[Analysis of palliative sedation in hospitalised elderly patients: Effectiveness of a protocol].

Science.gov (United States)

Mateos-Nozal, Jesús; García-Cabrera, Lorena; Montero Errasquín, Beatriz; Cruz-Jentoft, Alfonso José; Rexach Cano, Lourdes

2016-01-01

To measure changes in the practice of palliative sedation during agony in hospitalised elderly patients before and after the implementation of a palliative sedation protocol. A retrospective before-after study was performed in hospitalised patients over 65 years old who received midazolam during hospital admission and died in the hospital in two 3-month periods, before and after the implementation of the protocol. Non-sedative uses of midazolam and patients in intensive care were excluded. Patient and admission characteristics, the consent process, withdrawal of life-sustaining treatments, and the sedation process (refractory symptom treated, drug doses, assessment and use of other drugs) were recorded. Association was analysed using the Chi(2) and Student t tests. A total of 143 patients were included, with no significant differences between groups in demographic characteristics or symptoms. Do not resuscitate (DNR) orders were recorded in approximately 70% of the subjects of each group, and informed consent for sedation was recorded in 91% before vs. 84% after the protocol. Induction and maintenance doses of midazolam followed protocol recommendations in 1.3% before vs 10.4% after the protocol was implemented (P=.02) and adequate rescue doses were used in 1.3% vs 11.9% respectively (P=.01). Midazolam doses were significantly lower (9.86mg vs 18.67mg, Psedation score was used in 8% vs. 12% and the Palliative Care Team was involved in 35.5% and 16.4% of the cases (P=.008) before and after the protocol, respectively. Use of midazolam slightly improved after the implementation of a hospital protocol on palliative sedation. The percentage of adequate sedations and the general process of sedation were mostly unchanged by the protocol. More education and further assessment is needed to gauge the effect of these measures in the future. Copyright © 2015 SEGG. Published by Elsevier Espana. All rights reserved.

A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer.

Science.gov (United States)

Hawley, Philippa Helen; Byeon, Jai Jun

2008-05-01

Constipation is a common and distressing condition in patients with cancer, especially those taking opioid analgesics. Many institutions prevent and treat constipation with titrated laxatives, which is known as a bowel protocol. An effective and well-tolerated bowel protocol is a very important component of cancer care, and there is little evidence on which to base selection of the most appropriate agents. This study compares a protocol of the stimulant laxative sennosides alone with a protocol of sennosides plus the stool softener docusate, in hospitalized patients at an oncology center. The docusate-containing protocol had an initial docusate-only step for patients not taking opioids, and four to six 100-mg capsules of docusate sodium in addition to the sennosides for the rest of the protocol. Thirty patients received the sennosides-only (S) protocol and 30 the sennosides plus docusate (DS) protocol. The efficacy and adverse effects of the protocols were monitored for 5-12 days. The two protocols were used sequentially, creating two cohorts, one on each protocol. Eighty percent of patients were taking oral opioids and 72% were admitted for symptom control/supportive care. Over a total of 488 days of observation it was found that the S protocol produced more bowel movements than the DS protocol, and in the symptom control/supportive care patients this difference was statistically significant (p sennosides did not reduce bowel cramps, and was less effective in inducing laxation than the sennosides-only protocol. Further research into the appropriate use of docusate and into the details of bowel protocol design are required.

Examining recombinant human TSH primed 131I therapy protocol in patients with metastatic differentiated thyroid carcinoma: comparison with the traditional thyroid hormone withdrawal protocol

International Nuclear Information System (INIS)

Rani, Deepa; Kaisar, Sushma; Awasare, Sushma; Kamaldeep; Abhyankar, Amit; Basu, Sandip

2014-01-01

Recombinant human thyroid-stimulating hormone (rhTSH)-based protocol is a promising recent development in the management of differentiated thyroid carcinoma (DTC). The objectives of this prospective study were: (1) to assess the feasibility and efficacy of the rhTSH primed 131 I therapy protocol in patients with DTC with distant metastatic disease, (2) to perform lesional dosimetry in this group of patients compared to the traditional protocol, (3) to document the practical advantages (patient symptoms and hospital stay) of the rhTSH protocol compared to the traditional thyroid hormone withdrawal protocol, (4) to document and record any adverse effect of this strategy, (5) to compare the renal function parameters, and (6) to compare the serum TSH values achieved in either of the protocols in this group of patients. The study included 37 patients with metastatic DTC having lung or skeletal metastases or both. A comparison of lesional radiation absorbed dose, hospital stay, renal function tests, and symptom profile was undertaken between the traditional thyroid hormone withdrawal protocol and rhTSH-based therapy protocol. Dosimetric calculations of metastatic lesions were performed using lesion uptake and survey meter readings for calculation of effective half-life. Non-contrast-enhanced CT was used for assessment of tumor volume. Quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL forms. A comparison of pretreatment withdrawal thyroglobulin (TG) was done with the withdrawal TG level 3 months after treatment. The mean effective half-life of 131 I in metastatic lesions was less during the rhTSH protocol (29.49 h) compared to the thyroid hormone withdrawal protocol (35.48 h), but the difference was not statistically significant (p = 0.056). The mean 24-h % uptake of the lesions during the traditional protocol (4.84 %) was slightly higher than the 24-h % uptake during the rhTSH protocol (3.56 %), but the

Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients.

Science.gov (United States)

Chan, Kevin; Moran, John; Hlatky, Mark; Lafayette, Richard

2009-06-01

Anemia management remains complicated in patients with endstage renal disease on hemodialysis. We wished to evaluate the effect of protocol adherence to EPO and intravenous iron dosing on achieving the desired range of hemoglobin levels. A cohort of hemodialysis patients was studied to evaluate the rate of adherence to EPO and iron dosing protocols over a 5 month period. A database was completed to evaluate all known comorbidities, demographic factors, and facility issues that might affect hemoglobin levels. A logistic regression model was employed to evaluate the effect of adherence to the anemia protocols on the probability of achieving a hemoglobin level below, within or above the targeted range of 11-12.5 g/dl. Among 2114 patients, we found that adherence to both the EPO and iron dosing protocol resulted in the greatest probability of achieving the target hemoglobin range (56 +/- 5% in anemia protocol adherent patients versus 42 +/- 7% in non adherent patients). This was predominantly due to a lowered risk of having above target hemoglobin levels rather than below. The use of the anemia protocols was associated with lower rates of hospitalization (9 +/- 0.7 visits/100 months in adherent group vs 15 +/- 2 in non adherent group) and lower utilization of both EPO and intravenous iron. Furthermore, patients in the adherent groups had less variability of their hemoglobin levels month by month, at least as judged by standard deviation. Adherence to anemia protocols, as practiced in the dialysis units included in this cohort, may improve hemodialysis patients' ability to achieve target hemoglobin levels, and by avoiding above target hemoglobin values, lower drug utilization and reduce variability of hemoglobin levels.

Coping-Infused Dialogue through Patient-Preferred Live Music: A Medical Music Therapy Protocol and Randomized Pilot Study for Hospitalized Organ Transplant Patients.

Science.gov (United States)

Hogan, Tyler James; Silverman, Michael J

2015-01-01

Solid organ transplant patients often experience a variety of psychosocial stressors that can lead to distress and may hinder successful recovery. Using coping-infused dialogue (CID) through patient- preferred live music (PPLM) music therapy sessions may improve mood and decrease pain while also imparting psychoeducational knowledge concerning the identification of local and global problems and coping skills. The purpose of this pilot study was to develop a coping-based medical music therapy protocol that combines coping-infused dialogue (CID) with patient-preferred live music (PPLM) and measure the effects of the resulting CID-PPLM protocol on mood (positive and negative affect) and pain in hospitalized transplant patients. Our study used a pre-/posttest single-session wait-list control design. Participants (N=25) were randomly assigned to experimental (CID-PPLM) or control (usual care) conditions. Participants in the CID-PPLM condition received a single 30-minute session that integrated stressor identification and knowledge of coping skills (CID) with patient-preferred live music (PPLM). Results indicated no between-group differences at pretest and significant correlations between pre- and posttest measures. Concerning posttest ANCOVA analyses, there were significant between-group differences in positive affect, negative affect, and pain, with experimental participants having more favorable posttest scores than control participants. Effect sizes were in the medium-to-large range for positive affect (η2=.198), negative affect (η2=.422), and pain (η2=.303). CID through receptive PPLM may be an effective protocol for improving mood and decreasing pain in organ transplant recipients. MT interventions can be an important tool to develop rapport and enhance outcomes with patients. As greater engagement during interventions may have stronger treatment effects, we recommend future research examining patient engagement as a potential mediator of intervention effects

Nursing intervention protocol for adult patients experiencing chronic low back pain

Directory of Open Access Journals (Sweden)

Nadia Mohamed Taha

2015-12-01

Full Text Available Aim: The aim of this study was to evaluate the effectiveness of a nursing intervention protocol targeting the knowledge and practice of adult patients experiencing low back pain. Design: A quasi-experimental research design. Methods: Pre-post assessment of outcome was used in this study. The study was conducted in the outpatient clinic of the physical therapy department at Zagazig University Hospital and Beni-Suef University Hospital, Egypt. Sample: 40 participants diagnosed with chronic low back pain (lasting for longer than six months. Seven of the 40 dropped out during the follow-up phase for personal or logistical reasons. Tools included sections for demographic characteristics, knowledge and practice assessment; in addition to the Oswestry Disability Index, and Visual Analogue Scale (VAS. Results: The application of an instruction protocol intervention for low back pain was effective in improving patient knowledge and practice, with associated amelioration of the severity of pain and disability among them. The effect was still apparent at the three-month follow-up. Conclusion: It is recommended that the study be replicated using a more robust randomized clinical trial design. Nonetheless, the instruction protocol with the designed booklet may be adopted as an element of the care services offered to patients suffering LBP, given the clear positive effects on patient knowledge, which would undoubtedly help them decide on the most preferential management approach.

Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation

DEFF Research Database (Denmark)

Møller, M H; Adamsen, S; Thomsen, R W

2011-01-01

Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU.......Morbidity and mortality rates in patients with perforated peptic ulcer (PPU) remain substantial. The aim of the present study was to evaluate the effect of a multimodal and multidisciplinary perioperative care protocol on mortality in patients with PPU....

Examining recombinant human TSH primed {sup 131}I therapy protocol in patients with metastatic differentiated thyroid carcinoma: comparison with the traditional thyroid hormone withdrawal protocol

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Rani, Deepa; Kaisar, Sushma; Awasare, Sushma; Kamaldeep; Abhyankar, Amit; Basu, Sandip [Bhabha Atomic Research Centre (BARC), Radiation Medicine Centre, Mumbai (India)

2014-09-15

Recombinant human thyroid-stimulating hormone (rhTSH)-based protocol is a promising recent development in the management of differentiated thyroid carcinoma (DTC). The objectives of this prospective study were: (1) to assess the feasibility and efficacy of the rhTSH primed {sup 131}I therapy protocol in patients with DTC with distant metastatic disease, (2) to perform lesional dosimetry in this group of patients compared to the traditional protocol, (3) to document the practical advantages (patient symptoms and hospital stay) of the rhTSH protocol compared to the traditional thyroid hormone withdrawal protocol, (4) to document and record any adverse effect of this strategy, (5) to compare the renal function parameters, and (6) to compare the serum TSH values achieved in either of the protocols in this group of patients. The study included 37 patients with metastatic DTC having lung or skeletal metastases or both. A comparison of lesional radiation absorbed dose, hospital stay, renal function tests, and symptom profile was undertaken between the traditional thyroid hormone withdrawal protocol and rhTSH-based therapy protocol. Dosimetric calculations of metastatic lesions were performed using lesion uptake and survey meter readings for calculation of effective half-life. Non-contrast-enhanced CT was used for assessment of tumor volume. Quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QOL forms. A comparison of pretreatment withdrawal thyroglobulin (TG) was done with the withdrawal TG level 3 months after treatment. The mean effective half-life of {sup 131}I in metastatic lesions was less during the rhTSH protocol (29.49 h) compared to the thyroid hormone withdrawal protocol (35.48 h), but the difference was not statistically significant (p = 0.056). The mean 24-h % uptake of the lesions during the traditional protocol (4.84 %) was slightly higher than the 24-h % uptake during the rhTSH protocol (3.56 %), but

A SAFE PROTOCOL FOR RAPID DESENSITIZATION IN PATIENTS WITH CYSTIC FIBROSIS AND ANTIBIOTIC HYPERSENSITIVITY

Science.gov (United States)

Legere, Henry J.; Palis, Ross I.; Bouza, Tito Rodriguez; Uluer, Ahmet Z.; Castells, Mariana C.

2009-01-01

Background CF patients often demonstrate hypersensitivity to one or multiple antibiotics due to frequent and repeated exposures. Attempts at antibiotic desensitization in this population are historically complicated by higher reaction rates, failure to complete the procedure and consequent withholding of first-line therapy. This study evaluates the outcomes of a rapid desensitization protocol developed at our institution. Methods We retrospectively reviewed the medical records of 15 patients undergoing 52 rapid antibiotic desensitizations at Brigham and Women’s Hospital and Children’s Hospital Boston utilizing our protocol. Results Mean FEV1 % predicted was 44.1 (SD 16.5), with two patients at desensitized during bilateral lung transplantation. Adverse reactions during desensitization occurred in 13.4%, and most were mild. 100% of patients completed the protocol and ultimately tolerated subsequent full-strength antibiotic courses. Conclusions CF patients with antibiotic hypersensitivity can safely receive first-line antibiotics via our rapid desensitization protocol, including those with severe obstructive lung disease. PMID:19740711

Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study.

Science.gov (United States)

Ethier, Cheryl; Burry, Lisa; Martinez-Motta, Carlos; Tirgari, Sam; Jiang, Depeng; McDonald, Ellen; Granton, John; Cook, Deborah; Mehta, Sangeeta

2011-04-01

Analgesics and sedatives are integral for the relief of pain and anxiety in critically ill patients. However, these agents may contribute to amnesia for intensive care unit (ICU) events; which has been associated with development of posttraumatic stress disorder. Drug administration strategies that minimize sedative use have been associated with less amnesia. The objective of this pilot study was to evaluate recall of ICU stay in patients managed with 2 sedation strategies: a sedation protocol or a combination of sedation protocol and daily sedative/analgesic interruption. A questionnaire was administered on day 3 following ICU discharge to evaluate patients' recollections of pain, anxiety, fear, and sleep, as well as memories for specific ICU procedures. Participants were ICU survivors who had been enrolled in SLEAP - a randomized pilot trial comparing two sedation strategies, at 3 university-affiliated medical/surgical ICUs. Twenty-one patients who regained orientation within 72 hours of ICU discharge completed the questionnaire. More than 50% of patients recalled experiencing pain, anxiety, and fear to a moderate or extreme extent; and 57% reported inadequate sleep while in the ICU. Of the 21 patients, 48%, 33%, and 29% had no memories of endotracheal tube suctioning, being on a "breathing machine," and being bathed, respectively. A notable percentage of patients discharged from the ICU report moderate to extreme pain, anxiety, and fear, and inability to sleep during their ICU stay; and 29% to 48% have no recall of specific ICU events. Copyright © 2011 Elsevier Inc. All rights reserved.

Clinical benefits after the implementation of a multimodal perioperative protocol in elderly patients.

Science.gov (United States)

Aguilar-Nascimento, José Eduardo de; Salomão, Alberto Bicudo; Caporossi, Cervantes; Diniz, Breno Nadaf

2010-01-01

Multimodal protocol of perioperative care may enhance recovery after surgery. Based on evidence these new routines of perioperative care changed conventional prescriptions in surgery. To evaluate the results of a multimodal protocol (ACERTO protocol) in elderly patients. Non-randomized historical cohort study was performed at the surgical ward of a tertiary university hospital. One hundred seventeen patients aged 60 and older were submitted to elective abdominal operations under either conventional (n = 42; conventional group, January 2004-June 2005) or a fast-track perioperative protocol named ACERTO (n = 75; ACERTO group, July 2005-December 2007). Main endpoints were preoperative fasting time, postoperative day of re-feeding, volume of intravenous fluids, length of hospital stay and morbidity. The implantation of the ACERTO protocol was followed by a decrease in both preoperative fasting (15 [8-20] vs 4 [2-20] hours, P<0.001) and postoperative day of refeeding (1st [1st-10th] vs 0 [0-5th] PO day; P<0.01), and intravenous fluids (10.7 [2.5-57.5] vs 2.5 [0.5-82] L, P<0.001). The changing of protocols reduced the mean length of hospital stay by 4 days (6[1-43] vs 2[1-97] days; P = 0.002) and surgical site infection rate by 85.7% (19%; 8/42 vs 2.7%; 2/75, P<0.001; relative risk = 1.20; 95% confidence interval = 1.03-1.39). Per-protocol analysis showed that hospital stay in major operations diminished only in patients who completed the protocol (P<0.01). The implementation of multidisciplinary routines of the ACERTO protocol diminished both hospitalization and surgical site infection in elderly patients submitted to abdominal operations.

Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

Science.gov (United States)

Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B

2017-10-10

The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management

Protocol for the management of psychiatric patients with psychomotor agitation.

Science.gov (United States)

Vieta, Eduard; Garriga, Marina; Cardete, Laura; Bernardo, Miquel; Lombraña, María; Blanch, Jordi; Catalán, Rosa; Vázquez, Mireia; Soler, Victòria; Ortuño, Noélia; Martínez-Arán, Anabel

2017-09-08

Psychomotor agitation (PMA) is a state of motor restlessness and mental tension that requires prompt recognition, appropriate assessment and management to minimize anxiety for the patient and reduce the risk for escalation to aggression and violence. Standardized and applicable protocols and algorithms can assist healthcare providers to identify patients at risk of PMA, achieve timely diagnosis and implement minimally invasive management strategies to ensure patient and staff safety and resolution of the episode. Spanish experts in PMA from different disciplines (psychiatrists, psychologists and nurses) convened in Barcelona for a meeting in April 2016. Based on recently issued international consensus guidelines on the standard of care for psychiatric patients with PMA, the meeting provided the opportunity to address the complexities in the assessment and management of PMA from different perspectives. The attendees worked towards producing a consensus for a unified approach to PMA according to the local standards of care and current local legislations. The draft protocol developed was reviewed and ratified by all members of the panel prior to its presentation to the Catalan Society of Psychiatry and Mental Health, the Spanish Society of Biological Psychiatry (SEPB) and the Spanish Network Centre for Research in Mental Health (CIBERSAM) for input. The final protocol and algorithms were then submitted to these organizations for endorsement. The protocol presented here provides guidance on the appropriate selection and use of pharmacological agents (inhaled/oral/IM), seclusion, and physical restraint for psychiatric patients suspected of or presenting with PMA. The protocol is applicable within the Spanish healthcare system. Implementation of the protocol and the constituent algorithms described here should ensure the best standard of care of patients at risk of PMA. Episodes of PMA could be identified earlier in their clinical course and patients could be managed in

Safety of a "drip and ship" intravenous thrombolysis protocol for patients with acute ischemic stroke.

Science.gov (United States)

Mansoor, Simin; Zand, Ramin; Al-Wafai, Ameer; Wahba, Mervat N; Giraldo, Elias A

2013-10-01

The "drip and ship" approach for intravenous thrombolysis (IVT) is becoming the standard of care for patients with acute ischemic stroke (AIS) in communities without direct access to a stroke specialist. We aimed to demonstrate the safety of our "drip and ship" IVT protocol. This was a retrospective study of patients with AIS treated with IVT between January 2003 and January 2011. Information on patients' baseline characteristics, neuroimaging, symptomatic intracerebral hemorrhage (sICH), and mortality was obtained from our stroke registry. A group of patients were treated with IVT by an emergency physician in phone consultation with a board-certified vascular neurologist (BCVN) at 1 of our 3 stroke network-affiliated hospitals (SNAHs). These patients were subsequently transferred to our Joint Commission-certified primary stroke center (CPSC) after completion of IVT ("drip and ship" protocol). The other patients were treated directly by a BCVN at the CPSC. We studied 201 patients treated with IVT. Of them, 14% received IVT at a SNAH ("drip and ship" protocol) and 86% were treated at the CPSC. There were no significant differences between the 2 groups with regard to age, National Institutes of Health Stoke Scale score, stroke symptom onset-to-needle time, sICH, or in-hospital mortality. Our "drip and ship" protocol for IVT is safe. The protocol was not associated with an excess of sICH or in-hospital mortality compared with patients who received IVT at the CPSC. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Patient-Specific Internal Dosimetry Protocol for 131 treatment of differentiated thyroid cancer

International Nuclear Information System (INIS)

Deluca, G.M.; Rojo, Ana M.; Llina Fuentes, C.S.; Cabrejas, Mariana L.; Cabrejas, R.; Fadel, A.M.

2008-01-01

Full text: The most effective treatment against Differentiated Thyroid Cancer (DTC), in its most frequently types: papillar and follicular, is the administration of radioiodine. As a result of a multidisciplinary work, a dosimetrical protocol for radiological protection purpose has been developed that suggests the standards and formalisms for the determination of absorbed doses due to the administration of 131 I activity to DTC patients. This dosimetrical protocol takes into account individual data of each patient (age, gender, the presence or absence of metastases, physiology, physiopathology, biochemical parameters) and involves clinical aspects, the equipment that should be used and the dose assessment procedure of each treatment. Based on the Medical Internal radiation Dose (MIRD) scheme and considering the major critical organs for this therapy, the dosimetrical protocol states the 'how-to' of the following procedures, in adults and paediatric cases: 1) estimation of the red marrow dose (with/without bone metastases) to avoid mielotoxicity (200 cGy); 2) Estimation of the retention / dose rate / dose in lungs after 48 hours from the administration of radioiodine to avoid lung fibrosis; 3) Estimation of the testes dose in young male patients to avoid oligospermia; 4) Estimation of the maximum activity which can be safely administered without damaging the most critical organ for each patient; and 5) Acquisition of images and retention data from patients. This dosimetrical protocol also specifies the requirements and basic steps that should be followed, the essential information, the complementary studies and the basic equipment required to perform an appropriate internal dosimetry evaluation. To be fully implemented, the dosimetrical protocol needs the constitution of a multidisciplinary team including physicians, medical physicists and technicians. Clear instructions should be provided to the patient as his full collaboration is essential. Even though empirical

Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial.

Science.gov (United States)

Kim, Sungha; Kim, Jae Kyoun; Son, Mi Ju; Kim, Dongwoung; Song, Bongkeun; Son, Ilhong; Kang, Hyung Won; Lee, Jongdeok; Kim, Sungchul

2018-04-13

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that causes paralysis of limb, swallowing, and breathing muscles. Riluzole, the Food and Drug Administration-approved drug for ALS, provides minimal benefit, prolonging patient life by only 2-3 months. Previous studies have found a neuro-protective and anti-neuroinflammatory effect of Mecasin, with retrospective studies providing suggestive evidence for a beneficial effect of Mecasin. The aim of this study was to develop a protocol to determine the proper dosage of Mecasin. This is a phase II-A, multi-center, randomized study with three arms. Thirty-six patients with ALS will be randomly assigned to one of three groups, each receiving the standard treatment with 100 mg of riluzole in addition to one of 1.6 g of Mecasin, 2.4 g of Mecasin, or a placebo. The Primary outcome is the Korean version of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised result after 12 weeks of treatment. Secondary outcomes include results of the Short Form Health Survey-8, Medical Research Council Scale, Visual Analogue Scale for Pain, Hamilton Rating Scale for Depression, Fatigue Severity Scale, Patient Global Impression of Change, pulmonary function test, forced expiratory volume in 1 s and its ratio to forced vital capacity, creatine kinase, and body weight. The frequencies of total adverse events and serious adverse events will be described and documented. The trial protocol has been approved by the Institutional Review Board of the Wonkwang University Gwangju and Sanbon Hospital (2016-5-4 and 2016-34-01, respectively). An Investigational New Drug status (30731) was granted by the Korea Food and Drug Administration. This trial will aim to identify the optimal dosage of Mecasin. Additionally, it will test the efficacy and safety of Mecasin in conjunction with standard treatment, riluzole, for alleviating the functional decline in patients with ALS. Korean National Clinical Trial Registry CRIS; KCT

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

Science.gov (United States)

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol.

Science.gov (United States)

Hargraves, J Lee; Bonollo, Debra; Person, Sharina D; Ferguson, Warren J

2018-04-12

Uncontrolled hypertension is a significant public health problem in the U.S. with about one half of people able to keep blood pressure (BP) under control. Uncontrolled hypertension leads to increased risk of stroke, heart attack, and death. Furthermore, the social and economic costs of poor hypertension control are staggering. People living with hypertension can benefit from additional educational outreach and support. This randomized trial conducted at two Community Health Centers (CHCs) in Massachusetts assessed the effect of community health workers (CHWs) assisting patients with hypertension. In addition to the support provided by CHWs, the study uses video narratives from patients who have worked to control their BP through diet, exercise, and better medication adherence. Participants enrolled in the study were randomly assigned to immediate intervention (I) by CHWs or a delayed intervention (DI) (4 to 6 months later). Each participant was asked to meet with the CHW 5 times (twice in person and three times telephonically). Study outcomes include systolic and diastolic BP, diet, exercise, and body mass index. CHWs working directly with patients, using multiple approaches to support patient self-management, can be effective agents to support change in chronic illness management. Moreover, having culturally appropriate tools, such as narratives available through videos, can be an important, cost effective aid to CHWs. Recruitment and intervention delivery within a busy CHC environment required adaptation of the study design and protocols for staff supervision, data collection and intervention delivery and lessons learned are presented. Clinical Trials.gov registration submitted 8/17/16: Protocol ID# 5P60MD006912-02 and Clinical trials.gov ID# NCT02874547 Community Health Workers Using Patient Stories to Support Hypertension Management. Copyright © 2018. Published by Elsevier Inc.

Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

International Nuclear Information System (INIS)

Deblaere, K.; Vandemaele, P.; Achten, E.; Backes, W.H.; Hofman, P.; Wilmink, J.; Boon, P.A.; Vonck, K.; Boon, P.; Troost, J.; Vermeulen, J.; Aldenkamp, A.

2002-01-01

Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

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Deblaere, K.; Vandemaele, P.; Achten, E. [MRI Department -1 K12, Department of Radiology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Backes, W.H.; Hofman, P.; Wilmink, J. [Department of Neuroradiology, University Hospital Maastricht, Postbus 5800, 6202 AZ Maastricht (Netherlands); Boon, P.A.; Vonck, K. [Department of Neurology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Boon, P. [Department of Medical Psychology, University Hospital Maastricht (Netherlands); Troost, J. [Department of Neurology, University Hospital Maastricht (Netherlands); Vermeulen, J. [S.E.I.N Heemstede, Psychological Laboratory, Achterweg 5, 2103 SW Heemstede (Netherlands); Aldenkamp, A. [Epilepsy Center ' Kempenhaeghe' , Postbus 61, 5900 AB Heeze (Netherlands)

2002-08-01

Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

An efficient RFID authentication protocol to enhance patient medication safety using elliptic curve cryptography.

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Zhang, Zezhong; Qi, Qingqing

2014-05-01

Medication errors are very dangerous even fatal since it could cause serious even fatal harm to patients. In order to reduce medication errors, automated patient medication systems using the Radio Frequency Identification (RFID) technology have been used in many hospitals. The data transmitted in those medication systems is very important and sensitive. In the past decade, many security protocols have been proposed to ensure its secure transition attracted wide attention. Due to providing mutual authentication between the medication server and the tag, the RFID authentication protocol is considered as the most important security protocols in those systems. In this paper, we propose a RFID authentication protocol to enhance patient medication safety using elliptic curve cryptography (ECC). The analysis shows the proposed protocol could overcome security weaknesses in previous protocols and has better performance. Therefore, the proposed protocol is very suitable for automated patient medication systems.

A novel protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery under cardiopulmonary bypass.

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Odaka, Mizuho; Minakata, Kenji; Toyokuni, Hideaki; Yamazaki, Kazuhiro; Yonezawa, Atsushi; Sakata, Ryuzo; Matsubara, Kazuo

2015-08-01

This study aimed to develop and assess the effectiveness of a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. We established a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. This novel protocol was assessed by comparing patients undergoing open heart surgery before (control group; n = 30) and after its implementation (protocol group; n = 31) at Kyoto University Hospital between July 2012 and January 2013. Surgical site infections (SSIs) were observed in 4 control group patients (13.3 %), whereas no SSIs were observed in the protocol group patients (P open heart surgery.

The impact of a chest tube management protocol on the outcome of trauma patients with tube thoracostomy.

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de Abreu, Emanuelle Maria Sávio; Machado, Carla Jorge; Pastore Neto, Mario; de Rezende Neto, João Baptista; Sanches, Marcelo Dias

2015-01-01

to investigate the effect of standardized interventions in the management of tube thoracostomy patients and to assess the independent effect of each intervention. A chest tube management protocol was assessed in a retrospective cohort study. The tube thoracostomy protocol (TTP) was implemented in August 2012, and consisted of: antimicrobial prophylaxis, chest tube insertion in the operating room (OR), admission post chest tube thoracostomy (CTT) in a hospital floor separate from the emergency department (ED), and daily respiratory therapy (RT) sessions post-CTT. The inclusion criteria were, hemodynamic stability, patients between the ages of 15 and 59 years, and injury severity score (ISS) chest wall, lung, and pleura. During the study period 92 patients were managed according to the standardized protocol. The outcomes of those patients were compared to 99 patients treated before the TTP. Multivariate logistic regression analysis was performed to assess the independent effect of each variable of the protocol on selected outcomes. Demographics, injury severity, and trauma mechanisms were similar among the groups. As expected, protocol compliance increased after the implementation of the TTP. There was a significant reduction (pchest tube days. Respiratory therapy was independently linked to significant reduction (pchest tube insertion was associated with significant (ptrauma patients.

Is extended biopsy protocol justified in all patients with suspected ...

African Journals Online (AJOL)

2012-01-03

Jan 3, 2012 ... Objective: To determine the significance of an extended 10-core transrectal biopsy protocol in different categories of patients with suspected prostate cancer using digital guidance. Materials and Methods: We studied 125 men who were being evaluated for prostate cancer. They all had an extended.

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

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Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

Optic neuritis in paediatric patients: Experience over 27 years and a management protocol.

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Monge Galindo, L; Martínez de Morentín, A L; Pueyo Royo, V; García Iñiguez, J P; Sánchez Marco, S; López-Pisón, J; Peña-Segura, J L

2018-03-08

In this article, we present our experience on optic neuritis (ON) and provide a diagnostic/therapeutic protocol, intended to rule out other aetiologies (particularly infection), and a fact sheet for parents. We conducted a descriptive, retrospective study of patients with ON over a 27-year period (1990-2017). A review of the available scientific evidence was performed in order to draft the protocol and fact sheet. Our neuropaediatrics department has assessed 20,744 patients in the last 27 years, of whom 14 were diagnosed with ON: 8 had isolated ON, 1 had multiple sclerosis (MS), 1 had clinically isolated syndrome (CIS), 3 had acute disseminated encephalomyelitis, and 1 had isolated ON and a history of acute disseminated encephalomyelitis one year previously. Patients' age range was 4-13 years; 50% were boys. Eight patients were aged over 10: 7 had isolated ON and 1 had MS. Nine patients had bilateral ON, and 3 had retrobulbar ON. MRI results were normal in 7 patients and showed involvement of the optic nerve only in 2 patients and optic nerve involvement + central nervous system demyelination in 5. Thirteen patients received corticosteroids. One patient had been vaccinated against meningococcus-C the previous month. Progression was favourable, except in the patient with MS. A management protocol and fact sheet are provided. ON usually has a favourable clinical course. In children aged older than 10 years with risk factors for MS or optic neuromyelitis (hyperintensity on brain MRI, oligoclonal bands, anti-NMO antibody positivity, ON recurrence), the initiation of immunomodulatory treatment should be agreed with the neurology department. The protocol is useful for diagnostic decision-making, follow-up, and treatment of this rare disease with potentially major repercussions. The use of protocols and fact sheets is important. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Qualitative approach to patient-reported outcomes in oncology: protocol of a French study.

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Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

2015-07-10

The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients' eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients' perspectives about the care they receive, as well as families' and doctors' perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and divergences of these perspectives and how to address the needs of all

Feasibility and radiation dose of high-pitch acquisition protocols in patients undergoing dual-source cardiac CT.

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Sommer, Wieland H; Albrecht, Edda; Bamberg, Fabian; Schenzle, Jan C; Johnson, Thorsten R; Neumaier, Klement; Reiser, Maximilian F; Nikolaou, Konstatin

2010-12-01

The objective of this study was to compare image quality and radiation dose between high-pitch and established retrospectively and prospectively gated cardiac CT protocols using an Alderson-Rando phantom and a set of patients. An anthropomorphic Alderson-Rando phantom equipped with thermoluminiscent detectors and a set of clinical patients underwent the following cardiac CT protocols: high-pitch acquisition (pitch 3.4), prospectively triggered acquisition, and retrospectively gated acquisition (pitch 0.2). For patients with sinus rhythm below 65 beats per minute (bpm), high-pitch protocol was used, whereas for patients in sinus rhythm between 65 and 100 bpm, prospective triggering was used. Patients with irregular heart rates or heart rates of ≥ 100 bpm, were examined using retrospectively gated acquisition. Evaluability of coronary artery segments was determined, and effective radiation dose was derived from the phantom study. In the phantom study, the effective radiation dose as determined with thermoluminescent detector (TLD) measurements was lowest in the high-pitch acquisition (1.21, 3.12, and 11.81 mSv, for the high-pitch, the prospectively triggered, and the retrospectively gated acquisition, respectively). There was a significant difference with respect to the percentage of motion-free coronary artery segments (99%, 87%, and 92% for high-pitch, prospectively triggered, and retrospectively gated, respectively (p pitch protocol (p pitch scans have the potential to reduce radiation dose up to 61.2% and 89.8% compared with prospectively triggered and retrospectively gated scans. High-pitch protocols lead to excellent image quality when used in patients with stable heart rates below 65 bpm.

Is extended biopsy protocol justified in all patients with suspected ...

African Journals Online (AJOL)

Objective: To determine the significance of an extended 10-core transrectal biopsy protocol in different categories of patients with suspected prostate cancer using digital guidance. Materials and Methods: We studied 125 men who were being evaluated for prostate cancer. They all had an extended 10-core digitally guided ...

Breaking bad news-what patients want and what they get: evaluating the SPIKES protocol in Germany.

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Seifart, C; Hofmann, M; Bär, T; Riera Knorrenschild, J; Seifart, U; Rief, W

2014-03-01

Evaluation of the SPIKES protocol, a recommended guideline for breaking bad news, is sparse, and information about patients' preferences for bad-news delivery in Germany is lacking. Being the first actual-theoretical comparison of a 'breaking bad news' guideline, the present study evaluates the recommended steps of the SPIKES protocol. Moreover, emotional consequences and quality of bad-news delivery are investigated. A total of 350 cancer patients answered the MABBAN (Marburg Breaking Bad News Scale), a questionnaire representing the six SPIKES subscales, asking for the procedure, perception and satisfaction of the first cancer disclosure and patient's assign to these items. Only 46.2% of the asked cancer patients are completely satisfied with how bad news had been broken to them. The overall quality is significantly related to the emotional state after receiving bad news (r = -0.261, P bad news were delivered, and the resulting rang list of patients' preferences indicates that the SPIKES protocol do not fully meet the priorities of cancer patients in Germany. It could be postulated that the low satisfaction of patients observed in this study reflects the highly significant difference between patients' preferences and bad-news delivery. Therefore, some adjunctions to the SPIKES protocol should be considered, including a frequent reassurance of listeners' understanding, the perpetual possibility to ask question, respect for prearrangement needs and the conception of bad-news delivery in a two-step procedure.

General Anaesthesia Protocols for Patients Undergoing Electroconvulsive Therapy

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Narayanan, Aravind; Lal, Chandar; Al-Sinawi, Hamed

2017-01-01

Objectives This study aimed to review general anaesthesia protocols for patients undergoing electroconvulsive therapy (ECT) at a tertiary care hospital in Oman, particularly with regards to clinical profile, potential drug interactions and patient outcomes. Methods This retrospective study took place at the Sultan Qaboos University Hospital (SQUH), Muscat, Oman. The electronic medical records of patients undergoing ECT at SQUH between January 2010 and December 2014 were reviewed for demographic characteristics and therapy details. Results A total of 504 modified ECT sessions were performed on 57 patients during the study period. All of the patients underwent a uniform general anaesthetic regimen consisting of propofol and succinylcholine; however, they received different doses between sessions, as determined by the treating anaesthesiologist. Variations in drug doses between sessions in the same patient could not be attributed to any particular factor. Self-limiting tachycardia and hypertension were periprocedural complications noted among all patients. One patient developed aspiration pneumonitis (1.8%). Conclusion All patients undergoing ECT received a general anaesthetic regimen including propofol and succinylcholine. However, the interplay of anaesthetic drugs with ECT efficacy could not be established due to a lack of comprehensive data, particularly with respect to seizure duration. In addition, the impact of concurrent antipsychotic therapy on anaesthetic dose and subsequent complications could not be determined. PMID:28417028

A comparative study of biological and metabolic biomarkers between healthy individuals and patients with acne vulgaris: A cross-sectional study protocol.

