety. A pretest, posttest, nonexperimental design was used. Patient safety education questionnaires were distributed to a convenience sample of 181 nursing students before the intervention, and 141 questionnaires after the intervention in one university in the East of England. The intervention consisted of two face-to-face lectures and one facilitated group work discussion. Seventy-one responses from pre- and posttest stages were matched. Paired t test, McNemar's test, and frequency measures were used for data analysis. The findings suggest that there are statistically significant differences in the subscales of the error and patient safety and personal influence over safety. The differences in the students' answers on patient safety knowledge before and after the interventions were not statistically significant. Although the student nurses highly commended the teaching delivered in this study, the use of experimental design in future curriculum evaluation may provide a more complementary insight to the findings of this study. Copyright © 2015 Elsevier Inc. All rights reserved.

Nurse Value-Added and Patient Outcomes in Acute Care

PubMed Central

Yakusheva, Olga; Lindrooth, Richard; Weiss, Marianne

2014-01-01

Objective The aims of the study were to (1) estimate the relative nurse effectiveness, or individual nurse value-added (NVA), to patients’ clinical condition change during hospitalization; (2) examine nurse characteristics contributing to NVA; and (3) estimate the contribution of value-added nursing care to patient outcomes. Data Sources/Study Setting Electronic data on 1,203 staff nurses matched with 7,318 adult medical–surgical patients discharged between July 1, 2011 and December 31, 2011 from an urban Magnet-designated, 854-bed teaching hospital. Study Design Retrospective observational longitudinal analysis using a covariate-adjustment value-added model with nurse fixed effects. Data Collection/Extraction Methods Data were extracted from the study hospital's electronic patient records and human resources databases. Principal Findings Nurse effects were jointly significant and explained 7.9 percent of variance in patient clinical condition change during hospitalization. NVA was positively associated with having a baccalaureate degree or higher (0.55, p = .04) and expertise level (0.66, p = .03). NVA contributed to patient outcomes of shorter length of stay and lower costs. Conclusions Nurses differ in their value-added to patient outcomes. The ability to measure individual nurse relative value-added opens the possibility for development of performance metrics, performance-based rankings, and merit-based salary schemes to improve patient outcomes and reduce costs. PMID:25256089

Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE).

PubMed

Servagi-Vernat, Stéphanie; Créhange, Gilles; Bonnetain, Franck; Mertens, Cécile; Brain, Etienne; Bosset, Jean François

2017-07-13

The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older. This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO). This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older. Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.

A phase I dose-finding study of silybin phosphatidylcholine (milk thistle) in patients with advanced hepatocellular carcinoma.

PubMed

Siegel, Abby B; Narayan, Rupa; Rodriguez, Rosa; Goyal, Abhishek; Jacobson, Judith S; Kelly, Kara; Ladas, Elena; Lunghofer, Paul J; Hansen, Ryan J; Gustafson, Daniel L; Flaig, Thomas W; Tsai, Wei Yann; Wu, David P H; Lee, Valerie; Greenlee, Heather

2014-01-01

To determine the maximum tolerated dose per day of silybin phosphatidylcholine (Siliphos) in patients with advanced hepatocellular carcinoma (HCC) and hepatic dysfunction. Patients with advanced HCC not eligible for other therapies based on poor hepatic function were enrolled in a phase I study of silybin phosphatidylcholine. A standard phase I design was used with 4 planned cohorts, dose escalating from 2, 4, 8, to 12 g per day in divided doses for 12 weeks. Three participants enrolled in this single institution trial. All enrolled subjects consumed 2 g per day of study agent in divided doses. Serum concentrations of silibinin and silibinin glucuronide increased within 1 to 3 weeks. In all 3 patients, liver function abnormalities and tumor marker α-fetoprotein progressed, but after day 56 the third patient showed some improvement in liver function abnormalities and inflammatory biomarkers. All 3 participants died within 23 to 69 days of enrolling into the trial, likely from hepatic failure, but it could not be ruled out that deaths were possibly due to the study drug. Short-term administration of silybin phosphatidylcholine in patients with advanced HCC resulted in detectable increases in silibinin and its metabolite, silibinin glucuronide. The maximum tolerated dose could not be established. Since patients died soon after enrollment, this patient population may have been too ill to benefit from an intervention designed to improve liver function tests.

An Educational Intervention to Enhance Nurse Leaders' Perceptions of Patient Safety Culture

PubMed Central

Ginsburg, Liane; Norton, Peter G; Casebeer, Ann; Lewis, Steven

2005-01-01

Objective To design a training intervention and then test its effect on nurse leaders' perceptions of patient safety culture. Study Setting Three hundred and fifty-six nurses in clinical leadership roles (nurse managers and educators/CNSs) in two Canadian multi-site teaching hospitals (study and control). Study Design A prospective evaluation of a patient safety training intervention using a quasi-experimental untreated control group design with pretest and posttest. Nurses in clinical leadership roles in the study group were invited to participate in two patient safety workshops over a 6-month period. Individuals in the study and control groups completed surveys measuring patient safety culture and leadership for improvement prior to training and 4 months following the second workshop. Extraction Methods Individual nurse clinical leaders were the unit of analysis. Exploratory factor analysis of the safety culture items was conducted; repeated-measures analysis of variance and paired t-tests were used to evaluate the effect of the training intervention on perceived safety culture (three factors). Hierarchical regression analyses looked at the influence of demographics, leadership for improvement, and the training intervention on nurse leaders' perceptions of safety culture. Principal Findings A statistically significant improvement in one of three safety culture measures was shown for the study group (p<.001) and a significant decline was seen on one of the safety culture measures for the control group (p<.05). Leadership support for improvement was found to explain significant amounts of variance in all three patient safety culture measures; workshop attendance explained significant amounts of variance in one of the three safety culture measures. The total R2 for the three full hierarchical regression models ranged from 0.338 and 0.554. Conclusions Sensitively delivered training initiatives for nurse leaders can help to foster a safety culture. Organizational leadership support for improvement is, however, also critical for fostering a culture of safety. Together, training interventions and leadership support may have the most significant impact on patient safety culture. PMID:16033489

Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience.

PubMed

Dahlberg, Suzanne E; Shapiro, Geoffrey I; Clark, Jeffrey W; Johnson, Bruce E

2014-07-01

Phase I trials have traditionally been designed to assess toxicity and establish phase II doses with dose-finding studies and expansion cohorts but are frequently exceeding the traditional sample size to further assess endpoints in specific patient subsets. The scientific objectives of phase I expansion cohorts and their evolving role in the current era of targeted therapies have yet to be systematically examined. Adult therapeutic phase I trials opened within Dana-Farber/Harvard Cancer Center (DF/HCC) from 1988 to 2012 were identified for sample size details. Statistical designs and study objectives of those submitted in 2011 were reviewed for expansion cohort details. Five hundred twenty-two adult therapeutic phase I trials were identified during the 25 years. The average sample size of a phase I study has increased from 33.8 patients to 73.1 patients over that time. The proportion of trials with planned enrollment of 50 or fewer patients dropped from 93.0% during the time period 1988 to 1992 to 46.0% between 2008 and 2012; at the same time, the proportion of trials enrolling 51 to 100 patients and more than 100 patients increased from 5.3% and 1.8%, respectively, to 40.5% and 13.5% (χ(2) test, two-sided P < .001). Sixteen of the 60 trials (26.7%) in 2011 enrolled patients to three or more sub-cohorts in the expansion phase. Sixty percent of studies provided no statistical justification of the sample size, although 91.7% of trials stated response as an objective. Our data suggest that phase I studies have dramatically changed in size and scientific scope within the last decade. Additional studies addressing the implications of this trend on research processes, ethical concerns, and resource burden are needed. © The Author 2014. Published by Oxford University Press. All rights reserved.

A noninferiority confirmatory trial of prasugrel versus clopidogrel in Japanese patients with non-cardioembolic stroke: rationale and study design for a randomized controlled trial - PRASTRO-I trial.

PubMed

Nagao, Takehiko; Toyoda, Kazunori; Kitagawa, Kazuo; Kitazono, Takanari; Yamagami, Hiroshi; Uchiyama, Shinichiro; Tanahashi, Norio; Matsumoto, Masayasu; Minematsu, Kazuo; Nagata, Izumi; Nishikawa, Masakatsu; Nanto, Shinsuke; Abe, Kenji; Ikeda, Yasuo; Ogawa, Akira

2018-04-01

This comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO)-I trial investigates the noninferiority of prasugrel to clopidogrel sulfate in the prevention of recurrence of primary events (ischemic stroke, myocardial infarction, and death from other vascular causes), and the long-term safety of prasugrel in Japanese patients with non-cardioembolic stroke. This was an active-controlled, randomized, double-blind, double-dummy, parallel-group study conducted between July 2011 and March 2016 at multiple centers around Japan. Patients had to meet eligibility criteria before receiving 3.75 mg prasugrel or 75 mg clopidogrel orally once daily for a period of 96-104 weeks. A total of 3747 patients were included in this trial; 1598 in the 3.75 mg prasugrel group and 1551 in the 75 mg clopidogrel group completed the study. During the study period, 287 (15.2%) patients in the prasugrel group and 311 (16.7%) in the clopidogrel group discontinued treatment. Baseline characteristics, safety, and efficacy results are forthcoming and will be published separately. This article presents the study design and rationale for a trial investigating the noninferiority of prasugrel to clopidogrel sulfate with regards to the inhibitory effect on primary events in patients with non-cardioembolic stroke.

A Novel Design for Drug-Drug Interaction Alerts Improves Prescribing Efficiency.

PubMed

Russ, Alissa L; Chen, Siying; Melton, Brittany L; Johnson, Elizabette G; Spina, Jeffrey R; Weiner, Michael; Zillich, Alan J

2015-09-01

Drug-drug interactions (DDIs) are common in clinical care and pose serious risks for patients. Electronic health records display DDI alerts that can influence prescribers, but the interface design of DDI alerts has largely been unstudied. In this study, the objective was to apply human factors engineering principles to alert design. It was hypothesized that redesigned DDI alerts would significantly improve prescribers' efficiency and reduce prescribing errors. In a counterbalanced, crossover study with prescribers, two DDI alert designs were evaluated. Department of Veterans Affairs (VA) prescribers were video recorded as they completed fictitious patient scenarios, which included DDI alerts of varying severity. Efficiency was measured from time-stamped recordings. Prescribing errors were evaluated against predefined criteria. Efficiency and prescribing errors were analyzed with the Wilcoxon signed-rank test. Other usability data were collected on the adequacy of alert content, prescribers' use of the DDI monograph, and alert navigation. Twenty prescribers completed patient scenarios for both designs. Prescribers resolved redesigned alerts in about half the time (redesign: 52 seconds versus original design: 97 seconds; p<.001). Prescribing errors were not significantly different between the two designs. Usability results indicate that DDI alerts might be enhanced by facilitating easier access to laboratory data and dosing information and by allowing prescribers to cancel either interacting medication directly from the alert. Results also suggest that neither design provided adequate information for decision making via the primary interface. Applying human factors principles to DDI alerts improved overall efficiency. Aspects of DDI alert design that could be further enhanced prior to implementation were also identified.

