A Pilot Study of CPAP Adherence Promotion by Peer Buddies with Sleep Apnea

PubMed Central

Parthasarathy, Sairam; Wendel, Christopher; Haynes, Patricia L.; Atwood, Charles; Kuna, Samuel

2013-01-01

Study Objectives: To evaluate patient ratings of the acceptability of a peer buddy system (PBS). To promote continuous positive airway pressure (CPAP) therapy adherence in patients with obstructive sleep apnea (OSA). To obtain preliminary data on the effectiveness of PBS on sleep-specific health-related quality of life and CPAP adherence. Design: Prospective, randomized, and controlled study. Setting: Academic Center. Participants: Thirty-nine patients with OSA and 13 patients with OSA who were experienced CPAP users. Interventions: Recently diagnosed patients with OSA were randomly assigned to either the PBS to promote CPAP adherence (intervention group) or usual care (control group). Measurements: Patient satisfaction, Functional Outcomes of Sleep Questionnaire (FOSQ), CPAP adherence, vigilance, self-efficacy, and patient activation were measured. Results: Ninety-one percent of the subjects rated the PBS as very satisfactory (68%) or satisfactory (23%). During the 90 days of therapy, weekly CPAP adherence was greater in the intervention than the usual care group (MANOVA; F = 2.29; p = 0.04). Patient satisfaction was positively correlated with CPAP adherence (R2 = 0.14; p = 0.02). We did not find any group differences for FOSQ, vigilance, self-efficacy, or patient activation in this pilot study. Conclusion: Our pilot study suggests that the PBS intervention is feasible and received high patient satisfaction ratings. CPAP adherence may be improved by peer-driven intervention, but a larger, adequately powered study is needed. Clinical Trial Information: ClinicalTrials.gov identifier: NCT01164683. Commentary: A commentary on this article appears in this issue on page 551. Citation: Parthasarathy S; Wendel C; Haynes PL; Atwood C; Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med 2013;9(6):543-550. PMID:23772186

Development and Feasibility of a Structured Goals of Care Communication Guide.

PubMed

Bekelman, David B; Johnson-Koenke, Rachel; Ahluwalia, Sangeeta C; Walling, Anne M; Peterson, Jamie; Sudore, Rebecca L

2017-09-01

Discussing goals of care and advance care planning is beneficial, yet how to best integrate goals of care communication into clinical care remains unclear. To develop and determine the feasibility of a structured goals of care communication guide for nurses and social workers. Developmental study with providers in an academic and Veterans Affairs (VA) health system (n = 42) and subsequent pilot testing with patients with chronic obstructive pulmonary disease or heart failure (n = 15) and informal caregivers (n = 4) in a VA health system. During pilot testing, the communication guide was administered, followed by semistructured, open-ended questions about the content and process of communication. Changes to the guide were made iteratively, and subsequent piloting occurred until no additional changes emerged. Provider and patient feedback to the communication guide. Iterative input resulted in the goals of care communication guide. The guide included questions to elicit patient understanding of and attitudes toward the future of illness, clarify values and goals, identify end-of-life preferences, and agree on a follow-up plan. Revisions to guide content and phrasing continued during development and pilot testing. In pilot testing, patients validated the importance of the topic; none said the goals of care discussion should not be conducted. Patients and informal caregivers liked the final guide length (∼30 minutes), felt it flowed well, and was clear. In this developmental and pilot study, a structured goals of care communication guide was iteratively designed, implemented by nurses and social workers, and was feasible based on administration time and acceptability by patients and providers.

[Pilot-experience in home care: bedridden aged patients of a basic health unit, Porto Alegre, Brazil].

PubMed

Marques, Giselda Quintana; Freitas, Ivani Bueno de Almeida

2009-12-01

The objectives of this study were to describe the development of a pilot-project in home care to bedridden aged patients at a Basic Health Unit, and identify demographic, social and health aspects of these patients, as well as relevant aspects reported by the health team that implemented the home care. The study had descriptive and evaluative characteristics. The patients' enrollment forms and health records and the project's records were analyzed. The pilot-experience permitted to develop the team's skills, in addition to being enriching and of great responsibility for the professionals and caregivers involved. The results indicated the need for continuous home care and adjustments in its organization with the purpose of increasing the areas for health care and improving the population's quality of life.

Using Patient Reported Outcomes and PROMIS in Research and Clinical Applications: Experiences from the PCORI Pilot Projects

PubMed Central

Bingham, Clifton O.; Bartlett, Susan J.; Merkel, Peter A.; Mielenz, Thelma J.; Pilkonis, Paul A.; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K.

2016-01-01

Purpose The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes, and in particular, the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Methods Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects’ experiences. Results Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. Conclusions The PCORI Pilot Projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders. PMID:26914103

Using patient-reported outcomes and PROMIS in research and clinical applications: experiences from the PCORI pilot projects.

PubMed

Bingham, Clifton O; Bartlett, Susan J; Merkel, Peter A; Mielenz, Thelma J; Pilkonis, Paul A; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K

2016-08-01

The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes and, in particular the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects' experiences. Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. The PCORI pilot projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders.

Conservative Management of Mechanical Neck Pain in a Helicopter Pilot.

PubMed

Alagha, Babak

2015-10-01

Acute and chronic spinal symptoms such as neck pain may limit flying performance significantly and disqualify the pilot from flight duty. Mechanical neck pain is very common among pilots because of their exposure to vibration, +GZ forces, helmet weight, poor neck posture during air combat maneuvers, previous neck injuries, and poor treatment plans for such injuries. Successful treatment of such injuries requires appropriate therapeutic procedures as well as an aeromedical assessment. The aim of this case study was to demonstrate the benefits of conservative procedures such as spinal manipulation and mobilization therapy (SMMT) and exercise therapy (ET) in treating chronic mechanical neck pain in an Iranian commercial helicopter pilot. A 36-yr-old male patient presented to the clinic with moderate, intermittent nonradicular chronic neck pain and limited range of motion over a 2-yr period. The patient was treated with cervical and upper thoracic SMMT followed by home ET for 5 wk. After this period, the patient reported significant recovery and improvement in range of motion in his neck. Mechanical neck pain is very common among helicopter pilots. Although Air Force and Navy waiver guides recommend nonsteroidal anti-inflammatory medications as well as SMMT and ET, there are currently very few published studies that examine the benefits of manual and exercise therapy for treating mechanical neck pain in commercial and military pilots. Based on the results of this study, it seems that SMMT and ET may be a safe and effective in treatment of uncomplicated mechanical neck pain in helicopter pilots. Alagha B. Conservative management of mechanical neck pain in a helicopter pilot.

Medication coaching program for patients with minor stroke or TIA: a pilot study.

PubMed

Sides, Elizabeth G; Zimmer, Louise O; Wilson, Leslie; Pan, Wenqin; Olson, Daiwai M; Peterson, Eric D; Bushnell, Cheryl

2012-07-25

Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Consecutive patients admitted with stroke or TIA with at least 2 medications changed between admission and discharge were included. The medication coach contacted intervention arm patients post-discharge via phone call to discuss risk factors, review medications and triage patients' questions to a stroke nurse and/or pharmacist. Intervention and control participants were contacted at 3 months for outcomes. The main outcomes were feasibility (appropriateness of script, ability to reach participants, and provide requested information) and participant evaluation of medication coaching. The median lengths of the coaching and follow-up calls with requested answers to these questions were 27 minutes and 12 minutes, respectively, and participant evaluations of the coaching were positive. The intervention participants were more likely to have seen their primary care provider than were control participants by 3 months post discharge. This medication coaching study executed early after discharge demonstrated feasibility of coaching and educating stroke patients with a trained coach. Results from our small pilot showed a possible trend towards improved appointment-keeping with primary care providers in those who received coaching.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

PubMed

Hubbard, Gill; Campbell, Anna; Davies, Zoe; Munro, Julie; Ireland, Aileen V; Leslie, Stephen; Watson, Angus Jm; Treweek, Shaun

2015-01-01

Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required. ISRCTN63510637; UKCRN id 14092.

Development and pilot testing of a patient-participatory pressure ulcer prevention care bundle.

PubMed

Gillespie, Brigid M; Chaboyer, Wendy; Sykes, Mark; O'Brien, Jennifer; Brandis, Susan

2014-01-01

This study developed and piloted a patient-centered pressure ulcer prevention care bundle for adult hospitalized patients to promote patient participation in prevention. The care bundle had 3 core messages: (1) keep moving, (2) care for your skin, and (3) ensure a good diet. A brief video, combined brochure/checklist, and poster were developed as training resources. Patient evaluation identified benefits of the care bundle; however, the combined checklist/brochure was rarely used.

HIV testing for acute medical admissions: evaluation of a pilot study in Leicester, England.

PubMed

Palfreeman, Adrian; Nyatsanza, Farai; Farn, Helen; McKinnon, Graham; Schober, Paul; McNally, Paul

2013-06-01

The 2008 UK National Guidelines for HIV testing recommended HIV testing should be offered to all general medical admissions aged 16-60 years in high prevalence areas, and that this should be evaluated to ensure this was effective in diagnosing previously undiagnosed HIV. HIV testing was introduced as a routine test for all patients admitted to the acute medical admissions unit, comparisons were made between the testing rates before, during and after this intervention. The pilot was initiated in August 2009. Prior to the pilot the unit was carrying out 15 tests per month. However, when the pilot was introduced 82 tests were being carried out per month with a total of 10 new diagnoses since the start of the pilot. The proportion of patients tested versus those eligible for testing remained low varying between 6% and 22% month by month. 10 patients we found to be HIV positive with a prevalence of approximately 1%, 10 fold higher than the cut off for cost effectiveness used in the guidelines. Overall the pilot showed that HIV testing could be delivered without the use of extra resources and is acceptable to patients.

Effects of sculpture based art therapy in dementia patients-A pilot study.

PubMed

Seifert, Kathrin; Spottke, Annika; Fliessbach, Klaus

2017-11-01

Art and art therapy open up interesting possibilities for dementia patients. However, it has not been evaluated scientifically so far, whether the art of sculpting has any benefits. In this non-randomized pilot study with twelve participants, we investigated the feasibility and acceptance of sculptural activity in patients with dementia and the effects on their well-being. A questionnaire was custom-designed to investigate five key aspects of well-being: mental state and concentration, corporeal memory, self-reliance, self-esteem and physicality. Remarkable improvements were seen in several subscales in the sculptural activity group, but not the control group: Mental state and concentration (nine of thirteen key aspects), self-reliance (four of five), self-esteem (one of one) and physicality (two of two). The results of this pilot study indicate the multidimensional effects of sculptural activity on patients living with dementia. The field would benefit greatly from further research.

ASSESSMENT OF MAST IN EUROPEAN PATIENT-CENTERED TELEMEDICINE PILOTS.

PubMed

Ekeland, Anne Granstrøm; Grøttland, Astrid

2015-01-01

Model for ASsessment of Telemedicine Applications (MAST) is a health technology assessment (HTA) inspired framework for assessing the effectiveness and contribution to quality of telemedicine applications based on rigorous, scientific data. This study reports from a study of how it was used and perceived in twenty-one pilots of the European project RENEWING HEALTH (RH). The objectives of RH were to implement large-scale, real-life test beds for the validation and subsequent evaluation of innovative patient-centered telemedicine services. The study is a contribution to the appraisal of HTA methods. A questionnaire was administered for project leaders of the pilots. It included questions about use and usefulness of MAST for (i) preceding considerations, (ii) evaluation of outcomes within seven domains, and (iii) considerations of transferability. Free text spaces allowed for proposals of improvement. The responses covered all pilots. A quantitative summary of use and a qualitative analysis of usefulness were performed. MAST was used and considered useful for pilot evaluations. Challenges included problems to scientifically determine alternative service options and outcome within the seven domains. Proposals for improvement included process studies and adding domains of technological usability, responsible innovation, health literacy, behavior change, caregiver perspectives and motivational issues of professionals. MAST was used according to its structure. Its usefulness in patient centered pilots can be improved by adding new stakeholder groups. Interdependencies between scientific rigor, resources and timeliness should be addressed. Operational options for improvements include process studies, literature reviews and sequential mini-HTAs for identification of areas for more elaborate investigations.

Chronic care coordination by integrating care through a team-based, population-driven approach: a case study.

PubMed

van Eeghen, Constance O; Littenberg, Benjamin; Kessler, Rodger

2018-05-23

Patients with chronic conditions frequently experience behavioral comorbidities to which primary care cannot easily respond. This study observed a Vermont family medicine practice with integrated medical and behavioral health services that use a structured approach to implement a chronic care management system with Lean. The practice chose to pilot a population-based approach to improve outcomes for patients with poorly controlled Type 2 diabetes using a stepped-care model with an interprofessional team including a community health nurse. This case study observed the team's use of Lean, with which it designed and piloted a clinical algorithm composed of patient self-assessment, endorsement of behavioral goals, shared documentation of goals and plans, and follow-up. The team redesigned workflows and measured reach (patients who engaged to the end of the pilot), outcomes (HbA1c results), and process (days between HbA1c tests). The researchers evaluated practice member self-reports about the use of Lean and facilitators and barriers to move from pilot to larger scale applications. Of 20 eligible patients recruited over 3 months, 10 agreed to participate and 9 engaged fully (45%); 106 patients were controls. Relative to controls, outcomes and process measures improved but lacked significance. Practice members identified barriers that prevented implementation of all changes needed but were in agreement that the pilot produced useful outcomes. A systematized, population-based, chronic care management service is feasible in a busy primary care practice. To test at scale, practice leadership will need to allocate staffing, invest in shared documentation, and standardize workflows to streamline office practice responsibilities.

Validity and reliability of a pilot scale for assessment of multiple system atrophy symptoms.

PubMed

Matsushima, Masaaki; Yabe, Ichiro; Takahashi, Ikuko; Hirotani, Makoto; Kano, Takahiro; Horiuchi, Kazuhiro; Houzen, Hideki; Sasaki, Hidenao

2017-01-01

Multiple system atrophy (MSA) is a rare progressive neurodegenerative disorder for which brief yet sensitive scale is required in order for use in clinical trials and general screening. We previously compared several scales for the assessment of MSA symptoms and devised an eight-item pilot scale with large standardized response mean [handwriting, finger taps, transfers, standing with feet together, turning trunk, turning 360°, gait, body sway]. The aim of the present study is to investigate the validity and reliability of a simple pilot scale for assessment of multiple system atrophy symptoms. Thirty-two patients with MSA (15 male/17 female; 20 cerebellar subtype [MSA-C]/12 parkinsonian subtype [MSA-P]) were prospectively registered between January 1, 2014 and February 28, 2015. Patients were evaluated by two independent raters using the Unified MSA Rating Scale (UMSARS), Scale for Assessment and Rating of Ataxia (SARA), and the pilot scale. Correlations between UMSARS, SARA, pilot scale scores, intraclass correlation coefficients (ICCs), and Cronbach's alpha coefficients were calculated. Pilot scale scores significantly correlated with scores for UMSARS Parts I, II, and IV as well as with SARA scores. Intra-rater and inter-rater ICCs and Cronbach's alpha coefficients remained high (> 0.94) for all measures. The results of the present study indicate the validity and reliability of the eight-item pilot scale, particularly for the assessment of symptoms in patients with early state multiple system atrophy.

A follow-up study of heroin addicts (VEdeTTE2): study design and protocol

PubMed Central

Vigna-Taglianti, Federica D; Mathis, Federica; Diecidue, Roberto; Burroni, Paola; Iannaccone, Antonio; Lampis, Fabio; Zuccaro, Piergiorgio; Pacifici, Roberta; Versino, Elisabetta; Davoli, Marina; Faggiano, Fabrizio

2007-01-01

Background In Italy, a large cohort study (VEdeTTE1) was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2) was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%). Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78%) but lower for cocaine (42.3%), highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the pilot phase underline the importance of the pilot phase when planning a follow-up study. PMID:17362515

Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study.

PubMed

Cammisuli, Sharon; Cavazzi, Enrico; Baldissarro, Eleonora; Leandri, Massimo

2016-08-01

Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) have sensory and motor deficits leading to inappropriate proprioceptive feedback, impaired postural control, and fall risk. Balance training with computerized force platforms has been successfully used in rehabilitation of balance disturbances, but programs specifically developed for CIPN patients are lacking. This pilot study evaluated a rehabilitation protocol exclusively based on visual computer-feedback balance training (VCFBT) to improve balance in patients with CIPN. Open-label, non-randomized pilot study, 4-week intervention with pre- vs. post-treatment evaluation. Outpatients of the Rehabilitation Institute of the Salvatore Maugeri Foundation, in Genoa, Italy. Seven out-patients with clinical-instrumental diagnosis of CIPN. At admission, patients were administered the Berg Balance Scale (BBS) and underwent static-dynamic posturography using a computerized force platform to objectively quantify their balance impairment. Their performance was compared to values of a normal age-matched population. Patients then underwent 4 weeks of VCFBT (three 60-minute sessions/week). At discharge, BBS and posturography were repeated and the results compared with those at admission. A significant pre- vs. post-treatment improvement was found in balance as measured by static-dynamic posturography (P=0.004) and BBS (P<0.002). Despite caution needed for the low sample size, this pilot study has shown preliminary evidence that intensive rehabilitation, based on VCFBT can produce a significant improvement in balance outcomes. To our knowledge, this is the first report in CIPN patients of a rehabilitation program based exclusively on VCFBT.

A pilot study to test multiple medication usage and driving functioning

DOT National Transportation Integrated Search

2008-06-01

The use of medications and multiple medications becomes more prevalent with increasing age. This pilot study explored the relationship between polypharmacy and driving functioning through separate but related research activities. A patient-level admi...

Methodological challenges in evaluating the effectiveness of women's crisis houses compared with psychiatric wards: findings from a pilot patient preference RCT.

PubMed

Howard, Louise M; Leese, Morven; Byford, Sarah; Killaspy, Helen; Cole, Laura; Lawlor, Caroline; Johnson, Sonia

2009-10-01

There are several methodological difficulties to address when evaluating acute psychiatric services. This study explored potential methods in evaluating the effectiveness of women's crisis houses compared with psychiatric wards in a pilot patient preference randomized controlled trial. Women requiring voluntary admission to a psychiatric hospital or women's crisis house were asked to enter this pilot and different options for recruitment were explored, including different recruitment sites in the pathway to admission and methods for including women without capacity. Forty-one percent (n = 42) of women entering the study agreed to be randomized and 59% (n = 61) entered patient preference arms. Only 7% of women were recruited before admission and 1 woman without capacity entered the study, despite procedures to facilitate this. Recruitment of patients with acute psychiatric crises is therefore challenging; researchers evaluating acute services should establish a consensus on how ethically and practically to recruit patients in this setting.

Pilot study of digital tools to support multimodal hand hygiene in a clinical setting.

PubMed

Thirkell, Gary; Chambers, Joanne; Gilbart, Wayne; Thornhill, Kerrill; Arbogast, James; Lacey, Gerard

2018-03-01

Digital tools for hand hygiene do not share data, limiting their potential to support multimodal programs. The Christie NHS Foundation Trust, United Kingdom, worked with GOJO (in the United States), MEG (in Ireland), and SureWash (in Ireland) to integrate their systems and pilot their combined use in a clinical setting. A 28-bed medical oncology unit piloted the system for 5 weeks. Live data from the tools were combined to create a novel combined risk status metric that was displayed publicly and via a management Web site. The combined risk status reduced over the pilot period. However, larger and longer duration studies are required to reach statistical significance. Staff and especially patient reaction was positive in that 70% of the hand hygiene training events were by patients. The digital tools did not negatively impact clinical workflow and received positive engagement from staff and patients. The combined risk status did not change significantly over the short pilot period because there was also no specific hand hygiene improvement campaign underway at the time of the pilot study. The results indicate that integrated digital tools can provide both rich data and novel tools that both measure impact and provide feedback to support the implementation of multimodal hand hygiene campaigns, reducing the need for significant additional personnel resources. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

A new computer-based counselling system for the promotion of physical activity in patients with chronic diseases--results from a pilot study.

PubMed

Becker, Annette; Herzberg, Dominikus; Marsden, Nicola; Thomanek, Sabine; Jung, Hartmut; Leonhardt, Corinna

2011-05-01

To develop a computer-based counselling system (CBCS) for the improvement of attitudes towards physical activity in chronically ill patients and to pilot its efficacy and acceptance in primary care. The system is tailored to patients' disease and motivational stage. During a pilot study in five German general practices, patients answered questions before, directly and 6 weeks after using the CBCS. Outcome criteria were attitudes and self-efficacy. Qualitative interviews were performed to identify acceptance indicators. Seventy-nine patients participated (mean age: 64.5 years, 53% males; 38% without previous computer experience). Patients' affective and cognitive attitudes changed significantly, self-efficacy showed only minor changes. Patients mentioned no difficulties in interacting with the CBCS. However, perception of the system's usefulness was inconsistent. Computer-based counselling for physical activity related attitudes in patients with chronic diseases is feasible, but the circumstances of use with respect to the target group and its integration into the management process have to be clarified in future studies. This study adds to the understanding of computer-based counselling in primary health care. Acceptance indicators identified in this study will be validated as part of a questionnaire on technology acceptability in a subsequent study. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study.

PubMed

Heit, Tammarie

2011-01-01

The purpose of this pilot study was to identify, measure and document an effect on the subjective multiple sclerosis symptoms and compare it to any objective data changes in the neuromuscular system of the head and neck, following the correction of the jaw position using a neuromuscular orthotic. The hope is to provide clinical evidence of improvement in the disease long-term without relying on the subjective evidence of remissions and exacerbations reported by the patient. The evidence found in the current pilot study measured improvement of head position, jaw position, jaw function, and airway in the neuromuscular bite position, which correlated with the improvement of subjective symptoms of craniomandibular dysfunction and multiple sclerosis. Studies show that the bite affects blood flow in the brain, which may explain the improvement of the patients in the current study.

Enhancing Access to Patient Education Information: A Pilot Usability Study

PubMed Central

Beaudoin, Denise E.; Rocha, Roberto A.; Tse, Tony

2005-01-01

Health care organizations are developing Web-based portals to provide patient access to personal health information and enhance patient-provider communication. This pilot study investigates two navigation models (“serial” and “menu-driven”) for improving access to education materials available through a portal. There was a trend toward greater user satisfaction with the menu-driven model. Model preference was influenced by frequency of Web use. Results should aid in the improvement of existing portals and in the development of new ones. PMID:16779179

Developing and pilot testing a shared decision-making intervention for dialysis choice.

PubMed

Finderup, Jeanette; Jensen, Jens K D; Lomborg, Kirsten

2018-04-17

Evidence is inconclusive on how best to guide the patient in decision-making around haemodialysis and peritoneal dialysis choice. International guidelines recommend involvement of the patient in the decision to choose the dialysis modality most suitable for the individual patient. Nevertheless, studies have shown lack of involvement of the patient in decision-making. To develop and pilot test an intervention for shared decision-making targeting the choice of dialysis modality. This study reflects the first two phases of a complex intervention design: phase 1, the development process and phase 2, feasibility and piloting. Because decision aids were a part of the intervention, the International Patient Decision Aid Standards were considered. The pilot test included both the intervention and the feasibility of the validated shared decision-making questionnaire (SDM Q9) and the Decision Quality Measure (DQM) applied to evaluate the intervention. A total of 137 patients tested the intervention. After the intervention, 80% of the patients chose dialysis at home reflecting an increase of 23% in starting dialysis at home prior to the study. The SDM Q9 showed the majority of the patients experienced this intervention as shared decision-making. An intervention based on shared decision-making supported by decision aids seemed to increase the number of patients choosing home dialysis. The SDM Q9 and DQM were feasible evaluation tools. Further research is needed to gain insight into the patients' experiences of involvement and the implications for their choice of dialysis modality. © 2018 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel: results of a pilot study.

PubMed

Cueva, Juan F; Calvo, Marcos; Anido, Urbano; León, Luis; Gallardo, Elena; Areses, Carmen; Bernárdez, Beatriz; Gayoso, Lucía; García, Jorge; Jesús Lamas, María; Curiel, Teresa; Vázquez, Francisca; Candamio, Sonia; Vidal, Yolanda; Javier Barón, Francisco; López, Rafael

2012-04-01

The objectives of this pilot study were to evaluate the safety and efficacy of the central nervous system stimulant methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel. Patients with early breast cancer who presented asthenia >3 on the Visual Analogue Scale (VAS) after the first cycle of docetaxel-based chemotherapy were included. Patients received two additional cycles of chemotherapy, one with methylphenidate (10 mg bid) and the other without methylphenidate. Asthenia was evaluated using VAS and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Distress was assessed using the Hospital Anxiety and Depression Scale (HADS), and quality of life using FACT-F. Ten patients were included and evaluated for efficacy and safety. Overall, cycles with methylphenidate were better tolerated than those without methylphenidate in terms of asthenia (VAS, p = 0.004; FACT-F, p = 0.027) and quality of life (FACT-F, p = 0.047). No significant differences were observed in terms of distress (HADS, p = 0.297). Six (60%) patients continued with methylphenidate after study end. Main adverse events during study were palpitations and insomnia (30% of patients each). This pilot study suggests that methylphenidate may reduce asthenia and improve quality of life in breast cancer patients treated with docetaxel.

Perceived outcomes of music therapy with Body Tambura in end of life care - a qualitative pilot study.

PubMed

Teut, Michael; Dietrich, Cordula; Deutz, Bernhard; Mittring, Nadine; Witt, Claudia M

2014-04-07

In recent years, music therapy is increasingly used in palliative care. The aim of this pilot study was to record and describe the subjective experiences of patients and their relatives undergoing music therapy with a Body Tambura in a German hospice and to develop hypotheses for future studies. In a qualitative interview pilot study, data collection and analyses were performed according to the methodological framework of grounded theory. We included German-speaking patients, or relatives of patients, receiving end of life care in an inpatient hospice setting. 11 persons consisting of 8 patients (age range 51-82 years, 4 male and 4 female) and 3 relatives were treated and interviewed. All patients suffered from cancer in an advanced stage. The most often described subjective experiences were a relaxing and calming effect, sensations that the body feels lighter, and the generation of relaxing images and visualizations. Family members enjoyed listening to the music and felt more connected with the sick family member. Patient reported beneficial aspects. The small sample size could be seen as a limitation. Assessment instruments measuring relaxation, stress, quality of life and should be included in future quantitative studies.

Cephalometric risk factors associated with myocardial infarction in patients suffering from obstructive sleep apnea: A pilot case-control study.

PubMed

Davoudmanesh, Zeinab; Bayat, Mohamad; Abbasi, Mohsen; Rakhshan, Vahid; Shariati, Mahsa

2017-01-01

Obstructive sleep apnea (OSA) and its craniofacial anatomic risk factors might play a role in several cardiovascular diseases, including myocardial infarction (MI). However, there are no data about cephalometric findings among OSA patients with MI. In this pilot case-control study, about 2000 individuals referred to the sleep center were evaluated according to apnea - hypopnea index (AHI) and other inclusion criteria. Included were 62 OSA male patients (AHI > 10), of whom 6 had an MI history. In both control (n = 56) and MI groups (n = 6), 18 cephalometric parameters were traced. Data were analyzed using independent samples t-test. Compared with control OSA patients, OSA patients with MI showed a significantly larger tongue length (p = 0.015). The other cephalometric variables were not significantly different between the two groups. An elongated tongue might be considered a risk factor for MI in OSA patients. The role of other variables remains inconclusive and open to investigation with larger samples (determined based on pilot studies such as this report) collected in longitudinal fashion.

Module for Interns in Medical Ethics: A Developmental Diegesis.

PubMed

Mahajan, Rajiv; Goyal, Parmod Kumar; Sidhu, Tanvir Kaur; Kaur, Upinder; Kaur, Sandeep; Gupta, Vitull

2017-12-01

Media report is rife with incidences of doctor-patients' conflict, and this partly is due to communication gap and unethical practices being adopted by the doctors. Our regular curriculum fails to impart any training in ethical issues in patient care. Imparting training to students in these soft-skills is the need of the hour. To develop a module for interns in medical ethics (MIME) in patient care, validate it and pilot run the module for standardization. After conducting faculty development workshop in curriculum designing and three rounds of Delphi with alumni, a module in medical ethics was developed and peer validated. The questionnaire for pilot run, questionnaire for future use of module delivery and pre- and post-test were also peer validated. The module was delivered to 17 interns as pilot run in the form of 4 days' workshop. After pilot run, the module was standardized to 10 broad topics and 3 days' workshop. The questionnaire for future delivery of module in regular routine was also validated during pilot run. Twenty-five faculty members participated in 1 day faculty development workshop and 59 alumni completed three rounds of Delphi. After peer review by five experts, a module of 11 broad areas was developed and was pilot run on 17 interns. Based on the feedback from pilot run, a standardized, validated 18 h teaching MIME in patient care was developed. Pilot study proves that curriculum innovation in the form of medical ethics training to interns; when as undergraduate students, they actively participate in patient care under supervision will go a long way in inculcating soft skills like ethics, compassion and communication in them.

Improving foot self-care knowledge, self-efficacy, and behaviors in patients with type 2 diabetes at low risk for foot ulceration: a pilot study.

PubMed

Fan, Lifeng; Sidani, Souraya; Cooper-Brathwaite, Angela; Metcalfe, Kelly

2014-12-01

The pilot study aimed to explore the effects of an educational intervention on patients' foot self-care knowledge, self-efficacy, and behaviors in adult patients with type 2 diabetes at low risk for foot ulceration. The intervention consisted of three sessions and was given over a 3-week period. A total of 70 eligible consenting participants were recruited for this pilot study. Fifty-six participants completed the study. The outcomes were assessed at pretest, following the first two sessions, and 3-month follow-up. The findings indicated that the foot self-care educational intervention was effective in improving foot self-care knowledge, self-efficacy and behaviors in adult patients with type 2 diabetes at low risk for foot ulceration. The findings support the effects of the intervention. Future research should evaluate its efficacy using a randomized clinical trial design, and a large sample of patients with type 2 diabetes at low risk for foot ulcerations. © The Author(s) 2013.

Efficacy of Dentaq® Oral and ENT Health Probiotic Complex on Clinical Parameters of Gingivitis in Patients Undergoing Fixed Orthodontic Treatment: A Pilot Study.

PubMed

Kolip, Duygu; Yılmaz, Nuray; Gökkaya, Berna; Kulan, Pinar; Kargul, Betul; MacDonald, Kyle W; Cadieux, Peter A; Burton, Jeremy P; James, Kris M

2016-09-01

Probiotics act as a unique approach to maintaining oral health by supplementing the endogenous oral bacteria with additional naturally occurring beneficial microbes to provide defense against pathogens harmful to teeth and gingiva. The aim of this pilot study was to clinically evaluate the effects of probiotics on plaque accumulation and gingival inflammation in subjects with fixed orthodontics. The pilot study was comprised of 15 healthy patients, aged 11 to 18 years, undergoing fixed orthodontic treatment. Patients used an all-natural, dissolving lozenge containing six proprietary probiotic strains (Dentaq® Oral and ENT Health Probiotic Complex)for 28 days. Gingival Index (GI) according to Löe-Silness and Plaque Index (PI) according to Quigley-Hein for all teeth were measured at baseline (Day Zero) and at the end of the probiotic regimen (Day 28). The mean baseline GI and PI scores within each patient decreased by 28.4% and 35.8%, respectively, by Day 28. Patients reported decreased tooth and gingival pain, decreased oral bleeding, and increased motivation to maintain proper oral hygiene over the course of the study. This pilot study provided preliminary support for the use of Dentaq Oral and ENT Health Probiotic Complex as a safe and effective natural health product for the reduction of plaque accumulation and gingival inflammation. The results demonstrate its potential therapeutic value and open the door for larger scale placebo-controlled clinical studies to verify these findings.

Sleep among bereaved caregivers of patients admitted to hospice: a 1-year longitudinal pilot study

PubMed Central

Slåtten, Kari; Saghaug, Elisabeth; Grov, Ellen Karine; Normann, Are Peder; Lee, Kathryn A; Bjorvatn, Bjørn; Gay, Caryl L

2016-01-01

Objectives This pilot study aimed to describe the sleep of partners and other family caregivers prior to and in the first year after a hospice patient's death. The study also evaluated the feasibility of the study protocol and determined the effect sizes in preparation for a full-scale study. Design The pilot study used a longitudinal, descriptive and comparative design. Setting and participants Participants included primary family caregivers of patients admitted to a hospice in Oslo, Norway. Primary outcome Caregiver sleep was measured subjectively with the Pittsburgh Sleep Quality Index (PSQI) and objectively using wrist actigraphy for 4 nights and 3 days at three different times: during the hospice stay, and at 6 and 12 months after the patient's death. Results 16 family caregivers (10 partners and 6 other family members) completed the 1-year study protocol. Overall, sleep quality and quantity were stable over time and at each assessment, approximately half of the sample had poor sleep quality, both by self-report and objective measures. However, the sleep trajectories differed significantly over time, with older caregivers (≥65 years) having significantly longer sleep durations than younger caregivers (<65 years). Furthermore, sleep quality also differed over time depending on the caregiver's relationship to the patient, with partner caregivers having significantly worse sleep quality than other family caregivers. Conclusions Caring for a dying family member is known to interfere with sleep, yet little is known about bereaved caregivers. The results of this pilot study demonstrate the feasibility of the longitudinal study protocol and indicate that sleep problems are common for caregivers and continue into the bereavement period, particularly for partner caregivers. The caregiver's relationship to the patient may be an important factor to consider in future studies. PMID:26729383

A pilot study to improve adherence among MS patients who discontinue treatment against medical advice.

PubMed

Bruce, Jared; Bruce, Amanda; Lynch, Sharon; Strober, Lauren; O'Bryan, Sean; Sobotka, Deborah; Thelen, Joan; Ness, Abigail; Glusman, Morgan; Goggin, Kathy; Bradley-Ewing, Andrea; Catley, Delwyn

2016-04-01

Between 30 and 50% of MS patients may prematurely discontinue disease modifying therapies. Little research has examined how to best talk with patients who have discontinued treatment against medical advice. The aim of this pilot study was to determine whether telephone counseling increases disease modifying therapy (DMT) re-initiation among nonadherent patients with multiple sclerosis (MS). Participants were eligible if they had relapsing-remitting disease, had stopped taking a DMT, and had no plan to re-initiate treatment despite a provider recommendation. Following a baseline assessment, 81 patients were randomly assigned to either five 20 min, weekly sessions of Motivational Interviewing/Cognitive Behavioral Therapy (MI-CBT) or Treatment as Usual (TAU) with brief education. At 10 weeks, patients initially assigned to TAU switched over to MI-CBT. Compared to patients in the TAU group, patients undergoing MI-CBT were significantly more likely to indicate they were re-initiating DMT (41.7 vs. 14.3%). These significant results were replicated among patients crossing over from TAU to MI-CBT. Treatment satisfaction was high, with 97% of participants reporting that they would recommend MI-CBT to other patients with MS. Results of this pilot study provide initial support for the use of MI-CBT among MS patients who have discontinued treatment against medical advice.Clinicaltrials.gov: NCT01925690.

Medication therapy management services in community pharmacy: a pilot programme in HIV specialty pharmacies.

PubMed

Rosenquist, Ashley; Best, Brookie M; Miller, Teresa A; Gilmer, Todd P; Hirsch, Jan D

2010-12-01

Pharmacist-provided medication therapy management services (MTMS) have been shown to increase patient's adherence to medications, improve health outcomes and reduce overall medical costs. The purpose of this study was to describe a pilot programme that provided pharmacy-based MTMS for patients with HIV/AIDS in the state of California, USA. Pharmacists from the 10 pilot pharmacies were surveyed using an online data collection tool. Information was collected to describe the types of MTMS offered, proportion of patients actively using specific MTMS, pharmacist beliefs regarding effect on patient outcomes and barriers to providing MTMS, ability to offer MTMS without pilot programme funding and specialized pharmacist or staff training. Each responding pharmacy (7 of 10) varied in the number of HIV/AIDS patients served and prescription volume. All pharmacists had completed HIV/AIDS-related continuing education programmes, and some had other advanced training. The type of MTMS being offered varied at each pharmacy with 'individualized counselling by a pharmacist when overuse or underuse was detected' and 'refill reminders by telephone' being actively used by the largest proportion of patients. Most, but not all, pharmacists cited reimbursement as a barrier to MTMS provision. Pharmacists believed the MTMS they provide resulted in improved satisfaction (patient and provider), medication usage, therapeutics response and patient quality of life. The type of MTMS offered, and proportion of patients actively using, varied among participating pilot pharmacies. © 2010 Blackwell Publishing Ltd.

Collaborative Care for Patients With Severe Personality Disorders: Preliminary Results and Active Ingredients From a Pilot Study (Part I).

PubMed

Stringer, Barbara; van Meijel, Berno; Karman, Pieter; Koekkoek, Bauke; Hoogendoorn, Adriaan W; Kerkhof, Ad J F M; Beekman, Aartjan T F

2015-07-01

To test if a collaborative care program (CCP) with nurses in a coordinating position is beneficial for patients with severe personality disorders. A pilot study with a comparative multiple case study design using mixed methods investigating active ingredients and preliminary results. Most patients, their informal caregivers, and nurses value (parts of) the CCP positively; preliminary results show a significant decrease in severity of borderline symptoms. With the CCP, we may expand the supply of available treatments for patients with (severe) personality disorders, but a larger randomized controlled trial is warranted to confirm our preliminary results. © 2014 Wiley Periodicals, Inc.

Psychosocial needs of older cancer patients: a pilot study abstract.

PubMed

Houldin, A D; Wasserbauer, N

1996-08-01

Approximately 50% of all cancers occur in persons aged 65 and over (American Cancer Society, 1994). However, the special psychological problems of these patients have been inadequately addressed (Massie & Holland, 1989). The psychosocial needs of older cancer patients were surveyed in this pilot study. Two-thirds of the older adults surveyed experienced concerns or problems. Almost 50% of the sample did not receive adequate assistance in dealing with their emotional needs and 69% did not receive sufficient spiritual support. Older cancer patients experience psychosocial distress and may benefit from professional assistance in dealing with these concerns.

How to address patients' defences: a pilot study of the accuracy of defence interpretations and alliance.

PubMed

Junod, Olivier; de Roten, Yves; Martinez, Elena; Drapeau, Martin; Despland, Jean-Nicolas

2005-12-01

This pilot study examined the accuracy of therapist defence interpretations (TAD) in high-alliance patients (N = 7) and low-alliance patients (N = 8). TAD accuracy was assessed in the two subgroups by comparing for each case the patient's most frequent defensive level with the most frequent defensive level addressed by the therapist when making defence interpretations. Results show that in high-alliance patient-therapist dyads, the therapists tend to address accurate or higher (more mature) defensive level than patients most frequent level. On the other hand, the therapists address lower (more immature) defensive level in low-alliance dyads. These results are discussed along with possible ways to better assess TAD accuracy.

Pilot study of enhanced tobacco-cessation services coverage for low-income smokers.

PubMed

Doescher, Mark P; Whinston, Melicent A; Goo, Alvin; Cummings, Diane; Huntington, Jane; Saver, Barry G

2002-01-01

This study explored the feasibility of covering nicotine replacement therapy (NRT) and paying for pharmacist-delivered smoking cessation counseling at the time of NRT pick-up for low-income, managed Medicaid and Basic Health Plan (a state insurance program) enrollees. A prospective pilot intervention was used at two community health centers (CHCs) and two community pharmacies. Participants were adult managed-Medicaid or Basic Health Plan enrollees who attended the pilot CHCs and smoked. An innovative insurance benefit that included coverage for NRT and $15 payment to the pharmacist to deliver cessation counseling with each prescription fill. Proportion of eligible patients who used the cessation benefit and patient and pharmacist satisfaction with the intervention. During the 9-month intervention, 32 patients at the pilot clinics were referred for NRT and pharmacist-delivered counseling. This number represented roughly 5% of eligible smokers. Of these, 26 received NRT with concomitant pharmacist-delivered cessation counseling at least once. Recipients reported a high level of satisfaction with this intervention. Pharmacists indicated they would continue providing counseling if reimbursement remained adequate and if counseling lasted no longer than 5-10 min. However, 12 (38%) who were referred were no longer insured by the sponsoring plan by the end of the 9-month pilot period. Pharmacist-delivered cessation counseling may be feasible and merits further study. More importantly, this pilot reveals two key obstacles in our low-income, culturally diverse setting: low participation and rapid turnover of insureds. Future interventions will need to address these barriers.

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.

Collaborative palliative care for advanced heart failure: outcomes and costs from the 'Better Together' pilot study.

PubMed

Pattenden, Jill F; Mason, Anne R; Lewin, R J P

2013-03-01

Patients with heart failure often receive little supportive or palliative care. 'Better Together' was a 2-year pilot study of a palliative care service for patients with advanced congestive heart failure (CHF). To determine if the intervention made it more likely that patients would be cared for and die in their place of choice, and to investigate its cost-effectiveness. This pragmatic non-randomised pilot evaluation was set in two English primary care trusts (Bradford and Poole). Prospective patient-level data on outcomes and costs were compared with data from a historical control group of clinically comparable patients. Outcomes included death in preferred place of care (available only for the intervention group) and 'hospital admissions averted'. Costs included medical procedures, inpatient care and the direct cost of providing the intervention. 99 patients were referred. Median survival from referral was 48 days in Bradford and 31 days in Poole. Most patients who died did so in their preferred place of death (Bradford 70%, Poole 77%). An estimated 14 and 18 hospital admissions for heart failure were averted in Bradford and Poole, respectively. The average cost-per-heart failure admission averted was £1529 in Bradford, but the intervention was cost saving in Poole. However, there was considerable uncertainty around these cost-effectiveness estimates. This pilot study provides tentative evidence that a collaborative home-based palliative care service for patients with advanced CHF may increase the likelihood of death in place of choice and reduce inpatient admissions. These findings require confirmation using a more robust methodological framework.

Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension.

PubMed

Wechsler, Robert T; Yates, Stephen L; Messenheimer, John; Leroy, Robert; Beller, Cynthia; Doty, Pamela

2017-02-01

Assess the safety of adjunctive lacosamide for the treatment of uncontrolled primary generalized tonic-clonic seizures in patients (16-65 years) with primary generalized (genetic) epilepsy (PGE). An open-label pilot safety study (SP0961; NCT01118949), comprising 12 weeks' historical baseline, 4 weeks' prospective baseline, 3 weeks' titration (target: 400mg/day adjunctive lacosamide) and 6 weeks' maintenance. Patients who continued to the extension study (SP0962; NCT01118962) then received ≤59 weeks of flexible treatment (100-800mg/day lacosamide with flexible dosing of concomitant antiepileptic drugs). The primary outcomes for SP0961 were the mean change (±standard deviation) in absence seizure or myoclonic seizure days per 28days from prospective baseline to maintenance; for SP0962, the incidence of treatment-emergent adverse events (TEAEs) and withdrawals because of TEAEs. Of the 49 patients who enrolled, 40 (82%) completed the pilot study and 9 discontinued (5 because of adverse events). Of the 39 patients who continued to the extension study, 10 discontinued (2 owing to TEAEs) and 29 (74%) completed the study. During the pilot study, patients reported a reduction in mean (±standard deviation) absence and myoclonic seizure days per 28days (-0.37±4.80, -2.19±5.80). Reductions were also observed during the extension study (-2.38±5.54, -2.78±6.43). Five patients in SP0961 and 2 patients in SP0962 experienced TEAEs of new or increased frequency of absence seizures or myoclonic seizures. The most common TEAEs during SP0961 were dizziness (39%) and nausea (27%), and during SP0962 were dizziness (26%) and upper respiratory tract infection (26%). The safety profile of adjunctive lacosamide was similar to that previously published. Adjunctive lacosamide did not systematically worsen absence or myoclonic seizures, and appears to be well tolerated in patients with PGE. Copyright © 2016. Published by Elsevier B.V.

Introduction of a 14-hour work shift model for housestaff in the medical ICU.

PubMed

Afessa, Bekele; Kennedy, Cassie C; Klarich, Kyle W; Aksamit, Timothy R; Kolars, Joseph C; Hubmayr, Rolf D

2005-12-01

To describe the outcomes of switching housestaff from a traditional model of "long-call" every 4 days to a 14-h work-shift model in a medical ICU (MICU) over a 5-week pilot period. Retrospective comparison of a 5-week pilot period for a 14-h work-shift model vs a 4-month period for the traditional model. The MICU of a tertiary medical center. A total of 626 patients admitted to the MICU and 34 internal medicine residents taking care of them. None. Severity-adjusted patient outcomes, housestaff performance on end-of-rotation examinations, and scheduled duty hours during the 5-week 14-h work-shift pilot period compared to a 16-week traditional nonpilot work period. There were no statistically significant differences in patients' adjusted mortality rates, hospital lengths of stay, or housestaff performance on end-of-rotation knowledge assessment examinations between the pilot and nonpilot periods. During the pilot period, each resident was scheduled to work for an average of 61.3 h weekly, and each fellow for 65.3 h weekly. In comparison, each resident and fellow was scheduled to work for an average of 73.3 h weekly during the nonpilot period. The 14-h work shift is a feasible option for housestaff rotation in the MICU. Although the power of our study to detect significant differences in mortality, length of stay, and educational outcomes was low, there was no evidence of compromised patient care or housestaff education associated with the 14-h shift model over the course of this 5-week pilot study.

Pilot study of combination transcriptional modulation therapy with sodium phenylbutyrate and 5-azacytidine in patients with acute myeloid leukemia or myelodysplastic syndrome.

PubMed

Maslak, P; Chanel, S; Camacho, L H; Soignet, S; Pandolfi, P P; Guernah, I; Warrell, R; Nimer, S

2006-02-01

Epigenetic mechanisms underlying tumorigenesis have recently received much attention as potential therapeutic targets of human cancer. We designed a pilot study to target DNA methylation and histone deacetylation through the sequential administration of 5-azacytidine followed by sodium phenylbutyrate (PB) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Ten evaluable patients (eight AML, two MDS) were treated with seven consecutive daily subcutaneous injections of 5-azacytidine at 75 mg/m2 followed by 5 days of sodium PB given intravenously at a dose of 200 mg/kg. Five patients (50%) were able to achieve a beneficial clinical response (partial remission or stable disease). One patient with MDS proceeded to allogeneic stem cell transplantation and is alive without evidence of disease 39 months later. The combination regimen was well tolerated with common toxicities of injection site skin reaction (90% of the patients) from 5-azacytidine, and somnolence/fatigue from the sodium PB infusion (80% of the patients). Correlative laboratory studies demonstrated the consistent reacetylation of histone H4, although no relationship with the clinical response could be demonstrated. Results from this pilot study demonstrate that a combination approach targeting different mechanisms of transcriptional modulation is clinically feasible with acceptable toxicity and measurable biologic and clinical outcomes.

Congestive heart failure adherence redesign trial: a pilot study

PubMed Central

Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

2014-01-01

Objective Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. Setting A large tertiary care medical centre in Chicago. Participants Low-income patients (80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. Conclusions This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. PMID:25475245

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study.

PubMed

McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa; Mele, Tina

2017-07-31

Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%-10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period.As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. NCT02466698; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study

PubMed Central

McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa

2017-01-01

Introduction Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%–10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. Methods and analysis We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period. As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. Ethics and dissemination This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot trial and subsequent main trial will be submitted for publication in a peer-reviewed journal. Trial registration number NCT02466698; Pre-results. PMID:28760801

Leap motion controlled videogame-based therapy for rehabilitation of elderly patients with subacute stroke: a feasibility pilot study.

PubMed

Iosa, Marco; Morone, Giovanni; Fusco, Augusto; Castagnoli, Marcello; Fusco, Francesca Romana; Pratesi, Luca; Paolucci, Stefano

2015-08-01

The leap motion controller (LMC) is a new optoelectronic system for capturing motion of both hands and controlling a virtual environment. Differently from previous devices, it optoelectronically tracks the fine movements of fingers neither using glows nor markers. This pilot study explored the feasibility of adapting the LMC, developed for videogames, to neurorehabilitation of elderly with subacute stroke. Four elderly patients (71.50 ± 4.51 years old) affected by stroke in subacute phase were enrolled and tested in a cross-over pilot trial in which six sessions of 30 minutes of LMC videogame-based therapy were added on conventional therapy. Measurements involved participation to the sessions, evaluated by means of the Pittsburgh Rehabilitation Participation Scale, hand ability and grasp force evaluated respectively by means of the Abilhand Scale and by means of the dynamometer. Neither adverse effects nor spasticity increments were observed during LMC training. Participation to the sessions was excellent in three patients and very good in one patient during the LMC trial. In this period, patients showed a significantly higher improvement in hand abilities (P = 0.028) and grasp force (P = 0.006). This feasibility pilot study was the first one using leap motion controller for conducting a videogame-based therapy. This study provided a proof of concept that LMC can be a suitable tool even for elderly patients with subacute stroke. LMC training was in fact performed with a high level of active participation, without adverse effects, and contributed to increase the recovery of hand abilities.

Association between plasma endocannabinoids and appetite in hemodialysis patients: a pilot study

USDA-ARS?s Scientific Manuscript database

Weight loss is a well-recognized complication in subjects undergoing hemodialysis for impaired kidney function. This pilot study explored whether plasma levels of compounds known to mediate appetite, the endocannabinoids (EC) and EC-like compounds derived from polyunsaturated fatty acids (PUFA), ar...

Glutamine supplementation favors weight loss in nondieting obese female patients. A pilot study.

PubMed

Laviano, A; Molfino, A; Lacaria, M T; Canelli, A; De Leo, S; Preziosa, I; Rossi Fanelli, F

2014-11-01

Glutamine supplementation improves insulin sensitivity in critically ill patients, and prevents obesity in animals fed a high-fat diet. We hypothesized that glutamine supplementation favors weight loss in humans. Obese and overweight female patients (n=6) were enrolled in a pilot, cross-over study. After recording anthropometric (that is, body weight, waist circumference) and metabolic (that is, glycemia, insulinemia, homeostatic model of insulin resistance (HOMA-IR)) characteristics, patients were randomly assigned to 4-week supplementation with glutamine or isonitrogenous protein supplement (0.5 g/KgBW/day). During supplementation, patients did not change their dietary habits nor lifestyle. At the end, anthropometric and metabolic features were assessed, and after 2 weeks of washout, patients were switched to the other supplement for 4 weeks. Body weight and waist circumference significantly declined only after glutamine supplementation (85.0±10.4 Kg vs 82.2±10.1 Kg, and 102.7±2.0 cm vs 98.9±2.9 cm, respectively; P=0.01). Insulinemia and HOMA-IR declined by 20% after glutamine, but not significantly so. This pilot study shows that glutamine is safe and effective in favoring weight loss and possibly enhancing glucose metabolism.

Clinical Outcome, Social Impact and Patient Expectation: a Purposive Sampling Pilot Evaluation of Patients in Benin Seven Years After Surgery.

PubMed

White, Michelle C; Randall, Kirsten; Avara, Esther; Mullis, Jenny; Parker, Gary; Shrime, Mark G

2018-05-01

Access to affordable and timely surgery is not equitable around the world. Five billion people lack access, and while non-governmental organizations (NGOs) help to meet this need, long-term surgical outcomes, social impact or patient experience is rarely reported. In 2016, Mercy Ships, a surgical NGO, undertook an evaluation of patients who had received surgery seven years earlier with Mercy Ships in 2009 in Benin. Using purposive sampling, patients who had received maxillofacial, plastics or orthopedic surgery were invited to attend a surgical evaluation day. In this pilot study, we used semi-structured interviews and questionnaire responses to assess patient expectation, surgical and social outcome. Our results show that seven years after surgery 35% of patients report surgery-related pain and 18% had sought further care for a clinical complication of their condition. However, 73% of patients report gaining social benefit from surgery, and overall patient satisfaction was 89%, despite 35% of patients saying that they were unclear what to expect after surgery indicating a mismatch of doctor/patient expectations and failure of the consent process. In conclusion, our pilot study shows that NGO surgery in Benin provided positive social impact associated with complication rates comparable to high-income countries when assessed seven years later. Key areas for further study in LMICs are: evaluation and treatment of chronic pain, consent and access to further care.

Pilot Study: Use of Mindfulness, Self-Compassion, and Yoga Practices With Low-Income and/or Uninsured Patients With Depression and/or Anxiety.

PubMed

Falsafi, Nasrin; Leopard, Louisa

2015-12-01

This pilot study was conducted to determine the effectiveness of mindfulness practices, including self-compassion and yoga, on depression and/or anxiety in uninsured and/or low-income patients. The design was repeated measures with one group. Patients received 8 weeks of mindfulness training including self-compassion and yoga. Depression and anxiety symptoms, self-compassion, and psychological well-being were measured four times. Interventions were effective in helping uninsured and low-income patients reduce depression and/or anxiety symptoms. This study may have implications for a cost-effective treatment for these disorders. The findings from this study can provide useful information to health care providers. © The Author(s) 2015.

Ballroom dancing as physical activity for patients with cancer: a systematic review and report of a pilot project.

PubMed

Rudolph, Ivonne; Schmidt, Thorsten; Wozniak, Tobias; Kubin, Thomas; Ruetters, Dana; Huebner, Jutta

2018-04-01

Physical activity has positive effects on cancer patients. Dancing addresses diverse bio-psycho-social aspects. Our aim was to assess the evidence on ballroom dancing and to develop the setting for a pilot project. We performed a systematic review, extracted the data and designed a pilot training based on standard curricula. We included cancer patients during or after therapy. Training duration was 90 min with one regular pause and individual pauses as needed. We retrieved two systematic reviews and six controlled studies. Types of dancing varied. Only one study used ballroom dancing. Dance training might improve well-being, physical fitness, fatigue and coping during and after therapy. Yet, evidence is scarce and data to derive the effect size are lacking; 27 patients and their partners took part in the pilot training. Patients and partners needed more time to learn the steps than is planned in regular ballroom classes. Participants were very satisfied with the adaptation of the training to their physical strength and estimated the training in a sheltered group. No side effects occurred. In spite of a high rate of participants reporting fatigue, 90 min of physical activity with only a few minutes of rest were manageable for all participants. Ballroom dancing may offer benefits for patients with respect to quality of life. Cancer patients prefer sheltered training setting and curricula of regular ballroom classes must be adapted for cancer patients. Strict curricula might reduce motivation and adherence and exclude patients with lower or variable fitness.

Integrated care pilot in north-west London: a mixed methods evaluation

PubMed Central

Curry, Natasha; Harris, Matthew; Gunn, Laura H.; Pappas, Yannis; Blunt, Ian; Soljak, Michael; Mastellos, Nikolaos; Holder, Holly; Smith, Judith; Majeed, Azeem; Ignatowicz, Agnieszka; Greaves, Felix; Belsi, Athina; Costin-Davis, Nicola; Jones Nielsen, Jessica D.; Greenfield, Geva; Cecil, Elizabeth; Patterson, Susan; Car, Josip; Bardsley, Martin

2013-01-01

Introduction This paper provides the results of a year-long evaluation of a large-scale integrated care pilot in north-west London. The pilot aimed to integrate care across primary, acute, community, mental health and social care for people with diabetes and/or those aged 75+ through care planning, multidisciplinary case reviews, information sharing and project management support. Methods The evaluation team conducted qualitative studies of change at organisational, clinician and patient levels (using interviews, focus groups and a survey); and quantitative analysis of change in service use and patient-level clinical outcomes (using patient-level datasets and a matched control study). Results The pilot had successfully engaged provider organisations, created a shared strategic vision and established governance structures. However, the engagement of clinicians was variable and there was no evidence to date of significant reductions in emergency admissions. There was some evidence of changes in care processes. Conclusion Although the pilot has demonstrated the beginnings of large-scale change, it remains in the early stages and faces significant challenges as it seeks to become sustainable for the longer term. It is critical that National Health Service managers and clinicians have realistic expectations of what can be achieved in a relatively short period of time. PMID:24167455

Integration of Diagnostic and Interventional MRI for the Study of Persistent Prostate Cancer after External Beam Radiotherapy

DTIC Science & Technology

2009-10-01

1500 ms). A clinical pilot study reported equivalence between central gland (CG) and peripheral zone (PZ) T1 values (CG: 1321±45 ms, n=14; PZ: 1359...across variable TI, the period of longitudinal recovery is kept independent of TI selection for any TR. Central to T1prep is RF cycling of an...pilot study A clinical pilot study involved 15 patients with low or intermediate risk localized prostate cancer and no history of prior therapy. The

Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study.

PubMed

Halkett, Georgia K B; Lobb, Elizabeth A; Miller, Lisa; Shaw, Thérèse; Moorin, Rachael; Long, Anne; King, Anne; Clarke, Jenny; Fewster, Stephanie; Nowak, Anna K

2017-02-11

The aim of this pilot study was to test the feasibility and acceptability of a family carer intervention for carers of patients with high-grade glioma (HGG). The intervention consisted of: (1) an initial telephone assessment of carer needs; (2) a personalised tabbed resource file; (3) nurse-led home visit; and (4) ongoing telephone support. Two consumer representatives reviewed the intervention resources. The intervention was then piloted with participants who were the primary carer for patients undergoing treatment for HGG in Western Australia. Two consumers provided feedback on the resource, and 10 carers participated in the pilot. Positive feedback was received about the resource manual and intervention. Suggestions were also made for changes which were implemented into the trial. The surveys were shortened based on feedback. Participants identified a large range of issues during nursing assessments which would not otherwise be identified or addressed for carers receiving routine care. As a result of providing the intervention, the nurse was able to make referrals to address needs that were identified. This pilot study enabled us to refine and test the Care-IS intervention and test the feasibility and acceptability of proposed survey instruments. We were also able to estimate recruitment and retention and the overall study timeline required for the randomised controlled trial we are now conducting. It has also demonstrated the role of the nurse who delivered the intervention and allowed us to refine communication and referral pathways.

The influence of individualized music on patients in physical restraints: a pilot study.

PubMed

Janelli, Linda M; Kanski, Genevieve W; Wu, Yow-Wu Bill

This pilot study explored the relationship between listening to preferred music and the behavioral responses of patients who are physically restrained. Thirty patients, ranging in age from 65 to 93, participated in one of three groups. The first group included patients who were out of restraining devices while listening to preferred music. Patients in the second group were out of restraining devices and not exposed to music. The third group comprised patients who were in restraining devices while listening to preferred music. Listening to preferred music had no significant effect on decreasing patients' negative behaviors or on increasing positive behaviors observed during the intervention phase of the study. The higher mean scores for positive behaviors and lower mean scores for negative behaviors for the first group may indicate some benefits to patients who are out of restraints and listening to preferred music.

Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study.

PubMed

Siegel, Pamela; da Motta, Pedro Mourão Roxo; da Silva, Luis G; Stephan, Celso; Lima, Carmen Silvia Passos; de Barros, Nelson Filice

2016-01-01

The purpose of this pilot study was to explore whether individualized Reiki given to cancer patients at a Brazilian hospital improved symptoms and well-being. Data from 36 patients who received 5 Reiki sessions were collected using the MYMOP and were compared before and after their treatment and also with 14 patients who did not receive Reiki and who acted as a comparison group. Twenty-one patients reported feeling better, 12 felt worse, and 3 reported no change. Of the comparison group, 6 patients reported feeling better and 8 felt worse. The Reiki practice delivered as part of the integrative care in oncology did produce clinically significant effects, although not statistically significant results, for more than half of the patients undergoing cancer treatment.

Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study.

PubMed

Spruit, Martijn A; Janssen, Paul P; Willemsen, Sonja C P; Hochstenbag, Monique M H; Wouters, Emiel F M

2006-05-01

Although lung cancer is a highly prevalent type of cancer, the effects of an inpatient multidisciplinary rehabilitation program on pulmonary function and exercise capacity have never been studied in these patients. Pulmonary function, 6-min walking distance and peak exercise capacity of 10 patients with a severely impaired pulmonary function following treatment of lung cancer were assessed in this pilot study before and after an 8-week inpatient multidisciplinary rehabilitation program. At baseline, patients had a restrictive pulmonary function and an apparent exercise intolerance (median 6-min walking distance: 63.6% predicted; median peak cycling load: 58.5% predicted). Despite the lack of change in median pulmonary function [FEV1: -0.01L, p = 0.5469], functional exercise capacity [145 m; 43.2% of the initial values, p=0.0020] and peak exercise capacity [26 W; 34.4% of the initial values, p = 0.0078] improved significantly compared to baseline. Future trials have to corroborate the present findings. Nevertheless, patients with lung cancer have a clear indication to start a comprehensive rehabilitation program following intensive treatment of their disease. In fact, based on the results of the present pilot study it appears that these patients are good candidates for pulmonary rehabilitation programs.

Type 2 diabetes risk screening in dental practice settings: a pilot study.

PubMed

Wright, D; Muirhead, V; Weston-Price, S; Fortune, F

2014-04-01

Dental surgeries are highlighted in the 2012 NICE guidance Preventing type 2 diabetes: risk identification and interventions for individuals at high risk as a suitable setting in which to encourage people to have a type 2 diabetes risk assessment. To assess the feasibility of implementing a type 2 diabetes risk screening pathway in dental settings using the NICE guidance tool. The study was carried out over two weeks in June 2013. The validated tool in the NICE guidance was used to determine risk. This included a questionnaire and BMI measurement used to determine a risk score. Patients were rated low, increased, moderate or high risk. All patients were given written advice on healthy lifestyle. Patients who were moderate or high risk were referred to their general medical practitioners for further investigation. Participating dental teams were asked to nominate a member who would be responsible for overseeing the screening and training the other team members. A total of 166 patients took part in the pilot (58% male, 75% aged 49 years or younger and 77% were from BME groups). Twenty-six low risk patients (15.7%), 61 increased risk patients (36.7%), 49 moderate-risk patients (29.5%) and 30 high-risk patients (18.1%) were identified during the pilot. Fifteen of the 49 patients (30.6%) identified as moderate-risk and 6 of the 30 high-risk patients (20%) had visited their GP to discuss their type 2 diabetes risk in response to the screening. The pilot suggests that people at risk of developing type 2 diabetes could be identified in primary, community and secondary dental care settings. The main challenges facing dental staff were time constraints, limited manpower and the low number of patients who visited their GP for further advice.

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

PubMed

Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

2017-11-13

Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient-reported outcomes will be collected at each time point. This pilot randomised controlled trial will investigate the viability of undertaking a larger-scale study investigating the effect of treating periodontitis and maintaining periodontal health on cardio-renal outcomes in patients with CKD. National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID: 18458), ID: ISRCTN10227738 . Registered retrospectively to both registers on 23 April 2015.

Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study

NASA Astrophysics Data System (ADS)

Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas

2017-03-01

Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.

An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

PubMed

Hunt, Sheena; Stebbings, Simon; McNamara, Debra

2016-10-28

This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

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

Improving awareness, accountability, and access through health coaching: qualitative study of patients' perspectives.

PubMed

Liddy, Clare; Johnston, Sharon; Irving, Hannah; Nash, Kate; Ward, Natalie

2015-03-01

To assess patients' experiences with and perceptions of health coaching as part of their ongoing care. A qualitative research design using semistructured interviews that were recorded and transcribed verbatim.Setting Ottawa, Ont. Eleven patients (> 18 years of age) enrolled in a health coaching pilot program who were at risk of or diagnosed with type 2 diabetes. Patients' perspectives were assessed with semistructured interviews. Interviews were conducted with 11 patients at the end of the pilot program, using a stratified sampling approach to ensure maximum variation. All patients found the overall experience with the health coaching program to be positive. Patients believed the health coaching program was effective in increasing awareness of how diabetes affected their bodies and health, in building accountability for their health-related actions, and in improving access to care and other health resources. Patients perceive one-on-one health coaching as an acceptable intervention in their ongoing care. Patients enrolled in the health coaching pilot program believed that there was an improvement in access to care, health literacy, and accountability,all factors considered to be precursors to behavioural change.

A feasibility pilot study on the use of text messages to track PTSD symptoms after a traumatic injury.

PubMed

Price, Matthew; Ruggiero, Kenneth J; Ferguson, Pamela L; Patel, Sachin K; Treiber, Frank; Couillard, Deborah; Fahkry, Samir M

2014-01-01

Monitoring posttraumatic stress disorder (PTSD) symptoms after a traumatic injury is beneficial for patients and providers. Text messages can be used to automatically monitor symptoms and impose minimal burden to patients and providers. The present study piloted such a strategy with traumatic injury patients. An automated daily text message was piloted to evaluate PTSD symptoms after discharge from the hospital. Twenty-nine patients who experienced a traumatic injury received 15 daily texts and were then followed up at 1-month and 3-months after discharge. 82.8% of the sample responded at least once and the average response rate per participant was 63.1%. Response rates were correlated with PTSD symptoms at baseline but not at any other time. Patient satisfaction with this approach was high. Text messages are a viable method to monitor PTSD symptoms after a traumatic injury. Such an approach should be evaluated on a larger scale as part of a more comprehensive early intervention for traumatic stress. Copyright © 2014 Elsevier Inc. All rights reserved.

Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

PubMed

Rahn, Anne C; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; van de Roemer, Adrianus; Mühlhauser, Ingrid; Heesen, Christoph

2016-09-20

Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire's internal consistency was moderate (Cronbach's alpha = 0.56). The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. German Clinical Trials Register: DRKS00008561 . Registered 8th of June 2015.

Spasmodic Dysphonia in Multiple Sclerosis Treatment With Botulin Toxin A: A Pilot Study.

PubMed

Di Stadio, Arianna; Bernitsas, Evanthia; Restivo, Domenico Antonio; Alfonsi, Enrico; Marchese-Ragona, Rosario

2018-04-09

This study aims to evaluate the effect of botulin toxin A in patients with multiple sclerosis (MS) affected by spasmodic dysphonia (SD) and to show the safety and effectiveness of this treatment in long-term observation. This is a pilot study on three relapsing-remitting MS patients with SD and their response to botulin toxin A. None of the patients reported dysphagia or other adverse events. Significant improvement was observed in terms of both voice quality and laryngostroboscopy results. The treatment effect was durable for 6-8 months. Botulin toxin A is a safe treatment that can be successfully used to treat SD in patients with MS. Larger studies are necessary to confirm our results. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

A multifaceted intervention to reduce inappropriate polypharmacy in primary care: research co-creation opportunities in a pilot study.