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Kim, Kyuseok; Ha, Injin; Kim, Eunok; Kim, Kyunglee

2017-11-01

Acne is a multifactorial dermatosis, which is influenced not only by hormones but also by the biochemical relationship between them and the pilosebaceous unit. Inflammatory cytokines, chemokines, active oxygen, and zinc are known to be associated with the development of acne. Further, steroid metabolism is known as one of the important factors related to sebum secretion and comedone formation in acne. However, there is a lack of studies comparing these human biomarkers between healthy individuals and patients with acne. In particular, no study has investigated the relationship between human biomarkers and patterns of acne yet.The purpose of this study is to investigate diagnostic human biomarkers in acne by comparing the biological and metabolic biomarkers between healthy individuals and patients with acne and identify the relationship between human biomarkers and patterns of acne.This study is a protocol for a cross-sectional study. Forty healthy participants and 60 patients with acne will be recruited at 1 center. We will collect their blood samples and analyze the molecular biological and metabolic biomarkers (cytokines, chemokines, reactive oxygen species, corticotropin-releasing hormone, zinc, amino acid, 1-carbon metabolite, lipid metabolite, etc.). Further, we will administer questionnaires regarding their diet, sleep, stress, and other factors relating to acne and measure their skin elasticity.The study protocol was approved by the Institutional Review Board of Oriental Medical Hospital at Kyung Hee Medical Center (KOMCIRB-161118-HR-062). Written informed consent will be obtained from all the participants. The trial was registered in the Clinical Research Information Service, Republic of Korea: KCT0002212.This trial will provide evidence regarding diagnostic human biomarkers in acne and the relationship between the human biomarkers and patterns of acne.

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

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Kate Fetterplace

2018-02-01

Full Text Available Abstract Background 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. Methods 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. Discussion 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. Trial registration

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

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Kim, Mikyung; Kim, Jung-Eun; Lee, Hye-Yoon; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Kim, Bo-Kyung; Cho, Jung Hyo; Kim, Joo-Hee

2017-08-11

Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep. This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment. This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences. KCT0002162; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated

Teamwork in Trauma: System Adjustment to a Protocol for the Management of Multiply Injured Patients.

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Vallier, Heather A; Moore, Timothy A; Como, John J; Dolenc, Andrea J; Steinmetz, Michael P; Wagner, Karl G; Smith, Charles E; Wilczewski, Patricia A

2015-11-01

We developed a protocol to determine the timing of definitive fracture care based on the adequacy of resuscitation. Inception of this project required a multidisciplinary group, including physicians from anesthesiology, general trauma and critical care, neurosurgery, orthopaedic spine, and orthopaedic trauma. The purposes of this study were to review our initial experience with adherence to protocol recommendations and to assess barriers to implementation. Prospective. Level 1 trauma center. Definitive fixation of pelvis, acetabulum, spine, and femur fractures within 36 hours of injury, based on laboratory parameters for acidosis. Three hundred five consecutive skeletally mature patients with Injury Severity Score ≥ 16 (mean, 26.4) and 346 fractures of the proximal or diaphyseal femur (n = 152), pelvic ring (n = 56), acetabulum (n = 44), and/or spine (n = 94) were treated surgically. Adherence to the protocol was defined as definitive fixation within 36 hours of injury in resuscitated patients. All patients were adequately resuscitated within that time. Patient demographic and injury characteristics, date and time of presentation, and reasons for delay were recorded. Two hundred fifty-one patients (82%) with 287 fractures were treated according to the protocol, whereas 54 patients (18%) with 59 fractures were definitively stabilized on a delayed basis (mean, 90 hours). Delay was not related to patient age, Injury Severity Score, day of week, or time of presentation. Before implementation of this protocol, 76% were treated on a delayed basis, demonstrating improvement for each fracture type: spine (79% of previous patients with delay), pelvis (57%), acetabulum (72%), and femur (22%); all P < 0.0001 for more frequently delayed surgery before the protocol. Surgeon choice to delay the procedure accounted for 67% of reasons for delay. Other reasons included intensivist choice (13%), operating room availability (7.4%), patient choice (3.7%), severe head injury (5

Economic evaluation of a clinical protocol for diagnosing emergency patients with suspected pulmonary embolism

Directory of Open Access Journals (Sweden)

Wolfe Rory

2006-06-01

Full Text Available Abstract Background The objective of this paper is to estimate the amount of cost-savings to the Australian health care system from implementing an evidence-based clinical protocol for diagnosing emergency patients with suspected pulmonary embolism (PE at the Emergency department of a Victorian public hospital with 50,000 presentations in 2001–2002. Methods A cost-minimisation study used the data collected in a controlled clinical trial of a clinical protocol for diagnosing patients with suspected PE. Thenumber and type of diagnostic tests in a historic cohort of 185 randomly selected patients, who presented to the emergency department with suspectedPE during an eight month period prior to the clinical trial (January 2002 -August 2002 were compared with the number and type of diagnostic tests in745 patients, who presented to the emergency department with suspected PE from November 2002 to August 2003. Current Medicare fees per test were usedas unit costs to calculate the mean aggregated cost of diagnostic investigation per patient in both study groups. A t-test was used to estimate the statistical significance of the difference in the cost of resources used for diagnosing PE in the control and in the intervention group. Results The trial demonstrated that diagnosing PE using an evidence-based clinical protocol was as effective as the existing clinical practice. The clinical protocol offers the advantage of reducing the use of diagnostic imaging, resulting in an average cost savings of at least $59.30 per patient. Conclusion Extrapolating the observed cost-savings of $59.30 per patient to the wholeof Australia could potentially result in annual savings between $3.1 million to $3.7 million.

Management of minor head injury in patients receiving oral anticoagulant therapy: a prospective study of a 24-hour observation protocol.

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Menditto, Vincenzo G; Lucci, Moira; Polonara, Stefano; Pomponio, Giovanni; Gabrielli, Armando

2012-06-01

Patients receiving warfarin who experience minor head injury are at risk of intracranial hemorrhage, and optimal management after a single head computed tomography (CT) scan is unclear. We evaluate a protocol of 24-hour observation followed by a second head CT scan. In this prospective case series, we enrolled consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. We implemented a structured clinical pathway, including 24-hour observation and a CT scan performed before discharge. We then evaluated the frequency of death, admission, neurosurgery, and delayed intracranial hemorrhage. We enrolled and observed 97 consecutive patients. Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Evaluation of a Progressive Mobility Protocol in Postoperative Cardiothoracic Surgical Patients.

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Floyd, Shawn; Craig, Sarah W; Topley, Darla; Tullmann, Dorothy

2016-01-01

Cardiothoracic surgical patients are at high risk for complications related to immobility, such as increased intensive care and hospital length of stay, intensive care unit readmission, pressure ulcer development, and deep vein thrombosis/pulmonary embolus. A progressive mobility protocol was started in the thoracic cardiovascular intensive care unit in a rural academic medical center. The purpose of the progressive mobility protocol was to increase mobilization of postoperative patients and decrease complications related to immobility in this unique patient population. A matched-pairs design was used to compare a randomly selected sample of the preintervention group (n = 30) to a matched postintervention group (n = 30). The analysis compared outcomes including intensive care unit and hospital length of stay, intensive care unit readmission occurrence, pressure ulcer prevalence, and deep vein thrombosis/pulmonary embolism prevalence between the 2 groups. Although this comparison does not achieve statistical significance (P mobility. This study has implications for nursing, hospital administration, and therapy services with regard to staffing and cost savings related to fewer complications of immobility. Future studies with a larger sample size and other populations are warranted.

Recall of ICU Stay in Patients Managed With a Sedation Protocol or a Sedation Protocol With Daily Interruption.

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Burry, Lisa; Cook, Deborah; Herridge, Margaret; Devlin, John W; Fergusson, Dean; Meade, Maureen; Steinberg, Marilyn; Skrobik, Yoanna; Olafson, Kendiss; Burns, Karen; Dodek, Peter; Granton, John; Ferguson, Niall; Jacka, Michael; Tanios, Maged; Fowler, Robert; Reynolds, Steven; Keenan, Sean; Mallick, Ranjeeta; Mehta, Sangeeta

2015-10-01

To 1) describe factual, emotional, and delusional memories of ICU stay for patients enrolled in the SLEAP (Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol) trial; 2) compare characteristics of patients with and without ICU recall, and patients with and without delusional memories; and 3) determine factors associated with delusional memories 28 days after ICU discharge. Prospective cohort. Sixteen North American medical and surgical ICUs. Critically ill, mechanically ventilated adults randomized in the SLEAP trial. Post-ICU interviews on days 3, 28, and 90 using the validated ICU Memory Tool. Overall, 289 of 297 ICU survivors (97%) (146 protocolized sedation and 143 protocolized sedation plus daily interruption patients) were interviewed at least once. Because there were no differences in recall status or types of memories between the two sedation groups, we present the findings for all patients rather than by study group. On days 3, 28, and 90, 28%, 26%, and 36% of patients, respectively, reported no recall of being in the ICU (overall perception, self-reported) (p = 0.75). Mean daily doses of benzodiazepines and opioids were lower in patients with no ICU recall than those with recall (p patients reporting no recall of ICU stay on day 3, 97% and 90% reported at least one factual and one emotional memory from ICU, respectively. Emotional memories declined with time after ICU discharge, particularly panic and confusion. Delusional memories 28 days after discharge were common (70%) yet unrelated to delirium (p = 0.84), recall status (p = 0.15), total dose of benzodiazepine (p = 0.78), or opioid (p = 0.21). Delusional memories were less likely with longer duration of mechanical ventilation (odds ratio, 0.955; 95% CI, 0.91-1.00; p = 0.04). Recall of ICU stay and types of memories reported were not influenced by the trial sedation strategy. Lack of ICU recall and delusional memories were common after ICU

Association between organisational and workplace cultures, and patient outcomes: systematic review protocol.

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Braithwaite, J; Herkes, J; Ludlow, K; Lamprell, G; Testa, L

2016-12-01

Despite widespread interest in the topic, no current synthesis of research is available analysing the linkages between organisational or workplace cultures on the one hand, and patient outcomes on the other. This protocol proposes a systematic review to analyse and synthesise the literature to date on this topic. The resulting review will discuss characteristics of included studies in terms of the type of healthcare settings researched, the measurements of organisational and workplace culture, patient outcomes measured and the influence of these cultures on patient outcomes. A systematic review will be conducted aiming to examine the associations between organisational and workplace cultures, and patient outcomes, guided by the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. An English language search of abstracts will be executed using the following academic databases: CINAHL, EMBASE, Ovid MEDLINE, Web of Science and PsycINFO. The review will include relevant peer-reviewed articles from randomised controlled trials (RCTs), non-RCTs, controlled before and after studies, interrupted time series studies, cross-sectional analyses, qualitative studies and mixed-method studies. Multiple researchers will be involved in assessing the quality of articles for inclusion in the review. This protocol documents a detailed search strategy, including terms and inclusion criteria, which will form the basis of the subsequent systematic review. Ethics approval is not required as no primary data will be collected. Results will be disseminated through a peer-reviewed publication and conference presentations. 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/.

Twenty Percent of Patients May Remain Colonized With Methicillin-resistant Staphylococcus aureus Despite a Decolonization Protocol in Patients Undergoing Elective Total Joint Arthroplasty.

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Baratz, Michael D; Hallmark, Ruth; Odum, Susan M; Springer, Bryan D

2015-07-01

Staphylococcus aureus is the most commonly isolated organism in periprosthetic joint infection (PJI). Resistant strains such as methicillin-resistant S aureus (MRSA) are on the rise, and many programs have instituted decolonization protocols. There are limited data on the success of S aureus nasal decolonization programs and their impact on PJI. The purposes of this study were to (1) determine the proportion of patients successfully decolonized using a 2-week protocol; (2) compare infection risks between our surveillance and decolonization protocol group against a historical control cohort to evaluate changes in proportions of S aureus infections; and (3) assess infection risk based on carrier type, comparing S aureus carriers with noncarrier controls. We retrospectively evaluated a group of 3434 patients who underwent elective primary and revision hip and knee arthroplasty over a 2-year period; each patient in the treatment group underwent a surveillance protocol, and a therapeutic regimen of mupurocin and chlorhexidine was instituted when colonization criteria were met. A 2009 to 2010 comparative historical cohort was chosen as the control group. We compared risks of infection between our treatment group and the historical control cohort. Furthermore, in patients who developed surgical site infections (SSIs), we compared the proportions of each S aureus type between the two cohorts. Finally, we compared infection rates based on carrier status. Surveillance for infection was carried out by the hospital infection control coordinator using the Centers for Disease Control and Prevention (CDC) criteria. During the time period of this study, the CDC defined hospital-acquired infection related to a surgical procedure as any infection diagnosed within 1 year of the procedure. With the numbers available, we had 41% power to detect a difference of 0.3% in infection rate between the treatment and control groups. To achieve 80% power, a total of 72,033 patients would be

PREMEDICATION PROTOCOLS IN DENTAL PRACTICE IN ALLERGIC PATIENTS.

OpenAIRE

Angelina Kisselova; Adriana Krasteva; Assya Krasteva

2011-01-01

The problem with choosing a suitable pre-medication protocols before local anesthesia in dentistry in allergic patients is always discussed, as in the dental practice different schemes are already proven (3,5). The propose of this communication is to share the experience on those pre-medication schemes in allergic patients during and outside pollen season.

Whole-body magnetic resonance angiography at 3 tesla using a hybrid protocol in patients with peripheral arterial disease

DEFF Research Database (Denmark)

Nielsen, Yousef W; Eiberg, Jonas P; Logager, Vibeke B

2009-01-01

The purpose of this study was to determine the diagnostic performance of 3T whole-body magnetic resonance angiography (WB-MRA) using a hybrid protocol in comparison with a standard protocol in patients with peripheral arterial disease (PAD). In 26 consecutive patients with PAD two different proto...

Implant loading protocols for edentulous patients with fixed prostheses: a systematic review and meta-analysis.

Science.gov (United States)

Papaspyridakos, Panos; Chen, Chun-Jung; Chuang, Sung-Kiang; Weber, Hans-Peter

2014-01-01

To report on the effect of immediate implant loading with fixed prostheses compared to early and conventional loading on implant and prosthesis survival, failure, and complications. An electronic and manual search was conducted to identify randomized controlled clinical trials (RCTs) as well as prospective and retrospective studies involving rough surface implants and implant fixed complete dental prostheses for edentulous patients. The 62 studies that fulfilled the inclusion criteria featured 4 RCTs, 2 prospective case-control studies, 34 prospective cohort studies, and 22 retrospective cohort studies. These studies yielded data from 2,695 patients (2,757 edentulous arches) with 13,653 implants. Studies were grouped according to the loading protocol applied; 45 studies reported on immediate loading, 8 on early loading, and 11 on conventional loading. For the immediate loading protocol with flap surgery, the implant and prosthesis survival rates ranged from 90.1% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). When immediate loading was combined with guided flapless implant placement, the implant survival rates ranged from 90% to 99.4%. For the early loading protocol, the implant and prosthesis survival rates ranged from 94.74% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). For the conventional loading protocol, the implant and prosthesis survival rates ranged from 94.95% to 100% and 87.5% to 100%, respectively (range of follow-up, 2 to 15 years). No difference was identified between maxilla and mandible. When selecting cases carefully and using dental implants with a rough surface, immediate loading with fixed prostheses in edentulous patients results in similar implant and prosthesis survival and failure rates as early and conventional loading. For immediate loading, most of the studies recommended a minimal insertion torque of 30 Ncm. The estimated 1-year implant survival was above 99% with all three

The RAPID protocol enhances patient recovery after both laparoscopic and open colorectal resections.

LENUS (Irish Health Repository)

Lloyd, G M

2010-06-01

Enhanced recovery after surgery (ERAS) programs can accelerate recovery and shorten the hospital stay after colorectal resections. The RAPID (remove, ambulate, postoperative analgesia, introduce diet) protocol is a simplified ERAS program that consists of a simplified, user-friendly single-page pro forma schedule. This study aimed to evaluate the impact of the RAPID protocol on patients undergoing both laparoscopic and open colorectal resections in two specialized colorectal units.

Comparison of four different preparation protocols to achieve bladder distension in patients with gross haematuria undergoing a CT urography

International Nuclear Information System (INIS)

Helenius, Malin; Segelsjo, Monica; Dahlman, Par; Magnusson, Anders

2012-01-01

Introduction: CT examination has been shown to be effective in detecting bladder cancer. Proper evaluation of the bladder requires it to be well distended. The purpose of the present study was to establish a preparation protocol to achieve satisfactory bladder distension without causing unacceptable patient discomfort. Material and method: We used four different preparation protocols (1: 0.5 L of fluid intake during a 1-h period, 2: Same as 1 with the addition of IV diuretics when the patient was examined, 3: 1 L of fluid intake during a 2-h period, 4: Same as 3 with the additional instruction to empty the bladder after 1 h. In protocols 1–3, the patients were asked not to empty their bladder during the preparation time). Bladder volume was calculated and bladder distension was judged as satisfactory or not by the radiologist. The patients answered questions about their ability to follow the preparation protocol and were requested to rate their need to empty the bladder pre-, during and post-examination. Results: Protocol 1 had the lowest bladder volume. Protocols 2, 3 and 4 were similar in bladder volume. However, Protocol 2 caused unacceptable patient discomfort, and the compliance was lowest in Protocol 4. Conclusion: Protocol 3, drinking 1 L of fluid during a 2-h period, gave satisfactory bladder distension, did not cause unacceptable discomfort in patients and did not have the lowest compliance.

Low-Frequency Repetitive Transcranial Magnetic Stimulation and Intensive Occupational Therapy for Poststroke Patients with Upper Limb Hemiparesis: Preliminary Study of a 15-Day Protocol

Science.gov (United States)

Kakuda, Wataru; Abo, Masahiro; Kobayashi, Kazushige; Momosaki, Ryo; Yokoi, Aki; Fukuda, Akiko; Ishikawa, Atsushi; Ito, Hiroshi; Tominaga, Ayumi

2010-01-01

The purpose of the study was to determine the safety and feasibility of a 15-day protocol of low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with intensive occupational therapy (OT) on motor function and spasticity in hemiparetic upper limbs in poststroke patients. Fifteen poststroke patients (age at study entry 55 [plus…

Protocol Adherence in Prehospital Medical Care Provided for Patients with Chest Pain and Loss of Consciousness; a Brief Report

Directory of Open Access Journals (Sweden)

Mostafa Mehrara

2017-01-01

Full Text Available Introduction: Although many protocols are available in the field of the prehospital medical care (PMC, there is still a notable gap between protocol based directions and applied clinical practice. This study measures the rate of protocol adherence in PMC provided for patients with chest pain and loss of consciousness (LOC.Method: In this cross-sectional study, 10 educated research assistants audited the situation of provided PMC for non-traumatic chest pain and LOC patients, presenting to the emergency department of a tertiary level teaching hospital, compare to national recommendations in these regards.Results: 101 cases with the mean age of 56.7 ± 12.3 years (30-78 were audited (55.4% male. 61 (60.3% patients had chest pain and 40 (39.7% cases had LOC. Protocol adherence rates for cardiac monitoring (62.3%, O2 therapy (32.8%, nitroglycerin administration (60.7%, and aspirin administration (52.5% in prehospital care of patients with chest pain were fair to poor. Protocol adherence rates for correct patient positioning (25%, O2 therapy (75%, cardiac monitoring (25%, pupils examination (25%, bedside glucometery (50%, and assessing for naloxone administration (55% in prehospital care of patients with LOC were fair to poor.Conclusion: There were more than 20% protocol violation regarding prehospital care of chest pain patients regarding cardiac monitoring, O2 therapy, and nitroglycerin and aspirin administration. There were same situation regarding O2 therapy, positioning, cardiac monitoring, pupils examination, bedside glucometery, and assessing for naloxone administration of LOC patients in prehospital setting.

A Standardized Protocol for the Prospective Follow-Up of Cleft Lip and Palate Patients.

Science.gov (United States)

Salimi, Negar; Jolanta, Aleksejūnienė; Edwin, Yen; Angelina, Loo

2018-01-01

To develop a standardized all-encompassing protocol for the assessment of cleft lip and palate patients with clinical and research implications. Electronic database searches were conducted and 13 major cleft centers worldwide were contacted in order to prepare for the development of the protocol. In preparation, the available evidence was reviewed and potential fistula-related risk determinants from 4 different domains were identified. No standardized protocol for the assessment of cleft patients could be found in any of the electronic database searches that were conducted. Interviews with representatives from several major centers revealed that the majority of centers do not have a standardized comprehensive strategy for the reporting and follow-up of cleft lip and palate patients. The protocol was developed and consisted of the following domains of determinants: (1) the sociodemographic domain, (2) the cleft defect domain, (3) the surgery domain, and (4) the fistula domain. The proposed protocol has the potential to enhance the quality of patient care by ensuring that multiple patient-related aspects are consistently reported. It may also facilitate future multicenter research, which could contribute to the reduction of fistula occurrence in cleft lip and palate patients.

Oral hygiene in patients with oral cancer undergoing chemotherapy and/or radiotherapy after prosthesis rehabilitation: protocol proposal.

Science.gov (United States)

Rapone, B; Nardi, G M; DI Venere, D; Pettini, F; Grassi, F R; Corsalini, M

2016-01-01

This study was aimed at assessing the effectiveness and the importance of an oral hygiene (OH) protocol in patients undergoing radiation therapy and chemotherapy after prosthesis rehabilitation, in order to reduce or minimize oral complications. This study was carried out at the Department of Dental Science, at the University of Bari-Italy from December 2012 to December 2015 on 34 selected patients with primary oral cancer undergoing chemotherapy and radiotherapy after prosthesis rehabilitation. They were divided into 2 groups according to their age, sex and cancer therapy. Seventeen patients were assigned to the control group and seventeen in the experimental one. In the experimental group (Table 1), patients underwent an oral hygiene protocol whereas in the control group (Table 2) patients received the usual care provided within the clinical setting. All the patients gave written informed consent. It has been asked and obtained the authorisation from the Ethics Committee of the Dental Science and Surgery Department. Results show that in patients undergoing the oral hygiene protocol, the complications and the risks of infection and permanent dental problems have been minimized. Indeed, of the seventeen patients undergoing the OH protocol, 70% obtained positive results and were satisfied with the program outcome. The role of the health care providers is essential to educate patients to adhere to the prescribed treatments and reinforce their motivation in oral hygiene. The oral hygiene procedures prevent and ameliorate oral complications due to the radiation therapy and chemotherapy.

Effectiveness of oxaliplatin desensitization protocols.

Science.gov (United States)

Cortijo-Cascajares, Susana; Nacle-López, Inmaculada; García-Escobar, Ignacio; Aguilella-Vizcaíno, María José; Herreros-de-Tejada, Alberto; Cortés-Funes Castro, Hernán; Calleja-Hernández, Miguel-Ángel

2013-03-01

Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR.

Clinical outcomes and cost effectiveness of accelerated diagnostic protocol in a chest pain center compared with routine care of patients with chest pain.

Science.gov (United States)

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (pdiagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (pdiagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (pdiagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), pdiagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14-0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources.

A protocol of early aggressive acceleration of tube feeding increases ileus without perceptible benefit in severely burned patients.

Science.gov (United States)

Kesey, Jennifer; Dissanaike, Sharmila

2013-01-01

Optimal nutrition is essential to the recovery of burned patients. The authors evaluated the efficacy of an aggressive nutrition delivery protocol. The following protocol was implemented: initiation of tube feeds within 4 hours, acceleration to goal rate within 8 hours, and tolerance of gastric residual volumes of 400 ml. Patients on the protocol formed the study group whereas patients admitted immediately before implementation served as controls for a study period of 7 days after admission. Outcome variables included ileus, prokinetic medication use, intensive care unit and overall length of stay, ventilator days and mortality. Variables were compared using bivariate analysis. The 42 study subjects and 34 controls were similar at baseline. Time to initiation was similar (6.8 vs 9.4 hours; P = .226), however, goal rate was achieved much sooner in the study group (11.2 vs 20.9 hours; P protocol was successfully implemented and resulted in early achievement of goal tube feed rates. However, this resulted in tube feed intolerance as manifested by more cases of clinical ileus.

Publication trends of study protocols in rehabilitation.

Science.gov (United States)

Jesus, Tiago S; Colquhoun, Heather L

2017-09-04

Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

Potentially inappropriate medicines in elderly hospitalised patients according to the EU(7)-PIM list, STOPP version 2 criteria and comprehensive protocol.

Science.gov (United States)

Mucalo, Iva; Hadžiabdić, Maja Ortner; Brajković, Andrea; Lukić, Sonja; Marić, Patricia; Marinović, Ivana; Bačić-Vrca, Vesna

2017-08-01

The aim of this study was to measure the prevalence of potentially inappropriate medications (PIMs) by using the EU(7)-PIM list, STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions) version 2 criteria and the new comprehensive protocol. This prospective study involved a sample of 276 consecutive elderly patients discharged from the university teaching hospital. Age, gender, diagnoses, medication history and medicines at discharge were recorded. The main outcome measure was the prevalence of PIMs according to each set of criteria: EU(7)-PIM list, STOPP version 2 criteria and comprehensive protocol. The median patient age (range) was 74 (65-92) years. The median number of prescribed medications was 7 (1-17). STOPP identified 393 PIMs affecting 190 patients (69%), EU(7)-PIM list identified 330 PIMs in 184 patients (66.7%) whilst the comprehensive protocol identified 134 PIMs in 102 patients (37%). STOPP version 2 criteria identified significantly more PIMs per patient than the other two protocols (p comprehensive protocol and was found as a more sensitive tool for PIM detection.

4-step 4-h carboplatin desensitization protocol for patients with gynecological malignancies showing platinum hypersensitivity: a retrospective study.

Science.gov (United States)

Takase, Naoto; Matsumoto, Koji; Onoe, Takuma; Kitao, Akihito; Tanioka, Maki; Kikukawa, Yoshitaka; Yamaguchi, Satoshi; Fujiwara, Kiyoshi; Negoro, Shunichi

2015-06-01

Platinum agents are essential for treating gynecological malignancies, particularly ovarian cancer. However, multiple carboplatin doses may cause hypersensitivity reactions (HSRs). Carboplatin desensitization prevents life-threatening HSRs and promotes the successful completion of planned chemotherapy. Since January 2010, carboplatin desensitization was performed at our institution. Solutions with 1/1000, 1/100, and 1/10 dilutions of carboplatin and an undiluted solution were prepared in 250 mL of 5% glucose. Each solution was administered as a 1-h intravenous infusion (4-step 4-h protocol). This retrospective analysis was approved by the institutional review board. From January 2010 to December 2013, 20 patients with gynecological malignancies (median age 62 years, range 43-74 years) received desensitization treatment. The International Federation of Gynecology and Obstetrics stages at presentation were I, II, III, and IV in 1, 1, 15, 13 patients, respectively. During first-line and second-line treatments, 3 and 17 patients, respectively, experienced carboplatin-induced HSRs. The median carboplatin cycle number was 11 (range 2-16). In the first desensitization cycle, 17 (85%) patients completed treatment without adverse events, 2 experienced Grade 1 HSRs but completed treatment, and 1 experienced Grade 3 HSR and discontinued treatment. The first desensitization cycle completion rate was 95%. Of 83 desensitization cycles administered, 79 (95.2%) were completed. No treatment-related deaths occurred. Most patients completed the planned chemotherapy. Our protocol could be conducted safely with shorter duration and simpler procedures than previous protocols. Carboplatin desensitization seems beneficial for patients with a history of carboplatin-induced HSRs; however, the risk of HSR recurrence still remains. Desensitization should therefore be performed only by well-trained staff.

End Stage Renal Disease: Not a Contraindication for Minor Oral Surgery-Protocol for the Management of Oral Surgery patients with ESRD on Hemodialysis.

Science.gov (United States)

Pendem, Sneha; Lakshmi Narayana, G; Ravi, Poornima

2017-06-01

To describe a safe and effective protocol for the management of patients with end stage renal disease (ESRD) undergoing minor oral surgery. A prospective cohort study was conducted on all patients with ESRD who were referred for dental consultation. A definite protocol was designed in consultation with the nephrologist to minimize the risk of bleeding and wound healing complications during and after the minor surgical procedures. 36 patients consented for the protocol to be followed while 4 patients did not comply with the protocol and in 2 cases the protocol could be followed. The intra operative, post operative bleeding, and the wound healing were assessed in these patients. 36 patients had uneventful extractions as the blood pressure was brought down to pre hypertensive stage following the protocol. 4 patients who did not comply with the protocol had episodes of bleeding in the post operative period. There were two special scenarios where additional precautions had to be taken have been discussed. The wound healing was satisfactory in all these patients. The protocol discussed in this article helps us provide safe minor oral surgical treatment in patients with ESRD.

Learning from positively deviant wards to improve patient safety: an observational study protocol.

Science.gov (United States)

Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

2015-12-11

Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 'positively deviant' and 5 matched 'comparison' wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer-reviewed, scientific journals, and presented at academic conferences. This study

Adherence to, and outcomes of, a galactomannan screening protocol in high-risk hematology patients.

Science.gov (United States)

Harricharan, S; Biederman, K; Bombassaro, A M; Lazo-Langner, A; Elsayed, S; Fulford, A; Delport, J A; Xenocostas, A

2018-04-01

A twice-weekly galactomannan (gm) screening protocol was implemented in high-risk hematology inpatients. Study objectives were to determine adherence to the protocol, use of selected resources, and patient outcomes. This retrospective cohort study compared outcomes of interest before and after implementation of gm screening. Adults undergoing matched related allogeneic hematopoietic stem-cell transplantation or induction chemotherapy for acute leukemia were eligible. Patients could be enrolled more than once and were evaluated as episodes. Adherence to the gm protocol was assessed in post-implementation episodes. Use of broad-spectrum antifungals (bsafs), consultations (infectious diseases, respirology), and diagnostic procedures (computed tomography imaging, bronchoalveolar lavage) were compared between phases, as were the patient outcomes of all-cause mortality and clinical success (alive and not taking a bsaf). Of 182 episodes consecutively screened, 70 per phase were enrolled. Clinical characteristics and duration of assessment were similar for the phases. Full or partial adherence to the protocol was observed in 61 post-implementation episodes (87%), with full adherence in 40 episodes (57%). More episodes in the pre-implementation phase than in the post-implementation phase involved receipt of bsafs, consultations, and diagnostics (27% vs. 7%, p = 0.02; 46% vs. 26%, p = 0.014; and 46% vs. 31%, p = 0.083 respectively). Although mortality was similar in the two phases, clinical success at the final assessment was observed in fewer pre-implementation than post-implementation episodes (79% vs. 98%, p < 0.001). Implementation of a gm screening protocol was feasible and associated with significantly fewer episodes involving receipt of bsafs and consultations, and with significantly more episodes showing clinical success.

Comparison of microdose GnRH agonist protocol with GnRH antagonist / letrazole protocol in patients with poor ovarian response

Directory of Open Access Journals (Sweden)

Yiğit Çakıroğlu

2013-09-01

Full Text Available Objective: To compare microdose GnRH agonist (MDL protocol with GnRH antagonist/letrazole (AL protocol in patients with poor ovarian response. Design: Randomised clinical trial. Setting: Kocaeli University Assisted Reproductive Centre Interventions: POR was diagnosed according to ESHRE Bologna criteria in case of presence of 2 out of 3 criteria. In the MDL group (n=27, 40µg/0.2 cc subcutaneous leuprolid acetate was given two times a day starting on the first day of menstrual cycle. On the second day of the cycle, gonadotrophin stimulation was started at 450-600 IU and/or 150 IU human menopausal gonadotrophin (hMG along with leuprolid. In the AL group (n=28, 5 mg letrazole was given for 5 days starting on the second day of the spontaneous cycle and after the 5th day of the cycle, 450-600 IU and/or 150 IU hMG was given. Main Outcome Measures: To compare the outcomes of MDL protocol with AL protocol in patients with poor ovarian response. Results: Stimulation days, total gonadotrophin dose (IU, peak E2 (pg/ml levels, and endometrial thickness were found to be statistically significantly lower in the AL group. While no cases of cycle cancellation was detected in the MDL group, statistically significantly higher rates of cycle cancellation (%35.7, p<0.001 was detected in the AL group. No statistically significant differences were detected in total oocyte numbers (3.7±2.9 vs 2.7±2.2, number of transferred embryos (1.4±0.5 vs 1.4±1.9, pregnancy rates (3/27 (%11.1 vs 2/28 (%7.1 and implantation rates (3/36 (%8.3 vs 2/22 (%9.1 in between the groups. Comment: Although AL protocol is not superior to MDL protocol in poor ovarian response patients, it may be used as an alternative protocol.

Serious gaming during multidisciplinary rehabilitation for patients with complex chronic pain or fatigue complaints: study protocol for a controlled trial and process evaluation.

Science.gov (United States)

Vugts, Miel A P; Joosen, Margot C W; Mert, Agali; Zedlitz, Aglaia; Vrijhoef, Hubertus J M

2017-06-08

Many individuals suffer from chronic pain or functional somatic syndromes and face boundaries for diminishing functional limitations by means of biopsychosocial interventions. Serious gaming could complement multidisciplinary interventions through enjoyment and independent accessibility. A study protocol is presented for studying whether, how, for which patients and under what circumstances, serious gaming improves patient health outcomes during regular multidisciplinary rehabilitation. A mixed-methods design is described that prioritises a two-armed naturalistic quasi-experiment. An experimental group is composed of patients who follow serious gaming during an outpatient multidisciplinary programme at two sites of a Dutch rehabilitation centre. Control group patients follow the same programme without serious gaming in two similar sites. Multivariate mixed-modelling analysis is planned for assessing how much variance in 250 patient records of routinely monitored pain intensity, pain coping and cognition, fatigue and psychopathology outcomes is attributable to serious gaming. Embedded qualitative methods include unobtrusive collection and analyses of stakeholder focus group interviews, participant feedback and semistructured patient interviews. Process analyses are carried out by a systematic approach of mixing qualitative and quantitative methods at various stages of the research. The Ethics Committee of the Tilburg School of Social and Behavioural Sciences approved the research after reviewing the protocol for the protection of patients' interests in conformity to the letter and rationale of the applicable laws and research practice (EC 2016.25t). Findings will be presented in research articles and international scientific conferences. A prospective research protocol for the naturalistic quasi-experimental outcome evaluation was entered in the Dutch trial register (registration number: NTR6020; Pre-results). © Article author(s) (or their employer(s) unless

Reference-based digital concept to restore partially edentulous patients following an immediate loading protocol: a pilot study

NARCIS (Netherlands)

Tahmaseb, A.; de Clerck, R.; Eckert, S.; Wismeijer, D.

2011-01-01

PURPOSE: To describe the use of a computer-aided three-dimensional planning protocol in combination with previously placed reference elements and computer-aided design/computer-assisted manufacture (CAD/CAM) technology to restore the partially edentulous patient. MATERIALS AND METHODS: Mini-implants

Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

Science.gov (United States)

Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

2015-09-04

Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

Radiographic examination protocol and patient dose in lateral cephalometric radiography in Korea

International Nuclear Information System (INIS)

Choi, Jin Woo

2010-01-01

To survey the radiographic examination protocol for lateral cephalometric radiographic examinations and to measure their patient doses in Korea and to compare the dose according to the size of hospital, the type of image receptor system, and the installation duration. The radiographic examination protocols (kVp, mA, and exposure time) for lateral cephalometric radiography were surveyed with 61 cephalometric radiographic equipments and their patient dose-area product (DAP) measured with a DAP meter (DIAMENTOR M4-KDK, PTW, Freiburg, Germany) for 51 cephalometric radiographic equipments. The radiographic examination protocols and patient doses were compared according to the size of hospital (university dental hospital, dental hospital, and dental clinic), the type of image receptor system (film-based, DR and CR type) and the installation duration, respectively. SPSS 12.0.1 for Windows (SPSS Inc., Chicago, USA) was used for independent t-test and ANOVA test. The average protocols were 77.0 kVp, 12.7 mA, 6.2 second for cephalometric radiography. The average patient dose (DAP) was 128.0 mGy cm2 and 3rd quartile dose (DAP) 161.1 mGy cm2 for cephalometric radiography for adult male. There was no statistically significant difference at average patient DAP according to the size of hospital, the type of image receptor system, and the installation duration, respectively. The average patient dose was 128.0 mGy cm2 and the third quartile patient dose 161.1 mGy cm2 for lateral cephalometric radiography for adult male in Korea.

Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

Directory of Open Access Journals (Sweden)

Abbas Aflatoonian

2017-08-01

Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

Science.gov (United States)

Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

2016-04-12

This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

Science.gov (United States)

Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

2012-02-01

Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

Patient controlled sedation using a standard protocol for dressing changes in burns: patients' preference, procedural details and a preliminary safety evaluation.

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Nilsson, Andreas; Steinvall, Ingrid; Bak, Zoltan; Sjöberg, Folke

2008-11-01

Patient controlled sedation (PCS) enables patients to titrate doses of drugs by themselves during different procedures involving pain or discomfort. We studied it in a prospective crossover design using a fixed protocol without lockout time to examine it as an alternative method of sedation for changing dressings in burned patients. Eleven patients with >10% total burn surface area (TBSA) had their dressings changed, starting with sedation by an anaesthetist (ACS). The second dressing change was done with PCS (propofol/alfentanil) and the third time the patients had to choose ACS or PCS. During the procedures, data on cardiopulmonary variables, sedation (bispectral index), pain intensity (VAS), procedural details, doses of drugs, and patients' preferences were collected to compare the two sedation techniques. The study data indicated that wound care in burned patients is feasible with a standardized PCS protocol. The patients preferred PCS to ACS on the basis of self-control, and because they had less discomfort during the recovery period. Wound care was also considered adequate by the staff during PCS. No respiratory (respiratory rate/transcutaneous PCO(2)) or cardiovascular (heart rate/blood pressure) adverse events were recorded at any time during any of the PCS procedures. The doses of propofol and alfentanil and BIS index decrease were less during PCS than ACS. Procedural pain was higher during PCS but lower after the procedure. We suggest that PCS using a standard protocol is an interesting alternative to anaesthetist-provided sedation during dressing changes. It seems effective, saves resources, is safe, and at same time is preferred by the patients. The strength of these conclusions is, however, hampered by the small size of this investigation and therefore further studies are warranted.

A prospective multi-centre study of the value of FDG-PET as part of a structured diagnostic protocol in patients with fever of unknown origin

International Nuclear Information System (INIS)

Bleeker-Rovers, Chantal P.; Vos, Fidel J.; Meer, Jos W.M. van der; Mudde, Aart H.; Dofferhoff, Anton S.M.; Geus-Oei, Lioe-Fee de; Rijnders, Anton J.; Krabbe, Paul F.M.; Corstens, Frans H.M.; Oyen, Wim J.G.

2007-01-01

Since 18 F-fluorodeoxyglucose (FDG) accumulates in neoplastic cells and in activated inflammatory cells, positron emission tomography (PET) with FDG could be valuable in diagnosing patients with fever of unknown origin (FUO). The aim of this study was to validate the use of FDG-PET as part of a structured diagnostic protocol in the general patient population with FUO. From December 2003 to July 2005, 70 patients with FUO were recruited from one university hospital (n=38) and five community hospitals (n=32). A structured diagnostic protocol including FDG-PET was used. A dedicated, full-ring PET scanner was used for data acquisition. FDG-PET scans were interpreted by two staff members of the department of nuclear medicine without further clinical information. The final clinical diagnosis was used for comparison with the FDG-PET results. Of all scans, 33% were clinically helpful. The contribution of FDG-PET to the final diagnosis did not differ significantly between patients diagnosed in the university hospital and patients diagnosed in the community hospitals. FDG-PET contributed significantly more often to the final diagnosis in patients with continuous fever than in patients with periodic fever. FDG-PET was not helpful in any of the patients with normal erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). FDG-PET is a valuable imaging technique as part of a diagnostic protocol in the general patient population with FUO and a raised ESR or CRP. (orig.)

[An integrative and transdiagnostic relaxation protocol for anxious patients. Results of a pilot study].

Science.gov (United States)

Servant, D; Germe, A; Autuori, M; De Almeida, F; Hay, M; Douilliez, C; Vaiva, G

2014-12-01

The literature data show that relaxation practice is effective in reducing anxiety symptoms. Different techniques such as progressive muscular relaxation, autogenic training, applied relaxation and meditation have been evaluated independently for anxiety disorders. The question is to know whether the combination of various techniques may be of interest in the transdiagnostic treatment of anxiety disorders. The present study assessed the short-term efficacy of a 10-week integrative and transdiagnostic relaxation program for anxiety disorders in outpatients of an anxiety disorders unit. The diagnoses were made according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and completed with an assessment of anxiety and depressive symptoms using: the State Trait Anxiety Inventory (STAI-Y, -S and -T), the Penn State Worry Questionnaire (PSWQ) and the Beck Depression Inventory (BDI-II). Four techniques were integrated into the structured 10-week protocol: breathing control, muscular relaxation, meditation and mental visualization. Twenty-eight patients (12 men and 16 women), mean age (S.D.)=38.82 years (11.57), were included in the study. All the included patients fulfilled the DSM-IV criteria for a current diagnosis of Generalized Anxiety Disorder (n=13) or Panic Disorder (n=15) with or without agoraphobia. At the end of the 10 sessions, we found a significant reduction in mean scores (S.D.) on the STAI-T from 53.179 (6.037) to 49.821 (8.028) (P<0.02), the BDI-II 20.964 (13.167) to 15.429 (11.341) (d=0.6543) and the QIPS 55.071 (10.677) to 49.679 (11.7) (d=0.5938). The observed reduction in the STAI-S (d=0.2776) was not significant. The results of this open study showed that this program significantly decreases the level of trait anxiety, depression and worry. The integrative and transdiagnostic relaxation program could represent an accessible and effective treatment to reduce anxious and depressive symptoms in various anxiety disorders

A pilot audit of a protocol for ambulatory investigation of predicted low-risk patients with possible pulmonary embolism.

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McDonald, A H; Murphy, R

2011-09-01

Patients with possible pulmonary embolism (PE) commonly present to acute medical services. Research has led to the identification of low-risk patients suitable for ambulatory management. We report on a protocol designed to select low-risk patients for ambulatory investigation if confirmatory imaging is not available that day. The protocol was piloted in the Emergency Department and Medical Assessment Area at the Royal Infirmary of Edinburgh. We retrospectively analysed electronic patient records in an open observational audit of all patients managed in the ambulatory arm over five months of use. We analysed 45 patients' records. Of these, 91.1% required imaging to confirm or refute PE, 62.2% received a computed tomography pulmonary angiogram (CTPA). In 25% of patients, PE was confirmed with musculoskeletal pain (22.7%), and respiratory tract infection (15.9%) the next most prevalent diagnoses. Alternative diagnoses was provided by CTPA in 32% of cases. We identified no adverse events or readmissions but individualised follow-up was not attempted. The data from this audit suggests this protocol can be applied to select and manage low-risk patients suitable for ambulatory investigation of possible PE. A larger prospective comparative study would be required to accurately define the safety and effectiveness of this protocol.

Difficulties in Controlling Mobilization Pain Using a Standardized Patient-Controlled Analgesia Protocol in Burns

OpenAIRE

Nilsson, Andreas; Kalman, Sigga; Arvidsson, Anders; Sjöberg, Folke

2011-01-01

The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like addi...

Modified enhanced recovery after surgery (ERAS) protocols for patients with obstructive colorectal cancer.

Science.gov (United States)

Shida, Dai; Tagawa, Kyoko; Inada, Kentaro; Nasu, Keiichi; Seyama, Yasuji; Maeshiro, Tsuyoshi; Miyamoto, Sachio; Inoue, Satoru; Umekita, Nobutaka

2017-02-16

Enhanced recovery after surgery (ERAS) protocols are now well-known to be useful for elective colorectal surgery, as they result in shorter hospital stays without adversely affecting morbidity. However, the efficacy and safety of ERAS protocols for patients with obstructive colorectal cancer have yet to be clarified. We evaluated 122 consecutive resections for obstructive colorectal cancer performed between July 2008 and November 2012 at Tokyo Metropolitan Bokutoh Hospital. Patients with rupture or impending rupture and those who received simple colostomy were excluded. The first set of 42 patients was treated based on traditional protocols, and the latter 80 according to modified ERAS protocols. The main endpoints were length of postoperative hospital stay, postoperative short-term morbidity, rate of readmission within 30 days, and mortality. Differences in modified ERAS protocols relative to traditional care include intensive preoperative counseling (by both surgeons and anesthesiologists), perioperative fluid management (avoidance of sodium/fluid overload), shortening of postoperative fasting period and early provision of oral nutrition, intraoperative warm air body heating, enforced postoperative mobilization, stimulation of gut motility, early removal of urinary catheter, and a multidisciplinary team approach to care. Median (interquartile range) postoperative hospital stay was 10 (10-14.25) days in the traditional group, and seven (7-8.75) days in the ERAS group, showing a 3-day reduction in hospital stay (p < 0.01). According to the Clavien-Dindo classification, overall incidences of grade 2 or higher postoperative complications for the traditional and ERAS groups were 15 and 10% (p = 0.48), and 30-day readmission rates were 0 and 1.3% (p = 1.00), respectively. As for mortality, one patient in the traditional group died and none in the ERAS group (p = 0.34). Modified ERAS protocols for obstructive colorectal cancer reduced hospital stay

Improving treatment times for patients with in-hospital stroke using a standardized protocol.

Science.gov (United States)

Koge, Junpei; Matsumoto, Shoji; Nakahara, Ichiro; Ishii, Akira; Hatano, Taketo; Sadamasa, Nobutake; Kai, Yasutoshi; Ando, Mitsushige; Saka, Makoto; Chihara, Hideo; Takita, Wataru; Tokunaga, Keisuke; Kamata, Takahiko; Nishi, Hidehisa; Hashimoto, Tetsuya; Tsujimoto, Atsushi; Kira, Jun-Ichi; Nagata, Izumi

2017-10-15

Previous reports have shown significant delays in treatment of in-hospital stroke (IHS). We developed and implemented our IHS alert protocol in April 2014. We aimed to determine the influence of implementation of our IHS alert protocol. Our implementation processes comprise the following four main steps: IHS protocol development, workshops for hospital staff to learn about the protocol, preparation of standardized IHS treatment kits, and obtaining feedback in a monthly hospital staff conference. We retrospectively compared protocol metrics and clinical outcomes of patients with IHS treated with intravenous thrombolysis and/or endovascular therapy between before (January 2008-March 2014) and after implementation (April 2014-December 2016). Fifty-five patients were included (pre, 25; post, 30). After the implementation, significant reductions occurred in the median time from stroke recognition to evaluation by a neurologist (30 vs. 13.5min, pvs. 26.5min, pvs. 16min, p=0.02). The median time from first neuroimaging to endovascular therapy had a tendency to decrease (75 vs. 53min, p=0.08). There were no differences in the favorable outcomes (modified Rankin scale score of 0-2) at discharge or the incidence of symptomatic intracranial hemorrhage between the two periods. Our IHS alert protocol implementation saved time in treating patients with IHS without compromising safety. Copyright © 2017 Elsevier B.V. All rights reserved.

Implementing a pain management nursing protocol for orthopaedic surgical patients: Results from a PAIN OUT project.

Science.gov (United States)

Cui, Cui; Wang, Ling-Xiao; Li, Qi; Zaslansky, Ruth; Li, Li

2018-04-01

To investigate the effect of introducing a standardised pain management nursing protocol in orthopaedic patients undergoing surgery. Postoperative pain is a common phenomenon but is still undertreated in hospitalised patients. Nurses' lack of sufficient knowledge and skills about pain management may be a contributing factor to poor outcomes. An interventional, separate sample pre- and post-test. A pain management nursing protocol was introduced and a handbook and training sessions regarding management of postsurgical pain were provided to the nurses on a Joint Orthopaedic ward at a university-affiliated general hospital in Guangzhou, China. Before and after the intervention, nurses' knowledge about pain management and attitudes were assessed, and perioperative management practices and pain-related patient-reported outcomes were evaluated. Sixteen and 15 registered nurses, and 77 and 71 patients participated in the study before and after the intervention, respectively. Nurses' scores related to knowledge and skills increased significantly after the protocol was introduced but were still insufficient with regard to pharmacological-related items. The proportion of patients receiving a combined opioid and nonopioid increased after the intervention. Clinically significant changes were observed in some patient-reported outcomes, such as worst pain since surgery, percentage of time experiencing severe pain, and pain interference with activities out of bed. There were significant changes in nonpharmacological methods administered by nurses to patients or used by patients to relieve pain. Implementation of a pain management nursing protocol combined with education in one surgical ward was associated with nurses' increased knowledge and attitudes regarding pain, a change in some management practices, and improvement in a number of pain-related patient-reported outcomes. It was feasible to develop and implement a standardised pain management nursing protocol and use it in the

Difficulties in controlling mobilization pain using a standardized patient-controlled analgesia protocol in burns.

Science.gov (United States)

Nilsson, Andreas; Kalman, Sigga; Sonesson, Lena Karin; Arvidsson, Anders; Sjöberg, Folke

2011-01-01

The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like additional analgesics. Patients were allowed free access to morphine with a PCA pump device. Bolus doses were set according to age, (100 - age)/24 = bolus dose (mg), and 6 minutes lockout time. Degrees of pain, morphine requirements, doses delivered and demanded, oral intake of food, and antiemetics given were used as endpoints. Acceptable pain (mean [SD]) was estimated to be 3.8 (1.3) on the NRS, and additional treatment was considered necessary at scores of 4.3 (1.6) or more. NRS at rest was 2.7 (2.2) and during mobilization 4.7 (2.6). Required mean morphine per day was 81 (15) mg, and the number of doses requested increased during the first 6 days after the burn. The authors found no correlation between dose of morphine required and any other variables. Background pain can be controlled adequately with a standard PCA protocol. During mobilization, the pain experienced was too intense, despite having the already high doses of morphine increased. The present protocol must be refined further to provide analgesia adequate to cover mobilization as well.

Evaluation of the efficacy of animal-assisted therapy based on the reality orientation therapy protocol in Alzheimer's disease patients: a pilot study.

Science.gov (United States)

Menna, Lucia Francesca; Santaniello, Antonio; Gerardi, Federica; Di Maggio, Annamaria; Milan, Graziella

2016-07-01

The aim of this study was to evaluate the efficacy of animal-assisted therapy (AAT) in elderly patients affected by Alzheimer's disease based on the formal reality orientation therapy (ROT) protocol. Our study was carried out at an Alzheimer's centre for 6 months. A homogeneous sample (age, Mini-Mental State Examination (MMSE), 15-item Geriatric Depression Scale (GDS)) of 50 patients was selected at random and successively. Patients were divided into three groups: (i) 20 patients received a course of AAT (AAT group) based on the ROT protocol; (ii) 20 patients were engaged exclusively in activities based on the ROT group; and (iii) 10 patients (control group) participated in no stimulations. MMSE and GDS were administered at time 0 (T0 ) and time 1 (T1 ) to all three groups. Differences within groups between T0 and T1 for GDS and MMSE scores were analyzed by Student's t-test. Differences between group means were analyzed using an anova test with the Bonferroni-Dunn test for post-hoc comparisons. Both the AAT group and ROT group had improved GDS scores and showed a slight improvement in terms of mood. On the GDS, the AAT group improved from 11.5 (T0 ) to 9.5 (T1 ), and the ROT group improved from 11.6 (T0 ) to 10.5 (T1 ). At the same time, a slight improvement in cognitive function, as measured by the MMSE, was observed. In the AAT group, mean MMSE was 20.2 at T0 and 21.5 at T1 , and in the ROT group, it was 19.9 at T0 and 20.0 at T1 . In the control group, the average values of both the GDS and MMSE remained unchanged. The Bonferroni-Dunn results showed statistically significant differences between groups, particularly between the AAT group and the other two (P therapy interventions based on the formal ROT protocol were effective and, compared to the ROT, provided encouraging and statistically significant results. © 2015 The Authors. Psychogeriatrics © 2015 Japanese Psychogeriatric Society.

Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

Science.gov (United States)

Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

2014-12-01

Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

A retrospective review of safety using a nursing driven protocol for autonomic dysreflexia in patients with spinal cord injuries.

Science.gov (United States)

Solinsky, Ryan; Svircev, Jelena N; James, Jennifer J; Burns, Stephen P; Bunnell, Aaron E

2016-11-01

Autonomic dysreflexia is a potentially life-threatening condition which afflicts a significant proportion of individuals with spinal cord injuries (SCI). To date, the safety and efficacy of several commonly used interventions for this condition have not been studied. A retrospective chart review of the safety of a previously implemented nursing driven inpatient autonomic dysreflexia protocol. Seventy-eight male patients with SCI who experienced autonomic dysreflexia while inpatient at our Veterans Affairs SCI unit over a 3-1/2-year period were included. The safety of a nursing driven protocol utilizing conservative measures, nitroglycerin paste, and oral hydralazine was evaluated. Occurrence of adverse events and relative hypotensive events during all episodes treated with the protocol, and efficacy of attaining target blood pressure for all episodes with protocol adherence and for initial episode experienced by each patient. Four hundred forty-five episodes of autonomic dysreflexia were recorded in the study period, with 92% adherence to the protocol. When the protocol was followed, target blood pressure was achieved for 97.6% of all episodes. Twenty-three total adverse events occurred (5.2% of all episodes). All adverse events were due to hypotension and only 0.9% required interventions beyond clinical monitoring. Of each patient's initial autonomic dysreflexia episode, 97.3% resolved using the protocol without need for further escalation of care. This inpatient nursing driven-protocol for treating autonomic dysreflexia utilizing conservative measures, nitroglycerin paste and oral hydralazine achieved target blood pressure with a high success rate and a low incidence of adverse events.

Five days of successful oral alimentation for hospitalized patients based upon passing the Yale Swallow Protocol.

Science.gov (United States)

Leder, Steven B; Suiter, Debra M

2014-09-01

This study aimed to determine the success of oral alimentation and patient retention rate 1 to 5 days after passing the Yale Swallow Protocol. Participants were 200 consecutive acute care inpatients referred for swallow assessment. Inclusion criteria were adequate cognitive abilities to participate safely, completing an oral mechanism examination, and passing the 3-ounce water swallow challenge. Exclusion criteria were altered mental status, failing the 3-ounce challenge, preadmission dysphagia, head-of-bed restrictions alimentation and retention rate. All patients who remained medically and neurologically stable drank thin liquids and ate successfully 1 to 5 days after passing the protocol. Mean (SD) volume of liquid ingested per day was 474.2 (435.5) cc. Patient retention declined steadily from day of testing (n = 200) through post-testing day 5 (n = 95). Passing the Yale Swallow Protocol allowed for initial determination of aspiration risk followed by successful oral alimentation for 1 to 5 days in medically and neurologically stable acute care hospitalized patients and without the need for instrumental dysphagia testing. The decline in patient retention was expected because of increasingly rapid transit through the acute care setting, which often renders longer follow-up problematic. © The Author(s) 2014.

Comparison of in-and outpatients protocols for providence night time only bracing in AIS patients -- compliance and satisfaction

DEFF Research Database (Denmark)

Al-Aubaidi, Zaid Tj; Tropp, Hans; Pedersen, Niels W

2013-01-01

BACKGROUND: Skeletally immature patients diagnosed with adolescent idiopathic scoliosis (AIS) and a Cobb angle above 25degrees is usually treated with a brace. Standard protocols in many centers include hospitalisation for a few days for the purpose of brace adaptation and fitting. The aim...... of this study is to compare compliance and satisfaction in hospitalization and out patient clinic protocols, at the initiation phase of brace treatment.Materials and methodsTwenty-four consecutive patients with AIS were initiated with the Providence night time only brace at our department between October 2008...

[Comparision of in vitro maturation applied in PCOS and non-PCOS patients undergo stimulated and unstimulated protocols].

Science.gov (United States)

Wang, Peiyu; Zhao, Junzhao; Jin, Congcong; Yu, Rong; Lin, Jia; Zhu, Ruru; Wu, Yonggen

2014-12-01

To compare the laboratory and clinical results between unstimulated in vitro maturation (IVM) and IVM converted from in vitro fertilization (IVF) in polycystic ovarian syndrome (PCOS) and non-PCOS patients. We divided 591 IVM cycles in the First Affiliated Hospital of Wenzhou Medical Univesity from Jan. 2008 to Dec. 2013 into 4 groups: group A1B1, PCOS patients underwent unstimulated IVM protocol, 240 cycles; group A1B2, PCOS patients underwent IVM converted from conventional stimulated IVF protocol, 153 cycles; group A2B1, non-PCOS patients underwent unstimutlated IVM protocol, 103 cycles; group A2B2, non-PCOS patient underwent IVM converted from conventional stimulated IVF protocol, 95 cycles. Multiple linear regression method and binary logistic regression method were used to assess the influence of PCOS and protocols for IVM on laboratory and clinical outcomes. The mean number of oocytes retrieved was positively related with PCOS [partial regression coefficient (B) = 3.37, P PCOS and IVM converted from IVF (B = 0.08, P = 0.010; B = 0.09, P = 0.001), as well as implantation rate related with them (B = 0.07, P = 0.010; B = 0.10, P PCOS and IVM converted from IVF improved hCG positive (hCG>10 U/L) rate (OR = 1.636, 95%CI: 1.113-2.204, P PCOS condition and protocol used (P > 0.05). PCOS and IVM converted from IVF protocol improved the high-quality embryo rate, implantation rate, hCG positive rate and clinical pregnancy rate. IVM converted from IVF protocol reduced the spontaneous abortion rate. PCOS patients may be more suitable for the IVM treatment. No matter PCOS or non-PCOS patients, IVM converted from IVF protocol had better pregnancy outcome than that of unstimulated cycle.

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review.

Science.gov (United States)

Gillman, Anna; Winkler, Renata; Taylor, Nicholas F

2017-06-01

The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes. A systematic review was conducted of research published in peer-reviewed journals. An electronic search of the EMBASE, CINAHL and MEDLINE databases was completed up to July 2016. A total of 8 studies were identified for inclusion: 5 randomised controlled trials, 2 cohort studies with matched cases and 1 single group pre-post intervention prospective study. A total of 215 rehabilitation inpatients and 30 acute patients with oropharyngeal dysphagia who required thickened fluids or were to remain 'nil by mouth', as determined by bedside swallow assessment and/or videofluoroscopy/fiberoptic endoscopic evaluation of swallowing, were included. Meta-analyses of the data from the rehabilitation studies revealed (1) low-quality evidence that implementing the protocol did not result in increased odds of having lung complications and (2) low-quality evidence that fluid intake may increase. Patients' perceptions of swallow-related quality of life appeared to improve. This review has found that when the protocol is closely adhered to and patients are carefully selected using strict exclusion criteria, including an evaluation of their cognition and mobility, adult rehabilitation inpatients with dysphagia to thin fluids can be offered the choice of implementing the Free Water Protocol. Further research is required to determine if the Free Water Protocol can be implemented in settings other than inpatient rehabilitation.

Results of a protocol of transfusion threshold and surgical technique on transfusion requirements in burn patients.

Science.gov (United States)

O'Mara, Michael S; Hayetian, Fernando; Slater, Harvey; Goldfarb, I William; Tolchin, Eric; Caushaj, Philip F

2005-08-01

Blood loss and high rates of transfusion in burn centers remains an area of ongoing concern. Blood use brings the risk of infection, adverse reaction, and immunosuppression. A protocol to reduce blood loss and blood use was implemented. Analysis included 3-year periods before and after institution of the protocol. All patients were transfused for a hemoglobin below 8.0 gm/dL. Operations per admission did not change during the two time periods (0.78 in each). Overall units transfused per operation decreased from 1.56+/-0.06 to 1.25+/-0.14 units after instituting the protocol (pburns of less than 20% surface area, declining from 386 to 46 units after protocol institution, from 0.37 to 0.04 units per admission, and from 0.79 to 0.08 units per operation in this group of smallest burns. There was no change noted in the larger burns. This study suggests that a defined protocol of hemostasis, technique, and transfusion trigger should be implemented in the process of burn excision and grafting. This will help especially those patients with the smallest burns, essentially eliminating transfusion need in that group.

Corifollitropin alfa followed by rFSH in a GnRH antagonist protocol for poor ovarian responder patients

DEFF Research Database (Denmark)

Polyzos, Nikolaos P; Devos, Michel; Humaidan, Peter

2013-01-01

OBJECTIVE: To identify whether women with poor ovarian response may benefit from treatment with corifollitropin alfa in a GnRH antagonist protocol. DESIGN: Retrospective pilot study. SETTING: University-based tertiary care center. PATIENT(S): Poor ovarian responders fulfilling the Bologna criteria...... developed by European Society for Human Reproduction and Embryology Consensus Group. INTERVENTION(S): Corifollitropin alfa (150 μg) followed by 300 IU rFSH in a GnRH antagonist protocol. MAIN OUTCOME MEASURE(S): Endocrinologic profile and ongoing pregnancy rates. RESULT(S): Among 43 women treated...

557 Test and Manage Protocol for 841 Patients Requiring Iodinated Contrast Media (Icm) in Pediatrics

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Diaz, Maria Cristina; Lavrut, Alberto Jorge; Spinelli, Silvia Susana

2012-01-01

Background ICM's adverse effects are quite frequent and potentially serious. The use of protocols to test and manage patients receiving ICM could help to decrease the adverse effects because they advise against the studies or prescribe the administration of premedication; however, its use in pediatrics is still limited. We describe the results of the use of a test and management protocol for pediatric patients requiring ICM. Methods All the patients of a pediatric hospital prescribed with ICM between 31st January 2008 and 5th March 2011 were included. The following variables have been analyzed: age, sex, type of study to be performed, diagnoses and hospitalized or outpatient, risk (regular, increased or non-advised) and the presence of adverse reactions. We also analyzed the relation between risk and age, sex and condition (chi cuadrado o t test). Significance level P < 0.05. Results We included 841 patients (56.9% male, age = 92.7 ± 24.5 months, 60% hospitalized). The most frequent test was chest Tc (36%) and the most frequent diagnosis was solid tumors (25%). Patients with increased risk were significantly lower than those with regular risk (75.7 ± 69.7 months vs 109.7 ± 61.6, P < 0.001). During the research period there were no adverse effects. Conclusions The classification of risk groups by this Goverment Buenos Aires City protocols allows a rational management of the patients requiring ICM and minimize the adverse effects.

Using an intervention mapping approach to develop a discharge protocol for intensive care patients.

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van Mol, Margo; Nijkamp, Marjan; Markham, Christine; Ista, Erwin

2017-12-19

Admission into an intensive care unit (ICU) may result in long-term physical, cognitive, and emotional consequences for patients and their relatives. The care of the critically ill patient does not end upon ICU discharge; therefore, integrated and ongoing care during and after transition to the follow-up ward is pivotal. This study described the development of an intervention that responds to this need. Intervention Mapping (IM), a six-step theory- and evidence-based approach, was used to guide intervention development. The first step, a problem analysis, comprised a literature review, six semi-structured telephone interviews with former ICU-patients and their relatives, and seven qualitative roundtable meetings for all eligible nurses (i.e., 135 specialized and 105 general ward nurses). Performance and change objectives were formulated in step two. In step three, theory-based methods and practical applications were selected and directed at the desired behaviors and the identified barriers. Step four designed a revised discharge protocol taking into account existing interventions. Adoption, implementation and evaluation of the new discharge protocol (IM steps five and six) are in progress and were not included in this study. Four former ICU patients and two relatives underlined the importance of the need for effective discharge information and supportive written material. They also reported a lack of knowledge regarding the consequences of ICU admission. 42 ICU and 19 general ward nurses identified benefits and barriers regarding discharge procedures using three vignettes framed by literature. Some discrepancies were found. For example, ICU nurses were skeptical about the impact of writing a lay summary despite extensive evidence of the known benefits for the patients. ICU nurses anticipated having insufficient skills, not knowing the patient well enough, and fearing legal consequences of their writings. The intervention was designed to target the knowledge

Whole-Body Magnetic Resonance Angiography at 3 Tesla Using a Hybrid Protocol in Patients with Peripheral Arterial Disease

International Nuclear Information System (INIS)

Nielsen, Yousef W.; Eiberg, Jonas P.; Logager, Vibeke B.; Schroeder, Torben V.; Just, Sven; Thomsen, Henrik S.

2009-01-01

The purpose of this study was to determine the diagnostic performance of 3T whole-body magnetic resonance angiography (WB-MRA) using a hybrid protocol in comparison with a standard protocol in patients with peripheral arterial disease (PAD). In 26 consecutive patients with PAD two different protocols were used for WB-MRA: a standard sequential protocol (n = 13) and a hybrid protocol (n = 13). WB-MRA was performed using a gradient echo sequence, body coil for signal reception, and gadoterate meglumine as contrast agent (0.3 mmol/kg body weight). Two blinded observers evaluated all WB-MRA examinations with regard to presence of stenoses, as well as diagnostic quality and degree of venous contamination in each of the four stations used in WB-MRA. Digital subtraction angiography served as the method of reference. Sensitivity for detecting significant arterial disease (luminal narrowing ≥ 50%) using standard-protocol WB-MRA for the two observers was 0.63 (95%CI: 0.51-0.73) and 0.66 (0.58-0.78). Specificities were 0.94 (0.91-0.97) and 0.96 (0.92-0.98), respectively. In the hybrid protocol WB-MRA sensitivities were 0.75 (0.64-0.84) and 0.70 (0.58-0.8), respectively. Specificities were 0.93 (0.88-0.96) and 0.95 (0.91-0.97). Interobserver agreement was good using both the standard and the hybrid protocol, with κ = 0.62 (0.44-0.67) and κ = 0.70 (0.59-0.79), respectively. WB-MRA quality scores were significantly higher in the lower leg using the hybrid protocol compared to standard protocol (p = 0.003 and p = 0.03, observers 1 and 2). Distal venous contamination scores were significantly lower with the hybrid protocol (p = 0.02 and p = 0.01, observers 1 and 2). In conclusion, hybrid-protocol WB-MRA shows a better diagnostic performance than standard protocol WB-MRA at 3 T in patients with PAD.

Design and Analysis of an Enhanced Patient-Server Mutual Authentication Protocol for Telecare Medical Information System.

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Amin, Ruhul; Islam, S K Hafizul; Biswas, G P; Khan, Muhammad Khurram; Obaidat, Mohammad S

2015-11-01

In order to access remote medical server, generally the patients utilize smart card to login to the server. It has been observed that most of the user (patient) authentication protocols suffer from smart card stolen attack that means the attacker can mount several common attacks after extracting smart card information. Recently, Lu et al.'s proposes a session key agreement protocol between the patient and remote medical server and claims that the same protocol is secure against relevant security attacks. However, this paper presents several security attacks on Lu et al.'s protocol such as identity trace attack, new smart card issue attack, patient impersonation attack and medical server impersonation attack. In order to fix the mentioned security pitfalls including smart card stolen attack, this paper proposes an efficient remote mutual authentication protocol using smart card. We have then simulated the proposed protocol using widely-accepted AVISPA simulation tool whose results make certain that the same protocol is secure against active and passive attacks including replay and man-in-the-middle attacks. Moreover, the rigorous security analysis proves that the proposed protocol provides strong security protection on the relevant security attacks including smart card stolen attack. We compare the proposed scheme with several related schemes in terms of computation cost and communication cost as well as security functionalities. It has been observed that the proposed scheme is comparatively better than related existing schemes.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

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Pastor, María-Ángeles; López-Roig, Sofía; Lledó, Ana; Peñacoba, Cecilia; Velasco, Lilian; Schweiger-Gallo, Inge; Cigarán, Margarita; Ecija, Carmen; Limón, Ramón; Sanz, Yolanda

2014-04-11

Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. The first data gathered have allowed us to identify the characteristics of the study population and

Implementation of a respiratory rehabilitation protocol: weaning from the ventilator and tracheostomy in difficult-to-wean patients with spinal cord injury.

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Gundogdu, Ibrahim; Ozturk, Erhan Arif; Umay, Ebru; Karaahmet, Ozgur Zeliha; Unlu, Ece; Cakci, Aytul

2017-06-01

Following repeated weaning failures in acute care services, spinal cord injury (SCI) patients who require prolonged mechanical ventilation and tracheostomy are discharged to their homes or skilled nursing facilities, with a portable mechanical ventilator (MV) and/or tracheostomy tube (TT) with excess risk of complications, high cost and low quality of life. We hypothesized that many difficult-to-wean patients with cervical SCI can be successfully managed in a rehabilitation clinic. The aim of our study was to develop a respiratory rehabilitation, MV weaning and TT decannulation protocol and to evaluate the effectiveness of this protocol in tetraplegic patients. A multidisciplinary and multifaceted protocol, including respiratory assessment and management themes, was developed and performed based on the findings from other studies in the literature. Tetraplegic patients with the diagnosis of difficult-to-wean, who were admitted to the rehabilitation clinic after having been discharged from the intensive care unit to their home with home-type MV and/or TT, were included in this prospective observational study. The respiratory rehabilitation protocol was applied to 35 tetraplegic patients (10 home-type MV and tracheostomy-dependent, and 25 tracheostomized patients) with C1-C7 ASIA impairment scale grade A, B, and C injuries. Seven out of 10 patients successfully weaned from MV and 30 of 35 patients were decannulated. Four patients were referred for diaphragm pace stimulation and tracheal stenosis surgery. The mean durations of MV weaning and decannulation were 37 and 31 days, respectively. A multifaceted, multidisciplinary respiratory management program can change the process of care used for difficult-to-wean patients with SCI. Implications for rehabilitation Findings from this study indicate the significance of a multidimensional evaluation of any reversible factors for prolonged MV- and/or TT-dependent SCI patients. Thus, rehabilitation specialists should take this

An Outcomes Study on the Effects of the Singapore General Hospital Burns Protocol.

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Liang, Weihao; Kok, Yee Onn; Tan, Bien Keem; Chong, Si Jack

2018-01-01

The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

Radiation dose reduction in CT-guided periradicular injections in lumbar spine: Feasibility of a new institutional protocol for improved patient safety

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Artner Juraj

2012-08-01

Full Text Available Abstract Background Image guided spinal injections are successfully used in the management of low back pain and sciatica. The main benefit of CT-guided injections is the safe, fast and precise needle placement, but the radiation exposure remains a serious concern. The purpose of the study was to test a new institutional low-dose protocol for CT-guided periradicular injections in lumbar spine to reduce radiation exposure while increasing accuracy and safety for the patients. Methods We performed a retrospective analysis of a prospective database during a 4-month period (Oct-Dec 2011 at a German University hospital using a newly established low-dose-CT-protocol for periradicular injections in patients suffering from lumbar disc herniation and nerve root entrapment. Inclusion criteria were acute or chronic nerve root irritation due to lumbar disc hernia, age over 18, compliance and informed consent. Excluded were patients suffering from severe obesity (BMI > 30, coagulopathy, allergy to injected substances, infection and non-compliant patients. Outcome parameters consisted of the measured dose length product (mGycm2, the amount of scans, age, gender, BMI and the peri-interventional complications. The results were compared to 50 patients, treated in the standard-interventional CT-protocol for spinal injections, performed in June-Oct 2011, who met the above mentioned inclusion criteria. Results A total amount of 100 patients were enrolled in the study. A significant radiation dose reduction (average 85.31% was achieved using the institutional low-dose protocol compared to standard intervention mode in CT-guided periradicular injections in lumbar spine. Using the low-dose protocol did not increase the complications rate in the analyzed cohort. Conclusions Low-dose-CT-protocols for lumbar perineural injections significantly reduce the exposure to radiation of non-obese patients without an increase of complications. This increases long-time patient

Restrictive blood transfusion protocol in liver resection patients reduces blood transfusions with no increase in patient morbidity.