Remote Monitoring Systems for Chronic Patients on Home Hemodialysis: Field Test of a Copresence-Enhanced Design.

PubMed

Liu, Na; Kim, Jinman; Jung, Younhyun; Arisy, Adani; Nicdao, Mary Ann; Mikaheal, Mary; Baldacchino, Tanya; Khadra, Mohamed; Sud, Kamal

2017-08-29

Patients undertaking long-term and chronic home hemodialysis (HHD) are subject to feelings of isolation and anxiety due to the absence of physical contact with their health care professionals and lack of feedback in regards to their dialysis treatments. Therefore, it is important for these patients to feel the "presence" of the health care professionals remotely while on hemodialysis at home for better compliance with the dialysis regime and to feel connected with health care professionals. This study presents an HHD system design for hemodialysis patients with features to enhance patient's perceived "copresence" with their health care professionals. Various mechanisms to enhance this perception were designed and implemented, including digital logbooks, emotion sharing, and feedback tools. The mechanism in our HHD system aims to address the limitations associated with existing self-monitoring tools for HHD patients. A field trial involving 3 nurses and 74 patients was conducted to test the pilot implementation of the copresence design in our HHD system. Mixed method research was conducted to evaluate the system, including surveys, interviews, and analysis of system data. Patients created 2757 entries of dialysis cases during the period of study. Altogether there were 492 entries submitted with "Very Happy" as the emotional status, 2167 entries with a "Happy" status, 56 entries with a "Neutral" status, 18 entries with an "Unhappy" status, and 24 entries with a "Very unhappy" status. Patients felt assured to share their emotions with health care professionals. Health care professionals were able to prioritize the review of the entries based on the emotional status and also felt assured to see patients' change in mood. There were 989 entries sent with short notes. Entries with negative emotions had a higher percentage of supplementary notes entered compared to the entries with positive and neutral emotions. The qualitative data further showed that the HHD system was able to improve patients' feelings of being connected with their health care professionals and thus enhance their self-care on HHD. The health care professionals felt better assured with patients' status with the use of the system and reported improved productivity and satisfaction with the copresence enhancement mechanism. The survey on the system usability indicated a high level of satisfaction among patients and nurses. The copresence enhancement design complements the conventional use of a digitized HHD logbook and will further benefit the design of future telehealth systems. ©Na Liu, Jinman Kim, Younhyun Jung, Adani Arisy, Mary Ann Nicdao, Mary Mikaheal, Tanya Baldacchino, Mohamed Khadra, Kamal Sud. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 29.08.2017.

Improving Patient Experience and Primary Care Quality for Patients With Complex Chronic Disease Using the Electronic Patient-Reported Outcomes Tool: Adopting Qualitative Methods Into a User-Centered Design Approach.

PubMed

Steele Gray, Carolyn; Khan, Anum Irfan; Kuluski, Kerry; McKillop, Ian; Sharpe, Sarah; Bierman, Arlene S; Lyons, Renee F; Cott, Cheryl

2016-02-18

Many mHealth technologies do not meet the needs of patients with complex chronic disease and disabilities (CCDDs) who are among the highest users of health systems worldwide. Furthermore, many of the development methodologies used in the creation of mHealth and eHealth technologies lack the ability to embrace users with CCDD in the specification process. This paper describes how we adopted and modified development techniques to create the electronic Patient-Reported Outcomes (ePRO) tool, a patient-centered mHealth solution to help improve primary health care for patients experiencing CCDD. This paper describes the design and development approach, specifically the process of incorporating qualitative research methods into user-centered design approaches to create the ePRO tool. Key lessons learned are offered as a guide for other eHealth and mHealth research and technology developers working with complex patient populations and their primary health care providers. Guided by user-centered design principles, interpretive descriptive qualitative research methods were adopted to capture user experiences through interviews and working groups. Consistent with interpretive descriptive methods, an iterative analysis technique was used to generate findings, which were then organized in relation to the tool design and function to help systematically inform modifications to the tool. User feedback captured and analyzed through this method was used to challenge the design and inform the iterative development of the tool. Interviews with primary health care providers (n=7) and content experts (n=6), and four focus groups with patients and carers (n=14) along with a PICK analysis-Possible, Implementable, (to be) Challenged, (to be) Killed-guided development of the first prototype. The initial prototype was presented in three design working groups with patients/carers (n=5), providers (n=6), and experts (n=5). Working group findings were broken down into categories of what works and what does not work to inform modifications to the prototype. This latter phase led to a major shift in the purpose and design of the prototype, validating the importance of using iterative codesign processes. Interpretive descriptive methods allow for an understanding of user experiences of patients with CCDD, their carers, and primary care providers. Qualitative methods help to capture and interpret user needs, and identify contextual barriers and enablers to tool adoption, informing a redesign to better suit the needs of this diverse user group. This study illustrates the value of adopting interpretive descriptive methods into user-centered mHealth tool design and can also serve to inform the design of other eHealth technologies. Our approach is particularly useful in requirements determination when developing for a complex user group and their health care providers.

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

Venous thromboembolism in cancer patients receiving neoadjuvant chemotherapy: a systematic review and meta-analysis.

PubMed

Di Nisio, M; Candeloro, M; Rutjes, A W S; Porreca, E

2018-05-13

Venous thromboembolism (VTE) is a frequent complication in cancer patients receiving adjuvant treatment. The risk of VTE during neoadjuvant chemo-radiotherapy remains unclear. This systematic review evaluated the incidence of VTE in patients with cancer receiving neoadjuvant treatment. MEDLINE and EMBASE databases were searched from inception to October 2017. Search results were supplemented with screening of conference proceedings of the American Society of Clinical Oncology (2009-2016) and the International Society of Thrombosis and Haemostasis (2003-2016). Two review authors independently screened titles and abstracts, and extracted data onto standardized forms. Twenty-eight cohort studies (7827 cancer patients, range 11 to 1398) were included. Twenty-five had a retrospective design. Eighteen cohorts included patients with gastrointestinal cancer representing over two-thirds of the whole study population (n = 6002, 78%). In total, 508 of 7768 patients were diagnosed with at least one VTE during neoadjuvant treatment for a pooled VTE incidence of 7% (95% CI, 5% to 10%) in absence of substantial between study heterogeneity. Heterogeneity was not explained by site of cancer or study design characteristics. VTE presented as pulmonary embolism in 22% to 96% of cases (16 cohorts), and it was symptomatic in 22% to 100% of patients (11 cohorts). Highest VTE rates were observed in patients with bladder (10.6%) or esophageal (8.4%) cancer. This review found a relatively high incidence of VTE in cancer patients receiving neoadjuvant therapy in the presence of some between study variation, which deserves further evaluation in prospective studies. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

PubMed Central

2012-01-01

Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775 PMID:22625878

Reconstruction design before tumour resection: A new concept of through-and-through cheek defect reconstruction.

PubMed

Gong, Zhao-Jian; Ren, Zhen-Hu; Wang, Kai; Tan, Hong-Yu; Zhang, Sheng; Wu, Han-Jiang

2017-11-01

To explore a new method of reconstruction of through-and-through cheek defects and to evaluate this method's efficacy and patient prognosis. This retrospective study included 70 patients who underwent reconstruction of through-and-through cheek defects. The surgical approach, design of facial skin incisions, selection and design of flaps, postoperative quality of life and prognosis of patients were recorded and reported. Postoperative quality of life gradually increased over time, and the mean scores of University of Washington Quality of Life (UW-QOL) Questionnaire was more than 80 at 1-year postoperatively. The appearance, oral competence, chewing, swallowing, speech and other oral functions were well recovered in about 90% of patients at 1-year postoperatively. This new idea of reconstruction before tumour resection, brings the effect of plastic and reconstructive surgery to a new height. Copyright © 2017. Published by Elsevier Ltd.

Development of a Personal Digital Assistant (PDA) based client/server NICU patient data and charting system.

PubMed

Carroll, A E; Saluja, S; Tarczy-Hornoch, P

2001-01-01

Personal Digital Assistants (PDAs) offer clinicians the ability to enter and manage critical information at the point of care. Although PDAs have always been designed to be intuitive and easy to use, recent advances in technology have made them even more accessible. The ability to link data on a PDA (client) to a central database (server) allows for near-unlimited potential in developing point of care applications and systems for patient data management. Although many stand-alone systems exist for PDAs, none are designed to work in an integrated client/server environment. This paper describes the design, software and hardware selection, and preliminary testing of a PDA based patient data and charting system for use in the University of Washington Neonatal Intensive Care Unit (NICU). This system will be the subject of a subsequent study to determine its impact on patient outcomes and clinician efficiency.

Analysis of Combined Data from Heterogeneous Study Designs: A Methodological Proposal from the Patient Navigation Research program

PubMed Central

Roetzheim, Richard G.; Freund, Karen M.; Corle, Don K.; Murray, David M.; Snyder, Frederick R.; Kronman, Andrea C.; Jean-Pierre, Pascal; Raich, Peter C.; Holden, Alan E. C.; Darnell, Julie S.; Warren-Mears, Victoria; Patierno, Steven; Design, PNRP; Committee, Analysis

2013-01-01

Background The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, each employing its own unique study design. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from members of the PNRP Design and Analysis Committee Purpose To review possible methodologies for analyzing combined data arising from heterogeneous study designs. Methods The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. Conclusions were based on simple consensus. The five approaches reviewed included: 1) Analyzing and reporting each project separately, 2) Combining data from all projects and performing an individual-level analysis, 3) Pooling data from projects having similar study designs, 4) Analyzing pooled data using a prospective meta analytic technique, 5) Analyzing pooled data utilizing a novel simulated group randomized design. Results Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and in their impact from differing project sample sizes. Limitations The conclusions reached were based on expert opinion and not derived from actual analyses performed. Conclusions The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multi-site community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs. PMID:22273587

Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program.

PubMed

Roetzheim, Richard G; Freund, Karen M; Corle, Don K; Murray, David M; Snyder, Frederick R; Kronman, Andrea C; Jean-Pierre, Pascal; Raich, Peter C; Holden, Alan Ec; Darnell, Julie S; Warren-Mears, Victoria; Patierno, Steven

2012-04-01

The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee. To review possible methodologies for analyzing combined data arising from heterogeneous study designs. The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design. Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes. The conclusions reached were based on expert opinion and not derived from actual analyses performed. The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.

Supporting cancer patients in illness management: usability evaluation of a mobile app.