PubMed

Anderson, Kristen; Foster, Michele M; Freeman, Christopher R; Scott, Ian A

2016-04-18

Co-creation (or co-design) represents the highest form of stakeholder engagement, but it can be infeasible to co-create with all stakeholders through all stages of a research project. The choice of stakeholders for co-design will depend on the study purpose and context of change. For this deprescribing pilot study, general practitioners were recognised as a critical gateway for co-creation, with patients' perspectives of the deprescribing process to be assessed in the evaluation of the pilot.

Efficacy of etidronate and sequential monofluorophosphate in severe postmenopausal osteoporosis: a pilot study.

PubMed

Ringe, J D; Dorst, A; Faber, H; Kipshoven, C; Rovati, L C; Setnikar, I

2005-05-01

In a three-year pilot study on 52 women with severe postmenopausal osteoporosis, treatment with etidronate followed by calcium and vitamin D (ECaD) was compared to etidronate followed by monofluorophosphate, calcium and vitamin D (EFCaD). BMD in lumbar spine, total hip and femoral neck increased significantly more with EFCaD than with ECaD. Pain-mobility score decreased significantly more with EFCaD than with ECaD (p=0.006). New vertebral fractures occurred in three patients under EFCaD (12%) and in nine under ECaD (35%), (p=0.048). Three patients under EFCaD (12%) and 15 under ECaD (58%) did not respond to therapy (p of difference=0.001). Mild or moderate adverse reactions were reported by 25 patients, with no significant difference between the two groups. The pilot study suggests that etidronate, sequentially followed by monofluorophosphate, could be a safe, effective and relatively inexpensive therapy in severe postmenopausal osteoporosis.

Testing the Feasibility and Acceptability of a Chaplaincy Intervention to Improving Treatment Attitudes and Self-Efficacy of Adolescents With Cystic Fibrosis: A Pilot Study

PubMed Central

Cheng, Joy; Purcell, Hillary N.; Dimitriou, Sophia M.; Grossoehme, Daniel H.

2015-01-01

Religious factors are known to contribute to treatment adherence in different patient populations, and religious coping has been found to be particularly important to adolescents dealing with chronic diseases. Adherence to prescribed treatments slows disease progression and contributes to desirable outcomes in most patients, and, therefore, adherence-promoting interventions provided by chaplains could be beneficial to various patient populations. The current article describes a pilot study to test the feasibility of a theoretically and empirically based chaplain intervention to promote treatment adherence for adolescents with CF. Cognitive interviews were conducted 24 with adolescents with CF, and content analysis was used to identify themes, which informed revision of the intervention protocol. The authors thought that presenting the methods and results of this pilot study would be helpful for chaplains who want to conduct intervention research. The results indicated that the proposed intervention was acceptable and feasible to deliver in hard copy or an electronic platform. PMID:25793423

A pilot study of distributed knowledge management and clinical decision support in the cloud.

PubMed

Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

2013-09-01

Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable path toward achieving better support of clinical decision-making across the widest range of health care providers. Published by Elsevier B.V.

The use of telehealth (text messaging and video communications) in patients with cystic fibrosis: A pilot study.

PubMed

Gur, Michal; Nir, Vered; Teleshov, Anna; Bar-Yoseph, Ronen; Manor, Eynav; Diab, Gizelle; Bentur, Lea

2017-05-01

Background Poor communications between cystic fibrosis (CF) patients and health-care providers may result in gaps in knowledge and misconceptions about medication usage, and can lead to poor adherence. We aimed to assess the feasibility of using WhatsApp and Skype to improve communications. Methods This single-centre pilot study included CF patients who were older than eight years of age assigned to two groups: one without intervention (control group), and one with intervention. Each patient from the intervention group received Skype-based online video chats and WhatsApp messages from members of the multidisciplinary CF team. CF questionnaires, revised (CFQ-R) scores, knowledge and adherence based on CF My Way and patients satisfaction were evaluated before and after three months. Feasibility was assessed by session attendance, acceptability and satisfaction survey. Descriptive analysis and paired and non-paired t-tests were used as applicable. Results Eighteen patients were recruited to this feasibility study (nine in each group). Each intervention group participant had between four and six Skype video chats and received 22-45 WhatsApp messages. In this small study, CFQ-R scores, knowledge, adherence and patient satisfaction were similar in both groups before and after the three-month intervention. Conclusions A telehealth-based approach, using Skype video chats and WhatsApp messages, was feasible and acceptable in this pilot study. A larger and longer multi-centre study is warranted to examine the efficacy of these interventions to improve knowledge, adherence and communication.

Sexual and gender minority health in medical curricula in new England: a pilot study of medical student comfort, competence and perception of curricula.

PubMed

Zelin, Nicole Sitkin; Hastings, Charlotte; Beaulieu-Jones, Brendin R; Scott, Caroline; Rodriguez-Villa, Ana; Duarte, Cassandra; Calahan, Christopher; Adami, Alexander J

2018-12-01

Sexual and gender minority (SGM) individuals experience high rates of harassment and discrimination when seeking healthcare, which contributes to substantial healthcare disparities. Improving physician training about gender identity, sexual orientation, and the healthcare needs of SGM patients has been identified as a critical strategy for mitigating these disparities. In 2014, the Association of American Medical Colleges (AAMC) published medical education competencies to guide undergraduate medical education on SGM topics. Conduct pilot study to investigate medical student comfort and competence about SGM health competencies outlined by the AAMC and evaluate curricular coverage of SGM topics. Six-hundred and fifty-eight students at New England allopathic medical schools (response rate 21.2%) completed an anonymous, online survey evaluating self-reported comfort and competence regarding SGM health competencies, and coverage of SGM health in the medical curriculum. 92.7% of students felt somewhat or very comfortable treating sexual minorities; 68.4% felt comfortable treating gender minorities. Most respondents felt not competent or somewhat not competent with medical treatment of gender minority patients (76.7%) and patients with a difference of sex development (81%). At seven schools, more than 50% of students indicated that the curriculum neither adequately covers SGM-specific topics nor adequately prepares students to serve SGM patients. The prevalence of self-reported comfort is greater than that of self-reported competence serving SGM patients in a convenience sample of New England allopathic medical students. The majority of participants reported insufficient curricular preparation to achieve the competencies necessary to care for SGM patients. This multi-institution pilot study provides preliminary evidence that further curriculum development may be needed to enable medical students to achieve core competencies in SGM health, as defined by AAMC. Further mixed methods research is necessary to substantiate and expand upon the findings of this pilot study. This pilot study also demonstrates the importance of creating specific evaluation tools to assess medical student achievement of competencies established by the AAMC.

Sexual and gender minority health in medical curricula in new England: a pilot study of medical student comfort, competence and perception of curricula

PubMed Central

Zelin, Nicole Sitkin; Hastings, Charlotte; Beaulieu-Jones, Brendin R.; Scott, Caroline; Rodriguez-Villa, Ana; Duarte, Cassandra

2018-01-01

ABSTRACT Background: Sexual and gender minority (SGM) individuals experience high rates of harassment and discrimination when seeking healthcare, which contributes to substantial healthcare disparities. Improving physician training about gender identity, sexual orientation, and the healthcare needs of SGM patients has been identified as a critical strategy for mitigating these disparities. In 2014, the Association of American Medical Colleges (AAMC) published medical education competencies to guide undergraduate medical education on SGM topics. Objective: Conduct pilot study to investigate medical student comfort and competence about SGM health competencies outlined by the AAMC and evaluate curricular coverage of SGM topics. Design: Six-hundred and fifty-eight students at New England allopathic medical schools (response rate 21.2%) completed an anonymous, online survey evaluating self-reported comfort and competence regarding SGM health competencies, and coverage of SGM health in the medical curriculum. Results: 92.7% of students felt somewhat or very comfortable treating sexual minorities; 68.4% felt comfortable treating gender minorities. Most respondents felt not competent or somewhat not competent with medical treatment of gender minority patients (76.7%) and patients with a difference of sex development (81%). At seven schools, more than 50% of students indicated that the curriculum neither adequately covers SGM-specific topics nor adequately prepares students to serve SGM patients. Conclusions: The prevalence of self-reported comfort is greater than that of self-reported competence serving SGM patients in a convenience sample of New England allopathic medical students. The majority of participants reported insufficient curricular preparation to achieve the competencies necessary to care for SGM patients. This multi-institution pilot study provides preliminary evidence that further curriculum development may be needed to enable medical students to achieve core competencies in SGM health, as defined by AAMC. Further mixed methods research is necessary to substantiate and expand upon the findings of this pilot study. This pilot study also demonstrates the importance of creating specific evaluation tools to assess medical student achievement of competencies established by the AAMC. PMID:29717635

Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study.

PubMed

Sitbon, Olivier; Jaïs, Xavier; Savale, Laurent; Cottin, Vincent; Bergot, Emmanuel; Macari, Elise Artaud; Bouvaist, Hélène; Dauphin, Claire; Picard, François; Bulifon, Sophie; Montani, David; Humbert, Marc; Simonneau, Gérald

2014-06-01

Patients with severe pulmonary arterial hypertension (PAH) in New York Heart Association (NYHA) functional class (FC) III/IV have a poor prognosis, despite survival benefits being demonstrated with intravenous epoprostenol. In this pilot study, the efficacy and safety of a triple combination therapy regimen in patients with severe PAH was investigated. Data from newly diagnosed NYHA FC III/IV PAH patients (n=19) initiated on upfront triple combination therapy (intravenous epoprostenol, bosentan and sildenafil) were collected retrospectively from a prospective registry. Significant improvements in 6-min walk distance and haemodynamics were observed after 4 months' triple combination therapy in 18 patients (p<0.01); 17 patients had improved to NYHA FC I or II. One patient was not included in the month 4 assessment (due to an emergency lung transplant in month 3). At the final evaluation (mean ± sd 32 ± 19 months), all 18 patients had sustained clinical and haemodynamic improvement. Overall survival estimates for the triple combination cohort were 100% at 1, 2 and 3 years. Expected survival calculated from the French equation was 75% (95% CI 68-82%), 60% (95% CI 50-70%) and 49% (95% CI 38-60%) at 1, 2 and 3 years, respectively. This pilot study provides preliminary evidence of the long-term benefits of upfront triple combination therapy in patients with severe PAH. ©ERS 2014.

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study

PubMed Central

Juhász, Márk; Nagy, Viktor L.; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F.

2014-01-01

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m−1 gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. PMID:25008086

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

PubMed

Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Active video gaming in patients with renal transplant: a pilot study

PubMed Central

2014-01-01

Background Patients with renal transplant are at higher risk of mortality from cardiovascular disease (CVD) compared with the general population. Physical activity has been shown to reduce the risk of CVD mortality in these patients. Unfortunately, barriers such as the harsh Canadian climate prevent patients from engaging in and harvesting the health benefits of physical activity. This pilot study explored active video gaming (AVG) as a way for patients with renal transplant to obtain physical activity and examined its effect on their functional status and quality of life (QOL). Main text We recruited nine patients for an 8-week prospective pilot study. All patients received a Microsoft Xbox 360™ video gaming console, a Microsoft Kinect™ sensor, and the video game Your Shape Fitness Evolved 2012. Assessment of each participant before and after the intervention included blood pressure measures, a 6-minute walk test, and the Godin Leisure Time Questionnaire (GLTQ). We analyzed all nine patients at the end of the 8-week study period, and found no changes in blood pressure or GLTQ scores. However, there was a significant increase in the 6-minute walk distance (P = 0.022), which represented a consistent increase for most patients (correlation = 0.977). In addition, participants over the age of 45 years (n = 4) were more likely to use the AVG system (P = 0.042). Conclusion AVG has the potential to improve the functional status in patients with renal transplant. Further research is required to corroborate the full health benefits of AVG in this patient population. PMID:25114788

Teledermatology via a social networking web site: a pilot study between a general hospital and a rural clinic.

PubMed

Garcia-Romero, Maria Teresa; Prado, Fernanda; Dominguez-Cherit, Judith; Hojyo-Tomomka, Maria Teresa; Arenas, Roberto

2011-10-01

Teledermatology via a free public social networking Web site is a practical tool to provide attention to patients who do not have access to dermatologic care. In this pilot study, a general practitioner sent consults to a dermatology department at a general hospital via Facebook(®). Forty-four patients were seen and treatment was installed. We identified both simple-to-treat, common skin diseases and rare congenital diseases that require genetic counseling and more complex treatment. The majority of patients (75%) benefited with the diagnoses and treatments offered, thus avoiding unnecessary expenses or transportation to urban areas.

Development and Feasibility of a COPD Self-Management Intervention Delivered with Motivational Interviewing Strategies

PubMed Central

Benzo, Roberto; Vickers, Kristin; Ernst, Denise; Tucker, Sharon; McEvoy, Charlene; Lorig, Kate

2013-01-01

BACKGROUND Self-management (SM) is proposed as the standard of care in chronic obstructive pulmonary disease (COPD) but details of the process and training required to deliver effective SM are not widely available. In addition, recent data suggest that patient engagement and motivation are critical ingredients for effective self-management. This manuscript carefully describes a self-management intervention using Motivational Interviewing skills, aimed to increase engagement and commitment in severe COPD patients. METHODS The intervention was developed and pilot tested for fidelity to protocol, for patient and interventionist feedback (qualitative) and effect on quality of life. Engagement between patient and interventionists was measured by the Working Alliance Inventory. The intervention was refined based in the results of the pilot study and delivered in the active arm of a prospective randomized study. RESULTS The pilot study suggested improvements in quality of life, fidelity to theory and patient acceptability. The refined self-management intervention was delivered 540 times in the active arm of a randomized study. We observed a retention rate of 86% (patients missing or not available for only 14% the scheduled encounters). CONCLUSIONS A self-management intervention, that includes motivational interviewing as the way if guiding patient into behavior change, is feasible in severe COPD and may increase patient engagement and commitment to self-management. This provides a very detailed description of the SM process for (the specifics of training and delivering the intervention) that facilitates replicability in other settings and could be translated to cardiac rehabilitation. PMID:23434613

Are large clinical trials in orthopaedic trauma justified?

PubMed

Sprague, Sheila; Tornetta, Paul; Slobogean, Gerard P; O'Hara, Nathan N; McKay, Paula; Petrisor, Brad; Jeray, Kyle J; Schemitsch, Emil H; Sanders, David; Bhandari, Mohit

2018-04-20

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Congestive heart failure adherence redesign trial: a pilot study.

PubMed

Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

2014-12-04

Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. A large tertiary care medical centre in Chicago. Low-income patients (80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. 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.

No-patch 23-gauge vitrectomy under topical anesthesia: a pilot study.

PubMed

Deka, Satyen; Bhattacharjee, Harsha; Barman, M J; Kalita, Kruto; Singh, Sunil Kumar

2011-01-01

A pilot study was designed to evaluate the safety and efficacy of 23-gauge vitrectomy under topical anesthesia. Five eyes of five patients underwent 23-gauge sutureless vitrectomy under topical anesthesia with a pledget soaked in 0.5% proparacaine hydrochloride anesthetic, for vitreous hemorrhage (four eyes), epiretinal membrane (one eye). Subjective pain and discomfort were graded using a visual analogue chart from 0 (no pain or discomfort) to 4 (severe pain and discomfort). At the end of surgery no patch was applied and patients were given dark glasses. Patients underwent an immediate postoperative assessment, followed by next day and one week postoperative evaluation. Four patients had Grade 0 pain during the surgery. One patient had Grade 1 pain during the placement and withdrawal of the micro cannulas. The surgical outcomes were favorable. 23-gauge vitrectomy under topical anesthesia is safe and effective in selected cases. Further study is recommended to validate the outcome of this study.

PC-based note taking in patient-centred diagnostic interviews: a thematic analysis of patient opinion elicited using a pilot survey instrument.

PubMed

Barker, Fiona; Court, Gemma

2011-01-01

Computers are used increasingly in patient-clinician consultations. There is the potential for PC use to have an effect on the communication process. The aim of this preliminary study was to investigate patient opinion regarding the use of PC-based note taking during diagnostic vestibular assessments. We gave a simple four-item questionnaire to 100 consecutive patients attending for vestibular assessment at a secondary referral level primary care trust audiology service. Written responses to two of the questionnaire items were subject to an inductive thematic analysis. The questionnaire was acceptable to patients, none refused to complete it. Dominant themes identified suggest that patients do perceive consistent positive benefits from the use of PC-based note taking. This pilot study's short survey instrument is usable and may provide insights into patients' perceptions of computer use in a clinical setting.

Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis.

PubMed

Meltzer, Eli O; Hadley, James; Blaiss, Michael; Benninger, Michael; Kimel, Miriam; Kleinman, Leah; Dupclay, Leon; Garcia, Jorge; Leahy, Michael; Georges, George

2005-02-01

To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. B-20.

[Development of an activity of daily living scale for patients with COPD: the Activity of Daily Living Dyspnea scale].

PubMed

Yoza, Yoshiyasu; Ariyoshi, Koya; Honda, Sumihisa; Taniguchi, Hiroyuki; Senjyu, Hideaki

2009-10-01

Patients with COPD often experience restriction in their activities of daily living (ADL) due to dyspnea. This type of restriction is unique to patients with COPD and cannot be adequately evaluated by the generic ADL scales. This study developed an ADL scale (the Activity of Daily Living Dyspnea scale [ADL-D scale]) for patients with COPD and investigated its validity and internal consistency. Patients with stable COPD were recruited and completed a pilot 26-item questionnaire. Patients also performed the Incremental Shuttle Walk Test (ISWT), and completed the St George's Respiratory Questionnaire (SGRQ), and Medical Research Council (MRC) dyspnea grade. There were 83 male participants who completed the pilot questionnaire. Following the pilot, 8 items that were not undertaken by the majority of subjects, and 3 items judged to be of low clinical importance by physical therapists were removed from the pilot questionnaire. The final ADL-D scale contained 15 items. Scores obtained with the ADL-D scale were significantly correlated with the MRC dyspnea grades, distance walked on the ISWT and SGRQ scores. The ADL-D scores were significantly different across the five grades of the MRC dyspnea grade. The ADL-D scale showed high consistency (Chronbach's alpha coefficient of 0.96). The ADL-D scale is a useful scale for assessing impairments in ADL in Japanese male patients with COPD.

Impact on seniors of the patient-centered medical home: evidence from a pilot study.

PubMed

Fishman, Paul A; Johnson, Eric A; Coleman, Kathryn; Larson, Eric B; Hsu, Clarissa; Ross, Tyler R; Liss, David; Tufano, James; Reid, Robert J

2012-10-01

To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic compared with seniors enrolled at the remaining 19 primary care clinics owned and operated by Group Health. Analyses of secondary data on quality and cost were conducted for 1,947 seniors in the PCMH clinic and 39,396 seniors in the 19 control clinics. Patient experience with care was based on survey data collected from 487 seniors in the PCMH clinic and of 668 in 2 specific control clinics that were selected for their similarities in organization and patient composition to the pilot clinic. After adjusting for baseline, seniors in the PCMH clinic reported higher ratings than controls on 3 of 7 patient experience scales. Seniors in the PCMH clinic had significantly greater quality outcomes over time, but this difference was not significant relative to control. PCMH patients used more e-mail, phone, and specialist visits but fewer emergency services and inpatient admissions for ambulatory care sensitive conditions. At 1 and 2 years, the PCMH and control clinics did not differ significantly in overall costs. A PCMH redesign can be associated with improvements in patient experience and quality without increasing overall cost.

Developing a Continuous Quality Improvement Assessment Using a Patient-Centered Approach in Optimizing Systemic Lupus Erythematosus Disease Control.

PubMed

Updyke, Katelyn Mariko; Urso, Brittany; Beg, Shazia; Solomon, James

2017-10-09

Systemic lupus erythematosus (SLE) is a multi-organ, autoimmune disease in which patients lose self-tolerance and develop immune complexes which deposit systemically causing multi-organ damage and inflammation. Patients often experience unpredictable flares of symptoms with poorly identified triggers. Literature suggests exogenous exposures may contribute to flares in symptoms. An online pilot survey was marketed globally through social media to self-reported SLE patients with the goal to identify specific subpopulations who are susceptible to disease state changes based on analyzed exogenous factors. The pilot survey was promoted for two weeks, 80 respondents fully completed the survey and were included in statistical analysis. Descriptive statistical analysis was performed on de-identified patient surveys and compared to previous literature studies reporting known or theorized triggers in the SLE disease state. The pilot survey identified similar exogenous triggers compared to previous literature, including antibiotics, increasing beef intake, and metal implants. The goal of the pilot survey is to utilize similar questions to develop a detailed internet-based patient interactive form that can be edited and time stamped as a method to promote continuous quality improvement assessments. The ultimate objective of the platform is to interact with SLE patients from across the globe longitudinally to optimize disease control and improve quality of care by allowing them to avoid harmful triggers.

Developing a Continuous Quality Improvement Assessment Using a Patient-Centered Approach in Optimizing Systemic Lupus Erythematosus Disease Control

PubMed Central

Urso, Brittany; Beg, Shazia; Solomon, James

2017-01-01

Systemic lupus erythematosus (SLE) is a multi-organ, autoimmune disease in which patients lose self-tolerance and develop immune complexes which deposit systemically causing multi-organ damage and inflammation. Patients often experience unpredictable flares of symptoms with poorly identified triggers. Literature suggests exogenous exposures may contribute to flares in symptoms. An online pilot survey was marketed globally through social media to self-reported SLE patients with the goal to identify specific subpopulations who are susceptible to disease state changes based on analyzed exogenous factors. The pilot survey was promoted for two weeks, 80 respondents fully completed the survey and were included in statistical analysis. Descriptive statistical analysis was performed on de-identified patient surveys and compared to previous literature studies reporting known or theorized triggers in the SLE disease state. The pilot survey identified similar exogenous triggers compared to previous literature, including antibiotics, increasing beef intake, and metal implants. The goal of the pilot survey is to utilize similar questions to develop a detailed internet-based patient interactive form that can be edited and time stamped as a method to promote continuous quality improvement assessments. The ultimate objective of the platform is to interact with SLE patients from across the globe longitudinally to optimize disease control and improve quality of care by allowing them to avoid harmful triggers. PMID:29226052

Piloting a generic cancer consumer quality index in six European countries.

PubMed

Wind, Anke; Roeling, Mark Patrick; Heerink, Jana; Sixma, Herman; Presti, Pietro; Lombardo, Claudio; van Harten, Wim

2016-09-02

Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries. The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors. A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation. This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care.

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms.

PubMed

Albrecht, Helmut; Vernon, Margaret; Solomon, Gail

2012-12-27

Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient's End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. The study was registered with clinicaltrials.gov (NCT01046136).

Predictors of Home Care Expenditures and Death at Home for Cancer Patients in an Integrated Comprehensive Palliative Home Care Pilot Program

PubMed Central

Howell, Doris M.; Abernathy, Tom; Cockerill, Rhonda; Brazil, Kevin; Wagner, Frank; Librach, Larry

2011-01-01

Purpose: Empirical understanding of predictors for home care service use and death at home is important for healthcare planning. Few studies have examined these predictors in the context of the publicly funded Canadian home care system. This study examined predictors for home care use and home death in the context of a “gold standard” comprehensive palliative home care program pilot in Ontario where patients had equal access to home care services. Methods: Secondary clinical and administrative data sources were linked using a unique identifier to examine multivariate factors (predisposing, enabling, need) on total home care expenditures and home death for a cohort of cancer patients enrolled in the HPCNet pilot. Results: Subjects with gastrointestinal symptoms (OR: 1.64; p=0.03) and those with higher income had increased odds of dying at home (OR: 1.14; p<0.001), whereas age, number of GP visits, gastrointestinal symptoms (i.e., nausea, vomiting, bowel obstruction) and eating problems (i.e., anorexia/cachexia) predicted home care expenditures. Conclusions: Predictors of home death found in earlier studies appeared less important in this comprehensive palliative home care pilot. An income effect for home death observed in this study requires examination in future controlled studies. Relevance: Access to palliative home care that is adequately resourced and organized to address the multiple domains of issues that patients/families experience at the end of life has the potential to enable home death and shift care appropriately from limited acute care resources. PMID:22294993

Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

ERIC Educational Resources Information Center

Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

2004-01-01

Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study.

PubMed

Wijayasinghe, Nelun; Andersen, Kenneth G; Kehlet, Henrik

2017-02-01

Persistent pain after breast cancer surgery (PPBCS) develops in 15% to 25% of patients, sometimes years after surgery. Approximately 50% of PPBCS patients have neuropathic pain in the breast, which may be due to dysfunction of the pectoral nerves. The Pecs local anesthetic block proposes to block these nerves and has provided pain relief for patients undergoing breast cancer surgery, but has yet to be evaluated in patients with PPBCS. The aim of this pilot study was to examine the effects of the Pecs block on summed pain intensity (SPI) and sensory function (through quantitative sensory testing [QST]) in eight patients with PPBCS. SPI and QST measurements were recorded before and 30 minutes after administration of the Pecs block (20 mL 0.25% bupivacaine). Pain intensity and sleep interference were measured daily before and after the block for 7 days. Patients experienced analgesia (P = 0.008) and reduced hypoesthesia areas to cold (P = 0.004) and warmth (P = 0.01) after 30 minutes. The reported pain relief (P = 0.02) and reduced sleep interference (P = 0.01) persisted for 7 days after the block. This pilot study suggests that the pectoral nerves play a role in the maintenance of pain in the breast area in PPBCS and begs for further research. © 2016 World Institute of Pain.

Effectiveness of an Integrated Approach to HIV and Hypertension Care in Rural South Africa: Controlled Interrupted Time-Series Analysis.

PubMed

Ameh, Soter; Klipstein-Grobusch, Kerstin; Musenge, Eustasius; Kahn, Kathleen; Tollman, Stephen; Gómez-Olivé, Francesc Xavier

2017-08-01

South Africa faces a dual burden of HIV/AIDS and noncommunicable diseases. In 2011, a pilot integrated chronic disease management (ICDM) model was introduced by the National Health Department into selected primary health care (PHC) facilities. The objective of this study was to assess the effectiveness of the ICDM model in controlling patients' CD4 counts (>350 cells/mm) and blood pressure [BP (<140/90 mm Hg)] in PHC facilities in the Bushbuckridge municipality, South Africa. A controlled interrupted time-series study was conducted using the data from patients' clinical records collected multiple times before and after the ICDM model was initiated in PHC facilities in Bushbuckridge. Patients ≥18 years were recruited by proportionate sampling from the pilot (n = 435) and comparing (n = 443) PHC facilities from 2011 to 2013. Health outcomes for patients were retrieved from facility records for 30 months. We performed controlled segmented regression to model the monthly averages of individuals' propensity scores using autoregressive moving average model at 5% significance level. The pilot facilities had 6% greater likelihood of controlling patients' CD4 counts than the comparison facilities (coefficient = 0.057; 95% confidence interval: 0.056 to 0.058; P < 0.001). Compared with the comparison facilities, the pilot facilities had 1.0% greater likelihood of controlling patients' BP (coefficient = 0.010; 95% confidence interval: 0.003 to 0.016; P = 0.002). Application of the model had a small effect in controlling patients' CD4 counts and BP, but showed no overall clinical benefit for the patients; hence, the need to more extensively leverage the HIV program for hypertension treatment.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

EFFECTS OF CONVERSATIONAL HYPNOSIS ON RELATIVE PARASYMPATHETIC TONE AND PATIENT COMFORT DURING AXILLARY BRACHIAL PLEXUS BLOCKS FOR AMBULATORY UPPER LIMB SURGERY:A Quasiexperimental Pilot Study.

PubMed

Boselli, Emmanuel; Musellec, Hervé; Bernard, Franck; Guillou, Nicolas; Hugot, Pierre; Augris-Mathieu, Caroline; Diot-Junique, Nathalie; Bouvet, Lionel; Allaouchiche, Bernard

2018-01-01

This two-center quasiexperimental pilot study was to determine the effect of conversational hypnosis on patient comfort and parasympathetic tone, which may represent a quantitative measure of hypnotic depth, during regional anesthesia. The patients received conversational hypnosis in one center and oral premedication in the other. The patients' subjective comfort (0-10 rating scale) and objective parasympathetic tone, as assessed by the Analgesia/Nociception Index (ANI), were measured before and after regional anesthesia. The parasympathetic tone and comfort scores evidenced a significantly greater increase in the hypnosis patients than in controls. These findings suggest that using conversational hypnosis during regional anesthesia may be followed by a subjective increase in patient comfort and an objective increase in parasympathetic tone, monitored by ANI.

Developing and Pilot Testing a Spanish Translation of CollaboRATE for Use in the United States.

PubMed

Forcino, Rachel C; Bustamante, Nitzy; Thompson, Rachel; Percac-Lima, Sanja; Elwyn, Glyn; Pérez-Arechaederra, Diana; Barr, Paul J

2016-01-01

Given the need for access to patient-facing materials in multiple languages, this study aimed to develop and pilot test an accurate and understandable translation of CollaboRATE, a three-item patient-reported measure of shared decision-making, for Spanish-speaking patients in the United States (US). We followed the Translate, Review, Adjudicate, Pre-test, Document (TRAPD) survey translation protocol. Cognitive interviews were conducted with Spanish-speaking adults within an urban Massachusetts internal medicine clinic. For the pilot test, all patients with weekday appointments between May 1 and May 29, 2015 were invited to complete CollaboRATE in either English or Spanish upon exit. We calculated the proportion of respondents giving the best score possible on CollaboRATE and compared scores across key patient subgroups. Four rounds of cognitive interviews with 26 people were completed between January and April 2015. Extensive, iterative refinements to survey items between interview rounds led to final items that were generally understood by participants with diverse educational backgrounds. Pilot data collection achieved an overall response rate of 73 percent, with 606 (49%) patients completing Spanish CollaboRATE questionnaires and 624 (51%) patients completing English CollaboRATE questionnaires. The proportion of respondents giving the best score possible on CollaboRATE was the same (86%) for both the English and Spanish versions of the instrument. Our translation method, guided by emerging best practices in survey and health measurement translation, encompassed multiple levels of review. By conducting four rounds of cognitive interviews with iterative item refinement between each round, we arrived at a Spanish language version of CollaboRATE that was understandable to a majority of cognitive interview participants and was completed by more than 600 pilot questionnaire respondents.

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

A 24-h a la carte food service as support for patients at nutritional risk: a pilot study.

PubMed

Munk, T; Seidelin, W; Rosenbom, E; Nielsen, A L; Klausen, T W; Nielsen, M A; Thomsen, T

2013-06-01

Undernutrition and insufficient energy and protein intake is a common problem in hospitalised patients. The aim of this pilot study was to investigate whether a novel hospital menu would be an effective strategy for increasing nutritional intake in patients at nutritional risk. A historically controlled intervention pilot study was conducted. Forty patients at nutritional risk were offered a novel hospital menu as a supplement to the ordinary hospital menu. The menu consisted of 36 naturally energy-enriched small dishes served on demand 24 h a day. Energy and protein intake were calculated as the mean over a period of 3 days. No significant difference in energy and protein intake was observed between the groups; however, a significant (P = 0.001) time gradient in total energy intake was observed in the intervention group. Moreover, a significant (P = 0.03) time gradient in energy intake received from the novel menu was observed. The dishes from the novel menu were mainly ordered from 11.00 h to 14.00 h and from 17.00 h to 18.00 h. No overall significant differences in energy and protein intake between the groups were found. However, the present pilot study revealed a significant time gradient in total energy intake (P = 0.001) and in energy intake from the novel menu (P = 0.03). This indicates the need to include a run-in period when investigating novel hospital menus as a support for patients at nutritional risk. Additionally, food service, available 24 h a day, appears to be unnecessary. © 2012 The Authors Journal of Human Nutrition and Dietetics © 2012 The British Dietetic Association Ltd.

An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

PubMed

Mody, Sheila K; Haunschild, Carolyn; Farala, John Paul; Honerkamp-Smith, Gordon; Hur, Vivian; Kansal, Leena

2016-01-01

This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age. This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants received either usual care or the educational handout. The 10-question test assessed increased knowledge of which AEDs affected efficacy of certain hormonal contraceptives and was assessed by calculating the improvement in score between the pretest and posttest. The educational handout included the names of AEDs that have drug interactions with certain contraceptives and the efficacy of the contraceptives. A total of 42 epilepsy patients participated in this study. Fourteen participants were taking AEDs that are enzyme p450 inducers and 13 participants were taking Lamotrigine. Twenty women were randomized to receive the educational handout and 22 women were randomized to usual care. We found no statistical difference in the groups with regard to age, ethnicity or level of education. We found a significantly higher improvement in quiz scores in the educational handout group (3.65 point increase) compared to the usual care group (0.68 point increase) as calculated by the Student's two-sample t test (p<.001). An educational handout on drug interactions and contraceptives resulted in increased short-term information retention on this topic among reproductive-age female epilepsy patients. This pilot study highlights the need for further larger studies to evaluate the impact of educational interventions on improving patient knowledge about the drug interaction of AEDs and hormonal contraceptives. Copyright © 2016. Published by Elsevier Inc.

Pilot study of a smartphone application designed to socially motivate cardiovascular disease patients to improve medication adherence.

PubMed

Fujita, Saki; Pitaktong, Isaree; Steller, Graeme Vosit; Dadfar, Victor; Huang, Qinwen; Banerjee, Sindhu; Guo, Richard; Nguyen, Hien Tan; Allen, Robert Harry; Martin, Seth Shay

2018-01-01

Social support received by patients from family and community has been identified as a key factor for success in improving medication adherence in those patients. This pilot study aimed to investigate the usability and feasibility of PillPal, a smartphone application that uses video-chatting as a social motivation medium to encourage medication adherence in cardiovascular disease (CVD) patients. We additionally gathered feedback on the Physician Calendar, an accompanying web platform that allows clinicians to view patient adherence data generated from the app. Thirty patients were recruited from the Johns Hopkins Hospital (JHH) Lipid Clinic (n=14) and Inpatient Cardiology Service (n=16) to pilot test the app. Data were obtained through in-person interviews in which patients tested out the app and answered standardized questions regarding the app's feasibility as a means to enhance social support, as well as its usability measured in terms of ease of use and patient comfort level with the video-chat technology. Cardiologists (n=10) from JHH were interviewed to gain feedback on the Physician Calendar. We recorded 43.4% participants who stated that PillPal would increase their motivation to take their medications; 96.7% stated the app was easy to use; and 70% stated they were comfortable with video-chatting while taking their medications. Patient factors such as current adherence level, disease severity, and personality were more predictive of positive app reviews than the perceived level of social support. Clinicians generally approved of the Physician Calendar, as they would be able to quickly screen for non-adherence and begin conversations with patients to address the root cause of their non-adherence. Based on pilot testing and interviews, using a smartphone app for video-chatting as a social support medium to improve patient medication adherence is feasible and has potential to increase medication adherence depending on certain patient characteristics. The Physician Calendar was deemed a useful tool by clinicians to quickly identify and understand reasons for medication non-adherence.

A Brief Peer Support Intervention for Veterans with Chronic Musculoskeletal Pain: A Pilot Study of Feasibility and Effectiveness

PubMed Central

Matthias, Marianne S.; McGuire, Alan B.; Kukla, Marina; Daggy, Joanne; Myers, Laura J.; Bair, Matthew J.

2016-01-01

Objective To pilot test a peer support intervention, involving peer delivery of pain self-management strategies, for veterans with chronic musculoskeletal pain. Design Pre-test/post-test with 4-month intervention period. Methods Ten peer coaches were each assigned 2 patients (n=20 patients). All had chronic musculoskeletal pain. Guided by a study manual, peer coach-patient pairs were instructed to talk bi-weekly for 4 months. Pain was the primary outcome and was assessed with the PEG, a 3-item version of the Brief Pain Inventory, and the PROMIS Pain Interference Questionnaire. Several secondary outcomes were also assessed. To assess change in outcomes, a linear mixed model with a random effect for peer coaches was applied. Results Nine peer coaches and 17 patients completed the study. All were male veterans. Patients’ pain improved at 4 months compared to baseline but did not reach statistical significance (PEG: p = .33, ICC [intra-class correlation] = .28, Cohen's d = −.25; PROMIS: p = .17, d = −.35). Of secondary outcomes, self-efficacy (p = .16, ICC = .56, d = .60) and pain centrality (p = .06, ICC = .32, d = −.62) showed greatest improvement, with moderate effect sizes. Conclusions This study suggests that peers can effectively deliver pain self-management strategies to other veterans with pain. Although this was a pilot study with a relatively short intervention period, patients improved on several outcomes. PMID:25312858

A Pilot Study of Cerebral and Hemodynamic Changes During Sedation with Low Dose of Thiopental Sodium or Propofol in Patients with Acute Brain Injury.

PubMed

Yaghoobi, Siamak; Khezri, Marzieh Beigom; Alamouti, Azam Mohammadi

2015-08-01

One of the most important therapeutic maneuvers in head injury patients is to maintain Intracranial Pressure (ICP) and Cerebral Perfusion Pressure (CPP) within normal levels. To compare the effects of low dose of thiopental sodium and propofol on reducing ICP and CPP in patients with head injury that scheduled for neurosurgical interventions. Using a randomized, crossover pilot study, we enrolled patients with head injury that scheduled for neurosurgical interventions admitted to ICU unit of a teaching hospital during 2010 to 2011. In this pilot study, patients randomized into two equal groups. The first group received bolus injection of thiopental sodium 2 mg/kg and a maintenance dose of 2 mg/kg/h and the second group was given a bolus dose of propofol 0.5 mg/kg followed by propofol infusion 20 μg/kg/min. All of patients were given dexamethasone 8 mg at time of catheter insertion. ICP measurement catheter was inserted for each patient and ICP, CPP, SPO2 and MAP were recorded hourly for a period of 6 hours. There was no significant difference in sex and age between the two study groups (p>0.05). The mean ICP, CPP, SPO2 and arterial blood pressure were found to be similar with no significant difference between both groups (p>0.05). Both propofol and thiopental sodium were equally effective in monitoring and maintaining CPP and MAP and eventually an ideal SPO2.

Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study.

PubMed

Herth, F J F; Schuler, H; Gompelmann, D; Kahn, N; Gasparini, S; Ernst, A; Schuhmann, M; Eberhardt, R

2012-02-01

One limitation of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the size of the available needles, frequently yielding only cells for cytological examination. The aim of this pilot study was to evaluate the efficacy and safety of newly developed needle forceps to obtain tissue for the histological diagnosis of enlarged mediastinal lymph nodes. Patients with enlarged, positron emission tomography (PET)-positive lymph nodes were included. The transbronchial needle forceps (TBNF), a sampling instrument combining the characteristics of a needle (bevelled tip for penetrating through the bronchial wall) with forceps (two serrated jaws for grasping tissue) was used through the working channel of the EBUS-TBNA scope. Efficacy and safety was assessed. 50 patients (36 males and 14 females; mean age 51 yrs) with enlarged or PET-positive lymph nodes were included in this pilot study. In 48 (96%) patients penetration of the bronchial wall was possible and in 45 patients tissue for histological diagnosis was obtained. In three patients TBNF provided inadequate material. For patients in whom the material was adequate for a histological examination, a specific diagnosis was established in 43 (86%) out of 50 patients (nonsmall cell lung cancer: n=24; small cell lung cancer: n=7; sarcoidosis: n=4; Hodgkin's lymphoma: n=4; tuberculosis: n=2; and non-Hodgkin's lymphoma: n=2).No clinically significant procedure-related complications were encountered. This study demonstrated that EBUS-TBNF is a safe procedure and provides diagnostic histological specimens of mediastinal lymph nodes.

Evaluation of peripheral binocular visual field in patients with glaucoma: a pilot study.

PubMed

Ana, Banc; Cristina, Stan; Dorin, Chiselita

2016-01-01

The objective of this study was to evaluate the peripheral binocular visual field (PBVF) in patients with glaucoma using the threshold strategy of Humphrey Field Analyzer. We conducted a case-control pilot study in which we enrolled 59 patients with glaucoma and 20 controls. All participants were evaluated using a custom PBVF test and central 24 degrees monocular visual field tests for each eye using the threshold strategy. The central binocular visual field (CBVF) was predicted from the monocular tests using the most sensitive point at each field location. The glaucoma patients were grouped according to Hodapp classification and age. The PBVF was compared to controls and the relationship between the PBVF and CBVF was tested. The areas of frame-induced artefacts were determined (over 50 degrees in each temporal field, 24 degrees superiorly and 45 degrees inferiorly) and excluded from interpretation. The patients presented a statistically significant generalized decrease of the peripheral retinal sensitivity compared to controls for Hodapp initial stage--groups aged 50-59 (t = 11.93 > 2.06; p < 0.05) and 60-69 (t = 7.55 > 2.06; p < 0.05). For the initial Hodapp stage there was no significant relationship between PBVF and CBVF (r = 0.39). For the moderate and advanced Hodapp stages, the interpretation of data was done separately for each patient. This pilot study suggests that glaucoma patients present a decrease of PBVF compared to controls and CBVF cannot predict the PBVF in glaucoma.

'Talking of Sex': developing and piloting a sexual health communication tool for use in primary care.

PubMed

Macdowall, Wendy; Parker, Rachael; Nanchahal, Kiran; Ford, Chris; Lowbury, Ruth; Robinson, Angela; Sherrard, Jackie; Martins, Helen; Fasey, Nicky; Wellings, Kaye

2010-12-01

To develop and pilot a communication aid aimed at increasing the frequency with which sexual health issues are raised proactively with young people in primary care. Group interviews among primary health care professionals to guide development of the tool, simulated consultations to pre-test it, and a pilot study to assess effectiveness. We developed an electronic consultation aid: Talking of Sex and piloted it in eight general practices across the UK. 188 patients and 58 practitioners completed questionnaires pre-intervention, and 92 patients and 45 practitioners post-intervention. There was a modest increase in the proportion of consultations in which sexual health was raised, from 28.1% pre-intervention to 32.6% post-intervention. In consultations with nurses the rise was more marked. More patients reported discussing preventive practices such as condom use post-intervention. Patients unanimously welcomed the opportunity to discuss sexual health matters with their practitioner. The tool has capacity to increase the frequency with which sexual health is raised in primary care, particularly by nurses, to influence the topics discussed, and to improve patient satisfaction. The tool has potential in increasing the proportion of young people whose sexual health needs are addressed in general practice. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Effect of an essential oil mixture on skin reactions in women undergoing radiotherapy for breast cancer: a pilot study.

PubMed

Halm, Margo A; Baker, Clarice; Harshe, Val

2014-12-01

This pilot study compared the effects of an essential oil mixture versus standard care on skin reactions in breast cancer patients receiving radiation. Using an experimental design, 24 patients were randomized to standard care (i.e., RadiaPlexRx™ ointment) or an essential oil mixture. Products were applied topically three times a day until 1 month postradiation. Weekly skin assessments were recorded and women completed patient satisfaction and quality of life (QOL) instruments at 3-, 6-, and 10-week intervals. No significant differences were found for skin, QOL, or patient satisfaction at interim or follow-up time points. Effect sizes were as follows: skin = .01 to .07 (small-medium effect); QOL = .01 to .04 (small effect); patient satisfaction = .02 (small effect). The essential oil mixture did not provide a better skin protectant effect than standard care. These findings suggest the essential oil mixture is equivalent to RadiaPlexRx, a common product used as standard care since it has been shown to be effective in protecting skin from radiation. Thus, this pilot provides evidence to support botanical or nonpharmaceutical options for women during radiotherapy for breast cancer. © The Author(s) 2014.

Usability of digital media in patients with COPD: a pilot study.

PubMed

Cheung, Amy; Janssen, Anton; Amft, Oliver; Wouters, Emiel F M; Spruit, Martijn A

2013-04-01

Digital media can be integrated in tele-monitoring solutions, serving as the main interface between the patient and the caregiver. Consequently, the selection of the most appropriate digital medium for the specified target group is critical to ensure compliance with the tele-monitoring system. This pilot study aims to gather insights from patients with chronic obstructive pulmonary disease (COPD) on the ease-of-use, efficacy, effectiveness, and satisfaction of different types of digital media. Five off-the-shelf digital media devices were tested on nine patients at CIRO+ in Horn, The Netherlands. Usability was evaluated by asking patients to use each device to answer questions related to their symptoms and health status. Subsequently, patients completed a paper-based device usability questionnaire, which assessed prior experience with digital media, device dimensions, device controllability, response speed, screen readability, ease-of-use, and overall satisfaction. After testing all the devices, patients ranked the devices according to their preference. We identified the netbook as the preferred type of device due to its good controllability, fast response time, and large screen size. The smartphone was the least favorite device as patients found the size of the screen to be too small, which made it difficult to interact with. The pilot study has provided important insights to guide the selection of the most appropriate type of digital medium for implementation in tele-monitoring solutions for patients with COPD. As the digital medium is an important interface to the patient in tele-monitoring solutions, it is essential that patients feel motivated to interact with the digital medium on a regular basis.

Pilot study of atomoxetine in patients with Parkinson's disease and dopa-unresponsive Freezing of Gait.

PubMed

Revuelta, Gonzalo J; Embry, Aaron; Elm, Jordan J; Gregory, Chris; Delambo, Amy; Kautz, Steve; Hinson, Vanessa K

2015-01-01

Freezing of gait (FoG) is a common and debilitating condition in Parkinson's disease (PD) associated with executive dysfunction. A subtype of FoG does not respond to dopaminergic therapy and may be related to noradrenergic deficiency. This pilot study explores the effects of atomoxetine on gait in PD patients with dopa-unresponsive FoG using a novel paradigm for objective gait assessment. Ten patients with PD and dopa-unresponsive FoG were enrolled in this eight-week open label pilot study. Assessments included an exploratory gait analysis protocol that quantified spatiotemporal parameters during straight-away walking and turning, while performing a dual task. Clinical, and subjective assessments of gait, quality of life, and safety were also administered. The primary outcome was a validated subjective assessment for FoG (FOG-Q). Atomoxetine was well tolerated, however, no significant change was observed in the primary outcome. The gait analysis protocol correlated well with clinical scales, but not with subjective assessments. DBS patients were more likely to increase gait velocity (p = 0.033), and improved in other clinical assessments. Objective gait analysis protocols assessing gait while dual tasking are feasible and useful for this patient population, and may be superior correlates of FoG severity than subjective measures. These findings can inform future trials in this population.

Sexual functioning of adult patients born with meningomyelocele. A pilot study.

PubMed

Vroege, J A; Zeijlemaker, B Y; Scheers, M M

1998-01-01

This pilot study was started to get an impression of the sexual activity and sexual difficulties of adult patients born with meningomyelocele in control at Utrecht University Hospital, and to find out whether these problems deserve more attention from the Spina Bifida Team. Seventeen patients (9 men, 8 women; aged 19-44) were asked to participate; 11 (8 men, 3 women) decided to take part in this study. All these patients were interviewed by their physician about their present sexual life; 6 of them also completed the 'Questionnaire for screening Sexual Dysfunctions' (QSD). With 1 exception, all patients expressed a desire for sexual contact. Five of them masturbated and 6 patients sometimes had sexual contact. Eight patients had problems in the field of sexuality, but only 3 were dissatisfied with their present sexual life. It is advantageous to invite adult patients born with meningomyelocele for an interview about their sexual life. When raising this subject, however, one has to act with caution: for quite a few patients (in this study mostly women) sexuality still is a delicate subject.

Primary care reform: a pilot study to test the evaluative potential of the Patient Enablement Instrument in Poland.

PubMed

Pawlikowska, T R B; Nowak, P R; Szumilo-Grzesik, W; Walker, J J

2002-04-01

Primary health care reform is underpinned by a move towards patient-centred holistic care. This pilot study uses the Patient Enablement Instrument (PEI) to assess outcome at a fundamental level: that of the patient and their doctor at consultation. Our aim was to assess the evaluative potential of the PEI in relation to a reform programme in Poland by (i) comparing the outcomes of consultations (using the PEI) carried out by nine doctors (three diploma GPs who had participated in the training programme, three GPs who had not participated in the training programme and three polyclinic internists); and (ii) relating PEI scores to a proxy quality process measure (consultation length). A cross-sectional quantitative questionnaire survey was carried out using the PEI. The subjects were patients consulting with nine doctors distributed within a single region around Gdansk. The overall results with the PEI and consultation length reflected UK experience. In addition, there were significant differences between groups in this pilot study. Patients seen by diploma GPs achieved higher patient enablement scores (mean 4.33, 95% confidence interval 4.09-4.58) relative to GPs (mean 3.44, 3.21-3.67) and polyclinic doctors (mean 3.23, 2.99-3.47). However, there is evidence of appreciable between-doctor variation in PEI scores within groups. The difference in patient enablement between groups was not affected by patient case mix, in contrast to the duration of consultation, which was. Holistically trained diploma GPs spent longer with patients with psychological problems. Patients seen by diploma GPs received longer consultations (mean 12.65 min, 95% confidence interval 12.18-13.13) relative to their colleagues (the GPs' mean was 10.11, 9.82-10.41 min; that of the polyclinic internists was 10.16, 9.81-10.50 min). The duration of consultation was positively correlated with patient enablement. The results of such training courses should be examined from the perspective of both the patient and their doctor. Significant differences were found in both patient enablement and consultation length between patients attending groups of doctors delivering primary care, but working from different paradigms. This pilot shows promising results which, if repeated in a larger study, would provide an objective means of evaluating such reform programmes.

[Changing of the patient safety culture in the pilot institutes of the Hungarian accreditation program].

PubMed

Lám, Judit; Merész, Gergő; Bakacsi, Gyula; Belicza, Éva; Surján, Cecília; Takács, Erika

2016-10-01

The accreditation system for health care providers was developed in Hungary aiming to increase safety, efficiency, and efficacy of care and optimise its organisational operation. The aim of this study was to assess changes of organisational culture in pilot institutes of the accreditation program. 7 volunteer pilot institutes using an internationally validated questionnaire were included. The impact study was performed in 2 rounds: the first before the introduction of the accreditation program, and the second a year later, when the standards were already known. Data were analysed using descriptive statistics and logistic regression models. Statistically significant (p<0.05) positive changes were detected in hospitals in three dimensions: organisational learning - continuous improvement, communication openness, teamwork within the unit while in outpatient clinics: overall perceptions of patient safety, and patient safety within the unit. Organisational culture in the observed institutes needs improvement, but positive changes already point to a safer care. Orv. Hetil., 2016, 157(42), 1667-1673.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

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.

A pilot study of oxcarbazepine versus acamprosate in alcohol-dependent patients.

PubMed

Croissant, Bernhard; Diehl, Alexander; Klein, Oliver; Zambrano, Sergio; Nakovics, Helmut; Heinz, Andreas; Mann, Karl

2006-04-01

This pilot study has been designed to collect preliminary data on the use of a new antiepileptic drug in the management of alcoholic patients. Oxcarbazepine (OXC) blocks voltage-sensitive sodium channels. Its metabolite reduces high-voltage-activated calcium currents in striatal and cortical neurons, thus reducing glutamatergic transmission at corticostriatal synapses. This reduction is of interest in the treatment of alcohol dependence, as acamprosate (ACP) modulates NMDA receptors, resulting in an inhibition of glutamatergic transmission. Furthermore, OXC has revealed a mood-stabilizing effect in bipolar affective disorders. We have compared OXC with ACP in relapse prevention in recently withdrawn alcohol-dependent patients. We investigated the efficacy and safety of OXC (vs ACP) by conducting a 24-week randomized, parallel-group, open-label, clinical trial on 30 acutely detoxified alcoholic patients. Survival analyses (Kaplan-Meier) were performed to look for evidence of a longer "survival" of patients receiving OXC. We assessed time to first severe relapse and additional secondary endpoints. After withdrawal, time to severe relapse and time to first consumption of any ethanol by OXC patients were not longer than for ACP patients. Abstinent patients in both study groups showed a significantly lower obsessive compulsive drinking scale-German version (OCDS-G) than relapsed patients. No undesired effects occurred when OXC patients consumed alcohol. Our findings indicate that it could be worthwhile to test relapse prevention using OXC in an adequate sample. While the current sample size clearly limits further conclusions from this pilot study, it is noteworthy that OXC is well tolerated, even when alcohol is on board. Thus, in medication-based relapse prevention, OXC could be a promising alternative for alcoholic patients unable to benefit from ACP or naltrexone or those who have affective liability. OXC certainly merits a larger placebo-controlled trial.

Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

PubMed

Aaron, Shawn D; Vandemheen, Katherine L; Freitag, Andreas; Pedder, Linda; Cameron, William; Lavoie, Annick; Paterson, Nigel; Wilcox, Pearce; Rabin, Harvey; Tullis, Elizabeth; Morrison, Nancy; Ratjen, Felix

2012-01-01

Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF). We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life. Over the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. ClinicalTrials.gov NCT00528190.

Pilot Study: Improving Patient Outcomes with Healing Touch.

PubMed

Hendricks, Kimberly; Wallace, Kelley F

2017-01-01

Healing Touch therapies use a practitioner's intentional placement of hands to influence the patient's energy fields to promote self-healing. In the changing climate of health care, in which the patient experience increasingly drives reimbursements, it is vital to find unique and meaningful ways beyond traditional medical therapies to ensure positive patient experiences. To that end, our peritoneal dialysis clinic staff adopted Jean Watson's theoretical framework, by which patients are treated as whole unique individuals with a "multidimensional system of energy, with a consciousness that can be affected by another to promote well-being." In a rapidly growing urban clinic of more than 100 patients, our nurses identified the need to provide more ways to improve patient care.Staff were educated on ways to set positive intentions for patient contacts and to incorporate patient narratives into contact. Optional daily prayer was initiated, and patients were invited to attend a new support group for peritoneal dialysis patients and their families. In addition, a preliminary pilot provided Healing Touch treatments to interested patients. That pilot was associated with improvement in 4 of 5 measured categories. Fatigue and pain decreased by 46% and 68% respectively. Stress and anxiety fell by 49%, and a large drop of 84% in depression was observed. Nausea was unchanged.

Family-Based Crisis Intervention with Suicidal Adolescents in the Emergency Room: A Pilot Study

ERIC Educational Resources Information Center

Wharff, Elizabeth A.; Ginnis, Katherine M.; Ross, Abigail M.

2012-01-01

The prevailing model of care for psychiatric patients in the emergency room (ER) is evaluation and disposition, with little or no treatment provided. This article describes the results of a pilot study of a family-based crisis intervention (FBCI) for suicidal adolescents and their families in a large, urban pediatric ER. FBCI is an intervention…

Evaluating the effectiveness of aromatherapy in reducing levels of anxiety in palliative care patients: results of a pilot study.

PubMed

Kyle, Gaye

2006-05-01

Results of the pilot study of the four counties randomised controlled trial to evaluate the effectiveness of aromatherapy massage with 1% Santalum album (Sandalwood) (group A) when compared with massage with Sweet Almond Carrier oil, (group B) or Sandalwood oil via an aromastone (group C), in reducing levels of anxiety in palliative care. The aims of the pilot study were to evaluate the effectiveness of aromatherapy in reducing anxiety in patients receiving palliative care in four counties. The primary end points of the research were to report a statistically significant difference in anxiety scores between experimental group (B) and comparison groups (A and C) and to influence the integration of aromatherapy into all aspects of palliative care. The limited data of the pilot study (N=34) tested the logistics of the research, particularly the 25% attrition rate and the robustness of the data collection tools. The results were not substantial enough to generate coherent statistics. Therefore no assumptions could be drawn from these results due to the inconsistencies that were bound to occur in such a small sample. However, the results do seem to support the notion that Sandalwood oil is effective in reducing anxiety.

Early Maladaptive Schemas in a Sample of Airline Pilots seeking Residential Substance Use Treatment: An Initial Investigation

PubMed Central

Shorey, Ryan C.; Brasfield, Hope; Anderson, Scott; Stuart, Gregory L.

2014-01-01

Background Recent research has begun to examine the early maladaptive schemas of substance abusers, as it is believed that targeting these core beliefs in treatment may result in improved substance use outcomes. One special population that has received scant attention in the research literature, despite high levels of substance use, is airline pilots. Aims The current study examined the early maladaptive schemas of a sample of airline pilots (n = 64) who were seeking residential treatment for alcohol dependence and whether they differed in early maladaptive schemas from non-pilot substance abusers who were also seeking residential treatment for alcohol dependence (n = 45). Method Pre-existing medical records from patients of a residential substance abuse treatment facility were reviewed for the current study. Results Of the 18 early maladaptive schemas, results demonstrated that pilots scored higher than non-pilots on the early maladaptive schema of unrelenting standards (high internalized standards of behavior), whereas non-pilots scored higher on insufficient self-control (low frustration tolerance and self-control). Conclusions Early maladaptive schemas may be a relevant treatment target for substance abuse treatment seeking pilots and non-pilots. PMID:24701252

Effectiveness and cost-effectiveness of admissions to women's crisis houses compared with traditional psychiatric wards: pilot patient-preference randomised controlled trial.

PubMed

Howard, L; Flach, C; Leese, M; Byford, S; Killaspy, H; Cole, L; Lawlor, C; Betts, J; Sharac, J; Cutting, P; McNicholas, S; Johnson, S

2010-08-01

Women's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards. To examine the effectiveness and cost-effectiveness of women's crisis houses by first examining the feasibility of a pilot patient-preference randomised controlled trial (PP-RCT) design (ISRCTN20804014). We used a PP-RCT study design to investigate women presenting in crisis needing informal admission. The four study arms were the patient preference arms of women's crisis house or hospital admission, and randomised arms of women's crisis house or hospital admission. Forty-one women entered the randomised arms of the trial (crisis house n = 19, wards n = 22) and 61 entered the patient-preference arms (crisis house n = 37, ward n = 24). There was no significant difference in outcomes (symptoms, functioning, perceived coercion, stigma, unmet needs or quality of life) or costs for any of the groups (randomised or preference arms), but women who obtained their preferred intervention were more satisfied with treatment. Although the sample sizes were too small to allow definite conclusions, the results suggest that when services are able to provide interventions preferred by patients, those patients are more likely to be satisfied with treatment. This pilot study provides some evidence that women's crisis houses are as effective as traditional psychiatric wards, and may be more cost-effective.

Balance exercise in patients with chronic sensory ataxic neuropathy: a pilot study.

PubMed

Riva, Nilo; Faccendini, Simone; Lopez, Ignazio D; Fratelli, Annamaria; Velardo, Daniele; Quattrini, Angelo; Gatti, Roberto; Comi, Giancarlo; Comola, Mauro; Fazio, Raffaella

2014-06-01

Although exercise therapy is considered part of the treatment of neuropathic patients, and somatosensory input is essential for motor learning, performance and neural plasticity, rehabilitation of patients with sensory ataxia has received little attention so far. The aim of this prospective pilot study was to explore the short- and medium-term efficacy of a 3-week intensive balance and treadmill exercise program in chronic ataxic neuropathy patients; 20 consecutive patients with leg overall disability sum score (ODSS-leg) ≥2, absent/mild motor signs, clinical and therapeutic stability ≥4 months were enrolled. Evaluations were done at baseline, at the end of treatment and at 3- and 6-month follow-up. Outcome measurements included: ODSS-leg, Berg balance scale, 6-min walk distance, and the functional independence measure (FIM) scale. The short-form-36 health status scale (SF-36) was used to measure health-related quality of life (HRQoL). ODSS-leg improved significantly compared with baseline, 3 weeks, 3 months (primary outcome), and 6 months follow-up. A significant improvement in all functional secondary outcome measurements and in some SF-36 subscales was also observed. This pilot study suggests that balance exercise is safe and well tolerated and might be effective in ameliorating disability and HRQoL in patients with chronic peripheral sensory ataxia. © 2014 Peripheral Nerve Society.

Participation of informal caregivers in the hospital care of elderly patients and their evaluations of the care given: pilot study in three different hospitals.

PubMed

Laitinen, P

1992-10-01

This action research is an ongoing study which will last from 1991 to 1993. The main purpose of the study is to increase the participation of informal caregivers in the hospital care of elderly patients without decreasing the quality of care. The data reported here are from a pilot study. This study had three aims: (a) to test reliability and validity of the measure used, (b) to investigate the current participation of informal caregivers in the hospital care of elderly patients (aged over 75), and (c) to evaluate and compare the quality of care from both the patients' and the informal caregivers' point of view in three different hospitals. The measure of quality of care was developed on the basis of need theories, mainly those of Maslow and Alderfer. Patients and caregivers were also asked to rate the participation of the caregivers in the hospital care of elderly patients. Participation consisted of 18 activities of daily living. The pilot test with 18 elderly hospital patients and seven family members or significant others showed differences between the two groups in perception of care received. Statistically significant differences (P < 0.001) were found in the following categories: mainly social needs, psychic and spiritual needs and totals. The results supported earlier findings that elderly patients are satisfied with and do not criticize their care. The younger generation (i.e. their children) is more demanding and has precise perceptions about the care given. Relatives could be used more in planning, evaluation and even implementation of care; however, their current participation in patient hospital care is minimal.

Development, modelling, and pilot testing of a complex intervention to support end-of-life care provided by Danish general practitioners.

PubMed

Winthereik, Anna Kirstine; Neergaard, Mette Asbjoern; Jensen, Anders Bonde; Vedsted, Peter

2018-06-20

Most patients in end-of-life with life-threatening diseases prefer to be cared for and die at home. Nevertheless, the majority die in hospitals. GPs have a pivotal role in providing end-of-life care at patients' home, and their involvement in the palliative trajectory enhances the patient's possibility to stay at home. The aim of this study was to develop and pilot-test an intervention consisting of continuing medical education (CME) and electronic decision support (EDS) to support end-of-life care in general practice. We developed an intervention in line with the first phases of the guidelines for complex interventions drawn up by the Medical Research Council. Phase 1 involved the development of the intervention including identification of key barriers to provision of end-of-life care for GPs and of facilitators of change. Furthermore the actual modelling of two components: CME meeting and EDS. Phase 2 focused on pilot-testing and intervention assessment by process evaluation. In phase 1 lack of identification of patients at the end of life and limited palliative knowledge among GPs were identified as barriers. The CME meeting and the EDS were developed. The CME meeting was a four-hour educational meeting performed by GPs and specialists in palliative care. The EDS consisted of two parts: a pop-up window for each patient with palliative needs and a list of all patients with palliative needs in the practice. The pilot testing in phase 2 showed that the CME meeting was performed as intended and 120 (14%) of the GPs in the region attended. The EDS was integrated in existing electronic records but was shut down early for external reasons; 50 (5%) GPs signed up. The pilot-testing demonstrated a need to strengthen the implementation as attending rate was low in the current set-up. We developed a complex intervention to support GPs in providing end-of-life care. The pilot-test showed general acceptance of the CME meetings. The EDS was shut down early and needs further evaluation before examining the whole intervention in a larger study, where evaluation could be based on patient-related outcomes and impact on end-of-life care. Clinicaltrials.gov ( NCT02050256 ) January 30, 2014.

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

PubMed

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

Pilot study on identification of incidents in healthcare transitions and concordance between medical records and patient interview data

PubMed Central

van Melle, Marije A; Erkelens, Daphne C A; van Stel, Henk F; de Wit, Niek J; Zwart, Dorien L M

2016-01-01

Objective To investigate whether transitional incidents can be identified from the medical records of the general practitioners and the hospital and to assess the concordance of transitional incidents between medical records and patient interviews. Design A pilot study. Setting The study was conducted in 2 regions in the Netherlands: a rural and an urban region. Participants A purposeful sample of patients who experienced a transitional incident or are at high risk of experiencing transitional incidents. Main outcome measures Transitional incidents were identified from both the interviews with patients and medical records and concordance was assessed. We also classified the transitional incidents according to type, severity, estimated cause and preventability. Results We identified 28 transitional incidents within 78 transitions of which 3 could not be found in the medical records and another 5 could have been missed without the patient as information source. To summarise, 8 (29%) incidents could have been missed using solely medical records, and 7 (25%) using the patients’ information exclusively. Concordance in transitional incidents between patient interviews and medical records was 64% (18/28). The majority of the transitional incidents were unsafe situations; however, 43% (12/28) of the incidents reached the patient and 18% (5/28) caused temporary patient harm. Over half of the incidents were potentially preventable. Conclusions This pilot study suggests that the majority of transitional incidents can be identified from medical records of the general practitioner and hospital. With this information, we aim to develop a measurement tool for transitional incidents in the medical record of general practitioner and hospital. PMID:27543588

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study.

PubMed

Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

2016-01-01

True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

A palliative care hotline for multiple sclerosis: A pilot feasibility study.

PubMed

Knies, Andrea K; Golla, Heidrun; Strupp, Julia; Galushko, Maren; Schipper, Sabine; Voltz, Raymond

2015-08-01

Research findings suggest that patients severely affected by multiple sclerosis benefit from palliative care. Our objectives were to (1) implement a pilot palliative care counseling hotline for severely affected multiple sclerosis patients and their caregivers in order to connect them to palliative care, and (2) evaluate its preliminary feasibility through a pilot study. The hotline was designed in cooperation with the local state association of the German Multiple Sclerosis Society and based on a review of the literature. The initial study setting for the hotline was the broader region of the cities Cologne and Bonn in Germany. The hotline was introduced through a magazine published by the German Multiple Sclerosis Society and leaflets sent to local healthcare providers. Calls were conducted using a semistructured interview guide and documented by a standardized case report form. Measures to assess feasibility were both quantitative (e.g., number of calls) and qualitative (e.g., criteria for eligibility for palliative care). During its pilot year, the hotline received 18 calls. Some 15 callers were included in the analysis, and 10 of these 15 were deemed eligible for palliative care due to such criteria as medical characteristics, care or nursing conditions, caregiver strain, and concerns regarding death and dying. Access to palliative care services could be provided for all 10 callers. Based on our pilot feasibility study, the hotline seems to be a valuable service for patients severely affected by multiple sclerosis (MS) and their caregivers in order to gain information about and access to palliative care. It will be extended on a nationwide scale through a grant of the German Multiple Sclerosis Society. Awareness of the hotline needs to be enhanced in order to attract and support a significant number of new callers.