Science.gov (United States)

Wehry, John; Cannon, Robert; Scoggins, Charles R; Puffer, Lisa; McMasters, Kelly M; Martin, Robert C G

2015-02-01

Management of anemia in surgical oncology patients remains one of the key quality components in overall care and cost. Continued reports demonstrate the effects of hospital transfusion, which has been demonstrated to lead to a longer length of stay, more complications, and possibly worse overall oncologic outcomes. The hypothesis for this study was that a dedicated restrictive transfusion protocol in patients undergoing hepatectomy would lead to less overall blood transfusion with no increase in overall morbidity. A cohort study was performed using our prospective database from January 2000 to June 2013. September 2011 served as the separation point for the date of operation criteria because this marked the implementation of more restrictive blood transfusion guidelines. A total of 186 patients undergoing liver resection were reviewed. The restrictive blood transfusion guidelines reduced the percentage of patients that received blood from 31.0% before January 9, 2011 to 23.3% after this date (P = .03). The liver procedure that was most consistently associated with higher levels of transfusion was a right lobectomy (16%). Prior surgery and endoscopic stent were the 2 preoperative interventions associated with receiving blood. Patients who received blood before and after the restrictive period had similar predictive factors: major hepatectomies, higher intraoperative blood loss, lower preoperative hemoglobin level, older age, prior systemic chemotherapy, and lower preoperative nutritional parameters (all P blood did not have worse overall progression-free survival or overall survival. A restrictive blood transfusion protocol reduces the incidence of blood transfusions and the number of packed red blood cells transfused. Patients who require blood have similar preoperative and intraoperative factors that cannot be mitigated in oncology patients. Restrictive use of blood transfusions can reduce cost and does adversely affect patients undergoing liver resection

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

Science.gov (United States)

Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

2016-09-29

Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www

Efficacy of protocol-based pharmacotherapy management on anticoagulation with warfarin for patients with cardiovascular surgery.

Science.gov (United States)

Katada, Y; Nakagawa, S; Minakata, K; Odaka, M; Taue, H; Sato, Y; Yonezawa, A; Kayano, Y; Yano, I; Nakatsu, T; Sakamoto, K; Uehara, K; Sakaguchi, H; Yamazaki, K; Minatoya, K; Sakata, R; Matsubara, K

2017-10-01

Anticoagulation therapy with warfarin requires periodic monitoring of prothrombin time-international normalized ratio (PT-INR) and adequate dose adjustments based on the data to minimize the risk of bleeding and thromboembolic events. In our hospital, we have developed protocol-based pharmaceutical care, which we called protocol-based pharmacotherapy management (PBPM), for warfarin therapy. The protocol requires pharmacists to manage timing of blood sampling for measuring PT-INR and warfarin dosage determination based on an algorithm. This study evaluated the efficacy of PBPM in warfarin therapy by comparing to conventional pharmaceutical care. From October 2013 to June 2015, a total of 134 hospitalized patients who underwent cardiovascular surgeries received post-operative warfarin therapy. The early series of patients received warfarin therapy as the conventional care (control group, n=77), whereas the latter received warfarin therapy based on the PBPM (PBPM group, n=68). These patients formed the cohort of the present study and were retrospectively analysed. The indications for warfarin included aortic valve replacement (n=56), mitral valve replacement (n=4), mitral valve plasty (n=22) and atrial fibrillation (n=29). There were no differences in patients' characteristics between both groups. The percentage time in therapeutic range in the first 10 days was significantly higher in the PBPM group (47.1%) than that in the control group (34.4%, PWarfarin therapy based on our novel PBPM was clinically safe and resulted in significantly better anticoagulation control compared to conventional care. © 2017 John Wiley & Sons Ltd.

Imaging algorithms and CT protocols in trauma patients: survey of Swiss emergency centers

International Nuclear Information System (INIS)

Hinzpeter, R.; Alkadhi, Hatem; Boehm, T.; Boll, D.; Constantin, C.; Del Grande, F.; Fretz, V.; Leschka, S.; Ohletz, T.; Broennimann, M.; Schmidt, S.; Treumann, T.; Poletti, P.A.

2017-01-01

To identify imaging algorithms and indications, CT protocols, and radiation doses in polytrauma patients in Swiss trauma centres. An online survey with multiple choice questions and free-text responses was sent to authorized level-I trauma centres in Switzerland. All centres responded and indicated that they have internal standardized imaging algorithms for polytrauma patients. Nine of 12 centres (75 %) perform whole-body CT (WBCT) after focused assessment with sonography for trauma (FAST) and conventional radiography; 3/12 (25 %) use WBCT for initial imaging. Indications for WBCT were similar across centres being based on trauma mechanisms, vital signs, and presence of multiple injuries. Seven of 12 centres (58 %) perform an arterial and venous phase of the abdomen in split-bolus technique. Six of 12 centres (50 %) use multiphase protocols of the head (n = 3) and abdomen (n = 4), whereas 6/12 (50 %) use single-phase protocols for WBCT. Arm position was on the patient's body during scanning (3/12, 25 %), alongside the body (2/12, 17 %), above the head (2/12, 17 %), or was changed during scanning (5/12, 42 %). Radiation doses showed large variations across centres ranging from 1268-3988 mGy*cm (DLP) per WBCT. Imaging algorithms in polytrauma patients are standardized within, but vary across Swiss trauma centres, similar to the individual WBCT protocols, resulting in large variations in associated radiation doses. (orig.)

Imaging algorithms and CT protocols in trauma patients: survey of Swiss emergency centers

Energy Technology Data Exchange (ETDEWEB)

Hinzpeter, R.; Alkadhi, Hatem [University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, Zurich (Switzerland); Boehm, T. [Kantonsspital Graubuenden, Department of Radiology, Chur (Switzerland); Boll, D. [University Hospital Basel, Department of Radiology and Nuclear Medicine, Basel (Switzerland); Constantin, C. [Spital Wallis, Department of Radiology, Visp (Switzerland); Del Grande, F. [Ospedale Regionale di Lugano, Department of Radiology, Lugano (Switzerland); Fretz, V. [Kantonsspital Winterthur, Institute of Radiology and Nuclear Medicine, Winterthur (Switzerland); Leschka, S. [Kantonsspital St Gallen, Division of Radiology and Nuclear Medicine, Gallen (Switzerland); Ohletz, T. [Kantonsspital Aarau, Department of Radiology, Aarau (Switzerland); Broennimann, M. [University Hospital Bern, Department of Diagnostic, Interventional and Pediatric Radiology, Bern (Switzerland); Schmidt, S. [Lausanne University Hospital, Department of Diagnostic and Interventional Radiology, Lausanne (Switzerland); Treumann, T. [Luzerner Kantonsspital, Institute of Radiology, Luzern 16 (Switzerland); Poletti, P.A. [Geneva University Hospital, Department of Radiology, Geneve (Switzerland)

2017-05-15

To identify imaging algorithms and indications, CT protocols, and radiation doses in polytrauma patients in Swiss trauma centres. An online survey with multiple choice questions and free-text responses was sent to authorized level-I trauma centres in Switzerland. All centres responded and indicated that they have internal standardized imaging algorithms for polytrauma patients. Nine of 12 centres (75 %) perform whole-body CT (WBCT) after focused assessment with sonography for trauma (FAST) and conventional radiography; 3/12 (25 %) use WBCT for initial imaging. Indications for WBCT were similar across centres being based on trauma mechanisms, vital signs, and presence of multiple injuries. Seven of 12 centres (58 %) perform an arterial and venous phase of the abdomen in split-bolus technique. Six of 12 centres (50 %) use multiphase protocols of the head (n = 3) and abdomen (n = 4), whereas 6/12 (50 %) use single-phase protocols for WBCT. Arm position was on the patient's body during scanning (3/12, 25 %), alongside the body (2/12, 17 %), above the head (2/12, 17 %), or was changed during scanning (5/12, 42 %). Radiation doses showed large variations across centres ranging from 1268-3988 mGy*cm (DLP) per WBCT. Imaging algorithms in polytrauma patients are standardized within, but vary across Swiss trauma centres, similar to the individual WBCT protocols, resulting in large variations in associated radiation doses. (orig.)

Developing a Mobility Protocol for Early Mobilization of Patients in a Surgical/Trauma ICU

Directory of Open Access Journals (Sweden)

Meg Zomorodi

2012-01-01

Full Text Available As technology and medications have improved and increased, survival rates are also increasing in intensive care units (ICUs, so it is now important to focus on improving the patient outcomes and recovery. To do this, ICU patients need to be assessed and started on an early mobility program, if stable. While the early mobilization of the ICU patients is not without risk, the current literature has demonstrated that patients can be safely and feasibly mobilized, even while requiring mechanical ventilation. These patients are at a high risk for muscle deconditioning due to limited mobility from numerous monitoring equipment and multiple medical conditions. Frequently, a critically ill patient only receives movement from nurses; such as, being turned side to side, pulled up in bed, or transferred from bed to a stretcher for a test. The implementation of an early mobility protocol that can be used by critical care nurses is important for positive patient outcomes minimizing the functional decline due to an ICU stay. This paper describes a pilot study to evaluate an early mobilization protocol to test the safety and feasibility for mechanically ventilated patients in a surgical trauma ICU in conjunction with the current unit standards.

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.

Science.gov (United States)

van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

2008-09-01

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.

Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Huppelschoten Aleida G

2012-09-01

Full Text Available Abstract Background Beside traditional outcomes of safety and (cost-effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients’ quality of life (QoL and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients’ QoL and distress levels. This paper presents the study protocol. Methods/Design In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire – Infertility, patients’ QoL (FertiQoL and levels of distress (SCREENIVF. The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients’ QoL and levels of distress will be collected by an addendum to the patients’ questionnaire and a professionals’ questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic’s culture as a possible determinant of an increase in patient-centered care. Discussion The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients’ QoL and distress in fertility care. Furthermore, determinants associated with a change

Use of a patient hand hygiene protocol to reduce hospital-acquired infections and improve nurses' hand washing.

Science.gov (United States)

Fox, Cherie; Wavra, Teresa; Drake, Diane Ash; Mulligan, Debbie; Bennett, Yvonne Pacheco; Nelson, Carla; Kirkwood, Peggy; Jones, Louise; Bader, Mary Kay

2015-05-01

Critically ill patients are at marked risk of hospital-acquired infections, which increase patients' morbidity and mortality. Registered nurses are the main health care providers of physical care, including hygiene to reduce and prevent hospital-acquired infections, for hospitalized critically ill patients. To investigate a new patient hand hygiene protocol designed to reduce hospital-acquired infection rates and improve nurses' hand-washing compliance in an intensive care unit. A preexperimental study design was used to compare 12-month rates of 2 common hospital-acquired infections, central catheter-associated bloodstream infection and catheter-associated urinary tract infection, and nurses' hand-washing compliance measured before and during use of the protocol. Reductions in 12-month infection rates were reported for both types of infections, but neither reduction was statistically significant. Mean 12-month nurse hand-washing compliance also improved, but not significantly. A hand hygiene protocol for patients in the intensive care unit was associated with reductions in hospital-acquired infections and improvements in nurses' hand-washing compliance. Prevention of such infections requires continuous quality improvement efforts to monitor lasting effectiveness as well as investigation of strategies to eliminate these infections. ©2015 American Association of Critical-Care Nurses.

A Higher-Calorie Refeeding Protocol Does Not Increase Adverse Outcomes in Adult Patients with Eating Disorders.

Science.gov (United States)

Matthews, Kylie; Hill, Jan; Jeffrey, Shane; Patterson, Susan; Davis, Amanda; Ward, Warren; Palmer, Michelle; Capra, Sandra

2018-04-12

Patients with eating disorders (EDs) are often considered a high-risk population to refeed. Current research advises using "start low, go slow" refeeding methods (∼1,000 kcal/day, advancing ∼500 kcal/day every 3 to 4 days) in adult patients with severe EDs to prevent the development of refeeding syndrome (RFS), typically characterized by decreases in serum electrolyte levels and fluid shifts. To compare the incidence of RFS and related outcomes using a low-calorie protocol (LC) (1,000 kcal) or a higher-calorie protocol (HC) (1,500 kcal) in medically compromised adult patients with EDs. This was a retrospective pre-test-post-test study. One hundred and nineteen participants with EDs, medically admitted to a tertiary hospital in Brisbane, Australia, between December 2010 and January 2017, were included (LC: n=26, HC: n=93). The HC refeeding protocol was implemented in September 2013. Differences in prevalence of electrolyte disturbances, hypoglycemia, edema, and RFS diagnoses were examined. χ 2 tests, Kruskal-Wallis H test, analysis of variance, and independent t tests were used to compare data between the two protocols. Descriptors were similar between groups (LC: 28±9 years, 96% female, 85% with anorexia nervosa, 31% admitted primarily because of clinical symptoms of exacerbated ED vs HC: 27±9 years, 97% female, 84% with anorexia nervosa, 44% admitted primarily because of clinical symptoms of exacerbated ED, P>0.05). Participants refed using the LC protocol had higher incidence rates of hypoglycemia (LC: 31% vs HC: 10%, P=0.012), with no statistical or clinical differences in electrolyte disturbances (LC: 65% vs HC: 45%, P=0.079), edema (LC: 8% vs HC: 6%, P=0.722) or diagnosed RFS (LC: 4% vs HC: 1%, P=0.391). A higher-calorie refeeding protocol appears to be safe, with no differences in rates of electrolyte disturbances or clinically diagnosed RFS and a lower incidence of hypoglycemia. Future research examining higher-calorie intakes, similar to those

Luteal blood flow in patients undergoing GnRH agonist long protocol

Directory of Open Access Journals (Sweden)

Takasaki Akihisa

2011-01-01

Full Text Available Abstract Background Blood flow in the corpus luteum (CL is closely related to luteal function. It is unclear how luteal blood flow is regulated. Standardized ovarian-stimulation protocol with a gonadotropin-releasing hormone agonist (GnRHa long protocol causes luteal phase defect because it drastically suppresses serum LH levels. Examining luteal blood flow in the patient undergoing GnRHa long protocol may be useful to know whether luteal blood flow is regulated by LH. Methods Twenty-four infertile women undergoing GnRHa long protocol were divided into 3 groups dependent on luteal supports; 9 women were given ethinylestradiol plus norgestrel (Planovar orally throughout the luteal phase (control group; 8 women were given HCG 2,000 IU on days 2 and 4 day after ovulation induction in addition to Planovar (HCG group; 7 women were given vitamin E (600 mg/day orally throughout the luteal phase in addition to Planovar (vitamin E group. Blood flow impedance was measured in each CL during the mid-luteal phase by transvaginal color-pulsed-Doppler-ultrasonography and was expressed as a CL-resistance index (CL-RI. Results Serum LH levels were remarkably suppressed in all the groups. CL-RI in the control group was more than the cutoff value (0.51, and only 2 out of 9 women had CL-RI values Conclusion Patients undergoing GnRHa long protocol had high luteal blood flow impedance with very low serum LH levels. HCG administration improved luteal blood flow impedance. This suggests that luteal blood flow is regulated by LH.

Desensitization protocols and their outcome.

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Marfo, Kwaku; Lu, Amy; Ling, Min; Akalin, Enver

2011-04-01

In the last decade, transplantation across previously incompatible barriers has increasingly become popular because of organ donor shortage, availability of better methods of detecting and characterizing anti-HLA antibodies, ease of diagnosis, better understanding of antibody-mediated rejection, and the availability of effective regimens. This review summarizes all manuscripts published since the first publication in 2000 on desensitized patients and discusses clinical outcomes including acute and chronic antibody-mediated rejection rate, the new agents available, kidney paired exchange programs, and the future directions in sensitized patients. There were 21 studies published between 2000 and 2010, involving 725 patients with donor-specific anti-HLA antibodies (DSAs) who underwent kidney transplantation with different desensitization protocols. All studies were single center and retrospective. The patient and graft survival were 95% and 86%, respectively, at a 2-year median follow-up. Despite acceptable short-term patient and graft survivals, acute rejection rate was 36% and acute antibody-mediated rejection rate was 28%, which is significantly higher than in nonsensitized patients. Recent studies with longer follow-up of those patients raised concerns about long-term success of desensitization protocols. The studies utilizing protocol biopsies in desensitized patients also reported higher subclinical and chronic antibody-mediated rejection. An association between the strength of DSAs determined by median fluorescence intensity values of Luminex single-antigen beads and risk of rejection was observed. Two new agents, bortezomib, a proteasome inhibitor, and eculizumab, an anti-complement C5 antibody, were recently introduced to desensitization protocols. An alternative intervention is kidney paired exchange, which should be considered first for sensitized patients. © 2011 by the American Society of Nephrology

Cost of Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS): prospective cohort study protocol.

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Teo, Irene; Singh, Ratna; Malhotra, Chetna; Ozdemir, Semra; Dent, Rebecca A; Kumarakulasinghe, Nesaretnam Barr; Yeo, Wee Lee; Cheung, Yin Bun; Malhotra, Rahul; Kanesvaran, Ravindran; Yee, Alethea Chung Pheng; Chan, Noreen; Wu, Huei Yaw; Chin, Soh Mun; Allyn, Hum Yin Mei; Yang, Grace Meijuan; Neo, Patricia Soek Hui; Nadkarni, Nivedita V; Harding, Richard; Finkelstein, Eric A

2018-04-23

Advanced cancer significantly impacts quality of life of patients and families as they cope with symptom burden, treatment decision-making, uncertainty and costs of treatment. In Singapore, information about the experiences of advanced cancer patients and families and the financial cost they incur for end-of-life care is lacking. Understanding of this information is needed to inform practice and policy to ensure continuity and affordability of care at the end of life. The primary objectives of the Cost of Medical Care of Patients with Advanced Serious Illness in Singapore (COMPASS) cohort study are to describe changes in quality of life and to quantify healthcare utilization and costs of patients with advanced cancer at the end of life. Secondary objectives are to investigate patient and caregiver preferences for diagnostic and prognostic information, preferences for end-of-life care, caregiver burden and perceived quality of care and to explore how these change as illness progresses and finally to measure bereavement adjustment. The purpose of this paper is to present the COMPASS protocol in order to promote scientific transparency. This cohort study recruits advanced cancer patients (n = 600) from outpatient medical oncology clinics at two public tertiary healthcare institutions in Singapore. Patients and their primary informal caregiver are surveyed every 3 months until patients' death; caregivers are followed until 6 months post patient death. Patient medical and billing records are obtained and merged with patient survey data. The treating medical oncologists of participating patients are surveyed to obtain their beliefs regarding care delivery for the patient. The study will allow combination of self-report, medical, and cost data from various sources to present a comprehensive picture of the end-of-life experience of advanced cancer patients in a unique Asian setting. This study is responsive to Singapore's National Strategy for Palliative Care which

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

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Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

��= 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Development of a new Emergency Medicine Spinal Immobilization Protocol for trauma patients and a test of applicability by German emergency care providers.

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Kreinest, Michael; Gliwitzky, Bernhard; Schüler, Svenja; Grützner, Paul A; Münzberg, Matthias

2016-05-14

In order to match the challenges of quickly recognizing and treating any life-threatening injuries, the ABCDE principles were established for the assessment and treatment of trauma patients. The high priority of spine protection is emphasized by the fact that immobilization of the cervical spine is performed at the very first step in the ABCDE principles. Immobilization is typically performed to prevent or minimize secondary damage to the spinal cord if instability of the spinal column is suspected. Due to increasing reports about disadvantages of spinal immobilization, the indications for performing spinal immobilization must be refined. The aim of this study was (i) to develop a protocol that supports decision-making for spinal immobilization in adult trauma patients and (ii) to carry out the first applicability test by emergency medical personnel. A structured literature search considering the literature from 1980 to 2014 was performed. Based on this literature and on the current guidelines, a new protocol that supports on scene decision-making for spinal immobilization has been developed. Parameters found in the literature concerning mechanisms and factors increasing the likelihood of spinal injury have been included in the new protocol. In order to test the applicability of the new protocol two surveys were performed on German emergency care providers by means of a questionnaire focused on correct decision-making if applying the protocol. Based on the current literature and guidelines, the Emergency Medicine Spinal Immobilization Protocol (E.M.S. IMMO Protocol) for adult trauma patients was developed. Following a fist applicability test involving 21 participants, the first version of the E.M.S. IMMO Protocol has to be graphically re-organized. A second applicability test comprised 50 participants with the current version of the protocol confirmed good applicability. Questions regarding immobilization of trauma patients could be answered properly using the E

Lung Ultrasonography in Patients With Idiopathic Pulmonary Fibrosis: Evaluation of a Simplified Protocol With High-Resolution Computed Tomographic Correlation.

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Vassalou, Evangelia E; Raissaki, Maria; Magkanas, Eleftherios; Antoniou, Katerina M; Karantanas, Apostolos H

2018-03-01

To compare a simplified ultrasonographic (US) protocol in 2 patient positions with the same-positioned comprehensive US assessments and high-resolution computed tomographic (CT) findings in patients with idiopathic pulmonary fibrosis. Twenty-five consecutive patients with idiopathic pulmonary fibrosis were prospectively enrolled and examined in 2 sessions. During session 1, patients were examined with a US protocol including 56 lung intercostal spaces in supine/sitting (supine/sitting comprehensive protocol) and lateral decubitus (decubitus comprehensive protocol) positions. During session 2, patients were evaluated with a 16-intercostal space US protocol in sitting (sitting simplified protocol) and left/right decubitus (decubitus simplified protocol) positions. The 16 intercostal spaces were chosen according to the prevalence of idiopathic pulmonary fibrosis-related changes on high-resolution CT. The sum of B-lines counted in each intercostal space formed the US scores for all 4 US protocols: supine/sitting and decubitus comprehensive US scores and sitting and decubitus simplified US scores. High-resolution CT-related Warrick scores (J Rheumatol 1991; 18:1520-1528) were compared to US scores. The duration of each protocol was recorded. A significant correlation was found between all US scores and Warrick scores and between simplified and corresponding comprehensive scores (P idiopathic pulmonary fibrosis. The 16-intercostal space simplified protocol in the lateral decubitus position correlated better with high-resolution CT findings and was less time-consuming compared to the sitting position. © 2017 by the American Institute of Ultrasound in Medicine.

Abdominal stab wound protocol: prospective study documents applicability for widespread use.

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Rosemurgy, A S; Albrink, M H; Olson, S M; Sherman, H; Albertini, J; Kramer, R; Camps, M; Reiss, A

1995-02-01

Traditionally, stab wounds violating the abdominal wall fascia led to exploratory celiotomy that was often nontherapeutic. In an attempt to limit the number of nontherapeutic celiotomies (NTC), we devised a protocol to prospectively study stab wounds violating the anterior abdominal wall fascia. Through protocol, abdominal stab wounds were explored in stable adults. If the anterior fascia was violated, paracentesis and, if necessary, peritoneal lavage was undertaken in the absence of previous abdominal surgery. If evisceration was noted, it was reduced and the patient lavaged. Fascial penetration was noted in 72 patients. 46 patients underwent celiotomy: because of shock/peritonitis in 8 (2 NTC), fascial penetration with a history of previous celiotomy in 7 (5 NTC), positive paracentesis in 20 (5 NTC), or positive lavage in 10 (4 NTC). One patient underwent late celiotomy without ill-effect after a negative lavage because she subsequently developed fever and localized peritonitis (ice pick injury to cecum). Eleven patients had evisceration; nine underwent celiotomy. Patients with abdominal stab wounds can be selectively managed safely. More than one-third with fascial penetration, some with evisceration, avoided exploration. Only one patient underwent delayed celiotomy and did so without detriment. Nontherapeutic celiotomy rates were highest in patients with previous abdominal surgery who, thereby, could not undergo paracentesis/lavage; excluding these patients, the nontherapeutic celiotomy rate was 17% (11/65) for those with fascial penetration.

Medical guidelines for the patient: introducing the life assistance protocols.

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Domínguez, David; Fernández, Carlos; Meneu, Teresa; Mocholí, Juan Bautista; Serafin, Riccardo

2008-01-01

This paper introduces our preliminary results in the modeling of Life Assistance Protocols, a new vision of medical guidelines and protocols through the lenses of p-Health. In this context the patient's role in the process is emphasized, the actions to be performed less defined and not only clinical situations considered, but also healthier lifestyle promotion processes accounted for, where the person's preferences and motivations play a key role. We propose a complete framework, balancing on classical clinical guideline models and covering both the theoretical and the practical aspects of the problem, describing it from conceptualization to the execution environment.

Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

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Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

2016-06-27

Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

Development of a Decision Support System to Predict Physicians' Rehabilitation Protocols for Patients with Knee Osteoarthritis

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Hawamdeh, Ziad M.; Alshraideh, Mohammad A.; Al-Ajlouni, Jihad M.; Salah, Imad K.; Holm, Margo B.; Otom, Ali H.

2012-01-01

To design a medical decision support system (MDSS) that would accurately predict the rehabilitation protocols prescribed by the physicians for patients with knee osteoarthritis (OA) using only their demographic and clinical characteristics. The demographic and clinical variables for 170 patients receiving one of three treatment protocols for knee…

Developing the Fourth Evaluation Dimension: A Protocol for Evaluation of Video From the Patient's Perspective During Major Incident Exercises.

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Haverkort, J J Mark; Leenen, Luke P H

2017-10-01

Presently used evaluation techniques rely on 3 traditional dimensions: reports from observers, registration system data, and observational cameras. Some of these techniques are observer-dependent and are not reproducible for a second review. This proof-of-concept study aimed to test the feasibility of extending evaluation to a fourth dimension, the patient's perspective. Footage was obtained during a large, full-scale hospital trauma drill. Two mock victims were equipped with point-of-view cameras filming from the patient's head. Based on the Major Incident Hospital's first experience during the drill, a protocol was developed for a prospective, standardized method to evaluate a hospital's major incident response from the patient's perspective. The protocol was then tested in a second drill for its feasibility. New insights were gained after review of the footage. The traditional observer missed some of the evaluation points, which were seen on the point-of-view cameras. The information gained from the patient's perspective proved to be implementable into the designed protocol. Use of point-of-view camera recordings from a mock patient's perspective is a valuable addition to traditional evaluation of trauma drills and trauma care. Protocols should be designed to optimize and objectify judgement of such footage. (Disaster Med Public Health Preparedness. 2017;11:594-599).

Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

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Verger, Antoine; Karcher, Gilles [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Djaballah, Wassila [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Fourquet, Nicolas [Clinique Pasteur, Toulouse (France); Rouzet, Francois; Le Guludec, Dominique [AP-HP, Hopital Bichat, Department of Nuclear Medicine, Paris (France); INSERM U 773 Inserm and Denis Diderot University, Paris (France); Koehl, Gregoire; Roch, Veronique [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Imbert, Laetitia [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Centre Alexis Vautrin, Department of Radiotherapy, Vandoeuvre (France); Poussier, Sylvain [INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Fay, Renaud [INSERM, Centre d' Investigation Clinique CIC-P 9501, Nancy (France); Marie, Pierre-Yves [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); INSERM U961, Nancy (France); Hopital de Brabois, CHU-Nancy, Medecine Nucleaire, Vandoeuvre-les-Nancy (France)

2013-03-15

The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving {sup 201}Tl (n = 120) or {sup 99m}Tc-sestamibi injected at low dose at stress ({sup 99m}Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ({sup 99m}Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, {sup 201}Tl 92 %, {sup 99m}Tc-Low 86 %, {sup 99m}Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the {sup 201}Tl or {sup 99m}Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 {+-} 101 kcounts) and dramatically enhanced with CZT SPECT (+279 {+-} 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

Directory of Open Access Journals (Sweden)

Anette Blümle

Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

[Carbapenem antibiotics in hospitalised paediatric patients. Adherence to a therapeutic protocol].

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Montesinos-Sanchis, Elena; Moraga-Llop, Fernando A; Soler-Palacín, Pere; Oliveras-Arenas, María; Larrosa Escartín, M Nieves; Martínez Gómez, Xavier; Figueras-Nadal, Concepción

2014-12-01

To describe the use of carbapenems in children hospitalised outside intensive care and onco-haematology units, and assess adherence to a therapeutic protocol. A retrospective observational study was conducted on the use of carbapenems between January 2009 and December 2010. The study included children with a community-acquired infectious disease or a health care-associated infectious disease, and who were admitted to paediatric areas of the Vall d'Hebron University Hospital (Barcelona, Spain), other than intensive care, neonatology and onco-haematology units. Clinical data were collected and antibiotic consumption data were provided by the Pharmacy Department. A total of 51 episodes fulfilled the inclusion criteria. Carbapenem as initial empirical treatment was indicated in 31.4%, and applied as rescue therapy in the remainder. The instructions of the protocol were adhered to in 70.6% of the empirical and 87.5% of the targeted prescriptions (77.6% overall). A better match was found for empirical carbapenem in patients with a previous admission or underlying condition. Factors such as diagnosis, age or antibiotic use prior to admission did not affect the empirical indication of carbapenem. The establishment of a treatment protocol with carbapenem indications in our centre since 2007 has yielded significantly better results on the appropriateness of the prescription than those obtained in other studies. Copyright © 2012 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Evaluation of the relationship between compliance with the follow-up and treatment protocol and health literacy in bladder tumor patients.

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Turkoglu, Ali Riza; Demirci, Hakan; Coban, Soner; Guzelsoy, Muhammet; Toprak, Erdem; Aydos, Mustafa Murat; Ture, Deniz Azkan; Ustundag, Yasemin

2018-03-07

To investigate the relationship between the compliance of bladder cancer patients with cystoscopic follow-up and the treatment protocol, and their health literacy. Patients who underwent transurethral resection surgery for bladder tumor were found to have non-muscular invasive bladder carcinoma on pathology examination and then underwent cystoscopic follow-up for 1 year or more were included in the study. Cystoscopic follow-up was recommended to the low- and high-risk groups in terms of progression and recurrence. The patients were evaluated with the Health Literacy Survey-European Union scale. The mean age of the patients was 67.13 ± 10.77 years. The treatment continuity rate was 80.50% (n = 33) in the adequate health literacy group (n = 41) and significantly higher than the 56.50% (n = 48) rate in the inadequate health literacy group (n = 85) (p = .008). The health literacy results revealed that the health promotion and general index score was higher in the group of patients under the age of 65. Adequate health literacy in bladder cancer patients is associated with better compliance with the treatment protocol. Young patients show better compliance with the follow-up protocol recommended by the physician. Increasing the follow-up protocol compliance of elderly patients with inadequate health literacy is necessary.

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

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Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

2010-01-01

To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

Centralization of politrauma. Study of Ferrara’s reality and simulation of an agreed-upon protocol

Directory of Open Access Journals (Sweden)

Luigi Melcarne

2011-09-01

Full Text Available In a time in which everybody’s asked a big effort to use hospitals, resources and emergency departments in a rational way, the Centralization – that is sending the right patient to the right hospital at the right time – allows an optimization of the resources and a better management of medical patients. In this study we examined the actual state of Centralization in the city of Ferrara where an experimental protocol of “centralization” has been introduced. This study has the purpose of simulating reality if the protocol had been introduced in the years 2008/2009. The results confirm not only that an important number of patients that were meant to be sent to the CTZ of Ferrara where instead sent to the PST but also that, on the contrary, patients from the suburbs that didn’t require advanced treatments were sent to the Sant’Anna hospital of Ferrara. So if medical literature already points out the advantages of a correct Centralization for patients with polytraumas; the study, based on the reality in Ferrara , shows how the creation of an agreed protocol with the goal to guide health workers at sending polytrauma patients to the right destination , instead of creating an excessive flow th the main hub, can improve the overall organization of health services, with an equal distribution between hub and spoke. When considering First Aid not always speed and rapidity guarantee survival; this is so much more real in the case of patients with polytrauma, where quality of cures assumes more importance than time.

Implementing Protocols to Improve Patient Safety in the Medical Imaging Department.

Science.gov (United States)

Carrizales, Gwen; Clark, Kevin R

2015-01-01

Patient safety is a focal point in healthcare because of recent changes issued by CMS. Hospital reimbursement rates have fallen, and these reimbursement rates are governed by CMS mandates regarding patient safety procedures. Reimbursement changes are reflected in the National Patient Safety Goals (NPSGs) administered annually by The Joint Commission. Medical imaging departments have multiple areas of patient safety concerns including effective handoff communication, proper patient identification, and safe medication/contrast administration. This literature review examines those areas of patient safety within the medical imaging department and reveals the need for continued protocol and policy changes to keep patients safe.

GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type.

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Lambalk, C B; Banga, F R; Huirne, J A; Toftager, M; Pinborg, A; Homburg, R; van der Veen, F; van Wely, M

2017-09-01

Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist was not the only variable between the compared study arms. The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. The Cochrane Menstrual Disorders and Subfertility Review Group specialized register of controlled trials and Pubmed and Embase databases were searched from inception until June 2016. Eligible trials were those that compared GnRH antagonist protocols and standard long GnRH agonist protocols in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF population, women with PCOS and women with poor ovarian response. Pre-planned subgroup analyses were performed for various antagonist treatment schedules. We included 50 studies. Of these, 34 studies reported on general IVF patients, 10 studies reported on PCOS patients and 6 studies reported on poor responders. In general IVF patients, ongoing pregnancy rate was significantly lower in the antagonist group compared with the agonist group (RR 0.89, 95% CI 0.82-0.96). In women with PCOS and in women with poor ovarian response, there was no evidence of a difference in ongoing pregnancy between the antagonist and agonist groups (RR 0.97, 95% CI 0.84-1.11 and RR 0.87, 95% CI 0.65-1.17, respectively). Subgroup analyses for various antagonist treatment schedules compared to the long protocol GnRH agonist showed a significantly lower ongoing

Radiation dose of cardiac dual-source CT: The effect of tailoring the protocol to patient-specific parameters

International Nuclear Information System (INIS)

Alkadhi, Hatem; Stolzmann, Paul; Scheffel, Hans; Desbiolles, Lotus; Baumueller, Stephan; Plass, Andre; Genoni, Michele; Marincek, Borut; Leschka, Sebastian

2008-01-01

Objective: To determine the radiation doses and image quality of different dual-source computed tomography coronary angiography (CTCA) protocols tailored to the heart rate (HR) and body mass index (BMI) of the patients. Materials and methods: Two hundred consecutive patients (68 women; mean age 61 ± 9 years) underwent either helical CTCA with retrospective ECG-gating or sequential CT with prospective ECG-triggering: 50 patients (any BMI, any HR) were examined with a standard, non-tailored protocol (helical CTCA, 120 kV, 330 mAs), whereas the other 150 patients were examined with a tailored protocol: 40 patients (group A, BMI ≤ 25 kg/sqm, HR ≤ 70 bpm) with sequential CTCA (100 kV, 190 mAs ref ), 43 patients (group B, BMI ≤ 25 kg/sqm, HR > 70 bpm) with helical CTCA (100 kV, 220 mAs), 28 patients (group C, BMI > 25 kg/sqm, HR ≤ 70 bpm) with sequential CTCA (120 kV, 330 mAs ref ), and 39 patients (group D, BMI > 25 kg/sqm, HR > 70 bpm) with helical CTCA (120 kV, 330 mAs). The effective radiation dose estimates were calculated from the dose-length-product for each patient. Image quality was classified as being diagnostic or non-diagnostic in each coronary segment. Results: Image quality was diagnostic in 2403/2460 (98%) and non-diagnostic in 57/2460 (2%) of all coronary segments. No significant differences in image quality were found among all five CTCA protocols (p = 0.78). The non-tailored helical CTCA protocol was associated with a radiation dose of 9.0 ± 1.0 mSv, being significantly higher compared to that using sequential CTCA (group A: 1.3 ± 0.3 mSv, p 70 bpm (group D: 8.5 ± 0.9 mSv, p = 0.51). Conclusions: Dual-source CTCA is associated with radiation doses ranging between 1.3 and 9.0 mSv, depending on the protocol used. Tailoring of the CTCA protocol to the HR and BMI of the individual patient results in dose reductions of up to 86%, while maintaining a diagnostic image quality of the examination

Care for diabetes patients using the Staged Diabetes Management protocol: an experience report - doi:10.5020/18061230.2006.p253

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Maria Lúcia Zanetti

2012-01-01

Full Text Available The work in multi professional health team has been acknowledged as important for the diabetic patient education. This study aimed at describing the implementation of a care assistance program using the Staged Diabetes Management (SDM protocol; also, characterizing the activities performed by the multi professional health team of the Nurse Education Center for Adults and Elderly, from Ribeirão Preto, in the treatment of diabetic patients. The study was developed from April, 2004 to April, 2005 through weakly meetings, combining individual and group activities coordinated by nurses, physicians, nutritionists, psychologists and physical educators. The results showed that the use of the SDM protocol contributed to improve diabetic patient’s metabolic control and consequently, drug cover up for diabetes mellitus, arterial hypertension and dislipidemia; also, increased the adherence to the nutrition program, to physical activity and the knowledge about the disease; and yet, reduced the signs and symptoms referred by the patients. This experience, showed the viability of implanting the referred protocol. The authors believe that the disclosure of this type of study might contribute to the guides commended by World Health Organization for the care of diabetic patients, specially the disease’s self-managed care.