PubMed

Mirkovic, Jelena; Kaufman, David R; Ruland, Cornelia M

2014-08-13

Mobile phones and tablets currently represent a significant presence in people's everyday lives. They enable access to different information and services independent of current place and time. Such widespread connectivity offers significant potential in different app areas including health care. Our goal was to evaluate the usability of the Connect Mobile app. The mobile app enables mobile access to the Connect system, an online system that supports cancer patients in managing health-related issues. Along with symptom management, the system promotes better patient-provider communication, collaboration, and shared decision making. The Connect Mobile app enables access to the Connect system over both mobile phones and tablets. The study consisted of usability tests of a high fidelity prototype with 7 cancer patients where the objectives were to identify existing design and functionality issues and to provide patients with a real look-and-feel of the mobile system. In addition, we conducted semistructured interviews to obtain participants' feedback about app usefulness, identify the need for new system features and design requirements, and measure the acceptance of the mobile app and its features within everyday health management. The study revealed a total of 27 design issues (13 for mobile apps and 14 for tablet apps), which were mapped to source events (ie, errors, requests for help, participants' concurrent feedback, and moderator observation). We also applied usability heuristics to identify violations of usability principles. The majority of violations were related to enabling ease of input, screen readability, and glanceability (15 issues), as well as supporting an appropriate match between systems and the real world (7 issues) and consistent mapping of system functions and interactions (4 issues). Feedback from participants also showed the cancer patients' requirements for support systems and how these needs are influenced by different context-related factors, such as type of access terminal (eg, desktop computer, tablet, mobile phone) and phases of illness. Based on the observed results, we proposed design and functionality recommendations that can be used for the development of mobile apps for cancer patients to support their health management process. Understanding and addressing users' requirements is one of the main prerequisites for developing useful and effective technology-based health interventions. The results of this study outline different user requirements related to the design of the mobile patient support app for cancer patients. The results will be used in the iterative development of the Connect Mobile app and can also inform other developers and researchers in development, integration, and evaluation of mobile health apps and services that support cancer patients in managing their health-related issues.

Toward the Design of Personalized Continuum Surgical Robots.

PubMed

Morimoto, Tania K; Greer, Joseph D; Hawkes, Elliot W; Hsieh, Michael H; Okamura, Allison M

2018-05-31

Robot-assisted minimally invasive surgical systems enable procedures with reduced pain, recovery time, and scarring compared to traditional surgery. While these improvements benefit a large number of patients, safe access to diseased sites is not always possible for specialized patient groups, including pediatric patients, due to their anatomical differences. We propose a patient-specific design paradigm that leverages the surgeon's expertise to design and fabricate robots based on preoperative medical images. The components of the patient-specific robot design process are a virtual reality design interface enabling the surgeon to design patient-specific tools, 3-D printing of these tools with a biodegradable polyester, and an actuation and control system for deployment. The designed robot is a concentric tube robot, a type of continuum robot constructed from precurved, elastic, nesting tubes. We demonstrate the overall patient-specific design workflow, from preoperative images to physical implementation, for an example clinical scenario: nonlinear renal access to a pediatric kidney. We also measure the system's behavior as it is deployed through real and artificial tissue. System integration and successful benchtop experiments in ex vivo liver and in a phantom patient model demonstrate the feasibility of using a patient-specific design workflow to plan, fabricate, and deploy personalized, flexible continuum robots.

A D-Optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients

PubMed Central

Hennig, Stefanie; Waterhouse, Timothy H; Bell, Scott C; France, Megan; Wainwright, Claire E; Miller, Hugh; Charles, Bruce G; Duffull, Stephen B

2007-01-01

What is already known about this subject • Itraconazole is a triazole antifungal used in the treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis (CF). • The pharmacokinetic (PK) properties of this drug and its active metabolite have been described before, mostly in healthy volunteers. • However, only sparse information from case reports were available of the PK properties of this drug in CF patients at the start of our study. What this study adds • This study reports for the first time the population pharmacokinetic properties of itraconazole and a known active metabolite, hydroxy-itraconazole in adult patients with CF. • As a result, this study offers new dosing approaches and their pharmacoeconomic impact as well as a PK model for therapeutic drug monitoring of this drug in this patient group. • Furthermore, it is an example of a successful d-optimal design application in a clinical setting. Aim The primary objective of the study was to estimate the population pharmacokinetic parameters for itraconazole and hydroxy-itraconazole, in particular, the relative oral bioavailability of the capsule compared with solution in adult cystic fibrosis patients, in order to develop new dosing guidelines. A secondary objective was to evaluate the performance of a population optimal design. Methods The blood sampling times for the population study were optimized previously using POPT v.2.0. The design was based on the administration of solution and capsules to 30 patients in a cross-over study. Prior information suggested that itraconazole is generally well described by a two-compartment disposition model with either linear or saturable elimination. The pharmacokinetics of itraconazole and the metabolite were modelled simultaneously using NONMEM. Dosing schedules were simulated to assess their ability to achieve a trough target concentration of 0.5 mg ml−1. Results Out of 241 blood samples, 94% were taken within the defined optimal sampling windows. A two-compartment model with first order absorption and elimination best described itraconazole kinetics, with first order metabolism to the hydroxy-metabolite. For itraconazole the absorption rate constants (between-subject variability) for capsule and solution were 0.0315 h−1 (91.9%) and 0.125 h−1 (106.3%), respectively, and the relative bioavailability of the capsule was 0.82 (62.3%) (confidence interval 0.36, 1.97), compared with the solution. There was no evidence of nonlinearity. Simulations from the final model showed that a dosing schedule of 500 mg twice daily for both formulations provided the highest chance of target success. Conclusion The optimal design performed well and the pharmacokinetics of itraconazole and hydroxy-itraconazole were described adequately by the model. The relative bioavailability for itraconazole capsules was 82% compared with the solution. PMID:17073891

Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design

PubMed Central

2013-01-01

Background Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting. Methods Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0–1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m2 every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients’ quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011. Discussion This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment. Trial registration ClinicalTrials.gov: NCT01473563 PMID:24090033

Patient‐centred improvements in health‐care built environments: perspectives and design indicators

PubMed Central

Douglas, Calbert H.; Douglas, Mary R.

2005-01-01

Abstract Objective  To explore patients’ perceptions of health‐care built environments, to assess how they perceived health‐care built facilities and designs. To develop a set of patient‐centred indicators by which to appraise future health‐care designs. Design  Qualitative and quantitative methodologies, including futures group conferencing, autophotographic study, novice‐expert exchanges and a questionnaire survey of a representative sample of past patients. Setting and participants  The research was carried out at Salford Royal Hospitals NHS Trust (SRHT), Greater Manchester, UK, selected for the study because of planned comprehensive redevelopment based on the new NHS vision for hospital care and service delivery for the 21st century. Participants included 35 patients who took part in an autophotographic study, eight focus groups engaged in futures conferencing, a sample of past inpatients from the previous 12 months that returned 785 completed postal questionnaires. Results  The futures group provided suggestions for radical improvements which were categorized into transport issues; accessibility and mobility; ground and landscape designs; social and public spaces; homeliness and assurance; cultural diversity; safety and security; personal space and access to outside. Patients’ autophotographic study centred on: the quality of the ward design, human interactions, the state and quality of personal space, and facilities for recreation and leisure. The novices’ suggestions were organized into categories of elemental factors representing patient‐friendly designs. Experts from the architectural and surveying professions and staff at SRHT in turn considered these categories and respective subsets of factors. They agreed with the novices in terms of the headings but differed in prioritizing the elemental factors. The questionnaire survey of past patients provided opinions about ward designs that varied according to where they stayed, single room, bay ward or long open ward. The main concerns were limitation of private space around the bed area, supportive of privacy and dignity, ward noise and other disturbances. Conclusions  Patients perceived sustainable health‐care environments to be supportive of their health and recovery. The design indicators developed from their perspectives and from their considerations for improvements to the health‐care built environment were based on their visions of the role of the health‐care facilities. These were homely environments that supported normal lifestyle and family functioning and designs that were supportive of accessibility and travel movements through transitional spaces. PMID:16098156

Digital health system for personalised COPD long-term management.

PubMed

Velardo, Carmelo; Shah, Syed Ahmar; Gibson, Oliver; Clifford, Gari; Heneghan, Carl; Rutter, Heather; Farmer, Andrew; Tarassenko, Lionel

2017-02-20

Recent telehealth studies have demonstrated minor impact on patients affected by long-term conditions. The use of technology does not guarantee the compliance required for sustained collection of high-quality symptom and physiological data. Remote monitoring alone is not sufficient for successful disease management. A patient-centred design approach is needed in order to allow the personalisation of interventions and encourage the completion of daily self-management tasks. A digital health system was designed to support patients suffering from chronic obstructive pulmonary disease in self-managing their condition. The system includes a mobile application running on a consumer tablet personal computer and a secure backend server accessible to the health professionals in charge of patient management. The patient daily routine included the completion of an adaptive, electronic symptom diary on the tablet, and the measurement of oxygen saturation via a wireless pulse oximeter. The design of the system was based on a patient-centred design approach, informed by patient workshops. One hundred and ten patients in the intervention arm of a randomised controlled trial were subsequently given the tablet computer and pulse oximeter for a 12-month period. Patients were encouraged, but not mandated, to use the digital health system daily. The average used was 6.0 times a week by all those who participated in the full trial. Three months after enrolment, patients were able to complete their symptom diary and oxygen saturation measurement in less than 1 m 40s (96% of symptom diaries). Custom algorithms, based on the self-monitoring data collected during the first 50 days of use, were developed to personalise alert thresholds. Strategies and tools aimed at refining a digital health intervention require iterative use to enable convergence on an optimal, usable design. 'Continuous improvement' allowed feedback from users to have an immediate impact on the design of the system (e.g., collection of quality data), resulting in high compliance with self-monitoring over a prolonged period of time (12-month). Health professionals were prompted by prioritisation algorithms to review patient data, which led to their regular use of the remote monitoring website throughout the trial. Trial registration: ISRCTN40367841 . Registered 17/10/2012.

Treatment of advanced gastrointestinal cancer with genetically modified autologous mesenchymal stem cells - TREAT-ME-1 - a phase I, first in human, first in class trial

PubMed Central

von Einem, Jobst C.; Peter, Sylvia; Günther, Christine; Volk, Hans-Dieter; Grütz, Gerald; Salat, Christoph; Stoetzer, Oliver; Nelson, Peter J.; Michl, Marlies; Modest, Dominik P.; Holch, Julian W.; Angele, Martin; Bruns, Christiane

2017-01-01

Purpose This phase I, first in human, first in class clinical study aimed at evaluating the safety, tolerability and efficacy of treatment with genetically modified mesenchymal stromal cells (MSC) in combination with ganciclovir (GCV). MSC_apceth_101 are genetically modified autologous MSCs used as vehicles for a cell-based gene therapy in patients with advanced gastrointestinal adenocarcinoma. Experimental design The study design consisted of a dose-escalation 3 + 3 design. All patients (n = 6) were treated with up to three applications of MSC_apceth_101, followed by GCV infusions given on three consecutive days starting 48 hours after injection of MSC_apceth_101. Three of six patients received a total dose of 1.5 × 106 cells/kg. Two patients received three doses of 1 × 106 cells/kg, while one patient received only two doses of 1 × 106 cells/kg due to a SADR. Results Six patients received MSC_apceth_101. No IMP-related serious adverse events occurred. Adverse-events related to IMP-injection were increased creatinine, cough, fever, and night sweat. TNF, IL-6, IL-8, IL-10 and sE-Selectin, showed that repeated application is immunologically safe, but induces a switch of the functional properties of monocytes to an inflammatory phenotype. Treatment induced stable disease in 4/6 patients, and progressive disease in 2/6 patients. Conclusion Treatment with MSC_apceth_101 in combination with GCV demonstrated acceptable safety and tolerability in patients with advanced gastrointestinal adenocarcinoma. PMID:29113291