Lifestyle modification with diet and exercise in obese patients with heart failure - A pilot study

USDA-ARS?s Scientific Manuscript database

There is a paucity of data regarding intentional weight loss in obese heart failure patients. This study sought to ascertain the safety and effectiveness of a lifestyle modification program in patients with systolic heart failure and metabolic syndrome. Patients (n=20) with systolic heart failure (e...

Associations Among Depressive Symptoms, Wellness, Patient Involvement, Provider Cultural Competency, and Treatment Nonadherence: A Pilot Study Among Community Patients Seen at a University Medical Center.

PubMed

Hooper, Lisa M; Huffman, Lauren E; Higginbotham, John C; Mugoya, George C T; Smith, Annie K; Dumas, Tia N

2018-02-01

Treatment nonadherence is a pernicious problem associated with increasing rates of chronic diseases, escalating healthcare costs, and rising mortality in some patients. Although researchers have suggested numerous factors related to treatment nonadherence, several understudied aspects warrant attention, such as primary-care settings, provider cultural competence, and patient involvement. Adding to the research base, the present pilot study examined 88 primarily Black American and White American community patients from a large university medical center in the southern part of the United States. The study explored two research questions: (a) To what extent are there associations among depressive symptoms, wellness, patient involvement, cultural competency, and treatment nonadherence in a racially diverse community patient population? And (b) to what extent do the study exploratory variables and background characteristics predict treatment nonadherence, both separately and jointly? Depressive symptoms, the patient's perception of a provider's cultural competence, and marital/partnered status were found to be statistically significantly associated with treatment nonadherence, but not entirely in the directions expected.

Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China

PubMed Central

He, Lixian; Zhao, Su; Weng, Heng; Yang, Guowang

2015-01-01

This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5–7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm3 after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy. PMID:25486597

Medication reconciliation in pediatric cardiology performed by a pharmacy technician: a prospective cohort comparison study.

PubMed

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model.

Medication Reconciliation in Pediatric Cardiology Performed by a Pharmacy Technician: A Prospective Cohort Comparison Study

PubMed Central

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Background: Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. Objectives: To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. Methods: This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. Results: The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. Conclusions: A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model. PMID:25762814

Comparison of mania patients suitable for treatment trials versus clinical treatment.

PubMed

Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population.

PubMed

Dick, Jonathan J; Nundy, Shantanu; Solomon, Marla C; Bishop, Keisha N; Chin, Marshall H; Peek, Monica E

2011-09-01

We pilot-tested a text message-based diabetes care program in an urban African-American population in which automated text messages were sent to participants with personalized medication, foot care, and appointment reminders and text messages were received from participants on adherence. Eighteen patients participated in a 4-week pilot study. Baseline surveys collected data about demographics, historical cell phone usage, and adherence to core diabetes care measures. Exit interview surveys (using close-coded and open-ended questions) were administered to patients at the end of the program. A 1-month follow-up interview was conducted surveying patients on perceived self-efficacy. Wilcoxon signed-rank tests were used to compare baseline survey responses about self-management activities to those at the pilot's end and at 1-month follow-up. Eighteen urban African-American participants completed the pilot study. The average age was 55 and the average number of years with diabetes was 8. Half the participants were initially uncomfortable with text messaging. Example messages include "Did you take your diabetes medications today" and "How many times did you check your feet for wounds this week?" Participants averaged 220 text messages with the system, responded to messages 80% of the time, and on average responded within 6 minutes. Participants strongly agreed that text messaging was easy to perform and helped with diabetes self-care. Missed medication doses decreased from 1.6 per week to 0.6 (p = .003). Patient confidence in diabetes self-management was significantly increased during and 1 month after the pilot (p = .002, p = .008). Text messaging may be a feasible and useful approach to improve diabetes self-management in urban African Americans. © 2011 Diabetes Technology Society.

An eHealth Intervention for Patients in Rural Areas: Preliminary Findings From a Pilot Feasibility Study

PubMed Central

Schrader, Geoffrey; Harris, Melanie; Newman, Lareen; Lynn, Sarah; Peterson, Leigh; Battersby, Malcolm

2014-01-01

Background eHealth facilitation of chronic disease management has potential to increase engagement and effectiveness and extend access to care in rural areas. Objective The objective of this study was to demonstrate the feasibility and acceptability of an eHealth system for the management of chronic conditions in a rural setting. Methods We developed an online management program which incorporated content from the Flinders Chronic Condition Management Program (Flinders Program) and used an existing software platform (goACT), which is accessible by patients and health care workers using either Web-enabled mobile phone or Internet, enabling communication between patients and clinicians. We analyzed the impact of this eHealth system using qualitative and simple quantitative methods. Results The eHealth system was piloted with 8 recently hospitalized patients from rural areas, average age 63 (SD 9) years, each with an average of 5 chronic conditions and high level of psychological distress with an average K10 score of 32.20 (SD 5.81). Study participants interacted with the eHealth system. The average number of logins to the eHealth system by the study participants was 26.4 (SD 23.5) over 29 weeks. The login activity was higher early in the week. Conclusions The pilot demonstrated the feasibility of implementing and delivering a chronic disease management program using a Web-based patient-clinician application. A qualitative analysis revealed burden of illness and low levels of information technology literacy as barriers to patient engagement. PMID:24927511

An eHealth Intervention for Patients in Rural Areas: Preliminary Findings From a Pilot Feasibility Study.

PubMed

Schrader, Geoffrey; Bidargaddi, Niranjan; Harris, Melanie; Newman, Lareen; Lynn, Sarah; Peterson, Leigh; Battersby, Malcolm

2014-06-12

eHealth facilitation of chronic disease management has potential to increase engagement and effectiveness and extend access to care in rural areas. The objective of this study was to demonstrate the feasibility and acceptability of an eHealth system for the management of chronic conditions in a rural setting. We developed an online management program which incorporated content from the Flinders Chronic Condition Management Program (Flinders Program) and used an existing software platform (goACT), which is accessible by patients and health care workers using either Web-enabled mobile phone or Internet, enabling communication between patients and clinicians. We analyzed the impact of this eHealth system using qualitative and simple quantitative methods. The eHealth system was piloted with 8 recently hospitalized patients from rural areas, average age 63 (SD 9) years, each with an average of 5 chronic conditions and high level of psychological distress with an average K10 score of 32.20 (SD 5.81). Study participants interacted with the eHealth system. The average number of logins to the eHealth system by the study participants was 26.4 (SD 23.5) over 29 weeks. The login activity was higher early in the week. The pilot demonstrated the feasibility of implementing and delivering a chronic disease management program using a Web-based patient-clinician application. A qualitative analysis revealed burden of illness and low levels of information technology literacy as barriers to patient engagement.

Recall of Fertility Discussion by Adolescent Female Cancer Patients: A Survey-Based Pilot Study.

PubMed

Zarnegar, Sara; Gosiengfiao, Yasmin; Rademaker, Alfred; Casey, Robert; Albritton, Karen H

2018-04-01

Many adolescent female cancer patients will survive into their reproductive years. Pediatric oncologists are advised to discuss oncofertility during treatment planning. In this pilot study, 19 adolescent females completed a retrospective survey assessing recall of a fertility discussion, satisfaction with fertility knowledge, and multiple factors that may influence recall, including parental involvement in decision-making. Eleven respondents (58%) remembered a discussion about infertility risk and 9 (47%) about fertility preservation. Most who recalled a discussion were satisfied with their fertility knowledge (10/11, 90.9%). In this study, we validated the feasibility of survey administration and identified trends in oncofertility counseling at our center.

[Efficacy of Arnica in varicose vein surgery: results of a randomized, double-blind, placebo-controlled pilot study].

PubMed

Wolf, M; Tamaschke, C; Mayer, W; Heger, M

2003-10-01

In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg

Pilot study of six Colorado dental hygiene independent practices.

PubMed

Astroth, D B; Cross-Poline, G N

1998-01-01

The purpose of this pilot study was to gather demographic data about six Colorado dental hygienists who were practicing independently and their practices as well as assess productivity and service mix, evaluate structure and process, and compare the findings in these practices to those of a study of California Health Manpower Pilot Project #139. A convenience sample of six dental hygiene independent practices was studied. A 21-item survey was distributed by mail to obtain demographic and practice information. Weekly surveys tracking patient visits and services provided were completed for three months. A general office audit to evaluate structure and a record audit of 22 patient records to evaluate process were conducted during visits at each practice site. The overall responses for each phase of this study were tabulated and frequencies were calculated using the SPSS/PC+ statistical package. The dental hygienists had practiced for an average of 13 years prior to establishing their practices. Four of the six practices were office-based, one was institution-based, and one was office- and institution-based. Health history, extraoral/intraoral examination, periodontal probing, adult prophylaxis, and oral hygiene instruction were provided during a majority of patient visits. The general office audit revealed compliance with infection control, office protocols for emergency situations, and practice management protocols. The patient record audit indicated a high standard for process of care for the practice sites. The six practices revealed a variety of backgrounds among the dental hygienists and diverse practice characteristics regarding both the populations served and practice settings. The services provided were consistent with allowable services for unsupervised practice. Compliance with specific guidelines was verified during the general office and patient record audits. Consistent with the findings of California Health Manpower Pilot Project #139, the care provided by the Colorado dental hygiene independent practitioners in this study and the environment in which the care was provided do not exhibit any undue risk to the health and safety of the public.

Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

PubMed Central

Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

2007-01-01

Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients

PubMed Central

Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

2016-01-01

Introduction Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. Methods and analysis 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0–4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1–2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Ethics and dissemination Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. Trial registration number NCT02377830; Pre-results. PMID:27059469

TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

PubMed

Kwek, Boon Eu Andrew; Ang, Tiing Leong; Ong, Peng Lan Jeannie; Tan, Yi Lyn Jessica; Ang, Shih Wen Daphne; Law, Ngai Moh; Thurairajah, Prem Harichander; Fock, Kwong Ming

2017-06-01

Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata. This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding. Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

An Investigation of Possible Correlations Between Individual Pilot Performance and Neurological Functions.

DTIC Science & Technology

1977-05-23

ed these findings with tests on peptic ulcer patients.1’ In 1949, Sau l , using a psychoanalytic approach in searching for correlates of personality...this area : PILOT PERFOR MANCE ANA L YSIS 1) With respect to the system developed and used for this study, research should be conducted to determine

Exceptional Responders Initial Feasibility Results

Cancer.gov

A pilot study evaluating identification of cancer patients who respond to treatment that is ineffective in at least 90 percent of patients found that it was indeed able to confirm a majority of proposed patients as exceptional responders based on clinical

Effects of Medication and Subthalamic Nucleus Deep Brain Stimulation on Tongue Movements in Speakers with Parkinson's Disease Using Electropalatography: A Pilot Study

ERIC Educational Resources Information Center

Hartinger, Mariam; Tripoliti, Elina; Hardcastle, William J.; Limousin, Patricia

2011-01-01

Parkinson's disease (PD) affects speech in the majority of patients. Subthalamic nucleus deep brain stimulation (STN-DBS) is particularly effective in reducing tremor and rigidity. However, its effect on speech is variable. The aim of this pilot study was to quantify the effects of bilateral STN-DBS and medication on articulation, using…

No-patch 23-gauge vitrectomy under topical anesthesia: A pilot study

PubMed Central

Deka, Satyen; Bhattacharjee, Harsha; Barman, M J; Kalita, Kruto; Singh, Sunil Kumar

2011-01-01

A pilot study was designed to evaluate the safety and efficacy of 23-gauge vitrectomy under topical anesthesia. Five eyes of five patients underwent 23-gauge sutureless vitrectomy under topical anesthesia with a pledget soaked in 0.5% proparacaine hydrochloride anesthetic, for vitreous hemorrhage (four eyes), epiretinal membrane (one eye). Subjective pain and discomfort were graded using a visual analogue chart from 0 (no pain or discomfort) to 4 (severe pain and discomfort). At the end of surgery no patch was applied and patients were given dark glasses. Patients underwent an immediate postoperative assessment, followed by next day and one week postoperative evaluation. Four patients had Grade 0 pain during the surgery. One patient had Grade 1 pain during the placement and withdrawal of the micro cannulas. The surgical outcomes were favorable. 23-gauge vitrectomy under topical anesthesia is safe and effective in selected cases. Further study is recommended to validate the outcome of this study. PMID:21350284

Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

PubMed

Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi

2015-06-01

This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (<1-min) on strategies for self-management of three domains: medical (adherence, symptoms, co-infections), mental health (social support, stress, positive cognitions), and nutrition and hygiene (per PLH preferences). Three ART appointment reminders are also sent each month. One-month pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms

PubMed Central

2012-01-01

Background Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. Methods The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient’s End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Results Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Conclusions Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. Trial registration The study was registered with clinicaltrials.gov (NCT01046136). PMID:23270519

[Rational Rehabilitation in the treatment of post-traumatic stress disorder (PTSD). A pilot study].

PubMed

Tomasoa, A T; Appelo, M T

2007-01-01

In a randomised controlled study, a type of cognitive behavior therapy known as Rational Rehabilitation proved effective in the treatment of patients with chronic mental symptoms. Post-traumatic stress disorder is a serious illness that occurs frequently and can last for many years. Rational Rehabilitation may also be an effective treatment for post-traumatic stress disorder. To investigate, via a pilot study, on the effect of Rational Rehabilitation in patients with post-traumatic stress disorder, whether a randomised controlled study is called for. Nineteen patients with post-traumatic stress disorder, who were awaiting regular treatment, opted to join the study. The effect of Rational Rehabilitation was studied in relation to: symptoms of post-traumatic stress disorder, degree of happiness experienced, autonomy, social support and need for further treatment. results Rational Rehabilitation seems to have a positive effect on all outcome measures, except flashbacks. A controlled study of the effect of Rational Rehabilitation in patients with post-traumatic stress disorder seems justified.

Effects of indoor gardening on sleep, agitation, and cognition in dementia patients--a pilot study.

PubMed

Lee, Y; Kim, S

2008-05-01

A pilot study was performed to examine the efficacy of indoor gardening on sleep, agitation and cognition of dementia patients. Twenty-three institutionalized dementia patients who had sleep disturbance and/or agitation participated in a 5-week study protocol of 1 week of baseline and 4 weeks of treatment. The study design was a one group repeated measures study. For the first and fifth week of the study period, sleep patterns, agitation, and cognition were evaluated using a sleep diary, Modified Cohen-Mansfield Agitation Inventory and revised Hasegawa Dementia Scale respectively. Significant improvement in wake after sleep onset, nap, nocturnal sleep time, and nocturnal sleep efficiency was identified. On the contrary sleep onset time, wake-up time, total sleep time did not change after indoor gardening. Agitation and cognition score was significantly improved. Indoor gardening was found to be effective for sleep, agitation, and cognition of dementia patients. Randomized controlled studies of larger sample size are needed to confirm treatment effect.

Biomechanical analysis of posture in patients with spinal kyphosis due to ankylosing spondylitis: a pilot study.

PubMed

Bot, S D; Caspers, M; Van Royen, B J; Toussaint, H M; Kingma, I

1999-05-01

Patients with ankylosing spondylitis may experience a progressive spinal kyphosis, which induces a forward and downward displacement of the centre of mass (COM) of the trunk. In this pilot study, the possible mechanisms used to compensate for the displacement of the trunk COM were analysed. Joint angles of hip, knee and ankle were determined in four patients with ankylosing spondylitis and compared to data of 18 healthy subjects. Each patient stood on a force platform and had to adopt several predefined postures, which were recorded by a video camera. In three patients, the hips were flexed when standing relaxed, and in all patients hip extension was limited. The knee angles of three patients were smaller and in two patients the angle of the ankles was larger compared to healthy subjects. The results suggest that the hip joints are at least no longer involved in balance control. This may imply that conservative therapy should focus on the prevention of restriction of the hip joints.

Doxorubicin and ifosfamide combination chemotherapy in previously treated acute leukemia in adults: a Southwest Oncology Group pilot study.

PubMed

Ryan, D H; Bickers, J N; Vial, R H; Hussein, K; Bottomley, R; Hewlett, J S; Wilson, H E; Stuckey, W J

1980-01-01

The Southwest Oncology Group did a limited institutional pilot study of the combination of doxorubicin and ifosfamide in the treatment of previously treated adult patients with acute leukemia. Thirty-four patients received one or two courses of the combination. All patients had received prior chemotherapy and 32 had received prior anthracycline chemotherapy. Three patients died before their responses could be fully evaluated. Fourteen patients achieved complete remission (41%) and one patient achieved partial remission. The complete remission rate was 27% for patients with acute myeloblastic leukemia (myelomonoblastic leukemia, monoblastic leukemia, and erythroleukemia) and 89% for patients with acute lymphocytic and undifferentiated leukemia (ALL). Toxic effects included severe hematologic reactions in 33 of 34 patients, hematuria in six patients, altered sensorium in one patient, and congestive heart failure in one patient. The safety of the combination was established and toxic side effects of this therapy were tolerable. The 89% complete remission rate for previously treated patients with ALL suggests that the combination of doxorubicin and ifosfamide may be particularly effective in ALL.

The Efficacy of Functional Electrical Stimulation of the Abdominal Muscles in the Treatment of Chronic Constipation in Patients with Multiple Sclerosis: A Pilot Study

PubMed Central

Peace, Carla

2016-01-01

Chronic constipation in patients with multiple sclerosis (MS) is common and the current methods of treatment are ineffective in some patients. Anecdotal observations suggest that functional electrical stimulation (FES) of the abdominal muscles may be effective in the management of constipation in these patients. Patients and Methods. In this exploratory investigation we studied the effects of FES on the whole gut transit time (WGTT) and the colonic transit time (CTT). In addition, we evaluated the treatment effect on the patients' constipation-related quality of life and on the use of laxatives and the use of manual bowel evacuation. FES was given for 30 minutes twice a day for a period of six weeks. Four female patients were studied. Results. The WGTT and CTT and constipation-related quality of life improved in all patients. The patients' use of laxatives was reduced. No adverse effects of FES treatment were reported. Conclusion. The findings of this pilot study suggest that FES applied to the abdominal muscles may be an effective treatment modality for severe chronic constipation in patients with MS. PMID:27200190

Comparison of mania patients suitable for treatment trials versus clinical treatment

PubMed Central

Talamo, Alessandra; Baldessarini, Ross J.; Centorrino, Franca

2008-01-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential “research subjects” met all 10 exclusion criteria. The remaining 52 “clinical patients” differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between “research subjects” and “clinical patients.” PMID:18484680

Evaluation of peripheral binocular visual field in patients with glaucoma: a pilot study

PubMed Central

Ana, Banc; Cristina, Stan; Dorin, Chiselita

2016-01-01

Objective: The objective of this study was to evaluate the peripheral binocular visual field (PBVF) in patients with glaucoma using the threshold strategy of Humphrey Field Analyzer. Methods: We conducted a case-control pilot study in which we enrolled 59 patients with glaucoma and 20 controls. All participants were evaluated using a custom PBVF test and central 24° monocular visual field tests for each eye using the threshold strategy. The central binocular visual field (CBVF) was predicted from the monocular tests using the most sensitive point at each field location. The glaucoma patients were grouped according to Hodapp classification and age. The PBVF was compared to controls and the relationship between the PBVF and CBVF was tested. Results: The areas of frame-induced artefacts were determined (over 50° in each temporal field, 24° superiorly and 45° inferiorly) and excluded from interpretation. The patients presented a statistically significant generalized decrease of the peripheral retinal sensitivity compared to controls for Hodapp initial stage - groups aged 50-59 (t = 11.93 > 2.06; p < 0.05) and 60-69 (t = 7.55 > 2.06; p < 0.05). For the initial Hodapp stage there was no significant relationship between PBVF and CBVF (r = 0.39). For the moderate and advanced Hodapp stages, the interpretation of data was done separately for each patient. Conclusions: This pilot study suggests that glaucoma patients present a decrease of PBVF compared to controls and CBVF cannot predict the PBVF in glaucoma. Abbreviations: CBVF = central binocular visual field, PBVF = peripheral binocular visual field, MD = mean deviation PMID:27220228

Implementation and evaluation of early gastroscopy for patients with dyspepsia and warning signs in Primary Care.

PubMed

García-Alonso, Francisco Javier; Hernández Tejero, María; Rubio Benito, Elvira; Valer, Paz; Guerra, Iván; García Ceballos, Victoria Gema; Noguerol, Mar; Llinares, Victoria; Bermejo, Fernando

2017-05-01

Dyspepsia is a common disorder in both Primary (PC) and Specialised Care (SC). Gastroscopy is recommended at the start of the study if there are warning signs, although it is not always available in PC. We developed a pilot project establishing an early gastroscopy programme for patients with dyspepsia and warning signs in PC, subsequently extending it to the entire healthcare area. The aim was to evaluate the requirements, impact and opinion of this service at the PC level. Demographic, symptomatic and endoscopic variables on the patients referred to SC from the pilot centre were recorded. A satisfaction survey was conducted among the PC physicians. The one-year pilot study and the first year of implementation of the programme were evaluated. A total of 355 patients were included (median age 56.4 years; IQR 45.5-64.3); 61.2% (56.1-66.3%) were women. The waiting time for examination was 1.5 weeks (IQR 1.5-2.5). Gastroscopy was correctly indicated in 82.7% (78.4-86.3%) of patients. The median number of requests per month was 1.1 per 10,000 adults (range 0.8-1.6). Monthly referrals to SC clinics from the pilot centre fell by 11 subjects (95% CI 5.9-16) with respect to the previous median of 58 (IQR 48-64.5). Almost all those polled (98.4%) considered the programme useful in routine practice. The availability of an early gastroscopy programme in PC for patients with dyspepsia and warning signs reduced the number of referrals to SC. Copyright © 2016 Elsevier España, S.L.U., AEEH y AEG. All rights reserved.

Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

PubMed Central

Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

2013-01-01

Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

Autonomic Evaluation of Patients With Gastroparesis and Neurostimulation: Comparisons of Direct/Systemic and Indirect/Cardiac Measures

PubMed Central

Stocker, Abigail; Abell, Thomas L.; Rashed, Hani; Kedar, Archana; Boatright, Ben; Chen, Jiande

2016-01-01

Background Disorders of nausea, vomiting, abdominal pain, and related problems often are manifestations of gastrointestinal, neuromuscular, and/or autonomic dysfunction. Many of these patients respond to neurostimulation, either gastric electrical stimulation or electroacupuncture. Both of these therapeutic techniques appear to influence the autonomic nervous system which can be evaluated directly by traditional testing and indirectly by heart rate variability. Methods We studied patients undergoing gastric neuromodulation by both systemic autonomic testing (39 patients, six males and 33 females, mean age 38 years) and systemic autonomic testing and heart rate variability (35 patients, seven males and 28 females, mean age 37 years) testing before and after gastric neuromodulation. We also performed a pilot study using both systemic autonomic testing and heart rate variability in a small number of patients (five patients, all females, mean age 48.6 years) with diabetic gastroparesis at baseline to compare the two techniques at baseline. Systemic autonomic testing and heart rate variability were performed with standardized techniques and gastric electrical stimulation was performed as previously described with electrodes implanted serosally in the myenteric plexus. Results Both systemic autonomic testing and heart rate variability measures were often abnormal at baseline and showed changes after gastric neuromodulation therapy in two groups of symptomatic patients. Pilot data on a small group of similar patients with systemic automatic nervous measures and heart rate variability showed good concordance between the two techniques. Conclusions Both traditional direct autonomic measures and indirect measures such as heart rate variability were evaluated, including a pilot study of both methods in the same patient group. Both appear to be useful in evaluation of patients at baseline and after stimulation therapies; however, a future full head-to-head comparison is warranted. PMID:27785318

A pilot study of inhaled methoxyflurane for procedural analgesia in children.

PubMed

Babl, Franz; Barnett, Peter; Palmer, Greta; Oakley, Ed; Davidson, Andrew

2007-02-01

Methoxyflurane (MF), a potent volatile anesthetic, can be used as an analgesic in subanesthetic concentrations. In Australia, MF is extensively used in children and adults as an analgesic in the prehospital setting via a hand-held inhaler device. We conducted a pilot study to explore its use as a patient controlled analgesic for painful procedures in children in the emergency department (ED). This is a prospective observational case series of children aged 5 years and older requiring procedural analgesia for brief painful procedures. Pain scores, depth of sedation, adverse events and patient, parent and staff satisfaction were assessed as well as consumption of MF measured. Fourteen patients (aged 6-13 years) received MF mainly for extremity injuries. Amount of MF consumed ranged from 0.36 to 3.06 g per patient inhaled over 4-25 min. There were no serious adverse events. No patient was deeply sedated. Five patients had mild brief self-resolving adverse events including agitation, euphoria, blurry vision, dizziness and cough. Four patients with fractures with initial high pain scores (> or =6) received MF for bridging analgesia with large drops in pain scores. Four patients who required fracture reductions with initial low scores did not achieve adequate analgesia. The remaining six patients had painful procedures undertaken with satisfactory analgesia. On the basis of this small pilot study of MF use in children in the ED, this agent appears to be a powerful analgesic. MF seems most useful as a self-titrated bridging analgesic agent in patients after extremity trauma. It appears less useful as a procedural agent when patients are unable to anticipate and achieve a sufficient level of analgesia before painful stimulus infliction. Pre- and intraprocedure coaching is an important aspect of its use especially if initial pain scores are low.

A pilot study of implantable cardiac device interrogation by emergency department personnel.

PubMed

Neuenschwander, James F; Hiestand, Brian C; Peacock, W Frank; Billings, John M; Sondrup, Cole; Hummel, John D; Abraham, William T

2014-03-01

Implanted devices (eg, pacemakers and defibrillators) provide valuable information and may be interrogated to obtain diagnostic information and to direct management. During admission to an emergency department (ED), significant time and cost are spent waiting for device manufacturer representatives or cardiologists to access the data. If ED personnel could safely interrogate implanted devices, more rapid disposition could occur, thus leading to potentially better outcomes at a reduced cost. This was a pilot study examining the feasibility of ED device interrogation. This was a prospective convenience sample study of patients presenting to the ED with any chief complaint and who had an implantable device capable of being interrogated by a Medtronic reader. After obtaining informed consent, study patients underwent device interrogation by ED research personnel. After reviewing the device data, the physician documented their opinions of the value of data in aiding care. Patients were followed up at intervals ranging from 30 days out to 1 year to determine adverse events relating to interrogation. Forty-four patients underwent device interrogation. Their mean age was 56 ± 14.7 years (range, 28-83), 75% (33/44) were male and 75% (33/44) were hospitalized from the ED. The interrogations took less than 10 minutes 89% of the time. In 60% of the cases, ED physicians reported the data-assisted patient care. No adverse events were reported relating to the ED interrogations. In this pilot study, we found that ED personnel can safely and quickly interrogate implantable devices to obtain potentially useful clinical data.

The patient assessment questionnaire: a new instrument for evaluating the interpersonal skills of vocational dental practitioners.

PubMed

Hurst, Y K; Prescott-Clements, L E; Rennie, J S

2004-10-23

This paper describes a pilot study aimed at evaluating a new instrument, the patient assessment questionnaire (PAQ), which uses patient ratings for the assessment of communication skills and professionalism in vocational practitioners (VDPs). The PAQ was developed as part of an assessment system designed to address all round competence. Acohort of 99 VDPs took part in the study. Questionnaires were distributed to consecutive patients in the general dental service at two time points in the training year. Data from the pilot study was analysed to determine whether the PAQ fulfilled the criteria for robust assessment. Results provide evidence of high levels of reliability, validity and feasibility of the PAQ instrument. All indications to date suggest that the PAQ will prove to be a valuable assessment tool. It is currently being evaluated as part of the system used to assess the all round competence of dental graduates undertaking vocational training in Scotland.

Comparing hospital staff and patient perceptions of customer service: a pilot study utilizing survey and focus group data.

PubMed

Fottler, Myron D; Dickson, Duncan; Ford, Robert C; Bradley, Kenneth; Johnson, Lee

2006-02-01

The measurement of patient satisfaction is crucial to enhancing customer service and competitive advantage in the health-care industry. While there are numerous approaches to such measurement, this paper provides a case study which compares and contrasts patient and staff perceptions of customer service using both survey and focus group data. Results indicate that there is a high degree of correlation between staff and patient perceptions of customer service based on both survey and focus group data. However, the staff and patient subgroups also provided complementary information regarding patient perceptions of their service experience. Staff members tended to have more negative perceptions of service attributes than did the patients themselves. The focus group results provide complementary information to survey results in terms of greater detail and more managerially relevant information. While these results are derived from a pilot study, they suggest that diversification of data sources beyond patient surveys may enhance the utility of customer service information. If further research can affirm these findings, they create exciting possibilities for gathering valid, reliable and cost-effective customer service information.

A multi-method pilot evaluation of an online diabetes exercise system.

PubMed

Schaarup, Clara; Hejlesen, Ole K

2015-01-01

The American Diabetes Association and The European Association of The Study of Diabetes recommend people with Type 2 diabetes to do moderate to vigorous aerobic exercise for 150 min per week to avoid late diabetic complications. However, most people with diabetes do not follow the recommendation. Consumer health information technology (CHIT) might play a role in supporting behavior changes that promote health and well-being. A CHIT prototype of an online diabetes exercise system, which contained the newest research of low volume high-intensity interval training (HIT), was developed. To test the system we used a multi-method pilot evaluation that includes; interviews, paper prototyping, heuristic evaluation, and test with patients. The patients expressed satisfaction with HIT and appreciated that the system was web-based. The findings from this pilot study inspire to further development and evaluation of online CHIT systems to diabetics.

Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.

PubMed

Keays, Melise A; Starke, Nathan; Lee, Simon C; Bernstein, Ira; Snodgrass, Warren T; Bush, Nicol C

2016-04-01

Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical practice. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors.

PubMed

Elkins, Gary; Marcus, Joel; Stearns, Vered; Hasan Rajab, M

2007-05-01

This single arm, pilot study investigated the use of hypnosis to reduce hot flashes in 16 breast cancer survivors. Each patient provided baseline data and received 4 weekly sessions of hypnosis that followed a standardized transcript. Patients were also instructed in self-hypnosis. Throughout the clinical care, patients completed daily diaries of the frequency and severity of their hot flashes. Patients also completed baseline and post-treatment ratings of the degree to which hot flashes interfered with daily activities and quality of life. Results indicated a 59% decrease in total daily hot flashes and a 70% decrease in weekly hot flash scores from their baselines. There was also a significant decrease in the degree to which hot flashes interfered with daily activities for all measures including work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life, and overall quality of life. This pilot study suggests that clinical hypnosis may be an effective non-hormonal and non-pharmacological treatment for hot flashes. A randomized, controlled clinical trial is planned to more definitively elucidate the efficacy and applicability of hypnosis for reducing hot flashes.

Complementary therapies in long-stay neurology in-patient settings.

PubMed

Walsh, E; Wilson, C

Complementary therapies have been embraced by many nurses, but the effectiveness of such regimes on the wellbeing of patients has never been researched successfully. This article describes a pilot study which evaluated their effects on long-stay neurology patients.

A pilot study of gene expression analysis in workers with hand-arm vibration syndrome.

PubMed

Maeda, Setsuo; Yu, Xiaozhong; Wang, Rui-Sheng; Sakakibara, Hisataka

2008-04-01

The purpose of this pilot study was to examine differences in gene expressions by cDNA microarray analysis of hand-arm vibration syndrome (HAVS) patients. Vein blood samples were collected and total RNA was extracted. All blood samples were obtained in the morning in one visit after a standard light breakfast. We performed microarray analysis with the labeled cDNA prepared by reverse transcription from RNA samples, using the Human CHIP version 1 (DNA Chip Research Inc, Yokohama, Japan). There are 2,976 genes on the chip, and these genes were selected from a cDNA library prepared with human peripheral white blood cells (WBC). Different gene levels between the HAVS patients and controls, and between groups of HAVS with different levels of symptoms, were indicated by the randomized variance model. The most up-regulated genes were analyzed for their possible functions and association with the occurrence of HAVS. From the results of this pilot study, although the results were obtained a limited number of subjects, it would appear that cDNA microarray analysis of HAVS patients has potential as a new objective method of HAVS diagnosis. Further research is needed to examine the gene expression with increased numbers of patients at different stages of HAVS.

How to differentiate congenital from noncongenital chronic neutropenia at the first medical examination? Proposal of score: A pilot study from the French Severe Chronic Neutropenia registry.

PubMed

Bejjani, Naim; Beaupain, Blandine; Bertrand, Yves; Bellanne-Chantelot, Christine; Donadieu, Jean

2017-12-01

We developed a diagnostic score to differentiate congenital from noncongenital neutropenia at the time of diagnosis using reliable data collected at the first visit of a patients with neutropenia. In a pilot retrospective study, we included 120 patients diagnosed with chronic neutropenia; 61 had congenital and 59 had noncongenital neutropenia. We reviewed patient medical charts and collected the initial complete blood count (CBC) and other reliable data. We used logistic regression to determine the probability that the neutropenia was congenital. On the initial CBC, the degree of neutropenia had no predictive value; only monocytosis >1.5 × 10 9 /l, hemoglobin <90 g/l, or mild thrombocytopenia <150 × 10 9 /l suggested congenital neutropenia. The most predictive factors for congenital neutropenia were a medical history (consanguinity and patient history of neutropenia), severe infections, and oral stomatitis or gingivitis at the time of diagnosis. The age at diagnosis had limited predictive value. A diagnosis of congenital neutropenia may be reliably suspected based only on information from the CBC, some basic information from patient and parent interviews, and a clinical examination. A pilot score with six factors that could be readily, reliably collected, should facilitate the diagnosis of congenital neutropenia. © 2017 Wiley Periodicals, Inc.

A linguistic study of patient-centered interviewing: emergent interactional effects.

PubMed

Hesson, Ashley M; Sarinopoulos, Issidoros; Frankel, Richard M; Smith, Robert C

2012-09-01

To evaluate interactional effects of patient-centered interviewing (PCI) compared to isolated clinician-centered interviewing (CCI). We conducted a pilot study comparing PCI (N=4) to CCI (N=4) for simulated new-patient visits. We rated interviews independently and measured patient satisfaction with the interaction via a validated questionnaire. We conducted interactional sociolinguistic analysis on the interviews and compared across three levels of analysis: turn, topic, and interaction. We found significant differences between PCI and CCI in physician responses to patients' psychosocial cues and concerns. The number and type of physician questions also differed significantly across PCI and CCI sets. Qualitatively, we noted several indicators of physician-patient attunement in the PCI interviews that were not present in the CCI interviews. They spanned diverse aspects of physician and patient speech, suggesting interactional accommodation on the part of both participants. This small pilot study highlights a variety of interactional variables that may underlie the effects associated with patient-centered interviewing (e.g., positive relationships, health outcomes). Question form, phonological accommodation processes, and use of stylistic markers are relatively unexplored in controlled studies of physician-patient interaction. This study characterizes several interactional variables for larger scale studies and contributes to models of patient-centeredness in practice. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The efficacy of Euphorbia prostrata in early grades of symptomatic hemorrhoids--a pilot study.

PubMed

Gupta, P J

2011-02-01

The medical treatment for hemorrhoids has undergone significant changes on introduction of new pharmaceutical agents in the last decade. Euphorbia Prostrata is a new molecule used for grade I and II hemorrhoids. Beneficial effects of the Euphorbia prostrata in hemorrhoids have multiple mechanisms that are due to its active constituents flavonoids, tannins and phenolic acid. This pilot study was performed to assess the effectiveness of this molecule in early grades of symptomatic hemorrhoids. In the present retrospective study, the effect of Euphorbia prostrata on patients with hemorrhoids was observed over a follow up period of 12 weeks. In all, 120 patients were studied. This included 63 males and 57 females. Patients with grade 1 and 2 were prescribed with one tablet of Euphorbia prostrata (Tab Sitcom, Panacea Biotec, India) to be consumed on empty stomach every morning for two weeks. Follow-up was carried out at 2, 4 and 12 weeks after commencement of treatment. The primary end point of the study was control of bleeding and secondary end points were regression of hemorrhoid mass, pruritus and discomfort in the anus. Ninty-nine patients (82%) had complete cessation of bleeding at the end of two weeks. Six patients needed another 2 week's treatment to achieve complete relief, amounting to a success rate of 87%. Anal itch was relieved in 73% of patients, while anal discomfort subsided in 90% of patients. None of the patient had reported any adversity with consumption of the drug. At the follow-up after 3 months of treatment, no patient reported with symptomatic recurrence. However, 37 of the 79 patients (46%) still had residual hemorrhoids on anoscopic examination. This pilot study shows that Euphorbia prostrata can be used as an effective and well-tolerated pharmaceutical agent in the treatment of early grades of hemorrhoids. Long-term follow-up and randomized control trials by comparing with other established formulations is necessary to justify reliance on this medication.

[Emotion Recognition in Patients with Peripheral Facial Paralysis - A Pilot Study].

PubMed

Konnerth, V; Mohr, G; von Piekartz, H

2016-02-01

The perception of emotions is an important component in enabling human beings to social interaction in everyday life. Thus, the ability to recognize the emotions of the other one's mime is a key prerequisite for this. The following study aimed at evaluating the ability of subjects with 'peripheral facial paresis' to perceive emotions in healthy individuals. A pilot study was conducted in which 13 people with 'peripheral facial paresis' participated. This assessment included the 'Facially Expressed Emotion Labeling-Test' (FEEL-Test), the 'Facial-Laterality-Recognition Test' (FLR-Test) and the 'Toronto-Alexithymie-Scale 26' (TAS 26). The results were compared with data of healthy people from other studies. In contrast to healthy patients, the subjects with 'facial paresis' show more difficulties in recognizing basic emotions; however the results are not significant. The participants show a significant lower level of speed (right/left: p<0.001) concerning the perception of facial laterality compared to healthy people. With regard to the alexithymia, the tested group reveals significantly higher results (p<0.001) compared to the unimpaired people. The present pilot study does not prove any impact on this specific patient group's ability to recognize emotions and facial laterality. For future studies the research question should be verified in a larger sample size. © Georg Thieme Verlag KG Stuttgart · New York.

Naturalistic Driving Study Investigating Self-Regulation Behavior in Early Alzheimer's Disease: A Pilot Study.

PubMed

Paire-Ficout, Laurence; Lafont, Sylviane; Conte, Fanny; Coquillat, Amandine; Fabrigoule, Colette; Ankri, Joël; Blanc, Frédéric; Gabel, Cécilia; Novella, Jean-Luc; Morrone, Isabella; Mahmoudi, Rachid

2018-05-16

Because cognitive processes decline in the earliest stages of Alzheimer's disease (AD), the driving abilities are often affected. The naturalistic driving approach is relevant to study the driving habits and behaviors in normal or critical situations in a familiar environment of participants. This pilot study analyzed in-car video recordings of naturalistic driving in patients with early-stage AD and in healthy controls, with a special focus on tactical self-regulation behavior. Twenty patients with early-stage AD (Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria), and 21 healthy older adults were included in the study. Data collection equipment was installed in their personal vehicles. Two expert psychologists assessed driving performance using a specially designed Naturalistic Driving Assessment Scale (NaDAS), paying particular attention to tactical self-regulation behavior, and they recorded all critical safety events. Poorer driving performance was observed among AD drivers: their tactical self-regulation behavior was of lower quality. AD patients had also twice as many critical events as healthy drivers and three times more "unaware" critical events. This pilot study using a naturalistic approach to accurately show that AD drivers have poorer tactical self-regulation behavior than healthy older drivers. Future deployment of assistance systems in vehicles should specifically target tactical self-regulation components.

How to Train an Injured Brain? A Pilot Feasibility Study of Home-Based Computerized Cognitive Training.

PubMed

Verhelst, Helena; Vander Linden, Catharine; Vingerhoets, Guy; Caeyenberghs, Karen

2017-02-01

Computerized cognitive training programs have previously shown to be effective in improving cognitive abilities in patients suffering from traumatic brain injury (TBI). These studies often focused on a single cognitive function or required expensive hardware, making it difficult to be used in a home-based environment. This pilot feasibility study aimed to evaluate the feasibility of a newly developed, home-based, computerized cognitive training program for adolescents who suffered from TBI. Additionally, feasibility of study design, procedures, and measurements were examined. Case series, longitudinal, pilot, feasibility intervention study with one baseline and two follow-up assessments. Nine feasibility outcome measures and criteria for success were defined, including accessibility, training motivation/user experience, technical smoothness, training compliance, participation willingness, participation rates, loss to follow-up, assessment timescale, and assessment procedures. Five adolescent patients (four boys, mean age = 16 years 7 months, standard deviation = 9 months) with moderate to severe TBI in the chronic stage were recruited and received 8 weeks of cognitive training with BrainGames. Effect sizes (Cohen's d) were calculated to determine possible training-related effects. The new cognitive training intervention, BrainGames, and study design and procedures proved to be feasible; all nine feasibility outcome criteria were met during this pilot feasibility study. Estimates of effect sizes showed small to very large effects on cognitive measures and questionnaires, which were retained after 6 months. Our pilot study shows that a longitudinal intervention study comprising our novel, computerized cognitive training program and two follow-up assessments is feasible in adolescents suffering from TBI in the chronic stage. Future studies with larger sample sizes will evaluate training-related effects on cognitive functions and underlying brain structures.

Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study.

PubMed

Vanderpol, Jitka; Bishop, Barbara; Matharu, Manjit; Glencorse, Mark

2015-01-26

Cryotherapy is the most common non-pharmacological pain-relieving method. The aim of this pilot study was to ascertain whether intranasal evaporative cooling may be an effective intervention in an acute migraine attack. Studies have previously demonstrated effectiveness of a variety of cryotherapy approaches. Intranasal evaporative cooling due to vascular anatomy, allows the transfer of venous blood from nasal and paranasal mucous membranes to the dura mater, thereby providing an excellent anatomical basis for the cooling processes. We conducted a prospective, open-label, observational, pilot study. Twenty-eight patients who satisfied the International Classification of Headache Disorders (ICHD 2) diagnostic criteria for migraine were recruited. A total of 20 treatments were administered in 15 patients. All patients provided pain severity scores and migraine-associated symptoms severity scores (based on a 0-10 visual analogue scale, [VAS]). Out of the 20 treatments, intranasal evaporative cooling rendered patients' pain and symptoms free immediately after treatment, in 8 of the treatments (40%), a further 10 treatments (50%) resulted in partial pain relief (headache reduced from severe or moderate to mild) and partial symptoms relief. At 2 hours, 9 treatments (45%) provided full pain and symptoms relief, with a further 9 treatments (45%) resulting in partial pain and symptoms relief. At 24 hours, 10 treatments (50%) resulted in patients reporting pain and symptom freedom and 3 (15%) provided partial pain relief. In summary 13 patients (87%) had benefit from the treatment within 2 hours that was sustained at 24 hours. Intranasal evaporative cooling gave considerable benefit to patients with migraine, improving headache severity and migraine-associated symptoms. A further randomised, placebo controlled, double blinded, parallel clinical trial is required to further investigate the potential of this application. Clinicaltrials.gov registered trial, ClinicalTrials.gov Identifier: NCT01898455.

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study

PubMed Central

Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

2016-01-01

True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus. PMID:26960786

Closing the circle of care: implementation of a web-based communication tool to improve emergency department discharge communication with family physicians.

PubMed

Hunchak, Cheryl; Tannenbaum, David; Roberts, Michael; Shah, Thrushar; Tisma, Predrag; Ovens, Howard; Borgundvaag, Bjug

2015-03-01

Postdischarge emergency department (ED) communication with family physicians is often suboptimal and negatively impacts patient care. We designed and piloted an online notification system that electronically alerts family physicians of patient ED visits and provides access to visitspecific laboratory and diagnostic information. Nine (of 10 invited) high-referring family physicians participated in this single ED pilot. A prepilot chart audit (30 patients from each family physician) determined the baseline rate of paper-based record transmission. A webbased communication portal was designed and piloted by the nine family physicians over 1 year. Participants provided usability feedback via focus groups and written surveys. Review of 270 patient charts in the prepilot phase revealed a 13% baseline rate of handwritten chart and a 44% rate of any information transfer between the ED and family physician offices following discharge. During the pilot, participant family physicians accrued 880 patient visits. Seven and two family physicians accessed online records for 74% and 12% of visits, respectively, an overall 60.7% of visits, corresponding to an overall absolute increase in receipt of patient ED visit information of 17%. The postpilot survey found that 100% of family physicians reported that they were ''often'' or ''always'' aware of patient ED visits, used the portal ''always'' or ''regularly'' to access patients' health records online, and felt that the web portal contributed to improved actual and perceived continuity of patient care. Introduction of a web-based ED visit communication tool improved ED-family physician communication. The impact of this system on improved continuity of care, timeliness of follow-up, and reduced duplication of investigations and referrals requires additional study.

Neurocognitive training in patients with high-grade glioma: a pilot study.

PubMed

Hassler, Marco Ronald; Elandt, Katarzyna; Preusser, Matthias; Lehrner, Johann; Binder, Petra; Dieckmann, Karin; Rottenfusser, Andrea; Marosi, Christine

2010-03-01

Although their neurocognitive performance is one of the major concerns of patients with high-grade gliomas (HGG) and although neurocognitive deficits have been described to be associated with negative outcome, neurocognitive rehabilitation is usually not integrated into the routine care of patients with malignant gliomas. In this pilot trial, a weekly group training session for attention, verbal, and memory skills was offered to patients with HGG with pre and post-training evaluation. Eleven patients, six with glioblastoma multiforme and five with WHO grade III gliomas, median age 50 years, with a Karnofsky performance score of 80-100 participated in ten group training sessions of 90 min. For evaluation at baseline and after the training by a neuropsychologist not involved in care or training of the patients, Trail Making Tests A and B (TMTA and TMTB), Hopkins Verbal Learning Test (HVLT), and the Controlled Oral Word Association Test (COWA) were used. Comparison of mean group differences between baseline and at post-training evaluation after 12 weeks revealed improvement across all neurocognitive variables. The patients showed a great diversity in their performances, with worsening, improvement, and stabilization. However, a significant group difference was detected only for the HVLT (score 19.6 +/- 8.9 at baseline, 23.6 +/- 8.8 after 12 weeks, P = 0.04). This pilot study shows that neurocognitive training in patients with HGG is feasible as group training with weekly sessions and might be able to induce improvements in attention and memory skills.

The Effect of Repetitive Rhythmic Precision Grip Task-Oriented Rehabilitation in Chronic Stroke Patients: A Pilot Study

ERIC Educational Resources Information Center

Dispa, Delphine; Lejeune, Thierry; Thonnard, Jean-Louis

2013-01-01

Most chronic stroke patients present with difficulty in the manipulation of objects. The aim of this study was to test whether an intensive program of precision grip training could improve hand functioning of patients at more than 6 months after a stroke. This was a cross-over study; hence, at inclusion, the patients were randomly divided into two…

Baicalin supplementation reduces serum biomarkers of skeletal muscle wasting and may protect against lean body mass reduction in cancer patients: Results from a pilot open-label study.

PubMed

Emanuele, Enzo; Bertona, Marco; Pareja-Galeano, Helios; Fiuza-Luces, Carmen; Morales, Javier Salvador; Sanchis-Gomar, Fabian; Lucia, Alejandro

2016-07-01

Muscle wasting in patients with cancer has been linked to an increased activity of nuclear factor κB (NF-κB) and higher circulating levels of activin-A (ActA), a negative growth factor for muscle mass. Baicalin is a natural flavonoid that can reduce skeletal muscle atrophy in animal models of cancer cachexia by inhibiting NF-κB. This pilot open-label study assessed the effects of baicalin supplementation (50 mg daily for 3 months) in cancer patients who showed involuntary weight loss >5% over the past 6 months. A total of 20 patients were investigated. Participants were evaluated at baseline and at the end of the 3-month study period for the following endpoints: 1) changes from baseline in serum NF-κB and ActA levels; and 2) change from baseline in lean body mass (LBM). We observed significant reduction in both NF-κB (p<0.05) and ActA (p<0.05) serum levels from baseline to 3 months. At 3 months, patients also showed a significant mean increase in LBM (+0.8 kg, p<0.05 compared with baseline). Our pilot open-label data suggest that baicalin supplementation is potentially useful for contrasting lean body mass reduction in cancer patients with involuntary weight loss, an effect which is likely mediated by the inhibition of negative growth factors for muscle mass.

Web-Based Evidence Based Practice Educational Intervention to Improve EBP Competence among BSN-Prepared Pediatric Bedside Nurses: A Mixed Methods Pilot Study

ERIC Educational Resources Information Center

Laibhen-Parkes, Natasha

2014-01-01

For pediatric nurses, their competence in EBP is critical for providing high-quality care and maximizing patient outcomes. The purpose of this pilot study was to assess and refine a Web-based EBP educational intervention focused on improving EBP beliefs and competence in BSN-prepared pediatric bedside nurses, and to examine the feasibility,…

Pilot study of a smartphone application designed to socially motivate cardiovascular disease patients to improve medication adherence

PubMed Central

Fujita, Saki; Pitaktong, Isaree; Steller, Graeme Vosit; Dadfar, Victor; Huang, Qinwen; Banerjee, Sindhu; Guo, Richard; Nguyen, Hien Tan; Allen, Robert Harry

2018-01-01

Background Social support received by patients from family and community has been identified as a key factor for success in improving medication adherence in those patients. This pilot study aimed to investigate the usability and feasibility of PillPal, a smartphone application that uses video-chatting as a social motivation medium to encourage medication adherence in cardiovascular disease (CVD) patients. We additionally gathered feedback on the Physician Calendar, an accompanying web platform that allows clinicians to view patient adherence data generated from the app. Methods Thirty patients were recruited from the Johns Hopkins Hospital (JHH) Lipid Clinic (n=14) and Inpatient Cardiology Service (n=16) to pilot test the app. Data were obtained through in-person interviews in which patients tested out the app and answered standardized questions regarding the app’s feasibility as a means to enhance social support, as well as its usability measured in terms of ease of use and patient comfort level with the video-chat technology. Cardiologists (n=10) from JHH were interviewed to gain feedback on the Physician Calendar. Results We recorded 43.4% participants who stated that PillPal would increase their motivation to take their medications; 96.7% stated the app was easy to use; and 70% stated they were comfortable with video-chatting while taking their medications. Patient factors such as current adherence level, disease severity, and personality were more predictive of positive app reviews than the perceived level of social support. Clinicians generally approved of the Physician Calendar, as they would be able to quickly screen for non-adherence and begin conversations with patients to address the root cause of their non-adherence. Conclusions Based on pilot testing and interviews, using a smartphone app for video-chatting as a social support medium to improve patient medication adherence is feasible and has potential to increase medication adherence depending on certain patient characteristics. The Physician Calendar was deemed a useful tool by clinicians to quickly identify and understand reasons for medication non-adherence. PMID:29445730

Development and pilot of an international survey: 'Radiation Therapists and Psychosocial Support'.

PubMed

Elsner, Kelly L; Naehrig, Diana; Halkett, Georgia K B; Dhillon, Haryana M

2018-06-07

Up to one third of radiation therapy patients are reported to have unmet psychosocial needs. Radiation therapists (RTs) have daily contact with patients and can provide daily psychosocial support to reduce patient anxiety, fear and loneliness. However, RTs vary in their values, skills, training, knowledge and involvement in providing psychosocial support. The aims of this study were to: (1) develop an online survey instrument to explore RT values, skills, training and knowledge regarding patient anxiety and psychosocial support, and (2) pilot the instrument with RT professionals to assess content validity, functionality and length. An online cross-sectional survey, titled 'Radiation therapists and psychosocial support' was developed. Items included patient vignettes, embedded items from RT research, and the Professional Quality of Life Scale (ProQOL5). Four radiation oncology departments volunteered to pilot the survey; each nominated four RT staff to participate. Survey data were analysed descriptively and qualitative feedback grouped and coded to determine whether the survey needed to be refined. Thirteen of sixteen RTs completed the pilot survey and feedback form. Median time to completion was 35 mins, with 54% of respondents stating this was too long. Respondents reported content, questions and response options were relevant and appropriate. Feedback was used to: refine the survey instrument, minimise responder burden and drop out and improve functionality and quality of data collection. This pilot of the 'Radiation therapists and psychosocial support' survey instrument demonstrated content validity and usability. The main survey will be circulated to a representative sample of RTs for completion. © 2018 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.

A Pilot Study of a Distress Tolerance Treatment for Opiate Dependent Patients Initiating Buprenorphine: Rationale, Methodology, and Outcomes

PubMed Central

Brown, Richard A.; Bloom, Erika Litvin; Hecht, Jacki; Moitra, Ethan; Herman, Debra S.; Stein, Michael D.

2016-01-01

Buprenorphine, an opioid that is a long-acting partial opiate agonist, is an efficacious treatment for opiate dependence that is growing in popularity. Nevertheless, evidence suggests that many patients will lapse within the first week of treatment, and that lapses are often associated with withdrawal-related or emotional distress. Recent research suggests that individuals’ reactions to this distress may represent an important treatment target. In the current study, we describe the development and outcomes from a preliminary pilot evaluation (N = 5) of a novel distress tolerance treatment for individuals initiating buprenorphine. This treatment incorporates exposure-based and acceptance-based treatment approaches that we have previously applied to the treatment of tobacco dependence. Results from this pilot study establish the feasibility and acceptability of this approach. We are now conducting a randomized controlled trial of this treatment that we hope will yield clinically significant findings and offer clinicians an efficacious behavioral treatment to complement the effects of buprenorphine. PMID:24973401

A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

PubMed

Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

2015-09-01

Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. © The Author(s) 2014.

Teaching and Assessing Doctor-Patient Communication Using Remote Standardized Patients and SKYPE: Feedback from Medical Residents

ERIC Educational Resources Information Center

Horber, Dot; Langenau, Erik E.; Kachur, Elizabeth

2014-01-01

Teaching and assessing doctor-patient communication has become a priority in medical education. This pilot study evaluated resident physicians' perceptions of teaching and assessing doctor-patient communication skills related to pain management using a web-based format. Fifty-nine resident physicians completed four doctor-patient clinical…

Evaluation of Branched-Narrative Virtual Patients for Interprofessional Education of Psychiatry Residents.

PubMed

Wilkening, G Lucy; Gannon, Jessica M; Ross, Clint; Brennan, Jessica L; Fabian, Tanya J; Marcsisin, Michael J; Benedict, Neal J

2017-02-01

This pilot study evaluated the utility of branched-narrative virtual patients in an interprofessional education series for psychiatry residents. Third-year psychiatry residents attended four interprofessional education advanced psychopharmacology sessions that involved completion of a branched-narrative virtual patient and a debriefing session with a psychiatric pharmacist. Pre- and post-assessments analyzed resident learning and were administered around each virtual patient. Simulation 4 served as a comprehensive review. The primary outcome was differences in pre- and post-assessment scores. Secondary outcomes included resident satisfaction with the virtual patient format and psychiatric pharmacist involvement. Post-test scores for simulations 1, 2, and 3 demonstrated significant improvement (p < 0.05) from pre-test scores. Scores for simulation 4 did not retain significance. Resident satisfaction with the branched-narrative virtual patient format and psychiatric pharmacist involvement was high throughout the series (100 %; n = 18). Although there are important methodological limitations to this study including a small sample size and absence of a comparator group, this pilot study supports the use of branched-narrative virtual patients in an interprofessional education series for advanced learners.

Introducing the health coach at a primary care practice: a pilot study (part 2).

PubMed

Lanese, Bethany Sneed; Dey, Asoke; Srivastava, Prashant; Figler, Robert

2011-01-01

It is well known that the cost of healthcare in the United States is a poor value proposition. One of the primary goals of the healthcare reform act is to reduce cost while improving healthcare quality. The authors believe that adding a health coach helps to achieve this goal. In part I, the authors discuss the role of a health coach in the healthcare field. They present the findings from a pilot study at a primary care practice managing diabetes of patients using a health coach. The findings from the study suggest that adding a health coach helps in cost savings as well as improved health for the patients.

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

PubMed

Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

2015-01-01

Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

Establishment of an Italian chronic migraine database: a multicenter pilot study.

PubMed

Barbanti, Piero; Fofi, L; Cevoli, S; Torelli, P; Aurilia, C; Egeo, G; Grazzi, L; D'Amico, D; Manzoni, G C; Cortelli, P; Infarinato, F; Vanacore, N

2018-05-01

To optimize chronic migraine (CM) ascertainment and phenotype definition, provide adequate clinical management and health care procedures, and rationalize economic resources allocation, we performed an exploratory multicenter pilot study aimed at establishing a CM database, the first step for developing a future Italian CM registry. We enrolled 63 consecutive CM patients in four tertiary headache centers screened with face-to-face interviews using an ad hoc dedicated semi-structured questionnaire gathering detailed information on life-style, behavioral and socio-demographic factors, comorbidities, and migraine features before and after chronicization and healthcare resource use. Our pilot study provided useful insights revealing that CM patients (1) presented in most cases symptoms of peripheral trigeminal sensitization, a relatively unexpected feature which could be useful to unravel different CM endophenotypes and to predict trigeminal-targeted treatments' responsiveness; (2) had been frequently admitted to emergency departments; (3) had undergone, sometime repeatedly, unnecessary or inappropriate investigations; (4) got rarely illness benefit exemption or disability allowance only. We deem that the expansion of the database-shortly including many other Italian headache centers-will contribute to more precisely outline CM endophenotypes, hence improving management, treatment, and economic resource allocation, ultimately reducing CM burden on both patients and health system.

An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study.

PubMed

Albini, Fabio; Xiaoqiu Liu; Torlasco, Camilla; Soranna, Davide; Faini, Andrea; Ciminaghi, Renata; Celsi, Ada; Benedetti, Matteo; Zambon, Antonella; di Rienzo, Marco; Parati, Gianfranco

2016-08-01

Uncontrolled hypertension is largely attributed to unsatisfactory doctor's engagement in its optimal management and to poor patients' compliance to therapeutic interventions. ICT and mobile Health solutions might improve these conditions, being widely available and providing highly effective communication strategies. To evaluate whether ICT and mobile Health tools are able to improve hypertension control by improving doctors' engagement and by increasing patients' education and involvement, and their compliance to lifestyle modification and prescribed drug therapy. In a pilot study, we have included 690 treated hypertensive patients with uncontrolled office blood pressure (BP), consecutively recruited by 9 general practitioners over 3 months. Patients were alternatively assigned to routine management based on repeated office visits or to an integrated ICT-based Patients Optimal Strategy for Treatment (POST) system including Home BP monitoring teletransmission, a dedicated web-based platform for patients' management by physicians (Misuriamo platform), and a smartphone mobile application (Eurohypertension APP, E-APP), over a follow-up of 6 months. BP values, demographic and clinical data were collected at baseline and at all follow-up visits (at least two). BP control and cardiovascular risk level have been evaluated at the beginning and at the end of the study. 89 patients did not complete the follow-up, thus data analysis was carried out in 601 of them (303 patients in the POST group and 298 in the control group). Office BP control (<;149/90 mmHg) was 40.0% in control group, and 72.3% in POST group at 6 month follow-up. At the same time Home BP control (<;135/85 mmHg average of 6 days) in POST group was 87.5%. this pilot study suggests that ICT based tools might be effective in improving hypertension management, implementing positive patients' involvement with better adherence to treatment prescriptions and providing the physicians with dynamic control of patients' home BP measurements, resulting in lesser clinical inertia.

A pilot trial of a telecommunications system in sleep apnea management.

PubMed

DeMolles, Deborah A; Sparrow, David; Gottlieb, Daniel J; Friedman, Robert

2004-08-01

Continuous positive airway pressure (CPAP) is an effective therapy for obstructive sleep apnea syndrome (OSAS), although many patients have difficulty adhering to this therapy. The purpose of this study was to investigate the effectiveness of totally automated telephone technology in improving adherence to prescribed CPAP therapy. This pilot study was a randomized clinical trial in 30 patients being started on CPAP therapy for OSAS. Patients were randomly assigned to use of a computer telephone system designed to improve CPAP adherence (telephone-linked communications for CPAP [TLC-CPAP]) in addition to usual care (n = 15) or to usual care alone (n = 15) for a period of 2 months. TLC-CPAP is a computer-based system that monitors patients' self-reported behavior and provides education and reinforcement through a structured dialogue. A sleep symptoms checklist and the Functional Outcomes of Sleep Questionnaire were administered at study entry and at 2-month follow up. Hours of CPAP use at effective mask pressure were measured by the CPAP device, stored in its memory, and retrieved at the 2-month visit. At 2 months, patients randomized to TLC-CPAP had fewer reported sleep-related symptoms (9.4 vs. 13.4, P = 0.047) than those receiving usual care. The average nightly CPAP use in the TLC-CPAP group was 4.4 hours compared with 2.9 hours (P = 0.076) in the usual-care group. This pilot study suggests that patients with OSAS started on CPAP and a concurrently administered automated education and counseling system had better CPAP adherence and better control of OSAS symptoms.

The Association between Generalized Anxiety Disorder, Subthreshold Anxiety Symptoms and Fear of Falling among Older Adults: Preliminary Results from a Pilot Study.

PubMed

Payette, Marie-Christine; Bélanger, Claude; Benyebdri, Fethia; Filiatrault, Johanne; Bherer, Louis; Bertrand, Josie-Anne; Nadeau, Alexandra; Bruneau, Marie-Andrée; Clerc, Doris; Saint-Martin, Monique; Cruz-Santiago, Diana; Ménard, Caroline; Nguyen, Philippe; Vu, T T Minh; Comte, Francis; Bobeuf, Florian; Grenier, Sébastien

2017-01-01

A relationship between generalized anxiety disorder (GAD) and fear of falling (FOF) has long been proposed but never specifically studied. This study aimed at analyzing the relationship between FOF and GAD or anxiety symptoms, while controlling for major depressive episodes (MDE), depressive symptoms, fall risk, and sociodemographic variables. Twenty-five older adults participated in this pilot study. Assessments included the following: Anxiety Disorder Interview Schedule, Geriatric Anxiety Inventory, Geriatric Depression Scale, Falls-Efficacy Scale-International. A multidisciplinary team evaluated fall risk. FOF was significantly correlated with GAD, MDE, anxiety and depressive symptoms, and fall risk, but not with sociodemographic variables. Multiple regression analyses indicated that GAD and anxiety symptoms were significantly and independently associated with FOF. Although the results of this pilot study should be replicated with larger samples, they suggest that FOF is associated with GAD and anxiety symptoms even when considering physical factors that increase the risk of falling. Treatment of FOF in patients with GAD may present a particular challenge because of the central role of intolerance of uncertainty, which may prevent patients from regaining confidence despite the reduction of fall risk. Clinicians should screen for GAD and anxiety symptoms in patients with FOF to improve detection and treatment.

Is laser speckle contrast analysis (LASCA) the new kid on the block in systemic sclerosis? A systematic literature review and pilot study to evaluate reliability of LASCA to measure peripheral blood perfusion in scleroderma patients.

PubMed

Cutolo, Maurizio; Vanhaecke, Amber; Ruaro, Barbara; Deschepper, Ellen; Ickinger, Claudia; Melsens, Karin; Piette, Yves; Trombetta, Amelia Chiara; De Keyser, Filip; Smith, Vanessa

2018-06-06

A reliable tool to evaluate flow is paramount in systemic sclerosis (SSc). We describe herein on the one hand a systematic literature review on the reliability of laser speckle contrast analysis (LASCA) to measure the peripheral blood perfusion (PBP) in SSc and perform an additional pilot study, investigating the intra- and inter-rater reliability of LASCA. A systematic search was performed in 3 electronic databases, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the pilot study, 30 SSc patients and 30 healthy subjects (HS) underwent LASCA assessment. Intra-rater reliability was assessed by having a first anchor rater performing the measurements at 2 time-points and inter-rater reliability by having the anchor rater and a team of second raters performing the measurements in 15 SSc and 30 HS. The measurements were repeated with a second anchor rater in the other 15 SSc patients, as external validation. Only 1 of the 14 records of interest identified through the systematic search was included in the final analysis. In the additional pilot study: intra-class correlation coefficient (ICC) for intra-rater reliability of the first anchor rater was 0.95 in SSc and 0.93 in HS, the ICC for inter-rater reliability was 0.97 in SSc and 0.93 in HS. Intra- and inter-rater reliability of the second anchor rater was 0.78 and 0.87. The identified literature regarding the reliability of LASCA measurements reports good to excellent inter-rater agreement. This very pilot study could confirm the reliability of LASCA measurements with good to excellent inter-rater agreement and found additionally good to excellent intra-rater reliability. Furthermore, similar results were found in the external validation. Copyright © 2018. Published by Elsevier B.V.

A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness.

PubMed

Matthias, Marianne S; McGuire, Alan B; Kukla, Marina; Daggy, Joanne; Myers, Laura J; Bair, Matthew J

2015-01-01

The aim of this study was to pilot test a peer support intervention, involving peer delivery of pain self-management strategies, for veterans with chronic musculoskeletal pain. Pretest/posttest with 4-month intervention period. Ten peer coaches were each assigned 2 patients (N = 20 patients). All had chronic musculoskeletal pain. Guided by a study manual, peer coach-patient pairs were instructed to talk biweekly for 4 months. Pain was the primary outcome and was assessed with the PEG, a three-item version of the Brief Pain Inventory, and the PROMIS Pain Interference Questionnaire. Several secondary outcomes were also assessed. To assess change in outcomes, a linear mixed model with a random effect for peer coaches was applied. Nine peer coaches and 17 patients completed the study. All were male veterans. Patients' pain improved at 4 months compared with baseline but did not reach statistical significance (PEG: P = 0.33, ICC [intra-class correlation] = 0.28, Cohen's d = -0.25; PROMIS: P = 0.17, d = -0.35). Of secondary outcomes, self-efficacy (P = 0.16, ICC = 0.56, d = 0.60) and pain centrality (P = 0.06, ICC = 0.32, d = -0.62) showed greatest improvement, with moderate effect sizes. This study suggests that peers can effectively deliver pain self-management strategies to other veterans with pain. Although this was a pilot study with a relatively short intervention period, patients improved on several outcomes. Published [2014]. This article is a U.S. Government work and is in the public domain in the USA.