Conservative Treatment Protocol for Keratocystic Odontogenic Tumour: a Follow-up Study of 3 Cases

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Gülsün Yildirim

2010-07-01

Full Text Available Background: The keratocystic odontogenic tumour is classified as a developmental cyst derived from the enamel organ or from the dental lamina. The treatment of keratocystic odontogenic tumour of the jaw remains controversial. The aim of this study was to report the outcome of our conservative treatment protocol for keratocystic odontogenic tumour.Methods: Three patients with different complaints referred to Oral and Maxillofacial Surgery Clinic, Faculty of Dentistry, Selçuk University. Initial biopsy was carried out in all patients and keratocystic odontogenic tumours was diagnosed subsequent to histopathological examination. The patients with keratocystic odontogenic tumours were treated by enucleation followed by open packing. This conservative treatment protocol was selected because of existing young aged patients. The average follow-up duration of the cases was 2 years.Results: Out of 3 cases, 2 lesions were present in mandible and 1 lesion in maxilla. There was no evidence of recurrence during follow-up. All the cases were monitored continuously with panoramic radiographs, computed tomography and clinical evaluations.Conclusions: This conservative treatment protocol for keratocystic odontogenic tumours, based on enucleation followed by open packing would be a possible choice with a view of offering low recurrence rate and low morbidity rate particularly in young patients.

Microdose flare-up vs. flexible-multidose GnRH antagonist protocols for poor responder patients who underwent ICSI.

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Esinler, I

2014-01-01

To compare the performance of microdose flare-up (MF) and flexible-multidose gonadotropin-releasing hormone (GnRH) antagonist protocols in poor responder patients who underwent intracytoplasmic sperm injection (ICSI). One hundred and 12 consecutive patients (217 cycles) suspected to have poor ovarian response were enrolled. Group 1 (MF GnRH agonist group) constituted 64 patients (135 cycles) who underwent MF GnRH agonist protocol. Group 2 (flexible-multidose GnRH antagonist group) constituted 48 patients (82 cycles) who underwent flexible-multidose GnRH antagonist protocol. The duration of stimulation (d) (11.5 +/- 2.1 vs. 10.4 +/- 2.7, p or = seven blastomeres and < 10% fragmentation at day 3 (35.9% vs. 65.1%, p < 0.05) were significantly lower in Group 1 when compared to Group 2. The number of embryos transferred (2.2 +/- 1.3 vs. 2.4 +/- 0.9), the clinical pregnancy per embryo transfer (16.3% vs. 25.8%), and the implantation rate (8.6% vs. 12.2%) were comparable between groups. Although the flexible-multidose GnRH antagonist protocol produced better oocyte and embryo parameters, the clinical pregnancy rate and the implantation rates were comparable between the flexible-multidose GnRH antagonist and MF protocols in poor responder patients.

Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU.

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Frazzitta, Giuseppe; Zivi, Ilaria; Valsecchi, Roberto; Bonini, Sara; Maffia, Sara; Molatore, Katia; Sebastianelli, Luca; Zarucchi, Alessio; Matteri, Diana; Ercoli, Giuseppe; Maestri, Roberto; Saltuari, Leopold

2016-01-01

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome. Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively. Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, pverticalization protocol, started since the acute stages, improves the short-term and long-term functional and neurological outcome of ABI patients. clinicaltrials.gov NCT02828371.

Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

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O'Neill-Kerr, Alex; Yassin, Anhar; Rogers, Stephen; Cornish, Janie

2017-09-01

The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

Protocol for physical assessment in patients with fibromyalgia syndrome.

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dos Santos, Michele R; Moro, Claudia M C; Vosgerau, Dilmeire S R

2014-01-01

Fibromyalgia syndrome (FMS) is a chronic disease that causes pain and fatigue, presenting a negative impact on quality of life. Exercise helps maintaining physical fitness and influences directly on the improvement of quality of life. Develop a protocol for health-related physical fitness assessment of patients with FMS with tests that are feasible and appropriate for this population. An exploratory and analytical literature review was performed, seeking to determine the tests used by the scientific community. With this in mind, we performed a literature revision through the use of virtual libraries databases: PubMed, Bireme, Banco de Teses e Dissertações da Capes and Biblioteca Digital Brasileira de Teses e Dissertações, published in between 1992-2012. A variety of tests was found; the following, by number of citations, stood out: Body Mass Index (BMI) and bioimpedance; 6-minute walk; handgrip strength (dynamometer, 1RM [Repetition Maximum]); Sit and reach and Shoulder flexibility; Foot Up and Go, and Flamingo balance. These are the tests that should make up the protocol for the physical evaluation of FMS patients, emphasizing their ease of use.

Efficacy of Acute Pain Control Protocol in Triage Department on Analgesics Administration Time and Patients' Satisfaction

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Seyedhossein Seyyedhoseini Davaraani

2014-07-01

Full Text Available Objective: Current study was conducted to develop a pain control protocol by Morphine Sulfate (MS Suppository in triage ward with the main primary outcomes of first analgesic administration time, patients' satisfaction and also the changes in pain intensity. Methods: In this randomized clinical trial, 318 consecutive patients attending to an academic tertiary health care center in Tehran, Iran in 2011 and 2012 were enrolled. The patients were randomly assigned to receive either routine pain control by emergency medicine residents in emergency department (n=132 or pain control protocol in triage level by nurses (n=186. Those with pain in control group were treated with conventional pain control program and those in intervention group with pain intensities higher than four were treated with suppository stat 10 mg dose of MS administered by nurses in triage ward. Results: The mean change in pain intensity was significantly (P<0.0001 higher in intervention group (4.2 versus 0.2 and the first analgesic administration time was significantly different between groups (P<0.05 being less in the intervention group (43.1 versus 4.6. Also the patients' satisfaction was significantly higher in the intervention group (P<0.0001. No drug adverse effects were seen. Conclusions: Totally, according to the obtained results, it may be concluded that acute pain control protocol in triage department by suppository of MS would result in reduced analgesics administration time and higher patients' satisfaction.   Keywords: Analgesia; Emergency Department; Pain Control

Standardized Duplex Ultrasound-Based Protocol for Early Diagnosis of Transplant Renal Artery Stenosis: Results of a Single-Institution Retrospective Cohort Study

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Vincenzo Li Marzi

2018-01-01

Full Text Available Transplant renal artery stenosis (TRAS is the most frequent vascular complication after kidney transplantation (KT and has been associated with potentially reversible refractory hypertension, graft dysfunction, and reduced patient survival. The aim of the study is to describe the outcomes of a standardized Duplex Ultrasound- (DU- based screening protocol for early diagnosis of TRAS and for selection of patients potentially requiring endovascular intervention. We retrospectively reviewed our prospectively collected database of KT from January 1998 to select patients diagnosed with TRAS. The follow-up protocol was based on a risk-adapted, dynamic subdivision of eligible KT patients in different risk categories (RC with different protocol strategies (PS. Of 598 patients included in the study, 52 (9% patients had hemodynamically significant TRAS and underwent percutaneous angioplasty (PTA and stent placement. Technical and clinical success rates were 97% and 90%, respectively. 7 cases of restenosis were recorded at follow-up and treated with re-PTA plus stenting. Both DU imaging and clinical parameters improved after stent placement. Prospective high-quality studies are needed to test the efficacy and safety of our protocol in larger series. Accurate trial design and standardized reporting of patient outcomes will be key to address the current clinical needs.

Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

International Nuclear Information System (INIS)

Verger, Antoine; Karcher, Gilles; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, Francois; Le Guludec, Dominique; Koehl, Gregoire; Roch, Veronique; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Marie, Pierre-Yves

2013-01-01

The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving 201 Tl (n = 120) or 99m Tc-sestamibi injected at low dose at stress ( 99m Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ( 99m Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, 201 Tl 92 %, 99m Tc-Low 86 %, 99m Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p 201 Tl or 99m Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 ± 101 kcounts) and dramatically enhanced with CZT SPECT (+279 ± 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

A comparison between r-LH and urinary supplements containing LH activity in patients undergoing the microdose GnRH agonist flare protocol for in-vitro fertilization: a pilot study.

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Shavit, Tal; Agdi, Mohammed; Son, Weon Y; Hasson, Josseph; Dahan, Michael H

2016-08-01

The aim of this study was to compare pregnancy rates and stimulation parameters in patients with diminished ovarian reserve, who were treated with recombinant human luteinizing hormone (r-LH) or menopausal gonadotropins (hMG), as part of a microdose flare protocol. A retrospective cohort study was performed. Comparisons between the group that was stimulated with r-LH plus follicle stimulating hormone (FSH) to those treated with hMG and FSH, were performed. Measurements included: medication doses, number of oocyte collected, number of embryos obtained, pregnancy and clinical pregnancy rates. Patients in the r-LH group (N.=40) had significant higher clinical pregnancy rates (33% vs. 14%; P=0.04) and used lower dose of LH (1938 IU vs. 2807 IU; P=0.02) compared to patients that were stimulated with hMG (N.=39). r-LH may offer advantages for the treatment of diminished ovarian reserve when performing a microdose flare protocol when compared to hMG. Both larger and prospective studies should be carried out to confirm these findings.

Goal-Directed Fluid Resuscitation Protocol Based on Arterial Waveform Analysis of Major Burn Patients in a Mass Burn Casualty.

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Chiao, Hao-Yu; Chou, Chang-Yi; Tzeng, Yuan-Sheng; Wang, Chih-Hsin; Chen, Shyi-Gen; Dai, Niann-Tzyy

2018-02-01

Adequate fluid titration during the initial resuscitation period of major burn patients is crucial. This study aimed to evaluate the feasibility and efficacy of a goal-directed fluid resuscitation protocol that used hourly urine output plus the arterial waveform analysis FloTrac (Edwards LifeSciences, Irvine, Calif) system for major burns to avoid fluid overload. We conducted a retrospective cohort study of 43 major burn patients at the Tri-Service General Hospital after the Formosa Fun Coast Dust Explosion on June 27, 2015. Because of the limited capacity of intensive care units (ICUs), 23 intubated patients were transferred from the burn wards or emergency department to the ICU within 24 hours. Fluid administration was adjusted to achieve a urine output of 30 to 50 mL/h, cardiac index greater than 2.5 L/min/m, and stroke volume variation (SVV) less than 12%. The hourly crystalloid fluid infusion rate was titrated based on SVV and hourly urine output. Of the 23 critically burned patients admitted to the ICU, 13 patients who followed the goal-directed fluid resuscitation protocol within 12 hours postburn were included in the analysis. The mean age (years) was 21.8, and the mean total body surface area (TBSA) burned (%) was 68.0. The mean Revised Baux score was 106.8. All patients sustained inhalation injury. The fluid volumes administered to patients in the first 24 hours and the second 24 hours (mL/kg/% total body surface area) were 3.62 ± 1.23 and 2.89 ± 0.79, respectively. The urine outputs in the first 24 hours and the second 24 hours (mL/kg/h) were 1.13 ± 0.66 and 1.53 ± 0.87, respectively. All patients achieved the established goals within 32 hours postburn. In-hospital mortality rate was 0%. The SVV-based goal-directed fluid resuscitation protocol leads to less unnecessary fluid administration during the early resuscitation phase. Clinicians can efficaciously manage the dynamic body fluid changes in major burn patients under the guidance of the protocol.

Split bolus technique in polytrauma: a prospective study on scan protocols for trauma analysis

NARCIS (Netherlands)

Beenen, Ludo F. M.; Sierink, Joanne C.; Kolkman, Saskia; Nio, C. Yung; Saltzherr, Teun Peter; Dijkgraaf, Marcel G. W.; Goslings, J. Carel

2015-01-01

For the evaluation of severely injured trauma patients a variety of total body computed tomography (CT) scanning protocols exist. Frequently multiple pass protocols are used. A split bolus contrast protocol can reduce the number of passes through the body, and thereby radiation exposure, in this

A Conscious Sedation Protocol for Videolaryngostroboscopy in Pediatric Patients

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Samantha Anne

2010-01-01

Full Text Available Objective. To determine best sedation protocol for videolaryngostroboscopy in children unable to tolerate non-sedated evaluation. Materials and Methods. Consecutive case series of 10 children with voice disturbances, unable to tolerate nonsedated videolaryngostroboscopy at an academic tertiary care children’s hospital. Flexible fiberoptic videolaryngostroboscopy was performed and interpreted by pediatric otolaryngologist and speech and language pathologist. Sedation was administered with newly described protocol that allowed functional portion of evaluation. Main Outcome Measures: ability to follow commands and tolerate flexible fiberoptic videolaryngostroboscopy. Secondary Outcome Measures: total phonation time, complications, need for subsequent videolaryngostroboscopic attempts, clinical outcomes, and follow-up. Results. 10 children underwent procedure under conscious sedation. 9/10 children were able to perform simple tasks and maintain adequate phonation time to complete stroboscopic exam. 1/10 patients failed to complete exam because of crying during entire exam. Mean exam time was 2 minutes 52 seconds (SD 86 seconds, phonation time is 1 minute 44 seconds (SD 60 seconds, and number of tasks completed was 10.5 (SD 8.6. Conclusions. Conscious sedation for videolaryngostroboscopy can be safely and effectively performed in children unable to comply with nonsedated examination. Such studies provide valuable diagnostic information to make a diagnosis and to devise a treatment plan.

The Protocol of Choice for Treatment of Snake Bite

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Afshin Mohammad Alizadeh

2016-01-01

Full Text Available The aim of the current study is to compare three different methods of treatment of snake bite to determine the most efficient one. To unify the protocol of snake bite treatment in our center, we retrospectively reviewed files of the snake-bitten patients who had been referred to us between 2010 and 2014. They were contacted for follow-up using phone calls. Demographic and on-arrival characteristics, protocol used for treatment (WHO/Haddad/GF, and outcome/complications were evaluated. Patients were entered into one of the protocol groups and compared. Of a total of 63 patients, 56 (89% were males. Five, 19, and 28 patients were managed by Haddad, WHO, or GF protocols, respectively. Eleven patients had fallen into both GF and WHO protocols and were excluded. Serum sickness was significantly more common when WHO protocol was used while 100% of the compartment syndromes and 71% of deformities had been reported after GF protocol. The most important complications were considered to be deformity, compartment syndrome, and amputation and were more frequent after the use of WHO and GF protocols (23.1% versus 76.9%; none in Haddad; P = NS. Haddad protocol seems to be the best for treatment of snake-bitten patients in our region. However, this cannot be strictly concluded because of the limited sample size and nonsignificant P values.

The effect of daily sedation interruption protocol on early incidence of ventilator-associated pneumonia among patients hospitalized in critical care units receiving mechanical ventilation

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Mehdi Shahabi

2016-01-01

Full Text Available Background: Ventilator-associated pneumonia (VAP is a common side effect in patients who receive intravenous sedation infusion. In routine care, after starting sedation infusion for patients who receive mechanical ventilation, interruption of sedation starts without protocol. This study aimed to evaluate the effect of daily sedation vacation protocol on the incidence of VAP in mechanically ventilated patients. Materials and Methods: In this clinical trial study, 80 patients with intravenous sedation infusion were selected and randomly allocated to intervention and control groups. In the intervention group, daily sedation vacation protocol and in the control group, routine sedation vacation was followed. Modified clinical pulmonary infection score questionnaire was completed before intervention and on the third, fourth, and fifth days after intervention. Data were analyzed by using repeated measures analysis of variance (ANOVA, Chi-square, and independent t-test. Results: The results of this study showed that the incidence rate of VAP in the intervention and control groups was 0% versus 15% on the third day of intervention, 12.5% versus 50% on the fourth day, and 27.5% versus 55.3% on the fifth day of intervention in the intervention and control groups, respectively. The incidence of VAP in the intervention group was significantly lower than in the control group (P < 0.05. Conclusions: The results of this study showed that in patients with intravenous sedation, infusion of a daily sedation vacation protocol may reduce the incidence of VAP. Therefore, in order to prevent VAP, nurses are recommended to use this daily sedation vacation protocol.

Clinicopathologic characteristics, laboratory parameters, treatment protocols, and outcomes of pancreatic cancer: a retrospective cohort study of 1433 patients in China

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Shuisheng Zhang

2018-05-01

Full Text Available Objectives The prognosis of people with pancreatic cancer is extremely unfavorable. However, the prognostic factors remain largely undefined. We aimed to perform comprehensive analyses of clinicopathologic characteristics, laboratory parameters, and treatment protocols for exploring their role as prognostic factors of pancreatic cancer. Methods Patients diagnosed with pancreatic cancer and hospitalized at the China National Cancer Center between April 2006 and May 2016 were enrolled in this retrospective cohort study. Clinicopathologic characteristics, laboratory parameters, and treatment protocols were compared among patients at different stages of the disease. The association between these factors and overall survival (OS was analyzed using the Kaplan–Meier method and Cox proportional hazards model. Results The present study included 1,433 consecutive patients with pancreatic cancer. Median OS was 10.6 months (95% confidence interval [CI] 9.8–11.3 months, with 1-, 3-, and 5-year survival rates of 43.7%, 14.8%, and 8.8%, respectively. Cox multivariate analysis findings identified the following factors as independent predictors of OS: gender (female vs male, hazard ratio 0.72, 95% CI [0.54–0.95]; elevated total bilirubin (TBil; 1.82, 1.34–2.47; elevated carbohydrate antigen 19-9 (CA19-9; 1.72, 1.17–2.54; tumor being located in pancreatic body and tail (1.52, 1.10–2.10; advanced T stage (T3-4 vs T1-2, 1.62, 1.15–2.27; lymph node metastasis (1.57, 1.20–2.07; distant metastasis (1.59, 1.12–2.27; the presence of surgical resection (0.53, 0.34–0.81; and the presence of systemic chemotherapy (0.62, 0.45–0.82. Conclusions Being male, elevated TBil and carcinoembryonic antigen, tumor being located in pancreatic body and tail, advanced T stage, lymph node and distant metastasis, the absence of surgical resection, and the absence of systematic chemotherapy were associated with worse OS in patients with pancreatic cancer.

Trauma surgeon becomes consultant: evaluation of a protocol for management of intermediate-level trauma patients.

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Fallon, Sara C; Delemos, David; Christopher, Daniel; Frost, Mary; Wesson, David E; Naik-Mathuria, Bindi

2014-01-01

At our level 1 pediatric trauma center, 9-54 intermediate-level ("level 2") trauma activations are received per month. Previously, the surgery team was required to respond to and assume responsibility for all patients who had "level 2" trauma activations. In 8/2011, we implemented a protocol where the emergency room (ER) physician primarily manages these patients with trauma consultation for surgical evaluation or admission. The purpose of this study was to prospectively evaluate the effects of the new protocol to ensure that patient safety and quality of care were maintained. We compared outcomes of patients treated PRE-implementation (10/2010-7/2011) and POST-implementation (9/2011-5/2012), including surgeon consultation rate, utilization of imaging and laboratory testing, ER length of stay, admission rate, and missed injuries or readmissions. Statistical analysis included chi-square and Student's t-test. We identified 472 patients: 179 in the PRE and 293 in the POST period. The populations had similar baseline clinical characteristics. The surgical consultation rate in the POST period was only 42%, with no missed injuries or readmissions. The ER length of stay did not change. However, in the POST period there were significant decreases in the admission rate (73% to 44%) and the mean number of CT scans (1.4 to 1), radiographs (2.4 to 1.7), and laboratory tests (5.1 to 3.3) ordered in the emergency room (all p<0.001). Intermediate-level pediatric trauma patients can be efficiently and safely managed by pediatric emergency room physicians, with surgical consultation only as needed. The protocol change improved resource utilization by decreasing testing and admissions and streamlining resident utilization in an era of reduced duty hours. © 2014.

Sincalide - the final protocol

International Nuclear Information System (INIS)

Clarke, E.A.; Notghi, A.; Hesslewood, S.R.; Harding, L.K.

2002-01-01

Full text: HIDA biliary studies examine the gallbladder (GB) to give a percentage ejection fraction (EF). Porcine CCK was an accepted agent for stimulating the GB prior to being withdrawn in the UK from 1998. Sincalide (a synthetic CCK) was the suggested replacement. We have tried many administration regimes in an attempt to get results comparable with our established CCK protocols. Dose concentration and length of infusion times have been studied. Initially a dose of 10 ngm/kg/min given over 2 minutes (manufacturer's recommended dose) was used. This gave falsely low ejection fractions. The dose was reduced to 3 ngm/kg/min over 3 minutes as it was felt the higher dose may be causing constriction of the sphincter of Oddi. This gave a slight improvement with 22 % of patients having normal EF (>35 %). The length of infusion was extended to 15 minutes and the dose concentration reduced again to 0.6 ngm/kg/min. 62 % of patients had a normal EF. However, on many of the curves the gallbladder was still contracting on completion of the 15 minute infusion and began to refill immediately after stopping Sincalide. A further change of protocol was indicated. The infusion time was extended to 30 minutes and the dose concentration per minute kept the same. Imaging began at 30 minutes post HIDA injection and continued for a total of 50 minutes. Sincalide infusion began at 35 minutes if a GB was visualized. This protocol has been performed on 17 patients. 53 % of these had a normal result (comparable with a normal rate of 40 % previously established with CCK) with a mean EF of 60 %. The mean EF of patients with abnormal studies was 15 %. Curves showed a plateau by 30 minutes in 94 % of patients indicating that gallbladder contraction was complete. No normal range is available so results were compared with ultrasound (US). All patients who had an abnormal US scan also had abnormal HIDA results. Three patients had a normal US scan and abnormal HIDA study. These are currently

Protocol updated for the treatment of patients in radiotherapy with implanted cardiac devices

International Nuclear Information System (INIS)

Martin Martin, G.; Bermudez Luna, R.; Rodriguez Rodriguez, C.; Lopez Fernandez, A.; Rodriguez Perez, A.; Sotoca Ruiz, A.

2013-01-01

Radiotherapy treatment can be safely performed in patients with pacemakers or implanted defibrillators, however, it is very important to ensure that the patient receives the minimum dose possible in your heart device. Is considered essential good coordination with the cardiology service before, during and after radiotherapy treatment for the patient safety. Finally we present a protocol updated to treat these patients in radiotherapy. (Author)

Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol.

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Cuff, Derek J; Pupello, Derek R

2012-11-01

This study evaluated patient outcomes and rotator cuff healing after arthroscopic rotator cuff repair using a postoperative physical therapy protocol with early passive motion compared with a delayed protocol that limited early passive motion. The study enrolled 68 patients (average age, 63.2 years) who met inclusion criteria. All patients had a full-thickness crescent-shaped tear of the supraspinatus that was repaired using a transosseous equivalent suture-bridge technique along with subacromial decompression. In the early group, 33 patients were randomized to passive elevation and rotation that began at postoperative day 2. In the delayed group, 35 patients began the same protocol at 6 weeks. Patients were monitored clinically for a minimum of 12 months, and rotator cuff healing was assessed using ultrasound imaging. Both groups had similar improvements in preoperative to postoperative American Shoulder and Elbow Surgeons scores (early group: 43.9 to 91.9, P rotator cuff healing, or range of motion between the early and delayed groups. Patients in the early group and delayed group both demonstrated very similar outcomes and range of motion at 1 year. There was a slightly higher rotator cuff healing rate in the delayed passive range of motion group compared with the early passive range of motion group (91% vs 85%). Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain.

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van der Roer, Nicole; van Tulder, Maurits; van Mechelen, Willem; de Vet, Henrica

2008-02-15

Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with nonspecific chronic low back pain. The intensive group training protocol combines exercise therapy, back school, and behavioral principles. Two studies found a significant reduction in absenteeism for a graded activity program in occupational health care. This program has not yet been evaluated in a primary care physiotherapy setting. Participating physical therapists in primary care recruited 114 patients with chronic nonspecific low back pain. Eligible patients were randomized to either the protocol group or the guideline group. Outcome measures included functional status (Roland Morris Disability Questionnaire), pain intensity (11-point numerical rating scale), general perceived effect and quality of life (EuroQol-5D). Cost data were measured with cost diaries and included direct and indirect costs related to low back pain. After 52 weeks, the direct health care costs were significantly higher for patients in the protocol group, largely due to the costs of the intervention. The mean difference in total costs amounted to [Euro sign] 233 (95% confidence interval: [Euro sign] -2.185; [Euro sign] 2.764). The cost-effectiveness planes indicated no significant differences in cost effectiveness between the 2 groups. The results of this economic evaluation showed no difference in total costs between the protocol group and the guideline group. The differences in effects were small and not statistically significant. At present, national implementation of the protocol is not recommended.

Development of a Web Portal for Physical Activity and Symptom Tracking in Oncology Patients: Protocol for a Prospective Cohort Study.

Science.gov (United States)

Marthick, Michael; Dhillon, Haryana M; Alison, Jennifer A; Cheema, Birinder S; Shaw, Tim

2018-05-15

Significant benefits accrue from increasing physical activity levels in people with a history of cancer. Physical activity levels can be increased using behavioral change interventions in this population. Access to Web portals and provision of activity monitors to provide feedback may support behavior change by encouraging patient engagement in physical therapy. The Web portal evaluated in this study will provide a system to monitor physical activity and sleep, for use by both clinician and patient, along with symptom and health-related quality of life tracking capabilities. The aim of this study was to outline a protocol for a feasibility study focused on a Web-based portal that provides activity monitoring and personalized messaging to increase physical activity in people with cancer. Using a longitudinal cohort design, people with cancer will be serially allocated to 3 intervention cohorts of 20 participants each and followed for 10 weeks. Cohort 1 will be provided a wearable activity monitor and access to a Web-based portal. Cohort 2 will receive the same content as Cohort 1 and in addition will receive a weekly activity summary message. Cohort 3 will receive the same content as Cohorts 1 and 2 and in addition will receive a personalized weekly coaching message. Feasibility of the use of the portal is the primary outcome. Results are expected in early 2018. Outcome measures will include goal attainment and completion rate. This study will provide information about the feasibility of investigating eHealth initiatives to promote physical activity in people with cancer. RR1-10.2196/9586. ©Michael Marthick, Haryana M Dhillon, Jennifer A Alison, Birinder S Cheema, Tim Shaw. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.05.2018.

The Dysphagia in Stroke Protocol Reduces Aspiration Pneumonia in Patients with Dysphagia Following Acute Stroke: a Clinical Audit.

Science.gov (United States)

Perry, Sarah E; Miles, Anna; Fink, John N; Huckabee, Maggie-Lee

2018-03-30

Cough reflex testing has been evaluated as a component of the clinical swallowing assessment as a means of identifying patients at risk of aspiration during swallowing. A previous study by our research group found good sensitivity and specificity of the cough reflex test for identifying patients at risk of aspiration post-stroke, yet its use did not decrease pneumonia rates, contrary to previous reports. The aim of this study was to expand on our earlier work by implementing a clinical management protocol incorporating cough reflex testing within the same healthcare setting and compare patient outcomes to those from the original study and to evaluate clinical outcomes in patients with acute stroke who were managed using the Dysphagia in Stroke Protocol (DiSP). Secondarily, to compare those outcomes to historical data prior to implementation of the DiSP. This clinical audit measured outcomes from 284 patients with acute stroke managed per the DiSP, which guides use of videofluoroscopic swallowing study and patient management based on clinical exam with cough reflex testing. Data from our previous trial were included for comparison of pre- and post-DiSP patient outcomes. Data collection took place between November 2012 and April 2016 at four urban hospitals within New Zealand. Following implementation of the DiSP, the rate of aspiration pneumonia (10%) was substantially lower than the pre-DiSP rate (28%), with no pneumonia readmissions within 3 months. Pneumonia-related mortality was unchanged. By 3 months, 81% of the patients were on a normal diet and 67% had returned home, compared to pre-DiSP outcomes of 55% and 55% respectively. Previous work has suggested that simply implementing cough reflex testing in dysphagia management may not be sufficient to improve patient outcomes. The present study adds to this picture by suggesting that the true variable of influence may be the way in which the results of the test are applied to patient care. There is a strong case

Development of a diagnostic protocol for dizziness in elderly patients in general practice: a Delphi procedure.

NARCIS (Netherlands)

Maarsingh, O.R.; Dros, J.; Weert, H.C. van; Schellevis, F.G.; Bindels, P.J.; Horst, H.E. van der

2009-01-01

BACKGROUND: Dizziness in general practice is very common, especially in elderly patients. The empirical evidence for diagnostic tests in the evaluation of dizziness is scarce. Aim of our study was to determine which set of diagnostic tests should be part of a diagnostic protocol for evaluating

An investigation into the nutritional status of patients receiving an Enhanced Recovery After Surgery (ERAS) protocol versus standard care following Oesophagectomy.

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Benton, Katie; Thomson, Iain; Isenring, Elisabeth; Mark Smithers, B; Agarwal, Ekta

2018-06-01

Enhanced Recovery After Surgery (ERAS) protocols have been effectively expanded to various surgical specialities including oesophagectomy. Despite nutrition being a key component, actual nutrition outcomes and specific guidelines are lacking. This cohort comparison study aims to compare nutritional status and adherence during implementation of a standardised post-operative nutritional support protocol, as part of ERAS, compared to those who received usual care. Two groups of patients undergoing resection of oesophageal cancer were studied. Group 1 (n = 17) underwent oesophagectomy between Oct 2014 and Nov 2016 during implementation of an ERAS protocol. Patients in group 2 (n = 16) underwent oesophagectomy between Jan 2011 and Dec 2012 prior to the implementation of ERAS. Demographic, nutritional status, dietary intake and adherence data were collected. Ordinal data was analysed using independent t tests, and categorical data using chi-square tests. There was no significant difference in nutrition status, dietary intake or length of stay following implementation of an ERAS protocol. Malnutrition remained prevalent in both groups at day 42 post surgery (n = 10, 83% usual care; and n = 9, 60% ERAS). A significant difference was demonstrated in adherence with earlier initiation of oral free fluids (p nutrition protocol, within an ERAS framework, results in earlier transition to oral intake; however, malnutrition remains prevalent post surgery. Further large-scale studies are warranted to examine individualised decision-making regarding nutrition support within an ERAS protocol.

Evaluation of 2 amino acid protocols for kidney protection in patients treated with 90Y-DOTATOC for neuroendocrine tumors

International Nuclear Information System (INIS)

Arveschoug, A.K.; Kramer, S.M.J.; Iversen, P.; Froekiaer, J.; Groenbaek, H.

2015-01-01

Full text of publication follows. Background: peptide receptor radionuclide therapy (PRRT) is an established treatment for progressive neuroendocrine tumours (NET). Nephrotoxicity is the limiting factor using 90 Y-DOTATOC. Although administration of amino acids lowers the radioactive dose to the kidneys, delayed renal damage is a concern following therapy. Studies have indicated that prolonging the infusion of amino acids offers improved kidney protection. The intermittent infusion of amino acids up two days after PRRT has also been shown to further reduce renal uptake of radioactivity in pilot studies. Aim: We evaluated whether differences could be detected in GFR in patients treated with two different protocols for kidney protection using commercially available (Vamin-18) amino acid mixture (AAM); a standard protocol with 2 litres of AAM infused over 4 hours or a 24-hour infusion protocol with 3 litres of AAM. Material and method: GFR in 18 patients treated with infusion of 2 litres AAM of 4 hours was compared with GFR in 13 patients treated with 3 litres of AAM over 24 hours at 3 months, 6 months and 12 months after therapy with 90 Y DOTATOC. The majority of patients received the standard treatment of 3.7 GBq/m 2 90 Y DOTATOC every 8-10 weeks. The glomerular filtration rate (GFR) was estimated using the 51 Cr-EDTA plasma clearance by a single sample technique according to Groth and Aasted. Results: pre-existing risk factors associated with kidney failure were seen in 84 % of the patients. Other identified risk factors associated with kidney failure were former treatment with 90 Y-DOTATOC and/or chemotherapy, hypertension and diabetes. In the whole group of patients a significant fall in renal function was seen up to twelve months after PRRT. The median loss of kidney function was 30 ml/min/1.73m 2 (27 %) 12 months after treatment compared to pre-therapeutic values. Although no significant statistical difference was found comparing the two amino acid protocols

Combination Protocol of Low-Frequency rTMS and Intensive Occupational Therapy for Post-stroke Upper Limb Hemiparesis: a 6-year Experience of More Than 1700 Japanese Patients.

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Kakuda, Wataru; Abo, Masahiro; Sasanuma, Jinichi; Shimizu, Masato; Okamoto, Takatsugu; Kimura, Chikou; Kakita, Kiyohito; Hara, Hiroyoshi

2016-06-01

Several years ago, we proposed a combination protocol of repetitive transcranial magnetic stimulation (rTMS) and intensive occupational therapy (OT) for upper limb hemiparesis after stroke. Subsequently, the number of patients treated with the protocol has increased in Japan. We aimed to present the latest data on our proposed combination protocol for post-stroke upper limb hemiparesis as a result of a multi-institutional study. After confirming that a patient met the inclusion criteria for the protocol, they were scheduled to receive the 15-day inpatient protocol. In the protocol, two sessions of 20-min rTMS and 120-min occupational therapy were provided daily, except for Sundays and the days of admission/discharge. Motor function of the affected upper limb was evaluated by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT) at admission/discharge and at 4 weeks after discharge if possible. A total of 1725 post-stroke patients were studied (mean age at admission 61.4 ± 13.0 years). The scheduled 15-day protocol was completed by all patients. At discharge, the increase in FMA score, shortening in performance time of WMFT, and increase in functional ability scale (FAS) score of WMFT were significant (FMA score 46.8 ± 12.2 to 50.9 ± 11.4 points, p hemiparesis after stroke, although its efficacy should be confirmed in a randomized controlled study.

Comparison of radiation doses using weight-based protocol and dose modulation techniques for patients undergoing biphasic abdominal computed tomography examinations

Directory of Open Access Journals (Sweden)

Livingstone Roshan

2009-01-01

Full Text Available Computed tomography (CT of the abdomen contributes a substantial amount of man-made radiation dose to patients and use of this modality is on the increase. This study intends to compare radiation dose and image quality using dose modulation techniques and weight- based protocol exposure parameters for biphasic abdominal CT. Using a six-slice CT scanner, a prospective study of 426 patients who underwent abdominal CT examinations was performed. Constant tube potentials of 90 kV and 120 kV were used for all arterial and portal venous phase respectively. The tube current-time product for weight-based protocol was optimized according to patient′s body weight; this was automatically selected in dose modulations. The effective dose using weight-based protocol, angular and z-axis dose modulation was 11.3 mSv, 9.5 mSv and 8.2 mSv respectively for the patient′s body weight ranging from 40 to 60 kg. For patients of body weights ranging 60 to 80 kg, the effective doses were 13.2 mSv, 11.2 mSv and 10.6 mSv respectively. The use of dose modulation technique resulted in a reduction of 16 to 28% in radiation dose with acceptable diagnostic accuracy in comparison to the use of weight-based protocol settings.

Effectiveness of couch height-based patient set-up and an off-line correction protocol in prostate cancer radiotherapy

International Nuclear Information System (INIS)

Lin, Emile N.J.Th. van; Nijenhuis, Edwin; Huizenga, Henk; Vight, Lisette van der; Visser, Andries

2001-01-01

Purpose: To investigate set-up improvement caused by applying a couch height-based patient set-up method in combination with a technologist-driven off-line correction protocol in nonimmobilized radiotherapy of prostate patients. Methods and Materials: A three-dimensional shrinking action level correction protocol is applied in two consecutive patient cohorts with different set-up methods: the traditional 'laser set-up' group (n=43) and the 'couch height set-up' group (n=112). For all directions, left-right, ventro-dorsal, and cranio-caudal, random and systematic set-up deviations were measured. Results: The couch height set-up method improves the patient positioning compared to the laser set-up method. Without application of the correction protocol, both systematic and random errors reduced to 2.2-2.4 mm (1 SD) and 1.7-2.2 mm (1 SD), respectively. By using the correction protocol, systematic errors reduced further to 1.3-1.6 mm (1 SD). One-dimensional deviations were within 5 mm for >90% of the measured fractions. The required number of corrections per patient in the off-line correction protocol was reduced significantly during the course of treatment from 1.1 to 0.6 by the couch height set-up method. The treatment time was not prolonged by application of the correction protocol. Conclusions: The couch height set-up method improves the set-up significantly, especially in the ventro-dorsal direction. Combination of this set-up method with an off-line correction strategy, executed by technologists, reduces the number of set-up corrections required

Mac protocols for wireless sensor network (wsn): a comparative study

International Nuclear Information System (INIS)

Arshad, J.; Akram, Q.; Saleem, Y.

2014-01-01

Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

A 4D Digital Phantom for Patient-Specific Simulation of Brain CT Perfusion Protocols

NARCIS (Netherlands)

Boom, R. van den; Manniesing, R.; Oei, M.T.H.; Woude, W.J. van der; Smit, E.J.; Laue, H.O.A.; Ginneken, B. van; Prokop, M.

2014-01-01

Purpose Optimizing CT brain perfusion protocols is a challenge because of the complex interaction between image acquisition, calculation of perfusion data and patient hemodynamics. Several digital phantoms have been developed to avoid unnecessary patient exposure or suboptimum choice of parameters.