Designing Reliable Cohorts of Cardiac Patients across MIMIC and eICU

PubMed Central

Chronaki, Catherine; Shahin, Abdullah; Mark, Roger

2016-01-01

The design of the patient cohort is an essential and fundamental part of any clinical patient study. Knowledge of the Electronic Health Records, underlying Database Management System, and the relevant clinical workflows are central to an effective cohort design. However, with technical, semantic, and organizational interoperability limitations, the database queries associated with a patient cohort may need to be reconfigured in every participating site. i2b2 and SHRINE advance the notion of patient cohorts as first class objects to be shared, aggregated, and recruited for research purposes across clinical sites. This paper reports on initial efforts to assess the integration of Medical Information Mart for Intensive Care (MIMIC) and Philips eICU, two large-scale anonymized intensive care unit (ICU) databases, using standard terminologies, i.e. LOINC, ICD9-CM and SNOMED-CT. Focus of this work is lab and microbiology observations and key demographics for patients with a primary cardiovascular ICD9-CM diagnosis. Results and discussion reflecting on reference core terminology standards, offer insights on efforts to combine detailed intensive care data from multiple ICUs worldwide. PMID:27774488

Health Literacy Predicts Cardiac Knowledge Gains in Cardiac Rehabilitation Participants

ERIC Educational Resources Information Center

Mattson, Colleen C.; Rawson, Katherine; Hughes, Joel W.; Waechter, Donna; Rosneck, James

2015-01-01

Objective: Health literacy is increasingly recognised as a potentially important patient characteristic related to patient education efforts. We evaluated whether health literacy would predict gains in knowledge after completion of patient education in cardiac rehabilitation. Method: This was a re-post observational analysis study design based on…

Active-comparator design and new-user design in observational studies

PubMed Central

Yoshida, Kazuki; Solomon, Daniel H.; Kim, Seoyoung C.

2015-01-01

SUMMARY Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of rheumatoid arthritis treatments. However, unlike randomized controlled trials (RCTs), observational studies of drug effects face methodological challenges including confounding by indication. Two design principles - active comparator design and new user design can help mitigate such challenges in observational studies. To improve validity of study findings, observational studies should be designed in such a way that makes them more closely approximate RCTs. The active comparator design compares the drug of interest to another commonly used agent for the same indication, rather than a ‘non-user’ group. This principle helps select treatment groups similar in treatment indications (both measured and unmeasured characteristics). The new user design includes a cohort of patients from the time of treatment initiation, so that it can assess patients’ pretreatment characteristics and capture all events occurring anytime during follow-up. PMID:25800216

Proceedings of the Conference on the Design of Experiments in Army Research Development and Testing (21st)

DTIC Science & Technology

1976-05-01

treatment groups are in the ctual treatment received. This requires comparability of patients as they are intered into study , managed when on study , and...at time of entry into study is to select patients for a control group according to certain characteristics, namely those which are known to influence...control group of B patients could be selected from the literature, chosen on a matched basis from previously or concurrently conducted clinical studies

Some Chronic Rhinosinusitis Patients Have Significantly Elevated Populations of Seven Fungi in their Sinuses

EPA Science Inventory

Abstract: Objectives/Hypothesis: To measure the populations of 36 fungi in the homes and sinuses of chronic rhinosinusitis (CRS) and non-CRS patients. Study Design: Single-blind cross-sectional study. Methods: Populations of 36 fungi were measured in sinus samples and in the home...

Embedding the perceptions of people with dementia into quantitative research design.

PubMed

O'Rourke, Hannah M; Duggleby, Wendy; Fraser, Kimberly D

2015-05-01

Patient perspectives about quality of life are often found in the results of qualitative research and could be applied to steer the direction of future research. The purpose of this paper was to describe how findings from a body of qualitative research on patient perspectives about quality of life were linked to a clinical administrative dataset and then used to design a subsequent quantitative study. Themes from two systematic reviews of qualitative evidence (i.e., metasyntheses) identified what affects quality of life according to people with dementia. Selected themes and their sub-concepts were then mapped to an administrative dataset (the Resident Assessment Instrument 2.0) to determine the study focus, formulate nine hypotheses, and select a patient-reported outcome. A literature review followed to confirm existence of a knowledge gap, identify adjustment variables, and support design decisions. A quantitative study to test the association between conflict and sadness for people with dementia in long-term care was derived from metasynthesis themes. Challenges included (1) mapping broad themes to the administrative dataset; (2) decisions associated with inclusion of variables not identified by people with dementia from the qualitative research; and (3) selecting a patient-reported outcome, when the dataset lacked a valid subjective quality-of-life measure. Themes derived from a body of qualitative research capturing a target populations' perspective can be linked to administrative data and used to design a quantitative study. Using this approach, the quantitative findings will be meaningful with respect to the quality of life of the target population.

Community pharmacy--ideal location to screen and monitor hypertensive patients.

PubMed

Negru, Diana Simona; Diaconescu, Monica; Petculescu, Ana Maria; Bild, Veronica

2010-01-01

The goals of this study were (a) to create a patient electronic database by filling in the specially designed Patient Data Sheets (PDS) after interviewing hypertensive patients and (b) to evaluate pharmacists' opportunities for intervention in order to improve hypertensive patients' outcomes. Pharmacists from two Romanian chain community pharmacies interviewed all hypertensive patients that entered the pharmacies during the study period (November-December 2008) and selected 106 subjects using several selection criteria. Pharmacists recorded in specially designed Patient Data Sheet relevant information such as: demographic data, additional diagnostics (if any), lifestyle behaviors and therapeutic data. The records were then transferred into an electronic database and interpreted by the research team. Hypertension (HT) as a single disease was present in only 7 patients (6.6%), most of them being diagnosed with multiple illnesses (such as HT and cardiovascular disease (CVD) in 25 patients, HT and dyslipidemia (DL) in 20 patients). More than half of the subjects (61.3%) declared they have adopted at least one lifestyle modification component and almost 80% of the patients use two, three or more antihypertensive agents in their medication. The high incidence of complications among our hypertensive subjects justifies implementing blood pressure monitoring programs in community pharmacies and requires pharmacists' intervention for a better management of hypertension.

Enablers and barriers to using two-way information technology in the management of adults with diabetes: A descriptive systematic review.

PubMed

Macdonald, Emma M; Perrin, Byron M; Kingsley, Michael Ic

2017-01-01

Background This systematic review aimed to explore the enablers and barriers faced by adults with diabetes using two-way information communication technologies to support diabetes self-management. Methods Relevant literature was obtained from five databases using search strategies combining four major constructs: adults with diabetes, biomedical technology, communication technology and patient utilisation. Results Of 8430 unique articles identified, 48 were included for review. Risk of bias was assessed using either the Newcastle-Ottowa or Cochrane risk of bias assessment tools. Seventy-one percent of studies were of cohort design with the majority of studies assessed at high or unclear risk of bias. Consistently identified barriers included poorly designed interfaces requiring manual data entry and systems that lacked functionalities valued by patients. Commonly cited enablers included access to reliable technology, highly automated data entry and transmission, graphical display of data with immediate feedback, and supportive health care professionals and family members. Conclusions People with diabetes face a number of potentially modifiable barriers in using technology to support their diabetes management. In order to address these barriers, end users should be consulted in the design process and consideration given to theories of technology adoption to inform design and implementation. Systems should be designed to solve clinical or behavioural problems that are identified by patients as priorities. Technology should be as automated, streamlined, mobile, low cost and integrated as possible in order to limit the burden of usage for the patient and maximise clinical usefulness.

Designing Health Apps to Support Dietetic Professional Practice and Their Patients: Qualitative Results From an International Survey

PubMed Central

Lieffers, Jessica; Bauman, Adrian; Hanning, Rhona; Allman-Farinelli, Margaret

2017-01-01

Background Dietitians are engaging with mobile health (mHealth) technologies, particularly with diet and nutrition apps in their patient care. Despite the plethora of apps available, the majority are not designed with a dietitian’s input. Objective The aim of this study was to identify the user preferences of dietitians in relation to tools, resources, and design features for smartphone health apps that would support their dietetic professional practice and their patients. Methods As part of a larger international Web-based survey of health-app use among dietitians, three open-ended responses were included for specific exploration of app design features and additional resources or tools that could guide the development of apps for use in dietetic practice and patient care. Inductive thematic analysis of responses was conducted using the qualitative data analysis program, NVivo version 11 (QSR International Pty Ltd), to understand the design preferences and features valued by dietitians. Results The responses from 381 dietitian respondents were analyzed. Five key themes were identified. Dietitians wanted access to credible apps, suggesting that dietetic associations should have greater involvement in reviewing and endorsing evidence-based apps for use in dietary counseling. Improvements to the usability of apps, relating to their ease of use and design, were also raised, as self-monitoring of dietary behaviors using existing nutrition apps was deemed to be burdensome. Furthermore, apps providing dietitian-oriented support were favored, for example, those with the ability to streamline the dietary assessment process, so that dietitians could spend more time on dietary counseling and negotiating patient goals for dietary and lifestyle behavior change. Provision of patient-oriented support, such as functionality to tailor apps to patient-specific needs, was also considered important. Finally, respondents valued apps that could integrate into their work systems to enhance the quality of the dietitian-patient relationship. Conclusions App developers should draw upon the features and characteristics valued by dietitians to guide their development of apps that support dietetic practice and enhance patient care. Moreover, to achieve better dietitian and patient-centered app design, it is imperative that app developers take a collaborative approach with dietitians, their professional associations, and their patients. PMID:28363882

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

PubMed

Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

2008-10-01

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

Interventions to improve screening and appropriate referral of patients with cancer for psychosocial distress: systematic review

PubMed Central

Britton, Ben; Baker, Amanda L; Halpin, Sean A; Beck, Alison K; Carter, Gregory; Wratten, Chris; Bauer, Judith; Forbes, Erin; Booth, Debbie

2018-01-01

Objectives The primary aim of the review was to determine the effectiveness of strategies to improve clinician provision of psychosocial distress screening and referral of patients with cancer. Design Systematic review. Data sources Electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO and Cumulative Index to Nursing and Allied Health Literature (CINAHL)) were searched until July 2016. Inclusion criteria Population: adult patients with cancer and clinical staff members. Intervention: any strategy that aimed to improve the rate of routine screening and referral for detected distress of patients with cancer. Comparison: no intervention controls, ‘usual’ practice or alternative interventions. Outcome: (primary) any measure of provision of screening and/or referral for distress, (secondary) psychosocial distress, unintended adverse effects. Design: trials with or without a temporal comparison group, including randomised and non-randomised trials, and uncontrolled pre–post studies. Data extraction and analysis Two review authors independently extracted data. Heterogeneity across studies precluded quantitative assessment via meta-analysis and so a narrative synthesis of the results is presented. Results Five studies met the inclusion criteria. All studies were set in oncology clinics or departments and used multiple implementation strategies. Using the Grades of Recommendation, Assessment, Development and Evaluation, the overall rating of the certainty of the body of evidence reported in this review was assessed as very low. Three studies received a methodological quality rating of weak and two studies received a rating of moderate. Only one of the five studies reported a significant improvement in referrals. Conclusions The review identified five studies of predominantly poor quality examining the effectiveness of strategies to improve the routine implementation of distress screening and referral for patients with cancer. Future research using robust research designs, including randomised assignment, are needed to identify effective support strategies to maximise the potential for successful implementation of distress screening and referral for patients with cancer. PROSPERO registration number CRD42015017518. PMID:29306881

Translating the use of an enriched environment poststroke from bench to bedside: study design and protocol used to test the feasibility of environmental enrichment on stroke patients in rehabilitation.