An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment.

PubMed

Hall, Sue; Lewith, George; Brien, Sarah; Little, Paul

2008-12-01

Kinesiology is a complementary therapy assessing subtle change in manual muscle testing results to select individualised treatments. We report the exploratory 2-stage development and pilot of a sham kinesiology treatment for use in a clinical trial to evaluate the specific effects of this intervention. 1. To design, pilot and assess the credibility of a sham kinesiology treatment in a kinesiology-aware population. 2. To pilot the sham kinesiology in a cross-over study of sham versus real kinesiology, and to make an exploratory assessment of its credibility in a kinesiology-naïve population. 1. 10 kinesiology-aware volunteers received a specially designed sham treatment weekly for 5 weeks which was subject to a credibility assessment. 2. 10 kinesiology-naïve patients with low back pain were randomised to receive 4 real and 4 sham treatments in a cross-over design; the treatments were subject to a credibility assessment. 100% of participants found the sham protocol a credible treatment as measured by the credibility questionnaire. 100% of patients having real treatment first did not recognise that the second set of treatments were sham. Small numbers precluded the use of formal statistical tests. In this small sample it appeared feasible to deliver an apparently credible sham kinesiology treatment. This feasibility study has allowed us to develop a sham treatment for use in a larger prospective clinical trial of kinesiology in patients with low back pain. 2008 S. Karger AG, Basel.

Effect of a polyherbal formulation cream on diabetic neuropathic pain among patients with type 2 diabetes – A pilot study

PubMed Central

Viswanathan, Vijay; Rajsekar, Seena; Selvaraj, Bamila; Kumpatla, Satyavani

2016-01-01

Background & objectives: Painful diabetic neuropathy is a common complication of diabetes and can severely limit patients’ daily functions. The aim of this pilot study was to evaluate the safety and effect of using a polyherbal formulation in reducing the symptoms of diabetic neuropathic pain in comparison with placebo among patients with type 2 diabetes. Methods: A total of 50 (M:F = 33:17) consecutive type 2 diabetes patients with painful diabetic neuropathy were enrolled in this study. All these patients had either two or more symptoms of diabetic neuropathy such as pain, burning and pricking sensations and numbness in their feet. They were randomly assigned to two groups: group 1 (n = 26) patients were treated with polyherbal formulation cream and group 2 (n = 24) patients were administered placebo. The patients were followed up for six months. Changes in the symptoms of painful diabetic neuropathy of each patient were recorded at baseline, third and sixth month using the Diabetic Neuropathic Score. Results: The mean age of the patients, duration of diabetes and glycated haemoglobin (HbA1c) were similar in both groups at baseline. During follow up visits, there was a decrease in the HbA1c levels in the study and control groups. The symptoms of painful diabetic neuropathy were also similar in both groups at baseline. A significant decrease in symptoms of neuropathic pain was observed among the group of patients treated with polyherbal formulation cream (76.9 per cent) compared to the placebo-treated group (12.5 per cent) (P<0.001), at the end of the final follow up. Interpretation & conclusions: In this pilot study polyherbal formulation cream was found to be effective as well as safe to treat painful diabetic neuropathy. However, its long term use needs to be evaluated for any further effectiveness and side effects. PMID:27934800

Usability testing of a monitoring and feedback tool to stimulate physical activity.

PubMed

van der Weegen, Sanne; Verwey, Renée; Tange, Huibert J; Spreeuwenberg, Marieke D; de Witte, Luc P

2014-01-01

A MONITORING AND FEEDBACK TOOL TO STIMULATE PHYSICAL ACTIVITY, CONSISTING OF AN ACTIVITY SENSOR, SMARTPHONE APPLICATION (APP), AND WEBSITE FOR PATIENTS AND THEIR PRACTICE NURSES, HAS BEEN DEVELOPED: the 'It's LiFe!' tool. In this study the usability of the tool was evaluated by technology experts and end users (people with chronic obstructive pulmonary disease or type 2 diabetes, with ages from 40-70 years), to improve the user interfaces and content of the tool. THE STUDY HAD FOUR PHASES: 1) a heuristic evaluation with six technology experts; 2) a usability test in a laboratory by five patients; 3) a pilot in real life wherein 20 patients used the tool for 3 months; and 4) a final lab test by five patients. In both lab tests (phases 2 and 4) qualitative data were collected through a thinking-aloud procedure and video recordings, and quantitative data through questions about task complexity, text comprehensiveness, and readability. In addition, the post-study system usability questionnaire (PSSUQ) was completed for the app and the website. In the pilot test (phase 3), all patients were interviewed three times and the Software Usability Measurement Inventory (SUMI) was completed. After each phase, improvements were made, mainly to the layout and text. The main improvement was a refresh button for active data synchronization between activity sensor, app, and server, implemented after connectivity problems in the pilot test. The mean score on the PSSUQ for the website improved from 5.6 (standard deviation [SD] 1.3) to 6.5 (SD 0.5), and for the app from 5.4 (SD 1.5) to 6.2 (SD 1.1). Satisfaction in the pilot was not very high according to the SUMI. The use of laboratory versus real-life tests and expert-based versus user-based tests revealed a wide range of usability issues. The usability of the It's LiFe! tool improved considerably during the study.

Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495].

PubMed

van Hout, Hein P J; Nijpels, Giel; van Marwijk, Harm W J; Jansen, Aaltje P D; Van't Veer, Petronella J; Tybout, Willemijn; Stalman, Wim A B

2005-09-08

The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Main study: The main study concerns a randomized controlled in primary care practices (PCP) with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1) visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2) determine the care priorities together with the patient; (3) design and execute interventions according to protocols; (4) and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search): 1) Vulnerable Elders Screen, 2) Strawbridge's frailty screen, and 3) COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. The design holds several unique elements such as early identification of frail persons combined with case-management by nurses. From two pilots we learned that of three potential postal frailty measures, the COOP-WONCA charts were completed best by elderly and that preventive home visits by nurses were positively evaluated to have potential for quality of care improvement.

Low-dose aspirin in polycythaemia vera: a pilot study. Gruppo Italiano Studio Policitemia (GISP).

PubMed

1997-05-01

In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males. aged 17-80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 +/- 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.

PubMed

Lomenick, Jefferson P; Buchowski, Maciej S; Shoemaker, Ashley H

2016-06-01

Hypothalamic obesity (HO) is a common complication of hypothalamic tumors, and effective therapies are lacking. The objective of this pilot study was to investigate changes in body weight before and during treatment with exenatide. This was a prospective, open-label, 52-week pilot study of exenatide (10 mcg b.i.d.) in adults with HO. Ten patients enrolled, and eight completed the study. Study measures included indirect calorimetry, body composition, buffet meals, diet recall, actigraphy, and hormone assays. Participants had obesity with a baseline weight of 137.2 ± 37.6 kg. Exenatide therapy was well tolerated. Change in weight with exenatide therapy was not significant (-1.4 ± 4.3 kg [95% CI -4.9 to 2.2], P = 0.40), but six out of eight completers lost weight (-6.2 to -0.2 kg). Participants reported significantly lower intake on food recall during treatment compared with baseline (7837.8 ± 2796.6 vs. 6258.4 ± 1970.7 kJ [95% CI -2915.8 to -242.6], P = 0.027), but there was no change in intake during buffet meals. Significant weight loss was not observed in patients with HO treated with exenatide, but 75% of completers had stable or decreasing weight. Further studies are needed to evaluate weight loss efficacy in patients with HO. © 2016 The Obesity Society.

Motor/Prefrontal Transcranial Direct Current Stimulation (tDCS) Following Lumbar Surgery Reduces Postoperative Analgesia Use.

PubMed

Glaser, John; Reeves, Scott T; Stoll, William David; Epperson, Thomas I; Hilbert, Megan; Madan, Alok; George, Mark S; Borckardt, Jeffrey J

2016-05-01

Randomized, controlled pilot trial. The present study is the first randomized, double-blind, sham-controlled pilot clinical trial of transcranial direct current stimulation (tDCS) for pain and patient-controlled analgesia (PCA) opioid usage among patients receiving spine surgery. Lumbar spinal surgeries are common, and while pain is often a complaint that precedes surgical intervention, the procedures themselves are associated with considerable postoperative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery and new analgesic strategies are needed that can be used adjunctively to existing strategies potentially to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including tDCS are beginning to demonstrate promise as treatments for a variety of pain conditions. Twenty-seven patients undergoing lumbar spine procedures at Medical University of South Carolina were randomly assigned to receive four 20-minute sessions of real or sham tDCS during their postsurgical hospital stay. Patient-administered hydromorphone usage was tracked along with numeric rating scale pain ratings. The effect of tDCS on the slope of the cumulative PCA curve was significant (P < 0.001) and tDCS was associated with a 23% reduction in PCA usage. In the real tDCS group a 31% reduction was observed in pain-at-its-least ratings from admission to discharge (P = 0.027), but no other changes in numeric rating scale pain ratings were significant in either group. The present pilot trial is the first study to demonstrate an opioid sparing effect of tDCS after spine surgical procedures. Although this was a small pilot trial in a heterogeneous sample of spinal surgery patients, a moderate effect-size was observed for tDCS, suggesting that future work in this area is warranted. 2.

Caregiving tasks and caregiver burden; effects of an psycho-educational intervention in partners of patients with post-operative heart failure.

PubMed

Ågren, Susanna; Strömberg, Anna; Jaarsma, Tiny; Luttik, Marie Louise A

2015-01-01

To evaluate the effects of a psycho-educational intervention on caregiver burden in partners of patients with postoperative heart failure. Since partners of cardiac surgery patients play a significant role in the patient's recovery, it is important to address their needs during hospitalization and after discharge. Forty-two patients with postoperative heart failure and their partners participated in a randomized controlled pilot study. Dyads in the intervention group received psycho-educational support from a multidisciplinary team. Dyads in the control group received usual care. No significant differences were found in the performance of caregiving tasks and perceived caregiver burden in the control versus the intervention group. A pilot study exploring the effects of a psycho-educational intervention in patients and their partners did not reveal significant effects with regard to reduced feelings of burden in partners. Alleviating caregiver burden in partners may need a more intense or specific approach. Copyright © 2015 Elsevier Inc. All rights reserved.

Using Video Conferencing to Deliver a Brief Motivational Intervention for Alcohol and Sex Risk to Emergency Department Patients: A Proof-of-Concept Pilot Study

PubMed Central

Celio, Mark A.; Mastroleo, Nadine R.; DiGuiseppi, Graham; Barnett, Nancy P.; Colby, Suzanne M.; Kahler, Christopher W.; Operario, Don; Suffoletto, Brian; Monti, Peter M.

2016-01-01

Brief motivational intervention (MI) is an efficacious approach to reduce heavy drinking and associated sexual risk behavior among Emergency Department (ED) patients, but the intensity of demands placed on ED staff makes the implementation of in-person MIs logistically challenging. This proof-of-concept pilot study examined the acceptability and logistic feasibility of using video-conferencing technology to deliver an MI targeting heavy drinking and risky sexual behavior to patients in an ED setting. Rigorous screening procedures were employed to ensure that the pilot sample represents the target portion of ED patients who would benefit from this multi-target MI. Mixed qualitative and quantitative data from a sample of seven ED patients (57% Female; Mage = 35 years) who received MI by video conference consistently demonstrated high levels of satisfaction, engagement, and acceptability. The observed completion rate supports logistic feasibility, and patient feedback identified methods to improve the experience by using high-definition hardware, ensuring stronger network connectivity, and effectively communicating information regarding protection of privacy. Post-intervention patient ratings and independent ratings of the audio-recorded sessions (using the Motivational Interviewing Skills Coding system) were very high, suggesting that intervention fidelity and MI adherence was not compromised by delivery modality. Collectively, these data suggest video conferencing is a viable technology that can be employed to implement brief evidence-based MIs in ED settings. PMID:28649188

Using Video Conferencing to Deliver a Brief Motivational Intervention for Alcohol and Sex Risk to Emergency Department Patients: A Proof-of-Concept Pilot Study.

PubMed

Celio, Mark A; Mastroleo, Nadine R; DiGuiseppi, Graham; Barnett, Nancy P; Colby, Suzanne M; Kahler, Christopher W; Operario, Don; Suffoletto, Brian; Monti, Peter M

2017-01-01

Brief motivational intervention (MI) is an efficacious approach to reduce heavy drinking and associated sexual risk behavior among Emergency Department (ED) patients, but the intensity of demands placed on ED staff makes the implementation of in-person MIs logistically challenging. This proof-of-concept pilot study examined the acceptability and logistic feasibility of using video-conferencing technology to deliver an MI targeting heavy drinking and risky sexual behavior to patients in an ED setting. Rigorous screening procedures were employed to ensure that the pilot sample represents the target portion of ED patients who would benefit from this multi-target MI. Mixed qualitative and quantitative data from a sample of seven ED patients (57% Female; M age = 35 years) who received MI by video conference consistently demonstrated high levels of satisfaction, engagement, and acceptability. The observed completion rate supports logistic feasibility, and patient feedback identified methods to improve the experience by using high-definition hardware, ensuring stronger network connectivity, and effectively communicating information regarding protection of privacy. Post-intervention patient ratings and independent ratings of the audio-recorded sessions (using the Motivational Interviewing Skills Coding system) were very high, suggesting that intervention fidelity and MI adherence was not compromised by delivery modality. Collectively, these data suggest video conferencing is a viable technology that can be employed to implement brief evidence-based MIs in ED settings.

Digital Photography as an Educational Food Logging Tool in Obese Patients with Type 2 Diabetes: Lessons Learned from A Randomized, Crossover Pilot Trial

PubMed Central

Ehrmann, Brett J.; Anderson, Robert M.; Piatt, Gretchen A.; Funnell, Martha M.; Rashid, Hira; Shedden, Kerby; Douyon, Liselle

2014-01-01

Purpose The purpose of this pilot study is to investigate the utility of, and areas of refinement for, digital photography as an educational tool for food logging in obese patients with type 2 diabetes (T2DM). Methods Thirty-three patients aged 18-70 with T2DM, BMI at least 30 kg/m2, and A1C 7.5-9% were recruited from an endocrinology clinic and randomized to a week of food logging using a digital camera (DC) or paper diary (PD), crossing over for week two. Patients then viewed a presentation about dietary effects on blood glucose, using patient DC and blood glucose entries. Outcomes of adherence (based on number of weekly entries), changes in mean blood glucose and frequency of blood glucose checks, and patient satisfaction were compared between methods. Patient feedback on the DC intervention and presentation was also analyzed. Results Thirty patients completed the study. Adherence was identical across methods. The mean difference in number of entries was not significant between methods. This difference increased and neared statistical significance (favoring DC) among patients who were adherent for at least one week (21 entries, with 2 entries per day for 5 of 7 days, n=25). Mean blood glucose did not significantly decrease in either method. Patient satisfaction was similar between interventions. Feedback indicated concerns over photograph accuracy, forgetting to use the cameras, and embarrassment using them in public. Conclusion Though comparable to PD in adherence, blood glucose changes, and patient satisfaction in this pilot trial, patient feedback suggested specific areas of refinement to maximize utility of DC-based food logging as an educational tool in T2DM. PMID:24168836

The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study.

PubMed

Hubbard, Gill; O'Carroll, Ronan; Munro, Julie; Mutrie, Nanette; Haw, Sally; Mason, Helen; Treweek, Shaun

2016-01-01

Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials' protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design. A pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients' and clinicians' perceptions and experiences of the main trial procedures were explored by interview. Quantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation. Qualitative study: Thirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation. The study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials. ISRCTN63510637.

Comparing the psychological stress between non-smoking patients and smoking patients who experience abrupt smoking cessation during hospitalization for acute myocardial infarction: a pilot study.

PubMed

Pfaff, Kathryn A; El-Masri, Maher M; Fox-Wasylyshyn, Susan M

2009-01-01

Stress is an untoward condition in patients with acute myocardial infarction (AMI). Abrupt nicotine withdrawal is associated with increased symptoms of stress. However, little is known about the impact of smoking cessation on the psychological indicators of stress among hospitalized AMI patients. In this pilot study we compared the psychological stressors between non-smoking AMI patients and smoking patients who abruptly ceased smoking following admission to the CCU. A cross-sectional survey was piloted on a sample of 57 AMI patients (29 smokers and 28 nonsmokers) on the second day of admission to the CCU. Psychological stress was measured using the Profile of Mood States and the Insomnia Severity Index. Multivariate analysis of covariance (MANCOVA) suggested that after adjusting for age, smokers experienced significantly higher overall levels of stress than non-smokers (F = 3.13; p = 0.016). Post-hoc analyses suggested that scores of depression (p = 0.033), anxiety (p = 0.007), and anger (p = 0.017) were particularly higher among smokers, as compared to non-smokers. However, the two groups were not different with regard to their scores on fatigue (p = 0.528) and insomnia (p = 0.299). Abrupt smoking cessation may expose patients admitted with AMI symptoms to higher levels of psychological stress. Given the potential damaging impact of psychological stressors on the physical outcomes of these patients, these findings demonstrate the need for continued assessment and research related to the management of nicotine withdrawal following AMI.

Older, vulnerable patient view: a pilot and feasibility study of the patient measure of safety (PMOS) with patients in Australia.

PubMed

Taylor, Natalie; Hogden, Emily; Clay-Williams, Robyn; Li, Zhicheng; Lawton, Rebecca; Braithwaite, Jeffrey

2016-06-08

The UK-developed patient measure of safety (PMOS) is a validated tool which captures patient perceptions of safety in hospitals. We aimed (1) to investigate the extent to which the PMOS is appropriate for use with stroke, acute myocardial infarction (AMI) and hip fracture patients in Australian hospitals and (2) to pilot the PMOS for use in a large-scale, national study 'Deepening our Understanding of Quality in Australia' (DUQuA). Stroke, AMI and hip fracture patients (n=34) receiving care in 3 wards in 1 large hospital. 2 phases were conducted. First, a 'think aloud' study was used to determine the validity of PMOS with this population in an international setting, and to make amendments based on patient feedback. The second phase tested the revised measure to establish the internal consistency reliability of the revised subscales, and piloted the recruitment and administration processes to ensure feasibility of the PMOS for use in DUQuA. Of the 43 questions in the PMOS, 13 (30%) were amended based on issues patients highlighted for improvement in phase 1. In phase 2, a total of 34 patients were approached and 29 included, with a mean age of 71.3 years (SD=16.39). Internal consistency reliability was established using interitem correlation and Cronbach's α for all but 1 subscale. The most and least favourably rated aspects of safety differed between the 3 wards. A study log was categorised into 10 key feasibility factors, including liaising with wards to understand operational procedures and identify patterns of patient discharge. Capturing patient perceptions of care is crucial in improving patient safety. The revised PMOS is appropriate for use with vulnerable older adult groups. The findings from this study have informed key decisions made for the deployment of this measure as part of the DUQuA study. 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/

A Pilot Study of Common Bile Duct Reconstruction with CorMatrix Extracellular Matrix in Swine (Sus scrofa)

DTIC Science & Technology

2015-02-06

additional pages if necessary.) PROTOCOL#: FDG20140008A DATE: 6 February 2015 PROTOCOL TITLE: A Pilot Study of Common Bile Duct Reconstruction with...obstruction or bile peritonitis. This was reported to the IACUC chair. 9. REDUCTION, REFINEMENT, OR REPLACEMENT OF ANIMAL USE; REPLACEMENT...benefit the DoD/USAF? We developed a porcine model of common bile duct injury and interposition grafting, gained experience managing these patients

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

PubMed

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

PubMed

Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

2013-07-02

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. ISRCTN62019087.

Feasibility, acceptance and long-term exercise behaviour in cancer patients: an exercise intervention by using a swinging-ring system.

PubMed

Crevenna, Richard; Cenik, Fadime; Galle, Anton; Komanadj, Tanya Sedghi; Keilani, Mohammad

2015-10-01

Aim of this pilot study was to describe feasibility and acceptance of an exercise intervention by using an unique swinging-ring system with the goal to promote long-term exercise behaviour in cancer patients. The included cancer patients (n = 13, male:f emale (m:f) = 7:6, age = 56 ± 11, range 38-74a) were invited to perform a home-based exercise intervention. All participants of this pilot study were instructed how to use the smovey® Vibroswing. They could choose how to use the swinging-ring system, for example only indoor or only outdoor (single or in a group) or both. Feasibility and acceptance were assessed after 12 months (T2). Handgrip strength (Jamar hand dynamometer) and health-related quality of life (QOL, SF-36 Health survey) were assessed at baseline (T1) and after 12 months (T2). A total of 10 (77%) patients (m:f = 5:5, 59 ± 9 years, range = 46-74) could be assessed at baseline and after 12 months. The exercise intervention showed no adverse events and was well accepted. Approximately 77% of patients of the study population have been exercising for more than 12 months. Furthermore, this intervention was able to increase handgrip strength in the participants. QOL improved as well in all domains. The results of this small pilot study indicate that regular physical exercise with this swinging-ring system seems to be safe, and to promote long-term exercise behaviour of the included patients. Furthermore, this study population showed benefits in terms of increased handgrip strength and of improved QOL.

A Pilot Study to Improve Access to Eye Care Services for Patients in Rural India by Implementing Community Ophthalmology through Innovative Telehealth Technology.

PubMed

John, Sheila; Premila, M; Javed, Mohd; Vikas, G; Wagholikar, Amol

2015-01-01

To inform about a very unique and first of its kind telehealth pilot study in India that has provided virtual telehealth consultation to eye care patients in low resource at remote villages. Provision of Access to eye care services in remote population is always challenging due to pragmatic reasons. Advances in Telehealth technologies have provided an opportunity to improve access to remote population. However, current Telehealth technologies are limited to face-to-face video consultation only. We inform about a pilot study that illustrates real-time imaging access to ophthalmologists. Our innovative software led technology solution allowed screening of patients with varying ocular conditions. Eye camps were conducted in 2 districts in South India over a 12-month period in 2014. Total of 196 eye camps were conducted. Total of 19,634 patients attended the eye camps. Innovative software was used to conduct consultation with the ophthalmologist located in the city hospital. The software enabled virtual visit and allowed instant sharing of fundus camera images for assessment and diagnosis. About 71% of the patients were found to have Refractive Error problems, 15% of them were found to have cataract, 7% of the patients were diagnosed to have Retina problems and 7% of the patients were found to have other ocular diseases. The patients requiring cataract surgery were immediately transferred to city hospital for treatment. Software led assessment of fundus camera images assisted in identifying retinal eye diseases. Our real-time virtual visit software assisted in specialist care provision and illustrated a novel tele health solution for low resource population.

The Promoting Effective Advance Care for Elders (PEACE) randomized pilot study: theoretical framework and study design.

PubMed

Allen, Kyle R; Hazelett, Susan E; Radwany, Steven; Ertle, Denise; Fosnight, Susan M; Moore, Pamela S

2012-04-01

Practice guidelines are available for hospice and palliative medicine specialists and geriatricians. However, these guidelines do not adequately address the needs of patients who straddle the 2 specialties: homebound chronically ill patients. The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) randomized pilot study. PEACE is an ongoing 2-group randomized pilot study (n=80) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management, psychosocial and emotional support, and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy. The population comprises new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program. All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible. The intervention is based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses, uses evidence-based protocols, emphasizes patient activation, and integrates with community-based long-term care and other community agencies. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for community-based, chronically ill older adults. © Mary Ann Liebert, Inc.

Respiratory muscle endurance training reduces chronic neck pain: A pilot study.

PubMed

Wirth, B; Ferreira, T Duarte; Mittelholzer, M; Humphreys, B K; Boutellier, U

2016-11-21

Patients with chronic neck pain show also respiratory dysfunctions. To investigate the effects of respiratory muscle endurance training (RMET) on chronic neck pain. In this pilot study (single-subject design: 3 baseline measurements, 4 measurements during RMET), 15 neck patients (49.3 ± 13.7 years; 13 females) conducted 20 sessions of home-based RMET using a SpiroTiger® (normocapnic hyperpnoea). Maximal voluntary ventilation (MVV), maximal inspiratory (Pimax) and expiratory (Pemax) pressure were measured before and after RMET. Neck flexor endurance, cervical and thoracic mobility, forward head posture, chest wall expansion and self-assessed neck disability [Neck Disability Index (NDI), Bournemouth questionnaire] were weekly assessed. Repeated measure ANOVA (Bonferroni correction) compared the first and last baseline and the last measurement after RMET. RMET significantly increased MVV (p= 0.025), Pimax (p= 0.001) and Pemax (p< 0.001). During RMET, neck disability significantly decreased (NDI: p= 0.001; Bournemouth questionnaire: p= 0.002), while neck flexor endurance (p< 0.001) and chest wall expansion (p< 0.001) increased. The changes in respiratory and musculoskeletal parameters did not correlate. RMET emerged from this pilot study as a feasible and effective therapy for reducing disability in patients with chronic neck pain. The underlying mechanisms, including blood gas analyses, need further investigation in a randomized controlled study.

Academic-Community Partnership to Develop a Patient-Centered Breast Cancer Risk Reduction Program for Latina Primary Care Patients.

PubMed

Castañeda, Sheila F; Giacinto, Rebeca E; Medeiros, Elizabeth A; Brongiel, Ilana; Cardona, Olga; Perez, Patricia; Talavera, Gregory A

2016-06-01

This collaborative study sought to address Latina breast cancer (BC) disparities by increasing health literacy (HL) in a community health center situated on the US-Mexico border region of San Diego County. An academic-community partnership conducted formative research to develop a culturally tailored promotora-based intervention with 109 individuals. The Spanish language program, entitled Nuestra Cocina: Mesa Buena, Vida Sana (Our Kitchen: Good Table, Healthy Life), included six sessions targeting HL, women's health, BC risk reduction, and patient-provider communication; sessions include cooking demonstrations of recipes with cancer-risk-reducing ingredients. A pilot study with 47 community health center Latina patients was conducted to examine the program's acceptability, feasibility, and ability to impact knowledge and skills. Pre- and post-analyses demonstrated that participants improved their self-reported cancer screening, BC knowledge, daily fruit and vegetable intake, and ability to read a nutrition label (p < 0.05). Results of the pilot study demonstrate the importance of utilizing patient-centered culturally appropriate noninvasive means to educate and empower Latina patients.

Academic-Community Partnership to Develop a Patient-Centered Breast Cancer Risk Reduction Program for Latina Primary Care Patients

PubMed Central

Castañeda, Sheila F.; Giacinto, Rebeca E.; Medeiros, Elizabeth A.; Brongiel, Ilana; Cardona, Olga; Perez, Patricia; Talavera, Gregory A.

2015-01-01

This collaborative study sought to address Latina breast cancer (BC) disparities by increasing health literacy (HL) in a community health center situated on the US-Mexico border region of San Diego County. An academic-community partnership conducted formative research to develop a culturally tailored promotora-based intervention with 109 individuals. The Spanish language program, entitled Nuestra Cocina: Mesa Buena, Vida Sana (Our Kitchen: Good Table, Healthy Life), included six sessions targeting HL, women’s health, BC risk reduction, and patient-provider communication; sessions include cooking demonstrations of recipes with cancer-risk-reducing ingredients. A pilot study with 47 community health center Latina patients was conducted to examine the program’s acceptability, feasibility, and ability to impact knowledge and skills. Pre- and post-analyses demonstrated that participants improved their self-reported cancer screening, BC knowledge, daily fruit and vegetable intake, and ability to read a nutrition label (p<0.05). Results of the pilot study demonstrate the importance of utilizing patient-centered culturally appropriate noninvasive means to educate and empower Latina patients. PMID:27271058

Automatic Calculation of Hydrostatic Pressure Gradient in Patients with Head Injury: A Pilot Study.

PubMed

Moss, Laura; Shaw, Martin; Piper, Ian; Arvind, D K; Hawthorne, Christopher

2016-01-01

The non-surgical management of patients with traumatic brain injury is the treatment and prevention of secondary insults, such as low cerebral perfusion pressure (CPP). Most clinical pressure monitoring systems measure pressure relative to atmospheric pressure. If a patient is managed with their head tilted up, relative to their arterial pressure transducer, then a hydrostatic pressure gradient (HPG) can act against arterial pressure and cause significant errors in calculated CPP.To correct for HPG, the arterial pressure transducer should be placed level with the intracranial pressure transducer. However, this is not always achieved. In this chapter, we describe a pilot study investigating the application of speckled computing (or "specks") for the automatic monitoring of the patient's head tilt and subsequent automatic calculation of HPG. In future applications this will allow us to automatically correct CPP to take into account any HPG.

Physical and cognitive stimulation in Alzheimer Disease. the GAIA Project: a pilot study.

PubMed

Maci, Tiziana; Pira, Francesco Le; Quattrocchi, Graziella; Nuovo, Santo Di; Perciavalle, Vincenzo; Zappia, Mario

2012-03-01

Several data suggest that physical activity and cognitive stimulation have a positive effect on the quality of life (QoL) of people with Alzheimer's disease (AD), slowing the decline due to the disease. A pilot project was undertaken to assess the effect of cognitive stimulation, physical activity, and socialization on patients with AD and their informal caregiver's QoL and mood. Fourteen patients with AD were randomly divided into active treatment group and control group. At the end of treatment, a significant improvement in apathy, anxiety, depression, and QoL in the active treatment group was found. Considering caregivers, those of the active treatment group exhibited a significant improvement in their mood and in their perception of patients' QoL. This study provides evidence that a combined approach based on cognitive stimulation, physical activity, and socialization is a feasible tool to improve mood and QoL in patients with AD and their caregivers.

Low literacy self-care management patient education for a multi-lingual heart failure population: Results of a pilot study.

PubMed

Dickson, Victoria Vaughan; Chyun, Deborah; Caridi, Cristina; Gregory, Jill K; Katz, Stuart

2016-02-01

The purpose of this pilot study was to test the impact of language-free, low literacy self-care management patient education materials in an ethnically diverse multilingual heart failure (HF) population. A one group pre-test-post-test design measured changes in self-care, knowledge and health-related quality of life (HRQL) after a 1 month intervention using language-free, low literacy self-care management patient education materials and delivered by a health educator. The ethnically diverse sample (n=21) was predominately male (72%), 48% Black, 42% Hispanic, and 28% marginal/inadequate literacy. There were significant improvements in self-care and knowledge but not HRQL. Language-free, low literacy self-care patient education may facilitate improved self-care and knowledge in diverse populations who are at risk for poor HF outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

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

Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.

Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores overmore » time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.« less

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

PubMed

Rollmann, Denise C; Novotny, Paul J; Petersen, Ivy A; Garces, Yolanda I; Bauer, Heather J; Yan, Elizabeth S; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A; Issa Laack, Nadia N

2015-07-01

The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. Copyright © 2015 Elsevier Inc. All rights reserved.

Oral rehydration therapy for preoperative fluid and electrolyte management.

PubMed

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients.

Oral Rehydration Therapy for Preoperative Fluid and Electrolyte Management

PubMed Central

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Aim: Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. Methods: The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. Results: In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. Conclusion: These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients. PMID:21897763

A pilot study of a Medication Rationalization (MERA) intervention

PubMed Central

Whitty, Rachel; Porter, Sandra; Battu, Kiran; Bhatt, Pranjal; Koo, Ellen; Kalocsai, Csilla; Wu, Peter; Delicaet, Kendra; Bogoch, Isaac I.; Wu, Robert; Downar, James

2018-01-01

Background: Many seriously ill and frail inpatients receive potentially inappropriate or harmful medications and do not receive medications for symptoms of advanced illness. We developed and piloted an interprofessional Medication Rationalization (MERA) approach to deprescribing inappropriate medications and prescribing appropriate comfort medications. Methods: We conducted a single-centre pilot study of inpatients at risk of 6-month mortality from advanced age or morbidity. The MERA team reviewed the patients' medications and made recommendations on the basis of guidelines. We measured end points for feasibility, acceptability, efficiency and effectiveness. Results: We enrolled 61 of 115 (53%) eligible patients with a mean age of 79.6 years (standard deviation [SD] 11.7 yr). Patients were taking an average of 11.5 (SD 5.2) medications before admission and had an average of 2.1 symptoms with greater than 6/10 severity on the revised Edmonton Symptom Assessment System. The MERA team recommended 263 medication changes, of which 223 (85%) were accepted by both the medical team and the patient. MERA team's recommendations resulted in the discontinuation of 162 medications (mean 3.1 per patient), dose changes for 48 medications (mean 0.9 per patient) and the addition of 13 medications (mean 0.2 per patient). Patients who received the MERA intervention stopped significantly more inappropriate medications than similar non-MERA comparison patients for whom data were collected retrospectively (3.1 v. 0.9 medications per patient, p < 0.01). The MERA approach was highly acceptable to patients and medical team members. Interpretation: The MERA intervention is feasible, acceptable, efficient and possibly effective for changing medication use among seriously ill and frail elderly inpatients. Scalability and effectiveness may be improved through automation and integration with medication reconciliation programs. PMID:29467186

Mining Clinicians' Electronic Documentation to Identify Heart Failure Patients with Ineffective Self-Management: A Pilot Text-Mining Study.

PubMed

Topaz, Maxim; Radhakrishnan, Kavita; Lei, Victor; Zhou, Li

2016-01-01

Effective self-management can decrease up to 50% of heart failure hospitalizations. Unfortunately, self-management by patients with heart failure remains poor. This pilot study aimed to explore the use of text-mining to identify heart failure patients with ineffective self-management. We first built a comprehensive self-management vocabulary based on the literature and clinical notes review. We then randomly selected 545 heart failure patients treated within Partners Healthcare hospitals (Boston, MA, USA) and conducted a regular expression search with the compiled vocabulary within 43,107 interdisciplinary clinical notes of these patients. We found that 38.2% (n = 208) patients had documentation of ineffective heart failure self-management in the domains of poor diet adherence (28.4%), missed medical encounters (26.4%) poor medication adherence (20.2%) and non-specified self-management issues (e.g., "compliance issues", 34.6%). We showed the feasibility of using text-mining to identify patients with ineffective self-management. More natural language processing algorithms are needed to help busy clinicians identify these patients.

SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

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

Thwaites, D; Holloway, L; Bailey, M

2015-06-15

Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction andmore » mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions, improved treatment quality and potential practice changes. The early indications from the distributed learning and radiomics pilots strengthen this. Improved routine patient data quality should strengthen such rapid learning systems.« less

[A pilot study on pain assessment among elderly with severe dementia
in residential aged care facilities of Reggio Emilia district].

PubMed

Bargellini, Annalisa; Mastrangelo, Stefano; Cervi, Monica; Bagnasco, Michele; Reghizzi, Jlenia; Coriani, Sandra

2017-01-01

. A pilot study on pain assessment among elderly with severe dementia in residential aged care facilities of Reggio Emilia district. Despite the availability of pain assessment tools and best practice recommendations for the assessment and management of pain in people with severe dementia, pain in residential aged care facilities is still undetected or misinterpreted. To assess pain prevalence and analgesic load medication in people with severe cognitive impairment admitted to residential aged care facilities of Reggio Emilia (Italy) province. A pilot cross-sectional study was conducted on 84 elderly patients affected by severe dementia and resident in aged care facilities. Pain was assessed with the PAINAD observational scale, both at rest and during routine procedures: positioning in bed, from bed to standing position, from bed to chair or during the medication of a pressure sore (under challenge). 33.4% of patients had pain at rest, mainly mild, and 86.9 % under challenge. During routine interventions, in 64 patients (76.2%) pain increased compared to at rest condition (for 39, 2/3, moderate-severe); although 46 of them were prescribed as-required analgesic medication, none had received the drug. Also patients with analgesics on regular basis experienced more pain during routine procedures. Many patients experienced pain during routine procedures. The regular use of pain assessment tools and adequate training of all healthcare professionals are essential requirements for an effective pain control.

Effects of compensatory cognitive training intervention for breast cancer patients undergoing chemotherapy: a pilot study.

PubMed

Park, Jin-Hee; Jung, Yong Sik; Kim, Ku Sang; Bae, Sun Hyoung

2017-06-01

Numerous breast cancer patients experience cognitive changes during and after chemotherapy. Chemotherapy-related cognitive impairment can significantly affect quality of life. This pilot study attempted to determine the effects of a compensatory cognitive training on the objective and subjective cognitive functioning of breast cancer patients receiving adjuvant chemotherapy. Fifty-four patients were assigned to either a compensatory cognitive training or waitlist condition. They were assessed at baseline (T1), the completion of the 12-week intervention (T2), and 6 months after intervention completion (T3). Outcomes were assessed using the standardized neuropsychological tests and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), version 3. Raw data were converted to T-scores based on baseline scores, and a repeated-measures ANCOVA, adjusting for age, intelligence, depression, and treatment, was used for analysis. The effect sizes for differences in means were calculated. The intervention group improved significantly over time compared to the waitlist group on objective cognitive function. Among ten individual neuropsychological measures, immediate memory, delayed memory, verbal fluency in category, and verbal fluency in letter showed significant group × time interaction. In subjective cognitive function, scores of the waitlist group significantly decrease over time on perceived cognitive impairments, in contrast to those of the intervention group. The 12-week compensatory cognitive training significantly improved the objective and subjective cognitive functioning of breast cancer patients. Because this was a pilot study, further research using a larger sample and longer follow-up durations is necessary.

Thirst distress and interdialytic weight gain: how do they relate?

PubMed

Jacob, Sheena; Locking-Cusolito, Heather

2004-01-01

Thirst is a frequent and stressful symptom experienced by hemodialysis patients. Several studies have noted a positive relationship between thirst and interdialytic weight gain (IDWG). These factors prompted us to consider ways that we could intervene to reduce thirst and IDWG through an educative, supportive nursing intervention. This paper presents the results of a pilot research project, the purpose of which was to: examine the relationship between thirst distress (the negative symptoms associated with thirst) and IDWG in a sample of our patients, describe patients' strategies for management of thirst, and establish the necessary sample size for the planned intervention study. The pilot research project results showed that in a small sample of 20, there was a mildly positive, though not statistically significant, correlation between thirst distress and IDWG (r = 0.117). Subjects shared a wide variety of thirst management strategies including: limiting salt intake, using ice chips, measuring daily allotment, performing mouth care, eating raw fruits and vegetables, sucking on hard candy and chewing gum. This pilot research project showed that given an alpha of 0.05 and a power of 80%, we will require a sample of 39 subjects to detect a 20% change in IDWG. We will employ these results to plan our intervention study, first by establishing the appropriate sample size and second by incorporating identified patient strategies into an educational pamphlet that will form the basis of our intervention.

Endoscopic procedure with a modified Reiki intervention: a pilot study.

PubMed

Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

2010-01-01

This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

Clinical outcomes of a novel therapeutic vaccine with Tax peptide-pulsed dendritic cells for adult T cell leukaemia/lymphoma in a pilot study.

PubMed

Suehiro, Youko; Hasegawa, Atsuhiko; Iino, Tadafumi; Sasada, Amane; Watanabe, Nobukazu; Matsuoka, Masao; Takamori, Ayako; Tanosaki, Ryuji; Utsunomiya, Atae; Choi, Ilseung; Fukuda, Tetsuya; Miura, Osamu; Takaishi, Shigeo; Teshima, Takanori; Akashi, Koichi; Kannagi, Mari; Uike, Naokuni; Okamura, Jun

2015-05-01

Adult T cell leukaemia/lymphoma (ATL) is a human T cell leukaemia virus type-I (HTLV-I)-infected T cell malignancy with poor prognosis. We herein developed a novel therapeutic vaccine designed to augment an HTLV-I Tax-specific cytotoxic T lymphocyte (CTL) response that has been implicated in anti-ATL effects, and conducted a pilot study to investigate its safety and efficacy. Three previously treated ATL patients, classified as intermediate- to high-risk, were subcutaneously administered with the vaccine, consisting of autologous dendritic cells (DCs) pulsed with Tax peptides corresponding to the CTL epitopes. In all patients, the performance status improved after vaccination without severe adverse events, and Tax-specific CTL responses were observed with peaks at 16-20 weeks. Two patients achieved partial remission in the first 8 weeks, one of whom later achieved complete remission, maintaining their remission status without any additional chemotherapy 24 and 19 months after vaccination, respectively. The third patient, whose tumour cells lacked the ability to express Tax at biopsy, obtained stable disease in the first 8 weeks and later developed slowly progressive disease although additional therapy was not required for 14 months. The clinical outcomes of this pilot study indicate that the Tax peptide-pulsed DC vaccine is a safe and promising immunotherapy for ATL. © 2015 John Wiley & Sons Ltd.

Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment.

PubMed

Kho, Michelle E; Truong, Alexander D; Zanni, Jennifer M; Ciesla, Nancy D; Brower, Roy G; Palmer, Jeffrey B; Needham, Dale M

2015-02-01

The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients. We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124. We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019). In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research. Copyright © 2014 Elsevier Inc. All rights reserved.

The effect of individualized patient education, along with emotional support, on the quality of life of breast cancer patients - A pilot study.

PubMed

Sajjad, Sehrish; Ali, Asho; Gul, Raisa B; Mateen, Ahmed; Rozi, Shafquat

2016-04-01

This study aimed to determine the effect of individualized patient education along with emotional support on the quality of life (QoL) of breast cancer patients undergoing chemotherapy. It also aimed to determine the intervention's feasibility in the Pakistani context. A quasi-experimental design, with pre- and post-test, in two groups, via time block, was used. The study was conducted at a public hospital in Karachi with a sample of 50 patients; 25 patients each in the intervention and control group. The intervention was delivered over a period of six weeks. It comprised verbal and written patient education, availability of a nurse during patients' chemotherapy administration and over the telephone, and a telephone follow-up of the patients by the nurse. patients' QoL was assessed at baseline and at the sixth week of receiving chemotherapy. Tests indicated a significant improvement in the overall QoL, breast cancer subscale scores, and the physical and emotional well-being of the intervention group, as compared to the control group. The intervention effect size was moderate (0.655) for the QoL. The intervention was found to be effective in improving patients' QoL. However, a larger study, in a multi-center setting, is recommended to ascertain the findings of this pilot study. Copyright © 2016 Elsevier Ltd. All rights reserved.

"Placebo effect is probably what we refer to as patient healing power": A qualitative pilot study examining how Norwegian complementary therapists reflect on their practice.

PubMed

Stub, Trine; Foss, Nina; Liodden, Ingrid

2017-05-12

Complementary therapists spend considerable time with their patients, especially in the first consultation. The communication between patients and their therapists is important for raising consciousness and activation of the patient's self-healing power. Thus, the aims in this study were to delineate what complementary therapists regard as essential in patient consultations, their view of the healing process, and how the therapists understand the placebo effect and its position in the healing process. Semi-structured individual interviews (n = 4), focus group interview (n = 1) and participant observation were conducted among four different complementary therapists in a Norwegian community. The text data was transcribed verbatim and the analysis of the material was conducted according to conventional and direct content analysis. Some codes were predefined and others were defined during the analysis. The pilot study showed that the implemented methods seems feasible and fit well with the aims of this study. Complementary therapists (chiropractor, naprapath (musculoskeletal therapist), acupuncturist and acupuncturist/homeopath) representing four different complementary modalities participated. A combination of the conversation and examination during the first consultation formed the basis for the therapist's choice of treatment. A successful consultation was characterized by a fruitful relationship between the therapist and the patient. Moreover, the therapist needs to be humble and show the patient respect. Patients' positive beliefs and expectations about the treatment play a significant role in the healing process. The more hope the therapist can bring about, the more easily the patient can start believing that it is possible to get well. This was a pilot study. Therefore the findings should be appreciated as limited and preliminary. Therapists' and patients' mutual understanding and treatment goals were essential for a successful consultation. The therapists emphasized their professional skills and therapeutic competence as important when building fruitful relationships with their patients. Exerting authority and making the patient feel confident were essential factors for a successful healing process. The complementary therapists understood the placebo effect as the patient's self-healing power, resulting from establishing trust and belief in the treatment process.

Evaluating Two Evidence-Based Intervention Strategies to Promote CRC Screening Among Latino Adults in a Primary Care Setting.

PubMed

Castañeda, Sheila F; Bharti, Balambal; Espinoza-Giacinto, Rebeca Aurora; Sanchez, Valerie; O'Connell, Shawne; Muñoz, Fatima; Mercado, Sylvia; Meza, Marie Elena; Rojas, Wendy; Talavera, Gregory A; Gupta, Samir

2017-06-20

Regular use of colorectal cancer screening can reduce incidence and mortality, but participation rates remain low among low-income, Spanish-speaking Latino adults. We conducted two distinct pilot studies testing the implementation of evidence-based interventions to promote fecal immunochemical test (FIT) screening among Latinos aged 50-75 years who were not up-to-date with CRC screening (n = 200) at a large Federally Qualified Health Center (FQHC) in San Diego, CA. One pilot focused on an opportunistic clinic visit "in-reach" intervention including a 30-min session with a patient navigator, review of an educational "flip-chart," and a take-home FIT kit with instructions. The second pilot was a system-level "outreach" intervention consisting of mailed materials (i.e., FIT kit, culturally and linguistically tailored instructions, and a pre-paid return envelope). Both received follow-up calls to promote screening completion and referrals for additional screening and treatment if needed. The primary outcome was FIT kit completion and return within 3 months assessed through electronic medical records. The in-reach pilot consisted of mostly insured (85%), women (82%), and Spanish-speaking (88%) patients. The outreach pilot consisted of mostly of Spanish-speaking (73%) women (64%), half of which were insured (50%). At a 3-month follow-up, screening completion was 76% for in-reach and 19% for outreach. These data demonstrate that evidence-based strategies to promote CRC screening can be implemented successfully within FQHCs, but implementation (particularly of mailed outreach) may require setting and population-specific optimization. Patient, provider, and healthcare system related implementation approaches and lessons learned from this study may be implemented in other primary care settings.

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

PubMed

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

Changes in microflora in dental plaque from cancer patients undergoing chemotherapy and the relationship of these changes with mucositis: A pilot study.

PubMed

Vozza, Iole; Caldarazzo, Vito; Ottolenghi, Livia

2015-05-01

To assess changes in oral microflora in dental plaque from cancer patients within 7 days of the first course of chemotherapy, and the relationship of the changes with mucositis. Thirty cancer patients, divided into a test group undergoing chemotherapy and a control group no undergoing chemotherapy, were enrolled in this pilot study. Oral microflora were cultured from three samples of dental plaque at t0 (before chemotherapy), t1 (1 day after chemotherapy) and t2 (7 days after chemotherapy). Single and crossed descriptive analyses were used to establish prevalence, and the χ² test was used to establish the statistical significance of the differences observed in distributions (significance level: P<0.05). In most patients (57%), oral microflora consisted mainly of Gram-positive cocci, while the remaining 43% of the bacterial flora also had periodontal-pathogenic species. No Porphyromonas gingivalis appeared in the test group. Actinobacillus was the least frequently found bacterium among periodontal pathogens in the test group, while Fusobacterium nucleatum was the most frequently found. No significant differences were found in quantitative bacterial changes between t0, t1 and t2 in either the test or control groups, or between the two groups. According to World Health Organization scores, oral mucositis developed in 10 patients (66.6%) in the test group. The results of this pilot study indicate that there were no changes in microflora in dental plaque in cancer patients within 7 days of the first course of chemotherapy. No correlations between oral mucositis and specific microorganisms were assessed.

CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.

PubMed

Kho, Michelle E; Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

2016-04-08

Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. NCT02377830; Pre-results. 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/

Patient participation in cancer clinical trials: A pilot test of lay navigation.

PubMed

Cartmell, Kathleen B; Bonilha, Heather S; Matson, Terri; Bryant, Debbie C; Zapka, Jane G; Bentz, Tricia A; Ford, Marvella E; Hughes-Halbert, Chanita; Simpson, Kit N; Alberg, Anthony J

2016-08-15

Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Voucher-Based Contingent Reinforcement of Smoking Abstinence among Methadone-Maintained Patients: A Pilot Study

ERIC Educational Resources Information Center

Dunn, Kelly E.; Sigmon, Stacey C.; Thomas, Colleen S.; Heil, Sarah H.; Higgins, Stephen T.

2008-01-01

This study evaluated the efficacy of a contingency management (CM) intervention to promote smoking cessation in methadone-maintained patients. Twenty participants, randomized into contingent (n = 10) or noncontingent (n = 10) experimental conditions, completed the 14-day study. Abstinence was determined using breath carbon monoxide and urine…

Emotional wellbeing of blind patients in a pilot trial with subretinal implants.

PubMed

Peters, Tobias; Klingberg, Stefan; Zrenner, Eberhart; Wilhelm, Barbara

2013-06-01

Participation in first human applications of retinal neuroprosthesis may create psychological stress for blind retinitis pigmentosa patients. The aim of this study was to assess the emotional wellbeing of patients undergoing implantation of a subretinal implant. Nine blind patients participating in a pilot trial with subretinal implants were enlisted. The Brief Symptom Inventory (BSI), a short self-report scale of nine primary symptoms, was used to assess reaction to the psychological distress related to study participation. The number and the intensity of symptoms were analysed, and global scores for overall psychological distress (tGSI), severity of reported symptoms (tPDSI), and level number of self-reported symptoms (tPST) were calculated. The questionnaire was administered before implantation, 2-3 times during the trial and before explantation. There were no significant alterations during the trial for the average scores of the nine primary symptoms. One patient, however, showed values higher than the norm, for six subscores before implantation and for eight subscores before explantation. A significant improvement was found in both the overall psychological distress level (tGSI) and the severity of reported symptoms (tPDSI) at the final visit, compared to those at the study start. The number of self-reported symptoms (tPST) was not significantly altered. In the first ongoing pilot trial with an active, cable-bound subretinal implant, we found that trial participation and the implant procedure and subsequent testing did not have any adverse effects on the participants' emotional wellbeing. Their distress generally improved during study participation, rather than showing signs of decreased wellbeing.

Collagen content as a risk factor in breast cancer? A pilot clinical study

NASA Astrophysics Data System (ADS)

Pifferi, Antonio; Quarto, Giovanna; Abbate, Francesca; Balestreri, Nicola; Menna, Simona; Cassano, Enrico; Cubeddu, Rinaldo; Taroni, Paola

2015-07-01

A retrospective pilot clinical study on time domain multi-wavelength (635 to 1060 nm) optical mammography was exploited to assess collagen as a breast-cancer risk factor on a total of 109 subjects (53 healthy and 56 with malignant lesions). An increased cancer occurrence is observed on the 15% subset of patients with higher age-matched collagen content. Further, a similar clustering based on the percentage breast density leads to a different set of patients, possibly indicating collagen as a new independent breast cancer risk factor. If confirmed statistically and on larger numbers, these results could have huge impact on personalized diagnostics, health care systems, as well as on basic research.

Depression and experience of vision loss in group of adults in rehabilitation setting: mixed-methods pilot study.

PubMed

Senra, Hugo; Vieira, Cristina R; Nicholls, Elizabeth G; Leal, Isabel

2013-01-01

There is a paucity of literature regarding the relationship between the experience of vision loss and depression. Therefore, the current pilot study aimed to explore whether significant differences existed in levels of depression between adults with different vision loss experiences. A group of adults aged between 20 and 65 yr old with irreversible vision loss in a rehabilitation setting was interviewed. Semistructured interviews were conducted in order to explore patients' experience of vision loss. The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive levels; 39.5% (n = 15) of patients met CES-D criteria for depression. In addition, higher levels of depression (p < 0.05) were identified in patients whose interviews revealed greater self-awareness of impairment, inadequate social support, and longer rehabilitation stay. Current findings draw attention to variables such as self-awareness of impairment and perceived social support and suggest that depression following vision loss may be related to patients' emotional experiences of impairment and adjustment processes.

Visualizing Patterns of Drug Prescriptions with EventFlow: A Pilot Study of Asthma Medications in the Military Health System

DTIC Science & Technology

2013-06-01

1 Visualizing Patterns of Drug Prescriptions with EventFlow: A Pilot Study of Asthma Medications in the...asthmatics within the Military Health System (MHS). Visualizing the patterns of asthma medication use surrounding a LABA prescription is a quick way to...random sample of 100 asthma patients under age 65 with a new LABA prescription from January 1, 2006-March 1, 2010 in MHS healthcare claims. Analysis was

Adaptive Inferential Feedback Partner Training for Depression: A Pilot Study

ERIC Educational Resources Information Center

Dobkin, Roseanne DeFronzo; Allen, Lesley A.; Alloy, Lauren B.; Menza, Matthew; Gara, Michael A.; Panzarella, Catherine

2007-01-01

Adaptive inferential feedback (AIF) partner training is a cognitive technique that teaches the friends and family members of depressed patients to respond to the patients' dysfunctional thoughts in a targeted manner. These dysfunctional attributions, which AIF addresses, are a common residual feature of depression amongst remitted patients, and…

Care Planning for Prostate Cancer Patients on Active Surveillance

DTIC Science & Technology

2016-10-01

intervention (PCPEP) for prostate cancer patients on active surveillance ( Study Specific Aim 1). As part of the adoption process, we will: (Aim 1a...evaluate the acceptability and feasibility of the program with prostate cancer patients on active surveillance in a small pilot study ( Study Specific...to a poster depicting the study finding on “Treatment 4 Decision-making and Adherence to Active Surveillance in Prostate Cancer Patients” presented

Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program

PubMed Central

Riemann-Lorenz, Karin; Eilers, Marlene; von Geldern, Gloria; Schulz, Karl-Heinz; Köpke, Sascha; Heesen, Christoph

2016-01-01

Background Dietary factors have been discussed to influence risk or disease course of multiple sclerosis (MS). Specific diets are widely used among patients with MS. Objective To design and pilot-test an evidence based patient education program on dietary factors in MS. Methods We performed a systematic literature search on the effectiveness of dietary interventions in MS. A web-based survey among 337 patients with MS and 136 healthy controls assessed knowledge, dietary habits and information needs. An interactive group education program was developed and pilot-tested. Results Fifteen randomised-controlled trials (RCTs) were included in the systematic review. Quality of evidence was low and no clear benefit could be seen. Patients with MS significantly more often adhered to a `Mediterranean Diet`(29.7% versus 14.0%, p<0.001) compared to controls. 143 (42%) of the patients with MS had tried special MS diets. Important information needs addressed effectiveness of MS diets (44%) and relation between nutrition and MS (43%). A pilot test of our newly developed patient education program with 13 participants showed excellent comprehensibility and the MS-specific content was judged as very important. However, the poor evidence base for dietary approaches in MS was perceived disappointing. Conclusions Development and pilot-testing of an evidence-based patient education program on nutrition and MS is feasible. Patient satisfaction with the program suffers from the lack of evidence. Further research should focus on generating evidence for the potential influence of lifestyle habits (diet, physical activity) on MS disease course thus meeting the needs of patients with MS. PMID:27764237

Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.

PubMed

Riemann-Lorenz, Karin; Eilers, Marlene; von Geldern, Gloria; Schulz, Karl-Heinz; Köpke, Sascha; Heesen, Christoph

2016-01-01

Dietary factors have been discussed to influence risk or disease course of multiple sclerosis (MS). Specific diets are widely used among patients with MS. To design and pilot-test an evidence based patient education program on dietary factors in MS. We performed a systematic literature search on the effectiveness of dietary interventions in MS. A web-based survey among 337 patients with MS and 136 healthy controls assessed knowledge, dietary habits and information needs. An interactive group education program was developed and pilot-tested. Fifteen randomised-controlled trials (RCTs) were included in the systematic review. Quality of evidence was low and no clear benefit could be seen. Patients with MS significantly more often adhered to a `Mediterranean Diet`(29.7% versus 14.0%, p<0.001) compared to controls. 143 (42%) of the patients with MS had tried special MS diets. Important information needs addressed effectiveness of MS diets (44%) and relation between nutrition and MS (43%). A pilot test of our newly developed patient education program with 13 participants showed excellent comprehensibility and the MS-specific content was judged as very important. However, the poor evidence base for dietary approaches in MS was perceived disappointing. Development and pilot-testing of an evidence-based patient education program on nutrition and MS is feasible. Patient satisfaction with the program suffers from the lack of evidence. Further research should focus on generating evidence for the potential influence of lifestyle habits (diet, physical activity) on MS disease course thus meeting the needs of patients with MS.

Post-operative shampoo effects in neurosurgical patients: a pilot experimental study.

PubMed

Palese, Alvisa; Moreale, Renzo; Noacco, Massimo; Pistrino, Flavia; Mastrolia, Irene; Sartor, Assunta; Scarparo, Claudio; Skrap, Miran

2015-04-01

Neurosurgical site infections are an important issue. Among the acknowledged preventive tactics, the non-shaving technique is well established in the neurosurgical setting. However, given that patient's hair around the surgical site may retain biologic material that emerges during the surgical procedure or that may simply become dirty, which may increase the risk of surgical site infections, if and when shampooing should be offered remains under debate. A pilot experimental study was undertaken from 2011 to 2012. A series of neurosurgical patients not affected by conditions that would increase the risk of post-operative infection were assigned randomly to the exposed group (receiving shampoo 72 h after surgical procedure) or control group (receiving standard dressing surveillance without shampooing). Comfort, surgical site contamination (measured as the number of colony-forming units [CFU]), and SSIs at 30 d after surgery were the main study outcomes. A total of 53 patients were included: 25 (47.2%) received a shampoo after 72 h whereas 28 (52.8%) received standard care. Patients who received a shampoo reported a similar level of comfort (average=8.04; standard deviation [SD] 1.05) compared with those receiving standard care (average 7.3; SD 3.2) although this was not statistically significant (p=0.345). No statistically significant difference emerged in the occurrence of surgical site contamination between the groups, and no SSIs were detected within 30 d. In our pilot study, the results of which are not generalizable because of the limited sample of patients involved, a gentle shampoo offered 72 h after the surgical procedure did not increase the SSIs occurrence or the contamination of the surgical site, although it may increase the perception of comfort by patients. Further studies are strongly recommended involving a larger sample size and designed to include more diversified neurosurgical patients undergoing surgical procedures in different centers.

Group supervision for healthcare professionals within primary care for patients with psychosomatic health problems: a pilot intervention study.

PubMed

Bullington, Jennifer; Cronqvist, Agneta

2018-03-01

In primary health care, efficacious treatment strategies are lacking for these patients, although the most prominent symptoms accounting for consultation in primary care often cannot be related to any biological causes. The aim was to explore whether group supervision from a specific phenomenological theory of psychosomatics could provide healthcare professionals treating patients with psychosomatic health issues within primary care a deeper understanding of these conditions and stimulate profession-specific treatment strategies. Our research questions were as follows: (i) What is the healthcare professionals' understanding of psychosomatics before and after the intervention? (ii) What are the treatment strategies for this group of patients before and after the intervention? The study was an explorative qualitative intervention pilot study. The six participants from a primary healthcare setting in a medium-sized city in Sweden participated in the study. A supervision group was formed, based on a mix of professions, age, gender and years of clinical experience. Supervision consisted of one 75-minutes meeting every month during the course of 6 months. Participants were interviewed before and after the supervision intervention. The study showed two distinct categories emerged from the data. One category of healthcare professionals espoused a psycho-educative approach, while the other lacked a cohesive approach. The supervision improved the second category of healthcare professionals' understanding of psychosomatics. The psycho-educative group did not change their understanding of psychosomatics, although they felt strengthened in their approach by the supervision. Profession-specific strategies were not developed. This pilot study indicates that a relatively short supervision intervention can aid clinicians in their clinical encounters with these patients; however, further research is necessary to ascertain the value of the specific phenomenologically based supervision intervention. © 2017 Nordic College of Caring Science.

Use of 99mTc-Tilmanocept as a Single Agent for Sentinel Lymph Node Identification in Breast Cancer: A Retrospective Pilot Study.

PubMed

Unkart, Jonathan T; Wallace, Anne M

2017-09-01

99m Tc-tilmanocept received recent Food and Drug Administration approval for lymphatic mapping in 2013. However, to our knowledge, no prior studies have evaluated the use of 99m Tc-tilmanocept as a single agent in sentinel lymph node (SLN) biopsy in breast cancer. Methods: We executed this retrospective pilot study to assess the ability of 99m Tc-tilmanocept to identify sentinel nodes as a single agent in clinically node-negative breast cancer patients. Patients received a single intradermal injection overlying the tumor of either 18.5 MBq (0.5 mCi) of 99m Tc-tilmanocept on the day of surgery or 74.0 MBq (2.0 mCi) on the day before surgery by a radiologist. Immediate 3-view lymphoscintigraphy was performed. Intraoperatively, SLNs were identified with a portable γ-probe. A node was classified as hot if the count (per second) of the node was more than 3 times the background count. Descriptive statistics are reported. Results: Nineteen patients underwent SLN biopsy with single-agent 99m Tc-tilmanocept. Immediate lymphoscintigraphy identified at least 1 sentinel node in 13 of 17 patients (76.5%). Intraoperatively, at least 1 (mean, 1.7 ± 0.8; range, 1-3) hot node was identified in all patients. Three patients (15.8%) had 1 disease-positive SLN. Conclusion: In this small, retrospective pilot study, 99m Tc-tilmanocept performed well as a single agent for intraoperative sentinel node identification in breast cancer. A larger, randomized clinical trial is warranted to compare 99m Tc-tilmanocept as a single agent with other radiopharmaceuticals for sentinel node identification in breast cancer. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

The Subgingival Microbiome of Periodontal Pockets With Different Probing Depths in Chronic and Aggressive Periodontitis: A Pilot Study.

PubMed

Shi, Meng; Wei, Yiping; Hu, Wenjie; Nie, Yong; Wu, Xiaolei; Lu, Ruifang

2018-01-01

Periodontitis is a kind of infectious disease initiated by colonization of subgingival periodontal pathogens, which cause destruction of tooth-supporting tissues, and is a predominant threat to oral health as the most common cause of loss of teeth. The aim of this pilot study was to characterize the subgingival bacterial biodiversity of periodontal pockets with different probing depths in patients with different forms of periodontitis. Twenty-one subgingival plaque samples were collected from three patients with chronic periodontitis (ChP), three patients with aggressive periodontitis (AgP) and three periodontally healthy subjects (PH). Each patient with periodontitis was sampled at three sites, at different probing depths (PDs, one each at 4 mm, 5-6 mm, and ≥ 7 mm). Using 16S rRNA gene high-throughput sequencing and bioinformatic analysis, we found that subgingival communities in health and periodontitis samples largely differed. Meanwhile, Acholeplasma, Fretibacterium, Porphyromonas, Peptococcus, Treponema_2, Defluviitaleaceae_UCG_011, Filifactor , and Mycoplasma increased with the deepening of the pockets in ChP, whilst only Corynebacterium was negatively associated with PD. In AgP, Corynebacterium and Klebsiella were positively associated with PD, while Serratia, Pseudoramibacter, Defluviitaleaceae_UCG_011 , and Desulfobulbus were negatively associated with PD. And among these two groups, Corynebacterium shifted differently. Moreover, in subgingival plaque, the unweighted UniFrac distances between samples from pockets with different PD in the same patients were significantly lower than those from pockets within the same PD category from different patients. This study demonstrated the shift of the subgingival microbiome in individual teeth sites during disease development. Within the limitation of the relative small sample size, this pilot study shed new light on the dynamic relationship between the extent of periodontal destruction and the subgingival microbiome.

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

PubMed

Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

PubMed

Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

2015-02-01

Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

Financial impact of allogeneic hematopoietic cell transplantation on patients and families over 2 years: results from a multicenter pilot study.

PubMed

Denzen, E M; Thao, V; Hahn, T; Lee, S J; McCarthy, P L; Rizzo, J D; Ammi, M; Drexler, R; Flesch, S; James, H; Omondi, N; Murphy, E; Pederson, K; Majhail, N S

2016-09-01

Hematopoietic cell transplantation (HCT) is a procedure that can significantly influence the socioeconomic wellbeing of patients, caregivers and their families. Among 30 allogeneic HCT recipients and their caregivers enrolled on a pilot study evaluating the feasibility of studying financial impact of HCT, 16 agreed to participate in the long-term phase, completed a baseline questionnaire and received phone interviews at 6, 12, 18 and 24 months post HCT. Analyses showed that by 2 years post HCT, 54% of patients who previously contributed to household earnings had not returned to work and 80% of patients/caregivers reported transplant as having moderate to great impact on household income. However, patients' levels of confidence in their abilities to meet household financial obligations increased from baseline to 2 years. A relatively large proportion of patients reported inability to pay for medical care through this time period. Case studies demonstrated that patients' individual perceptions of the financial impact of HCT varies considerably, regardless of actual income. We demonstrate the feasibility of conducting a study to evaluate the financial impact of allogeneic HCT through 2 years post transplantation. Some patients/caregivers continue to experience a significant long-term financial burden after this procedure. Our study lays the foundation for a larger evaluation of patient/caregiver financial burden associated with HCT.

Ziprasidone versus clozapine in the treatment of dually diagnosed (DD) patients with schizophrenia and cannabis use disorders: a randomized study.

PubMed

Schnell, Thomas; Koethe, Dagmar; Krasnianski, Anna; Gairing, Stefanie; Schnell, Knut; Daumann, Jörg; Gouzoulis-Mayfrank, Euphrosyne

2014-01-01

Clozapine is considered to be particularly effective in the treatment of dually diagnosed (DD) patients with psychosis and substance use disorders. However, its use is restricted by potentially severe side effects. The aim of the present pilot study was to compare the effects of clozapine with the newer second generation antipsychotic (SGA) ziprasidone in DD-patients. Thirty (n = 30) patients with schizophrenia and cannabis abuse/dependence were randomized to ziprasidone or clozapine and were followed up for up to 12 months. Cannabis use was reduced in both groups during follow-up. Clozapine treatment was associated with less positive symptoms of schizophrenia, more side effects and poorer compliance with treatment. Results from this small pilot RCT suggest beneficial effects of both clozapine and ziprasidone in the treatment of cannabis use disorders in psychotic patients. Larger-scale RCTs are needed in order to assess advantages and disadvantages of the different SGAs in dually diagnosed populations. © American Academy of Addiction Psychiatry.