Comparison of subareolar injection lymphoscintigraphy with the 1-day and the 2-day protocols for the detection of sentinel lymph nodes in patients with breast cancer

International Nuclear Information System (INIS)

Seok, Ju-Won; Kim, In-Ju; Heo, Young-Jun; Yang, You-Jung; Choi, Yoo-Shin; Kim, Beom-Gyu; Park, Seoug-Jun

2009-01-01

Lymphoscintigraphy and sentinel node biopsy are used for the detection of axillary lymph node metastasis in breast cancer patients. However, currently there is no standardized technique. For the detection of axillary lymph node metastasis by lymphoscintigraphy and sentinel node biopsy, in patients with breast cancer, we compared the results of subareolar injections administered on the day of surgery (1-day protocol) with injections administered on the day before surgery (2-day protocol). This study included 412 breast cancer patients who underwent surgery between 2001 and 2004. For the 1-day protocol (1 h before surgery) 0.8 ml of Tc-99m Tin-Colloid (37 MBq) was injected in 203 in the subareolar region on the morning of the surgery. For the 2-day protocol (16 h before surgery) 0.8 ml of Tc-99m Tin-Colloid (185 MBq) was injected in 209 patients on the afternoon before surgery. Lymphoscintigraphy was performed in the supine position and sentinel node identification was performed by hand-held gamma probe during surgery. Among 203 patients with the 1-day protocol, 185 cases (91.1%) were identified by sentinel node lymphoscintigraphy, and 182 cases (89.7%) were identified by gamma probe. Among the 209 patients, in the 2-day protocol, 189 cases (90.4%) had the sentinel node identified by lymphoscintigraphy, and 182 cases (87.1%) by the gamma probe. There was no significant difference in the identification rate of the sentinel node between the 1-day and 2-day protocols by lymphoscintigraphy and the gamma probe (p>0.05, p>0.05). The results of the identification of the sentinel node by subareolar injection according to 1-day or 2-day protocol, in breast cancer patients, showed no significant differences. Because the 2-day protocol allows for an adequate amount of time to perform the lymphoscintigraphy, it is a more useful protocol for the identification of sentinel nodes in patients with breast cancer. (author)

Standardised test protocol (Constant Score) for evaluation of functionality in patients with shoulder disorders

DEFF Research Database (Denmark)

Ban, Ilija; Troelsen, Anders; Christiansen, David Høyrup

2013-01-01

INTRODUCTION: The Constant Score (CS), developed as a scoring system to evaluate overall functionality of patients with shoulder disorders, is widely used but has been criticised for relying on an imprecise terminology and for lack of a standardised methodology. A modified guideline was therefore...... differences. One of the authors of the modified CS approved both the English and the Danish test protocol. CONCLUSION: A simple test protocol of the modified CS was developed in both English and Danish. With precise terminology and definitions, the test protocol is the first of its kind. We suggest its use...

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

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van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

2014-06-25

The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed

Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial.

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Wilkes, Scott; Pearce, Simon; Ryan, Vicky; Rapley, Tim; Ingoe, Lorna; Razvi, Salman

2013-03-22

The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old. SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine. Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear. Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings. Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L). Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit. Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors. Qualitative study using in-depth interviews to understand patients' willingness to take part in a randomized controlled trial and participants' experience of the intervention. Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over registered in 2008 in primary care practices, studying their 4-year cardiovascular outcomes to inform the power of SORTED

[Ethical and legal duty of anesthesiologists regarding Jehovah's Witness patient: care protocol].

Science.gov (United States)

Takaschima, Augusto Key Karazawa; Sakae, Thiago Mamôru; Takaschima, Alexandre Karazawa; Takaschima, Renata Dos Santos Teodoro; de Lima, Breno José Santiago Bezerra; Benedetti, Roberto Henrique

Jehovah's Witnesses patients refuse blood transfusions for religious reasons. Anesthesiologists must master specific legal knowledge to provide care to these patients. Understanding how the Law and the Federal Council of Medicine treat this issue is critical to know how to act in this context. The aim of this paper was to establish a treatment protocol for the Jehovah's Witness patient with emphasis on ethical and legal duty of the anesthesiologist. The article analyzes the Constitution, Criminal Code, resolutions of the Federal Council of Medicine (FCM), opinions, and jurisprudence to understand the limits of the conflict between the autonomy of will of Jehovah's Witnesses to refuse transfusion and the physician's duty to provide the transfusion. Based on this evidence, a care protocol is suggested. The FCM resolution 1021/1980, the penal code Article 135, which classifies denial of care as a crime and the Supreme Court decision on the HC 268,459/SP process imposes on the physician the obligation of blood transfusion when life is threatened. The patient's or guardian's consent is not necessary, as the autonomy of will manifestation of the Jehovah's Witness patient refusing blood transfusion for himself and relatives, even in emergencies, is no not forbidden. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Reducing the Indication for Ventilatory Support in the Severely Burned Patient: Results of a New Protocol Approach at a Regional Burn Center.

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Gille, Jochen; Bauer, Nicole; Malcharek, Michael J; Dragu, Adrian; Sablotzki, Armin; Taha, Hischam; Czeslick, Elke

2016-01-01

Initial management of the severely injured routinely includes sedation and mechanical ventilatory support. However, nonjudiciously applied mechanical ventilatory support can itself lead to poorer patient outcomes. In an attempt to reduce this iatrogenic risk, a standardized, in-house, five-point protocol providing clinical guidance on the use and duration of ventilation was introduced and analyzed, and the impact on patient outcomes was assessed. In 2007, a protocol for early spontaneous breathing was introduced and established in clinical practice. This protocol included: 1) early extubation (≤6 hours after admission) in the absence of absolute ventilatory indication; 2) avoidance of "routine intubation" in spontaneously breathing patients; 3) early postoperative extubation, including patients requiring multiple surgical interventions; 4) intensive chest and respiratory physiotherapy with routine application of expectorants; and 5) early active mobilization. A retrospective clinical study compared patients (group A) over a 2-year period admitted under the new protocol with a historical patient group (group B). Patients in group A (n = 38) had fewer ventilator days over the time-course of treatment (3 [1; 5.8] vs 18.5 days [0.5; 20.5]; P = .0001) with a lower rate of tracheostomies (15.8 vs 54%; P = .0003). Patients on ventilation at admission in group A had shorter ventilation periods after admission (4.75 [4; 22.25] vs 378 hours [8.5; 681.5]; P = .0003), and 66.7% of these patients were extubated within 6 hours of admission (vs 9.1% in group B). No patients fulfilling the inclusion criteria required re- or emergency intubation. In the first 5 days of treatment, significantly lower Sequential Organ Failure Assessment scores were recorded in group A. There was also a trend for lower mortality rates (0 [0%] vs 6 [14%]), sepsis rates (24 [63.2%] vs 37 [88.1%]), and cumulative fluid balance on days 3 and 7 in group A. In contrast, group A demonstrated an elevated

Incompatible type A plasma transfusion in patients requiring massive transfusion protocol: Outcomes of an Eastern Association for the Surgery of Trauma multicenter study.

Science.gov (United States)

Stevens, W Tait; Morse, Bryan C; Bernard, Andrew; Davenport, Daniel L; Sams, Valerie G; Goodman, Michael D; Dumire, Russell; Carrick, Matthew M; McCarthy, Patrick; Stubbs, James R; Pritts, Timothy A; Dente, Christopher J; Luo-Owen, Xian; Gregory, Jason A; Turay, David; Gomaa, Dina; Quispe, Juan C; Fitzgerald, Caitlin A; Haddad, Nadeem N; Choudhry, Asad; Quesada, Jose F; Zielinski, Martin D

2017-07-01

With a relative shortage of type AB plasma, many centers have converted to type A plasma for resuscitation of patients whose blood type is unknown. The goal of this study is to determine outcomes for trauma patients who received incompatible plasma transfusions as part of a massive transfusion protocol (MTP). As part of an Eastern Association for the Surgery of Trauma multi-institutional trial, registry and blood bank data were collected from eight trauma centers for trauma patients (age, ≥ 15 years) receiving emergency release plasma transfusions as part of MTPs from January 2012 to August 2016. Incompatible type A plasma was defined as transfusion to patient blood type B or type AB. Of the 1,536 patients identified, 92% received compatible plasma transfusions and 8% received incompatible type A plasma. Patient characteristics were similar except for greater penetrating injuries (48% vs 36%; p = 0.01) in the incompatible group. In the incompatible group, patients were transfused more plasma units at 4 hours (median, 9 vs. 5; p plasma to patients with blood groups B and AB as part of a MTP does not appear to be associated with significant increases in morbidity or mortality. Therapeutic study, level IV.

Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

Directory of Open Access Journals (Sweden)

Fayers Peter

2010-09-01

Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

Balancing selected medication costs with total number of daily injections: a preference analysis of GnRH-agonist and antagonist protocols by IVF patients.

Science.gov (United States)

Sills, E Scott; Collins, Gary S; Salem, Shala A; Jones, Christopher A; Peck, Alison C; Salem, Rifaat D

2012-08-30

During in vitro fertilization (IVF), fertility patients are expected to self-administer many injections as part of this treatment. While newer medications have been developed to substantially reduce the number of these injections, such agents are typically much more expensive. Considering these differences in both cost and number of injections, this study compared patient preferences between GnRH-agonist and GnRH-antagonist based protocols in IVF. Data were collected by voluntary, anonymous questionnaire at first consultation appointment. Patient opinion concerning total number of s.c. injections as a function of non-reimbursed patient cost associated with GnRH-agonist [A] and GnRH-antagonist [B] protocols in IVF was studied. Completed questionnaires (n = 71) revealed a mean +/- SD patient age of 34 +/- 4.1 yrs. Most (83.1%) had no prior IVF experience; 2.8% reported another medical condition requiring self-administration of subcutaneous medication(s). When out-of-pocket cost for [A] and [B] were identical, preference for [B] was registered by 50.7% patients. The tendency to favor protocol [B] was weaker among patients with a health occupation. Estimated patient costs for [A] and [B] were $259.82 +/- 11.75 and $654.55 +/- 106.34, respectively (p cost difference increased. This investigation found consistently higher non-reimbursed direct medication costs for GnRH-antagonist IVF vs. GnRH-agonist IVF protocols. A conditional preference to minimize downregulation (using GnRH-antagonist) was noted among some, but not all, IVF patient sub-groups. Compared to IVF patients with a health occupation, the preference for GnRH-antagonist was weaker than for other patients. While reducing total number of injections by using GnRH-antagonist is a desirable goal, it appears this advantage is not perceived equally by all IVF patients and its utility is likely discounted heavily by patients when nonreimbursed medication costs reach a critical level.

Evaluation of an adult insulin infusion protocol at an academic medical center.

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Petrov, Katerina I; Burns, Tammy L; Drincic, Andjela

2012-05-01

Acknowledging evidence of possible detrimental effects of tightly controlled blood glucose levels, the American Association of Clinical Endocrinologists and the American Diabetes Association published a consensus statement recommending less strict control for most diabetic patients. As a result of these recommendations, our academic center at Creighton University Medical Center revised its adult insulin infusion protocol to target blood glucose levels ranging from 120 to 180 mg/dL for regular (standard) glycemic control and 80 to 120 mg/dL for tight control; previous targets had ranged from 80 to 180 mg/dL and 70 to 110 mg/dL, respectively. The primary objective was to evaluate the time that blood glucose values were within the target range for patients receiving the new protocol, compared with patients receiving the previous protocol. Our study was designed to evaluate the effectiveness and safety of the revised protocol. Using a retrospective chart review, we collected data for 4 months from patients on the old insulin protocol (May to August 2009) and for 4 months from patients on the new protocol (September to December 2009). Secondary endpoints included the number of hypoglycemic episodes (blood glucose below 70 mg/dL) and severe hypoglycemic episodes (blood glucose 40 mg/dL or lower) experienced by patients receiving the new insulin protocol compared with those receiving the former protocol. Patient characteristics were similar at baseline. Blood glucose values stayed within the target range for a significantly shorter time with the new protocol than with the former protocol (44.6% vs. 56.8%, respectively; P protocol. No statistically significant differences in hypoglycemia were observed after the protocol was changed. Hypoglycemia occurred in 31% of the former-protocol patients compared with 18% of the revised-protocol patients. Severe hypoglycemia was experienced by 2.1% of patients on the old protocol and by 3.1% of patients on the new protocol. Rates of

Long-term impact of pre-operative physical rehabilitation protocol on the 6-min walk test of patients with adolescent idiopathic scoliosis: A randomized clinical trial

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V.L. dos Santos Alves

2015-05-01

Full Text Available Background: Monitored physical activities in patients with adolescent idiopathic scoliosis (AIS have been shown to improve physical performance, endurance and cardiopulmonary function and may be assessed by the 6-min walk test (6MWT. We aimed to evaluate the long-term results of the 6MWT after a rehabilitation protocol employed before surgical correction for AIS. Methods: This prospective randomized clinical trial studied the impact of a 4-month pre-operative physical rehabilitation protocol on post-operative cardiopulmonary function and physical endurance, by using the 6MWT, in patients with AIS submitted to surgical correction, comparing them to matched controls without physical rehabilitation. Studied variables were heart and respiratory rate, systolic and diastolic blood pressure, peripheral blood oxygen saturation, Borg score, and distance walked. Patients were assessed at baseline, after 4 months of rehabilitation, and 3, 6 and 12 months post-operatively. Results: A total of 50 patients with AIS were included in the study and allocated blindly, by simple randomization, into either one of the two groups, with 25 patients each: study group (pre-operative physical rehabilitation and control group. The physical rehabilitation protocol promoted significant progressive improvement in heart and respiratory rate, peripheral blood oxygen saturation, distance walked, and level of effort assessed by the Borg scale after surgery. Conclusions: Post-surgical recovery, evaluated by 6MWT, was significantly better in patients who underwent a 4-month pre-operative physical rehabilitation protocol. Keywords: Scoliosis, Exercise, Exercise movement techniques, Exercise therapy, Exercise test

Comparative study of 2 oral care protocols in intensive care units.

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Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

2017-03-01

The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Effect of a preoperative decontamination protocol on surgical site infections in patients undergoing elective orthopedic surgery with hardware implantation.

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Bebko, Serge P; Green, David M; Awad, Samir S

2015-05-01

365 patients developed an SSI) than the SSI rate in the control group (3.8%; 13 of 344 patients developed an SSI) (P = .02). Multivariate logistic regression identified MRSA decontamination as an independent predictor of not developing an SSI (adjusted odds ratio, 0.24 [95% CI, 0.08-0.77]; P = .02). Our study demonstrates that preoperative MRSA decontamination with chlorhexidine washcloths and oral rinse and intranasal povidone-iodine decreased the SSI rate by more than 50% among patients undergoing elective orthopedic surgery with hardware implantation. Universal decontamination using this low-cost protocol may be considered as an additional prevention strategy for SSIs in patients undergoing orthopedic surgery with hardware implantation and warrants further study.

Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

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Pérez-Mármol, Jose Manuel; García-Ríos, M Carmen; Barrero-Hernandez, Francisco J; Molina-Torres, Guadalupe; Brown, Ted; Aguilar-Ferrándiz, María Encarnación

2015-11-05

Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities. This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38). This trial is

[Clinical outcomes and economic analysis of two ovulation induction protocols in patients undergoing repeated IVF/ICSI cycles].

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Chen, Xiao; Geng, Ling; Li, Hong

2014-04-01

To compare the clinical outcomes and cost-effectiveness of luteal phase down-regulation with gonadotrophin-releasing hormone (GnRH) agonist protocol and GnRH antagonist protocol in patients undergoing repeated in vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI) cycles. A retrospective analysis of clinical outcomes and costs was conducted among 198 patients undergoing repeated IVF-ICSI cycles, including 109 receiving luteal phase down-regulation with GnRH agonist protocol (group A) and 89 receiving GnRH antagonist protocol (group B). The numbers of oocytes retrieved and good embryos, clinical pregnancy rate, abortion rate, the live birth rate, mean total cost, and the cost-effective ratio were compared between the two groups. In patients undergoing repeated IVF-ICSI cycles, the two protocols produced no significant differences in the number of good embryos, clinical pregnancy rate, abortion rate, or twin pregnancy rate. Compared with group B, group A had better clinical outcomes though this difference was not statistically significant. The number of retrieved oocytes was significantly greater and live birth rate significantly higher in group A than in group B (9.13=4.98 vs 7.11=4.74, and 20.2% vs 9.0%, respectively). Compared with group B, group A had higher mean total cost per cycle but lower costs for each oocyte retrieved (2729.11 vs 3038.60 RMB yuan), each good embryo (8867.19 vs 9644.85 RMB yuan), each clinical pregnancy (77598.06 vs 96139.85 RMB yuan). For patients undergoing repeated IVF/ICSI cycle, luteal phase down-regulation with GnRH agonist protocol produces good clinical outcomes with also good cost-effectiveness in spite an unsatisfactory ovarian reserve.

Development and Pilot Implementation of a Search Protocol to Improve Patient Safety on a Psychiatric Inpatient Unit.

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Abela-Dimech, Frances; Johnston, Kim; Strudwick, Gillian

A mental health organization in Ontario, Canada, noted an increase in unsafe items entering locked inpatient units. The purpose of this project was to develop and implement a search protocol to improve patient, staff, and visitor safety by preventing unsafe items from entering a locked inpatient unit. Under the guidance of a clinical nurse specialist, an interprofessional team used the Failure Mode and Effects Analysis framework to identify what items were considered unsafe, how these unsafe items were entering the unit, and what strategies could be used to prevent these items from entering the unit. A standardized search protocol was identified as a strategy to prevent items from entering the unit. The standardized search protocol was developed and piloted on 1 unit. To support the search protocol, an interprofessional team created a poster using a mnemonic aid to educate patients, staff, and visitors about which items could not be brought onto the unit. Educational sessions on the search protocol were provided for staff. The difference between the number of incidents before and after the implementation of the search protocol was statistically significant. Safety on an inpatient unit was increased as incidents of unsafe items entering the unit decreased.

Patient Transfers and Risk of Back Injury: Protocol for a Prospective Cohort Study With Technical Measurements of Exposure.

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Vinstrup, Jonas; Madeleine, Pascal; Jakobsen, Markus Due; Jay, Kenneth; Andersen, Lars Louis

2017-11-08

order to identify risk factors for back injuries related to patient transfers and intensity of LBP. Data collection is scheduled to commence during the winter of 2017. The design of this study is novel in its combination of technical measurements applied on a prospective cohort, and the results will provide important information about which assistive devices are associated with intensity of LBP and risk of back injury related to patient transfers. Furthermore, this study will shed light on the dose-response relationship between intensity, duration, and frequency of patient transfers and the intensity of LPB in Danish nurses, and will thereby help to guide and improve electronic health practices among this population. ©Jonas Vinstrup, Pascal Madeleine, Markus Due Jakobsen, Kenneth Jay, Lars Louis Andersen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.11.2017.

Oral contraceptive pretreatment does not improve outcome in microdose gonadotrophin-releasing hormone agonist protocol among poor responder intracytoplasmic sperm injection patients.

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Duvan, Candan Iltemir; Berker, Bulent; Turhan, Nilgun Ozturk; Satiroglu, Hakan

2008-01-01

To compare oral contraceptive (OC) pretreatment plus microdose GnRH-a in flare-up protocol and non-OC microdose GnRH-a in flare-up protocol among poor responder ICSI patients. A retrospective analysis of poor responder ICSI patients. Patients were divided into two groups according to used microdose protocol. Precycle treatment with OC followed by follicular phase administration of 40 microg s.c. leuprolide acetate (LA) every 12 h beginning on after 2 day pill-free period and rFSH administration was begun on the third day of LA administration (OC-Group, n=26). Alternatively on day 2 after menses, patients were administered similar stimulation regime (non-OC Group, n=27). There were no significant differences between groups in the number of oocytes, peak estradiol levels, endometrial thickness, fertilization rates and embryo quality. Implantations and pregnancy rates per embryo transfer were similar. OC pretreatment plus microdose GnRHa in flare-up protocol does not offer advantages over non-OC microdose GnRHa in flare-up protocol among poor responder ICSI patients.

Pharmacogenetics and induction/consolidation therapy toxicities in acute lymphoblastic leukemia patients treated with AIEOP-BFM ALL 2000 protocol.

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Franca, R; Rebora, P; Bertorello, N; Fagioli, F; Conter, V; Biondi, A; Colombini, A; Micalizzi, C; Zecca, M; Parasole, R; Petruzziello, F; Basso, G; Putti, M C; Locatelli, F; d'Adamo, P; Valsecchi, M G; Decorti, G; Rabusin, M

2017-01-01

Drug-related toxicities represent an important clinical concern in chemotherapy, genetic variants could help tailoring treatment to patient. A pharmacogenetic multicentric study was performed on 508 pediatric acute lymphoblastic leukemia patients treated with AIEOP-BFM 2000 protocol: 28 variants were genotyped by VeraCode and Taqman technologies, deletions of GST-M1 and GST-T1 by multiplex PCR. Toxicities were derived from a central database: 251 patients (49.4%) experienced at least one gastrointestinal (GI) or hepatic (HEP) or neurological (NEU) grade III/IV episode during the remission induction phase: GI occurred in 63 patients (12.4%); HEP in 204 (40.2%) and NEU in 44 (8.7%). Logistic regression model adjusted for sex, risk and treatment phase revealed that ITPA rs1127354 homozygous mutated patients showed an increased risk of severe GI and NEU. ABCC1 rs246240 and ADORA2A rs2236624 homozygous mutated genotypes were associated to NEU and HEP, respectively. These three variants could be putative predictive markers for chemotherapy-related toxicities in AIEOP-BFM protocols.

Interactive verification of Markov chains: Two distributed protocol case studies

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Johannes Hölzl

2012-12-01

Full Text Available Probabilistic model checkers like PRISM only check probabilistic systems of a fixed size. To guarantee the desired properties for an arbitrary size, mathematical analysis is necessary. We show for two case studies how this can be done in the interactive proof assistant Isabelle/HOL. The first case study is a detailed description of how we verified properties of the ZeroConf protocol, a decentral address allocation protocol. The second case study shows the more involved verification of anonymity properties of the Crowds protocol, an anonymizing protocol.

Multiprofissional electronic protocol in ophtalmology with enfasis in strabismus

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CHRISTIE GRAF RIBEIRO

Full Text Available ABSTRACT Objective: to create and validate an electronic database in ophthalmology focused on strabismus, to computerize this database in the form of a systematic data collection software named Electronic Protocol, and to incorporate this protocol into the Integrated System of Electronic Protocols (SINPE(c. Methods: this is a descriptive study, with the methodology divided into three phases: (1 development of a theoretical ophthalmologic database with emphasis on strabismus; (2 computerization of this theoretical ophthalmologic database using SINPE(c and (3 interpretation of the information with demonstration of results to validate the protocol. We inputed data from the charts of fifty patients with known strabismus through the Electronic Protocol for testing and validation. Results: the new electronic protocol was able to store information regarding patient history, physical examination, laboratory exams, imaging results, diagnosis and treatment of patients with ophthalmologic diseases, with emphasis on strabismus. We included 2,141 items in this master protocol and created 20 new specific electronic protocols for strabismus, each with its own specifics. Validation was achieved through correlation and corroboration of the symptoms and confirmed diagnoses of the fifty included patients with the diagnostic criteria for the twenty new strabismus protocols. Conclusion: a new, validated electronic database focusing on ophthalmology, with emphasis on strabismus, was successfully created through the standardized collection of information, and computerization of the database using proprietary software. This protocol is ready for deployment to facilitate data collection, sorting and application for practitioners and researchers in numerous specialties.

Minimizing variance in Care of Pediatric Blunt Solid Organ Injury through Utilization of a hemodynamic-driven protocol: a multi-institution study.

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Cunningham, Aaron J; Lofberg, Katrine M; Krishnaswami, Sanjay; Butler, Marilyn W; Azarow, Kenneth S; Hamilton, Nicholas A; Fialkowski, Elizabeth A; Bilyeu, Pamela; Ohm, Erika; Burns, Erin C; Hendrickson, Margo; Krishnan, Preetha; Gingalewski, Cynthia; Jafri, Mubeen A

2017-12-01

An expedited recovery protocol for management of pediatric blunt solid organ injury (spleen, liver, and kidney) was instituted across two Level 1 Trauma Centers, managed by nine pediatric surgeons within three hospital systems. Data were collected for 18months on consecutive patients after protocol implementation. Patient demographics (including grade of injury), surgeon compliance, National Surgical Quality Improvement Program (NSQIP) complications, direct hospital cost, length of stay, time in the ICU, phlebotomy, and re-admission were compared to an 18-month control period immediately preceding study initiation. A total of 106 patients were treated (control=55, protocol=51). Demographics were similar among groups, and compliance was 78%. Hospital stay (4.6 vs. 3.5days, p=0.04), ICU stay (1.9 vs. 1.0days, p=0.02), and total phlebotomy (7.7 vs. 5.3 draws, p=0.007) were significantly less in the protocol group. A decrease in direct hospital costs was also observed ($11,965 vs. $8795, p=0.09). Complication rates (1.8% vs. 3.9%, p=0.86, no deaths) were similar. An expedited, hemodynamic-driven, pediatric solid organ injury protocol is achievable across hospital systems and surgeons. Through implementation we maintained quality while impacting length of stay, ICU utilization, phlebotomy, and cost. Future protocols should work to further limit resource utilization. Retrospective cohort study. Level II. Copyright © 2017 Elsevier Inc. All rights reserved.

Ethical and legal duty of anesthesiologists regarding Jehovah's Witness patient: care protocol.

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Takaschima, Augusto Key Karazawa; Sakae, Thiago Mamôru; Takaschima, Alexandre Karazawa; Takaschima, Renata Dos Santos Teodoro; Lima, Breno José Santiago Bezerra de; Benedetti, Roberto Henrique

Jehovah's Witnesses patients refuse blood transfusions for religious reasons. Anesthesiologists must master specific legal knowledge to provide care to these patients. Understanding how the Law and the Federal Council of Medicine treat this issue is critical to know how to act in this context. The aim of this paper was to establish a treatment protocol for the Jehovah's Witness patient with emphasis on ethical and legal duty of the anesthesiologist. The article analyzes the Constitution, Criminal Code, resolutions of the Federal Council of Medicine, opinions, and jurisprudence to understand the limits of the conflict between the autonomy of will of Jehovah's Witnesses to refuse transfusion and the physician's duty to provide the transfusion. Based on this evidence, a care protocol is suggested. The Federal Council of Medicine resolution 1021/1980, the penal code Article 135, which classifies denial of care as a crime and the Supreme Court decision on the HC 268,459/SP process imposes on the physician the obligation of blood transfusion when life is threatened. The patient's or guardian's consent is not necessary, as the autonomy of will manifestation of the Jehovah's Witness patient refusing blood transfusion for himself and relatives, even in emergencies, is no not forbidden. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

Optimizing a Treadmill Ramp Protocol to Evaluate Aerobic Capacity of Hemiparetic Poststroke Patients.

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Bernardes, Wendell L; Montenegro, Rafael A; Monteiro, Walace D; de Almeida Freire, Raul; Massaferri, Renato; Farinatti, Paulo

2018-03-01

Bernardes, WL, Montenegro, RA, Monteiro, WD, de Almeida Freire, R, Massaferri, R, and Farinatti, P. Optimizing a treadmill ramp protocol to evaluate aerobic capacity of hemiparetic poststroke patients. J Strength Cond Res 32(3): 876-884, 2018-A correct assessment of cardiopulmonary capacity is important for aerobic training within motor rehabilitation of poststroke hemiparetic patients (PSHPs). However, specific cardiopulmonary exercise testing (CPET) for these patients are scarce. We proposed adaptations in a protocol originally developed for PSHPs by Ovando et al. (CPET1). We hypothesized that our adapted protocol (CPET2) would improve the original test, by preventing early fatigue and increasing patients' peak performance. Eleven PSHPs (52 ± 14 years, 10 men) performed both protocols. CPET2 integrated changes in final speed (100-120% vs. 140% maximal speed in 10-m walking test), treadmill inclination (final inclination of 5 vs. 10%), and estimated test duration (10 vs. 8 minutes) to smooth the rate of workload increment of CPET1. Peak oxygen uptake (V[Combining Dot Above]O2peak) (20.3 ± 6.1 vs. 18.6 ± 5.0 ml·kg·min; p = 0.04), V[Combining Dot Above]O2 at gas exchange transition (V[Combining Dot Above]O2-GET) (11.5 ± 2.9 vs. 9.8 ± 2.0 ml·kg·min; p = 0.04), and time to exhaustion (10 ± 3 vs. 6 ± 2 minutes; p higher in CPET2 than in CPET1. Slopes and intercepts of regressions describing relationships between V[Combining Dot Above]O2 vs. workload, heart rate vs. workload, and V[Combining Dot Above]O2 vs. heart rate were similar between CPETs. However, standard errors of estimates obtained for regressions between heart rate vs. workload (3.0 ± 1.3 vs. 3.8 ± 1.0 b·min; p = 0.004) and V[Combining Dot Above]O2 vs. heart rate (6.0 ± 2.1 vs. 4.8 ± 2.4 ml·kg·min; p = 0.05) were lower in CPET2 than in CPET1. In conclusion, the present adaptations in Ovando's CPET protocol increased exercise tolerance of PSHPs, eliciting higher V[Combining Dot Above]O2peak

Review of therapeutic agents for burns pruritus and protocols for management in adult and paediatric patients using the GRADE classification

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Goutos Ioannis

2010-10-01

Full Text Available To review the current evidence on therapeutic agents for burns pruritus and use the Grading of Recommendations, Assessment, Development and Evaluation (GRADE classification to propose therapeutic protocols for adult and paediatric patients. All published interventions for burns pruritus were analysed by a multidisciplinary panel of burns specialists following the GRADE classification to rate individual agents. Following the collation of results and panel discussion, consensus protocols are presented. Twenty-three studies appraising therapeutic agents in the burns literature were identified. The majority of these studies (16 out of 23 are of an observational nature, making an evidence-based approach to defining optimal therapy not feasible. Our multidisciplinary approach employing the GRADE classification recommends the use of antihistamines (cetirizine and cimetidine and gabapentin as the first-line pharmacological agents for both adult and paediatric patients. Ondansetron and loratadine are the second-line medications in our protocols. We additionally recommend a variety of non-pharmacological adjuncts for the perusal of clinicians in order to maximise symptomatic relief in patients troubled with postburn itch. Most studies in the subject area lack sufficient statistical power to dictate a ′gold standard′ treatment agent for burns itch. We encourage clinicians to employ the GRADE system in order to delineate the most appropriate therapeutic approach for burns pruritus until further research elucidates the most efficacious interventions. This widely adopted classification empowers burns clinicians to tailor therapeutic regimens according to current evidence, patient values, risks and resource considerations in different medical environments.

A reliable transmission protocol for ZigBee-based wireless patient monitoring.

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Chen, Shyr-Kuen; Kao, Tsair; Chan, Chia-Tai; Huang, Chih-Ning; Chiang, Chih-Yen; Lai, Chin-Yu; Tung, Tse-Hua; Wang, Pi-Chung

2012-01-01

Patient monitoring systems are gaining their importance as the fast-growing global elderly population increases demands for caretaking. These systems use wireless technologies to transmit vital signs for medical evaluation. In a multihop ZigBee network, the existing systems usually use broadcast or multicast schemes to increase the reliability of signals transmission; however, both the schemes lead to significantly higher network traffic and end-to-end transmission delay. In this paper, we present a reliable transmission protocol based on anycast routing for wireless patient monitoring. Our scheme automatically selects the closest data receiver in an anycast group as a destination to reduce the transmission latency as well as the control overhead. The new protocol also shortens the latency of path recovery by initiating route recovery from the intermediate routers of the original path. On the basis of a reliable transmission scheme, we implement a ZigBee device for fall monitoring, which integrates fall detection, indoor positioning, and ECG monitoring. When the triaxial accelerometer of the device detects a fall, the current position of the patient is transmitted to an emergency center through a ZigBee network. In order to clarify the situation of the fallen patient, 4-s ECG signals are also transmitted. Our transmission scheme ensures the successful transmission of these critical messages. The experimental results show that our scheme is fast and reliable. We also demonstrate that our devices can seamlessly integrate with the next generation technology of wireless wide area network, worldwide interoperability for microwave access, to achieve real-time patient monitoring.

The safety of a novel early mobilization protocol conducted by ICU physicians: a prospective observational study

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Keibun Liu

2018-02-01

Full Text Available Abstract Background There are numerous barriers to early mobilization (EM in a resource-limited intensive care unit (ICU without a specialized team or an EM culture, regarding patient stability while critically ill or in the presence of medical devices. We hypothesized that ICU physicians can overcome these barriers. The aim of this study was to investigate the safety of EM according to the Maebashi EM protocol conducted by ICU physicians. Methods This was a single-center prospective observational study. All consecutive patients with an unplanned emergency admission were included in this study, according to the exclusion criteria. The observation period was from June 2015 to June 2016. Data regarding adverse events, medical devices in place during rehabilitation, protocol adherence, and rehabilitation outcomes were collected. The primary outcome was safety. Results A total of 232 consecutively enrolled patients underwent 587 rehabilitation sessions. Thirteen adverse events occurred (2.2%; 95% confidence interval, 1.2–3.8% and no specific treatment was needed. There were no instances of dislodgement or obstruction of medical devices, tubes, or lines. The incidence of adverse events associated with mechanical ventilation or extracorporeal membrane oxygenation (ECMO was 2.4 and 3.6%, respectively. Of 587 sessions, 387 (66% sessions were performed at the active rehabilitation level, including sitting out of the bed, active transfer to a chair, standing, marching, and ambulating. ICU physicians attended over 95% of these active rehabilitation sessions. Of all patients, 143 (62% got out of bed within 2 days (median 1.2 days; interquartile range 0.1–2.0. Conclusions EM according to the Maebashi EM protocol conducted by ICU physicians, without a specialized team or EM culture, was performed at a level of safety similar to previous studies performed by specialized teams, even with medical devices in place, including mechanical ventilation or ECMO

Physical Therapy Protocols for Arthroscopic Bankart Repair.

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DeFroda, Steven F; Mehta, Nabil; Owens, Brett D

Outcomes after arthroscopic Bankart repair can be highly dependent on compliance and participation in physical therapy. Additionally, there are many variations in physician-recommended physical therapy protocols. The rehabilitation protocols of academic orthopaedic surgery departments vary widely despite the presence of consensus protocols. Descriptive epidemiology study. Level 3. Web-based arthroscopic Bankart rehabilitation protocols available online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs were included for review. Individual protocols were reviewed to evaluate for the presence or absence of recommended therapies, goals for completion of ranges of motion, functional milestones, exercise start times, and recommended time to return to sport. Thirty protocols from 27 (16.4%) total institutions were identified out of 164 eligible for review. Overall, 9 (30%) protocols recommended an initial period of strict immobilization. Variability existed between the recommended time periods for sling immobilization (mean, 4.8 ± 1.8 weeks). The types of exercises and their start dates were also inconsistent. Goals to full passive range of motion (mean, 9.2 ± 2.8 weeks) and full active range of motion (mean, 12.2 ± 2.8 weeks) were consistent with other published protocols; however, wide ranges existed within the reviewed protocols as a whole. Only 10 protocols (33.3%) included a timeline for return to sport, and only 3 (10%) gave an estimate for return to game competition. Variation also existed when compared with the American Society of Shoulder and Elbow Therapists' (ASSET) consensus protocol. Rehabilitation protocols after arthroscopic Bankart repair were found to be highly variable. They also varied with regard to published consensus protocols. This discrepancy may lead to confusion among therapists and patients. This study highlights the importance of attending surgeons being very clear and specific with

Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study: A study of protocols in Greater London

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Ford Tamsin

2008-06-01

Full Text Available Abstract Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS to Adult Mental Health Services (AMHS in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005 of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65% responded to the survey. Teams varied in type (generic/targeted/in-patient, catchment area (locality-based, wider or national and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37 was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33. In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in

Protocol compliance and time management in blunt trauma resuscitation.

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Spanjersberg, W R; Bergs, E A; Mushkudiani, N; Klimek, M; Schipper, I B

2009-01-01

To study advanced trauma life support (ATLS) protocol adherence prospectively in trauma resuscitation and to analyse time management of daily multidisciplinary trauma resuscitation at a level 1 trauma centre, for both moderately and severely injured patients. All victims of severe blunt trauma were consecutively included. Patients with a revised trauma score (RTS) of 12 were resuscitated by a "minor trauma" team and patients with an RTS of less than 12 were resuscitated by a "severe trauma" team. Digital video recordings were used to analyse protocol compliance and time management during initial assessment. From 1 May to 1 September 2003, 193 resuscitations were included. The "minor trauma" team assessed 119 patients, with a mean injury severity score (ISS) of 7 (range 1-45). Overall protocol compliance was 42%, ranging from 0% for thoracic percussion to 93% for thoracic auscultation. The median resuscitation time was 45.9 minutes (range 39.7-55.9). The "severe team" assessed 74 patients, with a mean ISS of 22 (range 1-59). Overall protocol compliance was 53%, ranging from 4% for thoracic percussion to 95% for thoracic auscultation. Resuscitation took 34.8 minutes median (range 21.6-44.1). Results showed the current trauma resuscitation to be ATLS-like, with sometimes very low protocol compliance rates. Timing of secondary survey and radiology and thus time efficiency remains a challenge in all trauma patients. To assess the effect of trauma resuscitation protocols on outcome, protocol adherence needs to be improved.