PubMed

Janssen, H; Ada, L; Karayanidis, F; Drysdale, K; McElduff, P; Pollack, M; White, J; Nilsson, M; Bernhardt, J; Spratt, N J

2012-08-01

Environmental enrichment, a paradigm investigated extensively in animal models, is an intervention, which by design facilitates motor, sensory, social, and cognitive activity. It has been shown to improve poststroke motor and cognitive function in animal models of stroke. This is the first study to attempt to translate this intervention from the laboratory to the clinical setting. The overall aim of this pilot study is to test the feasibility of using environmental enrichment with stroke patients in a rehabilitation setting. The aim is to enrich the environment of stroke survivors in a rehabilitation ward and measure changes in their activity (physical, cognitive, and social activity). Prospective nonrandomized block design intervention study. In the control phase we will determine the change in activity levels of patients treated in a usual rehabilitation environment over time. In the intervention phase structured observational techniques (behavioural mapping) will be used to quantify the change in activity levels of patients exposed to environmental enrichment. The primary outcome is change in activity level. Additional data collected on entry to and exit from the study will include: cognitive function using a battery of cognitive tests, general function using the Functional Independence Measure, mood using the Patient Health Questionnaire 9 and boredom using the Stroke Rehabilitation Boredom Survey. Quality of life will be assessed using the Assessment of Quality of Life 1 month postdischarge from rehabilitation. Australian New Zealand Clinical Trials Registry# ACTRN12611000629932. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Subjective memory impairment in general practice : Short overview and design of a mixed methods study.

PubMed

Pentzek, Michael; Leve, Verena; Leucht, Verena

2017-05-01

Public awareness for dementia is rising and patients with concerns about forgetfulness are not uncommon in general practice. For the general practitioner (GP) subjectively perceived memory impairment (SMI) also offers a chance to broach the issue of cognitive function with the patient. This may support GPs' patient-centered care in terms of a broader frailty concept. What is SMI (definition, operationalization, prevalence and burden)? Which conceptions and approaches do GPs have regarding SMI? Narrative overview of recent SMI criteria and results, selective utilization of results from a systematic literature search on GP dementia care, non-systematic search regarding SMI in general practice, deduction of a study design from the overview and development according to international standards. Studies revealed that approximately 60% of GP patients aged >74 reported a declining memory, every sixth person had concerns about this aspect and only relatively few seek medical advice. Concerns about SMI are considered a risk factor for future dementia. Specific general practice conceptions about SMI could not be identified in the literature. Using guidelines for mixed methods research, the design of an exploratory sequential mixed methods study is presented, which should reveal different attitudes of GPs towards SMI. Subjective memory impairment (SMI) is a common feature and troubles a considerable proportion of patients. Neuropsychiatric research is progressing, but for the transfer of the SMI concept into routine practice, involvement of GP research is necessary. A new study aims to make a contribution to this.

A Usability Study of a Serious Game in Cognitive Rehabilitation: A Compensatory Navigation Training in Acquired Brain Injury Patients

PubMed Central

van der Kuil, Milan N. A.; Visser-Meily, Johanna M. A.; Evers, Andrea W. M.; van der Ham, Ineke J. M.

2018-01-01

Acquired brain injury patients often report navigation impairments. A cognitive rehabilitation therapy has been designed in the form of a serious game. The aim of the serious game is to aid patients in the development of compensatory navigation strategies by providing exercises in 3D virtual environments on their home computers. The objective of this study was to assess the usability of three critical gaming attributes: movement control in 3D virtual environments, instruction modality and feedback timing. Thirty acquired brain injury patients performed three tasks in which objective measures of usability were obtained. Mouse controlled movement was compared to keyboard controlled movement in a navigation task. Text-based instructions were compared to video-based instructions in a knowledge acquisition task. The effect of feedback timing on performance and motivation was examined in a navigation training game. Subjective usability ratings of all design options were assessed using questionnaires. Results showed that mouse controlled interaction in 3D environments is more effective than keyboard controlled interaction. Patients clearly preferred video-based instructions over text-based instructions, even though video-based instructions were not more effective in context of knowledge acquisition and comprehension. No effect of feedback timing was found on performance and motivation in games designed to train navigation abilities. Overall appreciation of the serious game was positive. The results provide valuable insights in the design choices that facilitate the transfer of skills from serious games to real-life situations. PMID:29922196

A Usability Study of a Serious Game in Cognitive Rehabilitation: A Compensatory Navigation Training in Acquired Brain Injury Patients.

PubMed

van der Kuil, Milan N A; Visser-Meily, Johanna M A; Evers, Andrea W M; van der Ham, Ineke J M

2018-01-01

Acquired brain injury patients often report navigation impairments. A cognitive rehabilitation therapy has been designed in the form of a serious game. The aim of the serious game is to aid patients in the development of compensatory navigation strategies by providing exercises in 3D virtual environments on their home computers. The objective of this study was to assess the usability of three critical gaming attributes: movement control in 3D virtual environments, instruction modality and feedback timing. Thirty acquired brain injury patients performed three tasks in which objective measures of usability were obtained. Mouse controlled movement was compared to keyboard controlled movement in a navigation task. Text-based instructions were compared to video-based instructions in a knowledge acquisition task. The effect of feedback timing on performance and motivation was examined in a navigation training game. Subjective usability ratings of all design options were assessed using questionnaires. Results showed that mouse controlled interaction in 3D environments is more effective than keyboard controlled interaction. Patients clearly preferred video-based instructions over text-based instructions, even though video-based instructions were not more effective in context of knowledge acquisition and comprehension. No effect of feedback timing was found on performance and motivation in games designed to train navigation abilities. Overall appreciation of the serious game was positive. The results provide valuable insights in the design choices that facilitate the transfer of skills from serious games to real-life situations.

Patient-specific polyetheretherketone facial implants in a computer-aided planning workflow.

PubMed

Guevara-Rojas, Godoberto; Figl, Michael; Schicho, Kurt; Seemann, Rudolf; Traxler, Hannes; Vacariu, Apostolos; Carbon, Claus-Christian; Ewers, Rolf; Watzinger, Franz

2014-09-01

In the present study, we report an innovative workflow using polyetheretherketone (PEEK) patient-specific implants for esthetic corrections in the facial region through onlay grafting. The planning includes implant design according to virtual osteotomy and generation of a subtraction volume. The implant design was refined by stepwise changing the implant geometry according to soft tissue simulations. One patient was scanned using computed tomography. PEEK implants were interactively designed and manufactured using rapid prototyping techniques. Positioning intraoperatively was assisted by computer-aided navigation. Two months after surgery, a 3-dimensional surface model of the patient's face was generated using photogrammetry. Finally, the Hausdorff distance calculation was used to quantify the overall error, encompassing the failures in soft tissue simulation and implantation. The implant positioning process during surgery was satisfactory. The simulated soft tissue surface and the photogrammetry scan of the patient showed a high correspondence, especially where the skin covered the implants. The mean total error (Hausdorff distance) was 0.81 ± 1.00 mm (median 0.48, interquartile range 1.11). The spatial deviation remained less than 0.7 mm for the vast majority of points. The proposed workflow provides a complete computer-aided design, computer-aided manufacturing, and computer-aided surgery chain for implant design, allowing for soft tissue simulation, fabrication of patient-specific implants, and image-guided surgery to position the implants. Much of the surgical complexity resulting from osteotomies of the zygoma, chin, or mandibular angle might be transferred into the planning phase of patient-specific implants. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Fixed Full Arches Supported by Tapered Implants with Knife-Edge Thread Design and Nanostructured, Calcium-Incorporated Surface: A Short-Term Prospective Clinical Study

PubMed Central

Bechara, Soheil; Lukosiunas, Algirdas; Kubilius, Ricardas

2017-01-01

Purpose. To evaluate implant survival, peri-implant bone loss, and complications affecting fixed full-arch (FFA) restorations supported by implants with a knife-edge thread design and nanostructured, calcium-incorporated surface. Methods. Between January 2013 and December 2015, all patients referred for implant-supported FFA restorations were considered for enrollment in this study. All patients received implants with a knife-edge thread design and nanostructured calcium-incorporated surface (Anyridge®, Megagen, South Korea) were restored with FFA restorations and enrolled in a recall program. The final outcomes were implant survival, peri-implant bone loss, biologic/prosthetic complications, and “complication-free” survival of restorations. Results. Twenty-four patients were selected. Overall, 215 implants were inserted (130 maxilla, 85 mandible), 144 in extraction sockets and 71 in healed ridges. Thirty-six FFAs were delivered (21 maxilla, 15 mandible): 27 were immediately loaded and 9 were conventionally loaded. The follow-up ranged from 1 to 3 years. Two fixtures failed, yielding an implant survival rate of 95.9% (patient-based). A few complications were registered, for a “complication-free” survival of restorations of 88.9%. Conclusions. FFA restorations supported by implants with a knife-edge thread design and nanostructured, calcium-incorporated surface are successful in the short term, with high survival and low complication rates; long-term studies are needed to confirm these outcomes. PMID:28246595

Development of finite element model for customized prostheses design for patient with pelvic bone tumor.

PubMed

Iqbal, Taimoor; Shi, Lei; Wang, Ling; Liu, Yaxiong; Li, Dichen; Qin, Mian; Jin, Zhongmin

2017-06-01

The aim of this study was to design a hemi-pelvic prosthesis for a patient affected by pelvic sarcoma. To investigate the biomechanical functionality of the pelvis reconstructed with designed custom-made prosthesis, a patient-specific finite element model of whole pelvis with primary ligaments inclusive was constructed based on the computed tomography images of the patient. Then, a finite element analysis was performed to calculate and compare the stress distribution between the normal and implanted pelvis models when undergoing three different static conditions-both-leg standing, single-leg standing for the healthy and the affected one. No significant differences were observed in the stresses between the normal and reconstructed pelvis for both-leg standing, but 20%-40% larger stresses were predicted for the peak stress of the single-leg standing (affected side). Moreover, two- to threefold of peak stresses were predicted within the prostheses compared to that of the normal pelvis especially for single-leg standing case, however, still below the allowable fatigue limitation. The study on the load transmission functionality of prosthesis indicated that it is crucial to carry out finite element analysis for functional evaluation of the designed customized prostheses before three-dimensional printing manufacturing, allowing better understanding of the possible peak stresses within the bone as well as the implants for safety precaution. The finite element model can be equally applicable to other bone tumor model for biomechanical studying.