Osteopathy for Endometriosis and Chronic Pelvic Pain - a Pilot Study.

PubMed

Sillem, M; Juhasz-Böss, I; Klausmeier, I; Mechsner, S; Siedentopf, F; Solomayer, E

2016-09-01

Introduction: Pelvic pain is a common problem in gynaecological practice. It is often unclear whether definite causality exists between reported symptoms and objective clinical findings of the female genital tract, and medical or operative treatments do not always achieve long-term resolution of symptoms. Methods: This pilot study investigated 28 patients (age 20-65, median 36.5 years) from a gynaecology practice whose only clinical finding was painful pelvic floor muscle tightness. Following standardised gynaecological and physiotherapist examination, all patients received osteopathic treatment. Pain had been present for a median of 3 years (range 1 month to 20 years). 14 patients had previously confirmed endometriosis. Treatment success was evaluated on consultation with patients in person or in writing. Results: 22 of the 28 participants completed the treatment according to plan. Overall, 17 reported symptom improvement, while 10 of the 14 patients with endometriosis did. Conclusion: Osteopathy is well received by women with painful pelvic floor muscle tightness and appears to be an effective treatment option.

Effect of patient age awareness on diagnostic agreement of chronic or aggressive periodontitis between clinicians; a pilot study.

PubMed

Oshman, Sarah; El Chaar, Edgard; Lee, Yoonjung Nicole; Engebretson, Steven

2016-07-25

The aim of this pilot study was to test whether diagnostic agreement of aggressive and chronic periodontitis amongst Board Certified Periodontists, is influenced by knowledge of a patient's age. In 1999 at the International World Workshop age was removed as a diagnostic criteria for aggressive periodontitis. The impact of this change on the diagnostic reliability amongst clinicians has not yet been assessed. Nine periodontal case reports were twice presented to sixteen board certified periodontists, once with age withheld and again with patient age provided. Participants were instructed to choose a diagnosis of Chronic Periodontitis or Aggressive Periodontitis. Diagnostic agreement was calculated using the Fleiss Kappa test. Including the patients' age in case report information increased diagnostic agreement (the kappa statistic) from 0.49 (moderate agreement) to 0.61 (substantial agreement). These results suggest that knowledge of a patients' age influenced clinical diagnosis, when distinguishing between aggressive periodontitis and chronic periodontitis, which may in turn impact treatment decision-making.

The herbal medicine daikenchuto ameliorates an impaired anorectal motor activity in postoperative pediatric patients with an anorectal malformation--a pilot study.

PubMed

Takagi, Akiko; Yagi, Minoru; Tanaka, Yoshiaki; Asagiri, Kimio; Asakawa, Takahiro; Tanaka, Hiroaki; Ishii, Shinji; Egami, Hideaki; Akaiwa, Masao; Tsuru, Tomomitsu

2010-01-01

Fecoflowmetry (FFM) has been introduced to simulate natural anorectal evacuation. So far, few reports have described the effect of the herbal medicine Daikenchuto (DKT) on impaired anorectal motor function. The aim of this pilot study was to assess anorectal motor function by FFM in postoperatively impaired patients with an anorectal malformation (ARM) before and after administration of DKT. Six postoperative patients with ARM (mean age, 7.8 years) who complained of intractable constipation with soiling in spite of administration of magnesia as a laxative were assessed over an extended period. These patients received 0.3 g/kg/d of DKT for an average of 128 days. Evacuative rate and maximum fecal stream flow were seen to increase significantly after administration of DKT when compared with values before administration of DKT. In conclusion, DKT had a favorable clinical effect on anorectal motor function in postoperative patients with ARM.

Improving Health Care Quality and Patient Safety Through Peer-to-Peer Assessment: Demonstration Project in Two Academic Medical Centers.

PubMed

Mort, Elizabeth; Bruckel, Jeffrey; Donelan, Karen; Paine, Lori; Rosen, Michael; Thompson, David; Weaver, Sallie; Yagoda, Daniel; Pronovost, Peter

Despite decades of investment in patient safety, unintentional patient harm remains a major challenge in the health care industry. Peer-to-peer assessment in the nuclear industry has been shown to reduce harm. The study team's goal was to pilot and assess the feasibility of this approach in health care. The team developed tools and piloted a peer-to-peer assessment at 2 academic hospitals: Massachusetts General Hospital and Johns Hopkins Hospital. The assessment evaluated both the institutions' organizational approach to quality and safety as well as their approach to reducing 2 specific areas of patient harm. Site visits were completed and consisted of semistructured interviews with institutional leaders and clinical staff as well as direct patient observations using audit tools. Reports with recommendations were well received and each institution has developed improvement plans. The study team believes that peer-to-peer assessment in health care has promise and warrants consideration for wider adoption.

A pilot study to assess the pharmacy impact of implementing a chemotherapy-induced nausea or vomiting collaborative disease therapy management in the outpatient oncology clinics.

PubMed

Jackson, Kasey; Letton, Cathy; Maldonado, Andy; Bodiford, Andrew; Sion, Amy; Hartwell, Rebekah; Graham, Anastasia; Bondarenka, Carolyn; Uber, Lynn

2018-01-01

Background Collaborative drug therapy management is a formal partnership between a pharmacist and physician to allow the pharmacist to manage a patient's drug therapy. Literature supports collaborative disease therapy management can improve patient outcomes, improve medication adherence, enhance medication safety, and positively influence healthcare expenditures. Chemotherapy induced nausea or vomiting is considered one of the most distressing and feared adverse events among patients receiving chemotherapy. Chemotherapy induced nausea or vomiting can impact a patient's quality of life and may affect compliance with the treatment plan. Purpose The objective of this pilot study was to determine the pharmacy impact of implementing a chemotherapy induced nausea or vomiting collaborative disease therapy management protocol in the outpatient oncology clinics at a National Cancer Institute (NCI)-designated cancer center associated with an academic medical center. The primary endpoint was to determine the number and type of chemotherapy induced nausea or vomiting clinical interventions made by the oncology pharmacists. Secondary endpoints included comparing patient's Multinational Association for Supportive Care in Cancer scores and revenue of pharmacists' services. Methods The credentialed oncology pharmacists were consulted by an oncologist to manage chemotherapy induced nausea or vomiting. Patients were included in the chemotherapy induced nausea or vomiting collaborative disease therapy management if they were seen in an outpatient oncology clinic from October 2016 to January 2017 and had a referral from a qualified provider to help manage chemotherapy induced nausea or vomiting. Patients admitted to the hospital at the time of consult were excluded from the study. The pharmacists interviewed patients and provided recommendations. The pharmacists followed up with the patient via a telephone call or during the next scheduled clinic visit to assess their symptoms. Results The chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study was implemented in October 2016. From October 2016 to January 2017, there were 45 consults for the management of chemotherapy induced nausea or vomiting. The pharmacists made 188 clinical interventions, which included addition of new medications (37%), patient education (34%), deletion of medications (10%), changing a dose/duration/frequency (8%), and other interventions (11%). Multinational Association for Supportive Care in Cancer symptom scores were available for 5 patients, in which all showed improvements from baseline with the pharmacists' clinical interventions. Conclusions The implementation of our chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study has shown favorable results after a 4-month evaluation period. The pharmacists have made a substantial number of clinical interventions and provided patient education to patients undergoing chemotherapy.

Impact of a Focused Approach for Discharge Teaching Regarding the Use of Aspirin as Anticoagulant After Joint Replacement Surgery.

PubMed

Wittig-Wells, Deborah; Higgins, Melinda; Davis, Erica; Johnson, Ifeya; Louis, Latalya; Mason, Olga; Samms-McPherson, Jacqueline; Sims, Sandra; Jacob, Ani

2015-01-01

Patient education for the use and administration of aspirin (ASA) as an anticoagulant may be deficient. To pilot a knowledge assessment tool regarding the use of aspirin (ASA) as an anticoagulant and to evaluate the impact of a focused approach for discharge teaching. One-group pretest-posttest pilot study. Convenience sample of patients hospitalized for total knee and total hip arthroplasty. Researcher developed ASA quiz. Focused education on aspirin as an anticoagulant. There was a statistically significant improvement in knowledge (Wilcoxon rank sum test Z = 3.880, p < .001).

Trials, tribulations, and triumphs of a pilot initiative to optimize the management of wounds complicated by diabetes within the home.

PubMed

Hodgins, Marilyn J; Logan, Susan M; Price, Karla; Thompson, Carol

2014-01-01

To support home health care nurses in their efforts to optimize the management of patients with wounds complicated by diabetes, an initiative was introduced that incorporated a standardized assessment tool, electronic data entry, and the provision of written treatment recommendations with supporting rationale prepared by nurses with expertise in diabetes and wound care. A pilot study was conducted that provided preliminary evidence of the feasibility of this initiative as well as its potential effect on outcomes for patients, nurses, and the home care program.

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

PubMed

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

A pilot study of expenditures on, and utilization of resources in, health care in adults with congenital heart disease.

PubMed

Moons, P; Siebens, K; De Geest, S; Abraham, I; Budts, W; Gewillig, M

2001-05-01

Congenital cardiac disease may be a chronic condition, necessitating life-long follow-up for a substantial proportion of the patients. Such patients, therefore, are often presumed to be high users of resources for health care. Information on utilization of resources in adults with congenital heart disease, however, is scarce. This retrospective pilot study, performed in Belgium, investigated 192 adults with congenital heart disease to measure the annual expenditures and utilization of health care and compared the findings with data from the general population. We also sought to explore demographic and clinical parameters as predictors for the expenditures. Hospitalization was documented in 20.3% of the patients, with a median length of stay of 5 days. The overall payment by health insurance associations in 1997 was 1794.5 ECU per patient, while patients paid on average 189.5 ECU out-of-pocket. For medication, the average reimbursement and out-of-pocket expenses were estimated at 78 ECU and 20 ECU, respectively. Expenditures for patients with congenital heart disease were considerably higher than the age and gender-corrected expenditures for the general population (411.7 ECU), though this difference was accounted for by only one-eighth of the cohort of those with congenital heart disease. In general, higher expenditures were associated with abnormal left ventricular end-diastolic diameter, female gender, functional impairment and higher age, although the explained variance was limited. Our study has provided pilot data on the economic outcomes for patients with congenital heart diseases. We have identified parameters that could predict expenditure, but which will have to be examined in future research. This is needed to develop guidelines for health insurance for those with congenital heart diseases.

A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.

PubMed

Blackhall, Leslie; Petroni, Gina; Shu, Jianfen; Baum, Lora; Farace, Elena

2009-05-01

Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinal was self-administered at a dose of 100 mg/d during weeks 1-2, and 200 mg during weeks 3-4. Assessments were performed at baseline, 2, and 4 weeks. BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p < 0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social/family well-being, were improved (p < 0.05) at 2 and 4 weeks. Significant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modafinil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity. In this pilot study modafinil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.

Correlation of serum MMP3 and other biomarkers with clinical outcomes in patients with ankylosing spondylitis: A pilot study

USDA-ARS?s Scientific Manuscript database

The studies aimed to assess a set of biomarkers for their correlations with disease activity/severity of patients with ankylosing spondylitis (AS). A total of 24 AS patients were treated with etanercept and prospectively followed for 12 weeks. Serum levels of TNF-alpha, IFN-gamma, TGF-beta, IL6, IL1...

Age, gender, neck circumference, and Epworth sleepiness scale do not predict obstructive sleep apnea (OSA) in moderate to severe chronic obstructive pulmonary disease (COPD): The challenge to predict OSA in advanced COPD.

PubMed

Soler, Xavier; Liao, Shu-Yi; Marin, Jose Maria; Lorenzi-Filho, Geraldo; Jen, Rachel; DeYoung, Pamela; Owens, Robert L; Ries, Andrew L; Malhotra, Atul

2017-01-01

The combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is associated with substantial morbidity and mortality. We hypothesized that predictors of OSA among patients with COPD may be distinct from OSA in the general population. Therefore, we investigated associations between traditional OSA risk factors (e.g. age), and sleep questionnaires [e.g. Epworth Sleepiness Scale] in 44 patients with advanced COPD. As a second aim we proposed a pilot, simplified screening test for OSA in patients with COPD. In a prospective, observational study of patients enrolled in the UCSD Pulmonary Rehabilitation Program we collected baseline characteristics, cardiovascular events (e.g. atrial fibrillation), and sleep questionnaires [e.g. Pittsburgh Sleep Quality Index (PSQI)]. For the pilot questionnaire, a BMI ≥25 kg/m2 and the presence of cardiovascular disease were used to construct the pilot screening test. Male: 59%; OSA 66%. FEV1 (mean ± SD) = 41.0±18.2% pred., FEV1/FVC = 41.5±12.7%]. Male gender, older age, and large neck circumference were not associated with OSA. Also, Epworth Sleepiness Scale and the STOP-Bang questionnaire were not associated with OSA in univariate logistic regression. In contrast, BMI ≥25 kg/m2 (OR = 3.94, p = 0.04) and diagnosis of cardiovascular disease (OR = 5.06, p = 0.03) were significantly associated with OSA [area under curve (AUC) = 0.74]. The pilot COPD-OSA test (OR = 5.28, p = 0.05) and STOP-Bang questionnaire (OR = 5.13, p = 0.03) were both associated with OSA in Receiver Operating Characteristics (ROC) analysis. The COPD-OSA test had the best AUC (0.74), sensitivity (92%), and specificity (83%). A ten-fold cross-validation validated our results. We found that traditional OSA predictors (e.g. gender, Epworth score) did not perform well in patients with more advanced COPD. Our pilot test may be an easy to implement instrument to screen for OSA. However, a larger validation study is necessary before further clinical implementation is warranted.

Age, gender, neck circumference, and Epworth sleepiness scale do not predict obstructive sleep apnea (OSA) in moderate to severe chronic obstructive pulmonary disease (COPD): The challenge to predict OSA in advanced COPD

PubMed Central

Marin, Jose Maria; Lorenzi-Filho, Geraldo; Jen, Rachel; DeYoung, Pamela; Owens, Robert L.; Ries, Andrew L.; Malhotra, Atul

2017-01-01

The combination of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is associated with substantial morbidity and mortality. We hypothesized that predictors of OSA among patients with COPD may be distinct from OSA in the general population. Therefore, we investigated associations between traditional OSA risk factors (e.g. age), and sleep questionnaires [e.g. Epworth Sleepiness Scale] in 44 patients with advanced COPD. As a second aim we proposed a pilot, simplified screening test for OSA in patients with COPD. In a prospective, observational study of patients enrolled in the UCSD Pulmonary Rehabilitation Program we collected baseline characteristics, cardiovascular events (e.g. atrial fibrillation), and sleep questionnaires [e.g. Pittsburgh Sleep Quality Index (PSQI)]. For the pilot questionnaire, a BMI ≥25 kg/m2 and the presence of cardiovascular disease were used to construct the pilot screening test. Male: 59%; OSA 66%. FEV1 (mean ± SD) = 41.0±18.2% pred., FEV1/FVC = 41.5±12.7%]. Male gender, older age, and large neck circumference were not associated with OSA. Also, Epworth Sleepiness Scale and the STOP-Bang questionnaire were not associated with OSA in univariate logistic regression. In contrast, BMI ≥25 kg/m2 (OR = 3.94, p = 0.04) and diagnosis of cardiovascular disease (OR = 5.06, p = 0.03) were significantly associated with OSA [area under curve (AUC) = 0.74]. The pilot COPD-OSA test (OR = 5.28, p = 0.05) and STOP-Bang questionnaire (OR = 5.13, p = 0.03) were both associated with OSA in Receiver Operating Characteristics (ROC) analysis. The COPD-OSA test had the best AUC (0.74), sensitivity (92%), and specificity (83%). A ten-fold cross-validation validated our results. We found that traditional OSA predictors (e.g. gender, Epworth score) did not perform well in patients with more advanced COPD. Our pilot test may be an easy to implement instrument to screen for OSA. However, a larger validation study is necessary before further clinical implementation is warranted. PMID:28510598

Feasibility of a combined aerobic and strength training program and its effects on cognitive and physical function in institutionalized dementia patients. A pilot study.

PubMed

Bossers, Willem J R; Scherder, Erik J A; Boersma, Froukje; Hortobágyi, Tibor; van der Woude, Lucas H V; van Heuvelen, Marieke J G

2014-01-01

We examined the feasibility of a combined aerobic and strength training program in institutionalized dementia patients and studied the effects on cognitive and physical function. Thirty-three patients with dementia, recruited from one nursing home, participated in this non-randomized pilot study (25 women; age = 85.2±4.9 years; Mini Mental State Examination = 16.8±4.0). In phase 1 of the study, seventeen patients in the Exercise group (EG) received a combined aerobic and strength training program for six weeks, five times per week, 30 minutes per session, in an individually supervised format and successfully concluded the pre and posttests. In phase 2 of the study, sixteen patients in the Social group (SG) received social visits at the same frequency, duration, and format and successfully concluded the pre and posttests. Indices of feasibility showed that the recruitment and adherence rate, respectively were 46.2% and 86.3%. All EG patients completed the exercise program according to protocol without adverse events. After the six-week program, no significant differences on cognitive function tests were found between the EG and SG. There was a moderate effect size in favor for the EG for the Visual Memory Span Forward; a visual attention test. There were significant differences between groups in favor for the EG with moderate to large effects for the physical tests Walking Speed (p = .003), Six-Minute Walk Test (p = .031), and isometric quadriceps strength (p = .012). The present pilot study showed that it is feasible to conduct a combined aerobic and strength training program in institutionalized patients with dementia. The selective cognitive visual attention improvements and more robust changes in motor function in favor of EG vs. SG could serve as a basis for large randomized clinical trials. trialregister.nl 1230.

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

PubMed

Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

2016-06-01

Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Pilot parallel three-arm randomised controlled trial nested within feasibility work. Two UK NHS departments of upper gastrointestinal surgery. Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%). Rapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study. Current Controlled Trials ISRCTN59036820. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.

Effectiveness of Electroconvulsive Therapy in Persistent Methamphetamine Psychosis: A Pilot Study

PubMed Central

Ziaaddini, Hassan; Roohbakhsh, Toktam; Nakhaee, Nouzar; Ghaffari-Nejad, Alireza

2015-01-01

Background Persistent methamphetamine (METH) psychosis is a psychotic state beyond 1-month after abstinence, for which there is no effective treatment. This study aimed to evaluate the effectiveness of electroconvulsive therapy (ECT) in persistent METH psychosis patients hospitalized at Shahid Beheshti Hospital, Kerman, Iran, from 6 September 2012 until 6 September 2013, who were not remitted after treatment with olanzapine. Methods This research was a pilot study on hospitalized patients. After 4 weeks of treatment with olanzapine, 10 out of 71 studied patients did not show complete remission of psychotic symptoms despite their response to the treatment. The mentioned 10 patients were divided into 2 groups by random digit numbers. 5 patients had continued olanzapine and other 5 received 6 sessions of bilateral ECT every other day in addition to olanzapine. Findings Remission rate of patients in the initial 4 weeks was 78.7%. Reduction in total brief psychiatric rating scale (BPRS) scale at the end of 1-week compared with the next week demonstrated improvement in the symptoms until the end of the study. There was no significant difference in BPRS scores between weeks 4 and 6 in the two groups. Conclusion This research demonstrated that few sessions of ECT in persistent METH psychosis will not lead to remission in all patients. PMID:26322206

Psychoeducational support to post cardiac surgery heart failure patients and their partners--a randomised pilot study.

PubMed

Ågren, Susanna; Berg, Sören; Svedjeholm, Rolf; Strömberg, Anna

2015-02-01

Postoperative heart failure is a serious complication that changes the lives of both the person who is critically ill and family in many ways. The purpose of this study was to evaluate the effects of an intervention in postoperative heart failure patient-partner dyads regarding health, symptoms of depression and perceived control. Pilot study with a randomised controlled design evaluating psychosocial support and education from an interdisciplinary team. Patients with postoperative heart failure and their partners. SF-36, Beck Depression Inventory, Perceived Control at baseline, 3 and 12 months. A total of 42 patient-partner completed baseline assessment. Partners in the intervention group increased health in the role emotional and mental health dimensions and patients increased health in vitality, social function and mental health dimensions compared with the control group. Patients' perceived control improved significantly in the intervention group over time. Psychoeducational support to post cardiac surgery heart failure dyads improved health in both patients and partners at short term follow-up and improved patients' perceived control at both short and long-term follow-up. Psychoeducational support appears to be a promising intervention but the results need to be confirmed in larger studies. Copyright © 2014 Elsevier Ltd. All rights reserved.

The affordability for patients of a new universal MDR-TB coverage model in China.

PubMed

Ruan, Y-Z; Li, R-Z; Wang, X-X; Wang, L-X; Sun, Q; Chen, C; Xu, C-H; Su, W; Zhao, J; Pang, Y; Cheng, J; Wang, Q; Fu, Y-T; Huan, S-T; Chen, M-T; Scano, F; Floyd, K; Chin, D P; Fitzpatrick, C

2016-05-01

China has piloted a new model of universal coverage for multidrug-resistant tuberculosis (MDR-TB), designed to rationalize hospital use of drugs and tests and move away from fee-for-service payment towards a standard package with financial protection against catastrophic health costs. To evaluate the affordability to patients of this new model. This was an observational study of 243 MDR-TB cases eligible for enrolment on treatment under the project. We assessed the affordability of the project from the perspective of households, with a focus on catastrophic costs. Of the 243 eligible cases, 172 (71%) were enrolled on treatment; of the 71 cases not enrolled, 26 (37%) cited economic reasons. The 73 surveyed cases paid an average of RMB 5977 (US$920) out-of-pocket in search costs incurred outside the pilot model. Within the pilot, they paid another RMB 2094 (US$322) in medical fees and RMB 5230 (US$805) in direct non-medical costs. Despite 90% reimbursement of medical fees, 78% of households experienced catastrophic costs, including indirect costs. The objectives of the pilot model are aligned with health reform in China and universal health coverage globally. Enrollment would almost certainly be higher with 100% reimbursement of medical fees, but patient enablers will be required to truly eliminate catastrophic costs.

QUETIAPINE IMPROVES RESPONSE INHIBITION IN ALCOHOL DEPENDENT PATIENTS: A PLACEBO-CONTROLLED PILOT STUDY

PubMed Central

Moallem, Nathasha; Ray, Lara A.

2013-01-01

Rationale Quetiapine has been shown to be a promising medication for the treatment of alcoholism. As an atypical antipsychotic medication with antagonist activity at D1 and D2, 5-HT1A and 5-HT2A, H1 and α1 and α2 receptors, quetiapine has been found to decrease impulsivity in other psychiatric disorders but its effects on impulsivity have not been studied in alcohol dependent patients. Objective This study seeks to test the effects of quetiapine on a specific dimension of impulsivity, namely response inhibition. This pilot study seeks to further elucidate the mechanisms of action of quetiapine for alcohol use disorders. Method A total of 20 non-treatment seeking alcohol dependent individuals were randomized to one of the following conditions in a double-blind, placebo-controlled design: (1) quetiapine (400 mg/day); or (2) matched placebo. Participants completed two counterbalanced intravenous placebo-alcohol administration sessions as well as behavioral measure of response inhibition (i.e. stop signal task) pre and post placebo-alcohol administration sessions. Results Analyses revealed a significant effect of quetiapine in improving response inhibition as measured by the stop signal task. These results provide preliminary evidence suggesting that quetiapine improves response inhibition in alcohol dependent patients, as compared to placebo. Conclusion This pilot study contributes a novel putative mechanism of action of quetiapine in alcoholism, namely an improvement in response inhibition. PMID:22037407

Ostomy creation with fewer sutures using tissue adhesives (cyanoacrylates) in inflammatory bowel disease: a pilot study.

PubMed

Uchino, M; Ikeuchi, H; Bando, T; Sasaki, H; Chohno, T; Horio, Y; Takesue, Y

2018-03-01

Introduction Fistula formation around the ostomy site is a stoma-related complication often requiring surgical intervention. This complication may be caused by sutures or may develop as a complication of inflammatory bowel disease. Before conducting a clinical trial, we set out to investigate the safety of ostomy creation with fewer sutures using tissue adhesives in this pilot study. Methods Patients with inflammatory bowel disease who required surgery with ostomy creation at the Hyogo College of Medicine between January 2014 and December 2015 were enrolled. Safety was assessed by evaluating the incidence of stoma-related complications. Ostomy was restricted to loop ileostomy and was created with two sutures and tissue adhesives. Results A total of 14 patients were enrolled. Mean body mass index was 18.9 ± 2.0 kg/m 2 . There were no cases of ostomy retraction and no severe adverse events were observed. Conclusions This pilot study demonstrates that ostomy creation using tissue adhesives is safe. Although retraction and adverse events were not observed, even in patients with inflammatory bowel disease who generally exhibit delayed wound healing, the body mass index was extremely low in this series. This study does not strongly recommend ostomy creation with tissue adhesives; further studies are needed to clarify the efficacy and safety of the procedure.

Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.

PubMed

Sakuraba, Atsushi; Sato, Toshiro; Morohoshi, Yuichi; Matsuoka, Katsuyoshi; Okamoto, Susumu; Inoue, Nagamu; Takaishi, Hiromasa; Ogata, Haruhiko; Iwao, Yasushi; Hibi, Toshifumi

2012-06-01

The effect of granulocyte and monocyte adsorption apheresis (GMA) on prevention of relapse of ulcerative colitis (UC) is not clear. This was a pilot open-labeled, prospective, randomized, unblinded study to compare the tolerability and efficacy of intermittent GMA (once every 2 weeks) with mercaptopurine to maintain remission of UC. Twenty-one patients with UC, who had achieved remission by induction therapies were randomly assigned to receive either intermittent GMA (N = 10) or oral mercaptopurine (0.5 mg/kg per day; N = 11). The study period was 24 months. The rate of the patients maintaining remission and the incidences of adverse effects were compared between the two groups. At 24 months, seven of 10 patients (70.0%) on intermittent GMA and seven of 11 patients (63.6%, P = 1.00) on oral mercaptopurine were still in remission. Three patients relapsed in each group. One patient taking mercaptopurine, but none receiving intermittent GMA, dropped out because of adverse effects. Intermittent therapy with GMA was well tolerated and a substantial proportion of patients maintained remission. Intermittent GMA therapy in maintaining remission of UC merits further investigation. © 2012 The Authors. Therapeutic Apheresis and Dialysis © 2012 International Society for Apheresis.

Electrolytic ablation as an adjunct to liver resection: Safety and efficacy in patients.

PubMed

Wemyss-Holden, Simon A; Berry, David P; Robertson, Gavin S M; Dennison, Ashley R; De La M Hall, Pauline; Maddern, Guy J

2002-08-01

Electrolytic ablation is a relatively new method for the local destruction of colorectal liver metastases. Experimental work in animal models has shown this method to be safe and efficacious. However, before proceeding to clinical trials it was necessary to confirm these findings in a pilot study of five patients. Five patients with colorectal liver metastases were studied prospectively. Each patient underwent a potentially curative liver resection. One of the metastases to be removed was treated using electrolysis before resection. Each patient was monitored closely during and after electrolysis to determine any morbidity associated with the treatment. Once resected, the metastases were examined histologically for completeness of ablation. All patients tolerated the electrolysis well; there were no deaths or complications related to the treatment. Histological examination of the resected metastases which had been treated electrolytically showed complete tissue destruction with no viable malignant cells remaining at the site of treatment. This pilot study of electrolytic ablation of liver metastases in five patients showed the treatment to be well tolerated and safe. Additionally, it demonstrated total destruction of the malignant tissue at the site of electrolysis. Based on these encouraging results, clinical trials can now begin.

A pilot study of peptide vaccines for VEGF receptor 1 and 2 in patients with recurrent/progressive high grade glioma.

PubMed

Shibao, Shunsuke; Ueda, Ryo; Saito, Katsuya; Kikuchi, Ryogo; Nagashima, Hideaki; Kojima, Atsuhiro; Kagami, Hiroshi; Pareira, Eriel Sandika; Sasaki, Hikaru; Noji, Shinobu; Kawakami, Yutaka; Yoshida, Kazunari; Toda, Masahiro

2018-04-20

Early-phase clinical studies of glioma vaccines have shown feasibility and encouraging preliminary clinical activity. A vaccine that targets tumor angiogenesis factors in glioma microenvironment has not been reported. Therefore, we performed a pilot study to evaluate the safety and immunogenicity of a novel vaccination targeting tumor angiogenesis with synthetic peptides for vascular endothelial growth factor (VEGF) receptor epitopes in patients with recurrent/progressive high grade gliomas. Eight patients received intranodal vaccinations weekly at a dose of 2mg/kg bodyweight 8 times. T-lymphocyte responses against VEGF receptor (VEGFR) epitopes were assessed by enzyme linked immunosorbent spot assays. This treatment was well-tolerated in patients. The first four vaccines induced positive immune responses against at least one of the targeted VEGFR epitopes in the peripheral blood mononuclear cells in 87.5% of patients. The median overall survival time in all patients was 15.9 months. Two achieved progression-free status lasting at least 6 months. Two patients with recurrent GBM demonstrated stable disease. Plasma IL-8 level was negatively correlated with overall survival. These data demonstrate the safety and immunogenicity of VEGFR peptide vaccines targeting tumor vasculatures in high grade gliomas.

Effects of a multifaceted minimal-lift environment for nursing staff: pilot results.

PubMed

Zadvinskis, Inga M; Salsbury, Susan L

2010-02-01

Nursing staff are at risk for musculoskeletal injuries because of the physical nature of patient handling. The purpose of this study is to examine the effectiveness of a multifaceted minimal-lift environment on reported equipment use, musculoskeletal injury rates, and workers' compensation costs for patient-handling injuries. The pilot study consists of a mixed measures design, with both descriptive and quasi-experimental design elements. The intervention consists of engineering (minimal-lift equipment), administrative (nursing policy), and behavioral (peer coach program) controls. The comparison nursing unit has received engineering controls only. The convenience sample includes nursing staff employed on two medical-surgical nursing units, who provide direct patient care at least 50% of the time. Nursing staff employed in a multifaceted lift environment report greater lift equipment use and experience less injury, with reduced worker's compensation costs.

Outcomes of a pilot study in chiropractic practices in Western Australia.

PubMed

Amorin-Woods, Lyndon G; Parkin-Smith, Gregory F; Nedkoff, Lee; Fisher, Colleen

2016-01-01

This paper reports the quantitative outcomes of a mixed-methods pilot study of the characteristics and demographics of chiropractic practices and patients in Western Australia. This was a mixed-methods data transformation model (qualitative to quantitative) pilot study. A non-random sample of chiropractic practices across Western Australia was recruited and data collected anonymously from consecutive new patients using an online platform. Data covered practice and patient demographics and characteristics, alongside quality of life measures. A descriptive quantitative analysis characterised the sample, and the patient population was stratified by main reason for presentation to compare characteristics according to the presence of secondary complaints. Odds ratios were calculated to estimate the odds of a secondary complaint for various combinations of main complaints, from univariate logistic regression models. Of the 539 registered practitioners in WA in July 2014, 33 agreed to participate, from 20 different practices. Ten participating practices provided data on 325 adult new patients. The recruited practices (metropolitan n  = 8, regional n  = 2) had a positive response rate of 79.7 % ( n  = 301 metropolitan and n  = 24 regional patients), mean age 36.3 years (range 18-74) (53.2 % female). Spinal problems were reported as the main reason for consultation by 67 % and as secondary reasons by 77.2 % of patients. People presented primarily for health maintenance or a general health check in 11.4 %, and as a secondary reason 14.8 %. There were 30 % of people below societal norms for the SF-12 Physical Component Score (mean 47.19, 95 % CI; 46.27-48.19) and 86 % for the Mental Component Score (mean 36.64, 95 % CI; 35.93-37.65), Pain Impact Questionnaire mean scores were 54.60 (95 % CI; 53.32-55.88). Patients presented to chiropractors in Western Australia with a fairly wide range of conditions, but primarily spinal and musculoskeletal-related problems. A significant proportion of patients had associated, or found to be at risk of, depression. Consequently, there are responsibilities and opportunities for chiropractors with respect to providing care services that include health promotion and well-being education related to musculoskeletal/spinal and mental health. This pilot study supports the feasibility of a future confirmatory study where the potential role of chiropractors in spinal/musculoskeletal health management may be explored. ACTRN12616000434493: Australian New Zealand Clinical Trials Registry (ANZCTR), Registered 5 April 2016, First participant enrolled 01 July 2014 Retrospectively Registered.

Development and Validation of Simulated Virtual Patients to Impart Early Clinical Exposure in Endocrine Physiology

ERIC Educational Resources Information Center

Gupta, Akriti; Singh, Satendra; Khaliq, Farah; Dhaliwal, Upreet; Madhu, S. V.

2018-01-01

In the country presently, preclinical medical students are not routinely exposed to real patients. Thus, when they start clinical postings, they are found to have poor clinical reasoning skills. Simulated virtual patients (SVPs) can improve clinical skills without endangering real patients. This pilot study describes the development of two SVPs in…

Chronic Pain and PTSD: A Guide for Patients

MedlinePlus

... VA for Vets Performance Based Interviewing Clinical Trainees (Academic Affiliations) Employees & Contractors Talent Management System (TMS) VA ... stress. Search Pilots Search PILOTS *, the largest citation database on PTSD. What is PILOTS? Subscribe Sign up ...

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

PubMed Central

2013-01-01

Background Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. Methods 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Results Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. Conclusion In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles. PMID:23914834

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke.

PubMed

Dohle, Carolin I; Rykman, Avrielle; Chang, Johanna; Volpe, Bruce T

2013-08-05

Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles.

Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

PubMed

Bakitas, Marie; Dionne-Odom, J Nicholas; Pamboukian, Salpy V; Tallaj, Jose; Kvale, Elizabeth; Swetz, Keith M; Frost, Jennifer; Wells, Rachel; Azuero, Andres; Keebler, Konda; Akyar, Imatullah; Ejem, Deborah; Steinhauser, Karen; Smith, Tasha; Durant, Raegan; Kono, Alan T

2017-08-31

Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

Patient and nurse preferences for nurse handover—using preferences to inform policy: a discrete choice experiment protocol

PubMed Central

Spinks, Jean; Chaboyer, Wendy; Bucknall, Tracey; Tobiano, Georgia; Whitty, Jennifer A

2015-01-01

Introduction Nursing bedside handover in hospital has been identified as an opportunity to involve patients and promote patient-centred care. It is important to consider the preferences of both patients and nurses when implementing bedside handover to maximise the successful uptake of this policy. We outline a study which aims to (1) identify, compare and contrast the preferences for various aspects of handover common to nurses and patients while accounting for other factors, such as the time constraints of nurses that may influence these preferences.; (2) identify opportunities for nurses to better involve patients in bedside handover and (3) identify patient and nurse preferences that may challenge the full implementation of bedside handover in the acute medical setting. Methods and analysis We outline the protocol for a discrete choice experiment (DCE) which uses a survey design common to both patients and nurses. We describe the qualitative and pilot work undertaken to design the DCE. We use a D-efficient design which is informed by prior coefficients collected during the pilot phase. We also discuss the face-to-face administration of this survey in a population of acutely unwell, hospitalised patients and describe how data collection challenges have been informed by our pilot phase. Mixed multinomial logit regression analysis will be used to estimate the final results. Ethics and dissemination This study has been approved by a university ethics committee as well as two participating hospital ethics committees. Results will be used within a knowledge translation framework to inform any strategies that can be used by nursing staff to improve the uptake of bedside handover. Results will also be disseminated via peer-reviewed journal articles and will be presented at national and international conferences. PMID:26560060

Treatment of inflammatory facial acne vulgaris in Chinese patients with the 1450-nm diode laser: a pilot study

NASA Astrophysics Data System (ADS)

Liu, Huaxu; Dang, Yongyan; Wang, Zhan; Ma, Li; Ren, Qiushi

2007-02-01

The 1450-nm diode laser has been found to be effective for the treatment of inflammatory acne in USA, Europe and Japan. However, there is no report on its efficacy in Chinese acne vulgaris patients. We conduct this pilot study to evaluate the efficacy and safety of the 1450-nm diode laser in the treatment of inflammatory facial acne vulgaris in Chinese patients. Nineteen patients with inflammatory facial acne were treated with the 1450-nm diode laser at 4- to 6-week intervals. Clinical photographs and lesion counts were obtained at baseline and after each treatment. Subjective evaluation of response to treatment and pain was assessed using a questionnaire. In our study, clinical improvement was seen in all patients and was generally dramatic. Lesion counts decreased 34% after one treatment (p<0.01), 56% after two treatments (p<0.01), and 81% after three treatments (p<0.01). However, the treatment-related pain was comparatively hard to be tolerated in Chinese patitents, and the other main adverse effect was the hyper-pigmentation after treatments (36.84%, 7/19).

Comparison of two humidification systems for long-term noninvasive mechanical ventilation.

PubMed

Nava, S; Cirio, S; Fanfulla, F; Carlucci, A; Navarra, A; Negri, A; Ceriana, P

2008-08-01

There is no consensus concerning the best system of humidification during long-term noninvasive mechanical ventilation (NIMV). In a technical pilot randomised crossover 12-month study, 16 patients with stable chronic hypercapnic respiratory failure received either heated humidification or heat and moisture exchanger. Compliance with long-term NIMV, airway symptoms, side-effects and number of severe acute pulmonary exacerbations requiring hospitalisation were recorded. Two patients died. Intention-to-treat statistical analysis was performed on 14 patients. No significant differences were observed in compliance with long-term NIMV, but 10 out of 14 patients decided to continue long-term NIMV with heated humidification at the end of the trial. The incidence of side-effects, except for dry throat (significantly more often present using heat and moisture exchanger), hospitalisations and pneumonia were not significantly different. In the present pilot study, the use heated humidification and heat and moisture exchanger showed similar tolerance and side-effects, but a higher number of patients decided to continue long-term noninvasive mechanical ventilation with heated humidification. Further larger studies are required in order to confirm these findings.

Combining biofeedback and Narrative Exposure Therapy for persistent pain and PTSD in refugees: a pilot study

PubMed Central

Morina, Naser; Maier, Thomas; Bryant, Richard; Knaevelsrud, Christine; Wittmann, Lutz; Rufer, Michael; Schnyder, Ulrich; Müller, Julia

2012-01-01

Objective Many traumatised refugees suffer from both persistent pain and posttraumatic stress disorder (PTSD). To date, no specific guidelines exist for treatment of this group of patients. This paper presents data on a pilot treatment study conducted with 15 traumatised refugees with persistent pain and PTSD. Methods Participants received 10 sessions of pain-focused treatment with biofeedback (BF) followed by 10 sessions of Narrative Exposure Therapy (NET). Structured interviews and standardised questionnaires were used to assess symptoms of pain intensity, pain disability, PTSD and quality of life directly before and after treatment and at 3 months follow-up. Results Following the combined intervention, participants showed a significant reduction in both pain and PTSD symptoms, as well as improved quality of life. Additionally, biofeedback increased motivation for subsequent trauma-focused therapy, which in turn was related to larger PTSD treatment gains. Conclusion This pilot study provides initial evidence that combining BF and NET is safe, acceptable, and feasible in patients with co-morbid persistent pain and PTSD. PMID:22893834

Health-related quality of life of cancer patients with peripherally inserted central catheter: a pilot study.

PubMed

Kang, Junren; Chen, Wei; Sun, Wenyan; Ge, Ruibin; Li, Hailong; Ma, Enling; Su, Qingxia; Cheng, Fang; Hong, Jinhua; Zhang, Yuanjuan; Lei, Cheng; Wang, Xinchuan; Jin, Aiyun; Liu, Wanli

2017-09-11

This pilot exploratory study aimed to compare the health-related quality of life (HRQOL) among patients diagnosed with different types of cancer receiving peripherally inserted central catheters (PICCs). A multicenter cross-section study of cancer patients with PICCs was performed from February 1, 2013 to April 24, 2014. The primary objective of this study was to compare HRQOL in different cancer type patients with PICC. HRQOL was examined based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30). Multiple linear regression models were conducted for coping with potential confounding variables. We also examined PICC-related quality of daily life with a self-made questionnaire. Three hundred and fifty-seven cancer patients with PICC completed the survey in nine teaching hospitals. Lung cancer patients with PICC reported the worst dyspnea. Digestive tract cancer patients reported the worst appetite loss. Patients with hematologic malignancy reported the worst emotional, social function, fatigue and financial impact. Breast cancer patients reported better HRQOL. Baseline variables were proven not significant predictors of EORTC QLQ-C30 global health status. In self-made survey, pain after PICC insertion was null or a little in 98.6% of cancer patients. Limitation of upper extremity activity was null or a little in 94.1% of patients. HRQOL varies in different types of cancer patients with PICC. PICC may have a low impact on cancer patients' HRQOL. Further large sample studies are needed.

Medical student, nursing student, and non-health care respondents' implicit attitudes toward doctors and patients: Development and a pilot study of a new implicit attitudes test (IAT).

PubMed

Schwartz, Alan; Mazouni, Abdelhamid

2017-01-01

Medical educators have been concerned that medical students may decline in empathy for patients during the course of their training, based on studies measuring clinical empathy using psychometrically strong self-report measures. Clinical empathy is a complex construct, incorporating attitudes toward patients but also other components, such as professional detachment. Triangulation of extant measures with instruments based on nonreactive methods could provide a better understanding of whether and how physician attitudes toward patients may be changing during training. We sought to develop and pilot-test such a nonreactive method. We develop variations of an implicit association test (IAT) designed to measure attitudes toward physicians and patients based on speed of reaction to images of actors and positive and negative words. In the IATs, the same actors are photographed as doctors, clinic outpatients, hospitalized inpatients, and as a "general public" control. We examine preliminary evidence for their validity by collecting pilot data from internet participants (not involved in the health professions), medical students, and nursing students. Internet participants (n = 314) and nursing students (n = 31) had more negative associations (IAT scores) with doctors than did medical students (n = 89); nursing students and female internet participants had more positive associations with hospitalized patients than did medical students and male internet participants. Medical students' associations with hospitalized patients varied by year of training. This IAT may provide insight into implicit attitudes among those who enter training for the health profession and changes in those attitudes that may be inculcated during that training.

Spinal cord injury rehabilitation patient and physical therapist perspective: a pilot study.

PubMed

Sliwinski, Martha M; Smith, Ryan; Wood, Andrea

2016-01-01

The objectives of this retrospective observational study were to explore physical therapists' perceived involvement of patients with SCI in physical therapy (PT) rehabilitation, second to explore individuals with SCI perceived involvement in PT rehabilitation, third to compare how patients and physical therapists perceive involvement in PT rehabilitation and last to explore patients' perceived involvement with satisfaction with life (SWL). This study was conducted in the United States. Two 11-item questionnaires were designed one for physical therapists and one for patients. The items were rated on a Likert-type agreement scale. Thirty physical therapists completed the patient involvement questionnaire for physical therapists and nine individuals with SCI completed the patient involvement questionnaire and SWL scale. We certify that all applicable governmental and institutional guidelines were followed during the course of this research. The results indicated that both physical therapists and patients were overall in agreement that patients were involved in their PT rehabilitation on most items. The two items that received the lowest Likert scores by the therapists and patients were friends and family involvement in therapy and gender-related issues. The item, individualized patient goals, received the largest discrepancy between therapists and patients. The sample size was too small to observe a trend with SWL and perceived involvement. Patients and PTs from this pilot overall agree patients are included in treatment; however, the discrepancy in scores related to individualized goals requires further research.

Frailty status as a predictor of three month cognitive and functional recovery following spinal surgery: a prospective pilot study.

PubMed

Rothrock, Robert J; Steinberger, Jeremy M; Badgery, Henry; Hecht, Andrew C; Cho, Samuel K; Caridi, John M; Deiner, Stacie

2018-05-21

Background Context As increasing numbers of elderly Americans undergo spinal surgery, it is important to identify which patients are at highest risk for poor cognitive and functional recovery. Frailty is a geriatric syndrome which has been closely linked to poor outcomes, and short form screening may be a helpful tool for preoperative identification of at risk patients. Purpose To conduct a pilot study on the usefulness of a short-form screening tool to identify elderly patients at increased risk for prolonged cognitive and functional recovery following elective spine surgery. Study Design/Setting Prospective, comparative cohort study. Patient Sample 100 patients over age 65 undergoing elective spinal surgery (cervical or lumbar) at a single, large academic medical center from 2013-2014. Outcome Measures FRAIL scale, Quality of Recovery Scale (PQRS), and Instrumental Activities (IADLs) scores. Methods Included patients were given the FRAIL scale and stratified as robust, pre-frail, or frail. Post-operative Quality of Recovery Scale (PQRS) and Instrumental Activities (IADLs) scores were also obtained. Patients were re-examined at 1 day, 3 days, 1 month, and 3 months after surgery for cognitive recovery at 3-months, and secondarily, functional recovery at 3-months. This study was funded in part by grants from the National Institute on Aging (K23-17-015, National Institutes of Health, Bethesda, Maryland, USA) and the American Federation for Aging Research (New York City, NY, USA). Results At 3-months, only 50% of frail patients had recovered to their cognitive baseline compared to 60.7% of pre-frail and 69.2% of robust patients (trend). At 3-months, 66.7% of frail patients had recovered to their functional baseline compared to 57% of pre-frail and 76.9% of robust patients (trend). Using multivariate regression modelling, at 3 months, frail patients were less likely to have recovered to their cognitive baseline compared to pre-frail and robust patients (OR 0.39, CI 0.131-1.161). Conclusions This pilot study demonstrates a trend towards poorer cognitive recovery 3-months following elective spinal surgery for frail patients. Frailty screening can help pre-operatively identify patients who may experience protracted cognitive and functional recovery. Copyright © 2018. Published by Elsevier Inc.

A pilot study investigating the effect of parathyroidectomy on arterial stiffness and coronary artery calcification in patients with primary hyperparathyroidism.

PubMed

Dural, Cem; Okoh, Alexis Kofi; Seicean, Andreea; Yigitbas, Hakan; Thomas, George; Yazici, Pinar; Shoenhagen, Paul; Doshi, Krupa; Halliburton, Sandra; Berber, Eren

2016-01-01

Arterial stiffness (AS) and coronary artery calcification (CAC) are predictors of cardiovascular risk and can be measured noninvasively. The aim of this study was to analyze the effects of parathyroidectomy on AS and CAC in patients with primary hyperparathyroidism (PHP). This prospective, institutional review board-approved study included 21 patients with PHP, who underwent parathyroidectomy. Before and 6 months after parathyroidectomy, AS was assessed by measuring central systolic pressure (CSP), central pulse pressure, augmentation pressure (AP), and augmentation index (AIx); the CAC score (Agatston) was calculated on noncontrast computed tomography. AS parameters were compared with unaffected controls from donor nephrectomy database. Preoperative CSP and AIx parameters in PHP patients were higher than those in donor nephrectomy patients (P = .004 and P = .039, respectively). Preoperative total CAC score was zero in 15 patients (65%) and ranged from the 72nd to the 99th percentile in 6 patients (26%). Although there were no changes in CAC or AS after parathyroidectomy on average, there was variability in individual patient responses on AS. This pilot study demonstrates that CAC is not altered in PHP patients at short-term follow-up after parathyroidectomy. The heterogeneous changes in AS after parathyroidectomy warrant further investigation in a larger study with longer follow-up. Copyright © 2016 Elsevier Inc. All rights reserved.

Financial Impact of Allogeneic Hematopoietic Cell Transplantation on Patients and Families over 2-years: Results from a Multicenter Pilot Study

PubMed Central

Denzen, Ellen M.; Thao, Viengneesee; Hahn, Theresa; Lee, Stephanie J.; McCarthy, Philip L.; Rizzo, J. Douglas; Ammi, Monique; Drexler, Rebecca; Flesch, Susan; James, Heather; Omondi, Nancy; Murphy, Elizabeth; Pederson, Kate; Majhail, Navneet S.

2016-01-01

Hematopoietic cell transplantation (HCT) is a procedure that can significantly influence the socioeconomic wellbeing of patients, caregivers and their families. Among 30 allogeneic HCT recipients and their caregivers enrolled on a pilot study evaluating the feasibility of studying financial impact of HCT, 16 agreed to participate in the long-term phase, completed a baseline questionnaire and received phone interviews at 6, 12, 18 and 24 months post-HCT. Analyses showed that by 2-years post-HCT, 54% of patients who previously contributed to household earnings had not returned to work and 80% of patients/caregivers reported transplant as having moderate to great impact on household income. However, patients’ level of confidence in their ability to meet household financial obligations increased from baseline to 2-years. A relatively large proportion of patients reported inability to pay for medical care through this time period. Case studies demonstrated patient individual perception of financial impact of HCT varies considerably, regardless of actual income. We demonstrate the feasibility of conducting a study to evaluate financial impact of allogeneic HCT through 2-years post-transplantation. Some patients/caregivers continue to experience significant long-term financial burden after this procedure. Our study lays the foundation for a larger evaluation of patient/caregiver financial burden associated with HCT. PMID:27088381

A pilot study to test psychophonetics methodology for self-care and empathy in compassion fatigue, burnout and secondary traumatic stress

PubMed Central

Butler, Nadine

2013-01-01

Abstract Background Home-based care is recognised as being a stressful occupation. Practitioners working with patients experiencing high levels of trauma may be susceptible to compassion fatigue, with the sustained need to remain empathic being a contributing factor. Objectives The aim of this research was to evaluate psychophonetics methodology for self-care and empathy skills as an intervention for compassion fatigue. Objectives were to measure levels of compassion fatigue pre-intervention, then to apply the intervention and retest levels one month and six months post-intervention. Method The research applied a pilot test of a developed intervention as a quasi-experiment. The study sample comprised home-based carers working with HIV-positive patients at a hospice in Grabouw, a settlement in the Western Cape facing socioeconomic challenge. Results The result of the pilot study showed a statistically-significant improvement in secondary traumatic stress, a component of compassion fatigue, measured with the ProQOL v5 instrument post-intervention. Conclusion The results gave adequate indication for the implementation of a larger study in order to apply and test the intervention. The study highlights a dire need for further research in this field.

Assessment of dyspnoea in the emergency department by numeric and visual scales: A pilot study.

PubMed

Placido, Rui; Gigaud, Carine; Gayat, Etienne; Ferry, Axelle; Cohen-Solal, Alain; Plaisance, Patrick; Mebazaa, Alexandre; Laribi, Said

2015-04-01

Dyspnoea is a common and often debilitating symptom that affects up to 50% of patients admitted to acute tertiary care hospitals. The primary purpose of this study was to compare the numeric rating scale (NRS) and the visual analogue scale (VAS) for dyspnoea evaluation in the ED setting. This was a cohort study of patients admitted to the ED in a university hospital, with dyspnoea as the chief complaint. The agreement of the two dyspnoea scales was assessed using the intraclass correlation coefficient (ICC). One hundred and seventeen patients were included in this analysis. The median age for the whole study population was 67 years and 42% of patients were male. The aetiology of dyspnoea was acute heart failure (AHF) in 35% of patients. There was good agreement between the two scores (ICC=0.795; 95% CI=0.717-0.853; P<0.001). This pilot study demonstrated that numerical rating and visual analogue scales agree well when assessing the severity of dyspnoea in the ED. Further studies with larger cohorts of patients are needed to confirm these preliminary results. Copyright © 2015 Société française d’anesthésie et de réanimation (Sfar). All rights reserved.

CO2 laser for the treatment of diabetic foot ulcers with exposed bone. A consecutive series of type 2 diabetic patients.

PubMed

Monami, M; Mirabella, C; Scatena, A; Nreu, B; Zannoni, S; Aleffi, S; Giannoni, L; Mannucci, E

2017-08-01

The treatment of foot ulcers with exposed bone is challenging, because of the risk of infection and of difficulties in the development of granulation tissue. A CO 2 laser beam could be used to produce discontinuities in periosteum, allowing the exposure of blood containing multipotent stem cells, capable of initiating the healing process. The local application of platelet-rich plasma (PRP) has been proposed as a therapeutic tool for accelerating healing in foot ulcers, including those in patients with diabetes. Aim of the present pilot, proof-of-concept study is the assessment of the therapeutic potential of CO 2 laser treatment, either alone or combined with PRP, in the treatment of diabetic foot ulcers with exposed bone. We performed a pilot, uncontrolled 3-month observation study on a consecutive series of 9 type two diabetic patients and foot ulcers with exposed bone. A CO 2 -laser was used for producing nine discontinuities on periosteum for each cm 2 , by directing the focused laser beam on the bone until bleeding. The procedure was repeated up to 6 times, at a distance of 1 week and ulcers assessed weekly until the end of the study (3 months). In the last 5 of the 14 patients, the treatment described above was associated with PRP. Of the nine patients treated, four healed, and one more patient developed granulation tissue covering entirely bone surface. Out of the four patients who did not heal, one underwent minor amputation. Among the five patients treated with a combination of CO 2 laser and PRP, two healed within 3 months, and two more patients developed granulation tissue covering entirely bone surface; the fifth patient did not show any improvement and underwent amputation. The present pilot experience represents a novelty in this field showing a possible use of CO 2 -laser in the treatment of diabetic foot ulcers.

Minocycline in leprosy patients with recent onset clinical nerve function impairment.

PubMed

Narang, Tarun; Arshdeep; Dogra, Sunil

2017-01-01

Nerve function impairment (NFI) in leprosy may occur and progress despite multidrug therapy alone or in combination with corticosteroids. We observed improvement in neuritis when minocycline was administered in patients with type 2 lepra reaction. This prompted us to investigate the role of minocycline in recent onset NFI, especially in corticosteroid unresponsive leprosy patients. Leprosy patients with recent onset clinical NFI (<6 months), as determined by Monofilament Test (MFT) and Voluntary Muscle Test (VMT), were recruited. Minocycline 100mg/day was given for 3 months to these patients. The primary outcome was the proportion of patients with 'restored,' 'improved,' 'stabilized,' or 'deteriorated' NFI. Secondary outcomes included any improvement in nerve tenderness and pain. In this pilot study, 11 patients were recruited. The progression of NFI was halted in all; with 9 out of 11 patients (81.82%) showing ?restored? or ?improved? sensory or motor nerve functions, on assessment with MFT and VMT. No serious adverse effects due to minocycline were observed. Our pilot study demonstrates the efficacy and safety of minocycline in recent onset NFI in leprosy patients. However, larger and long term comparative trials are needed to validate the efficacy of minocycline in leprosy neuropathy. © 2016 Wiley Periodicals, Inc.

The development and piloting of the REnal specific Advanced Communication Training (REACT) programme to improve Advance Care Planning for renal patients.

PubMed

Bristowe, Katherine; Shepherd, Kate; Bryan, Liz; Brown, Heather; Carey, Irene; Matthews, Beverley; O'Donoghue, Donal; Vinen, Katie; Murtagh, Fliss E M

2014-04-01

In recent years, the End-Stage Kidney Disease population has increased and is ever more frail, elderly and co-morbid. A care-focused approach needs to be incorporated alongside the disease focus, to identify those who are deteriorating and improve communication about preferences and future care. Yet many renal professionals feel unprepared for such discussions. To develop and pilot a REnal specific Advanced Communication Training (REACT) programme to address the needs of End-Stage Kidney Disease patients and renal professionals. Two-part study: (1) development of the REnal specific Advanced Communication Training programme informed by multi-professional focus group and patient survey and (2) piloting of the programme. The REnal specific Advanced Communication Training programme was piloted with 16 participants (9 renal nurses/health-care assistants and 7 renal consultants) in two UK teaching hospitals. The focus group identified the need for better information about end-of-life phase, improved awareness of patient perspectives, skills to manage challenging discussions, 'hands on' practice in a safe environment and follow-up to discuss experiences. The patient survey demonstrated a need to improve communication about concerns, treatment plans and decisions. The developed REnal specific Advanced Communication Training programme was acceptable and feasible and was associated with a non-significant increase in confidence in communicating about end-of-life issues (pre-training: 6.6/10, 95% confidence interval: 5.7-7.4; post-training: 6.9/10, 95% confidence interval: 6.1-7.7, unpaired t-test - p = 0.56), maintained at 3 months. There is a need to improve end-of-life care for End-Stage Kidney Disease patients, to enable them to make informed decisions about future care. Challenges include prioritising communication training among service providers.

Viruses in bronchiectasis: a pilot study to explore the presence of community acquired respiratory viruses in stable patients and during acute exacerbations.

PubMed

Mitchell, Alicia B; Mourad, Bassel; Buddle, Lachlan; Peters, Matthew J; Oliver, Brian G G; Morgan, Lucy C

2018-05-22

Bronchiectasis is a chronic respiratory condition. Persistent bacterial colonisation in the stable state with increased and sometimes altered bacterial burden during exacerbations are accepted as key features in the pathophysiology. The extent to which respiratory viruses are present during stable periods and in exacerbations is less well understood. This study aimed to determine the incidence of respiratory viruses within a cohort of bronchiectasis patients with acute exacerbations at a teaching hospital and, separately, in a group of patients with stable bronchiectasis. In the group of stable patients, a panel of respiratory viruses were assayed for using real time quantitative PCR in respiratory secretions and exhaled breath. The Impact of virus detection on exacerbation rates and development of symptomatic infection was evaluated. Routine hospital-based viral PCR testing was only requested in 28% of admissions for an exacerbation. In our cohort of stable bronchiectasis patients, viruses were detected in 92% of patients during the winter season, and 33% of patients during the summer season. In the 2-month follow up period, 2 of 27 patients presented with an exacerbation. This pilot study demonstrated that respiratory viruses are commonly detected in patients with stable bronchiectasis. They are frequently detected during asymptomatic viral periods, and multiple viruses are often present concurrently.

Plasma Metabolites Predict Severity of Depression and Suicidal Ideation in Psychiatric Patients-A Multicenter Pilot Analysis.

PubMed

Setoyama, Daiki; Kato, Takahiro A; Hashimoto, Ryota; Kunugi, Hiroshi; Hattori, Kotaro; Hayakawa, Kohei; Sato-Kasai, Mina; Shimokawa, Norihiro; Kaneko, Sachie; Yoshida, Sumiko; Goto, Yu-Ichi; Yasuda, Yuka; Yamamori, Hidenaga; Ohgidani, Masahiro; Sagata, Noriaki; Miura, Daisuke; Kang, Dongchon; Kanba, Shigenobu

2016-01-01

Evaluating the severity of depression (SOD), especially suicidal ideation (SI), is crucial in the treatment of not only patients with mood disorders but also psychiatric patients in general. SOD has been assessed on interviews such as the Hamilton Rating Scale for Depression (HAMD)-17, and/or self-administered questionnaires such as the Patient Health Questionnaire (PHQ)-9. However, these evaluation systems have relied on a person's subjective information, which sometimes lead to difficulties in clinical settings. To resolve this limitation, a more objective SOD evaluation system is needed. Herein, we collected clinical data including HAMD-17/PHQ-9 and blood plasma of psychiatric patients from three independent clinical centers. We performed metabolome analysis of blood plasma using liquid chromatography mass spectrometry (LC-MS), and 123 metabolites were detected. Interestingly, five plasma metabolites (3-hydroxybutyrate (3HB), betaine, citrate, creatinine, and gamma-aminobutyric acid (GABA)) are commonly associated with SOD in all three independent cohort sets regardless of the presence or absence of medication and diagnostic difference. In addition, we have shown several metabolites are independently associated with sub-symptoms of depression including SI. We successfully created a classification model to discriminate depressive patients with or without SI by machine learning technique. Finally, we produced a pilot algorithm to predict a grade of SI with citrate and kynurenine. The above metabolites may have strongly been associated with the underlying novel biological pathophysiology of SOD. We should explore the biological impact of these metabolites on depressive symptoms by utilizing a cross species study model with human and rodents. The present multicenter pilot study offers a potential utility for measuring blood metabolites as a novel objective tool for not only assessing SOD but also evaluating therapeutic efficacy in clinical practice. In addition, modification of these metabolites by diet and/or medications may be a novel therapeutic target for depression. To clarify these aspects, clinical trials measuring metabolites before/after interventions should be conducted. Larger cohort studies including non-clinical subjects are also warranted to clarify our pilot findings.

A Preliminary Inquiry into Physicians' Perceptions of Patient Self-Control.

ERIC Educational Resources Information Center

Shapiro, Johanna; Shapiro, Deane H., Jr.

1980-01-01

The findings of a small pilot study, in which the perception of 16 obstetrician/gynocologists regarding their patients' degree of self-control as it related to medical problems, are analyzed. Findings suggested the physicians exhibited confusion about the concept of self-control and its applicability to patient care. (Author/MLW)

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Pilot Study: Detection of Gastric Cancer From Exhaled Air Analyzed With an Electronic Nose in Chinese Patients.

PubMed

Schuermans, Valérie N E; Li, Ziyu; Jongen, Audrey C H M; Wu, Zhouqiao; Shi, Jinyao; Ji, Jiafu; Bouvy, Nicole D

2018-06-01

The aim of this pilot study is to investigate the ability of an electronic nose (e-nose) to distinguish malignant gastric histology from healthy controls in exhaled breath. In a period of 3 weeks, all preoperative gastric carcinoma (GC) patients (n = 16) in the Beijing Oncology Hospital were asked to participate in the study. The control group (n = 28) consisted of family members screened by endoscopy and healthy volunteers. The e-nose consists of 3 sensors with which volatile organic compounds in the exhaled air react. Real-time analysis takes place within the e-nose, and binary data are exported and interpreted by an artificial neuronal network. This is a self-learning computational system. The inclusion rate of the study was 100%. Baseline characteristics differed significantly only for age: the average age of the patient group was 57 years and that of the healthy control group 37 years ( P value = .000). Weight loss was the only significant different symptom ( P value = .040). A total of 16 patients and 28 controls were included; 13 proved to be true positive and 20 proved to be true negative. The receiver operating characteristic curve showed a sensitivity of 81% and a specificity of 71%, with an accuracy of 75%. These results give a positive predictive value of 62% and a negative predictive value of 87%. This pilot study shows that the e-nose has the capability of diagnosing GC based on exhaled air, with promising predictive values for a screening purpose.

An autonomous mobile system for the management of COPD.

PubMed

van der Heijden, Maarten; Lucas, Peter J F; Lijnse, Bas; Heijdra, Yvonne F; Schermer, Tjard R J

2013-06-01

Managing chronic disease through automated systems has the potential to both benefit the patient and reduce health-care costs. We have developed and evaluated a disease management system for patients with chronic obstructive pulmonary disease (COPD). Its aim is to predict and detect exacerbations and, through this, help patients self-manage their disease to prevent hospitalisation. The carefully crafted intelligent system consists of a mobile device that is able to collect case-specific, subjective and objective, physiological data, and to alert the patient by a patient-specific interpretation of the data by means of probabilistic reasoning. Collected data are also sent to a central server for inspection by health-care professionals. We evaluated the probabilistic model using cross-validation and ROC analyses on data from an earlier study and by an independent data set. Furthermore a pilot with actual COPD patients has been conducted to test technical feasibility and to obtain user feedback. Model evaluation results show that we can reliably detect exacerbations. Pilot study results suggest that an intervention based on this system could be successful. Copyright © 2013 Elsevier Inc. All rights reserved.

iPhone ECG screening by practice nurses and receptionists for atrial fibrillation in general practice: the GP-SEARCH qualitative pilot study.

PubMed

Orchard, Jessica; Freedman, Saul Benedict; Lowres, Nicole; Peiris, David; Neubeck, Lis

2014-05-01

Atrial fibrillation (AF) is often asymptomatic and substantially increases stroke risk. A single-lead iPhone electrocardiograph (iECG) with a validated AF algorithm could make systematic AF screening feasible in general practice. A qualitative screening pilot study was conducted in three practices. Receptionists and practice nurses screened patients aged ≥65 years using an iECG (transmitted to a secure website) and general practitioner (GP) review was then provided during the patient's consultation. Fourteen semi-structured interviews with GPs, nurses, receptionists and patients were audio-recorded, transcribed and analysed thematically. Eighty-eight patients (51% male; mean age 74.8 ± 8.8 years) were screened: 17 patients (19%) were in AF (all previously diagnosed). The iECG was well accepted by GPs, nurses and patients. Receptionists were reluctant, whereas nurses were confident in using the device, explaining and providing screening. AF screening in general practice is feasible. A promising model is likely to be one delivered by a practice nurse, but depends on relevant contextual factors for each practice.

A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis.

PubMed

Zernicke, Jan; Kedor, Claudia; Müller, Angela; Burmester, Gerd-Rüdiger; Reißhauer, Anett; Feist, Eugen

2016-08-18

Physical exercises and physiotherapy are of great importance for maintenance of joint function in patients with rheumatoid arthritis (RA). However, many RA patients complain about problems to receive prescriptions or have a lack of access to physiotherapy. Recent reports have shown positive effects of the Wii game console on physical and psychosocial conditions of patients with other underlying diseases. The primary objectives of this prospective controlled pilot study were to investigate feasibility and patients' assessment using an animated home-based exercise program. This pilot study was conducted as a single-center, cross-over trial with two treatment arms over 24 weeks. Eligibility criteria included patients with RA reaching low disease activity under therapy with a biological disease modifying anti-rheumatic drug (bDMARD). After detailed instruction, 15 patients started with a conventional home-based physical exercise program and 15 patients began with a predefined animated exercise program by using the Wii game console for 12 weeks. Afterwards, patients were crossed-over to the other treatment arm for another period of 12 weeks. Multi-methodical assessments were performed by qualitative analysis of the interview-data as well as statistical analysis of functional tests and patient reported outcomes (PRO's). Evaluation of the interviews indicated feasibility and usefulness of the chosen animated home-based exercise program. Forefoot disabilities were identified as a main limiting factor for performing some of the animated exercises. After 12 weeks, both treatment arms showed improvement of functional tests without significant differences between groups: Overall muscle strength improved for a mean value of 10 Newton (+12 %) and the mean 6-min walk test (6-MWT) distance increased for 28 meters (+5 %). This study showed that an animated home-based exercise program by using a Wii game console was feasible and beneficial for RA patients. Compared to standard physical home exercises, similar effects were observed indicating that such an animated program might be an alternative supportive option for RA patients. ClinicalTrials.gov ID: NCT02658370 (19-Jan-2016).