A Prospective Trial on Initiation Factor 4E (eIF4E) Overexpression and Cancer Recurrence in Node-Positive Breast Cancer

PubMed Central

McClusky, Derek R.; Chu, Quyen; Yu, Herbert; DeBenedetti, Arrigo; Johnson, Lester W.; Meschonat, Carol; Turnage, Richard; McDonald, John C.; Abreo, Fleurette; Li, Benjamin D. L.

2005-01-01

Objective: A previous study of patients with stage I to III breast cancer showed that those patients whose tumors were in the highest tertile of eIF4E overexpression experienced a higher risk for recurrence. This study was designed to determine whether high eIF4E overexpression predicts cancer recurrence independent of nodal status by specifically targeting patients with node-positive disease. Methods: The prospective trial was designed to accrue 168 patients with node-positive breast cancer to detect a 2.5-fold increase in risk for recurrence. eIF4E level was quantified by Western blots as x-fold elevated compared with breast tissues from noncancer patients. End points measured were disease recurrence and cancer-related death. Statistical analyses performed include survival analysis by the Kaplan-Meier method, log-rank test, and Cox proportional hazard model. Results: One hundred seventy-four patients with node-positive breast cancer were accrued. All patients fulfilled study inclusion and exclusion criteria, treatment protocol, and surveillance requirements, with a compliance rate >95%. The mean eIF4E elevation was 11.0 ± 7.0-fold (range, 1.4–34.3-fold). Based on previously published data, tertile distribution was as follow: 1) lowest tertile (<7.5-fold) = 67 patients, 2) intermediate tertile (7.5–14-fold) = 54 patients, and 3) highest tertile (>14-fold) = 53 patients. At a median follow up of 32 months, patients with the highest tertile had a statistically significant higher cancer recurrence rate (log-rank test, P = 0.002) and cancer-related death rate (P = 0.036) than the lowest group. Relative risk calculations demonstrated that high eIF4E patients had a 2.4-fold increase in relative risk increase for cancer recurrence (95% confidence interval, 1.2–4.1; P = 0.01). Conclusions: In this prospective study designed to specifically address risk for recurrence in patients with node-positive breast cancer, the patients whose tumors were in the highest tertile of eIF4E overexpression had a 2.4-fold increase in relative risk for cancer recurrence. Therefore, eIF4E overexpression appears to be an independent predictor of a worse outcome in patients with breast cancer independent of nodal status. PMID:16192819

The Bimetric cementless total hip replacement: 7-18 year follow-up assessing the influence of acetabular design on survivorship.

PubMed

Russell, R C; Ghassemi, A; Dorrell, J H; Powles, D P

2009-08-01

The purpose of this study was to evaluate the mid- to long-term survivorship of Bimetric cementless total hip replacement and assess how it is affected by the acetabular design. This was a retrospective analysis of 127 Bimetric cementless total hip replacements in 110 patients with a follow-up of 7-18 years. A single design stem and three different cementless metal-backed acetabular designs were used. Patients were assessed clinically using the Harris hip score and radiologically by independent review of current hip radiographs. There was only one case of aseptic loosening of the femoral stem. The earliest acetabular design showed a high failure rate whilst the latter two designs showed a 96% survivorship at a mean of 9.5 years. We conclude that a combination of the bimetric stem with either of the latter acetabular cup designs has a good mid- to long-term performance.

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

PubMed Central

2014-01-01

Background Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Methods/Design Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. Discussion The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. Trial registration Clinicaltrials.gov: NCT01866800, 30 April 30 2013. PMID:24986373

Assessing the Quality, Feasibility, and Efficacy of Electronic Patient Platforms Designed to Support Adolescents and Young Adults With Cancer: A Systematic Review Protocol

PubMed Central

McCann, Lisa

2017-01-01

Background A range of innovative websites, mobile technologies, eHealth and mHealth platforms have emerged to support adolescents and young adults (AYAs) with cancer. Previous reviews have identified these various applications and solutions, but no review has summarized the quality, feasibility, and efficacy of existing patient platforms (inclusive of websites, mobile technologies, mHealth and eHealth platforms) developed specifically for young people with cancer. Objective This paper describes the design of a protocol to conduct a review of published studies or reports which describe or report on an existing platform designed specifically for AYAs who have had a cancer diagnosis. Methods A search string was developed using a variety of key words and Medical Subject Heading and applied to bibliographic databases. General data (sample characteristics, patient platform development, design and, if applicable, pilot testing outcomes) will be extracted from reports and studies. Drawing on a previously developed coding schematic, the identified patient platforms will be coded for mode of delivery into (1) automated functions, (2) communicative functions, and (3) use of supplementary modes. An adapted version of the Mobile App Rating Scale (MARS) will be used to assess the of quality of each identified patient platform. The methodological quality of included studies will be assessed using the Quality Assessment Criteria for Evaluating Primary Research Papers from a Variety of Fields (QualSyst). Both authors will independently screen eligible studies for final inclusion and will both be responsible for data extraction and appraisal. Data will be synthesized narratively to provide an overview of identified patient platforms. Results The review began in October 2016 and is currently in progress. The review paper will be submitted for peer-review and publication in the summer of 2017. Conclusions This review will be unique in its focus on assessing, where possible, the quality and efficacy of patient platforms for adolescents and young adults diagnosed with cancer. Results generated from this review will provide an invaluable insight into the utility of modern technology in supporting young people with cancer. PMID:28096067

Physicians' evaluations of patients' decisions to refuse oncological treatment

PubMed Central

van Kleffens, T; van Leeuwen, E

2005-01-01

Objective: To gain insight into the standards of rationality that physicians use when evaluating patients' treatment refusals. Design of the study: Qualitative design with indepth interviews. Participants: The study sample included 30 patients with cancer and 16 physicians (oncologists and general practitioners). All patients had refused a recommended oncological treatment. Results: Patients base their treatment refusals mainly on personal values and/or experience. Physicians mainly emphasise the medical perspective when evaluating patients' treatment refusals. From a medical perspective, a patient's treatment refusal based on personal values and experience is generally evaluated as irrational and difficult to accept, especially when it concerns a curative treatment. Physicians have a different attitude towards non-curative treatments and have less difficulty accepting a patient's refusal of these treatments. Thus, an important factor in the physician's evaluation of a treatment refusal is whether the treatment refused is curative or non-curative. Conclusion: Physicians mainly use goal oriented and patients mainly value oriented rationality, but in the case of non-curative treatment refusal, physicians give more emphasis to value oriented rationality. A consensus between the value oriented approaches of patient and physician may then emerge, leading to the patient's decision being understood and accepted by the physician. The physician's acceptance is crucial to his or her attitude towards the patient. It contributes to the patient's feeling free to decide, and being understood and respected, and thus to a better physician–patient relationship. PMID:15738431

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

A protocol for a discrete choice experiment: understanding preferences of patients with cancer towards their cancer care across metropolitan and rural regions in Australia.

PubMed

Wong, Shu Fen; Norman, Richard; Dunning, Trisha L; Ashley, David M; Lorgelly, Paula K

2014-10-24

Medical decision-making in oncology is a complicated process and to date there are few studies examining how patients with cancer make choices with respect to different features of their care. It is also unknown whether patient choices vary by geographical location and how location could account for observed rural and metropolitan cancer differences. This paper describes an ongoing study that aims to (1) examine patient and healthcare-related factors that influence choices of patients with cancer; (2) measure and quantify preferences of patients with cancer towards cancer care using a discrete choice experiment (DCE) and (3) explore preference heterogeneity between metropolitan and rural locations. A DCE is being conducted to understand how patients with cancer choose between two clinical scenarios accounting for different patient and healthcare-related factors (and levels). Preliminary qualitative research was undertaken to guide the development of an appropriate DCE design including characteristics that are important and relevant to patients with cancer. A fractional factorial design using the D-efficiency criteria was used to estimate interactions among attributes. Multinomial logistic regression will be used for the primary DCE analysis and to control for sociodemographic and clinical characteristics. The Barwon Health Human Research Ethics Committee approved the study. Findings from the study will be presented in national/international conferences and peer-reviewed journals. Our results will form the basis of a feasibility study to inform the development of a larger scale study into preferences of patients with cancer and their association with cancer outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies.

PubMed

Lee, Heeyoung; Song, Seungyeon; Oh, Yun-Kyoung; Kang, WonKu; Kim, Eunyoung

2017-04-01

To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. We systematically searched three electronic databases for eligible studies. In the studies included (n=18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR)=1.07 (95% confidence interval (CI): 0.79-1.46, P=0.66) for RCTs, and RR=0.77 (95% CI: 0.58-1.04, P=0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Evaluating the Usability and Usefulness of a Mobile App for Atrial Fibrillation Using Qualitative Methods: Exploratory Pilot Study.

PubMed

Hirschey, Jaclyn; Bane, Sunetra; Mansour, Moussa; Sperber, Jodi; Agboola, Stephen; Kvedar, Joseph; Jethwani, Kamal

2018-03-15

Atrial fibrillation (AFib) is the most common form of heart arrhythmia and a potent risk factor for stroke. Nonvitamin K antagonist oral anticoagulants (NOACs) are routinely prescribed to manage AFib stroke risk; however, nonadherence to treatment is a concern. Additional tools that support self-care and medication adherence may benefit patients with AFib. The aim of this study was to evaluate the perceived usability and usefulness of a mobile app designed to support self-care and treatment adherence for AFib patients who are prescribed NOACs. A mobile app to support AFib patients was previously developed based on early stage interview and usability test data from clinicians and patients. An exploratory pilot study consisting of naturalistic app use, surveys, and semistructured interviews was then conducted to examine patients' perceptions and everyday use of the app. A total of 12 individuals with an existing diagnosis of nonvalvular AFib completed the 4-week study. The average age of participants was 59 years. All participants somewhat or strongly agreed that the app was easy to use, and 92% (11/12) reported being satisfied or very satisfied with the app. Participant feedback identified changes that may improve app usability and usefulness for patients with AFib. Areas of usability improvement were organized by three themes: app navigation, clarity of app instructions and design intent, and software bugs. Perceptions of app usefulness were grouped by three key variables: core needs of the patient segment, patient workflow while managing AFib, and the app's ability to support the patient's evolving needs. The results of this study suggest that mobile tools that target self-care and treatment adherence may be helpful to AFib patients, particularly those who are newly diagnosed. Additionally, participant feedback provided insight into the varied needs and health experiences of AFib patients, which may improve the design and targeting of the intervention. Pilot studies that qualitatively examine patient perceptions of usability and usefulness are a valuable and often underutilized method for assessing the real-world acceptability of an intervention. Additional research evaluating the AFib Connect mobile app over a longer period, and including a larger, more diverse sample of AFib patients, will be helpful for understanding whether the app is perceived more broadly to be useful and effective in supporting patient self-care and medication adherence. ©Jaclyn Hirschey, Sunetra Bane, Moussa Mansour, Jodi Sperber, Stephen Agboola, Joseph Kvedar, Kamal Jethwani. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 15.03.2018.