Investigating the Efficacy of Practical Skill Teaching: A Pilot-Study Comparing Three Educational Methods

ERIC Educational Resources Information Center

Maloney, Stephen; Storr, Michael; Paynter, Sophie; Morgan, Prue; Ilic, Dragan

2013-01-01

Effective education of practical skills can alter clinician behaviour, positively influence patient outcomes, and reduce the risk of patient harm. This study compares the efficacy of two innovative practical skill teaching methods, against a traditional teaching method. Year three pre-clinical physiotherapy students consented to participate in a…

Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre?

PubMed

Wilcock, Andrew; Manderson, CathAnn; Weller, Rebecca; Walker, George; Carr, Diane; Carey, Anne-Marie; Broadhurst, Debbie; Mew, June; Ernst, Edzard

2004-05-01

A randomised controlled pilot study was carried out to examine the effects of adjunctive aromatherapy massage on mood, quality of life and physical symptoms in patients with cancer attending a specialist unit. Participants were randomised to conventional day care alone or day care plus weekly aromatherapy massage using a standardised blend of oils for four weeks. At baseline and at weekly intervals, patients rated their mood, quality of life and the intensity and bother of two symptoms most important to them. Forty-six patients were recruited to the study. Due to a large number of withdrawals, only 11 of 23 (48%) patients in the aromatherapy group and 18 of 23 (78%) in the control group completed all four weeks. Mood, physical symptoms and quality of life improved in both groups. There was no statistically significant difference between groups in any of the outcome measures. Despite a lack of measurable benefit, all patients were satisfied with the aromatherapy and wished to continue. Whilst this pilot study has shown that a randomised controlled trial of complementary therapy is feasible, it has also identified several areas that would require further consideration when designing future studies, e.g., the recruitment and retention of appropriate numbers of patients and the outcome measures used.

Implementation of shared decision-making in oncology: development and pilot study of a nurse-led decision-coaching programme for women with ductal carcinoma in situ.

PubMed

Berger-Höger, Birte; Liethmann, Katrin; Mühlhauser, Ingrid; Steckelberg, Anke

2017-12-06

To implement informed shared decision-making (ISDM) in breast care centres, we developed and piloted an inter-professional complex intervention. We developed an intervention consisting of three components: an evidence-based patient decision aid (DA) for women with ductal carcinoma in situ, a decision-coaching led by specialised nurses (breast care nurses and oncology nurses) and structured physician encounters. In order to enable professionals to gain ISDM competencies, we developed and tested a curriculum-based training programme for specialised nurses and a workshop for physicians. After successful testing of the components, we conducted a pilot study to test the feasibility of the entire revised intervention in two breast care centres. Here the acceptance of the intervention by women and professionals, the applicability to the breast care centres' procedures, women's knowledge, patient involvement in treatment decision-making assessed with the MAPPIN'SDM-observer instrument MAPPIN'O dyad, and barriers to and facilitators of the implementation were taken into consideration. We used questionnaires, structured verbal and written feedback and video recordings. Qualitative data were analysed descriptively, and mean values and ranges of quantitative data were calculated. To test the DA, focus groups and individual interviews were conducted with 27 women. Six expert reviews were obtained. The components of the nurse training were tested with 18 specialised nurses and 19 health science students. The development and piloting of the components were successful. The pilot test of the entire intervention included seven patients. In general, the intervention is applicable. Patients attained adequate knowledge (range of correct answers: 9-11 of 11). On average, a basic level of patient involvement in treatment decision-making was observed for nurses and patient-nurse dyads (M(MAPPIN-O dyad ): 2.15 and M(MAPPIN-O nurse ): 1.90). Relevant barriers were identified; physicians barely tolerated women's preferences that were not in line with the medical recommendation. Classifying women as inappropriate for ISDM due to age or education led physicians to neglect eligible women during the recruitment phase. Decision-coaching is feasible. Nevertheless, there are some indications that structural changes are needed for long-term implementation. We are currently evaluating the intervention in a cluster randomised controlled trial in 16 breast care centres.

Designing a multifaceted survivorship care plan to meet the information and communication needs of breast cancer patients and their family physicians: results of a qualitative pilot study.

PubMed

Haq, Rashida; Heus, Lineke; Baker, Natalie A; Dastur, Daisy; Leung, Fok-Han; Leung, Eman; Li, Benjamin; Vu, Kathy; Parsons, Janet A

2013-07-25

Following the completion of treatment and as they enter the follow-up phase, breast cancer patients (BCPs) often recount feeling 'lost in transition', and are left with many questions concerning how their ongoing care and monitoring for recurrence will be managed. Family physicians (FPs) also frequently report feeling ill-equipped to provide follow-up care to BCPs. In this three-phase qualitative pilot study we designed, implemented and evaluated a multi-faceted survivorship care plan (SCP) to address the information needs of BCPs at our facility and of their FPs. In Phase 1 focus groups and individual interviews were conducted with 35 participants from three stakeholder groups (BCPs, FPs and oncology specialist health care providers (OHCPs)), to identify specific information needs. An SCP was then designed based on these findings, consisting of both web-based and paper-based tools (Phase 2). For Phase 3, both sets of tools were subsequently evaluated via focus groups and interviews with 26 participants. Interviews and focus groups were audio taped, transcribed and content analysed for emergent themes and patterns. In Phase 1 patients commented that web-based, paper-based and human resources components were desirable in any SCP. Patients did not focus exclusively on the post-treatment period, but instead spoke of evolving needs throughout their cancer journey. FPs indicated that any tools to support them must distill important information in a user-friendly format. In Phase 2, a pilot SCP was subsequently designed, consisting of both web-based and paper-based materials tailored specifically to the needs of BCPs as well as FPs. During Phase 3 (evaluation) BCPs indicated that the SCP was effective at addressing many of their needs, and offered suggestions for future improvements. Both patients and FPs found the pilot SCP to be an improvement from the previous standard of care. Patients perceived the quality of the BCP-FP relationship as integral to their comfort with FPs assuming follow-up responsibilities. This pilot multi-component SCP shows promise in addressing the information needs of BCPs and the FPs who care for them. Next steps include refinement of the different SCP components, further evaluation (including usability testing), and planning for more extensive implementation.

[The final situation in the Turkey "Stent for Life" project].

PubMed

Ertaş, Gökhan; Kozan, Omer; Değertekin, Muzaffer; Kervan, Umit; Aksoy, Mehmet; Koç, Orhan; Göktekin, Omer

2012-09-01

The Stent for Life (SFL) project's main mission is to increase the use of primary percutaneous coronary intervention (PCI) in more than 70% of all acute ST segment elevation myocardial infarction (STEMI) patients. Previous to the SFL project, thrombolysis was the dominant reperfusion strategy since a low percentage of acute STEMI patients had access to primary PCI in our country. In this study, we present the main barriers of access to primary PCI in the centers that were involved with the SFL project. Patients with acute STEMI admitted to the centers that were involved in the SFL project between 2009 and 2011 were included in the analysis. Since the inception of the SFL project, the primary PCI rate has reached over 90% in SFL pilot cities. In the last 5 years, the number of ambulances and emergency stations has increased. Since the collaboration with 112 Emergency Service, a great majority of cases were reached via the emergency medical system. The mean door-to-balloon time for the pilot cities was 54.72±43.66 minutes. After three years of the SFL project, primary PCI has emerged as the preferred reperfusion strategy for patients with STEMI in pilot cities.

Longitudinal Brain Magnetic Resonance Imaging CO2 Stress Testing in Individual Adolescent Sports-Related Concussion Patients: A Pilot Study.

PubMed

Mutch, W Alan C; Ellis, Michael J; Ryner, Lawrence N; Morissette, Marc P; Pries, Philip J; Dufault, Brenden; Essig, Marco; Mikulis, David J; Duffin, James; Fisher, Joseph A

2016-01-01

Advanced neuroimaging studies in concussion have been limited to detecting group differences between concussion patients and healthy controls. In this small pilot study, we used brain magnetic resonance imaging (MRI) CO2 stress testing to longitudinally assess cerebrovascular responsiveness (CVR) in individual sports-related concussion (SRC) patients. Six SRC patients (three males and three females; mean age = 15.7, range = 15-17 years) underwent longitudinal brain MRI CO2 stress testing using blood oxygen level-dependent (BOLD) MRI and model-based prospective end-tidal CO2 targeting under isoxic conditions. First-level and second-level comparisons were undertaken using statistical parametric mapping (SPM) to score the scans and compare them to an atlas of 24 healthy control subjects. All tests were well tolerated and without any serious adverse events. Anatomical MRI was normal in all study participants. The CO2 stimulus was consistent between the SRC patients and control subjects and within SRC patients across the longitudinal study. Individual SRC patients demonstrated both quantitative and qualitative patient-specific alterations in CVR (p < 0.005) that correlated strongly with clinical findings, and that persisted beyond clinical recovery. Standardized brain MRI CO2 stress testing is capable of providing a longitudinal assessment of CVR in individual SRC patients. Consequently, larger prospective studies are needed to examine the utility of brain MRI CO2 stress testing as a clinical tool to help guide the evaluation, classification, and longitudinal management of SRC patients.

Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial.

PubMed

Roman, Pablo; Estévez, Ángeles F; Sánchez-Labraca, Nuria; Cañadas, Fernando; Miras, Alonso; Cardona, Diana

2017-10-24

Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study.

Impact of High-Intensity-NIV on the heart in stable COPD: a randomised cross-over pilot study.

PubMed

Duiverman, Marieke Leontine; Maagh, Petra; Magnet, Friederike Sophie; Schmoor, Claudia; Arellano-Maric, Maria Paola; Meissner, Axel; Storre, Jan Hendrik; Wijkstra, Peter Jan; Windisch, Wolfram; Callegari, Jens

2017-05-02

Although high-intensity non-invasive ventilation has been shown to improve outcomes in stable COPD, it may adversely affect cardiac performance. Therefore, the aims of the present pilot study were to compare cardiac and pulmonary effects of 6 weeks of low-intensity non-invasive ventilation and 6 weeks of high-intensity non-invasive ventilation in stable COPD patients. In a randomised crossover pilot feasibility study, the change in cardiac output after 6 weeks of each NIV mode compared to baseline was assessed with echocardiography in 14 severe stable COPD patients. Furthermore, CO during NIV, gas exchange, lung function, and health-related quality of life were investigated. Three patients dropped out: two deteriorated on low-intensity non-invasive ventilation, and one presented with decompensated heart failure while on high-intensity non-invasive ventilation. Eleven patients were included in the analysis. In general, cardiac output and NTproBNP did not change, although individual effects were noticed, depending on the pressures applied and/or the co-existence of heart failure. High-intensity non-invasive ventilation tended to be more effective in improving gas exchange, but both modes improved lung function and the health-related quality of life. Long-term non-invasive ventilation with adequate pressure to improve gas exchange and health-related quality of life did not have an overall adverse effect on cardiac performance. Nevertheless, in patients with pre-existing heart failure, the application of very high inspiratory pressures might reduce cardiac output. The trial was registered in the Deutsches Register Klinischer Studien (DRKS-ID: DRKS00007977 ).

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study.

PubMed

Jun, Seungah; Lee, Jung Hee; Gong, Han Mi; Chung, Yeon-Joong; Kim, Ju-Ran; Park, Chung A; Choi, Seong Hun; Lee, Geon-Mok; Lee, Hyun-Jong; Kim, Jae Soo

2018-01-12

Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain. This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment; NSAIDs; and miniscalpel acupuncture treatment combined with NSAIDs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three sessions of miniscalpel acupuncture over a three-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for three weeks). Primary and secondary outcomes will be measured at weeks 0 (baseline), 1, 2, 3 (primary end point), and 7 (four weeks after treatment completion) using the visual analogue scale and the Neck Disability Index, EuroQol 5-dimension questionnaire, and Patients' Global Impression of Change scale, respectively. Adverse events will also be recorded. This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture treatment combined with NSAIDs for chronic neck pain. Korean Clinical Research Information Service registry, KCT0002258 . Registered on 9 March 2017.

Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center: Results of the Pilot Study.

PubMed

Lai, Xiaobin; Wong, Frances Kam Yuet; Leung, Carenx Wai Yee; Lee, Lai Ha; Wong, Jessica Shuk Yin; Lo, Yim Fan; Ching, Shirley Siu Yin

2015-01-01

The increasing number of cancer patients and inadequate communication in clinics are posing challenges to cancer patients receiving outpatient-based chemotherapy and healthcare providers. A nurse-led care program was proposed as one way of dealing with at least some of these challenges. The objectives of the pilot study were to assess the feasibility of the subject recruitment, care, and data collection procedures and to explore the acceptability of this program. A pilot study with a 1-group pretest-posttest design was conducted. Five cancer patients receiving chemotherapy in a chemotherapy day center participated. Each patient had a nurse consultation before chemotherapy and received 2 telephone calls after the first and second cycles of chemotherapy. Four questionnaires were adopted to evaluate the subjects' quality of life, self-efficacy, symptom experiences, and satisfaction with care. Questionnaires were completed before the chemotherapy and after the second cycle. The subjects were also interviewed to understand their comments on the service. The recruitment, care, and data collection procedures were completed smoothly. Slight changes were observed in quality of life and self-efficacy. All 5 subjects were highly satisfied with the care. The nurse-led care program is feasible and acceptable. The effect of the nurse-led care program will be evaluated in a single-center, open, randomized controlled trial. If the encouraging results can be confirmed, it may be an effective approach to improving the quality of ambulatory chemotherapy care. It would also shed light on the development of nurse-led care in other areas.

Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

PubMed

Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

2017-02-01

To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( P<0.01). This pilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

Modafinil for Clozapine-Treated Schizophrenia Patients: A Double-Blind, Placebo-Controlled Pilot Trial

PubMed Central

Freudenreich, Oliver; Henderson, David C.; Macklin, Eric A.; Evins, A. Eden; Fan, Xiaoduo; Cather, Cori; Walsh, Jared P.; Goff, Donald C.

2016-01-01

Background Patients with schizophrenia often suffer from cognitive deficits and negative symptoms that are poorly responsive to antipsychotics including clozapine. Clozapine-induced sedation can worsen cognition and impair social and occupational functioning. Objectives To evaluate the efficacy, tolerability, and safety of modafinil for negative symptoms, cognition, and wakefulness/fatigue in DSM-IV–diagnosed schizophrenia patients treated with clozapine. Method A double-blind, placebo-controlled, flexible-dosed 8-week pilot trial was conducted between September 2003 and September 2007, adding modafinil up to 300 mg/d to stabilized schizophrenia outpatients receiving clozapine. Psychopathology, cognition, and wakefulness/fatigue were assessed with standard rating scales. Results Thirty-five patients were randomly assigned to treatment with study drug and included in the analysis. Modafinil did not reduce negative symptoms or wakefulness/fatigue or improve cognition compared to placebo. Modafinil was well tolerated and did not worsen psychosis. Conclusions Results of this pilot trial do not support routine use of modafinil to treat negative symptoms, cognitive deficits, or wakefulness/fatigue in patients on clozapine. However, given our limited power to detect a treatment effect and the clear possibility of a type II error, larger trials are needed to resolve or refute a potential therapeutic effect of uncertain magnitude. Trial Registration clinicaltrials.gov Identifier: NCT00573417 PMID:19689921

Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

PubMed

Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

2017-08-01

There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

mCare: using secure mobile technology to support soldier reintegration and rehabilitation.

PubMed

Poropatich, Ronald K; Pavliscsak, Holly H; Tong, James C; Little, Jeanette R; McVeigh, Francis L

2014-06-01

The U.S. Army Medical Department conducted a pilot mobile health project to determine the requirements for coordination of care for "Wounded Warriors" using mobile messaging. The primary objective was to determine if a secure mobile health (mhealth) intervention provided to geographically dispersed patients would improve contact rates and positively impact the military healthcare system. Over 21 months, volunteers enrolled in a Health Insurance Portability and Accountability Act-compliant, secure mobile messaging initiative called mCare. The study included males and females, 18-61 years old, with a minimum of 60 days of outpatient recovery. Volunteers were required to have a compatible phone. The mhealth intervention included appointment reminders, health and wellness tips, announcements, and other relevant information to this population exchanged between care teams and patients. Provider respondents reported that 85% would refer patients to mCare, and 56% noted improvement in appointment attendance (n=90). Patient responses also revealed high acceptability of mCare and refined the frequency and delivery times (n=114). The pilot project resulted in over 84,000 outbound messages and improved contact rates by 176%. The mCare pilot project demonstrated the feasibility and administrative effectiveness of a scalable mhealth application using secure mobile messaging and information exchanges, including personalized patient education.

Synthesis of qualitative linguistic research--a pilot review integrating and generalizing findings on doctor-patient interaction.

PubMed

Nowak, Peter

2011-03-01

There is a broad range qualitative linguistic research (sequential analysis) on doctor-patient interaction that had only a marginal impact on clinical research and practice. At least in parts this is due to the lack of qualitative research synthesis in the field. Available research summaries are not systematic in their methodology. This paper proposes a synthesis methodology for qualitative, sequential analytic research on doctor-patient interaction. The presented methodology is not new but specifies standard methodology of qualitative research synthesis for sequential analytic research. This pilot review synthesizes twelve studies on German-speaking doctor-patient interactions, identifies 45 verbal actions of doctors and structures them in a systematics of eight interaction components. Three interaction components ("Listening", "Asking for information", and "Giving information") seem to be central and cover two thirds of the identified action types. This pilot review demonstrates that sequential analytic research can be synthesized in a consistent and meaningful way, thus providing a more comprehensive and unbiased integration of research. Future synthesis of qualitative research in the area of health communication research is very much needed. Qualitative research synthesis can support the development of quantitative research and of educational materials in medical training and patient training. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)--a pilot study.

PubMed

Shetty, Ananth Samith; Chamukuttan, Snehalatha; Nanditha, Arun; Raj, Roopesh Kumar Champat; Ramachandran, Ambady

2011-11-01

To investigate the acceptability and feasibility of using short message services (SMS) via cell phones to ensure adherence to management prescriptions by diabetic patients. Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0% to 10% were randomized to the control arm (n = 105) to receive standard care and to the intervention arm (SMS, n = 110). Messages in English on principles of diabetes management were sent once in 3 days, the contents and frequencies varied as per the patients' preferences. The study duration was 1 year. All participants were advised to report for quarterly clinic visits. A comparative assessment of the clinical, biochemical and anthropometric outcomes was made among the groups at the annual visit. Annual review was possible in 71% of intervention group and 63% of control group. SMS was acceptable to the patients and the median number requested was 2 per week. HbA1c and plasma lipids improved significantly in the SMS group. The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes.

A pilot study of bendamustine in advanced bile duct cancer.

PubMed

Schoppmeyer, Konrad; Kreth, Florian; Wiedmann, Marcus; Mössner, Joachim; Preiss, Rainer; Caca, Karel

2007-07-01

We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.

Increased risk of paclitaxel-induced peripheral neuropathy in patients using clopidogrel: a retrospective pilot study.

PubMed

Matsuo, Mitsuhiro; Ito, Hisakatsu; Takemura, Yoshinori; Hattori, Mizuki; Kawakami, Masaaki; Takahashi, Norimasa; Yamazaki, Mitsuaki

2017-08-01

Paclitaxel-induced peripheral neuropathy (PIPN) is one of the serious adverse events associated with paclitaxel-based cancer treatments. A recent case study showed that the antiplatelet agent clopidogrel inhibits paclitaxel metabolism via cytochrome P450 (CYP) 2C8, resulting in severe PIPN. The aim of this study was to determine the impact of clopidogrel as a risk factor for the development of PIPN, using a retrospective cohort study. Data from paclitaxel-treated patients with or without clopidogrel and low-dose aspirin treatment were retrieved from medical charts. A total of 161 adult patients were included in this study: 135 were controls, 9 were clopidogrel-treated and 17 were aspirin-treated. The clopidogrel group had a greater proportion of males and a higher rate of comorbidities, such as diabetes mellitus and dyslipidemia, than the control group. However, patient characteristics were similar between the clopidogrel and aspirin groups. Severe PIPN was diagnosed in 3 (2.2%) and 2 (22.2%) patients in the control and clopidogrel groups, respectively (odds ratio: 12.0; p = 0.031). No patients in the aspirin group presented with severe neuropathy. These pilot data suggest that concomitant treatment with clopidogrel leads to a greater risk of PIPN. The avoidance of concomitant clopidogrel use may be effective in reducing clopidogrel-associated PIPN.

Pilot validation of an individualised pharmacokinetic algorithm for protamine dosing after systemic heparinisation for cardiopulmonary bypass.

PubMed

Miles, Lachlan F; Marchiori, Paolo; Falter, Florian

2017-09-01

This manuscript represents a pilot study assessing the feasibility of a single-compartment, individualised, pharmacokinetic algorithm for protamine dosing after cardiopulmonary bypass. A pilot cohort study in a specialist NHS cardiothoracic hospital targeting patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patients received protamine doses according to a pharmacokinetic algorithm (n = 30) or using an empirical, fixed-dose model (n = 30). Categorical differences between the groups were evaluated using the Chi-squared test or Fisher's exact test. Continuous data was analysed using a paired Student's t-test for parametric data and the paired samples Wilcoxon test for non-parametric data. Patients who had protamine dosing according to the algorithm demonstrated a lower protamine requirement post-bypass relative to empirical management as measured by absolute dose (243 ± 49mg vs. 305 ± 34.7mg; p<0.001) and the heparin to protamine ratio (0.79 ± 0.12 vs. 1.1 ± 0.15; p<0.001). There was no difference in the pre- to post-bypass activated clotting time (ACT) ratio (1.05 ± 0.12 vs. 1.02 ± 0.15; p=0.9). Patients who received protamine according to the algorithm had no significant difference in transfusion requirement (13.3% vs. 30.0%; p=0.21). This study showed that an individualized pharmacokinetic algorithm for the reversal of heparin after cardiopulmonary bypass is feasible in comparison with a fixed dosing strategy and may reduce the protamine requirement following on-pump cardiac surgery.

Acupuncture in shoulder pain and functional impairment after neck dissection: A prospective randomized pilot study.

PubMed

Deganello, Alberto; Battat, Nir; Muratori, Enrico; Cristofaro, Glauco; Buongiorno, Ana; Mannelli, Giuditta; Picconi, Mario; Giachetti, Rita; Borsotti, Giulia; Gallo, Oreste

2016-08-01

The efficacy of conventional physiotherapy and antiinflammatory/analgesic drugs in the management of shoulder pain and functional disability following neck dissection is often disappointing. Acupuncture is a safe and well-tolerated method. We report the results regarding our pilot trial of acupuncture versus conventional care in the management of postoperative shoulder pain and dysfunction after neck dissection. Pilot study. Patients at a tertiary university center with chronic pain or dysfunction attributed to neck dissection were randomly assigned to either weekly acupuncture or usual care (eg., physical therapy, analgesia, and/or antiinflammatory drugs) for 5 consecutive weeks. The Constant-Murley score, a composite measure of pain, function, and activities of daily living, was the primary outcome measure. As secondary end point, The Neck Dissection Impairment Index (NDII) was used to quantify site-specific, self-reported quality of life (QOL). After randomization, 48 patients completed the study (23 and 25 patients on acupuncture and control arms, respectively). Constant-Murley scores improved more in the acupuncture group (gain difference between groups 13.6, P < 0.01), a statistically significant improvement in site-specific QOL was also recorded at NDII (gain difference between groups 11.5, P < 0.01). Acupuncture is safe and effective; it should be introduced and offered to patients suffering from neck pain and dysfunction related to neck dissection. 2b. Laryngoscope, 126:1790-1795, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

European Cardiomyopathy Pilot Registry: EURObservational Research Programme of the European Society of Cardiology.

PubMed

Elliott, Perry; Charron, Philippe; Blanes, Juan Ramon Gimeno; Tavazzi, Luigi; Tendera, Michal; Konté, Marème; Laroche, Cécile; Maggioni, Aldo P

2016-01-07

Cardiomyopathies are a heterogeneous group of disorders associated with premature death due to ventricular arrhythmia or heart failure. The purpose of this study was to examine the characteristics of patients enrolled in the pilot phase of the EURObservational Research Programme (EORP) cardiomyopathy registry. Between 1 December 2012 and 30 November 2013, four cardiomyopathy phenotypes were studied: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM). Twenty-seven centres in 12 countries participated; 1115 patients were enrolled. The commonest cardiomyopathy was HCM (n = 681), followed by DCM (n = 346), ARVC (n = 59), and RCM (n = 29); 423 patients (46.4% of those reported) had familial disease; and 56 (5.0%) had rare disease phenocopies. Median age at enrolment and diagnosis was 54 [interquartile range (IQR), 42-64] and 46 years (IQR, 32-58), respectively; fewer patients with ARVC and more with RCM were diagnosed in the upper age quartile (P < 0.0001). There was a male predominance for all cardiomyopathies except RCM (P = 0.0023). Most patients were in New York Heart Association functional class I (n = 813) at enrolment; 139 (12.5%) reported syncope, most frequently in ARVC (P = 0.0009). Five hundred and seven (45.5%) patients underwent cardiac magnetic resonance imaging, 117 (10.6%) endomyocardial biopsy, and 462 (41.4%) genetic testing with a causative mutation reported in 236 individuals (51.1%). 1026 patients (92.0%) were receiving drug therapy; 316 (28.3%) had received an implantable cardioverter defibrillator (highest proportion in ARVC, P < 0.0001). This pilot study shows that services for patients with cardiomyopathy are complex, requiring access to a large range of invasive and non-invasive investigations and involvement of multidisciplinary teams. Treatment regimens are equally multifaceted and show that patients are likely to need long-term follow-up in close liaison with expert centres. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: Journals.permissions@oup.com.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

PubMed Central

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. Discussion This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. Trial registration ISRCTN62019087 PMID:23819476

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

A randomized, pilot study to assess the efficacy and safety of curcumin in patients with active rheumatoid arthritis.

PubMed

Chandran, Binu; Goel, Ajay

2012-11-01

Curcumin is known to possess potent antiinflammatory and antiarthritic properties. This pilot clinical study evaluated the safety and effectiveness of curcumin alone, and in combination with diclofenac sodium in patients with active rheumatoid arthritis (RA). Forty-five patients diagnosed with RA were randomized into three groups with patients receiving curcumin (500 mg) and diclofenac sodium (50 mg) alone or their combination. The primary endpoints were reduction in Disease Activity Score (DAS) 28. The secondary endpoints included American College of Rheumatology (ACR) criteria for reduction in tenderness and swelling of joint scores. Patients in all three treatment groups showed statistically significant changes in their DAS scores. Interestingly, the curcumin group showed the highest percentage of improvement in overall DAS and ACR scores (ACR 20, 50 and 70) and these scores were significantly better than the patients in the diclofenac sodium group. More importantly, curcumin treatment was found to be safe and did not relate with any adverse events. Our study provides the first evidence for the safety and superiority of curcumin treatment in patients with active RA, and highlights the need for future large-scale trials to validate these findings in patients with RA and other arthritic conditions. Copyright © 2012 John Wiley & Sons, Ltd.

Burden, quality of life, and social support in caregivers of patients undergoing radiotherapy for head and neck cancer: A pilot study

PubMed Central

Nightingale, Chandylen L; Curbow, Barbara A; Wingard, John R; Pereira, Deidre B; Carnaby, Giselle D

2017-01-01

Objective The purpose of this pilot study was to (1) obtain preliminary data on changes in burden and quality of life in head and neck cancer caregivers during and shortly following patient radiotherapy, (2) assess the relationship between perceived social support and burden as well as perceived social support and quality of life in caregivers during radiotherapy, and (3) identify preferences for sources of support among caregivers during radiotherapy. Methods Caregivers completed burden and quality of life instruments at the start of patient radiotherapy (T1), 5 weeks into radiotherapy (T2), and 1 month post-radiotherapy (T3) and instruments for perceived social support and support preferences at T2 only. Results Caregivers showed a trend toward increased burden and worsened quality of life for the majority of subscales at T2 or T3 than at T1. Caregivers reported significantly lower esteem and significantly greater disruption at T2 than at T1 and significantly worse health at T3 than at T2. Higher perceived social support was typically associated with lower burden and higher quality of life at T2. Spouses/partners were the most commonly preferred source of support. Discussion These pilot findings suggest that caregivers experience psychosocial impairments during and shortly after patient radiotherapy, but more research using larger samples is warranted. PMID:27068111

A pilot study of delivering peer health messages in an HIV clinic via mobile media.

PubMed

Winstead-Derlega, Christopher; Rafaly, Mary; Delgado, Sarah; Freeman, Jason; Cutitta, Katherine; Miles, Tony; Ingersoll, Karen; Dillingham, Rebecca

2012-01-01

This pilot study tested the feasibility and impact of using mobile media devices to present peer health messages to human immunodeficiency virus (HIV)-positive patients. A convenience sample of 30 adult patients from an outpatient HIV clinic serving a mostly rural catchment area in central Virginia volunteered for the study. Participants viewed short videos of people discussing HIV health topics on an Apple (Cupertino, CA) iPod® touch® mobile device. Pre- and post-intervention surveys assessed attitudes related to engagement in care and disease disclosure. Participants found delivery of health information by the mobile device acceptable in a clinic setting. They used the technology without difficulty. Participants reported satisfaction with and future interest in viewing such videos after using the mobile devices. The majority of participants used the device to access more videos than requested, and many reported the videos "hit home." There were no significant changes in participant perceptions about engagement in care or HIV disclosure after the intervention. This pilot study demonstrates the feasibility and acceptability of using mobile media technology to deliver peer health messages. Future research should explore how to best use mobile media to improve engagement in care and reduce perceptions of stigma.

Pilot Study on the Safety and Tolerability of Extended Release Niacin for HIV-infected Patients with Hypertriglyceridemia

PubMed Central

Souza, Scott A; Walsh, Erica J; Shippey, Ford; Shikuma, Cecilia

2010-01-01

Background To determine the safety and tolerability of extended release niacin (ERN) in HIV-infected patients. Methods This was a pilot, open-label, 36 week study evaluating the safety and tolerability of ERN in HIV-infected patients with hypertriglyceridemia. Subjects with cardiovascular disease, diabetes or liver disease were excluded. Subjects with persistent elevation of triglyceride (TG) >200 after 8 weeks on American Heart Association Step One and Two Diets were started on ERN 500mg once daily, with continuation of the diet and exercise recommendations until the end of the study. ERN was increased by 500mg every 4 weeks, to a maximum of 1500mg/day, depending on subject tolerability. Safety and tolerability of ERN were assessed. Results Ten subjects enrolled received ERN. Dose titration and maintenance to 1500mg/day were achieved in all 10 subjects. No subject required dose adjustment. Mild flushing was experienced in 8 subjects. Asymptomatic hypophosphotemia was noted in 4 subjects; all resolved with oral phosphate supplementation. Median TG was reduced by 254 mg/dL (p<0.05). Non-significant changes were noted in liver enzymes, HDL, LDL, and total cholesterol. Fasting insulin and glucose levels did not change with treatment. Conclusion In this pilot study, ERN was well-tolerated and resulted in reduction of TG. Although the results of this study are promising, the study is limited in the small number of subjects. Further investigation is warranted. PMID:20533755

Identifying unintended consequences of quality indicators: a qualitative study.

PubMed

Lester, Helen E; Hannon, Kerin L; Campbell, Stephen M

2011-12-01

For the first 5 years of the UK primary care pay for performance scheme, the Quality and Outcomes Framework (QOF), quality indicators were introduced without piloting. However, in 2009, potential new indicators were piloted in a nationally representative sample of practices. This paper describes an in-depth exploration of family physician, nurse and other primary-care practice staff views of the value of piloting with a particular focus on unintended consequences of 13 potential new QOF indicators. Fifty-seven family-practice professionals were interviewed in 24 representative practices across England. Almost all interviewees emphasised the value of piloting in terms of an opportunity to identify unintended consequences of potential QOF indicators in 'real world' settings with staff who deliver day-to-day care to patients. Four particular types of unintended consequences were identified: measure fixation, tunnel vision, misinterpretation and potential gaming. 'Measure fixation,' an inappropriate attention on isolated aspects of care, appeared to be the key unintended consequence. In particular, if the palliative care indicator had been introduced without piloting, this might have incentivised poorer care in a minority of practices with potential harm to vulnerable patients. It is important to identify concerns and experiences about unintended consequences of indicators at an early stage when there is time to remove or adapt problem indicators. Since the UK government currently spends over £1 billion each year on QOF, the £150,000 spent on each piloting cohort (0.0005% of the total QOF budget) appears to be good value for money.

Airplane pilot mental health and suicidal thoughts: a cross-sectional descriptive study via anonymous web-based survey.

PubMed

Wu, Alexander C; Donnelly-McLay, Deborah; Weisskopf, Marc G; McNeely, Eileen; Betancourt, Theresa S; Allen, Joseph G

2016-12-15

The Germanwings Flight 9525 crash has brought the sensitive subject of airline pilot mental health to the forefront in aviation. Globally, 350 million people suffer from depression-a common mental disorder. This study provides further information on this important topic regarding mental health especially among female airline pilots. This is the first study to describe airline pilot mental health-with a focus on depression and suicidal thoughts-outside of the information derived from aircraft accident investigations, regulated health examinations, or identifiable self-reports, which are records protected by civil aviation authorities and airline companies. This is a descriptive cross-sectional study via an anonymous web-based survey administered between April and December 2015. Pilots were recruited from unions, airline companies, and airports via convenience sampling. Data analysis included calculating absolute number and prevalence of health characteristics and depression scores. One thousand eight hundred thirty seven (52.7%) of the 3485 surveyed pilots completed the survey, with 1866 (53.5%) completing at least half of the survey. 233 (12.6%) of 1848 airline pilots responding to the Patient Health Questionnaire 9 (PHQ-9), and 193 (13.5%) of 1430 pilots who reported working as an airline pilot in the last seven days at time of survey, met depression threshold-PHQ-9 total score ≥ 10. Seventy-five participants (4.1%) reported having suicidal thoughts within the past two weeks. We found a significant trend in proportions of depression at higher levels of use of sleep-aid medication (trend test z = 6.74, p < 0.001) and among those experiencing sexual harassment (z = 3.18, p = 0.001) or verbal harassment (z = 6.13, p < 0.001). Hundreds of pilots currently flying are managing depressive symptoms perhaps without the possibility of treatment due to the fear of negative career impacts. This study found 233 (12.6%) airline pilots meeting depression threshold and 75 (4.1%) pilots reporting having suicidal thoughts. Although results have limited generalizability, there are a significant number of active pilots suffering from depressive symptoms. We recommend airline organizations increase support for preventative mental health treatment. Future research will evaluate additional risk factors of depression such as sleep and circadian rhythm disturbances.

[Pattern of injuries and prophylaxis in paragliding].

PubMed

Schulze, W; Hesse, B; Blatter, G; Schmidtler, B; Muhr, G

2000-06-01

This study will present trends and recommendations to increase active and passive safety in paragliding on the basis of current state-of-the-art equipment and typical patterns of injury. This German-Swiss teamwork presents data of 55 male and 9 female patients treated after paragliding accidents between 1994 to 1998 respectively 1996 to 1998. 43.7% of the pilots presented with multiple injuries, 62.5% suffered spinal fractures and 18.8% pelvic fractures. 28.4% of the injured pilots were admitted with injuries of the lower extremities mainly affecting the tarsus or the ankle joint. Only three patients with single injuries could be treated in an ambulatory setting. 54.0% of the injuries left the patients with lasting functional residues and complaints. Main causes of accidents were either pilot error in handling the paraglider or general lack of awareness about potential risk factors. 46.0% of injuries occurred during landing, 42.9% of injuries during the flight and another 11.1% of injuries during starting procedures. With noticeable enhanced performance sails of the beginners and intermediate level are increasingly popular. Protective helmets and sturdy footwear reaching above the ankle joint are indispensable pieces of equipment. The use of protective gloves is highly recommended. Back protection devices of the new generation provide the best passive prophylaxis for the pilot against pelvic and spinal cord injuries. This area hold the most promise for increasing safety and reducing risk of injury in future, apart from using beginners and intermediate wings. After acquisition of the pilot license performance and security training provide the best preparing to master unforeseeable situations.

Electronic protocol of respiratory physical therapy in patients with idiopathic adolescent scoliosis.

PubMed

Cano, Danila Vieira Baldini; Malafaia, Osvaldo; Alves, Vera Lúcia dos Santos; Avanzi, Osmar; Pinto, José Simão de Paula

2011-01-01

To create a clinical database of respiratory function in patients with adolescent idiopathic scoliosis; computerize and store this clinical data through the use of a software; incorporate this electronic protocol to the SINPE© (Integrated Electronic Protocols System) and analyze a pilot project with interpretation of results. From the literature review a computerized data bank of clinical data of postural deviations was set up (master protocol). Upon completion of the master protocol a specific protocol of respiratory function in patients with adolescent idiopathic scoliosis was designed and a pilot project was conducted to collect and analyze data from ten patients. It was possible to create the master protocol of postural deviations and the specific protocol of respiratory function in patients with adolescent idiopathic scoliosis. The data collected in the pilot project was processed by the SINPE ANALYZER©, generating charts and statistics. The establishment of the clinical database of adolescent idiopathic scoliosis was possible. Computerization and storage of clinical data using the software were viable. The electronic protocol of adolescent idiopathic scoliosis could be incorporated into the SINPE© and its use in the pilot project was successful.

Participation of Asian-American women in cancer treatment research: a pilot study.

PubMed

Nguyen, Tung T; Somkin, Carol P; Ma, Yifei; Fung, Lei-Chun; Nguyen, Thoa

2005-01-01

Few Asian-American women participate in cancer treatment trials. In a pilot study to assess barriers to participation, we mailed surveys to 132 oncologists and interviewed 19 Asian-American women with cancer from Northern California. Forty-four oncologists responded. They reported as barriers language problems, lack of culturally relevant cancer information, and complex protocols. Most stated that they informed Asian-American women about treatment trials. Only four women interviewed knew about trials. Other patient-identified barriers were fear of side effects, language problems, competing needs, and fear of experimentation. Family decision making was a barrier for both oncologists and patients. Compared to non-Asian oncologists, more Asian oncologists have referred Asian-American women to industry trials and identified barriers similar to patients' reports. Our findings indicate that Asian-American women need to be informed about cancer treatment trials, linguistic barriers should be addressed, and future research should evaluate cultural barriers such as family decision making.

Detection of bleeding disorders in Lebanon: outcomes of a pilot programme.

PubMed

Djambas Khayat, C; Samaha, H; Noun, P; Bakhos Asmar, J D; Taher, A; Adib, S; Inati, A; Sakr, S

2014-03-01

To promote management and awareness of bleeding disorders in Lebanon, a pilot programme was launched in 2009 by the Lebanese Hemophilia Association assisted by World Federation of Hemophilia. The aim of this study was to diagnose patients with bleeding disorders and to assess the potential challenges in implementing a screening programme. The pilot project was launched in 26 social health centres in the Bekaa valley. The study tools included the evaluation of the Tossetto Bleeding Score and the Pictorial Bleeding Assessment Chart (PBAC) for menstruation. Persons with a bleeding score higher than 2 and PBAC higher than 185 were eligible for further blood tests including the prothrombin time, partial thromboplastin time, complete blood count, bleeding time and von Willebrand ristocetin cofactor activity. 643 patients were enrolled, of whom 60.6% were women. Overall, 91 persons had an abnormal score. 50 eligible patients were tested: 32 had normal tests, nine new patients with severe Von Willebrand were discovered, 4 had VW:RiCo of 40, 3 prolonged APTT and 2 thrombocytopaenia. There was a clear correlation between the severity of the score and the willingness to perform the tests (P = 0.02). Women were reluctant to participate fully when investigators were men. The probability of adherence to the screening protocol is significantly increased when directed by women health care professional. For patients with milder forms, global screening programmes were neither feasible nor acceptable but those more severely affected have to be identified. Providers are crucial in preselecting patients with blood problems who are not coping well. © 2013 John Wiley & Sons Ltd.

Cytokines and T-Lymphocute count in patients in the acute and chronic phases of Bartonella bacilliformis infection in an endemic area in peru: a pilot study.

PubMed

Huarcaya, Erick; Best, Ivan; Rodriguez-Tafur, Juan; Maguiña, Ciro; Solórzano, Nelson; Menacho, Julio; Lopez De Guimaraes, Douglas; Chauca, Jose; Ventosilla, Palmira

2011-01-01

Human Bartonellosis has an acute phase characterized by fever and hemolytic anemia, and a chronic phase with bacillary angiomatosis-like lesions. This cross-sectional pilot study evaluated the immunology patterns using pre- and post-treatment samples in patients with Human Bartonellosis. Patients between five and 60 years of age, from endemic areas in Peru, in the acute or chronic phases were included. In patients in the acute phase of Bartonellosis a state of immune peripheral tolerance should be established for persistence of the infection. Our findings were that elevation of the anti-inflammatory cytokine IL-10 and numeric abnormalities of CD4(+) and CD8(+) T-Lymphocyte counts correlated significantly with an unfavorable immune state. During the chronic phase, the elevated levels of IFN-γ and IL-4 observed in our series correlated with previous findings of endothelial invasion of B. henselae in animal models.

Direct-to-consumer communication on prescription only medicines via the internet in the Netherlands, a pilot study. Opinion of the pharmaceutical industry, patient associations and support groups.

PubMed

Fabius, A Mariette; Cheung, Ka-Chun; Rijcken, Cristianne J F; Vinkers, Christiaan H; Talsma, Herre

2004-06-01

Investigation of the current application of direct-to-consumer (DTC) communication on prescription only medicines via the Intemet in the Netherlands. Questionnaires were sent by e-mail to 43 Dutch innovative pharmaceutical industries and 130 Patient Association and Support Groups (PASGs). In this pilot study, the response of the pharmaceutical industry was rather low but the impression is that they were willing to invest in DTC communication. The majority of the websites of PASGs did not link to websites of pharmaceutical companies. The PASGs had no opinion whether patients can make a good distinction between DTC advertising and information on websites of the pharmaceutical industry nor about the quality. PASGs did not think unambiguously about the impact on the patient-doctor relationship. The impact of DTC communication on prescription only medicines via the internet is not yet clear in the Netherlands.

A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

PubMed

Koffel, Erin; Kuhn, Eric; Petsoulis, Napoleon; Erbes, Christopher R; Anders, Samantha; Hoffman, Julia E; Ruzek, Josef I; Polusny, Melissa A

2018-03-01

There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study ( n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment.

Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique.

PubMed

Lin, Yen-Ko; Chen, Chao-Wen; Lee, Wei-Che; Lin, Tsung-Ying; Kuo, Liang-Chi; Lin, Chia-Ju; Shi, Leiyu; Tien, Yin-Chun; Cheng, Yuan-Chia

2017-11-29

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients' knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department (ED) were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts' opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

PubMed

Carroll, Sandra L; McGillion, Michael; Stacey, Dawn; Healey, Jeff S; Browne, Gina; Arthur, Heather M; Thabane, Lehana

2013-10-22

Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. ClinicalTrials.gov: NCT01876173.

The New Nitinol Conformable Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Pilot Experience as Bridge to Surgery Treatment

PubMed Central

2014-01-01

Introduction. Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Materials and Methods. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Results. Ten patients (7 male (70%)), with a mean age of 69.2 ± 10.1, were evaluated. The mean length of the stenosis was 3.6 ± 0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7–21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. Conclusion. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction. PMID:24526914

A combined intervention to reduce interruptions during medication preparation and double-checking: a pilot-study evaluating the impact of staff training and safety vests.

PubMed

Huckels-Baumgart, Saskia; Niederberger, Milena; Manser, Tanja; Meier, Christoph R; Meyer-Massetti, Carla

2017-10-01

The aim was to evaluate the impact of staff training and wearing safety vests as a combined intervention on interruptions during medication preparation and double-checking. Interruptions and errors during the medication process are common and an important issue for patient safety in the hospital setting. We performed a pre- and post-intervention pilot-study using direct structured observation of 26 nurses preparing and double-checking 431 medication doses (225 pre-intervention and 206 post-intervention) for 36 patients (21 pre-intervention and 15 post-intervention). With staff training and the introduction of safety vests, the interruption rate during medication preparation was reduced from 36.8 to 28.3 interruptions per hour and during double-checking from 27.5 to 15 interruptions per hour. This pilot-study showed that the frequency of interruptions decreased during the critical tasks of medication preparation and double-checking after the introduction of staff training and wearing safety vests as part of a quality improvement process. Nursing management should acknowledge interruptions as an important factor potentially influencing medication safety. Unnecessary interruptions can be successfully reduced by considering human and system factors and increasing both staff and nursing managers' awareness of 'interruptive communication practices' and implementing physical barriers. This is the first pilot-study specifically evaluating the impact of staff training and wearing safety vests on the reduction of interruptions during medication preparation and double-checking. © 2017 John Wiley & Sons Ltd.

F30. SMARTPHONE APPLICATION “ROBIN”: FEASIBILITY, ENGAGEMENT AND SATISFACTION OF A SMARTPHONE APPLICATION APPROACH TO SUPPORT TREATMENT OF (ATTENUATED) PSYCHOTIC SYMPTOMS IN ADOLESCENTS

PubMed Central

Traber-Walker, Nina; Metzler, Sibylle; Gerstenberg, Miriam; Walitza, Susanne; Franscini, Maurizia

2018-01-01

Abstract Background There is increasing interest in using mobile technologies such as smartphones application in mental health care. First research results from the use of smartphone applications in the treatment of psychotic disorders are promising. Current analysis showed, that especially young people would be interested in smartphone applications within treatment settings. However, there is a lack of investigations in this population. There is also little known about mobile technologies in the work with attenuated psychotic symptoms. To address these gaps, we developed “Robin”, a specific smartphone application to support the therapy of adolescents with attenuated or full-blown psychotic symptoms. The smartphone application targets medication adherence, real-time symptom assessment and provides help coping with symptoms and stressful situations in daily life. Methods Based on existing literature and our clinical expertise within a specialized outpatient care for adolescents with (attenuated) psychotic symptoms, a first modular version of the app was developed and adapted after first pilot investigations with patients (N=7, Age 14–18) and therapists (N=10). Participants of the pilot investigation completed a questionnaire regarding usability and acceptance of the application. Furthermore, we investigated how the patients used the application in their daily life by analyzing the user data from the application. In September 2017, the development of the smartphone application has been finalized and we have started with a systematic clinical evaluation study for testing the efficiency of the app. The application is only used in combination with psychotherapy in our university hospital for child and adolescent psychiatry. Results The data from our pilot investigation showed, that “Robin” was accepted by clinicians and patients. All clinicians said they would like to use the application to enrich their therapeutic approaches. All patients in the pilot project used the application in their daily life. Especially modules with information about symptoms and coping strategies were frequently used. Since September 2017, first patients have been included to the systematic evaluation study. In Florence 2018, we will present first data from this study about feasibility, engagement and subjectively perceived benefit of the smartphone application. Discussion The first feedbacks from the pilot investigation were encouraging. The findings were used to improve and adapt the application. Since September 2017, the application is used in psychotherapy and an evaluation study has started. This is one of the first clinical trials to test the efficacy of a specific application developed for adolescents with psychotic and with attenuated psychotic symptoms.

Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial.

PubMed

MacInnes, Douglas; Kinane, Catherine; Beer, Dominic; Parrott, Janet; Craig, Tom; Eldridge, Sandra; Marsh, Ian; Krotofil, Joanna; Priebe, Stefan

2013-08-16

Forensic mental health services have largely ignored examining patients' views on the nature of the services offered to them. A structured communication approach (DIALOG) has been developed with the aim of placing the patient's perspective on their care at the heart of the discussions between patients and clinicians. The effectiveness of the structured communication approach in community mental health services has been demonstrated, but no trial has taken place in a secure psychiatric setting. This pilot study is evaluating a 6-month intervention combining DIALOG with principles of solution-focused therapy on quality of life in medium-secure settings. A cluster randomized controlled trial design is being employed to conduct a 36-month pilot study. Participants are recruited from six medium-secure inpatient services, with 48 patients in the intervention group and 48 in the control group. The intervention uses a structured communication approach. It comprises six meetings between patient and nurse held monthly over a 6-month period. During each meeting, patients rate their satisfaction with a range of life and treatment domains with responses displayed on a tablet. The rating is followed by a discussion of how to improve the current situation in those domains identified by the patient. Assessments take place prior to the intervention (baseline), at 6 months (postintervention) and at 12 months (follow-up). The primary outcome is the patient's self-reported quality of life. This study aims to (1) establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial, (2) determine the variability of the outcomes of interest (quality of life, levels of satisfaction, disturbance, ward climate and engagement with services), (3) estimate the costs of the intervention and (4) refine the intervention following the outcome of the study based upon the experiences of the nurses and patients. The intervention allows patients to have a greater say in how they are treated and targets care in areas that patients identify as important to them. It is intended to establish systems that support meaningful patient and caregiver involvement and participation. Current Controlled Trials, ISRCTN34145189.

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

Home-based aerobic conditioning for management of symptoms of fibromyalgia: a pilot study.

PubMed

Harden, R Norman; Song, Sharon; Fasen, Jo; Saltz, Samuel L; Nampiaparampil, Devi; Vo, Andrew; Revivo, Gadi

2012-06-01

This pilot study was designed to evaluate the impact of a home-based aerobic conditioning program on symptoms of fibromyalgia and determine if changes in symptoms were related to quantitative changes in aerobic conditioning (VO(2) max). Twenty-six sedentary individuals diagnosed with fibromyalgia syndrome participated in an individualized 12-week home-based aerobic exercise program with the goal of daily aerobic exercise of 30 minutes at 80% of estimated maximum heart rate. The aerobic conditioning took place in the participants' homes, outdoors, or at local fitness clubs at the discretion of the individual under the supervision of a physical therapist. Patients were evaluated at baseline and completion for physiological level of aerobic conditioning (VO(2) max), pain ratings, pain disability, depression, and stress. In this pilot study subjects who successfully completed the 12-week exercise program demonstrated an increase in aerobic conditioning, a trend toward decrease in pain measured by the McGill Pain Questionnaire-Short Form and a weak trend toward improvements in visual analog scale, depression, and perceived stress. Patients who were unable or unwilling to complete this aerobic conditioning program reported significantly greater pain and perceived disability (and a trend toward more depression) at baseline than those who completed the program. Patients suffering from fibromyalgia who can participate in an aerobic conditioning program may experience physiological and psychological benefits, perhaps with improvement in symptoms of fibromyalgia, specifically pain ratings. More definitive trials are needed, and this pilot demonstrates the feasibility of the quantitative VO2 max method. Subjects who experience significant perceived disability and negative affective symptoms are not likely to maintain a home-based conditioning program, and may need a more comprehensive interdisciplinary program offering greater psychological and social support. Wiley Periodicals, Inc.

The Measurement of Causes of Patient Satisfaction and Dissatisfaction within Clinics at an Army Medical Treatment Facility

DTIC Science & Technology

1984-05-01

Satisfaction Measures Between Clinics.... 39 Lessons Learned From the Pilot Studies ...................... 42 Telephonic Versus Clinic Survey...Between Clinics. 63 Comments from Survey Participants ....................... 64 Lessons Learned from the Study ............................. 67...attempted to apply principles learned from a review of the multitude of studies conducted in the area of patient satisfaction. Validated dimensions of

A virtual patient software program to improve pharmacy student learning in a comprehensive disease management course.

PubMed

Douglass, Mark A; Casale, Jillian P; Skirvin, J Andrew; DiVall, Margarita V

2013-10-14

To implement and assess the impact of a virtual patient pilot program on pharmacy students' clinical competence skills. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students' posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes.

Effect of Aromatherapy Massage on Chemotherapy-Induced Peripheral Neuropathic Pain and Fatigue in Patients Receiving Oxaliplatin: An Open Label Quasi-Randomized Controlled Pilot Study.

PubMed

Izgu, Nur; Ozdemir, Leyla; Bugdayci Basal, Fatma

2017-12-02

Patients receiving oxaliplatin may experience peripheral neuropathic pain and fatigue. Aromatherapy massage, a nonpharmacological method, may help to control these symptoms. The aim of this open-label, parallel-group, quasi-randomized controlled pilot study was to investigate the effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin. Stratified randomization was used to allocate 46 patients to 2 groups: intervention (n = 22) and control (n = 24). Between week 1 and week 6, participants in the intervention group (IG) received aromatherapy massage 3 times a week. There was no intervention in weeks 7 and 8. The control group (CG) received routine care. Neuropathic pain was identified using the Douleur Neuropathique 4 Questions; severity of painful paresthesia was assessed with the numerical rating scale; fatigue severity was identified with the Piper Fatigue Scale. At week 6, the rate of neuropathic pain was significantly lower in the IG, when compared with the CG. The severity of painful paresthesia based on numerical rating scale in the IG was significantly lower than that in the CG at weeks 2, 4, and 6. At week 8, fatigue severity in the IG was significantly lower when compared with CG (P < .05). Aromatherapy massage may be useful in the management of chemotherapy-induced peripheral neuropathic pain and fatigue. This pilot study suggests that aromatherapy massage may be useful to relieve neuropathic pain and fatigue. However, there is a need for further clinical trials to validate the results of this study.

Modafinil treatment for fatigue in HIV+ patients: a pilot study.

PubMed

Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard; Ferrando, Stephen J

2004-12-01

Fatigue is widespread among human immunodeficiency virus-positive (HIV+) patients, yet few studies have assessed effective treatments. The authors conducted a pilot study to evaluate the efficacy of modafinil for fatigue in this clinical population. Response was evaluated after a 4-week open-label trial. Data were collected from February 2003 through January 2004. Responders were offered 8 additional weeks of modafinil. Inclusion criteria included written approval from the primary care physician, clinically significant fatigue, current use of anti-retroviral medications, and the absence of treatable medical conditions known to cause fatigue. Exclusion criteria included untreated major depression and current substance abuse. Major outcome measures were the Fatigue Severity Scale, Chalder Fatigue Scale, Hamilton Rating Scale for Depression, Beck Depression Inventory, and neuropsychological tests assessing verbal memory, speed of processing, and executive function. Immunologic and virologic measures were performed at baseline and week 4 to assess safety of treatment. All 30 patients who enrolled completed 4 weeks of treatment; 24 (80%) were rated as responders. Responders showed statistically significant improvement on all measures of fatigue, depressive symptoms, and executive function, while nonresponders did not. Mean values of CD4 cell count and HIV RNA viral load did not change. The most common side effect was headache, followed by irritability and feeling "hyper." This pilot study shows encouraging results for modafinil in alleviation of fatigue in HIV+ patients. In addition, depressive symptoms were substantially reduced. Improvements on measures of verbal memory and executive function were significant, but in the absence of a placebo control, the magnitude of effect due to practice cannot be determined.

An Ai Chi-based aquatic group improves balance and reduces falls in community-dwelling adults: A pilot observational cohort study.

PubMed

Skinner, Elizabeth H; Dinh, Tammy; Hewitt, Melissa; Piper, Ross; Thwaites, Claire

2016-11-01

Falls are associated with morbidity, loss of independence, and mortality. While land-based group exercise and Tai Chi programs reduce the risk of falls, aquatic therapy may allow patients to complete balance exercises with less pain and fear of falling; however, limited data exist. The objective of the study was to pilot the implementation of an aquatic group based on Ai Chi principles (Aquabalance) and to evaluate the safety, intervention acceptability, and intervention effect sizes. Pilot observational cohort study. Forty-two outpatients underwent a single 45-minute weekly group aquatic Ai Chi-based session for eight weeks (Aquabalance). Safety was monitored using organizational reporting systems. Patient attendance, satisfaction, and self-reported falls were also recorded. Balance measures included the Timed Up and Go (TUG) test, the Four Square Step Test (FSST), and the unilateral Step Tests. Forty-two patients completed the program. It was feasible to deliver Aquabalance, as evidenced by the median (IQR) attendance rate of 8.0 (7.8, 8.0) out of 8. No adverse events occurred and participants reported high satisfaction levels. Improvements were noted on the TUG, 10-meter walk test, the Functional Reach Test, the FSST, and the unilateral step tests (p < 0.05). The proportion of patients defined as high falls risk reduced from 38% to 21%. The study was limited by its small sample size, single-center nature, and the absence of a control group. Aquabalance was safe, well-attended, and acceptable to participants. A randomized controlled assessor-blinded trial is required.

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

PubMed

Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in patients at high-risk of future fracture when compared with a multifaceted quality improvement intervention aimed at patients and physicians. Even with case-management, nearly half of patients did not receive appropriate care. clinicaltrials.gov identifier: NCT00152321.

Integrating an internet-mediated walking program into family medicine clinical practice: a pilot feasibility study.

PubMed

Goodrich, David E; Buis, Lorraine R; Janney, Adrienne W; Ditty, Megan D; Krause, Christine W; Zheng, Kai; Sen, Ananda; Strecher, Victor J; Hess, Michael L; Piette, John D; Richardson, Caroline R

2011-06-24

Regular participation in physical activity can prevent many chronic health conditions. Computerized self-management programs are effective clinical tools to support patient participation in physical activity. This pilot study sought to develop and evaluate an online interface for primary care providers to refer patients to an Internet-mediated walking program called Stepping Up to Health (SUH) and to monitor participant progress in the program. In Phase I of the study, we recruited six pairs of physicians and medical assistants from two family practice clinics to assist with the design of a clinical interface. During Phase II, providers used the developed interface to refer patients to a six-week pilot intervention. Provider perspectives were assessed regarding the feasibility of integrating the program into routine care. Assessment tools included quantitative and qualitative data gathered from semi-structured interviews, surveys, and online usage logs. In Phase I, 13 providers used SUH and participated in two interviews. Providers emphasized the need for alerts flagging patients who were not doing well and the ability to review participant progress. Additionally, providers asked for summary views of data across all enrolled clinic patients as well as advertising materials for intervention recruitment. In response to this input, an interface was developed containing three pages: 1) a recruitment page, 2) a summary page, and 3) a detailed patient page. In Phase II, providers used the interface to refer 139 patients to SUH and 37 (27%) enrolled in the intervention. Providers rarely used the interface to monitor enrolled patients. Barriers to regular use of the intervention included lack of integration with the medical record system, competing priorities, patient disinterest, and physician unease with exercise referrals. Intention-to-treat analyses showed that patients increased walking by an average of 1493 steps/day from pre- to post-intervention (t = (36) = 4.13, p < 0.01). Providers successfully referred patients using the SUH provider interface, but were less willing to monitor patient compliance in the program. Patients who completed the program significantly increased their step counts. Future research is needed to test the effectiveness of integrating SUH with clinical information systems over a longer evaluation period.

APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study

PubMed Central

Marino, Marcello; Crimi, Gabriele; Maiorana, Florinda; Rizzotti, Diego; Lettieri, Corrado; Bettari, Luca; Zuccari, Marco; Sganzerla, Paolo; Tresoldi, Simone; Adamo, Marianna; Ghiringhelli, Sergio; Sponzilli, Carlo; Pasquetto, Giampaolo; Pavei, Andrea; Pedon, Luigi; Bassan, Luciano; Bollati, Mario; Camisasca, Paola; Trabattoni, Daniela; Brancati, Marta; Poli, Arnaldo; Panciroli, Claudio; Lettino, Maddalena; Tarelli, Giuseppe; Tarantini, Giuseppe; De Luca, Leonardo; Varbella, Ferdinando; Musumeci, Giuseppe; De Servi, Stefano

2017-01-01

Objectives To first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation. Design Retrospective, pilot study. Setting 22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery. Participants 440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics. Primary and secondary outcome measures Proportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD. Results Of the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001). Conclusions Use of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting is limited. This pilot study documents the feasibility of measuring appropriateness and guideline adherence in clinical practice and identifies substantial opportunities for quality improvement. Trial registration number NCT02748603. PMID:28877948

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Oral health knowledge deficit: A barrier for seeking periodontal therapy? A pilot study

PubMed Central

Hosadurga, Rajesh; Boloor, Vinita; Kashyap, Rajesh

2015-01-01

Context: In developing countries many chronic conditions including periodontitis are on the rise. Oral health attitudes and beliefs are important factors affecting oral health behavior. Aims: The aim of this pilot study was to assess the existing knowledge about periodontal disease and its impact on treatment seeking behavior in a group of population visiting the out-patient Department of Periodontics, Yenepoya Dental College, India. This study also attempted to identify deficit in the knowledge if present. Settings and Design: This is a written questionnaire based pilot study. 143 subjects (89 male and 54 female) agreed to participate in the study. Simple random sampling was used for recruitment. Subjects and Methods: A written questionnaire consisting of 18 questions was given to the patients. Only one correct answer was present and the score given was + 1. The knowledge of the subjects was reflected by their ability to select a correct answer from the number of distractors (multiple choices, prespecified answers). Statistical Analysis Used: SPSS software version 15.0 is used for all statistical analysis. The Chi-square test was employed to assess the passive knowledge of the participants in relation to their age. Results: We found a deficit in the knowledge in all the topics investigated. No consistent relationship between age and gender was found. Female respondents had better knowledge about oral hygiene compared to males. Conclusion: We made an attempt to assess the knowledge of periodontitis among the participants of this study. Knowledge deficit was found in the population surveyed. This knowledge deficit could be one of the reasons why patients do not seek periodontal treatment routinely unless there are acute symptoms. There is urgent need to educate the patients about the periodontal disease, the need for the treatment of periodontitis and advanced treatment modalities available. PMID:26644723

Treatment of Lymphedema with Saam Acupuncture in Patients with Breast Cancer: A Pilot Study

PubMed Central

Jeong, Young Ju; Kwon, Hyo Jung; Park, Young Sun; Kwon, Oh Chang; Shin, Im Hee

2015-01-01

Abstract Background: Lymphedema is a troublesome complication affecting quality of life (QoL) in many women after breast-cancer treatment. Recent studies have suggested that acupuncture can reduce symptoms of lymphedema in breast-cancer survivors. Objectives: This was a pilot study. It was designed to assess the feasibility and the safety of acupuncture with the Saam acupuncture method for treating lymphedema in Korean patients after surgical therapy for breast cancer. Materials and Methods: This was a prospective, single-arm, observational pilot study using before and after measurements. The study was conducted at the East-West Medical Center at the Daegu Catholic University Medical Center, in Daegu, Korea. The subjects were 9 patients with breast cancer who presented with lymphedema of the upper limb ipsilateral to surgery. Saam acupuncture was administered 3 times per week for 6 consecutive weeks, for 30±5 minutes at each session.The primary outcome measure was severity of lymphedema as assessed by stages of lymphedema, a visual analogue scale (VAS), and by circumferential measurements of the upper extremity. The secondary outcome measure was QoL, which was assessed by a self-administered questionnaire using the Short Form–36 questionnaire. Results: Acupuncture reduced severity of lymphedema significantly, as assessed by the VAS (P<0.001) as well as by circumferential measurements of the upper extremity. Four weeks after the final treatment, symptoms were not aggravated. SF-36 scores remained significant for health status at the end of treatment. Conclusions: The Saam acupuncture method appeared to provide reduction of lymphedema among women after they had undergone surgery for breast cancer. A randomized, controlled prospective study with a larger sample size is required to clarify the role of acupuncture for managing lymphedema in patients with breast cancer. PMID:26155321

Chronic psychiatric patients without psychiatric care: a pilot study.

PubMed

Längle, G; Welte, W; Rösger, U; Günthner, A; U'Ren, R

2000-10-01

The study is based on the hypothesis that in any catchment area there are patients with chronic mental illness who are unknown to a comprehensive psychiatric/psychosocial care system. A standardized questionnaire was sent to all general practitioners in a circumscribed catchment area in southwestern Germany in an attempt to identify such a group, to ascertain what the practitioners considered to be the needs of these patients, and to find out why the patients were not receiving specialized psychiatric care. Of 97 general practitioners contacted, 62 returned the questionnaire. Within a study period of 3 months, 89 patients were identified as having a significant psychiatric disorder, of whom 53% were older than 60 years and 15% were schizophrenic. General practitioners most frequently said that provision of specialized psychiatric care was the most pressing need of these patients, followed by a need for psychosocial services. They also said that the major reason patients did not participate in the mental health system was patient refusal of such services. Having identified the existence of a group of chronic psychiatric patients who are not receiving specialized psychiatric care, further in-depth field studies to pursue some of the issues raised in this pilot study will be necessary to determine whether further efforts to reach psychiatric patients without defined psychiatric care would be worthwhile. These issues include estimates of the prevalence of such patients in a defined population, patients' more specific reasons for refusal of psychiatric care, and the quality of psychiatric care they receive from general practitioners in comparison with patients who receive more conventional psychiatric care.

Development and Pilot Evaluation of a Psychosocial Intervention Program for Patients with Age-Related Macular Degeneration

ERIC Educational Resources Information Center

Birk, Tanja; Hickl, Susanne; Wahl, Hans-Werner; Miller, Daniel; Kammerer, Annette; Holz, Frank; Becker, Stefanie; Volcker, Hans E.

2004-01-01

Purpose: The psychosocial needs of patients suffering from severe visual loss associated with advanced age-related macular degeneration (ARMD) are generally ignored in the clinical routine. The aim of this study was to develop and evaluate a psychosocial intervention program for ARMD patients. This intervention program was based on six modules…

MyPectus: First-in-human pilot study of remote compliance monitoring of teens using dynamic compression bracing to correct pectus carinatum.

PubMed

Harrison, Brittany; Stern, Lily; Chung, Philip; Etemadi, Mozziyar; Kwiat, Dillon; Roy, Shuvo; Harrison, Michael R; Martinez-Ferro, Marcelo

2016-04-01

Patient compliance is a crucial determinant of outcomes in treatments involving medical braces, such as dynamic compression therapy for pectus carinatum (PC). We performed a pilot study to assess a novel, wireless, real-time monitoring system (MyPectus) to address noncompliance. Eight patients (10-16years old) with moderately severe PC deformities underwent bracing. Each patient received a data logger device inserted in the compression brace to sense temperature and pressure. The data were transmitted via Bluetooth 4.0 to an iOS smartphone app, then synced to cloud-based storage, and presented to the clinician on a web-based dashboard. Patients received points for brace usage on the app throughout the 4-week study, and completed a survey to capture patient-reported usage patterns. In all 8 patients, the data logger sensed and recorded data, which connected through all MyPectus system components. There were occasional lapses in data collection because of technical difficulties, such as limited storage capacity. Patients reported positive feedback regarding points. The components of the MyPectus system recorded, stored, and provided data to patients and clinicians. The MyPectus system will inform clinicians about issues related to noncompliance: discrepancy between patient-reported and sensor-reported data regarding brace usage; real-time, actionable information; and patient motivation. Copyright © 2015 Elsevier Inc. All rights reserved.

Medical student, nursing student, and non-health care respondents' implicit attitudes toward doctors and patients: Development and a pilot study of a new implicit attitudes test (IAT)

PubMed Central

Mazouni, Abdelhamid

2017-01-01

Introduction Medical educators have been concerned that medical students may decline in empathy for patients during the course of their training, based on studies measuring clinical empathy using psychometrically strong self-report measures. Clinical empathy is a complex construct, incorporating attitudes toward patients but also other components, such as professional detachment. Triangulation of extant measures with instruments based on nonreactive methods could provide a better understanding of whether and how physician attitudes toward patients may be changing during training. We sought to develop and pilot-test such a nonreactive method. Methods We develop variations of an implicit association test (IAT) designed to measure attitudes toward physicians and patients based on speed of reaction to images of actors and positive and negative words. In the IATs, the same actors are photographed as doctors, clinic outpatients, hospitalized inpatients, and as a “general public” control. We examine preliminary evidence for their validity by collecting pilot data from internet participants (not involved in the health professions), medical students, and nursing students. Results Internet participants (n = 314) and nursing students (n = 31) had more negative associations (IAT scores) with doctors than did medical students (n = 89); nursing students and female internet participants had more positive associations with hospitalized patients than did medical students and male internet participants. Medical students’ associations with hospitalized patients varied by year of training. Discussion This IAT may provide insight into implicit attitudes among those who enter training for the health profession and changes in those attitudes that may be inculcated during that training. PMID:28813524

Measuring the impacts of seclusion on psychiatry inpatients and the effectiveness of a pilot single-session post-seclusion counselling intervention.

PubMed

Whitecross, Fiona; Seeary, Amy; Lee, Stuart

2013-12-01

Despite the accumulation of evidence demonstrating patients' accounts of trauma associated with seclusion, the use of evidence-based post-seclusion debriefing is not apparent in the published work. This study aimed to identify the impacts seclusion has on an individual using the Impact of Events - Revised (IES-R), a standardized and widely used measure of trauma symptoms, and measure the effectiveness of a post-seclusion counselling intervention in mitigating the experience of seclusion-related trauma and reducing time spent in seclusion. The study design involved a comparison of the seclusion-related trauma and time in seclusion that was experienced by consenting patients managed on the two inpatient wards of Alfred Psychiatry. To investigate the efficacy of post-seclusion counselling to reduce event-related trauma as well as the use of seclusion, a brief single-session intervention was piloted comparing outcomes for patients treated on a ward implementing semistructured post-seclusion counselling and patients treated on a ward continuing with post-seclusion support as usual. A total of 31 patients consented to participate, with approximately 47% reporting trauma symptoms consistent with 'probable post-traumatic stress disorder' (IES-R total score, >33), although there was no difference in trauma experience between groups. Significantly fewer hours were spent in seclusion for patients treated on the ward piloting the post-seclusion counselling intervention. Findings, therefore, highlight not only the potential for significant trauma stemming from a seclusion event, but also the capacity for the implementation of such interventions as post-seclusion counselling to raise awareness of the need to minimize time spent in seclusion for patients. © 2013 Australian College of Mental Health Nurses Inc.

Successful pharmacogenetics-based optimization of unboosted atazanavir plasma exposure in HIV-positive patients: a randomized, controlled, pilot study (the REYAGEN study).

PubMed

Bonora, S; Rusconi, S; Calcagno, A; Bracchi, M; Viganò, O; Cusato, J; Lanzafame, M; Trentalange, A; Marinaro, L; Siccardi, M; D'Avolio, A; Galli, M; Di Perri, G

2015-11-01

Atazanavir without ritonavir, despite efficacy and tolerability, shows low plasma concentrations that warrant optimization. In a randomized, controlled, pilot trial, stable HIV-positive patients on atazanavir/ritonavir (with tenofovir/emtricitabine) were switched to atazanavir. In the standard-dose arm, atazanavir was administered as 400 mg once daily, while according to patients' genetics (PXR, ABCB1 and SLCO1B1), in the pharmacogenetic arm: patients with unfavourable genotypes received 200 mg of atazanavir twice daily. EudraCT number: 2009-014216-35. Eighty patients were enrolled with balanced baseline characteristics. The average atazanavir exposure was 253 ng/mL (150-542) in the pharmacogenetic arm versus 111 ng/mL (64-190) in the standard-dose arm (P < 0.001); 28 patients in the pharmacogenetic arm (75.7%) had atazanavir exposure >150 ng/mL versus 14 patients (38.9%) in the standard-dose arm (P = 0.001). Immunovirological and laboratory parameters had a favourable outcome throughout the study with non-significant differences between study arms. Atazanavir plasma exposure is higher when the schedule is chosen according to the patient's genetic profile. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study.

PubMed

Wirz, Stefan; Conrad, Stefan; Shtrichman, Ronit; Schimo, Kai; Hoffmann, Eva

2017-01-01

Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group ( n = 43), opioids dispensed by nurses, and a test group ( n = 27), opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group ( P value < 0.05). The test group took 67% more pills than the control group, indicating enhanced compliance. Pain scores were significantly lower for patients in the test group ( P value < 0.05). Over 90% of PCoA Acute users were satisfied with its use. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

Patients' quality of life after stopping plasma exchange: a pilot study.

PubMed

Dahlan, Randah; McCormick, Brendan B; Alkhattabi, Maan; Gallo, Kerri; Clark, William F; Rock, Gail

2014-10-01

Plasma exchange is being widely used to treat various serious medical conditions. There has been very little follow-up data to describe the quality of life (QOL) of plasma exchange-recipients after active plasma exchange has stopped. To assess the QOL of plasma exchange recipients after stopping plasma exchange. A pilot study, based on responses to a postal questionnaire and clinical data obtained from the patients' charts, was carried out. The scores were computed from questionnaire responses and analyzed. The response rate was 59% with 58 patients completing a questionnaire three months after their final plasma exchange therapy. We identified significant heterogeneity in the quality of life of plasma exchange recipients after stopping plasma exchange therapy. This could be driven by different patient co-morbidities. We recommend that during follow up visits, a multi-disciplinary approach including consultation with a social worker might be considered for patients who may continue to have some limitations in their psychosocial activities post-discontinuation of plasma exchange. The high response rate to the questionnaire indicates that PLEX patients are interested in being involved in QOL studies, which suggests potential support for a prospective study of QOL with pre and post questionnaires and more detailed tracking of baseline co-morbidities. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effectiveness of cognitive behavioral therapy based on the pain sustainment/exacerbation model in patients with tension-type headache: a pilot study.

PubMed

Motoya, Ryo; Oda, Keiko; Ito, Eiji; Ichikawa, Masahiro; Sato, Taku; Watanabe, Tadashi; Sakuma, Jun; Saito, Kiyoshi; Niwa, Shin-Ichi; Yabe, Hirooki

2014-01-01

The purpose of this study was to carry out a program of Cognitive Behavioral Therapy (CBT) based on the pain sustainment/exacerbation model for tension-type headache (TTH) patients and to examine the effectiveness as a pilot study. The participants were 4 TTH patients who consulted the outpatient clinic of a university hospital. It consisted of 4 individualized sessions as CBT program (including psychological education, self-monitoring, relaxation technique, cognitive restricting and exposure), and a follow-up examination was carried out 1 month after its completion. The sessions, each of which was 60 minutes long, were executed at weekly intervals. As a result, the score of the Pain Catastrophizing Scale (PCS) decreased after program compared with before program in all patients. The score of escape/avoidance was also reduced at the post-program and follow-up (1 month later) compared with the score of pre-program in patients except Case 2, in whom the score was 0 throughout the study. The degree of the Headache Impact Test (HIT-6) improved by program and changed to "mild" or "none" in all participants. These findings show that in patients with TTH this short CBT program has effect on pain catastrophizing, escape/avoidance and daily disability.

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7)

PubMed Central

Deal, Linda S.; DiBenedetti, Dana B.; Nelson, Lauren; Fehnel, Sheri E.; Brown, T. Michelle

2016-01-01

Objective Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Methods Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014–July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Results Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Conclusions Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED. PMID:27486542

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7).

PubMed

Herman, Barry K; Deal, Linda S; DiBenedetti, Dana B; Nelson, Lauren; Fehnel, Sheri E; Brown, T Michelle

2016-01-01

Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

'Never heard of it'- understanding the public's lack of awareness of a new electronic patient record.

PubMed

Bratan, Tanja; Stramer, Katja; Greenhalgh, Trisha

2010-12-01

The introduction of electronic patient records that are accessible by multiple providers raises security issues and requires informed consent - or at the very least, an opportunity to opt out. Introduction of the Summary Care Record (SCR) (a centrally stored electronic summary of a patient's medical record) in pilot sites in the UK was associated with low awareness, despite an intensive public information programme that included letters, posters, leaflets, and road shows. To understand why the public information programme had limited impact and to learn lessons for future programmes. Linguistic and communications analysis of components of the programme, contextualized within a wider mixed-method case study of the introduction of the SCR in pilot sites. Theoretical insights from linguistics and communication studies were applied. The context of the SCR pilots and the linked information programme created inherent challenges which were partially but not fully overcome by the efforts of campaigners. Much effort was put into designing the content of a mail merge letter, but less attention was given to its novelty, linguistic style, and rhetorical appeal. Many recipients viewed this letter as junk mail or propaganda and discarded it unread. Other components of the information programme were characterized by low visibility, partly because only restricted areas were participating in the pilot. Relatively little use was made of interpersonal communication channels. Despite ethical and legal imperatives, informed consent for the introduction of shared electronic records may be difficult to achieve through public information campaigns. Success may be more likely if established principles of effective mass and interpersonal communication are applied. © 2010 Blackwell Publishing Ltd.

Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pilot study.

PubMed

McComb, Alyssa; Warkentin, Lindsey M; McNeely, Margaret L; Khadaroo, Rachel G

2018-01-01

Elderly individuals who are hospitalized due to emergency abdominal surgery spend over 80% of their recovery time in bed, resulting in early and rapid muscle loss. As these elderly individuals have a lower physiological reserve, the impact of muscle wasting on function may be profound. The objectives of this study are to (1) create an independently led post-surgical reconditioning program and (2) pilot its implementation, while assessing the feasibility and safety of the program. The BE FIT program was generated with hospital rehabilitation staff to target lower limb strength, balance, and endurance. This pilot study was assessed using a sequential before and after trial, with a cohort of patients aged ≥ 65 years enrolled in the Elder-friendly Approaches to the Surgical Environment (EASE) study. Change in 30-s sit-to-stand performance between postoperative day 2 and discharge was compared between Usual Care pre- and post-BE FIT participants. A total of 66 patients participated in the sub-study, 33 Usual Care and 33 BE FIT. Mean (SD) age was 76.2 (8.78); 44 (67%) were female, with 11 (17%) reporting mild/moderate frailty on the CHSA Clinical Frailty Scale. BE FIT participants had a median of three rehab days and self-reported completing an average of 83% of the exercises. The adjusted between group difference showed that the BE FIT patients were able to complete more stands than the Usual Care (1.9 stands (0.94), p  = 0.05). There were no reported adverse events. The reconditioning program was shown to be safe and feasible within the hospital setting for the elderly emergency abdominal surgery patients. More rigorous assessment is needed to confirm this effectiveness and to better assess patient adherence to self-directed exercise. Registration #NCT02233153 through ClinicalTrials.gov. Registered September 8, 2014.

Morpho-functional evaluation of small bowel using wireless motility capsule and video capsule endoscopy in patients with known or suspected Crohn's disease: pilot study.

PubMed

Yung, Diana; Douglas, Sarah; Hobson, Anthony R; Giannakou, Andry; Plevris, John N; Koulaouzidis, Anastasios

2016-04-01

SmartPill(®) (Given Imaging Corp.,Yoqneam,Israel) is an ingestible, non-imaging capsule that records physiological data including contractions and pH throughout the gastrointestinal tract. There are scarce data looking at SmartPill(®) assessment of patients with known/suspected small-bowel Crohn's Disease (CD). This pilot study aims to investigate feasibility and safety of SmartPill(®) to assess gut motility in this group.  Over 1 year, patients with known/suspected CD, referred for small-bowel capsule endoscopy (SBCE), were invited to participate and 12 were recruited (7 female, 5 male, mean age 44.2 ± 16.6 years). They underwent hydrogen breath test to exclude small-bowel bacterial overgrowth, patency capsule (Agile(®)), and provided stool samples for fecal calprotectin (FC). Patients ingested PillCam(®)SB2 and SmartPill(®) 4 hours apart. Using unpublished data, 33 healthy controls also were identified for the study. P < 0.05 was considered statistically significant. Of the 12 patients enrolled, 10 underwent complete Smartpill(®) examination (1 stomach retention, 1 dropout). Pillcam(®) was complete in 10 (1 dropout, 1 stomach retention). Mean fecal calprotectin was 340 ± 307.71 mcg/g. The study group had longer transit times and lower gut motility index than did the controls. The difference in motility appears to be statistically significant (P < 0.05). Longer transit times for SmartPill(®) (not statistically significant) may have been due to different specifications between the capsules. Limitations included transient Smartpill(®) signal loss (5/10 studies). This is the first pilot to attempt combining SBCE and SmartPill(®) to assess small-bowel CD. Data on motility in CD are scarce. Multimodal information can provide a clearer clinical picture. Despite concerns about capsule retention in CD patients, SmartPill(®) seems safe for use if a patency capsule is employed beforehand.

A 24-month, double-blind, placebo-controlled multicentre pilot study of the efficacy and safety of nicergoline 60 mg per day in elderly hypertensive patients with leukoaraiosis.

PubMed

Bès, A; Orgogozo, J M; Poncet, M; Rancurel, G; Weber, M; Bertholom, N; Calvez, R; Stehlé, B

1999-05-01

In this pilot study, 72 non-demented and non-depressive elderly hypertensive patients with evidence of leukoaraiosis on cerebral computed tomography scan (Rezek score: > 16) were randomly assigned to receive either nicergoline 30 mg b.i.d. (n = 36) or a placebo (n = 36) for 24 months. All patients received antihypertensives and their hypertension was controlled under treatment. They were evaluated by nine neuropsychological tests exploring memory, concentration, verbal and motor performances, administered at baseline and at every six-month interval during the study period. At baseline, the two groups were comparable for all demographic and clinical characteristics, including cognitive functions, except for the delayed recall of the Auditory Verbal Learning Test (AVLT), which was better in the placebo group (P = 0.04). Changes in scores over time were compared between the two groups. At the last visit, patients on nicergoline (n = 31) were found to have deteriorated less or to have improved more on test scores than the patients on placebo (n = 30). Significant differences were observed for memory function (AVLT short term recall, P = 0.026; AVLT delayed recall, P = 0.013; and, Benton Visual Retention Test, P = 0.002) and attention and concentration (Letter Cancellation Test, P = 0.043; and, WAIS-R Digit Symbol subtest, P = 0.006). The Rezek score remained unchanged in the two groups. Tolerance of nicergoline was similar to that of placebo. In conclusion, this study shows that nicergoline 30 mg b.i. d. administered over a 24-month period attenuates the deterioration in cognitive functions in elderly hypertensive patients with leukoaraiosis. Whether these effects were specific for this type of white matter changes could not be determined in the context of this pilot study. Copyright 1999 Lippincott Williams & Wilkins

The Utility of Pitch Elevation in the Evaluation of Oropharyngeal Dysphagia: Preliminary Findings

ERIC Educational Resources Information Center

Malandraki, Georgia A.; Hind, Jacqueline A.; Gangnon, Ronald; Logemann, Jeri A.; Robbins, JoAnne

2011-01-01

Purpose: To evaluate the utility of a pitch elevation task in the assessment of oropharyngeal dysphagia. Method: This study was a pilot prospective cohort study including 40 consecutive patients (16 male and 24 female) who were referred by their physician for a swallowing evaluation. Patients were evaluated with a noninstrumental clinical…

Mobile application as a prenatal education and engagement tool: A randomized controlled pilot.

PubMed

Ledford, Christy J W; Canzona, Mollie Rose; Cafferty, Lauren A; Hodge, Joshua A

2016-04-01

Research has shown that mobile applications provide a powerful alternative to traditional paper diaries; however, little data exists in comparing apps to the traditional mode of paper as a patient education and engagement tool in the clinical setting. This study was designed to compare the effectiveness of a mobile app versus a spiral-notebook guide throughout prenatal care. This randomized (n=173) controlled pilot was conducted at an East Coast community hospital. Chi-square and repeated-measures analysis of variance was used to test intervention effects in the sample of 127 pregnant mothers who completed their prenatal care in the healthcare system. Patients who were distributed the mobile application used the tool to record information about pregnancy more frequently (p=.04) and developed greater patient activation (p=.02) than patients who were distributed notebooks. No difference was detected on interpersonal clinical communication. A mobile application successfully activated a patient population in which self-management is a critical factor. This study shows that mobile apps can prompt greater use and result in more activated patients. Findings may be translated to other patient populations who receive recurring care for chronic disease. Published by Elsevier Ireland Ltd.

Quantitative assessment of joint position sense recovery in subacute stroke patients: a pilot study.

PubMed

Kattenstroth, Jan-Christoph; Kalisch, Tobias; Kowalewski, Rebecca; Tegenthoff, Martin; Dinse, Hubert R

2013-11-01

To assess joint position sense performance in subacute stroke patients using a novel quantitative assessment. Proof-of-principle pilot study with a group of subacute stroke patients. Assessment at baseline and after 2 weeks of intervention. Additional data for a healthy age-matched control group. Ten subacute stroke patients (aged 65.41 years (standard deviation 2.5), 4 females, 2.3 weeks (standard deviation 0.2)) post-stroke receiving in-patient standard rehabilitation and repetitive electrical stimulation of the affected hand. Joint position sense was assessed based on the ability of correctly perceiving the opening angles of the finger joints. Patients had to report size differences of polystyrene balls of various sizes, whilst the balls were enclosed simultaneously by the affected and the non-affected hands. A total of 21 pairwise size comparisons was used to quantify joint position performance. After 2 weeks of therapeutic intervention a significant improvement in joint position sense performance was observed; however, the performance level was still below that of a healthy control group. The results indicate high feasibility and sensitivity of the joint position test in subacute stroke patients. Testing allowed quantification of both the deficit and the rehabilitation outcome.

Wireless Technology to Track Surgical Patients after Discharge: A Pilot Study.

PubMed

Dawes, Aaron J; Reardon, Sarah; Chen, Victor L; Kaiser, William; Russell, Marcia M; Ko, Clifford Y; Lin, Anne Y

2015-10-01

Failure to detect changes in patients' postoperative health status increases the risk of adverse outcomes, including complications and readmission. We sought to design and implement a real-time surveillance system for postoperative colorectal surgery patients using wireless health technology. Participants were assigned a preprogrammed tablet computer during their inpatient hospitalization, and asked to complete a daily survey regarding their postoperative health status until their first clinic visit. Surveys were transmitted wirelessly to a secure database for review. As a pilot study, we report on our first 20 consecutively enrolled patients, monitored for 265 patient days. Overall compliance was 63 per cent (data available for 166 of the 265 days), but varied by patient from 26 to 100 per cent. We were able to reliably collect basic data on postoperative health status as well as patient-reported outcomes not previously captured by standard assessment techniques. Qualitative data suggest that the experience strengthened patients' relationship with their surgeon and aided in their recovery. Postoperative remote monitoring is feasible, and provides more detailed and complete information to the clinical team. Wireless health technology represents an opportunity to close the information gap between discharge and first clinic visit, and, eventually, to improve patient-provider communication, increase patient satisfaction, and prevent unnecessary readmissions.

A pilot retrospective study of the relationship between estrogen use and pancreatitis/pancreatic function in women with chronic abdominal pain.

PubMed

Lieb, John G; Toskes, Phillip P

2013-05-10

Estrogens are thought to cause pancreatitis by raising triglyceride levels but whether there are other effects on the pancreas is debatable. To better elucidate the relationship between estrogens and pancreatitis and pancreatic function in a pilot study. Our retrospectively collected database of 224 patients who had undergone secretin stimulation testing was queried for females with available medication histories, who were then divided into two groups: those taking estrogens (E) and those not on estrogens (N). Mann Whitney U and Fisher's exact tests were used. Seventy of the patients in the database were females with available medication histories. Thirty-five (50.0%) were taking estrogens. Twenty-nine (82.9%) of the E patients experienced any type of pancreatitis (i.e., acute pancreatitis, acute relapsing pancreatitis, chronic pancreatitis) while only 19 (54.3%) of the N patients did (P=0.019). During secretin stimulation testing, the peak bicarbonate levels for E and N patients were 80±18 and 90±23 mEq/L, respectively (P=0.058). When patients with any type of pancreatitis were excluded, E patients still displayed decreased peak bicarbonate levels in response to secretin (90±18 vs. 104±19 mEq/L; P=0.021). Weight, age, triglyceride levels, frequency of patients with cholecystectomy and biliary stones did not significantly differ between the two groups (E and N respectively). These pilot data suggest exogenous estrogens may be related to the development of acute pancreatitis and acute relapsing pancreatitis, and probably to a lesser degree chronic pancreatitis, perhaps through a triglyceride independent mechanism. During secretin stimulation testing, peak bicarbonate production may be diminished in women on estrogens (even in those who have never had pancreatitis). Further study is necessary to better define the relationship between estrogen use, pancreatitis, and pancreatic function.

The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

PubMed

Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

2016-05-01

Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

A pilot study of peptide vaccines for VEGF receptor 1 and 2 in patients with recurrent/progressive high grade glioma

PubMed Central

Shibao, Shunsuke; Ueda, Ryo; Saito, Katsuya; Kikuchi, Ryogo; Nagashima, Hideaki; Kojima, Atsuhiro; Kagami, Hiroshi; Pareira, Eriel Sandika; Sasaki, Hikaru; Noji, Shinobu; Kawakami, Yutaka; Yoshida, Kazunari; Toda, Masahiro

2018-01-01

Object Early-phase clinical studies of glioma vaccines have shown feasibility and encouraging preliminary clinical activity. A vaccine that targets tumor angiogenesis factors in glioma microenvironment has not been reported. Therefore, we performed a pilot study to evaluate the safety and immunogenicity of a novel vaccination targeting tumor angiogenesis with synthetic peptides for vascular endothelial growth factor (VEGF) receptor epitopes in patients with recurrent/progressive high grade gliomas. Methods Eight patients received intranodal vaccinations weekly at a dose of 2mg/kg bodyweight 8 times. T-lymphocyte responses against VEGF receptor (VEGFR) epitopes were assessed by enzyme linked immunosorbent spot assays. Results This treatment was well-tolerated in patients. The first four vaccines induced positive immune responses against at least one of the targeted VEGFR epitopes in the peripheral blood mononuclear cells in 87.5% of patients. The median overall survival time in all patients was 15.9 months. Two achieved progression-free status lasting at least 6 months. Two patients with recurrent GBM demonstrated stable disease. Plasma IL-8 level was negatively correlated with overall survival. Conclusion These data demonstrate the safety and immunogenicity of VEGFR peptide vaccines targeting tumor vasculatures in high grade gliomas. PMID:29765561

Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study.

PubMed

Feliu-Soler, Albert; Pascual, Juan Carlos; Elices, Matilde; Martín-Blanco, Ana; Carmona, Cristina; Cebolla, Ausiàs; Simón, Vicente; Soler, Joaquim

2017-01-01

The aim of this randomized pilot study is to investigate the effects of a short training programme in loving-kindness and compassion meditation (LKM/CM) in patients with borderline personality disorder. Patients were allocated to LKM/CM or mindfulness continuation training (control group). Patients in the LKM/CM group showed greater changes in Acceptance compared with the control group. Remarkable changes in borderline symptomatology, self-criticism and self-kindness were also observed in the LKM/CM group. Mechanistic explanations and therapeutic implications of the findings are discussed. Three weeks of loving-kindness and compassion meditations increased acceptance of the present-moment experience in patients with borderline personality disorder. Significant improvements in the severity of borderline symptoms, self-criticism, mindfulness, acceptance and self-kindness were observed after the LKM/CM intervention. LKM/CM is a promising complementary strategy for inclusion in mindfulness-based interventions and Dialectical Behavioural Therapy for treating core symptoms in borderline personality disorder. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

[Photodynamic therapy of dysplasias and early carcinomas in Barrett esophagus with a diode laser system--a pilot study].

PubMed

Zöpf, T; Rosenbaum, A; Apel, D; Jakobs, R; Arnold, J C; Riemann, J F

2001-04-15

Photodynamic therapy (PDT) of dysplasia and early cancer of the esophagus could show good results in the potential of ablation. Unfortunately, the existing expensive and temperamental dye laser systems foiled a broad clinical use. In this pilot study, we investigated the feasibility of an inexpensive and maintenance-free diode laser system for PDT of dysplasia and early cancer in Barrett's esophagus. Eight patients with Barrett's esophagus and/or early cancer were treated. As light source we used a diode laser system with a maximum power output of 2 W and a wavelength of 633 +/- 3 nm. One patient was treated initially with Photosan-3, seven patients received 5-aminolevulinic acid. In all patients we could achieve reduction in length and/or histologically proven downgrading. In three quarters of the patients, complete eradication of adenocarcinoma could be attained. Columnar-lined metaplastic epithelium could also be completely eradicated. PDT using a diode laser system is comparably effective in Barrett's esophagus/early cancer as PDT with dye laser systems. PDT is a gentle and effective technique with little side effects.

A Randomized, Controlled Trial of Wholistic Hybrid Derived From Eye Movement Desensitization and Reprocessing and Emotional Freedom Technique (WHEE) for Self-Treatment of Pain, Depression, and Anxiety in Chronic Pain Patients

PubMed Central

Benor, Daniel; Rossiter-Thornton, John; Toussaint, Loren

2016-01-01

In this pilot study, a convenience sample of 24 chronic pain patients (17 with chronic fatigue syndrome/fibromyalgia) were randomized into WHEE treatment and wait-list control groups for 6 weeks. Assessments of depression, anxiety, and pain were completed before, during, and at 1 and 3 months after treatment. Wait-listed patients then received an identical course of WHEE and assessments. WHEE decreased anxiety (P < .5) and depression (P < .05) compared with the control group. The wait-list-turned-WHEE assessments demonstrated decreased pain severity (P < .05) and depression (P < .04) but not pain interference or anxiety. WHEE appears a promising method for pain, anxiety, and depression in patients with chronic pain, compared to standard medical care alone. Though a small pilot study, the present results suggest that further research appears warranted. An incidental finding was that a majority of patients with chronic pain had suffered psychological trauma in childhood and/or adulthood. PMID:27432773

Cardiac Rehabilitation Online Pilot: Extending Reach of Cardiac Rehabilitation.

PubMed

Higgins, Rosemary O; Rogerson, Michelle; Murphy, Barbara M; Navaratnam, Hema; Butler, Michael V; Barker, Lauren; Turner, Alyna; Lefkovits, Jeffrey; Jackson, Alun C

While cardiac rehabilitation (CR) is recommended for all patients after an acute cardiac event, limitations exist in reach. The purpose of the current study was to develop and pilot a flexible online CR program based on self-management principles "Help Yourself Online." The program was designed as an alternative to group-based CR as well as to complement traditional CR. The program was based on existing self-management resources developed previously by the Heart Research Centre. Twenty-one patients admitted to Cabrini Health for an acute cardiac event were recruited to test the program. The program was evaluated using qualitative and quantitative methods. Quantitative results demonstrated that patients believed the program would assist them in their self-management. Qualitative evaluation, using focus group and interview methods with 15 patients, showed that patients perceived the online CR approach to be a useful instrument for self-management. Broader implications of the data include the acceptability of the intervention, timing of intervention delivery, and patients' desire for additional online community support.

Integrated Primary Care Teams (IPCT) pilot project in Quebec: a protocol paper

PubMed Central

Contandriopoulos, Damien; Duhoux, Arnaud; Roy, Bernard; Amar, Maxime; Bonin, Jean-Pierre; Borges Da Silva, Roxane; Brault, Isabelle; Dallaire, Clémence; Dubois, Carl-Ardy; Girard, Francine; Jean, Emmanuelle; Larue, Caroline; Lessard, Lily; Mathieu, Luc; Pépin, Jacinthe; Cockenpot, Aurore

2015-01-01

Introduction The overall aim of this project is to help develop knowledge about primary care delivery models likely to improve the accessibility, quality and efficiency of care. Operationally, this objective will be achieved through supporting and evaluating 8 primary care team pilot sites that rely on an expanded nursing role within a more intensive team-based, interdisciplinary setting. Methods and analysis The first research component is aimed at supporting the development and implementation of the pilot projects, and is divided into 2 parts. The first part is a logical analysis based on interpreting available scientific data to understand the causal processes by which the objectives of the intervention being studied may be achieved. The second part is a developmental evaluation to support teams in the field in a participatory manner and thereby learn from experience. Operationally, the developmental evaluation phase mainly involves semistructured interviews. The second component of the project design focuses on evaluating pilot project results and assessing their costs. This component is in turn made up of 2 parts. Part 1 is a pre-and-post survey of patients receiving the intervention care to analyse their care experience. In part 2, each patient enrolled in part 1 (around 4000 patients) will be matched with 2 patients followed within a traditional primary care model, so that a comparative analysis of the accessibility, quality and efficiency of the intervention can be performed. The cohorts formed in this way will be followed longitudinally for 4 years. Ethics and dissemination The project, as well as all consent forms and research tools, have been accepted by 2 health sciences research ethics committees. The procedures used will conform to best practices regarding the anonymity of patients. PMID:26700294

Paragliding accidents in remote areas.

PubMed

Fasching, G; Schippinger, G; Pretscher, R

1997-08-01

Paragliding is an increasingly popular hobby, as people try to find new and more adventurous activities. However, there is an increased and inherent danger with this sport. For this reason, as well as the inexperience of many operators, injuries occur frequently. This retrospective study centers on the helicopter rescue of 70 individuals in paragliding accidents. All histories were examined, and 43 patients answered a questionnaire. Nineteen (42%) pilots were injured when taking off, 20 (44%) during the flight, and six (13%) when landing. Routine and experience did not affect the prevalence of accident. Analysis of the causes of accident revealed pilot errors in all but three cases. In 34 rescue operations a landing of the helicopter near the site of the accident was possible. Half of the patients had to be rescued by a cable winch or a long rope fixed to the helicopter. Seven (10%) of the pilots suffered multiple trauma, 38 (54%) had injuries of the lower extremities, and 32 (84%) of them sustained fractures. Injuries to the spine were diagnosed in 34 cases with a fracture rate of 85%. One patient had an incomplete paraplegia. Injuries to the head occurred in 17 patients. No paraglider pilot died. The average hospitalization was 22 days, and average time of working inability was 14 weeks. Fourteen (34%) patients suffered from a permanent damage to their nerves or joints. Forty-three percent of the paragliders continued their sport despite the accident; two of them had another accident. An improved training program is necessary to lower the incidence of paragliding accidents. Optimal equipment to reduce injuries in case of accidents is mandatory. The helicopter emergency physician must perform a careful examination, provide stabilization of airways and circulation, give analgesics, splint fractured extremities, and transport the victim on a vacuum mattress to the appropriate hospital.

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

PubMed

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study.

PubMed

Benhamou, Pierre Yves; Huneker, Erik; Franc, Sylvia; Doron, Maeva; Charpentier, Guillaume

2018-06-01

Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach. A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters. Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70-180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses. This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety. This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.

Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.

PubMed

Adamson, Douglas; Blazeby, Jane; Nelson, Annmarie; Hurt, Chris; Nixon, Lisette; Fitzgibbon, Jim; Crosby, Tom; Staffurth, John; Evans, Mim; Kelly, Noreen Hopewell; Cohen, David; Griffiths, Gareth; Byrne, Anthony

2014-10-22

The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients' motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients' experiences of each trial arm. The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS. The trial was registered with Current Controlled Trials (registration number: ISRCTN12376468) on 10 July 2012.

Pilot study of intraoperative ultrasound-guided instrument placement in nerve transection surgery for peripheral nerve pain syndromes.

PubMed

Henning, P Troy; Wilson, Thomas J; Willsey, Matthew; John, Jessin K; Popadich, Miriana; Yang, Lynda J S

2017-03-01

Surgical transection of sensory nerves in the treatment of intractable neuropathic pain is a commonly performed procedure. At times these cases can be particularly challenging when encountering obese patients, when targeting deeper nerves or those with a variable branching pattern, or in the case of repeat operations. In this case series, the authors describe their experience with ultrasound-guided surgical instrument placement during transection of a saphenous nerve in the region of prior vascular surgery in 1 patient and in the lateral femoral cutaneous nerve in 2 obese patients. The authors also describe this novel technique and provide pilot data that suggests ultrasound-assisted surgery may allow for complex cases to be completed in an expedited fashion through smaller incisions.

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care.

PubMed

Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth R; Wulff, Jerome; Harrison, David A; Mouncey, Paul M; Peters, Mark J

2018-06-04

Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care. In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT. Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2). Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients. clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015.

BASIC Training: A Pilot Study of Balance/Strengthening Exercises in Heart Failure.

PubMed

McGuire, Rita; Honaker, Julie; Pozehl, Bunny; Hertzog, Melody

2018-05-19

The aim of this pilot study was to evaluate the effect of a multicomponent balance and resistance training intervention on physical function, balance, and falls in older (≥65 years) community-dwelling heart failure (HF) patients. Randomized, two-group repeated-measures experimental design. The intervention involved once weekly supervised group sessions with home sessions encouraged twice weekly. Focus groups held pre/post intervention. Outcome variables included measures of physical function, balance confidence, and falling risk. In a sample size of 33, the Dynamic Gait Index change from baseline to 12 weeks was significantly different in the groups (p = .029). The number of reported falls declined from 0.92 to 0.54 per participant. A supervised group session intervention can increase mobility and gait and reduce fall rate for HF patients. This study was designed to improve lower extremity strength, balance, and falls in elderly HF patients, thus reducing costs and improving quality of life for this population.

Ultrasound assessment of lung consolidation and reaeration after pleural effusion drainage in patients with Acute Respiratory Distress Syndrome: a pilot study.

PubMed

Chinardet, B; Brisson, H; Arbelot, C; Langeron, O; Rouby, J J; Lu, Q

2016-01-01

The aim of the pilot study was to assess by ultrasound changes in dimensions of lung consolidation and reaeration after drainage of large pleural effusion in patients with acute respiratory distress syndrome (ARDS). Lung ultrasound and blood gas were performed before, 2 hours (H2) and 24 hours (H24) after drainage of pleural effusion. Lung ultrasound aeration score was calculated. Cephalocaudal dimension and diaphragmatic transversal area of lung consolidation were measured. Ten patients were studied. Median volume of drained effusion was 675 ml at H2 and 895 at H24. Two hours after drainage, dimension of cephalocaudal consolidation and diaphragmatic transversal area decreased significantly. Lung reaeration after drainage occurred mainly in latero-inferior and postero-superior regions. PaO2/FiO2 increased significantly at H24. Ultrasound is a useful method to assess lung consolidation after pleural effusion drainage. Drainage of pleural effusion may lead to a decrease of lung consolidation and improvement of lung reaeration.

[Interrelationship among "NANDA, NOC and NIC". A pilot study and an evaluation of a nursing document].

PubMed

Gomez de Segura Navarro, Carlota; Esain Larrambe, Ainhoa; Tina Majuelo, Pilar; Guembe Ibáñez, Irene; Fernández Perea, Laura; Narvaiza Solís, M Jesús

2006-01-01

(a) to determine the effectiveness of a nursing document which integrates nursing diagnoses, nursing treatments/actions (NIC), and results (NOC); (b) to verify the application of the aforementioned document in a hospitalization unit. A descriptive, transversal and observational study. Nursing documents (NANDA, NIC and NOC taxonomies). PHASES: 1st: analysis of the content in the nursing documentation for 23 pneumonic patients: Selection of nursing diagnoses and the most frequent interdependent problems. 2nd: Selection of results and nursing treatment/actions. 3rd: Elaboration of the document and a description of the Likert scales to define the state of the indicators for each result. 4th: A pilot study of the document applied to 12 patients. the application of the document permits one to identify the real status of a patient; to establish specific objectives; to improve the recording of data; to observe the effectiveness of treatment; to include educational activities; to give greater continuity and quality to a treatment plan.

A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia.

PubMed

Moulier, Virginie; Fonteille, Véronique; Pélégrini-Issac, Mélanie; Cordier, Bernard; Baron-Laforêt, Sophie; Boriasse, Emeline; Durand, Emmanuel; Stoléru, Serge

2012-02-01

Gonadotropin-releasing hormone (GnRH) agonists, such as leuprorelin, are recommended in the patients with pedophilia at highest risk of offending. However, the cerebral mechanisms of the effects of these testosterone-decreasing drugs are poorly known. This study aimed to identify changes caused by leuprorelin in a pedophilic patient's brain responses to pictures representing children. Clinical, endocrine, and fMRI investigations were done of a man with pedophilia before leuprorelin therapy and 5 months into leuprorelin therapy. Patient was compared with an age-matched healthy control also assessed 5 months apart. Before therapy, pictures of boys elicited activation in the left calcarine fissure, left insula, anterior cingulate cortex, and left cerebellar vermis. Five months into therapy, all the above-mentioned activations had disappeared. No such activations and, consequently, no such decreases occurred in the healthy control. The results of this pilot study suggest that leuprorelin decreased activity in regions known to mediate the perceptual, motivational, and affective responses to visual sexual stimuli.

Evaluating the effect of clinical decision units on patient flow in seven Canadian emergency departments.

PubMed

Schull, Michael J; Vermeulen, Marian J; Stukel, Therese A; Guttmann, Astrid; Leaver, Chad A; Rowe, Brian H; Sales, Anne

2012-07-01

To evaluate the effect of emergency department (ED) clinical decision units (CDUs) on overall ED patient flow in a pilot project funded in 2008 by the Ontario Ministry of Health and Long-Term Care (MOHLTC). A retrospective analysis of unscheduled ED visits at seven CDU pilot and nine control sites was conducted using administrative data. The authors examined trends in CDU utilization and compared outcomes between pilot-CDU and control sites 1 year prior to implementation, with the first 18 months of CDU operation. Sites that were unsuccessful in their applications for CDU program funding served as controls. Outcomes included ED length of stay (LOS), admission rates, and ED revisit rates. At CDU sites, roughly 4% of ED patients were admitted to CDUs. The presence of a pilot-CDU was independently associated with a small reduction in ED LOS for all low-acuity patients (-0.14 hour, 95% confidence interval [CI]=-0.22 to -0.07) and nonadmitted patients (-0.11 hour, 95% CI=-0.16 to -0.07). A small independent effect on absolute hospital admission rate for all high-acuity patients (-0.8%, 95% CI=-1.5% to -0.03%) and moderate-acuity patients (-0.6%, 95% CI=-1.1% to -0.2%) was also observed. Pilot-CDUs were not associated with changes in ED revisit rates. With only 4% of ED patients admitted to CDUs, the potential for efficiency gains in these EDs was limited. Nonetheless, these findings suggest small improvements in the operation of the ED through CDU implementation. Although marginal, the observed effects of CDU operation were in the desired direction of reduced ED LOS, reduced admission rate, and no increase in ED revisit rate. © 2012 by the Society for Academic Emergency Medicine.

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial

PubMed Central

2013-01-01

Background Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients’ decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. Methods/design A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. Discussion Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. Trial registration ClinicalTrials.gov: NCT01876173 PMID:24148851

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Effect of trelagliptin on vascular endothelial functions and serum adiponectin level in patients with type 2 diabetes: a preliminary single-arm prospective pilot study.

PubMed

Ida, Satoshi; Murata, Kazuya; Betou, Katunori; Kobayashi, Chiaki; Ishihara, Yuki; Imataka, Kanako; Uchida, Akihiro; Monguchi, Kou; Kaneko, Ryutaro; Fujiwara, Ryoko; Takahashi, Hiroka

2016-11-04

Trelagliptin, an oral DPP-4 inhibitor, which is administered once per week and characterized by a long half-life in blood. The effects of trelagliptin on vascular endothelial functions have not been clarified to date. The objective of the present study was to examine the effects of trelagliptin on vascular endothelial functions in patients with type 2 diabetes mellitus (DM) using flow-mediated dilatation (FMD), adiponectin, and asymmetric dimethylarginine (ADMA) as evaluation indicators. This study was a preliminary single-arm prospective pilot study. The subjects of this study were type 2 DM patients aged 20-74 years, who visited our outpatient department. The patients were treated with trelagliptin, and their FMD, adiponectin, and ADMA levels were measured at baseline and at 12 weeks after initial treatment to determine the changes during the study period. A total of 27 patients, excluding three dropouts, were included in the population for analysis. Trelagliptin treatment showed no significant changes in FMD (2.42 ± 2.7% at baseline vs. 2.66 ± 3.8% post-treatment, P = 0.785) and ADMA (0.41 ± 0.0 µg/mL at baseline vs. 0.40 ± 0.0 µg/mL post-treatment, P = 0.402). Trelagliptin treatment resulted in a significant increase of serum adiponectin level (7.72 ± 6.9 µg/mL at baseline vs. 8.82 ± 8.3 µg/mL post-treatment, P < 0.002). In this pilot study, trelagliptin treatment showed no significant changes in FMD. On the other hand, it was believed that trelagliptin treatment may increase serum adiponectin level. Trial Registration http://www.umin.ac.jp (Trial ID UMIN000018311).

Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study.

PubMed

Berents, Teresa Løvold; Rønnevig, Jørgen; Søyland, Elisabeth; Gaustad, Peter; Nylander, Gro; Løland, Beate Fossum

2015-05-04

Public health nurses report on effects of fresh human milk as treatment for conjunctivitis, rhinitis and atopic eczema (AE), the latter being highly prevalent in early childhood. Emollients and topical corticosteroids are first line treatment of AE. As many caregivers have steroid phobia, alternative treatment options for mild AE are of interest. The aim of this small pilot study was to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with AE. This was a split body, controlled, randomized and physician blinded pilot study, of children with AE with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient was applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. The severity and area of the eczema spots was evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation. Of nine patients included, six completed the study. Mean age at inclusion was 18.5 months. The spots examined were localized on the arms, legs or cheeks. The spots were similar in severity, but differed in area. In one patient the eczema ceased after inclusion. In four patients both control and intervention areas increased during the intervention. The relative change in eczema area compared to baseline showed less increase in the intervention spots in two patients, whereas the opposite was observed in three. In four children Staphylococcus aureus was found in their eczema once or more. In three of the 28 human milk samples, Staphylococcus aureus, alfa haemolytic streptococci or coagulase negative staphylococci were detected. Staphylococcus aureus was found once both in human milk and in the eczema spots, no clinical signs of infection were however observed. No secondary infection due to milk application was detected. In this small pilot study, no effect was found on eczema spots treated with topical application of fresh human milk. (ClinicalTrials.gov Identifier, NCT02381028 ).

Stress and Depression in Relation to Functional Health Behaviors in African American Patients with Systemic Lupus Erythematosus.

PubMed

Williams, Edith M; Bruner, Larisa; Penfield, Megan; Kamen, Diane; Oates, James C

While increased psychological distress in SLE has been clinically and empirically reported, the relationship between emotional distress, treatment adherence, and disease activity are complex and even more unclear in African American lupus patients. In an effort to elucidate this phenomenon in these patients, this exploratory study aimed to investigate relationships between stress, depression, and various health behaviors in this group. Thirty patients invited to participate in this study were African American systemic lupus erythematosus (SLE) patients attending rheumatology clinics at the Medical University of South Carolina (MUSC). This study was part of a larger interventional pilot study, the Balancing Lupus Experiences with Stress Strategies (BLESS) study, that included a comprehensive battery of psychosocial, quality of life, and behavior change measures. When looking at the association between anxiety/stress and functionality, levels of reported stress had strong effects upon functionality, especially between health distress and functionality. When looking at the association between depressive symptoms and functionality, depressive symptoms had moderate effects upon social/role limitations and nights spent in the hospital. Not only did the larger pilot project demonstrate significant reductions in stress and depression as a result of workshop participation; this nested study also showed that those improvements were positively associated with improved health behaviors. These results could have implications for developing interventions to improve disease experience and quality of life in SLE patients with stress and depression.

Feasibility of using a personal digital assistant to self-monitor diet and fluid intake: a pilot study.

PubMed

Welch, Janet; Dowell, Shannon; Johnson, Cynthia S

2007-01-01

The feasibility of using an electronic device to self-monitor diet and fluid intake was assessed using the treatment implementation model. The three patients on hemodialysis who participated in this pilot study were asked to self-monitor diet and fluid intake for 12 weeks with a personal digital assistant. The intervention was delivered as intended; however, participants reported problems with usability, and compliance to self-monitoring was lower than desirable. Further adjustments to the intervention will be made before testing efficacy.

Attentional and physiological processing of food images in functional dyspepsia patients: A pilot study.

PubMed

Lee, In-Seon; Preissl, Hubert; Giel, Katrin; Schag, Kathrin; Enck, Paul

2018-01-23

The food-related behavior of functional dyspepsia has been attracting more interest of late. This pilot study aims to provide evidence of the physiological, emotional, and attentional aspects of food processing in functional dyspepsia patients. The study was performed in 15 functional dyspepsia patients and 17 healthy controls after a standard breakfast. We measured autonomic nervous system activity using skin conductance response and heart rate variability, emotional response using facial electromyography, and visual attention using eyetracking during the visual stimuli of food/non-food images. In comparison to healthy controls, functional dyspepsia patients showed a greater craving for food, a decreased intake of food, more dyspeptic symptoms, lower pleasantness rating of food images (particularly of high fat), decreased low frequency/high frequency ratio of heart rate variability, and suppressed total processing time of food images. There were no significant differences of skin conductance response and facial electromyography data between groups. The results suggest that high level cognitive functions rather than autonomic and emotional mechanisms are more liable to function differently in functional dyspepsia patients. Abnormal dietary behavior, reduced subjective rating of pleasantness and visual attention to food should be considered as important pathophysiological characteristics in functional dyspepsia.

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome.

PubMed

Palmer, Shea; Cramp, Fiona; Clark, Emma; Lewis, Rachel; Brookes, Sara; Hollingworth, William; Welton, Nicky; Thom, Howard; Terry, Rohini; Rimes, Katharine A; Horwood, Jeremy

2016-06-01

Joint hypermobility syndrome (JHS) is a heritable disorder associated with laxity and pain in multiple joints. Physiotherapy is the mainstay of treatment, but there is little research investigating its clinical effectiveness. To develop a comprehensive physiotherapy intervention for adults with JHS; to pilot the intervention; and to conduct a pilot randomised controlled trial (RCT) to determine the feasibility of conducting a future definitive RCT. Patients' and health professionals' perspectives on physiotherapy for JHS were explored in focus groups (stage 1). A working group of patient research partners, clinicians and researchers used this information to develop the physiotherapy intervention. This was piloted and refined on the basis of patients' and physiotherapists' feedback (stage 2). A parallel two-arm pilot RCT compared 'advice' with 'advice and physiotherapy' (stage 3). Random allocation was via an automated randomisation service, devised specifically for the study. Owing to the nature of the interventions, it was not possible to blind clinicians or patients to treatment allocation. Stage 1 - focus groups were conducted in four UK locations. Stages 2 and 3 - piloting of the intervention and the pilot RCT were conducted in two UK secondary care NHS trusts. Stage 1 - patient focus group participants (n = 25, three men) were aged > 18 years, had a JHS diagnosis and had received physiotherapy within the preceding 12 months. The health professional focus group participants (n = 16, three men; 14 physiotherapists, two podiatrists) had experience of managing JHS. Stage 2 - patient participants (n = 8) were aged > 18 years, had a JHS diagnosis and no other musculoskeletal conditions causing pain. Stage 3 - patient participants for the pilot RCT (n = 29) were as for stage 2 but the lower age limit was 16 years. For the pilot RCT (stage 3) the advice intervention was a one-off session, supplemented by advice booklets. All participants could ask questions specific to their circumstances and receive tailored advice. Participants were randomly allocated to 'advice' (no further advice or physiotherapy) or 'advice and physiotherapy' (an additional six 30-minute sessions over 4 months). The physiotherapy intervention was supported by a patient handbook and was delivered on a one-to-one patient-therapist basis. It aimed to increase patients' physical activity through developing knowledge, understanding and skills to better manage their condition. Data from patient and health professional focus groups formed the main outcome from stage 1. Patient and physiotherapist interview data also formed a major component of stages 2 and 3. The primary outcome in stage 3 related to the feasibility of a future definitive RCT [number of referrals, recruitment and retention rates, and an estimate of the value of information (VOI) of a future RCT]. Secondary outcomes included clinical measures (physical function, pain, global status, self-reported joint count, quality of life, exercise self-efficacy and adverse events) and resource use (to estimate cost-effectiveness). Outcomes were recorded at baseline, 4 months and 7 months. Stage 1 - JHS is complex and unpredictable. Physiotherapists should take a long-term holistic approach rather than treating acutely painful joints in isolation. Stage 2 - a user-informed physiotherapy intervention was developed and evaluated positively. Stage 3 - recruitment to the pilot RCT was challenging, primarily because of a perceived lack of equipoise between advice and physiotherapy. The qualitative evaluation provided very clear guidance to inform a future RCT, including enhancement of the advice intervention. Some patients reported that the advice intervention was useful and the physiotherapy intervention was again evaluated very positively. The rate of return of questionnaires was low in the advice group but reasonable in the physiotherapy group. The physiotherapy intervention showed evidence of promise in terms of primary and secondary clinical outcomes. The advice arm experienced more adverse events. The VOI analysis indicated the potential for high value from a future RCT. Such a trial should form the basis of future research efforts. A future definitive RCT of physiotherapy for JHS seems feasible, although the advice intervention should be made more robust to address perceived equipoise and subsequent attrition. Current Controlled Trials ISRCTN29874209. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 47. See the NIHR Journals Library website for further project information.

Acceptance and Commitment Therapy for Inpatients with Psychosis (the REACH Study): Protocol for Treatment Development and Pilot Testing

PubMed Central

Gaudiano, Brandon A.; Davis, Carter H.; Epstein-Lubow, Gary; Johnson, Jennifer E.; Mueser, Kim T.; Miller, Ivan W.

2017-01-01

Patients with schizophrenia-spectrum disorders frequently require treatment at inpatient hospitals during periods of acute illness for crisis management and stabilization. Acceptance and Commitment Therapy (ACT), a “third wave” cognitive-behavioral intervention that employs innovative mindfulness-based strategies, has shown initial efficacy in randomized controlled trials for improving acute and post-discharge outcomes in patients with psychosis when studied in acute-care psychiatric hospitals in the U.S. However, the intervention has not been widely adopted in its current form because of its use of an individual-only format and delivery by doctoral-level research therapists with extensive prior experience using ACT. The aim of the Researching the Effectiveness of Acceptance-based Coping during Hospitalization (REACH) Study is to adapt a promising acute-care psychosocial treatment for inpatients with psychosis, and to pilot test its effectiveness in a routine inpatient setting. More specifically, we describe our plans to: (a) further develop and refine the treatment and training protocols, (b) conduct an open trial and make further modifications based on the experience gained, and (c) conduct a pilot randomized controlled trial in preparation for a future fully-powered clinical trial testing the effectiveness of ACT. PMID:28475123

[Cyclic movement training versus conventional physiotherapy for rehabilitation of hemiparetic gait after stroke: a pilot study].

PubMed

Podubecka, J; Scheer, S; Theilig, S; Wiederer, R; Oberhoffer, R; Nowak, D A

2011-07-01

Recovery of impaired motor functions following stroke is commonly incomplete in spite of intensive rehabilitation programmes. At 6 months following a stroke up to 60 % of affected individuals still suffer from permanent motor deficits, in particular hemiparetic gait, that are relevant for daily life. Novel innovative therapeutic strategies are needed to enhance the recovery of impaired gait function following stroke. This pilot study has investigated the effectiveness of conventional physiotherapy in comparison to an apparative cyclic movement training over a period of 4 weeks to improve (i) power during a submaximal cyclic movement training of the lower limbs, (ii) cardiac fitness, (iii) balance and gait ability, and (iv) quality of life in stroke patients. In comparison to physiotherapy apparative cyclic movement training improved power, balance, cardiac fitness and quality of life to a greater extent. However, there was a statistically significant difference between both intervention groups only for balance but not for the other parameters assessed. The present pilot study should inspire future research with larger patient cohorts to allow appropriate judgement on the effectiveness of apparative cyclic movement training in stroke rehabilitation. © Georg Thieme Verlag KG Stuttgart · New York.

Using a multidimensional unfolding approach to assess multiple sclerosis patient preferences for disease-modifying therapy: a pilot study

PubMed Central

Sempere, Angel Perez; Vera-Lopez, Vanesa; Gimenez-Martinez, Juana; Ruiz-Beato, Elena; Cuervo, Jesús; Maurino, Jorge

2017-01-01

Purpose Multidimensional unfolding is a multivariate method to assess preferences using a small sample size, a geometric model locating individuals and alternatives as points in a joint space. The objective was to evaluate relapsing–remitting multiple sclerosis (RRMS) patient preferences toward key disease-modifying therapy (DMT) attributes using multidimensional unfolding. Patients and methods A cross-sectional pilot study in RRMS patients was conducted. Drug attributes included relapse prevention, disease progression prevention, side-effect risk and route and schedule of administration. Assessment of preferences was performed through a five-card game. Patients were asked to value attributes from 1 (most preferred) to 5 (least preferred). Results A total of 37 patients were included; the mean age was 38.6 years, and 78.4% were female. Disease progression prevention was the most important factor (51.4%), followed by relapse prevention (40.5%). The frequency of administration had the lowest preference rating for 56.8% of patients. Finally, 19.6% valued the side-effect risk attribute as having low/very low importance. Conclusion Patients’ perspective for DMT attributes may provide valuable information to facilitate shared decision-making. Efficacy attributes were the most important drug characteristics for RRMS patients. Multidimensional unfolding seems to be a feasible approach to assess preferences in multiple sclerosis patients. Further elicitation studies using multidimensional unfolding with other stated choice methods are necessary to confirm these findings. PMID:28615928

Alterations in the trapezius muscle in young patients with migraine--a pilot case series with MRI.

PubMed

Landgraf, M N; Ertl-Wagner, B; Koerte, I K; Thienel, J; Langhagen, T; Straube, A; von Kries, R; Reilich, P; Pomschar, A; Heinen, F

2015-05-01

Migraine is frequent in young adults and adolescents and often associated with neck muscle tension and pain. Common pathophysiological pathways, such as reciprocal cervico-trigeminal activation, are assumed. Tense areas within the neck muscles can be clinically observed many patients with migraine. The aim of this pilot case study was to visualize these tense areas via magnet resonance imaging (MRI). Three young patients with migraine were examined by an experienced investigator. In all three patients tense areas in the trapezius muscles were palpated. These areas were marked by nitroglycerin capsules on the adjacent skin surface. The MRI showed focal signal alterations at the marked locations within the trapezius muscles. Visualization of palpable tense areas by MRI may be usefully applied in the future to help elucidate the underlying pathophysiological processes of migraine. Copyright © 2015 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Simulated Conversations With Virtual Humans to Improve Patient-Provider Communication and Reduce Unnecessary Prescriptions for Antibiotics: A Repeated Measure Pilot Study.

PubMed

Schoenthaler, Antoinette; Albright, Glenn; Hibbard, Judith; Goldman, Ron

2017-04-19

Despite clear evidence that antibiotics do not cure viral infections, the problem of unnecessary prescribing of antibiotics in ambulatory care persists, and in some cases, prescribing patterns have increased. The overuse of antibiotics for treating viral infections has created numerous economic and clinical consequences including increased medical costs due to unnecessary hospitalizations, antibiotic resistance, disruption of gut bacteria, and obesity. Recent research has underscored the importance of collaborative patient-provider communication as a means to reduce the high rates of unnecessary prescriptions for antibiotics. However, most patients and providers do not feel prepared to engage in such challenging conversations. The aim of this pilot study was to assess the ability of a brief 15-min simulated role-play conversation with virtual humans to serve as a preliminary step to help health care providers and patients practice, and learn how to engage in effective conversations about antibiotics overuse. A total of 69 participants (35 providers and 34 patients) completed the simulation once in one sitting. A pre-post repeated measures design was used to assess changes in patients' and providers' self-reported communication behaviors, activation, and preparedness, intention, and confidence to effectively communicate in the patient-provider encounter. Changes in patients' knowledge and beliefs regarding antibiotic use were also evaluated. Patients experienced a short-term positive improvement in beliefs about appropriate antibiotic use for infection (F 1,30 =14.10, P=.001). Knowledge scores regarding the correct uses of antibiotics improved immediately postsimulation, but decreased at the 1-month follow-up (F 1,30 =31.16, P<.001). There was no change in patient activation and shared decision-making (SDM) scores in the total sample of patients (P>.10) Patients with lower levels of activation exhibited positive, short-term benefits in increased intent and confidence to discuss their needs and ask questions in the clinic visit, positive attitudes regarding participation in SDM with their provider, and accurate beliefs about the use of antibiotics (P<.10). The results also suggest small immediate gains in providers' attitudes about SDM (mean change 0.20; F 1,33 = 8.03, P=.01). This pilot study provided preliminary evidence on the efficacy of the use of simulated conversations with virtual humans as a tool to improve patient-provider communication (ie, through increasing patient confidence to actively participate in the visit and physician attitudes about SDM) for engaging in conversations about antibiotic use. Future research should explore if repeated opportunities to use the 15-min simulation as well as providing users with several different conversations to practice with would result in sustained improvements in antibiotics beliefs and knowledge and communication behaviors over time. The results of this pilot study offered several opportunities to improve on the simulation in order to bolster communication skills and knowledge retention. ©Antoinette Schoenthaler, Glenn Albright, Judith Hibbard, Ron Goldman. Originally published in JMIR Medical Education (http://mededu.jmir.org), 19.04.2017.

Surviving Sudden Cardiac Arrest: A Pilot Qualitative Survey Study of Survivors.

PubMed

Sawyer, Kelly N; Brown, Frances; Christensen, Roxanne; Damino, Colleen; Newman, Mary M; Kurz, Michael C

2016-06-01

Research describing survivors of sudden cardiac arrest (SCA) has centered on quantifying functional ability, perceived quality of life, and neurocognitive assessment. Many gaps remain, however, regarding survivors' psychosocial perceptions of life in the aftermath of cardiac arrest. An important influence upon those perceptions is the presence of support and its role in a survivor's life. An Internet-based pilot survey study was conducted to gather data from SCA survivors and friends and/or family members (FFMs) representing their support system. The survey was distributed to members of the Sudden Cardiac Arrest Foundation (SCAF) via the Internet by SCAF leadership. Questions included both discrete multiple-choice and open-ended formats. Inductive thematic analyses were completed by three independent researchers trained in qualitative research methodology to identify primary themes consistent among study participants until thematic saturation was achieved. No statistical inferences were made. A total of 205 surveys were returned over the 5-month study period (July to November 2013); nine were received blank, leaving 196 surveys available for review. Major themes identified for survivors (N = 157) include the significance of and desire to share experiences with others; subculture identification (unique experience from those suffering a heart attack); and the need to seek a new normal, both personally and inter-personally. Major themes identified for FFMs (N = 39) include recognition of loved one's memory loss; a lack of information at discharge, including expectations after discharge; and concern for the patient experiencing another cardiac arrest. This pilot, qualitative survey study suggests several common themes important to survivors, and FFMs, of cardiac arrest. These themes may serve as a basis for future patient-centered focus groups and the development of patient-centered guidelines for patients and support persons of those surviving cardiac arrest.

Poststroke dysphagia rehabilitation by repetitive transcranial magnetic stimulation: a noncontrolled pilot study.

PubMed

Verin, E; Leroi, A M

2009-06-01

Poststroke dysphagia is frequent and significantly increases patient mortality. In two thirds of cases there is a spontaneous improvement in a few weeks, but in the other third, oropharyngeal dysphagia persists. Repetitive transcranial magnetic stimulation (rTMS) is known to excite or inhibit cortical neurons, depending on stimulation frequency. The aim of this noncontrolled pilot study was to assess the feasibility and the effects of 1-Hz rTMS, known to have an inhibitory effect, on poststroke dysphagia. Seven patients (3 females, age = 65 +/- 10 years), with poststroke dysphagia due to hemispheric or subhemispheric stroke more than 6 months earlier (56 +/- 50 months) diagnosed by videofluoroscopy, participated in the study. rTMS at 1 Hz was applied for 20 min per day every day for 5 days to the healthy hemisphere to decrease transcallosal inhibition. The evaluation was performed using the dysphagia handicap index and videofluoroscopy. The dysphagia handicap index demonstrated that the patients had mild oropharyngeal dysphagia. Initially, the score was 43 +/- 9 of a possible 120 which decreased to 30 +/- 7 (p < 0.05) after rTMS. After rTMS, there was an improvement of swallowing coordination, with a decrease in swallow reaction time for liquids (p = 0.0506) and paste (p < 0.01), although oral transit time, pharyngeal transit time, and laryngeal closure duration were not modified. Aspiration score significantly decreased for liquids (p < 0.05) and residue score decreased for paste (p < 0.05). This pilot study demonstrated that rTMS is feasible in poststroke dysphagia and improves swallowing coordination. Our results now need to be confirmed by a randomized controlled study with a larger patient population.

An open pilot study of ambulatory photodynamic therapy using a wearable low-irradiance organic light-emitting diode light source in the treatment of nonmelanoma skin cancer.

PubMed

Attili, S K; Lesar, A; McNeill, A; Camacho-Lopez, M; Moseley, H; Ibbotson, S; Samuel, I D W; Ferguson, J

2009-07-01

Photodynamic therapy (PDT) is a popular treatment for nonmelanoma skin cancer with clearance rates of between 70% and 100%. Although reported to have a superior cosmetic outcome, the inconvenience of hospital visits and discomfort during therapy are considered drawbacks. To present an open pilot study of a low-irradiance, potentially disposable, lightweight, organic light-emitting diode (OLED), which is an area-emitting light source (2 cm diameter), suitable for ambulatory PDT. Twelve patients with Bowen's disease (eight) and superficial basal cell carcinoma (four) < 2 cm in diameter were recruited into the study following histological confirmation of the diagnosis. Two treatments (45-60 J cm(-2) red light, 550-750 nm, peak 620 nm, irradiance 5 mW cm(-2)) were administered 1 month apart following application of aminolaevulinic acid for 4 h. At the 12-month follow-up, seven of the 12 patients remained clear, with four of the nonresponders demonstrating peripheral margin failure. Patients were scored for pain during and immediately after treatment using the numerical rating scale (NRS; 1-10). All 12 subjects scored pain as < 2 using the NRS (median score 1). In contrast, a similar cohort of 50 consecutive patients from our routine PDT clinic (Aktilite inorganic LED source; 75 J cm(-2), irradiance 80 mW cm(-2)) scored a median of 6 on the NRS. Pain and inconvenience are practical barriers to the use of conventional PDT. This pilot study suggests that OLED-PDT is less painful than conventional PDT with the added advantage of being lightweight, and therefore has the potential for more convenient 'home PDT'. These results need to be validated in larger studies.

How to treat two adjacent missing teeth with dental implants. A systematic review on single implant-supported two-unit cantilever FDP's and results of a 5-year prospective comparative study in the aesthetic zone.

PubMed

Van Nimwegen, W G; Raghoebar, G M; Tymstra, N; Vissink, A; Meijer, H J A

2017-06-01

To conduct a systematic review on the clinical outcome of single implant-supported two-unit cantilever FDP's and to conduct a 5-year prospective comparative pilot study of patients with a missing central and lateral upper incisor treated with either a single implant-supported two-unit cantilever FDP or two implants with solitary implant crowns in the aesthetic zone. Medline, Embase and the Cochrane Central Register of Controlled Trials were searched (last search 1 August 2016) for eligible studies. In the comparative pilot study, an implant-cantilever group of five patients with a single implant-supported two-unit cantilever FDP (NobelReplace Groovy Regular Platform) was compared with an implant-implant group of five patients with two adjacent single implant-supported crowns (NobelReplace Groovy Regular Platform) in the aesthetic zone. Implant survival, marginal bone level (MBL) changes, pocket probing depth, papilla index and patient satisfaction were assessed during a 5-year follow-up period. Five of 276 articles were considered eligible for data extraction. Implant survival ranged from 96·6% to 100%. Marginal bone level changes were higher in the anterior region than in the posterior region. Technical complications occurred more often in the posterior than anterior region. In the 5-year comparative pilot study, no clinically significant differences in hard and soft peri-implant tissue levels occurred between both groups. Single implant-supported two-unit cantilever FDP's can be a viable alternative to the placement of two adjacent single implant crowns in the aesthetic zone. Due to technical complications, placement of two-unit cantilever crowns in the posterior region can be considered unwise. © 2017 John Wiley & Sons Ltd.

A pilot study of minocycline for the prevention of paclitaxel-associated neuropathy: ACCRU study RU221408I.