Barriers to successful implementation of care in home haemodialysis (BASIC-HHD):1. Study design, methods and rationale

PubMed Central

2013-01-01

Background Ten years on from the National Institute of Health and Clinical Excellence’ technology appraisal guideline on haemodialysis in 2002; the clinical community is yet to rise to the challenge of providing home haemodialysis (HHD) to 10-15% of the dialysis cohort. The renal registry report, suggests underutilization of a treatment type that has had a lot of research interest and several publications worldwide on its apparent benefit for both physical and mental health of patients. An understanding of the drivers to introducing and sustaining the modality, from organizational, economic, clinical and patient perspectives is fundamental to realizing the full benefits of the therapy with the potential to provide evidence base for effective care models. Through the BASIC-HHD study, we seek to understand the clinical, patient and carer related psychosocial, economic and organisational determinants of successful uptake and maintenance of home haemodialysis and thereby, engage all major stakeholders in the process. Design and methods We have adopted an integrated mixed methodology (convergent, parallel design) for this study. The study arms include a. patient; b. organization; c. carer and d. economic evaluation. The three patient study cohorts (n = 500) include pre-dialysis patients (200), hospital haemodialysis (200) and home haemodialysis patients (100) from geographically distinct NHS sites, across the country and with variable prevalence of home haemodialysis. The pre-dialysis patients will also be prospectively followed up for a period of 12 months from study entry to understand their journey to renal replacement therapy and subsequently, before and after studies will be carried out for a select few who do commence dialysis in the study period. The process will entail quantitative methods and ethnographic interviews of all groups in the study. Data collection will involve clinical and biomarkers, psychosocial quantitative assessments and neuropsychometric tests in patients. Organizational attitudes and dialysis unit practices will be studied together with perceptions of healthcare providers on provision of home HD. Economic evaluation of home and hospital haemodialysis practices will also be undertaken and we will apply scenario ("what … if") analysis using system dynamics modeling to investigate the impact of different policy choices and financial models on dialysis technology adoption, care pathways and costs. Less attention is often given to the patient’s carers who provide informal support, often of a complex nature to patients afflicted by chronic ailments such as end stage kidney disease. Engaging the carers is fundamental to realizing the full benefits of a complex, home-based intervention and a qualitative study of the carers will be undertaken to elicit their fears, concerns and perception of home HD before and after patient’s commencement of the treatment. The data sets will be analysed independently and the findings will be mixed at the stage of interpretation to form a coherent message that will be informing practice in the future. Discussion The BASIC-HHD study is designed to assemble pivotal information on dialysis modality choice and uptake, investigating users, care-givers and care delivery processes and study their variation in a multi-layered analytical approach within a single health care system. The study results would define modality specific service and patient pathway redesign. Study Registration This study has been reviewed and approved by the Greater Manchester West Health Research Authority National Research Ethics Service (NRES) The study is on the NIHR (CLRN) portfolio. PMID:24044499

Selection of the initial design for the two-stage continual reassessment method.

PubMed

Jia, Xiaoyu; Ivanova, Anastasia; Lee, Shing M

2017-01-01

In the two-stage continual reassessment method (CRM), model-based dose escalation is preceded by a pre-specified escalating sequence starting from the lowest dose level. This is appealing to clinicians because it allows a sufficient number of patients to be assigned to each of the lower dose levels before escalating to higher dose levels. While a theoretical framework to build the two-stage CRM has been proposed, the selection of the initial dose-escalating sequence, generally referred to as the initial design, remains arbitrary, either by specifying cohorts of three patients or by trial and error through extensive simulations. Motivated by a currently ongoing oncology dose-finding study for which clinicians explicitly stated their desire to assign at least one patient to each of the lower dose levels, we proposed a systematic approach for selecting the initial design for the two-stage CRM. The initial design obtained using the proposed algorithm yields better operating characteristics compared to using a cohort of three initial design with a calibrated CRM. The proposed algorithm simplifies the selection of initial design for the two-stage CRM. Moreover, initial designs to be used as reference for planning a two-stage CRM are provided.

Feasibility study of patient-specific surgical templates for the fixation of pedicle screws.

PubMed

Salako, F; Aubin, C-E; Fortin, C; Labelle, H

2002-01-01

Surgery for scoliosis, as well as other posterior spinal surgeries, frequently uses pedicle screws to fix an instrumentation on the spine. Misplacement of a screw can lead to intra- and post-operative complications. The objective of this study is to design patient-specific surgical templates to guide the drilling operation. From the CT-scan of a vertebra, the optimal drilling direction and limit angles are computed from an inverse projection of the pedicle limits. The first template design uses a surface-to-surface registration method and was constructed in a CAD system by subtracting the vertebra from a rectangular prism and a cylinder with the optimal orientation. This template and the vertebra were built using rapid prototyping. The second design uses a point-to-surface registration method and has 6 adjustable screws to adjust the orientation and length of the drilling support device. A mechanism was designed to hold it in place on the spinal process. A virtual prototype was build with CATIA software. During the operation, the surgeon places either template on patient's vertebra until a perfect match is obtained before drilling. The second design seems better than the first one because it can be reused on different vertebra and is less sensible to registration errors. The next step is to build the second design and make experimental and simulations tests to evaluate the benefits of this template during a scoliosis operation.

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

PubMed

Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

2017-08-01

As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

Factors Associated With Exercise Behavior in People With Parkinson Disease

PubMed Central

Cavanaugh, James T.; Earhart, Gammon M.; Ford, Matthew P.; Foreman, K. Bo; Fredman, Lisa; Boudreau, Jennifer K.; Dibble, Leland E.

2011-01-01

Background The benefits of exercise for reducing disability in people with Parkinson disease (PD) are becoming more evident. Optimal benefit, however, requires regular and sustained participation. Factors associated with engaging in regular exercise have received little scientific scrutiny in people with PD. Objective The purpose of this study was to explore factors associated with exercise behavior in patients with PD using the International Classification of Functioning, Disability and Health (ICF) as a guiding framework. Design This was a cross-sectional study. Methods The participants in this study were 260 patients with PD from 4 institutions. Participants were designated as “exercisers” or “nonexercisers” based on responses to the Stages of Readiness to Exercise Questionnaire. Exercise status was validated using the Physical Activity Scale for the Elderly and an activity monitor. Factors potentially associated with exercise behavior included measures of body structure and function, activity, participation, environmental factors, and personal factors. Their relative contributions were analyzed using logistic regression and quantified with odds ratios. Results One hundred sixty-four participants (63%) were designated as exercisers. Participants with high self-efficacy were more than twice as likely to engage in regular exercise than those with low self-efficacy (adjusted odds ratio=2.34, 95% confidence interval=1.30–4.23). College educated and older participants also were more likely to exercise. Disabling influences of impairments, activity limitations, and participation restrictions were not associated with exercise behavior. Limitations The cross-sectional nature of the study limited the ability to make causal inferences. Conclusions Self-efficacy, rather than disability, appears to be strongly associated with whether ambulatory, community-dwelling people with PD exercise regularly. The results of this study suggest that physical therapists should include strategies to increase exercise self-efficacy when designing patient intervention programs for patients with PD. PMID:22003171

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

PubMed

An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

2014-07-01

The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Customized versus Patient-Sized Cruciate-Retaining Total Knee Arthroplasty: An In Vivo Kinematics Study Using Mobile Fluoroscopy.

PubMed

Zeller, Ian M; Sharma, Adrija; Kurtz, William B; Anderle, Mathew R; Komistek, Richard D

2017-04-01

Historically, knee arthroplasties have been designed using average patient anatomy. Recent advances in imaging and manufacturing have facilitated the development of customized prostheses designed to fit the unique shape of individual patients. The purpose of this study is to determine if improving implant design through customized total knee arthroplasty (TKA) improves kinematic function. Using state-of-the-art mobile fluoroscopy, tibiofemoral kinematics were analyzed for 24 subjects with a customized individually made (CIM), cruciate-retaining TKA, and 14 subjects having an asymmetric condylar cruciate-retaining TKA. Subjects performed a weight-bearing deep knee bend and a rise from a seated position. Each patient was evaluated for weight-bearing range of motion, femorotibial translation, femorotibial axial rotation, and condylar liftoff occurrence. Subjects having a CIM TKA experienced greater weight-bearing knee flexion compared with the traditional posterior cruciate-retaining (PCR) TKA design. During flexion, the CIM TKA subjects consistently exhibited more posterior femoral rollback than the traditional PCR TKA subjects. The CIM TKA was found to have statistically greater axial rotation compared with the traditional PCR TKA (P = .05). Of note, only the CIM TKA patients experienced femoral internal rotation at full extension, as exhibited in a normal knee. Compared with the traditional PCR TKA, the CIM TKAs demonstrated minimal occurrences of paradoxical sliding and reverse rotation during flexion and extension. The CIM TKA subjects showed minimal liftoff and hence better stability in earlyflexion to midflexion compared with the traditional PCR subjects. The CIM TKA demonstrated kinematics more similar to a normal knee. Therefore, using customized implant technology through CIM TKA designs affords benefits including more normal motion compared with a traditional PCR TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

[Development of an integrative cognitive rehabilitation program for brain injured patients in the post-acute stage].

PubMed

Oh, Hyun Soo; Kim, Young Ran; Seo, Wha Sook; Seo, Yeon Ok

2005-04-01

This study was conducted to develop a comprehensive cognitive rehabilitation program that can be easily applied to brain injured patients by family members or nurses in community or hospital settings. A Systemic literature review design was used. Thirty-three related studies were reviewed. Based on the results of the literature review, the training tasks for attention were designated to enhancing 4 hierarchical areas, i.e., focused, selective, alternating, and divided attention. On the other hand, the memory rehabilitation tasks mainly consisted of mnemonic skills, such as the association method which helps patients memorize given information by linking together common attributes, the visual imagery method, and self-instruction method. The problem solving rehabilitation program included a task of games or plays which stimulated the patients' curiosity and interest. The training tasks for problem solving were to encourage the process of deriving reasonable solutions for a problematic situation resembling real problems that the patients were faced with in their everyday life. It is expected that the cognitive rehabilitation program developed from this study could help patients having difficulty in their every day life, due to a reduced cognitive ability resulting from brain injury, to effectively adapt to every day life.

Patients suffering from rheumatic disease describing own experiences from participating in Basic Body Awareness Group Therapy: A qualitative pilot study.

PubMed

Olsen, Aarid Liland; Skjaerven, Liv Helvik

2016-01-01

Rheumatic diseases have physical and psychological impact on patients' movement and function. Basic Body Awareness Therapy focuses on promoting more functional movement quality in daily life. The purpose of this study was to describe patient experiences from participating in Basic Body Awareness Group Therapy for inpatients with rheumatic disease. A phenomenological design included data collection in two focus group interviews with seven patients. Giorgi's four-step phenomenological method was used for data analysis. Four main themes emerged: (1) "Movement exploration-being guided in movement" described informants' exploration of bodily signals and movement habits; (2) "Movement awareness training in a relational perspective" informants described experiences from being in a group setting; (3) "Movement awareness-integration and insight" described informants' reflections on movement experiences; and (4) "Integrating and practicing new movement habits" informants described how they used their movement experiences in daily life. The study described perspectives in movement learning experienced by patients. The results support the view that contact with the body can help patients exploring and cultivating their own resources for a more functional movement quality. Descriptions of relational movement learning aspects can contribute to our understanding of physiotherapy group design.