PubMed

Pachman, Deirdre R; Dockter, Travis; Zekan, Patricia J; Fruth, Briant; Ruddy, Kathryn J; Ta, Lauren E; Lafky, Jacqueline M; Dentchev, Todor; Le-Lindqwister, Nguyet Anh; Sikov, William M; Staff, Nathan; Beutler, Andreas S; Loprinzi, Charles L

2017-11-01

Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Given that extensive animal data suggest that minocycline may prevent chemotherapy-induced neurotoxicity, the purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and the P-APS. Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks and were randomized to receive minocycline 200 mg on day 1 followed by 100 mg twice daily or a matching placebo. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy to measure P-APS and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment, to measure CIPN. Forty-seven patients were randomized. There were no remarkable differences noted between the minocycline and placebo groups for the overall sensory neuropathy score of the EORTC QLQ-CIPN20 or its individual components, which evaluate tingling, numbness and shooting/burning pain in hands and feet. However, patients taking minocycline had a significant reduction in the daily average pain score attributed to P-APS (p = 0.02). Not only were no increased toxicities reported with minocycline, but there was a significant reduction in fatigue (p = 0.02). Results of this pilot study do not support the use of minocycline to prevent CIPN, but suggest that it may reduce P-APS and decrease fatigue; further study of the impact of this agent on those endpoints may be warranted.

Quantum Physics Principles and Communication in the Acute Healthcare Setting: A Pilot Study.

PubMed

Helgeson, Heidi L; Peyerl, Colleen Kraft; Solheim-Witt, Marit

This pilot study explores whether clinician awareness of quantum physics principles could facilitate open communication between patients and providers. In the spirit of action research, this study was conceptualized with a holistic view of human health, using a mixed method design of grounded theory as an emergent method. Instrumentation includes surveys and a focus group discussion with twelve registered nurses working in an acute care hospital setting. Findings document that the preliminary core phenomenon, energy as information, influences communication in the healthcare environment. Key emergent themes include awareness, language, validation, open communication, strategies, coherence, incoherence and power. Research participants indicate that quantum physics principles provide a language and conceptual framework for improving their awareness of communication and interactions in the healthcare environment. Implications of this pilot study support the feasibility of future research and education on awareness of quantum physics principles in other clinical settings. Copyright © 2016 Elsevier Inc. All rights reserved.

Benefit of social media on patient engagement and satisfaction: Results of a 9-month, qualitative pilot study using Facebook.

PubMed

Dhar, Vikrom K; Kim, Young; Graff, Justin T; Jung, Andrew D; Garrett, Jennifer; Dick, Lauren E; Harris, Jenifer; Shah, Shimul A

2018-03-01

Despite the potential benefits of social media, health care providers are often hesitant to engage patients through these sites. Our aim was to explore how implementation of social media may affect patient engagement and satisfaction. In September 2016 a Facebook support group was created for liver transplant patients to use as a virtual community forum. Data including user demographics and group activity were reviewed. A survey was conducted evaluating users' perceptions regarding participation in the group. Over 9 months, 350 unique users (50% liver transplant patients, 36% caregivers/friends, 14% health care providers) contributed 339 posts, 2,338 comments, and 6,274 reactions to the group; 98% of posts were reacted to or commented on by other group members. Patients were the most active users compared with health care providers and caregivers. A total of 95% of survey respondents reported that joining the group had a positive impact on their care; and 97% reported that their main motivation for joining was to provide or receive support from other patients. This pilot study indicates that the integration of social media into clinical practice can empower surgeons to synthesize effectively a patient support community that augments patient engagement and satisfaction. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study.

PubMed

Cutshall, Susanne M; Wentworth, Laura J; Engen, Deborah; Sundt, Thoralf M; Kelly, Ryan F; Bauer, Brent A

2010-05-01

To assess the role of massage therapy in the cardiac surgery postoperative period. Specific aims included determining the difference in pain, anxiety, tension, and satisfaction scores of patients before and after massage compared with patients who received standard care. A randomized controlled trial comparing outcomes before and after intervention in and across groups. Saint Marys Hospital, Mayo Clinic, Rochester, Minnesota. Patients undergoing cardiovascular surgical procedures (coronary artery bypass grafting and/or valvular repair or replacement) (N=58). Patients in the intervention group received a 20-minute session of massage therapy intervention between postoperative days 2 and 5. Patients in the control group received standard care and a 20-minute quiet time between postoperative days 2 and 5. Linear Analogue Self-assessment scores for pain, anxiety, tension, and satisfaction. Statistically and clinically significant decreases in pain, anxiety, and tension scores were observed for patients who received a 20-minute massage compared with those who received standard care. Patient feedback was markedly positive. This pilot study showed that massage can be successfully incorporated into a busy cardiac surgical practice. These results suggest that massage may be an important therapy to consider for inclusion in the management of postoperative recovery of cardiovascular surgical patients. Copyright 2009 Elsevier Ltd. All rights reserved.

A pilot randomised controlled trial in intensive care patients comparing 7 days' treatment with empirical antibiotics with 2 days' treatment for hospital-acquired infection of unknown origin.

PubMed

Scawn, N; Saul, D; Pathak, D; Matata, B; Kemp, I; Stables, R; Lane, S; Haycox, A; Houten, R

2012-09-01

Management of cardiac intensive care unit (ICU) sepsis is complicated by the high incidence of systemic inflammatory response syndrome, which mimics sepsis but without an infective cause. This pilot randomised trial investigated whether or not, in the ICU, 48 hours of broad-spectrum antibiotic treatment was adequate to safely treat suspected sepsis of unknown and unproven origin and also the predictive power of newer biomarkers of sepsis. The main objective of this pilot study was to provide preliminary data on the likely safety and efficacy of a reduced course of antibiotics for the treatment of ICU infections of unknown origin. A pilot, single-centre, open-label randomised trial. This study was carried out in the ICU of a tertiary heart and chest hospital. Patients being treated within the ICU were recruited into the trial if the intensivist was planning to commence antibiotics because of evidence of systemic inflammatory response syndrome and a strong suspicion of infection but there was no actual known source for that infection. Broad-spectrum antibiotic treatment administered for 48 hours (experimental) compared with treatment for 7 days (control). The primary outcome was a composite outcome of the rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. Secondary outcomes included the duration of mechanical ventilation and ICU and hospital stay; the incidence of infection with Clostridium difficile (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008, or methicillin-resistant Staphylococcus aureus (MRSA) (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008; resource utilisation and costs associated with each of the two pilot arms; the ratio of patients screened to patients eligible to patients randomised; the incidence of crossover between groups; and the significance of newer biomarkers for sepsis for predicting patients' need for further antibiotics. A total of 46 patients were recruited into the trial, with 23 randomised to each group. There was no significant difference between the two groups in terms of the composite primary outcome measure. The risk difference was 0.12 [95% confidence interval (CI) 0.11 to 0.13; p = 0.3]. In the 2-day group, four patients (17.4%) required further antibiotics compared with three (13%) in the 7-day group. Four patients died within the trial period and the deaths were not trial related. Patients who died during the trial period received no additional antibiotics in excess of their trial allocation. There were no documented incidences of MRSA or C. difficile infection in either group. No significant differences in adverse events were observed between the groups. Key economic findings were mean antibiotic costs per patient of £168.97 for the 2-day group and £375.86 for the 7-day group. The potential per annum cost saving for the ICU of 2-day treatment was estimated to range from £108,140 to £126,060. Patient screening was considered the biggest barrier to recruitment. There was no crossover between the two randomised groups. Data verification ascertained > 98% accuracy in data collection. Baseline procalcitonin was found to be predictive of the composite outcome (death and needing further antibiotics) (odds ratio 1.79, 95% CI 1.20 to 2.67; p = 0.005). Analysis of baseline procalcitonin also indicated a trend towards it being a predictor of restarting antibiotics, with an odds ratio of 1.45 (95% CI 1.04 to 2.02; p = 0.01). Data from this pilot study suggest that there could be significant benefits of reducing broad-spectrum antibiotic use in the ICU without it undermining patient safety, with a potential cost saving in our unit of over £100,000 per year. Evidence from this pilot trial is not definitive but warrants further investigation using a large randomised controlled trial. Current Controlled Trials ISRCTN82694288. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 36. See the HTA programme website for further project information.

Efficacy and safety of a new coverlet device on skin microclimate management: a pilot study in critical care patients.

PubMed

Forriez, O; Masseline, J; Coadic, D; David, V; Trouiller, P; Sztrymf, B

2017-02-02

To test the effect of a new coverlet device, allowing air circulation at the body/underlying surface interface, on skin microclimate management. This prospective observational pilot study took place in a 15-bed university-affiliated intensive care unit. Overall, 34 mechanically ventilated patients were included. Skin humidity and temperature were monitored before and after the implementation of the tested device at the occiput, scapulas, buttocks and sacrum. Humidity and temperature were evaluated through surface skin impedance and an infra-red thermometer, respectively. Health professionals were asked to evaluate the device. After implementation of the coverlet device, there was a rapid, sustained and significant decrease in skin humidity at all sites ranging from 6 % to 15 %, excluding the occiput. Skin temperature also significantly decreased from 1 % at both scapulas, but not at the other studied body sites. No side effects were observed. Health professionals reported that the device was easy and quick to install. Although they did not report a subjective improvement in skin moisture or temperature, they considered the device to be efficient. Although limited by its design, this pilot study suggests a good efficacy of the studied device on skin microclimate management. Further data are warranted to test the clinical implications of our findings.

Barriers to implementing the World Health Organization's Trauma Care Checklist: A Canadian single-center experience.

PubMed

Nolan, Brodie; Zakirova, Rimma; Bridge, Jennifer; Nathens, Avery B

2014-11-01

Management of trauma patients is difficult because of their complexity and acuity. In an effort to improve patient care and reduce morbidity and mortality, the World Health Organization developed a trauma care checklist. Local stakeholder input led to a modified 16-item version that was subsequently piloted. Our study highlights the barriers and challenges associated with implementing this checklist at our hospital. The checklist was piloted over a 6-month period at St. Michael's Hospital, a Level 1 trauma center in Toronto, Canada. At the end of the pilot phase, individual, semistructured interviews were held with trauma team leaders and nursing staff regarding their experiences with the checklist. Axial coding was used to create a typology of attitudes and barriers toward the checklist, and then, vertical coding was used to further explore each identified barrier. Checklist compliance was assessed for the first 7 months. Checklist compliance throughout the pilot phase was 78%. Eight key barriers to implementing the checklist were identified as follows: perceived lack of time for the use of the checklist in critically ill patients, unclear roles, no memory trigger, no one to enforce completion, not understanding its importance or purpose, difficulty finding physicians at the end of resuscitation, staff/trainee changes, and professional hierarchy. The World Health Organization Trauma Care Checklist was a well-received tool; however, consideration of barriers to the implementation and staff adoption must be done for successful integration, with special attention to its use in critically ill patients. Therapeutic/care management, level V.

Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic Disorders

ClinicalTrials.gov

2005-06-23

Chediak-Higashi Syndrome; Graft Versus Host Disease; X-Linked Lymphoproliferative Syndrome; Familial Erythrophagocytic Lymphohistiocytosis; Hemophagocytic Lymphohistiocytosis; Virus-Associated Hemophagocytic Syndrome

Communication Profiles of Psychiatric Residents and Attending Physicians in Medication-Management Appointments: A Quantitative Pilot Study

ERIC Educational Resources Information Center

Castillo, Enrico G.; Pincus, Harold A.; Wieland, Melissa; Roter, Debra; Larson, Susan; Houck, Patricia; Reynolds, Charles F.; Cruz, Mario

2012-01-01

Objective: The authors quantitatively examined differences in psychiatric residents' and attending physicians' communication profiles and voice tones. Methods: Audiotaped recordings of 49 resident-patient and 35 attending-patient medication-management appointments at four ambulatory sites were analyzed with the Roter Interaction Analysis System…

Pilot testing of the effectiveness of nurse-guided, patient-centered heart failure education for older adults.

PubMed

Mathew, Shiny; Thukha, Henry

2017-12-13

Heart failure (HF) is the most common cause of hospitalization and rehospitalization among those 65 years and older. Effective HF self-management is recommended for reducing readmissions. This pilot study, through a one-group, pretest-posttest design, examines the effects of nurse-guided, patient-centered HF education on readmissions among older adults (n = 26) in a post-acute care unit. All selected participants received 3 sessions of tailored patient education. Their knowledge and self-care skills were measured pre- and post-intervention with the Atlanta Heart Failure Knowledge Test (A-HFKT) and the Self-Care of Heart Failure Index (SCHFI). Patients' HF-related knowledge and self-care skills showed statistically significant improvements, and only 1 patient was rehospitalized for any HF-related reason within 30 days post-discharge. These results suggest that HF rehabilitation teams could support better patient outcomes by assigning nursing staff to provide individualized patient education, as this can help ensure that patients understand discharge instructions for effective self-care. Copyright © 2017 Elsevier Inc. All rights reserved.

A Virtual Patient Software Program to Improve Pharmacy Student Learning in a Comprehensive Disease Management Course

PubMed Central

Casale, Jillian P.; Skirvin, J. Andrew; DiVall, Margarita V.

2013-01-01

Objective. To implement and assess the impact of a virtual patient pilot program on pharmacy students’ clinical competence skills. Design. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessment. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students’ posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Conclusion. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes. PMID:24159213

Improving maternity care in the Dominican Republic: a pilot study of a community-based participatory research action plan by an international healthcare team.

PubMed

Foster, Jennifer; Gossett, Sarah; Burgos, Rosa; Cáceres, Ramona; Tejada, Carmen; Dominguez García, Luis; Ambrosio Rosario, Angel; Almonte, Asela; Perez, Lydia J

2015-05-01

This article is a report of the process and results of a feasibility pilot study to improve the quality of maternity care in a sample of 31 women and their newborns delivering in a public, tertiary hospital in the Dominican Republic. The pilot study was the first "action step" taken as a result of a formative, community-based participatory research (CBPR) study conducted between 2008 and 2010 by an interdisciplinary, international partnership of U.S. academic researchers, Dominican medical/nursing personnel, and Dominican community health workers. Health personnel and community health workers separately identified indicators most important to measure quality of antepartum maternity care: laboratory and diagnostic studies and respectful, interpersonal communication. At the midpoint and the completion of data collection, the CBPR team evaluated the change in quality indicators to assess improvement in care. The pilot study supports the idea that joint engagement of community health workers, health personnel, and academic researchers with data creation and patient monitoring is motivating for all to continue to improve services in the cultural context of the Dominican Republic. © The Author(s) 2014.

Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

PubMed Central

Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

2015-01-01

Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

[Family-oriented group therapy in the treatment of female patients with anorexia and bulimia nervosa--a pilot study].

PubMed

Salbach, Harriet; Bohnekamp, Inga; Lehmkuhl, Ulrike; Pfeiffer, Ernst; Korte, Alexander

2006-07-01

Family therapy has proven effective in the treatment of anorexia nervosa (AN) and bulimia nervosa (BN) in adolescence. While cognitive-behavioural treatment has been shown to be effective in adult patients suffering from BN, there have been few studies on the effectiveness of psychotherapy in the treatment of adolescents. Since in the majority of AN patients their illness starts in mid-adolescence, and in late adolescence in BN patients, it is crucial to develop and evaluate treatment programmes for these disorders and age groups. In view of these arguments, a programme of group psychotherapy was set up for eating-disordered patients and their parents, combining disorder-specific psychoeducational components with a family group psychotherapy approach that is more open with regard to individual treatment goals. Patients participated together with their parents in the same group. The treatment programme was evaluated within the framework of a naturalistic single-group study design. Pre-post changes were assessed. 32 female patients (29 with AN, 3 with BN) and their parents took part in the treatment programme. All of the families completed the programme, which was interpreted as a high rate of acceptance. Pre-post analysis revealed a decrease in the degree of eating-disorder symptoms. The advantages and disadvantages of this treatment programme, as well as the limitations of the pilot study are critically discussed.

Prognostic value of the reactive oxygen species in severe sepsis and septic shock patients: a pilot study.

PubMed

Montini, Luca; DE Sole, Pasquale; Pennisi, Mariano A; Rossi, Cristina; Scatena, Roberto; DE Pascale, Gennaro; Bello, Giuseppe; Cutuli, Salvatore L; Antonelli, Massimo

2016-12-01

Reactive oxygen species (ROS) have been shown to play a role in the pathophysiology of sepsis. The aim of this study was to investigate ROS production over time in critically ill with sepsis patients and its correlation with outcome. This was a pilot single-centre prospective, observational study of patients consecutively admitted to our 18-general ICU. Over a period of 6 months all the consecutive patients with recent-onset of severe sepsis or septic shock were enrolled. Clinical and demographic characteristics of all patients were recorded. ROMs (ROS metabolites), reduced sulfhydryl groups (SH) and plasmatic lactate levels were collected at enrollment in the study and then every 5-7 days over 28 days or until sepsis resolution or death during sepsis. ROMs were analysed spectrophotometrically by the d-ROMs test (Diacron-Italia). SH were assayed in plasma by Ellman's reaction by spectrophotometric method. Septic shock-related mortality was defined as death that occurred during the follow up period, when the signs of shock remained, and death could not be attributed to causes other than septic shock by the attending physician. Twenty-five patients were studied. The SOFA score and the plasmatic lactate levels significantly correlated with the ROMs plasmatic levels. The mortality rate was higher in patients whose ROMs plasmatic levels decreased during septic shock evolution. Serial measurements of the ROMs plasmatic levels together with the SOFA score and lactate levels could help to identify septic shock patients with a very high probability of death.

Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study.

PubMed

Borckardt, Jeffrey J; Romagnuolo, Joseph; Reeves, Scott T; Madan, Alok; Frohman, Heather; Beam, Will; George, Mark S

2011-06-01

Emerging evidence shows that transcranial direct current stimulation (tDCS), a minimally invasive brain stimulation technique, has analgesic effects in chronic pain patients and in healthy volunteers with experimental pain. No studies have examined the analgesic effects of tDCS immediately after surgical/endoscopic procedures. Endoscopy investigating abdominal pain, especially ERCP, can cause significant postprocedural pain. To test the feasibility, efficacy, and safety of tDCS on post-ERCP pain and analgesia use. Randomized, sham-controlled, pilot study. Tertiary-care medical center. This study involved 21 patients who were hospitalized overnight for ERCP for unexplained right upper quadrant pain. Twenty minutes of real 2.0 mA tDCS or sham (anode over left prefrontal cortex; cathode over gut-representation of right sensory cortex) immediately after ERCP. Pain (visual analogue scale, McGill pain questionnaire, brief pain inventory), patient-controlled analgesia use, adverse events. Real tDCS was associated with 22% less total hydromorphone use, versus sham. The slope of the cumulative patient-controlled analgesia usage curve was significantly steeper in the sham tDCS group (F [2,13] = 15.96; P = .0003). Real tDCS patients reported significantly less pain interference with sleep (t [17] = 3.70; P = .002) and less throbbing pain (t [16] = 2.37; P = .03). Visual analogue scale pain and mood scores (4 hours post-ERCP) suggested a nonsignificant advantage for real tDCS, despite less hydromorphone use. Side effects of tDCS were limited to mild, self-limited tingling, itching, and stinging under electrodes. Small sample size, variability in chronic pain, and chronic opioid use. In this pilot study, tDCS appears to be safe, has minimal side effects, and may reduce postprocedural analgesia requirements and subjective pain ratings. Future studies appear warranted. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Touch massage: a pilot study of a complex intervention.

PubMed

Lindgren, Lenita; Lehtipalo, Stefan; Winsö, Ola; Karlsson, Marcus; Wiklund, Urban; Brulin, Christine

2013-11-01

To report and evaluate a complex touch massage intervention according to the British Medical Research Council framework. This study aimed to evaluate the effects of touch massage on levels of anxiety and physiological stress in patients scheduled for elective aortic surgery. The use of touch massage has increased during the past decade but no systematic studies have been implemented to investigate the effectiveness of such treatment. It is important to conduct multidisciplinary investigations into the effects of complex interventions such as touch massage. For this, the British Medical Research Council has provided a useful framework to guide the development, piloting, evaluation and reporting of complex intervention studies. A pilot study with a randomized controlled design including 20 patients (10 + 10) scheduled for elective aortic surgery. Selected outcome parameters included; self-reported anxiety, measured by the State-Trait Anxiety Inventory Form Y instrument, and physiological stress, measured by heart rate variability, blood pressure, respiratory frequency, oxygen saturation and concentrations of cortisol, insulin and glucose in serum. There were significant differences in self-reported anxiety levels before and after touch massage (p = 0.007), this was not observed in the control group (p = 0.833). There was a significant difference in self-reported anxiety levels between the touch massage group and the control group after touch massage and rest (p = 0.001). There were no significant differences in physiological stress-related outcome parameters between patients who received touch massage and controls. In our study, touch massage decreased anxiety levels in patients scheduled for elective aortic surgery, and the British Medical Research Council framework was a useful guideline for the development, evaluation and reporting of a touch massage intervention. Touch massage can reduce patients' anxiety levels and is thus an important nursing intervention in intensive and post-operative care. © 2013 The Authors. Nursing in Critical Care © 2013 British Association of Critical Care Nurses.

A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

PubMed

Matthews, James; Hall, Amanda M; Hernon, Marian; Murray, Aileen; Jackson, Ben; Taylor, Ian; Toner, John; Guerin, Suzanne; Lonsdale, Chris; Hurley, Deirdre A

2015-07-05

Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. © 2017 Royal College of Speech and Language Therapists.

Removing user fees for basic health services: a pilot study and national roll-out in Afghanistan

PubMed Central

Steinhardt, Laura C; Aman, Iqbal; Pakzad, Iqbalshah; Kumar, Binay; Singh, Lakhwinder P; Peters, David H

2011-01-01

Background User fees for primary care tend to suppress utilization, and many countries are experimenting with fee removal. Studies show that additional inputs are needed after removing fees, although well-documented experiences are lacking. This study presents data on the effects of fee removal on facility quality and utilization in Afghanistan, based on a pilot experiment and subsequent nationwide ban on fees. Methods Data on utilization and observed structural and perceived overall quality of health care were compared from before-and-after facility assessments, patient exit interviews and catchment area household surveys from eight facilities where fees were removed and 14 facilities where fee levels remained constant, as part of a larger health financing pilot study from 2005 to 2007. After a national user fee ban was instituted in 2008, health facility administrative data were analysed to assess subsequent changes in utilization and quality. Results The pilot study analysis indicated that observed and perceived quality increased across facilities but did not differ by fee removal status. Difference-in-difference analysis showed that utilization at facilities previously charging both service and drug fees increased by 400% more after fee removal, prompting additional inputs from service providers, compared with facilities that previously only charged service fees or had no change in fees (P = 0.001). Following the national fee ban, visits for curative care increased significantly (P < 0.001), but institutional deliveries did not. Services typically free before the ban—immunization and antenatal care—had immediate increases in utilization but these were not sustained. Conclusion Both pilot and nationwide data indicated that curative care utilization increased following fee removal, without differential changes in quality. Concerns raised by non-governmental organizations, health workers and community leaders over the effects of lost revenue and increased utilization require continued effort to raise revenues, monitor health worker and patient perceptions, and carefully manage health facility performance. PMID:22027924

Absence of accelerated atherosclerotic disease progression after intracoronary infusion of bone marrow derived mononuclear cells in patients with acute myocardial infarction--angiographic and intravascular ultrasound--results from the TErapia Celular Aplicada al Miocardio Pilot study.

PubMed

Arnold, Roman; Villa, Adolfo; Gutiérrez, Hipólito; Sánchez, Pedro L; Gimeno, Federico; Fernández, Maria E; Gutiérrez, Oliver; Mota, Pedro; Sánchez, Ana; García-Frade, Javier; Fernández-Avilés, Francisco; San Román, Jose A

2010-06-01

We tried to evaluate a putative negative effect on coronary atherosclerosis in patients receiving intracoronary infusion of unfractionated bone marrow mononuclear cells (BMMC) following an acute ST-elevation myocardial infarction. Peripheral blood mononuclear cells or enriched CD133(+) BMMC have been associated with accelerated atherosclerosis of the distal segment of the infarct related artery (IRA). Thirty-seven patients with ST-elevation myocardial infarction from the TECAM pilot study underwent intracoronary infusion of autologous BMMC 9 +/- 3.1 days after onset of symptoms. We compared angiographic changes from baseline to 9 months of follow-up in the distal non-stented segment of the IRA, as well as in the contralateral coronary artery, with a matched control group. A subgroup of 15 treated patients underwent additional IVUS within the distal segment of the IRA. No difference between stem cell and control group were found regarding changes in minimum lumen diameter (0.006 +/- 0.42 vs 0.06 +/- 0.41 mm, P = ns) and the percentage of stenosis (-2.68 +/- 12.33% vs -1.78 +/- 8.75%, P = ns) at follow-up. Likewise, no differences were seen regarding changes in the contralateral artery (minimum lumen diameter -0.004 +/- 0.54 mm vs -0.06 +/- 0.35 mm, P = ns). In the intravascular ultrasound substudy, no changes were demonstrated comparing baseline versus follow-up in maximum area stenosis and plaque volume. In this pilot study, analysis of a subgroup of patients found that intracoronary injection of unfractionated BMMC in patients with acute ST-elevation myocardial infarction was not associated with accelerated atherosclerosis progression at mid term. Prospective, randomised studies in large cohorts with long-term angiographic and intravascular ultrasound follow-up are necessary to determine the safety of this therapy. Copyright 2010 Mosby, Inc. All rights reserved.

Embedding fundamental care in the pre-registration nursing curriculum: Results from a pilot study.

PubMed

Feo, Rebecca; Donnelly, Frank; Frensham, Lauren; Conroy, Tiffany; Kitson, Alison

2018-05-01

International evidence suggests nursing is not providing fundamental care consistently or adequately, resulting in poor outcomes for patients and healthcare systems. One possible reason for this inadequate care delivery is nursing education, with fundamental care often implicit or invisible in nursing curricula. To understand how best to teach fundamental care to pre-registration (pre-licensure) students, we developed and piloted a six-week intervention that incorporated into the first-year curriculum a more explicit focus on fundamental care. A conceptual fundamental care framework was used to guide students' learning, and clinical skills sessions were structured to reinforce the framework's conceptual understanding and enable students to practice delivering fundamental care in an integrated manner. The intervention's impact was explored via a pre-post survey and focus groups. The survey demonstrated that the intervention did not affect students' ability to identify patients' fundamental care needs; however, focus groups showed the intervention assisted students in understanding the complexity of fundamental care and its importance to patients' experiences. The pilot provides preliminary evidence on the importance of embedding fundamental care into nursing curricula early and explicitly, and emphasising the integrated nature of such care, particularly through structured debriefs, consistent terminology, and opportunities for students to experience care as a patient. Copyright © 2018 Elsevier Ltd. All rights reserved.

Creation and preliminary validation of the screening for self-medication safety post-stroke scale (S-5).

PubMed

Kaizer, Franceen; Kim, Angela; Van, My Tram; Korner-Bitensky, Nicol

2010-03-01

Patients with stroke should be screened for safety prior to starting a self-medication regime. An extensive literature review revealed no standardized self-medication tool tailored to the multi-faceted needs of the stroke population. The aim of this study was to create and validate a condition-specific tool to be used in screening for self-medication safety in individuals with stroke. Items were generated using expert consultation and review of the existing tools. The draft tool was pilot-tested on expert stroke clinicians to receive feedback on content, clarity, optimal cueing and domain omissions. The final version was piloted on patients with stroke using a structured interviewer-administered interview. The tool was progressively refined and validated according to feedback from the 11 expert reviewers. The subsequent version was piloted on patients with stroke. The final version includes 16 questions designed to elicit information on 5 domains: cognition, communication, motor, visual-perception and, judgement/executive function/self-efficacy. The Screening for Safe Self-medication post-Stroke Scale (S-5) has been created and validated for use by health professionals to screen self-medication safety readiness of patients after stroke. Its use should also help to guide clinicians' recommendations and interventions aimed at enhancing self-medication post-stroke.

Room for improvement: tackling high-cost patients for high potential return.

PubMed

2004-06-01

Assuming that most DM programs do a decent job of managing the typical chronically ill patient, a California company decided to take on the atypical patient with a program that seeks out highly complex, at high-cost patients, and uses some non-traditional interventions to get these patients stabilized. In fact, pilot study results suggest developers may be on the right track with their "SWAT team" approach to care.

Psychometric Evaluation of the Knowledge, Skills, and Attitudes-Part I: Patient-Centered Care Scale (KSAI-PCCS): A Pilot Study

ERIC Educational Resources Information Center

Esslin, Patricia E.

2016-01-01

Recognition that adverse events are a significant cause for morbidity and mortality has led to a rise in global efforts to improve patient safety. Adaptations are needed in healthcare institutions and at the educational preparatory level for all healthcare providers. One change surrounds the significance of patient-centered care, an important…

The Effects of Exercise Education Intervention on the Exercise Behaviour, Depression, and Fatigue Status of Chronic Kidney Disease Patients

ERIC Educational Resources Information Center

Kao, Yu-Hsiu; Huang, Yi-Ching; Chen, Pei-Ying; Wang, Kuo-Ming

2012-01-01

Purpose: The purpose of this paper is to investigate the effects of an exercise education intervention on exercise behavior, depression and fatigue status of chronic kidney disease (CKD) patients. Design/methodology/approach: This was a pilot study using an exercise education program as an intervention for CKD patients. The authors used the…

Therapeutic alliance and obesity management in primary care - a cross-sectional pilot using the Working Alliance Inventory.

PubMed

Sturgiss, E A; Sargent, G M; Haesler, E; Rieger, E; Douglas, K

2016-12-01

Therapeutic alliance is a well-recognized predictor of patient outcomes within psychological therapy. It has not been applied to obesity interventions, and Bordin's theoretical framework shows particular relevance to the management of obesity in primary health care. This cross-sectional study of a weight management programme in general practice aimed to determine if therapeutic alliance was associated with patient outcomes. The Working Alliance Inventory short revised version (WAI-SR) was administered to 23 patients and 11 general practitioners (GPs) at the end of a 6-month weight management programme. Use of the WAI-SR indicated that the strength of therapeutic alliance varied between different patient-GP relationships in this pilot intervention. A robust therapeutic alliance was strongly associated with patient engagement in the weight management programme indicated by number of appointments. It was also associated with some general health and quality of life outcomes. These are promising results that require confirmation with larger studies in primary health care. The measurement of therapeutic alliance using the WAI-SR may predict patient attendance and outcomes in obesity interventions in primary healthcare settings. © 2016 World Obesity Federation.

Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

PubMed

Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

2015-11-01

Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study.

PubMed

Brunetti, Maddalena; Morkisch, Nadine; Fritzsch, Claire; Mehnert, Jan; Steinbrink, Jens; Niedeggen, Michael; Dohle, Christian

2015-01-01

Mirror therapy (MT) was found to improve motor function after stroke. However, there is high variability between patients regarding motor recovery. The following pilot study was designed to identify potential factors determining this variability between patients with severe upper limb paresis, receiving MT. Eleven sub-acute stroke patients with severe upper limb paresis participated, receiving in-patient rehabilitation. After a set of pre-assessments (including measurement of brain activity at the primary motor cortex and precuneus during the mirror illusion, using near-infrared spectroscopy as described previously), four weeks of MT were applied, followed by a set of post-assessments. Discriminant group analysis for MT responders and non-responders was performed. Six out of eleven patients were defined as responders and five as non-responders on the basis of their functional motor improvement. The initial motor function and the activity shift in both precunei (mirror index) were found to discriminate significantly between responders and non-responders. In line with earlier results, initial motor function was confirmed as crucial determinant of motor recovery. Additionally, activity response to the mirror illusion in both precunei was found to be a candidate for determination of the efficacy of MT.

Somatropin treatment of spinal muscular atrophy: a placebo-controlled, double-blind crossover pilot study.

PubMed

Kirschner, J; Schorling, D; Hauschke, D; Rensing-Zimmermann, C; Wein, U; Grieben, U; Schottmann, G; Schara, U; Konrad, K; Müller-Felber, W; Thiele, S; Wilichowski, E; Hobbiebrunken, E; Stettner, G M; Korinthenberg, R

2014-02-01

In preclinical studies growth hormone and its primary mediator IGF-1 have shown potential to increase muscle mass and strength. A single patient with spinal muscular atrophy reported benefit after compassionate use of growth hormone. Therefore we evaluated the efficacy and safety of growth hormone treatment for spinal muscular atrophy in a multicenter, randomised, double-blind, placebo-controlled, crossover pilot trial. Patients (n = 19) with type II/III spinal muscular atrophy were randomised to receive either somatropin (0.03 mg/kg/day) or placebo subcutaneously for 3 months, followed by a 2-month wash-out phase before 3 months of treatment with the contrary remedy. Changes in upper limb muscle strength (megascore for elbow flexion and hand-grip in Newton) were assessed by hand-held myometry as the primary measure of outcome. Secondary outcome measures included lower limb muscle strength, motor function using the Hammersmith Functional Motor Scale and other functional tests for motor function and pulmonary function. Somatropin treatment did not significantly affect upper limb muscle strength (point estimate mean: 0.08 N, 95% confidence interval (CI:-3.79;3.95, p = 0.965), lower limb muscle strength (point estimate mean: 2.23 N, CI:-2.19;6.63, p = 0.302) or muscle and pulmonary function. Side effects occurring during somatropin treatment corresponded with well-known side effects of growth hormone substitution in patients with growth hormone deficiency. In this pilot study, growth hormone treatment did not improve muscle strength or function in patients with spinal muscular atrophy type II/III. Copyright © 2013 Elsevier B.V. All rights reserved.

Diagnostic and therapeutic yield of a patient-controlled portable EEG device with dry electrodes for home-monitoring neurological outpatients-rationale and protocol of the HOMEONE pilot study.

PubMed

Neumann, Thomas; Baum, Anne Katrin; Baum, Ulrike; Deike, Renate; Feistner, Helmut; Hinrichs, Hermann; Stokes, Joseph; Robra, Bernt-Peter

2018-01-01

The HOME ONE study is part of the larger HOME project, which aims to provide evidence of diagnostic and therapeutic yield ("change of management") of a patient-controlled portable EEG device with dry electrodes for the purposes of EEG home-monitoring neurological outpatients. The HOME ONE study is the first step in the process of investigating whether outpatient EEG home-monitoring changes the diagnosis and treatment of patients in comparison to conventional EEG ("change of management"). Both EEG devices (conventional and portable) will be systematically compared via a two-phase intra-individual assessment.In the first phase (pilot study phase), both EEG devices will be used within neurologist practices (all other things being equal). This pilot study (involving 130 patients) will evaluate the technical usability and efficacy of the new portable dry electrode EEG recorder in comparison to conventional EEG devices. Judgements will be based on technical assessments and EEG record examinations of private practitioners and two experienced neurologists (percent of concordant readings and kappa values).The second phase (feasibility study phase) aims to assess patients' acceptability and feasibility of the EEG home-monitoring and will provide insights into the extent diagnostic and therapeutic yields can be expected.For this purpose, a conventional EEG will be recorded in neurologist practices. Thereafter, the practice staff will instruct the patients on how the portable EEG device functions. The patients will subsequently use the devices in their home environment.The evaluation will compare the before and after documented diagnostic findings and the therapeutic consequences of the private practitioners with those of two experienced neurologists. To the best of our knowledge, this will be the first study of its kind to examine new approaches to diagnosing unclear consciousness disorders or other disorders of the CNS or the cardiovascular system through the use of a patient-controlled portable EEG device with dry electrodes for the purpose of home-monitoring neurological outpatients. If the two phases of the HOME ONE study provide sufficient evidence of diagnostic and therapeutic yields, this would justify (indication-specific) full-scale randomized controlled trials or observational studies. DRKS DRKS00012685. Registered 9 August 2017, retrospectively registered.

Pilot Study of Patient and Caregiver Out-of-Pocket Costs of Allogeneic Hematopoietic Cell Transplantation

PubMed Central

Majhail, Navneet S; Rizzo, J Douglas; Hahn, Theresa; Lee, Stephanie J; McCarthy, Philip L; Ammi, Monique; Denzen, Ellen; Drexler, Rebecca; Flesch, Susan; James, Heather; Omondi, Nancy; Pedersen, Tanya L; Murphy, Elizabeth; Pederson, Kate

2012-01-01

Patient/caregiver out-of pocket costs associated with hematopoietic-cell transplantation (HCT) are not well known. We conducted a pilot study to evaluate patient/caregiver out-of-pocket costs in the first 3 months after allogeneic HCT. Thirty patients were enrolled at three sites. Prior to HCT, participants completed a baseline survey regarding household income and insurance coverage. Subsequently, they maintained a paper-based diary to track daily out-of-pocket expenses for the first 3 months after HCT. Telephone interviews were conducted to followup on missing/incomplete diaries and on study completion. Twenty-five patients/caregivers completed the baseline survey. Among these, the median pre-tax household income was $66,500 (range, $30-$375,000) and 48% had to temporarily relocate close to the transplant center. Insurance coverage was managed care plan (56%), Medicaid (20%), Medicare (17%) and other (8%). Twenty-two patients/caregivers completed ≥4 diaries; the median out-of-pocket expenses were $2,440 (range, $199-$13,769). Patients/caregivers who required temporary lodging had higher out-of-pocket expenses compared to those who did not (median, $5,247 vs. $716). Patients/caregivers can incur substantial out-of-pocket costs over the first 3 months, especially if they need to temporarily relocate close to the transplant center. Our study lays the foundation for future research on early and long-term financial impact of allogeneic HCT on patients/caregivers. PMID:23222378

Role of glucocorticoids on inflammatory response in nonimmunosuppressed patients with pneumonia: a pilot study.

PubMed

Montón, C; Ewig, S; Torres, A; El-Ebiary, M; Filella, X; Rañó, A; Xaubet, A

1999-07-01

The aim of the study was to assess the potential role of glucocorticoids (GC) in modulating systemic and pulmonary inflammatory responses in mechanically ventilated patients with severe pneumonia. Twenty mechanically ventilated patients with pneumonia treated at a respiratory intensive care unit (RICU) of a 1,000-bed teaching hospital were prospectively studied. All patients had received prior antimicrobial treatment. Eleven patients received GC (mean+/-SD dose of i.v. methylprednisolone 677+/-508 mg for 9+/-7 days), mainly for bronchial dilatation. Serum and bronchoalveolar lavage fluid (BALF) tumour necrosis factor (TNF)-alpha, interleukin (IL)-1beta, IL-6 and C-reactive protein levels were measured in all patients. The inflammatory response was attenuated in patients receiving GC, both systemically (IL-6 1,089+/-342 versus 630+/-385 pg x mL(-1), p=0.03; C-reactive protein 34+/-5 versus 19+/-5 mg x L(-1), p=0.04) and locally in BALF (TNF-alpha 118+/-50 versus 24+/-5 pg x mL(-1), p= 0.05; neutrophil count: 2.4+/-1.1 x 10(9) cells x L(-1) (93+/-3%) versus 1.9+/-1.8 x 10(9) cells x L(-1) (57+/-16%), p=0.03). Four of the 11 (36%) patients receiving GC died compared to six (67%) who were not receiving GC (p=0.37). The present pilot study suggests that glucocorticoids decrease systemic and lung inflammatory responses in mechanically ventilated patients with severe pneumonia receiving antimicrobial treatment.

The Interplay of "Big Five" Personality Factors and Metaphorical Schemas: A Pilot Study with 20 Lung Transplant Recipients

ERIC Educational Resources Information Center

Goetzmann, Lutz; Moser, Karin S.; Vetsch, Esther; Grieder, Erhard; Klaghofer, Richard; Naef, Rahel; Russi, Erich W.; Boehler, Annette; Buddeberg, Claus

2007-01-01

The aim of the present study was to investigate the interplay between personality factors and metaphorical schemas. The "Big Five" personality factors of 20 patients after lung transplantation were examined with the NEO-FFI. Patients were questioned about their social network, and self- and body-image. The interviews were assessed with metaphor…

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.

Short-term cognitive behavioral partial hospital treatment: a pilot study.

PubMed

Neuhaus, Edmund C; Christopher, Michael; Jacob, Karen; Guillaumot, Julien; Burns, James P

2007-09-01

Brief, cost-contained, and effective psychiatric treatments benefit patients and public health. This naturalistic pilot study examined the effectiveness of a 2-week, cognitive-behavioral therapy (CBT) oriented partial hospital program. Study participants were 57 patients with mood, anxiety, and/or personality disorders receiving treatment in a private psychiatric partial hospital (PH) setting. A flexible treatment model was used that adapts evidence-based CBT treatment interventions to the PH context with emphases on psychoeducation and skills training. Participants completed self-report measures at admission and after 1 and 2 weeks, to assess stabilization and functional improvements, with added attention to the acquisition of cognitive and behavioral skills. The data were analyzed using repeated measures analyses of variance and correlation. Participants reported a decrease in symptoms and negative thought patterns, improved satisfaction with life, and acquisition and use of cognitive and behavioral skills. Skill acquisition was correlated with symptom reduction, reduced negative thought patterns, and improved satisfaction with life. Results of this pilot study suggest that a 2-week PH program can be effective for a heterogeneous patient population with mood, anxiety, and/or personality disorders. These findings are promising given the prevalence of treatments of such brief duration in private sector PH programs subject to the managed care marketplace. Future studies are planned to test this flexible PH treatment model, with particular attention to the effectiveness of the CBT approach for the treatment of different disorders and to whether effectiveness is sustained at follow-up. Further study should also examine whether skill acquisition is a mechanism of change for symptom reduction and functional improvements.

Anesthesia with topical lidocaine hydrochloride gauzes in acute traumatic wounds in triage, a pilot study.

PubMed

Ridderikhof, Milan L; Leenders, Noukje; Goddijn, Helma; Schep, Niels W; Lirk, Philipp; Goslings, J Carel; Hollmann, Markus W

2016-09-01

Topical application of lidocaine in wounds has been studied in combination with vasoconstrictive additives, but the effect without these additives is unknown. The objective was to examine use of lidocaine-soaked gauzes without vasoconstrictive agents, in traumatic wounds in adult patients, applied in triage. A prospective pilot study was performed during 6 weeks in the Emergency Department of a level 1 trauma center. Wounds of consecutive adult patients were treated with a nursing protocol, consisting of lidocaine hydrochloride administration directly into the wound and leaving a lidocaine-soaked gauze, until wound treatment. Primary outcome was need for infiltration anesthesia. Secondary outcomes were Numerical Rating Scale (NRS) pain scores, adverse events and patient and physician satisfaction. Forty patients with a traumatic wound were included, 85% male with a wound on the arm. Thirty-seven patients needed a painful procedure as wound treatment. When suturing was necessary, 77% required additional infiltration anesthesia. Mean NRS pain scores decreased from 3.3 to 2.2 after application of the lidocaine gauze. No adverse events were recorded. Of the patients, 60% were satisfied with use of the lidocaine gauzes, compared to 40% of physicians. Lidocaine hydrochloride (2%) gauzes without vasoconstrictive additives cannot replace infiltration anesthesia in traumatic wounds. Copyright © 2016 Elsevier Ltd. All rights reserved.

Durable medical equipment recycling: a pilot program.

PubMed

Wright, Aaron J

2012-01-01

Our unfunded trauma patients often lack the access to adequate health care services and equipment after hospital discharge. We have developed and implemented a pilot program to provide reclaimed durable medical equipment to medically indigent trauma patients. Our program includes the reuse of items such as front-wheeled walkers, bedside commodes, shower chairs, crutches, and canes.

Improvement in Stress, General Self-Efficacy, and Health Related Quality of Life following Patient Education for Patients with Neuroendocrine Tumors: A Pilot Study.

PubMed

Haugland, Trude; Veenstra, Marijke; Vatn, Morten H; Wahl, Astrid K

2013-01-01

The purpose of the study was to evaluate changes in general self-efficacy, health related quality of life (HRQoL), and stress among patients with neuroendocrine tumors (NET) following a multidisciplinary educational intervention. Forty-one patients were enrolled in this exploratory pilot study. A total of 37 patients completed the full 26-week intervention based on the principles of self-efficacy. General self-efficacy was measured by the General Self-Efficacy Scale, HRQoL was measured with the SF-36, and stress was measured with the Impact of Event Scale. Mixed effect models were used to evaluate changes in general self-efficacy, mental and physical components of HRQoL, and stress adjusting for demographic and clinical variables. Results showed significant improvements in patients' general self-efficacy (β = 0.71; P < 0.05), physical component scores of HRQoL (β = 3.09; P < 0.01), and stress (β = -2.10, P = 0.008). Findings suggest that patients with NET have the capacity to improve their ability to cope with their disease, problem-solve, improve their physical status, and reduce their stress following an educational intervention based on the principles of self-efficacy. These preliminary data provide a basis for future randomized controlled trials to test interventions to improve HRQoL for patients with NET.

Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial.

PubMed

Naumann, Johannes; Grebe, Julian; Kaifel, Sonja; Weinert, Tomas; Sadaghiani, Catharina; Huber, Roman

2017-03-28

Despite advances in the treatment of depression, one-third of depressed patients fail to respond to conventional antidepressant medication. There is a need for more effective treatments with fewer side effects. The primary aim of this study was to determine whether hyperthermic baths reduce depressive symptoms in adults with depressive disorder. Randomized, two-arm placebo-controlled, 8-week pilot trial. Medically stable outpatients with confirmed depressive disorder (ICD-10: F32/F33) who were moderately depressed as determined by the 17-item Hamilton Scale for Depression (HAM-D) score ≥18 were randomly assigned to 2 hyperthermic baths (40 °C) per week for 4 weeks or a sham intervention with green light and follow-up after 4 weeks. Main outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). A total of 36 patients were randomized (hyperthermic baths, n = 17; sham condition, n = 19). The intention-to-treat analysis showed a significant (P = .037) difference in the change in HAM-D total score with 3.14 points after 4 interventions (T1) in favour of the hyperthermic bath group compared to the placebo group. This pilot study suggests that hyperthermic baths do have generalized efficacy in depressed patients. DRKS00004803 at drks-neu.uniklinik-freiburg.de, German Clinical Trials Register (registration date 2016-02-02), retrospectively registered.

Qualities of a good Singaporean psychiatrist: Qualitative differences between psychiatrists and patients.

PubMed

Tor, Phern-Chern; Tan, Jacinta O A

2015-06-01

Pilot studies in Singapore established four themes (personal values, professional, relationship, academic-executive) relating to the qualities of a good psychiatrist, and suggested potential differences of opinion between patients and psychiatrists. We sought to explore differences between patients and psychiatrists regarding the qualities of a good psychiatrist. Qualitative analysis of interviews using a modified grounded theory approach with 21 voluntary psychiatric inpatients and 18 psychiatrists. One hundred thirty-one separate qualities emerged from the data. The qualities of a good psychiatrist were viewed in the context of motivations, functions, methods, and results obtained, mirroring the themes established in the pilot studies. Patients and psychiatrists mostly concurred on the qualities of a good psychiatrist, with 62.6% of the qualities emerging from both groups. However significant differences existed. Patient-specific qualities included proof of altruistic motives, diligence, clinical competence, and positive results. What the psychiatrist represented to patients in relation to gender, culture, and clinical prestige also mattered to patients. Psychiatrist-specific qualities related to societal (e.g. public protection) and professional concerns (e.g. boundary issues). The results of this study demonstrate that patients and psychiatrists have different views about the qualities of a good psychiatrist. Patients may expect proof of care, diligence, and competence from the psychiatrist, along with positive results. In addition, psychiatrists should be mindful of what they represent to patients and how that can impact the doctor-patient relationship. © 2014 Wiley Publishing Asia Pty Ltd.

Lay Health Trainers Supporting Self-Management amongst Those with Low Heath Literacy and Diabetes: Lessons from a Mixed Methods Pilot, Feasibility Study.

PubMed

Bartlam, Bernadette; Rathod, Trishna; Rowlands, Gillian; Protheroe, Joanne

2016-01-01

This article reports a mixed methods process evaluation of a pilot feasibility randomised controlled trial comparing a Lay Health Trainer (LHT) intervention and usual care for those with poorly controlled Type 2 Diabetes Melitus (T2DM). Set in a deprived area in the UK, this research explores patient and health care practitioner (HCP) views on whether a structured interview between a patient and a Lay Health Trainer (LHT), for the purpose of developing a tailored self-management plan for patients, is acceptable and likely to change health behaviours. In doing so, it considers the implications for a future, randomised controlled trial (RCT). Participants were patients, LHTs delivering the intervention, service managers, and practice nurses recruiting patients to the study. Patients were purposively sampled on their responses to a baseline survey, and semistructured interviews were conducted within an exploratory thematic analysis framework. Findings indicate that the intervention is acceptable to patients and HCPs. However, LHTs found it challenging to work with older patients with long-term and/or complex conditions. In order to address this, given an ageing population and concomitant increases in those with such health needs, LHT training should develop skills working with these populations. The design of any future RCT intervention should take account of this.

Carer Appraisal Scale: A Pilot Study of a Novel Carer-Based Assessment of Patient Functioning.

PubMed

Jeyasingam, Neil

2018-03-01

Measurement of patient outcomes is an integral part of mental health service evaluation, as well as guiding clinical practice to ensure best outcomes for patients. Moreover, carers have long held a need for a voice in care outcomes. Despite there existing numerous tools for quantifying patient functioning based on clinician assessments or self-reports, there is a serious paucity of tools available for the carers of patients to appraise their functioning. This tool, developed for use in a community aged care psychiatric service, involves 4 sections-a global impression of patient progress, a scorable checklist of patient functioning in multiple domains, a qualitative section for identifying the most pressing concerns from the carer's perspective, and an open-ended feedback on treatment to date. In this pilot study, the Carer Appraisal Scale was found to have a fair correlation with the Health of Nation Outcomes Scale for over 65. This tool has potential for use in community aged care psychiatric services, as it provides a framework for communication of concerns, assists in prioritizing care, and adds value to clinician treatment plans, as well as providing another dimension to assessment of the patient while empowering carers in care participation. Practical implications of its use, limitations, and potential for modifications are also discussed.

Patient and nurse preferences for nurse handover-using preferences to inform policy: a discrete choice experiment protocol.

PubMed

Spinks, Jean; Chaboyer, Wendy; Bucknall, Tracey; Tobiano, Georgia; Whitty, Jennifer A

2015-11-11

Nursing bedside handover in hospital has been identified as an opportunity to involve patients and promote patient-centred care. It is important to consider the preferences of both patients and nurses when implementing bedside handover to maximise the successful uptake of this policy. We outline a study which aims to (1) identify, compare and contrast the preferences for various aspects of handover common to nurses and patients while accounting for other factors, such as the time constraints of nurses that may influence these preferences.; (2) identify opportunities for nurses to better involve patients in bedside handover and (3) identify patient and nurse preferences that may challenge the full implementation of bedside handover in the acute medical setting. We outline the protocol for a discrete choice experiment (DCE) which uses a survey design common to both patients and nurses. We describe the qualitative and pilot work undertaken to design the DCE. We use a D-efficient design which is informed by prior coefficients collected during the pilot phase. We also discuss the face-to-face administration of this survey in a population of acutely unwell, hospitalised patients and describe how data collection challenges have been informed by our pilot phase. Mixed multinomial logit regression analysis will be used to estimate the final results. This study has been approved by a university ethics committee as well as two participating hospital ethics committees. Results will be used within a knowledge translation framework to inform any strategies that can be used by nursing staff to improve the uptake of bedside handover. Results will also be disseminated via peer-reviewed journal articles and will be presented at national and international conferences. 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/

Finasteride for Chronic Central Serous Chorioretinopathy

PubMed Central

Forooghian, Farzin; Meleth, Annal D.; Cukras, Catherine; Chew, Emily Y.; Wong, Wai T.; Meyerle, Catherine B.

2010-01-01

Purpose To evaluate the safety and efficacy of finasteride, an inhibitor of dihyroxytestosterone (DHT) synthesis, in the treatment of chronic central serous chorioretinopathy (CSC). Methods Five patients with chronic CSC were prospectively enrolled in this pilot study. Patients were administered finasteride (5mg) daily for 3 months, following which study medication was withheld and patients were observed for 3 months. Main outcome measures included best-corrected visual acuity (BCVA), center-subfield macular thickness and subretinal fluid volume as assessed by optical coherence tomography (OCT). Serum DHT, serum testosterone, and urinary cortisol were also measured. Results There was no change in mean BCVA. Mean center-subfield macular thickness and subretinal fluid volume reached a nadir at 3 months, and rose to levels that were below baseline by 6 months. The changes in both OCT parameters paralleled changes in serum DHT level. In four patients, center-subfield macular thickness and/or subretinal fluid volume increased following discontinuation of finasteride. In the remaining patient, both OCT parameters normalized with finasteride and remained stable when the study medication was discontinued. Conclusion Finasteride may represent a novel medical treatment for chronic CSC. Larger controlled clinical trials are needed to further assess the efficacy of finasteride for the treatment of CSC. Summary Pilot study to evaluate finasteride for treatment of chronic central serous chorioretinopathy suggests efficacy and tolerability. PMID:21273946

Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.

Use of Electronic Tablets for Patient Education on Flushing Peripherally Inserted Central Catheters.

PubMed

Petroulias, Patricia L

The purpose of this study was to examine the efficacy of using an electronic tablet to provide patient education for flushing peripherally inserted central catheters (PICCs) as a way to reduce the incidence of occlusion. Eleven patients, newly diagnosed with cancer, participated in a pilot study that used a video on PICC flushing and remote coaching using FaceTime (Apple, Cupertino, CA) to teach patients how to maintain their PICCs in their homes. At the end of the 6-week intervention, no adverse outcomes (occlusions or infections) were noted among the patients who participated in the study.

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus

PubMed Central

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-01-01

Background Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). Results Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. Conclusion Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury. PMID:15679916

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus.

PubMed

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-10-26

BACKGROUND: Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). RESULTS: Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. CONCLUSION: Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury.

Is home-based palliative care cost-effective? An economic evaluation of the Palliative Care Extended Packages at Home (PEACH) pilot.

PubMed

McCaffrey, Nikki; Agar, Meera; Harlum, Janeane; Karnon, Jonathon; Currow, David; Eckermann, Simon

2013-12-01

The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home. Economic evaluation of a pilot randomised controlled trial with 28 days follow-up. Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home (PEACH) and usual care arms including: days at home; place of death; PEACH intervention costs; specialist palliative care service use; acute hospital and palliative care unit inpatient stays; and outpatient visits. PEACH mean intervention costs per patient ($3489) were largely offset by lower mean inpatient care costs ($2450) and in this arm, participants were at home for one additional day on average. Consequently, PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $1068, or $2547 if only within-study days of hospital admission are costed. All estimates are high uncertainty. The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care. Findings support the feasibility of conducting a definitive, fully powered study with longer follow-up and comprehensive economic evaluation.

Diagnosing upper extremity deep vein thrombosis with non-contrast-enhanced Magnetic Resonance Direct Thrombus Imaging: A pilot study.

PubMed

Dronkers, C E A; Klok, F A; van Haren, G R; Gleditsch, J; Westerlund, E; Huisman, M V; Kroft, L J M

2018-03-01

Diagnosing upper extremity deep vein thrombosis (UEDVT) can be challenging. Compression ultrasonography is often inconclusive because of overlying anatomic structures that hamper compressing veins. Contrast venography is invasive and has a risk of contrast allergy. Magnetic Resonance Direct Thrombus Imaging (MRDTI) and Three Dimensional Turbo Spin-echo Spectral Attenuated Inversion Recovery (3D TSE-SPAIR) are both non-contrast-enhanced Magnetic Resonance Imaging (MRI) sequences that can visualize a thrombus directly by the visualization of methemoglobin, which is formed in a fresh blood clot. MRDTI has been proven to be accurate in diagnosing deep venous thrombosis (DVT) of the leg. The primary aim of this pilot study was to test the feasibility of diagnosing UEDVT with these MRI techniques. MRDTI and 3D TSE-SPAIR were performed in 3 pilot patients who were already diagnosed with UEDVT by ultrasonography or contrast venography. In all patients, UEDVT diagnosis could be confirmed by MRDTI and 3D TSE-SPAIR in all vein segments. In conclusion, this study showed that non-contrast MRDTI and 3D TSE-SPAIR sequences may be feasible tests to diagnose UEDVT. However diagnostic accuracy and management studies have to be performed before these techniques can be routinely used in clinical practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Language of Engagement: "Aha!" Moments from Engaging Patients and Community Partners in Two Pilot Projects of the Patient-Centered Outcomes Research Institute.

PubMed

Tai-Seale, Ming; Sullivan, Greer; Cheney, Ann; Thomas, Kathleen; Frosch, Dominick

2016-01-01

Compared with people living in the community, researchers often have different frameworks or paradigms for thinking about health and wellness. These differing frameworks are often accompanied by differences in terminology or language. The purpose of this commentary is to describe some of our "Aha!" moments from conducting two pilot studies funded by the Patient-Centered Outcomes Research Institute. Over time, we came to understand how our language and word choices may have been acting as a wedge between ourselves and our community research partners. We learned that fruitful collaborative work must attend to the creation of a common language, which we refer to as the language of engagement. Such patient-centered language can effectively build a bridge between researchers and community partners. We encourage other researchers to think critically about their cultural competency, to be mindful of the social power dynamics between patient and physician, to reflect on how their understanding might differ from those of their patient partners, and to find ways to use a common language that engages patients and other community partners.

Laser ablation and 131-iodine: a 24-month pilot study of combined treatment for large toxic nodular goiter.

PubMed

Chianelli, M; Bizzarri, G; Todino, V; Misischi, I; Bianchini, A; Graziano, F; Guglielmi, R; Pacella, C M; Gharib, H; Papini, E

2014-07-01

It is normally recognized that the preferred treatment in large toxic thyroid nodules should be thyroidectomy. The aim of the study was to assess the efficacy of combined laser ablation treatment (LAT) and radioiodine 131 (131I) treatment of large thyroid toxic nodules with respect to rapidity of control of local symptoms, of hyperthyroidism, and of reduction of administered 131I activity in patients at refusal or with contraindications to surgery. We conducted a pilot study at a single center specializing in thyroid care. Fifteen patients were treated with LAT, followed by 131I (group A), and a series of matched consecutive patients were treated by 131I only (group B). Laser energy was delivered with an output power of 3 W (1800 J per fiber per treatment) through two 75-mm, 21-gauge spinal needles. Radioiodine activity was calculated to deliver 200 Gy to the hyperfunctioning nodule. Thyroid function, thyroid peroxidase antibody, thyroglobulin antibody, ultrasound, and local symptoms were measured at baseline and up to 24 months. Nodule volume reduction at 24 months was: 71.3 ± 13.4 vs 47.4 ± 5.5%, group A (LAT+131I) vs group B (131I), respectively; P < .001). In group A (LAT+131I), a reduction in radioiodine-administered activity was obtained (-21.1 ± 8.1%). Local symptom score demonstrated a more rapid reduction in group A (LAT+131I). In three cases, no 131I treatment was needed after LAT. In this pilot study, combined LAT/131I treatment induced faster and greater improvement of local and systemic symptoms compared to 131I only. This approach seems a possible alternative to thyroidectomy in patients at refusal of surgery.

A Randomized, Placebo-Controlled Pilot Study of Quetiapine-XR Monotherapy or Adjunctive Therapy to Antidepressant in Acute Major Depressive Disorder with Current Generalized Anxiety Disorder.

PubMed

Li, Ranran; Wu, Renrong; Chen, Jun; Kemp, David E; Ren, Ming; Conroy, Carla; Chan, Philip; Serrano, Mary Beth; Ganocy, Stephen J; Calabrese, Joseph R; Gao, Keming

2016-03-01

To pilot efficacy and safety data of quetiapine-XR monotherapy or adjunctive therapy to antidepressant(s) in the acute treatment of MDD with current generalized anxiety disorder (GAD). The Mini International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. Changes from baseline to endpoint in Hamilton Depression Rating Scale-17 items (HAMD-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Quick Inventory of Depression Symptomatology-16 items Self-Report (QIDS-16-SR) total scores, and other outcome measures were analyzed with the last observation carried forward strategy and/or mixed-effects modeling for repeated measures. Of the 34 patients screened, 23 patients were randomized to receive quetiapine-XR (n = 11) or placebo (n = 12), with 5 and 4 completing the study, respectively. The mean dose of quetiapine-XR was 154 ± 91 mg/d. The change from baseline to endpoint in the total scores of HAMD-17, HAM-A, QIDS-16-SR, and CGI-S were significant in the quetiapine-XR group, but only the change in HAM-A total score was significant in the placebo group. The differences in these changes between the two groups were only significant in CGI-S scores, with the rest of numerical larger in the quetiapine-XR group. The most common side effects from quetiapine-XR were dry mouth, somnolence/sedation, and fatigue. In this pilot study, quetiapine-XR was numerically superior to placebo in reducing depressive and anxiety symptoms in patients with MDD and current GAD. Large sample studies are warranted to support or refute these preliminary findings.

Cognitive Behavioral Therapy Using a Mobile Application Synchronizable With Wearable Devices for Insomnia Treatment: A Pilot Study

PubMed Central

Kang, Seung-Gul; Kang, Jae Myeong; Cho, Seong-Jin; Ko, Kwang-Pil; Lee, Yu Jin; Lee, Heon-Jeong; Kim, Leen; Winkelman, John W.

2017-01-01

Study Objectives: The use of telemedicine with a mobile application (MA) and a wearable device (WD) for the management of sleep disorders has recently received considerable attention. We designed an MA synchronizable with a WD for insomnia treatment. Our pilot study determined the efficacy of simplified group cognitive behavioral therapy for insomnia (CBT-I) delivered using our MA and assessed participant adherence to and satisfaction with the device. Methods: The efficacy of the CBT-I using MA (CBT-I-MA) was assessed by comparing sleep variables (sleep efficiency [SE], Insomnia Severity Index [ISI], and Pittsburgh Sleep Quality Inventory [PSQI] scores) before and after a 4-week treatment protocol in 19 patients with insomnia disorder patients. SE was assessed using a sleep diary, actigraphy, and the PSQI. Results: The intervention significantly improved all three measures of SE (P < .05), and the response rate to treatment was high (94.7%). Total ISI and PSQI scores and sleep latency, as measured by the sleep diary, improved significantly. Participants showed relatively good adherence to our MA, and sleep diary entries were made on 24.3 ± 3.8 of 28 days. Moreover, 94.7% of the participants reported that our MA was effective for treating insomnia. Conclusions: Our pilot study suggested the clinical usefulness of a CBT-I-MA. We expect that our findings will lead to further development and replication studies of CBT-I-MA. Citation: Kang SG, Kang JM, Cho SJ, Ko KP, Lee YJ, Lee HJ, Kim L, Winkelman JW. Cognitive behavioral therapy using a mobile application synchronizable with wearable devices for insomnia treatment: a pilot study. J Clin Sleep Med. 2017;13(4):633–640. PMID:28162145

Music for surgical abortion care study: a randomized controlled pilot study.

PubMed

Wu, Justine; Chaplin, William; Amico, Jennifer; Butler, Mark; Ojie, Mary Jane; Hennedy, Dina; Clemow, Lynn

2012-05-01

The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; p<.05). Both groups reported similarly high satisfaction scores. There were no group differences in pain. Music as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain. Copyright © 2012 Elsevier Inc. All rights reserved.

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

PubMed

McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings. Clinicaltrials.gov Identifier: NCT02791048.

Simulated Conversations With Virtual Humans to Improve Patient-Provider Communication and Reduce Unnecessary Prescriptions for Antibiotics: A Repeated Measure Pilot Study

PubMed Central

2017-01-01

Background Despite clear evidence that antibiotics do not cure viral infections, the problem of unnecessary prescribing of antibiotics in ambulatory care persists, and in some cases, prescribing patterns have increased. The overuse of antibiotics for treating viral infections has created numerous economic and clinical consequences including increased medical costs due to unnecessary hospitalizations, antibiotic resistance, disruption of gut bacteria, and obesity. Recent research has underscored the importance of collaborative patient-provider communication as a means to reduce the high rates of unnecessary prescriptions for antibiotics. However, most patients and providers do not feel prepared to engage in such challenging conversations. Objectives The aim of this pilot study was to assess the ability of a brief 15-min simulated role-play conversation with virtual humans to serve as a preliminary step to help health care providers and patients practice, and learn how to engage in effective conversations about antibiotics overuse. Methods A total of 69 participants (35 providers and 34 patients) completed the simulation once in one sitting. A pre-post repeated measures design was used to assess changes in patients’ and providers’ self-reported communication behaviors, activation, and preparedness, intention, and confidence to effectively communicate in the patient-provider encounter. Changes in patients’ knowledge and beliefs regarding antibiotic use were also evaluated. Results Patients experienced a short-term positive improvement in beliefs about appropriate antibiotic use for infection (F1,30=14.10, P=.001). Knowledge scores regarding the correct uses of antibiotics improved immediately postsimulation, but decreased at the 1-month follow-up (F1,30=31.16, P<.001). There was no change in patient activation and shared decision-making (SDM) scores in the total sample of patients (P>.10) Patients with lower levels of activation exhibited positive, short-term benefits in increased intent and confidence to discuss their needs and ask questions in the clinic visit, positive attitudes regarding participation in SDM with their provider, and accurate beliefs about the use of antibiotics (P<.10). The results also suggest small immediate gains in providers’ attitudes about SDM (mean change 0.20; F1,33= 8.03, P=.01). Conclusions This pilot study provided preliminary evidence on the efficacy of the use of simulated conversations with virtual humans as a tool to improve patient-provider communication (ie, through increasing patient confidence to actively participate in the visit and physician attitudes about SDM) for engaging in conversations about antibiotic use. Future research should explore if repeated opportunities to use the 15-min simulation as well as providing users with several different conversations to practice with would result in sustained improvements in antibiotics beliefs and knowledge and communication behaviors over time. The results of this pilot study offered several opportunities to improve on the simulation in order to bolster communication skills and knowledge retention. PMID:28428160