Systematic inquiry for design of health care information systems: an example of elicitation of the patient stakeholder perspective

PubMed Central

Eschler, Jordan; O’Leary, Katie; Kendall, Logan; Ralston, James D.; Pratt, Wanda

2017-01-01

The electronic health record (EHR) has evolved as a tool primarily dictated by the needs of health care clinicians and organizations, providing important functions supporting day to day work in health care. However, the EHR and supporting information systems contain the potential to incorporate patient workflows and tasks as well. Integrating patient needs into existing EHR and health management systems will require understanding of patients as direct stakeholders, necessitating observation and exploration of in situ EHR use by patients to envision new opportunities for future systems. In this paper, we describe the application of a theoretical framework (Vicente, 1999) to organize qualitative data during a multi-stage research study into patient engagement with EHRs. By using this method of systematic inquiry, we have more effectively elicited patient stakeholder needs and goals to inform the design of future health care information systems. PMID:29056874

Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior.

PubMed

Tai-Seale, Ming; Elwyn, Glyn; Wilson, Caroline J; Stults, Cheryl; Dillon, Ellis C; Li, Martina; Chuang, Judith; Meehan, Amy; Frosch, Dominick L

2016-04-01

Patient-provider communication and shared decision making are essential for primary care delivery and are vital contributors to patient experience and health outcomes. To alleviate communication shortfalls, we designed a novel, multidimensional intervention aimed at nudging both patients and primary care providers to communicate more openly. The intervention was tested against an existing intervention, which focused mainly on changing patients' behaviors, in four primary care clinics involving 26 primary care providers and 300 patients. Study results suggest that compared to usual care, both the novel and existing interventions were associated with better patient reports of how well primary care providers engaged them in shared decision making. Future research should build on the work in this pilot to rigorously examine the comparative effectiveness and scalability of these interventions to improve shared decision making at the point of care. Project HOPE—The People-to-People Health Foundation, Inc.

The Design of Adult Acute Care Units in U.S. Hospitals

PubMed Central

Catrambone, Cathy; Johnson, Mary E.; Mion, Lorraine C.; Minnick, Ann F.

2010-01-01

Purpose To describe the current state of design characteristics determined to be desirable by the Agency for Health Research and Quality (AHRQ) in U.S. adult medical, surgical, and intensive care units (ICUs). Design Descriptive study of patient visibility; distance to hygiene, toileting, charting, and supplies; unit configuration; percentage of private rooms; and presence or absence of carpeting in 56 ICUs and 81 medical-surgical units in six metropolitan areas. Methods Data were collected via observation, measurement, and interviews. Unit configurations were classified via an iterative process. Descriptive data were analyzed according to ICU and non-ICU status using SPSS (Version 15). Findings Analysis of unit configurations indicated eight unit designs. Statistical analysis showed inter- and intrahospital variation in unit configurations, percentage private rooms, carpeting, visibility, and distance to supplies and charting. Few units met the AHRQ designated design elements studied. Conclusions A wide gap exists between desirable characteristics in ICUs and medical-surgical units. Future research is needed to explore operationalization of unit design elements as risk adjustments, how design elements contribute to patient outcomes, and how design elements influence one another. Clinical Relevance There is room for improvement on almost every design variable, particularly on medical-surgical units. Future planning should take into consideration the interaction of bed capacity and unit configuration. PMID:19335681

Feasibility of motivational interviewing delivered by a glaucoma educator to improve medication adherence.

PubMed

Cook, Paul F; Bremer, Robert W; Ayala, A J; Kahook, Malik Y

2010-10-05

Adherence to glaucoma treatment is poor, potentially reducing therapeutic effects. A glaucoma educator was trained to use motivational interviewing (MI), a patient-centered counseling style, to improve adherence. This study was designed to evaluate whether MI was feasible in a busy ophthalmology practice. Feasibility was assessed using five criteria from the National Institutes of Health Behavior Change consortium: fidelity of intervention components to MI theory; success of the training process; delivery of MI-consistent interventions by the glaucoma educator; patient receipt of the intervention based on enrollment, attrition, and satisfaction; and patient enactment of changes in motivation and adherence over the course of the intervention. A treatment manual was designed by a multidisciplinary team with expertise in health psychology, public health, and ophthalmology. The glaucoma educator received 6 hours of training including role-play exercises, self-study, and individual supervision. His MI-related knowledge and skills increased following training, and he delivered exclusively MI-consistent interventions in 66% of patient encounters. 86% (12/14) of eligible patients agreed to be randomized into glaucoma educator support or a control condition. All 8 patients assigned to the glaucoma educator completed at least 2 of 6 planned contacts, and 50% (4/8) completed all 6 contacts. Patients assigned to the glaucoma educator improved over time in both motivation and adherence. The introduction of a glaucoma educator was feasible in a busy ophthalmology practice. Patients improved their adherence while participating in the glaucoma educator program, although this study was not designed to show a causal effect. The use of a glaucoma educator to improve glaucoma patients' medication adherence may be feasible at other ophthalmology clinics, and can be implemented with a standardized training approach. Pilot data show the intervention can be implemented with fidelity, is acceptable to patients and providers, and has the potential to improve adherence.

Developing a conceptual model for the application of patient and public involvement in the healthcare system in Iran.

PubMed

Azmal, Mohammad; Sari, Ali Akbari; Foroushani, Abbas Rahimi; Ahmadi, Batoul

2016-06-01

Patient and public involvement is engaging patients, providers, community representatives, and the public in healthcare planning and decision-making. The purpose of this study was to develop a model for the application of patient and public involvement in decision making in the Iranian healthcare system. A mixed qualitative-quantitative approach was used to develop a conceptual model. Thirty three key informants were purposely recruited in the qualitative stage, and 420 people (patients and their companions) were included in a protocol study that was implemented in five steps: 1) Identifying antecedents, consequences, and variables associated with the patient and the publics' involvement in healthcare decision making through a comprehensive literature review; 2) Determining the main variables in the context of Iran's health system using conceptual framework analysis; 3) Prioritizing and weighting variables by Shannon entropy; 4) designing and validating a tool for patient and public involvement in healthcare decision making; and 5) Providing a conceptual model of patient and the public involvement in planning and developing healthcare using structural equation modeling. We used various software programs, including SPSS (17), Max QDA (10), EXCEL, and LISREL. Content analysis, Shannon entropy, and descriptive and analytic statistics were used to analyze the data. In this study, seven antecedents variable, five dimensions of involvement, and six consequences were identified. These variables were used to design a valid tool. A logical model was derived that explained the logical relationships between antecedent and consequent variables and the dimensions of patient and public involvement as well. Given the specific context of the political, social, and innovative environments in Iran, it was necessary to design a model that would be compatible with these features. It can improve the quality of care and promote the patient and the public satisfaction with healthcare and legitimate the representative of people they served for. This model can provide a practical guide for managers and policy makers to involve people in making the decisions that influence their lives.

[Modeling integrative oncology care program for Arab patients in north Israel: towards quality of life improvement during chemotherapy].

PubMed

Ben-Arye, Eran; Dagash, Jamal; Silbermann, Michael; Saad, Bashar; Steiner, Mariana; Popper-Giveon, Ariela; Lev, Efraim; Agbarya, Abed; Sela, Gil Bar; Karkabi, Khaled; Schiff, Elad

2015-01-01

In the last decade, a number of integrative oncology programs have been established within leading oncology departments in Israel aiming to provide consultations that address patients' concerns and improve their quality of life (QOL). To identify Arab cancer patients' attitudes, needs and expectations concerning integration of complementary and traditional medicine (CTM) in their supportive oncology care. This article presents studies based on both qualitative (including interviews with patients, oncologists and CTM practitioners) and quantitative studies which were designed to evaluate patients' attitudes, needs and expectations regarding CTM integration in supportive oncology care. Of the 313 Arab respondents, 109 reported on the use of herbal medicine for cancer-associated outcomes. Over 78% of respondents considered QOL improvement as their main expectation of integrated CM consultation. Similar expectations were expressed in studies exploring 155 cancer care practitioners in Israel and Arab countries, 27 CTM-trained Arab practitioners, and a sample of 15 Arab patients referred to integrative medicine consultation. Arab cancer patients support QOL-oriented integrated medicine programs provided in oncology settings. Integrative medicine consultation should provide patients with an evidence-based recommendation on efficacy and safety of herbs commonly used concomitant with chemotherapy. We recommend designing integrative oncology training courses for physicians who will provide evidence-based consultation attuned with Arab patients' needs, concerns and cultural-sensitive orientation.

Administering the Sarcoidosis Health Questionnaire to sarcoidosis patients in Serbia

PubMed Central

Mihailović-Vučinić, Violeta; Gvozdenović, Branislav; Stjepanović, Mihailo; Vuković, Mira; Marković-Denić, Ljiljana; Milovanović, Aleksandar; Videnović-Ivanov, Jelica; Žugić, Vladimir; Škodrić-Trifunović, Vesna; Filipović, Snežana; Omčikus, Maja

2016-01-01

Objective: The aim of this study was to use a Serbian-language version of the disease-specific, self-report Sarcoidosis Health Questionnaire (SHQ), which was designed and originally validated in the United States, to assess health status in sarcoidosis patients in Serbia, as well as validating the instrument for use in the country. Methods: This was a cross-sectional study of 346 patients with biopsy-confirmed sarcoidosis. To evaluate the health status of the patients, we used the SHQ, which was translated into Serbian for the purposes of this study. We compared SHQ scores by patient gender and age, as well as by disease duration and treatment. Lower SHQ scores indicate poorer health status. Results: The SHQ scores demonstrated differences in health status among subgroups of the sarcoidosis patients evaluated. Health status was found to be significantly poorer among female patients and older patients, as well as among those with chronic sarcoidosis or extrapulmonary manifestations of the disease. Monotherapy with methotrexate was found to be associated with better health status than was monotherapy with prednisone or combination therapy with prednisone and methotrexate. Conclusions: The SHQ is a reliable, disease-specific, self-report instrument. Although originally designed for use in the United States, the SHQ could be a useful tool for the assessment of health status in various non-English-speaking populations of sarcoidosis patients. PMID:27167430

Kinect-based virtual rehabilitation and evaluation system for upper limb disorders: A case study.

PubMed

Ding, W L; Zheng, Y Z; Su, Y P; Li, X L

2018-04-19

To help patients with disabilities of the arm and shoulder recover the accuracy and stability of movements, a novel and simple virtual rehabilitation and evaluation system called the Kine-VRES system was developed using Microsoft Kinect. First, several movements and virtual tasks were designed to increase the coordination, control and speed of the arm movements. The movements of the patients were then captured using the Kinect sensor, and kinematics-based interaction and real-time feedback were integrated into the system to enhance the motivation and self-confidence of the patient. Finally, a quantitative evaluation method of upper limb movements was provided using the recorded kinematics during hand-to-hand movement. A preliminary study of this rehabilitation system indicates that the shoulder movements of two participants with ataxia became smoother after three weeks of training (one hour per day). This case study demonstrated the effectiveness of the designed system, which could be promising for the rehabilitation of patients with upper limb disorders.