I-123 IBZM-SPECT: improved acquisition protocol with HR-collimator

International Nuclear Information System (INIS)

Sandrock, D.; Ivancevic, V.; Dopichaj-Menge, U.; Gruber, D.; Munz, D.

2002-01-01

Aim: Aim of this study was to evaluate the impact of different acquisition and reconstruction protocols on the quality of SPECT diagnostics with I-123 IBZM in patients with diseases of the dopaminergic system. Material and Methods: Overall, 30 patients (19 men, 11 women, aged 22 - 80 years) were studied with SPECT after i.v. injection of 5 mCi (185 MBq) I-123 IBZM. Acquisition was performed 60 min p.i. (protocol A) using a medium energy collimator, a 64 x 64 matrix, 64 projections, step and shoot technique, 5.6 0 and 20 seconds per step with a MultiSPECT2 double-head gamma camera (Siemens). Immediately afterwards, a second acquisition (protocol B, 90 min p.i.) using a high resolution collimator, a 128 x 128 matrix, 60 projections, step and shoot technique, 3 0 and 30 seconds per step was performed. The reconstruction was done in filtered backprojection technique and a Butterworth filter of order 7, in protocol A using a cutoff of 0.5 and in protocol B of 0.4. Finally, the net count ratios of the basal ganglia to the frontal lobe(s) were calculated and compared with the clinical diagnosis. Results: The visual analysis yielded - as expected -a better image quality for protocol B (concordant impression of 3 independent observers) with more accurate delineation of the basal ganglia. The count ratios with protocol B were (mean) 0.19 higher (equivalent to 13 %) than with protocol A. In the group of patients with count ratios > 1.55 there was the highest (and significant) difference between protocols A and B with (mean count ratio difference) 0.32 (equivalent to 20 %). Protocol B also allowed a better differentiation between patients clinically staged normal and abnormal. In patients with unilateral disease, this difference between normal and abnormal was more prominent (in comparison to the contralateral side as well as compared to the reference value [1.5]). The comparison of the count ratios with the clinical data revealed 7 patients with borderline results with

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

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Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

Implementation of subcutaneous insulin protocol for non-critically ill hospitalized patients in andalusian tertiary care hospitals.

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Martínez-Brocca, María Asunción; Morales, Cristóbal; Rodríguez-Ortega, Pilar; González-Aguilera, Beatriz; Montes, Cristina; Colomo, Natalia; Piédrola, Gonzalo; Méndez-Muros, Mariola; Serrano, Isabel; Ruiz de Adana, Maria Soledad; Moreno, Alberto; Fernández, Ignacio; Aguilar, Manuel; Acosta, Domingo; Palomares, Rafael

2015-02-01

In 2009, the Andalusian Society of Endocrinology and Nutrition designed a protocol for subcutaneous insulin treatment in hospitalized non-critically ill patients (HIP). To analyze implementation of HIP at tertiary care hospitals from the Andalusian Public Health System. A descriptive, multicenter study conducted in 8 tertiary care hospitals on a random sample of non-critically ill patients with diabetes/hyperglycemia (n=306) hospitalized for ≥48 hours in 5 non-surgical (SM) and 2 surgical (SQ) departments. Type 1 and other specific types of diabetes, pregnancy and nutritional support were exclusion criteria. 288 patients were included for analysis (62.5% males; 70.3±10.3 years; 71.5% SM, 28.5% SQ). A scheduled subcutaneous insulin regimen based on basal-bolus-correction protocol was started in 55.9% (95%CI: 50.5-61.2%) of patients, 63.1% SM vs. 37.8% SQ (P<.05). Alternatives to insulin regimen based on basal-bolus-correction included sliding scale insulin (43.7%), diet (31.3%), oral antidiabetic drugs (17.2%), premixed insulin (1.6%), and others (6.2%). For patients previously on oral antidiabetic drugs, in-hospital insulin dose was 0.32±0.1 IU/kg/day. In patients previously on insulin, in-hospital insulin dose was increased by 17% [-13-53], and in those on insulin plus oral antidiabetic drugs, in-hospital insulin dose was increased by 26.4% [-6-100]. Supplemental insulin doses used for<40 IU/day and 40-80 IU/day were 72.2% and 56.7% respectively. HbA1c was measured in 23.6% of patients (95CI%: 18.8-28.8); 27.7% SM vs. 13.3% SQ (P<.05). Strategies are needed to improve implementation of the inpatient subcutaneous insulin protocol, particularly in surgical departments. Sliding scale insulin is still the most common alternative to insulin regimen based on basal-bolus-correction scheduled insulin. Metabolic control assessment during hospitalization should be encouraged. Copyright © 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU.

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Giuseppe Frazzitta

Full Text Available Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome.Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning were assessed on the third day from the injury (T0, at ICU discharge (T1 and at Rehab discharge (T2. Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively.Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy. Early verticalization started 12.4±7.3 (mean±SD days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01, while the total length of stay (ICU+Neurorehabilitation was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41. All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all, as well as after ICU stay (T1 vs T0, p<0.004 all and after Neurorehabilitation (T2 vs T1, p<0.004 all. The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006 and (borderline for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058.A stepping verticalization protocol, started since the acute stages, improves the

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

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Melanie Calvert

Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

Patient-controlled hospital admission for patients with severe mental disorders: study protocol for a nationwide prospective multicentre study.

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Thomsen, Christoffer Torgaard; Benros, Michael Eriksen; Hastrup, Lene Halling; Andersen, Per Kragh; Giacco, Domenico; Nordentoft, Merete

2016-09-28

Patient-controlled hospital admission for individuals with severe mental disorders is a novel approach in mental healthcare. Patients can admit themselves to a hospital unit for a short stay without being assessed by a psychiatrist or contacting the emergency department. Previous studies assessing the outcomes of patient-controlled hospital admission found trends towards reduction in the use of coercive measures and length of hospital stay; however, these studies have methodological shortcomings and small sample sizes. Larger studies are needed to estimate the effect of patient-controlled hospital admission on the use of coercion and of healthcare services. We aim to recruit at least 315 patients who are offered a contract for patient-controlled hospital admissions in eight different hospitals in Denmark. Patients will be followed-up for at least 1 year to compare the use of coercive measures and of healthcare services, the use of medications and suicidal behaviour. Descriptive statistics will be used to investigate hospitalisations, global assessment of functioning (GAF) and patient satisfaction with treatment. To minimise selection bias, we will match individuals using patient-controlled hospital admission and controls with a 1:5 ratio via a propensity score based on the following factors: sex, age group, primary diagnosis, substance abuse as secondary diagnosis, coercion, number of psychiatric bed days, psychiatric history, urbanity and suicidal behaviour. Additionally, a historical control study will be undertaken in which patients serve as their own control group prior to index date. The study has been approved by The Danish Health and Medicines Authority (j.nr.: 3-3013-934/1/) and by The Danish Data Protection Agency (j.nr.: 2012-58-0004). The study was categorised as a register study by The Danish Health Research Ethics Committee and therefore no further approval was needed (j.nr.: H-2-2014-FSP70). Findings will be disseminated through scientific

Shortened protocol in practical [11C]SA4503-PET studies for sigma1 receptor quantification

International Nuclear Information System (INIS)

Sakata, Muneyuki; Kimura, Yuichi; Ishikawa, Masatomo; Oda, Keiichi; Ishii, Kenji; Ishiwata, Kiichi; Naganawa, Mika; Hashimoto, Kenji; Chihara, Kunihiro

2008-01-01

In practical positron emission tomography (PET) diagnosis, a shortened protocol is preferred for patients with brain disorders. In this study, the applicability of a shortened protocol as an alternative to the 90-min PET scan with [ 11 C]SA4503 for quantitative sigma 1 receptor measurement was investigated. Tissue time-activity curves of 288 regions of interest in the brain from 32 [ 11 C]SA4503-PET scans of 16 healthy subjects prior to and following administration of a selective serotonin reuptake inhibitor (fluvoxamine or paroxetine) were applied to two algorithms of quantitative analysis; binding potential (BP) was derived from compartmental analysis based on nonlinear estimation, and total distribution volume (tDV) was derived from Logan plot analysis. As a result, although both BP and tDV tended to be underestimated by the shortened method, the estimates from the shortened protocol had good linear relationships with those of the full-length protocol. In conclusion, if approximately 10% differences in the estimated results are acceptable for a specific purpose, then a 60-min measurement protocol is capable of providing reliable results. (author)

Balancing selected medication costs with total number of daily injections: a preference analysis of GnRH-agonist and antagonist protocols by IVF patients

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Sills E

2012-08-01

Full Text Available Abstract Background During in vitro fertilization (IVF, fertility patients are expected to self-administer many injections as part of this treatment. While newer medications have been developed to substantially reduce the number of these injections, such agents are typically much more expensive. Considering these differences in both cost and number of injections, this study compared patient preferences between GnRH-agonist and GnRH-antagonist based protocols in IVF. Methods Data were collected by voluntary, anonymous questionnaire at first consultation appointment. Patient opinion concerning total number of s.c. injections as a function of non-reimbursed patient cost associated with GnRH-agonist [A] and GnRH-antagonist [B] protocols in IVF was studied. Results Completed questionnaires (n = 71 revealed a mean +/− SD patient age of 34 +/− 4.1 yrs. Most (83.1% had no prior IVF experience; 2.8% reported another medical condition requiring self-administration of subcutaneous medication(s. When out-of-pocket cost for [A] and [B] were identical, preference for [B] was registered by 50.7% patients. The tendency to favor protocol [B] was weaker among patients with a health occupation. Estimated patient costs for [A] and [B] were $259.82 +/− 11.75 and $654.55 +/− 106.34, respectively (p  Conclusions This investigation found consistently higher non-reimbursed direct medication costs for GnRH-antagonist IVF vs. GnRH-agonist IVF protocols. A conditional preference to minimize downregulation (using GnRH-antagonist was noted among some, but not all, IVF patient sub-groups. Compared to IVF patients with a health occupation, the preference for GnRH-antagonist was weaker than for other patients. While reducing total number of injections by using GnRH-antagonist is a desirable goal, it appears this advantage is not perceived equally by all IVF patients and its utility is likely discounted heavily by patients when nonreimbursed medication costs

Platinum desensitization in patients with carboplatin hypersensitivity: A single-institution retrospective study.

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Altwerger, Gary; Gressel, Gregory M; English, Diana P; Nelson, Wendelin K; Carusillo, Nina; Silasi, Dan-Arin; Azodi, Masoud; Santin, Alessandro; Schwartz, Peter E; Ratner, Elena S

2017-01-01

The carboplatin desensitization (CD) protocol presented here allows patients with either a positive skin test or a prior hypersensitivity reaction (HSR) to safely, rapidly and effectively continue with carboplatin infusions. Newly described factors can identify patients at risk for developing adverse events during CD. A retrospective review was performed on patients with gynecologic cancer who underwent CD between 2005 and 2014. The CD protocol uses a four-step dilution process over 3.5h. 129 patients underwent CD and completed a total of 788cycles. The desensitization protocol prevented HSRs in 96% (753 out of 788) of these cycles. Patients achieved an average of 6.1cycles (SD±4.55, range 0-23) with CD. The CD protocol allowed 73% (94 of 129) of the patients to undergo carboplatin infusion without reaction. Patients with moderate to life-threatening HSRs (grade 2 through 4) were 10.5years younger at initial CD than patients with grades 0 or 1 HSRs (52.3 vs. 63, P = 0.0307). One patient death occurred during her thirteenth desensitization cycle. The HSR in this case was complicated by pre-exisiting pulmonary hypertension. This is the largest study of its kind showing a safe, effective and rapid (3.5h) CD protocol. The majority of patients with a history of either carboplatin hypersensitivity reaction or a positive skin test completed the CD protocol without HSRs. Age was identified as a risk factor for HSR severity during CD. Age can be employed along with pre-load dependent cardiac conditions as a way to help risk stratify patients undergoing CD. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients.

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Altunkan, Sekip; Iliman, Nevzat; Altunkan, Erkan

2008-04-01

Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.

Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial.

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Wienert, Julian; Schwarz, Betje; Bethge, Matthias

2016-07-27

Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors. To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60 years with a Karnofsky Performance Status of ≥70 %, a preliminary positive social-medical prognosis of employability for at least 3 h/day within the next 6 months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients' capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC

Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol.

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Ware, Patrick; Ross, Heather J; Cafazzo, Joseph A; Laporte, Audrey; Seto, Emily

2018-05-03

Meta-analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared with the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. The objectives of this study are to (1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes, and their ability to self-care; (2) identify the contextual barriers and facilitators of implementation at the physician, clinic, and institutional level; (3) describe patient usage patterns to determine adherence and other behaviors in the telemonitoring program; and (4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the health care system (ie, public payer), hospital, and patient. The evaluation will use a mixed-methods approach. The quantitative component will include a pragmatic pre- and posttest study design for the impact and cost analyses, which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Furthermore, outcome data will be collected at 1, 12, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semistructured interviews with clinicians, and other program staff at baseline, 4 months, and 12 months after the program start date. Interviews conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. The telemonitoring program was launched in

Comparison of luteal estradiol patch and gonadotropin-releasing hormone antagonist suppression protocol before gonadotropin stimulation versus microdose gonadotropin-releasing hormone agonist protocol for patients with a history of poor in vitro fertilization outcomes.

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Weitzman, Vanessa N; Engmann, Lawrence; DiLuigi, Andrea; Maier, Donald; Nulsen, John; Benadiva, Claudio

2009-07-01

To compare IVF outcomes in poor-responder patients undergoing stimulation after luteal phase E(2) patch/GnRH antagonist (LPG) protocol versus microdose GnRH agonist protocol. Retrospective analysis. University-based IVF center. Forty-five women undergoing ovarian stimulation for IVF using the LPG protocol were compared with 76 women stimulated with the microdose GnRH agonist protocol from May 2005 to April 2006. Cancellation rate, number of oocytes retrieved, and clinical pregnancy rates. The mean number of oocytes (9.1 +/- 4.1 vs. 8.9 +/- 4.3) and mature oocytes (6.7 +/- 3.5 vs. 6.8 +/- 3.1) retrieved were similar, as were the fertilization rates (70.0% +/- 24.2% vs. 69.9% +/- 21.5%) and the number of embryos transferred (2.5 +/- 1.1 vs. 2.7 +/- 1.3). The cancellation rate was not significantly different between the groups (13/45, 28.9% vs. 23/76, 30.3%). Likewise, there were no significant differences among the implantation rate (15.0% vs. 12.5%), clinical pregnancy rate (43.3% vs. 45.1%), and ongoing pregnancy rate per transfer (33.3% vs. 26.0%) between both groups. This study demonstrates that the use of an E(2) patch and a GnRH antagonist during the preceding luteal phase in patients with a history of failed cycles can provide similar IVF outcomes when compared with the microdose GnRH agonist protocol.

The Trauma Time-Out: Evaluating the Effectiveness of Protocol-Based Information Dissemination in the Traumatically Injured Patient.

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Nolan, Heather R; Fitzgerald, Michael; Howard, Brett; Jarrard, Joey; Vaughn, Danny

Procedural time-outs are widely accepted safety standards that are protocolized in nearly all hospital systems. The trauma time-out, however, has been largely unstudied in the existing literature and does not have a standard protocol outlined by any of the major trauma surgery organizations. The goal of this study was to evaluate our institution's use of the trauma time-out and assess how trauma team members viewed its effectiveness. A multiple-answer survey was sent to trauma team members at a Level I trauma center. Questions included items directed at background, experience, opinions, and write-in responses. Most responders were experienced trauma team members who regularly participated in trauma codes. All respondents noted the total time required to complete the time-out was less than 5 min, with the majority saying it took less than 1 min. Seventy-five percent agreed that trauma time-outs should continue, with 92% noting that it improved understanding of patient presentation and prehospital evaluation. Seventy-seven percent said it improved understanding of other team member's roles, and 75% stated it improved patient care. Subgroups of physicians and nurses were statistically similar; yet, physicians did note that it improved their understanding of the team member's function more frequently than nurses. The trauma time-out can be an excellent tool to improve patient care and team understanding of the incoming trauma patient. Although used widely at multiple levels of trauma institutions, development of a documented protocol can be the next step in creating a unified safety standard.

Factors and motivations associated with use of e-cigarette among primary care patients in a prospective cohort study: e-TAC study protocol.

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Kinouani, Shérazade; Castéra, Philippe; Laporte, Catherine; Pétrègne, François; Gay, Bernard

2016-06-15

While the relationship between electronic cigarette use and smoking has often been studied, the association between electronic cigarette use and socioeconomic factors has received less attention. This is a study protocol aiming to describe the relationship between the consumption of psychoactive products (in particular: smoking) or some socioeconomic factors and the evolution of the use of electronic cigarette in primary healthcare over 1 year. Electronic cigarette, Tobacco, Alcohol and Cannabis (e-TAC) is a prospective multisite cohort study, including 473 patients at baseline and carrying out in general practices in the Aquitaine area (France). The volunteer patients participated in the study regardless of their initial reason for consultation. They filled out a self-administered questionnaire at baseline and will also do so after 12 months by phone, email or letter. The study will focus on the factors that explain the experimentation with or the current use of the electronic cigarette, as well as factors associated with their evolutions over time using multivariate logistic regression modelling or Cox regression modelling. This study received ethical approval from the University of Bordeaux Committee for the protection of persons. It was also approved by the National Commission for Data Processing and Freedoms. Findings will be submitted for publication in peer-reviewed journals and we will disseminate them by presentations at national or international conferences. RCB: 2015-A00778-41; 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/

Implementation of a Rapid, Protocol-based TIA Management Pathway.

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Jarhult, Susann J; Howell, Melissa L; Barnaure-Nachbar, Isabelle; Chang, Yuchiao; White, Benjamin A; Amatangelo, Mary; Brown, David F; Singhal, Aneesh B; Schwamm, Lee H; Silverman, Scott B; Goldstein, Joshua N

2018-03-01

Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED) with symptoms of transient ischemic attack (TIA). We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6-12 months after implementation. Outcomes included ED length of stay (LOS), hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18). Following the intervention, the inpatient admission rate decreased from 62% to 24% (pTIA among those with final diagnosis of TIA was 3% for both periods. Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

Directory of Open Access Journals (Sweden)

Ford Daniel E

2010-11-01

Full Text Available Abstract Background Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group. Methods The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates and patient participation (proportion referred who go to the website. We will then compare the effectiveness of the standard and augmented patient websites. Discussion Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login and patient outcomes (six-month smoking cessation. Trial Registration Web-delivered Provider Intervention for

Performance of a tracheostomy removal protocol for pediatric patients in rehabilitation after acquired brain injury: Factors associated with timing and possibility of decannulation.

Science.gov (United States)

Pozzi, Marco; Galbiati, Sara; Locatelli, Federica; Clementi, Emilio; Strazzer, Sandra

2017-11-01

We assessed the performance of a tracheostomy decannulation protocol privileging safety over quickness, in pediatric patients undergoing rehabilitation from severe acquired brain injury. We analyzed factors associated with decannulation timing and possibility and examined cases of failure. A safe decannulation protocol should minimize failures. Retrospective observational study. Patients aged 0-17 admitted to rehabilitation with tracheostomy in the last 15 years (n = 123). We collected data on clinical and respiratory conditions at admittance, during the first rehabilitation stay and following follow-up controls. We described the sample and tested associations of several factors with the possibility to decannulate patients during either the first stay or follow-up. We described failures, defined as the cases in which tracheostomy tube had to be placed back immediately or after less than 1 month from removal. At admittance, 93.5% patients were dysphagic and 37.9% had respiratory complications (mainly accumulation of supraglottic secretions). At first discharge, dysphagia was reduced (62.1%) and respiratory complications increased (41.1%). Tracheostomy was removed during the first stay in 55.3% patients, during follow-up in 13%, without failures among the 80 patients who followed the protocol. Four decannulations performed against protocol recommendations resulted in three failures. Decannulation was mainly prevented by the persistence of respiratory complications and dysphagia that constituted a relevant risk of aspiration and suffocation; decannulation was mainly postponed because of respiratory complications and breath-holding spells in very young children. By applying a decannulation protocol that privileges safety over quickness, we encountered no failure. Respiratory complications and dysphagia that lead to supraglottic stagnation, and breath-holding spells, are key elements to consider before performing decannulation in pediatric patients. © 2017 Wiley

A fixed protocol for outpatient clinic routines in the care of patients with severe renal failure.

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Hadimeri, Henrik; Frisenette-Fich, Carsten; Deurell, Sven-Ingemar; Svensson, Lars; Carlsson-Bjering, Lena; Fernström, Anders; Almroth, Gabriel; Melander, Stefan; Haarhaus, Mattias; Andersson, Per-Olof; Cassel, Agneta; Mauritz, Nils-Johan; Ståhl-Nilsson, Agneta; Wilske, Jan; Nordström, Kataryna; Oruda, Pavel; Eriksson, Marie; Larsson, Annelie Inghilesi; Stegmayr, Bernd

2013-07-01

The primary aim of this study was to assess whether a fixed protocol, using a specially trained team, for intermediate follow-up to fulfillment of guideline targets is non-inferior to conventional follow-up in the care of uraemic patients. A secondary aim was to investigate possible impact on patient outcome. The cohort comprised 424 patients from seven centers. Inclusion criteria were either serum creatinine exceeding 200 µmol/l or calculated clearance below 30 ml/min, representing CKD 4 or 5a. Six centers followed a standardized protocol (group 1). One center provided controls (group 2). The study design was prospective and interventional. The variables measured were blood hemoglobin, bicarbonate, calcium, phosphate, intact parathyroid hormone, albumin, renal function variables, blood pressure and RAAS blockade. The number of patients achieving the set goals was analyzed as a time trend to determine if the intervention resulted in an improvement. At baseline, group 1 had significantly lower GFR and higher serum creatinine, calcium, phosphate, calcium × phosphate product and bicarbonate, lower mean arterial pressure (MAP), systolic blood pressures and less use of RAAS. During the intervention, group 1 improved in the direction of guidelines for blood hemoglobin, albumin, bicarbonate and MAP. Outcome of secondary endpoints gave a risk of death of 30% in both groups, while the risk of renal replacement therapy was higher in group 1. However, the time to renal replacement therapy was significantly shorter in the intervention group, indicating that other variables than guideline achievements are important for the patient.

Retrospective analysis of prostate cancer patients with implanted gold markers using off-line and adaptive therapy protocols

International Nuclear Information System (INIS)

Litzenberg, Dale W.; Balter, James M.; Lam, Kwok L.; Sandler, Howard M.; Ten Haken, Randall K.

2005-01-01

Purpose: To determine the efficacy of applying adaptive and off-line setup correction models to bony anatomy and gold fiducial markers implanted in the prostate, relative to daily alignment to skin tattoos and daily on-line corrections of the implanted gold markers. Methods and Materials: Ten prostate cancer patients with implanted gold fiducial markers were treated using a daily on-line setup correction protocol. The patients' positions were aligned to skin tattoos and two orthogonal diagnostic digital radiographs were obtained before treatment each day. These radiographs were compared with digitally reconstructed radiographs to obtain the translational setup errors of the bony anatomy and gold markers. The adaptive, no-action-level and shrinking-action-level off-line protocols were retrospectively applied to the bony anatomy to determine the change in the setup errors of the gold markers. The protocols were also applied to the gold markers directly to determine the residual setup errors. Results: The percentage of remaining fractions that the gold markers fell within the adaptive margins constructed with 1.5σ' (estimated random variation) after 5, 10, and 15 measurement fractions was 74%, 88%, and 93% for the prone patients and 55%, 77%, and 93% for the supine patients, respectively. Using 2σ', the percentage after 5, 10, and 15 measurements was 85%, 95%, and 97% for the prone patients and 68%, 87%, and 99% for the supine patients, respectively. The average initial three-dimensional (3D) setup error of the gold markers was 0.92 cm for the prone patients and 0.70 cm for the supine patients. Application of the no-action-level protocol to bony anatomy with N m = 3 days resulted in significant benefit to 4 of 10 patients, but 3 were significantly worse. The residual average 3D setup error of the gold markers was 1.14 cm and 0.51 cm for the prone and supine patients, respectively. When applied directly to the gold markers with N m = 3 days, 5 patients benefited and

Adult Rhabdomyosarcoma Survival Improved With Treatment on Multimodality Protocols

International Nuclear Information System (INIS)

Gerber, Naamit Kurshan; Wexler, Leonard H.; Singer, Samuel; Alektiar, Kaled M.; Keohan, Mary Louise; Shi, Weiji; Zhang, Zhigang; Wolden, Suzanne

2013-01-01

Purpose: Rhabdomyosarcoma (RMS) is a pediatric sarcoma rarely occurring in adults. For unknown reasons, adults with RMS have worse outcomes than do children. Methods and Materials: We analyzed data from all patients who presented to Memorial Sloan-Kettering Cancer Center between 1990 and 2011 with RMS diagnosed at age 16 or older. One hundred forty-eight patients met the study criteria. Ten were excluded for lack of adequate data. Results: The median age was 28 years. The histologic diagnoses were as follows: embryonal 54%, alveolar 33%, pleomorphic 12%, and not otherwise specified 2%. The tumor site was unfavorable in 67% of patients. Thirty-three patients (24%) were at low risk, 61 (44%) at intermediate risk, and 44 (32%) at high risk. Forty-six percent were treated on or according to a prospective RMS protocol. The 5-year rate of overall survival (OS) was 45% for patients with nonmetastatic disease. The failure rates at 5 years for patients with nonmetastatic disease were 34% for local failure and 42% for distant failure. Among patients with nonmetastatic disease (n=94), significant factors associated with OS were histologic diagnosis, site, risk group, age, and protocol treatment. On multivariate analysis, risk group and protocol treatment were significant after adjustment for age. The 5-year OS was 54% for protocol patients versus 36% for nonprotocol patients. Conclusions: Survival in adult patients with nonmetastatic disease was significantly improved for those treated on RMS protocols, most of which are now open to adults

Adult Rhabdomyosarcoma Survival Improved With Treatment on Multimodality Protocols

Energy Technology Data Exchange (ETDEWEB)

Gerber, Naamit Kurshan [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Wexler, Leonard H. [Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Singer, Samuel [Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Alektiar, Kaled M. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Keohan, Mary Louise [Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Shi, Weiji; Zhang, Zhigang [Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Wolden, Suzanne, E-mail: woldens@mskcc.org [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States)

2013-05-01

Purpose: Rhabdomyosarcoma (RMS) is a pediatric sarcoma rarely occurring in adults. For unknown reasons, adults with RMS have worse outcomes than do children. Methods and Materials: We analyzed data from all patients who presented to Memorial Sloan-Kettering Cancer Center between 1990 and 2011 with RMS diagnosed at age 16 or older. One hundred forty-eight patients met the study criteria. Ten were excluded for lack of adequate data. Results: The median age was 28 years. The histologic diagnoses were as follows: embryonal 54%, alveolar 33%, pleomorphic 12%, and not otherwise specified 2%. The tumor site was unfavorable in 67% of patients. Thirty-three patients (24%) were at low risk, 61 (44%) at intermediate risk, and 44 (32%) at high risk. Forty-six percent were treated on or according to a prospective RMS protocol. The 5-year rate of overall survival (OS) was 45% for patients with nonmetastatic disease. The failure rates at 5 years for patients with nonmetastatic disease were 34% for local failure and 42% for distant failure. Among patients with nonmetastatic disease (n=94), significant factors associated with OS were histologic diagnosis, site, risk group, age, and protocol treatment. On multivariate analysis, risk group and protocol treatment were significant after adjustment for age. The 5-year OS was 54% for protocol patients versus 36% for nonprotocol patients. Conclusions: Survival in adult patients with nonmetastatic disease was significantly improved for those treated on RMS protocols, most of which are now open to adults.

Physical Trauma Patients with Symptoms of an Acute and Posttraumatic Stress Disorder: Protocol for an Observational Prospective Cohort Study.

Science.gov (United States)

Visser, Eva; Gosens, Taco; Den Oudsten, Brenda; De Vries, Jolanda

2018-03-29

underway. Data collection will be completed in November 2018. The first results will be expected in the first trimester of 2019. This is the first multi-method study in trauma patients that examines patients' experiences (qualitative design) as well as psychological disorders (observational prospective). This study will contribute to necessary information on psychological consequences after injury. Moreover, it provides knowledge about which patients to include in future psychological intervention research. Finally, awareness in clinicians about the psychological consequences can be created, so they are able to act more effectively to provide patient-oriented care. Netherlands Trial Registry NTR6258; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6258 (Archived by WebCite at http://www.webcitation.org/6xSCiO1bS). ©Eva Visser, Taco Gosens, Brenda Den Oudsten, Jolanda De Vries. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.03.2018.

Variation in diurnal sedation in mechanically ventilated patients who are managed with a sedation protocol alone or a sedation protocol and daily interruption.

Science.gov (United States)

Mehta, Sangeeta; Meade, Maureen; Burry, Lisa; Mallick, Ranjeeta; Katsios, Christina; Fergusson, Dean; Dodek, Peter; Burns, Karen; Herridge, Margaret; Devlin, John W; Tanios, Maged; Fowler, Robert; Jacka, Michael; Skrobik, Yoanna; Olafson, Kendiss; Cook, Deborah

2016-08-01

Mechanically ventilated patients may receive more sedation during the night than during the day, potentially delaying extubation. We compared nighttime and daytime benzodiazepine and opioid administration in adult patients enrolled in a multicenter sedation trial comparing protocolized sedation alone or protocolized sedation combined with daily sedation interruption; and we evaluated whether nighttime and daytime doses were associated with liberation from mechanical ventilation. This is a secondary analysis of a randomized trial which was conducted in 16 North American medical-surgical ICUs. In all 423 patients, nurses applied a validated sedation scale hourly to titrate benzodiazepine and opioid infusions to achieve a light level of sedation. Using fentanyl equivalents and midazolam equivalents, we compared dosages administered during night (19:00 to 07:00) and day (07:00 to 19:00) shifts. Using multivariable logistic regression we evaluated the association between nighttime and daytime opioid and sedative doses, and spontaneous breathing trial (SBT) conduct, SBT success, and extubation. Nighttime benzodiazepine and opioid doses were significantly higher than daytime doses (mean difference midazolam equivalents 23.3 mg, 95 % CI 12.9, 33.8, p Patients were more often restrained during day shifts (76.3 % vs 73.7 %, p patient despite successful SBT. Patients received higher doses of opioids and benzodiazepines at night. Higher nighttime doses were associated with SBT failure and delayed extubation. ClinicalTrials.gov NCT00675363 . Registered 7 May 2008.

Implant Rehabilitation Planning Protocol for the Edentulous Patient According to Denture Space, Lip Support, and Smile Line.

Science.gov (United States)

Lago, Laura; Rilo, Benito; Fernández-Formoso, Noelia; DaSilva, Luis

2017-08-01

Rehabilitation with implants is a challenge. Having previous evaluation criteria is key to establishing the best treatment for the patient. In addition to clinical and radiological aspects, the prosthetic parameters must be taken into account in the initial workup, since they allow discrimination between fixed and removable rehabilitation. We present a study protocol that analyzes three basic prosthetic aspects. First, denture space defines the need to replace teeth, tissue, or both. Second, lip support focuses on whether or not to include a flange. Third, the smile line warns of potential risks in esthetic rehabilitation. Combining these parameters allows us to make a decision as to the most suitable type of prosthesis. The proposed protocol is useful for assessing the prosthetic parameters that influence decision making as to the best-suited type of restoration. From this point of view, we think it is appropriate for the initial approach to the patient. In any case, other considerations of study may amend the proposal. © 2016 by the American College of Prosthodontists.

Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial.

Science.gov (United States)

Schujmann, Debora Stripari; Lunardi, Adriana Claudia; Fu, Carolina

2018-05-10

Enhanced mobility in the Intensive Care Unit (ICU) could minimize the negative effects of critical illness, such as declines in cognitive, muscular, respiratory, and functional capacity. We aim to compare the functional status at ICU discharge of patients who underwent a progressive mobilization protocol versus patients who received conventional physiotherapy. We also examine the level of physical activity in the ICU, the degree of pulmonary and muscle function, and the length of stay to analyze correlations between these variables. This is a protocol for a randomized controlled trial with blind evaluation. Ninety-six ICU patients will be recruited from a single center and randomly assigned to a control group or an intervention group. To determine the level of protocol activity the patient will receive, the patients' ability to participate actively and their muscle strength will be considered. The protocol consists of five phases, ranging from passive therapies to walking and climbing stairs. The primary outcome will be the functional status at ICU discharge, measured with the Barthel Index and the ICU Mobility Scale (IMS). Measured secondary outcomes will include the level of physical activity, maximal inspiratory and expiratory pressures, forced expiratory volume in 1 second, maximum voluntary ventilation, handgrip strength, surface electromyography of the lower limb muscles, and results of the Timed Up and Go and 2-Minute Walk tests. Evaluations will be made within 2 days of ICU discharge except for the level of activity, which will be evaluated daily. Physiological variables and activity level will be analyzed by chi-square and t tests, according to the intention-to-treat paradigm. Mobility and exercise in the ICU should be undertaken with intensity, quantity, duration, and frequency adjusted according to the patients' status. The results of this study may contribute to new knowledge of early mobility in the ICU, activity level, and varying benefits in critical

The Dana Farber consortium protocol (DFCP) vs. classic Hyper-CVAD for treatment of acute lymphoblastic leukemia in patients <50 Y. Single institution experience.

Science.gov (United States)

Alabdulwahab, Amal S; Elsayed, Hussein G; Sherisher, Mohamed A; Zeeneldin, Ahmed; Alghamdi, Khalofa; Elbjeirami, Wafaa M

2017-09-01

The use of intensive pediatric protocols for the treatment of ALL is being extended to older adults. Analysis of the efficacy and toxicity results of pediatric DFCP vs. classic Hyper-CVAD protocol for the treatment of patients with ALL Hyper-CVAD for first line treatment of patients with ALL Hyper-CVAD protocol. CR rate was 90.7% for DFCP vs. 83.7 for Hyper-CVAD (p 0.7). 3 Y Leukemia free survival was 57.4% (70.9% for DFCP vs. 41.6% Hyper-CVAD P 0.1) while 3Y OS was 62.6%% for the whole group, 72.6% DFCP vs. 48.5% Hyper-CVAD, P 0.04. Those with age Hyper-CVAD related to gall stones. Osteonecrosis affected 5 patients on DFCP. pediatric protocols are feasible in patients younger than 50 Y and they are more active than classic adult protocols. Although modifications of adult protocols may improve their results, this had to be investigated in randomized controlled trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

The impact of a multidisciplinary blood conservation protocol on patient outcomes and cost after cardiac surgery.

Science.gov (United States)

Ad, Niv; Holmes, Sari D; Patel, Jay; Shuman, Deborah J; Massimiano, Paul S; Choi, Elmer; Fitzgerald, David; Halpin, Linda; Fornaresio, Lisa M

2017-03-01

Although associations between transfusion and inferior outcomes have been documented, there is a lack of blood transfusion standardization in cardiac surgery. At the Inova Heart and Vascular Institute, a multidisciplinary, criterion-driven algorithm for transfusion management was implemented. We examined the effect of our blood conservation protocol on transfusion rates and outcomes after cardiac surgery and on stability of transfusion over time. Patients undergoing first-time cardiac surgery from 2006 (full year before protocol) were compared with those in 2009 (after protocol) and propensity score matched to improve balance. Data were prospectively collected. Stability of transfusion incidence also was compared (2005-2006 vs 2008-2014). After matching, 890 patients from each year were included. Use of blood products decreased from 54% in 2006 to 25% in 2009 (P platelets (P conservation program can significantly control blood transfusion rates, improve outcomes, and be sustained over time. Efforts are needed to implement evidence-based protocols to standardize and decrease blood use in cardiac surgery to improve outcomes and reduce cost. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

Science.gov (United States)

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

Science.gov (United States)

Brehmer, Jess L; Husband, Jeffrey B

2014-10-01

There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation

Benefit of carbohydrate deficient transferrin in detecting chronic alcohol abuse in the elderly: study protocol for a multicentre, non-randomized, open-label study

Directory of Open Access Journals (Sweden)

Cécile Schnell

2016-01-01

Ethics: The Committee for the Protection of Persons located in Strasbourg, France, delivered a favourable opinion on the study project. Informed consent: The physician or the health network′s care coordinator informs the patient about the study protocol and obtains the patient′s assent. The investigator completes a non-opposition file and a copy is given to the patient and to his/her relative or helper.

Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

Directory of Open Access Journals (Sweden)

Peter Fairbairn

2015-01-01

Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

Protocol for the administration of haemofiltration fluids and using patient group electrolytes direction.

Science.gov (United States)

Kingston, Diana; Sykes, Siobhan; Raper, Sarah

2002-01-01

A patient group direction (PGD) is a specific written instruction for the supply or administration of named medicines in an identified clinical situation The introduction of a PGD must demonstrate a benefit for patients Haemofiltration is widely accepted as the treatment of choice when caring for critically ill patients in acute renal failure on an intensive care unit The haemofiltration PGD improves patient care by providing standardisation in administration of fluids and electrolytes and enabling nurses to respond rapidly to changes in biochemistry during haemofiltration This paper describes the development and implementation of a protocol to enable nurses to administer haemofiltration fluids and electrolytes under a patient group direction.

Input of Psychosocial Information During Multidisciplinary Team Meetings at Medical Oncology Departments: Protocol for an Observational Study.

Science.gov (United States)

Horlait, Melissa; Van Belle, Simon; Leys, Mark

2018-02-26

Multidisciplinary team meetings (MDTMs) have become standard practice in oncology and gained the status of the key decision-making forum for cancer patient management. The current literature provides evidence that MDTMs are achieving their intended objectives but there are also indications to question the positive impact of MDTMs in oncology settings. For cancer management to be patient-centered, it is crucial that medical information as well as psychosocial aspects-such as the patients' living situation, possible family problems, patients' mental state, and patients' perceptions and values or preferences towards treatment or care-are considered and discussed during MDTMs. Previous studies demonstrate that failure to account for patients' psychosocial information has a negative impact on the implementation of the treatment recommendations formulated during MDTMs. Few empirical studies have demonstrated the predominant role of physicians during MDTMs, leading to the phenomenon that medical information is shared almost exclusively at the expense of psychosocial information. However, more in-depth insight on the underlying reasons why MDTMs fail to take into account psychosocial information of cancer patients is needed. This paper presents a research protocol for a cross-sectional observational study that will focus on exploring the barriers to considering psychosocial information during MDTMs at medical oncology departments. This protocol encompasses a cross-sectional comparative case study of MDTMs at medical oncology departments in Flanders, Belgium. MDTMs from various oncology subspecialties at inpatient medical oncology departments in multiple hospitals (academic as well as general hospitals) are compared. The observations focus on the "multidisciplinary oncology consultation" (MOC), a formally regulated and financed type of MDTM in Belgian oncology since 2003. Data are collected through nonparticipant observations of MOC-meetings. Observational data are

Evaluation of the Implementation of a Rapid Response Treatment Protocol for Patients with Acute Onset Stroke: Can We Increase the Number of Patients Treated and Shorten the Time Needed

Directory of Open Access Journals (Sweden)

Rajiv Advani

2014-06-01

Full Text Available Aims: This study aims to evaluate the implementation of a rapid response treatment protocol for patients presenting with acute onset ischemic stroke. Improvements of routines surrounding the admission and treatment of patients with intravenous thrombolysis (IVT, such as door-to-needle (DTN times, and increasing the numbers of patients treated are discussed. Methods: We conducted a retrospective analysis of all patients (n = 320 treated with IVT for acute onset ischemic stroke at the Stavanger University Hospital, Norway, between 2003 and 2012. In 2009, a succession of changes to pre- and intra-hospital routines were made as well as an improvement in the education of primary health care physicians, nurses and paramedics involved in the treatment of acute onset stroke patients (rapid response treatment protocol. Analyses of DTN times, onset-to-needle times and the number of patients treated per year were carried out to ascertain the effect of the changes made. The primary aim was to analyze DTN times to look for any changes, and the secondary aim was to analyze changes in the number of patients treated per year. Results: In the years after the implementation of the rapid treatment protocol, we saw an improvement in the median DTN time with a decrease from 73 to 50 min in the first year (p = 0.03, a decrease of 45 min in the second year (p = 0.01 and a decrease of 31 min in the third year (p Conclusions: The implementation of the rapid treatment protocol for acute onset ischemic stroke patients led to a significant decrease in the DTN time at our center. These improvements also produced an increase in the number of patients treated per year. The extension of the therapeutic window from 3 to 4.5 h for the use of intravenous recombinant tissue plasminogen activator also played a role in the increased treatment numbers.

GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type

NARCIS (Netherlands)

Lambalk, C. B.; Banga, F. R.; Huirne, J. A.; Toftager, M.; Pinborg, A.; Homburg, R.; van der Veen, F.; van Wely, M.

2017-01-01

Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist was not the only

Developing an Anti-Xa-Based Anticoagulation Protocol for Patients with Percutaneous Ventricular Assist Devices.

Science.gov (United States)

Sieg, Adam; Mardis, B Andrew; Mardis, Caitlin R; Huber, Michelle R; New, James P; Meadows, Holly B; Cook, Jennifer L; Toole, J Matthew; Uber, Walter E

2015-01-01

Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.

Study protocol for the Cities Changing Diabetes programme

DEFF Research Database (Denmark)

Napier, A David; Nolan, John J; Bagger, Malene

2017-01-01

and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial.

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Janse, Anthonie; Worm-Smeitink, Margreet; Bussel-Lagarde, José; Bleijenberg, Gijs; Nikolaus, Stephanie; Knoop, Hans

2015-08-12

Cognitive behavioural therapy (CBT) is an effective treatment for fatigue and disabilities in patients with chronic fatigue syndrome (CFS). However, treatment capacity is limited. Providing web-based CBT and tailoring the amount of contact with the therapist to the individual needs of the patient may increase the efficiency of the intervention. Web-based CBT for adolescents with CFS has proven to be effective in reducing fatigue and increasing school attendance. In the proposed study the efficacy of a web-based CBT intervention for adult patients with CFS will be explored. Two different formats of web-based CBT will be tested. In the first format named protocol driven feedback, patients report on their progress and receive feedback from a therapist according to a preset schedule. In the second format named support on demand, feedback and support of the therapist is only given when patients ask for it. The primary objective of the study is to determine the efficacy of a web-based CBT intervention on fatigue severity. A randomized clinical trial will be conducted. Two-hundred-forty adults who have been diagnosed with CFS according to the US Centers for Disease Control and Prevention (CDC) consensus criteria will be recruited and randomized to one of three conditions: web-based CBT with protocol driven feedback, web-based CBT with support on demand, or wait list. Feedback will be delivered by therapists specialized in CBT for CFS. Each of the web-based CBT interventions will be compared to a wait list condition with respect to its effect on the primary outcome measure; fatigue severity. Secondary outcome measures are level of disability, physical functioning, psychological distress, and the proportion of patients with clinical significant improvement in fatigue severity. Outcomes will be assessed at baseline and six months post randomization. The web-based CBT formats will be compared with respect to the time therapists need to deliver the intervention. As far as we

Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations.

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Song, Howard K; von Heymann, Christian; Jespersen, Christian M; Karkouti, Keyvan; Korte, Wolfgang; Levy, Jerrold H; Ranucci, Marco; Saugstrup, Trine; Sellke, Frank W

2014-05-01

Perioperative red blood cell transfusion is associated with adverse outcomes after cardiac operations. Although restrictive transfusion protocols have been developed, their safety and efficacy are not well demonstrated, and considerable variation in transfusion practice persists. We report our experience with a restrictive transfusion protocol. We analyzed the outcomes in 409 patients undergoing cardiac operations enrolled in a trial conducted at 30 centers worldwide. Blood products were administered on the basis of a transfusion algorithm applied across all centers, with a restrictive transfusion trigger of hemoglobin less than or equal to 6 g/dL. Transfusion was acceptable but not mandatory for hemoglobin 6 to 8 g/dL. For hemoglobin 8 to 10 g/dL, transfusion was acceptable only with evidence for end-organ ischemia. The patient population was moderately complex, with 20.5% having combined procedures and 29.6% having nonelective operations. The mean EuroSCORE for the population was 4.3, which predicted a substantial incidence of morbidity and mortality. Actual outcomes were excellent, with observed mortality of 0.49% and rates of cerebrovascular accident, myocardial infarction, and acute renal failure 1.2%, 6.1%, and 0.98%, respectively. The frequency of red blood cell transfusion was 33.7%, which varied significantly by center. Most transfusions (71.9%) were administered for hemoglobin 6 to 8 g/dL; 21.4% were administered for hemoglobin 8 to 10 g/dL with evidence for end-organ ischemia; 65.0% of patients avoided allogeneic transfusion altogether. A restrictive transfusion protocol can be safely applied in the care of moderate-risk patients undergoing cardiac operations. This strategy has significant potential to reduce transfusion and resource utilization in these patients, standardize transfusion practices across institutions, and increase the safety of cardiac operations. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights

Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU

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Bonini, Sara; Maffia, Sara; Molatore, Katia; Sebastianelli, Luca; Zarucchi, Alessio; Matteri, Diana; Ercoli, Giuseppe; Maestri, Roberto

2016-01-01

Background and Objective Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome. Methods Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale–DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively. Results Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all), as well as after ICU stay (T1 vs T0, p<0.004 all) and after Neurorehabilitation (T2 vs T1, p<0.004 all). The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006) and (borderline) for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058). Conclusions A stepping verticalization

Dopamine transporter imaging with [I-123]IPT SPECT in normal controls and Parkinson's patients: Feasibility study of a simplified SPECT scan protocol

International Nuclear Information System (INIS)

Kim, H. J.; Bong, J. K.; Nam, K. P.; Yang, S. O.; Moon, D. H.; Ryu, J. S.; Lee, H. K.

1997-01-01

[I-123]IPT has been used to measure changes in dopamine trasnporters with Parkinson's patients (PP). However, 2 hrs of imaging time without movement of patient's head partially limits its widespread use in routine clinical SPECT protocol. The purpose of this study was to evaluate the feasibility of a simplified IPT SPECT scan protocol using three 10 min scan data obtained at 0-10, 55-65, and 110-120 min postinjection and compared to current protocol using 23 scans obtained from O-120 min to quantify dopamine transporter binding in normal controls (NC) and PP. IPT labeled with 6.74±0.88mCi of I-123 was intravenously injected into 12 NC (age: 41±9) and 22 PP (age : 55±8) and the 5 min dynamic SPECT data were acquired for 2 hrs with Trionix triple-headed SPECT camera. SPECT images were reconstructed and attenuation corrected. [I-123] IPT quickly penetratd the blood-brain barrier and began to Ioacalize higher concentrations at the basal ganglia at 20 min after injection. The transporter parameter was measured using a variation of graphical analysis (VGA) and area ratio method (ARM) that derive the distribution volume ratios (R v =V 3 /V 2 for VGA, R A =V 3 /V 2 for ARM ) from multiple scan data without blood data, R v ' and R A ' measured from three 10 min scan data and compared with R v and R A measured from 23 scans for both NC and PP, (R v ', R v ') or NC and PP were (1.83±0.29, 2.21±0.34) and (0.63±0.34, 0.77±0.31), respectively. (R v ', R A ) for NC and PP were (1.11±0.22, 1.62±0.28) and (0.43±0.21, 0.65±0.24), respectively, Both (R v ', R v ) and (R A ', R A ) for NC were clearly separated from those for PP. R' v and R' A underestimated R v and R A by 18.4% and 33.5%, respectively, but R v ' and R A ' showed excellent correlations with R v (r=0.95) and R A (r=0.97), respectively. The results indicate that the three 10 min scan protocol may be feasible and allows us to differentiate dopamine transporter parameters in PP from those in NC

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

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Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Three-stage treatment protocol for recalcitrant distal femoral nonunion.

Science.gov (United States)

Ma, Ching-Hou; Chiu, Yen-Chun; Tu, Yuan-Kun; Yen, Cheng-Yo; Wu, Chin-Hsien

2017-04-01

In this study, we proposed a three-stage treatment protocol for recalcitrant distal femoral nonunion and aimed to analyze the clinical results. We retrospective reviewed 12 consecutive patients with recalcitrant distal femoral nonunion undergoing our three-stage treatment protocol from January 2010 to December 2014 in our institute. The three-stage treatment protocol comprised debridement of the nonunion site, lengthening to eliminate leg length discrepancy, deformity correction, stabilization with a locked plate, filling of the defect with cement spacer for inducing membrane formation, and bone reconstruction using a cancellous bone autograft (Masquelet technique) or free vascularized fibular bone graft. The bone union time, wound complication, lower limbs alignment, amount of lengthening, knee range of motion, and functional outcomes were evaluated. Osseous union with angular deformity lengthening was 5.88 cm (range 3.5-12 cm). Excellent or good outcomes were obtained in 9 patients. Although the current study involved only a small number of patients and the intervention comprised three stages, we believe that such a protocol may be a valuable alternative for the treatment of recalcitrant distal femoral nonunion.

A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

Science.gov (United States)

Mateescu, Radu; Serwe, Wendelin

Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

Pulmonary CT angiography protocol adapted to the hemodynamic effects of pregnancy.

LENUS (Irish Health Repository)

Ridge, Carole A

2012-02-01

OBJECTIVE: The purpose of this study was to compare the image quality of a standard pulmonary CT angiography (CTA) protocol with a pulmonary CTA protocol optimized for use in pregnant patients with suspected pulmonary embolism (PE). MATERIALS AND METHODS: Forty-five consecutive pregnant patients with suspected PE were retrospectively included in the study: 25 patients (group A) underwent standard-protocol pulmonary CTA and 20 patients (group B) were imaged using a protocol modified for pregnancy. The modified protocol used a shallow inspiration breath-hold and a high concentration, high rate of injection, and high volume of contrast material. Objective image quality and subjective image quality were evaluated by measuring pulmonary arterial enhancement, determining whether there was transient interruption of the contrast bolus by unopacified blood from the inferior vena cava (IVC), and assessing diagnostic adequacy. RESULTS: Objective and subjective image quality were significantly better for group B-that is, for the group who underwent the CTA protocol optimized for pregnancy. Mean pulmonary arterial enhancement and the percentage of studies characterized as adequate for diagnosis were higher in group B than in group A: 321 +\\/- 148 HU (SD) versus 178 +\\/- 67 HU (p = 0.0001) and 90% versus 64% (p = 0.05), respectively. Transient interruption of contrast material by unopacified blood from the IVC was observed more frequently in group A (39%) than in group B (10%) (p = 0.05). CONCLUSION: A pulmonary CTA protocol optimized for pregnancy significantly improved image quality by increasing pulmonary arterial opacification, improving diagnostic adequacy, and decreasing transient interruption of the contrast bolus by unopacified blood from the IVC.

Influence of a multidisciplinary protocol on nutritional status at diagnosis in amyotrophic lateral sclerosis.

Science.gov (United States)

López-Gómez, Juan José; Torres-Torres, Beatriz; Gómez-Hoyos, Emilia; Fernández-Buey, Nieves; Ortolá-Buigues, Ana; Castro-Lozano, Ángeles; Arenillas-Lara, Juan F; De Luis-Román, Daniel A

2018-04-01

The aim of this study were to understand the influence of a multidisciplinary care protocol in amyotrophic lateral sclerosis (ALS) on the change in the delay of remission to the nutrition specialist and the initial nutritional status. A cohort study was performed in 43 patients with ALS who were referred to the Nutrition Unit between April 2015 and April 2017. Anthropometric parameters and diagnostic times were collected, and the nutritional status was studied through subjective global assessment (SGA). Patients who were included before (control cohort [NoP]) and after (protocol cohort [P]) a multidisciplinary protocol were compared. The mean age of the participants was 66.79 y (10.86 y). Of the patients, 62.8% belonged to the protocol cohort. Patients who started the protocol had a lower delay in initial assessment by a nutrition specialist (P:2 [1-6] mo/NoP:12 [10-29] mo; P = 0.03). When the nutritional status was analyzed according to the SGA, more patients who did not initiate protocol were in the state of severe malnutrition (C) (P 22.2% versus NoP 60%; P = 0.01). Entry into the protocol was an independent protective factor of the presence of severe malnutrition at the beginning of the nutritional follow-up (odds ratio, 0.20; 95% confidence interval, 0.03-0.73; P = 0.02). The implementation of a multidisciplinary protocol in ALS allowed patients to present a lower percentage of severe malnutrition in an initial assessment by the nutrition specialist. This protocol is a protective factor for the presence of malnutrition at the beginning of support. Copyright © 2017 Elsevier Inc. All rights reserved.

Study protocol: a randomised controlled trial investigating the effect of exercise training on peripheral blood gene expression in patients with stable angina

Directory of Open Access Journals (Sweden)

Crossman David C

2010-10-01

Full Text Available Abstract Background Exercise training has been shown to reduce angina and promote collateral vessel development in patients with coronary artery disease. However, the mechanism whereby exercise exerts these beneficial effects is unclear. There has been increasing interest in the use of whole genome peripheral blood gene expression in a wide range of conditions to attempt to identify both novel mechanisms of disease and transcriptional biomarkers. This protocol describes a study in which we will assess the effect of a structured exercise programme on peripheral blood gene expression in patients with stable angina, and correlate this with changes in angina level, anxiety, depression, and exercise capacity. Methods/Design Sixty patients with stable angina will be recruited and randomised 1:1 to exercise training or conventional care. Patients randomised to exercise training will attend an exercise physiology laboratory up to three times weekly for supervised aerobic interval training sessions of one hour in total duration. Patients will undergo assessments of angina, anxiety, depression, and peripheral blood gene expression at baseline, after six and twelve weeks of training, and twelve weeks after formal exercise training ceases. Discussion This study will provide comprehensive data on the effect of exercise training on peripheral blood gene expression in patients with angina. By correlating this with improvement in angina status we will identify candidate peripheral blood transcriptional markers predictive of improvements in angina level in response to exercise training. Trial Registration Clinicaltrials.gov identifier: NCT01147952

Comparison of 2 comprehensive Class II treatment protocols including the bonded Herbst and headgear appliances: a double-blind study of consecutively treated patients at puberty.

Science.gov (United States)

Baccetti, Tiziano; Franchi, Lorenzo; Stahl, Franka

2009-06-01

The aim of this clinical trial was to compare the effects of 2 protocols for single-phase comprehensive treatment of Class II Division 1 malocclusion (bonded Herbst followed by fixed appliances [BH + FA] vs headgear followed by fixed appliances and Class II elastics [HG + FA]) at the pubertal growth spurt. Fifty-six Class II patients were enrolled in the trial and allocated by personal choice to 2 practices, where they underwent 1 of 2 treatment protocols (28 patients were treated consecutively with BH + FA, and 28 patients were treated consecutively with HG + FA). All patients started treatment at puberty (cervical stage [CS] 3 or CS 4) and completed treatment after puberty (CS 5 or CS 6). Lateral cephalograms were taken before therapy and 6 months after the end of comprehensive therapy, with an average interval of 28 months. Longitudinal observations of a matched group of 28 subjects with untreated Class II malocclusions were compared with the 2 treated groups. Analysis of variance (ANOVA) with post-hoc tests was used for statistical comparisons. Discriminant analysis was applied to identify preferential candidates for the BH + FA protocol on the basis of profile changes (advancement of the soft tissues of the chin). The success rate (full occlusal correction of the malocclusion after treatment) was 92.8% in both treatment groups. The BH + FA group showed a significant increase in mandibular protrusion. The increase in effective mandibular length (Co-Gn) was significantly greater in both treatment groups when compared with natural growth changes in the Class II controls. Significantly greater improvement in sagittal maxillomandibular relationships was found in the BH + FA group. Retrusion of maxillary incisors and mesial movement of mandibular molars were significant in the HG + FA group. The BH + FA group showed significantly greater forward movements of soft-tissue B-point and pogonion compared with both the HG + FA and the control groups. Two pretreatment

Implementation of the protocol on treatment of outpatients and hospitalized patients with iodine 131r

International Nuclear Information System (INIS)

Mildred De Mendoza, L.

1996-01-01

In Nuclear medicine different working protocols are used which are adequate for the treatment of patients with radioactive materials and which at the same time prevent the contamination of the occupationally exposed workers In Guatemala (the implementation of these protocols aims at keeping a records all the personal and centers that make use of iodine 131, improving the quality of diagnostic information; utilizing the necessary amount of radionuclide activity so as to ensure a good diagnosis and effectively utilizing economic resources

Optimized contrast volume for dynamic CT angiography in renal transplant patients using a multiphase CT protocol

International Nuclear Information System (INIS)

Helck, A.; Bamberg, F.; Sommer, W.H.; Wessely, M.; Becker, C.; Clevert, D.A.; Notohamiprodjo, M.; Reiser, M.; Nikolaou, K.

2011-01-01

Objectives: To study the feasibility of an optimized multiphase renal-CT-angiography (MP-CTA) protocol in patients with history of renal transplantation compared with Doppler-ultrasound (DUS). Methods: 36 Patients underwent both DUS and time-resolved, MP-CTA (12 phases), with a mean contrast-volume of 34.4 ± 5.1 ml. Quality of MP-CTA was assessed quantitatively (vascular attenuation) and qualitatively (grades 1–4, 1 = best). For the assessment of clinical value of MP-CTA, cases were grouped into normal, macrovascular (arterial/venous) and microvascular complications (parenchymal perfusion defect). DUS served as the standard of reference. Results: Using the best of 12 phases in each patient, optimal attenuation was 353 ± 111 HU, 337 ± 98 HU and 164 ± 51 HU in the iliac arteries, renal arteries, and renal veins, respectively. Mean image quality was 1.1 ± 0.3 (n = 36) and 2.1 ± 0.6 (n = 30) for the transplant renal arteries and veins, respectively. Six renal veins were non-diagnostic in MP-CTA. In 36 patients, MP-CTA showed 13 vascular complications and 10 parenchymal perfusion defects. DUS was not assessable in eight patients. Overall, MP-CTA showed 15 cases with pathology (42%) not identifiable with DUS. The mean effective radiation dose of the MP-CTA protocol was 13.5 ± 5.2 mSv. Conclusion: MP-CTA can be sufficiently performed with reduced contrast volume at reasonable radiation dose in renal transplant patients, providing substantially higher diagnostic yield than DUS.

Feasibility of a single-stage tracheostomy decannulation protocol with endoscopy in adult patients.

Science.gov (United States)

Cohen, Oded; Tzelnick, Sharon; Lahav, Yonatan; Stavi, Dekel; Shoffel-Havakuk, Hagit; Hain, Moshe; Halperin, Doron; Adi, Nimrod

2016-09-01

Gradual decrease in tube size and tube capping are considered the standard of care for tracheostomy decannulation. Both of these actions result in increased airway resistance. Immediate decannulation may offer a more tolerable approach. To assess the feasibility of immediate tracheostomy decannulation compared with the traditional decannulation methods. This study is a single institute, case-control retrospective study of patients between the years 2009 to 2014. The study group included all patients who underwent immediate decannulation, whereas the control group comprised patients who underwent traditional staged decannulation. An immediate decannulation protocol included admission to the intensive care unit, a comprehensive evaluation, decannulation, 24 hours of monitoring, and observation until discharge. Twenty-nine patients were included in the study group and 20 in the control group. No significant statistical difference was found between the two groups in the patients' medical history and tracheostomy data, except for the Acute Physiology and Chronic Health Evaluation II score and duration of the deflated cuff, which were significantly higher in the control group. A significant difference was found in the complication rate between the groups. In the staged decannulation group, four patients failed decannulation and required reinsertion of the tracheostomy cannula, whereas there were no such failures in the immediate decannulation group. Hospitalization duration after decannulation of the study group patients was significantly shorter than that of the control group. Immediate decannulation may offer a safe alternative for weaning from tracheostomy. It may also reduce the duration of the weaning process and hospitalization. 3b Laryngoscope, 126:2057-2062, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Impact of a pain protocol including hypnosis in major burns.

Science.gov (United States)

Berger, Mette M; Davadant, Maryse; Marin, Christian; Wasserfallen, Jean-Blaise; Pinget, Christophe; Maravic, Philippe; Koch, Nathalie; Raffoul, Wassim; Chiolero, René L

2010-08-01

Pain is a major issue after burns even when large doses of opioids are prescribed. The study focused on the impact of a pain protocol using hypnosis on pain intensity, anxiety, clinical course, and costs. All patients admitted to the ICU, aged >18 years, with an ICU stay >24h, accepting to try hypnosis, and treated according to standardized pain protocol were included. Pain was scaled on the Visual Analog Scale (VAS) (mean of daily multiple recordings), and basal and procedural opioid doses were recorded. Clinical outcome and economical data were retrieved from hospital charts and information system, respectively. Treated patients were matched with controls for sex, age, and the burned surface area. Forty patients were admitted from 2006 to 2007: 17 met exclusion criteria, leaving 23 patients, who were matched with 23 historical controls. Altogether patients were 36+/-14 years old and burned 27+/-15%BSA. The first hypnosis session was performed after a median of 9 days. The protocol resulted in the early delivery of higher opioid doses/24h (ppatient. A pain protocol including hypnosis reduced pain intensity, improved opioid efficiency, reduced anxiety, improved wound outcome while reducing costs. The protocol guided use of opioids improved patient care without side effects, while hypnosis had significant psychological benefits.

Effectiveness of a patient blood management protocol on reduction of allogenic red blood cell transfusions in orthopedic surgery.

Science.gov (United States)

Polanco-García, Mauricio; Capielo, Ana María; Miret, Xavier; Chamero, Antonio; Sainz, Julio; Revilla, Elena; Guinjoan, Antoni; Arranz, Teresa

2018-06-07

Patient blood management in orthopaedic surgery reduces transfusion risk. The best protocol is unknown. The effectiveness of a protocol based on the Seville Consensus on the reduction of transfusion risk is evaluated and a predictive transfusion equation is proposed in knee surgery. Cohort study in patients undergoing knee and hip arthroplasty from January 2014 to December 2015 at a second level complexity hospital in Vilafranca del Penedès (Barcelona). Patients with Hb between 10 and 13g/dL were classified as anaemic with or without iron deficiency and received iron or combination of iron and erythropoietin. On the day of surgery, tranexamic acid was administered, the Hb drop was measured the next day and the requirements and the transfusion lintel were measured during the stay. A total of 334 patients were included in the study. The implementation of the programme decreased the transfusion risk from 41.5% to 14.8% at the end of the study. In hip surgery, transfused patients were significantly older, sicker and with lower preoperative Hb. Tranexamic acid did not decrease bleeding. In knee surgery, the administration of tranexamic acid was the variable that most decreased the transfusion risk followed by a high preoperative Hb. The equation predicts transfusion risk with a sensitivity of 55% and specificity of 95.7%. The implementation of the programme reduces transfusion risk. The effectiveness of tranexamic acid varies according to surgery site. The use of iron and recombinant human erythropoietin is necessary to improve Hb. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Economic evaluation of a shortened standardised treatment regimen of antituberculosis drugs for patients with multidrug-resistant tuberculosis (STREAM): study protocol.

Science.gov (United States)

Gama, Elvis; Madan, Jason; Langley, Ivor; Girma, Mamo; Evans, Denise; Rosen, Sydney; Squire, S Bertel

2016-10-17

Multidrug-resistant tuberculosis (MDR-TB) poses a serious financial challenge to health systems and patients. The current treatment for patients with MDR-TB takes up to 24 months to complete. Evidence for a shorter regimen which differs from the standard WHO recommended MDR-TB regimen and typically lasts between 9 and 12 months has been reported from Bangladesh. This evaluation aims to assess the economic impact of a shortened regimen on patients and health systems. This evaluation is innovative as it combines patient and health system costs, as well as operational modelling in assessing the impact. An economic evaluation nested in a clinical trial with 2 arms will be performed at 4 facilities. The primary outcome measure is incremental cost to the health system of the study regimen compared with the control regimen. Secondary outcome measures are mean incremental costs incurred by patients by treatment outcome; patient costs by category (direct medical costs, transport, food and accommodation costs, and cost of guardians/accompanying persons and lost time); health systems cost by category and drugs; and costs related to serious adverse events. The study has been evaluated and approved by the Ethics Advisory Group of the International Union Against Tuberculosis and Lung Disease; South African Medical Research Ethics Committee; Wits Health Consortium Protocol Review Committee; University of the Witwatersrand Human Research Ethics Committee; University of Kwazulu-Natal Biomedical Research Ethics Committee; St Peter TB Specialized Hospital Ethical Review Committee; AHRI-ALERT Ethical Review Committee, and all participants will provide written informed consent. The results of the economic evaluation will be published in a peer-reviewed journal. ISRCTN78372190. 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/.

[Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

Science.gov (United States)

Cánovas Gaillemin, B; Sastre Martos, J; Moreno Segura, G; Llamazares Iglesias, O; Familiar Casado, C; Abad de Castro, S; López Pardo, R; Sánchez-Cabezudo Muñoz, M A

2011-01-01

Bariatric surgery has been shown to be an effective therapy for weight loss in patients with severe obesity, and the implementation of a multidisciplinar management protocol is recommended. To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Retrospective comparative study of the outcomes in patients previously operated (51 patients) and after the implementation of the protocol (66 patients). The following data were gathered: anthropometry, pre-and post-surgery comorbidities, post-surgical nutritional and surgical complications, validated Quality of Life questionnaire, and dietary habits. Withdrawals (l7.6%) and alcoholism (5.8%) were higher in patients pre- versus post-implementation of the protocol (4.5% vs. 3%, respectively), the differences being statistically significant. The mortality rate was 2% in the pre-protocol group and 0% in the postprotocol group. The dietary habits were better in the post-protocol group, the pre-protocol group presenting a higher percentage of feeding-behavior disorders (5.1%) although not reaching a statistical significance. The improvement in quality of life was higher in the post-protocol group for all items, but only reaching statistical significance in sexual activity (p = 0.004). In the pre-protocol group, 70.5% of the patients had more than one nutritional complication vs. 32.8% in the post-protocol group (p 50% in 81.3% in the pre-protocol group vs. 74.8% in the pos-protocol group) or the comorbidities. Bariatric surgery achieves excellent outcomes in weight loss, comorbidities, and quality of life, but presents nutritional, surgical, and psychiatric complications that require a protocol-based and multidisciplinary approach. Our protocol improves the outcomes regarding the withdrawal rates, feeding-behavior disorders, dietary habits, nutritional complications, and quality of life.

Cost-effectiveness analysis of a non-contrast screening MRI protocol for vestibular schwannoma in patients with asymmetric sensorineural hearing loss

International Nuclear Information System (INIS)

Crowson, Matthew G.; Rocke, Daniel J.; Kaylie, David M.; Hoang, Jenny K.; Weissman, Jane L.

2017-01-01

We aimed to determine if a non-contrast screening MRI is cost-effective compared to a full MRI protocol with contrast for the evaluation of vestibular schwannomas. A decision tree was constructed to evaluate full MRI and screening MRI strategies for patients with asymmetric sensorineural hearing loss. If a patient were to have a positive screening MRI, s/he received a full MRI. Vestibular schwannoma prevalence, MRI specificity and sensitivity, and gadolinium anaphylaxis incidence were obtained through literature review. Institutional charge data were obtained using representative patient cohorts. One-way and probabilistic sensitivity analyses were completed to determine CE model threshold points for MRI performance characteristics and charges. The mean charge for a full MRI with contrast was significantly higher than a screening MRI ($4089 ± 1086 versus $2872 ± 741; p < 0.05). The screening MRI protocol was more cost-effective than a full MRI protocol with a willingness-to-pay from $0 to 20,000 USD. Sensitivity analyses determined that the screening protocol dominated when the screening MRI charge was less than $4678, and the imaging specificity exceeded 78.2%. The screening MRI protocol also dominated when vestibular schwannoma prevalence was varied between 0 and 1000 in 10,000 people. A screening MRI protocol is more cost-effective than a full MRI with contrast in the diagnostic evaluation of a vestibular schwannoma. A screening MRI likely also confers benefits of shorter exam time and no contrast use. Further investigation is needed to confirm the relative performance of screening protocols for vestibular schwannomas. (orig.)

Cost-effectiveness analysis of a non-contrast screening MRI protocol for vestibular schwannoma in patients with asymmetric sensorineural hearing loss

Energy Technology Data Exchange (ETDEWEB)

Crowson, Matthew G.; Rocke, Daniel J.; Kaylie, David M. [Duke University Medical Center, Division of Otolaryngology-Head and Neck Surgery, Durham, NC (United States); Hoang, Jenny K. [Duke University Medical Center, Department of Radiology, Durham, NC (United States); Weissman, Jane L. [Oregon Health Sciences University, Professor Emerita of Diagnostic Radiology, Portland, OR (United States)

2017-08-15

We aimed to determine if a non-contrast screening MRI is cost-effective compared to a full MRI protocol with contrast for the evaluation of vestibular schwannomas. A decision tree was constructed to evaluate full MRI and screening MRI strategies for patients with asymmetric sensorineural hearing loss. If a patient were to have a positive screening MRI, s/he received a full MRI. Vestibular schwannoma prevalence, MRI specificity and sensitivity, and gadolinium anaphylaxis incidence were obtained through literature review. Institutional charge data were obtained using representative patient cohorts. One-way and probabilistic sensitivity analyses were completed to determine CE model threshold points for MRI performance characteristics and charges. The mean charge for a full MRI with contrast was significantly higher than a screening MRI ($4089 ± 1086 versus $2872 ± 741; p < 0.05). The screening MRI protocol was more cost-effective than a full MRI protocol with a willingness-to-pay from $0 to 20,000 USD. Sensitivity analyses determined that the screening protocol dominated when the screening MRI charge was less than $4678, and the imaging specificity exceeded 78.2%. The screening MRI protocol also dominated when vestibular schwannoma prevalence was varied between 0 and 1000 in 10,000 people. A screening MRI protocol is more cost-effective than a full MRI with contrast in the diagnostic evaluation of a vestibular schwannoma. A screening MRI likely also confers benefits of shorter exam time and no contrast use. Further investigation is needed to confirm the relative performance of screening protocols for vestibular schwannomas. (orig.)

Study protocol: evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH study) - work package II: palliative care for pediatric patients.

Science.gov (United States)

Ulrich, Lisa-R; Gruber, Dania; Hach, Michaela; Boesner, Stefan; Haasenritter, Joerg; Kuss, Katrin; Seipp, Hannah; Gerlach, Ferdinand M; Erler, Antje

2018-01-05

In 2007, the European Association of Palliative Care (EAPC) provided a comprehensive set of recommendations and standards for the provision of adequate pediatric palliative care. A number of studies have shown deficits in pediatric palliative care compared to EAPC standards. In Germany, pediatric palliative care patients can be referred to specialized outpatient palliative care (SOPC) services, which are known to enhance quality of life, e.g. by avoiding hospitalization. However, current regulations for the provision of SOPC in Germany do not account for the different circumstances and needs of children and their families compared to adult palliative care patients. The "Evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH)" study aims to perform a needs assessment for pediatric patients (children, adolescents and young adults) receiving SOPC. This paper presents the study protocol for this assessment (work package II). The study uses a sequential mixed-methods study design with a focus on qualitative research. Data collection from professional and family caregivers and, as far as possible, pediatric patients, will involve both a written questionnaire based on European recommendations for pediatric palliative care, and semi-structured interviews. Additionally, professional caregivers will take part in focus group discussions and participatory observations. Interviews and focus groups will be tape- or video-recorded, transcribed verbatim and analyzed in accordance with the principles of grounded theory (interviews) and content analysis (focus groups). A structured field note template will be used to record notes taken during the participatory observations. Statistical Package for Social Sciences (SPSS, version 22 or higher) will be used for descriptive statistical analyses. The qualitative data analyses will be software-assisted by MAXQDA (version 12 or higher). This study will provide important information on what matters

GnRH antagonist versus long agonist protocols in IVF

DEFF Research Database (Denmark)

Lambalk, C B; Banga, F R; Huirne, J A

2017-01-01

BACKGROUND: Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist...... was not the only variable between the compared study arms. OBJECTIVE AND RATIONALE: The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. SEARCH...... in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF...

Proposed protocol for realization of abdominal CT in patients admitted to the emergency room for trauma in HSJD

International Nuclear Information System (INIS)

Quesada Cascante, Lizbeth

2013-01-01

A protocol is established for computed tomography in trauma patients treated in emergency of Hospital San Juan de Dios. A literature review is conducted on abdominal CT protocols in specialized databases. The criteria, scanning, parameters and delay time are established for realization of abdominal CT in patients with traumatic emergencies in HSJD. Taking the thickness of the sections, the thickness of the sections in reconstruction, the quantities of contrast and the speed of injection in patients, have been standardized for the realization of abdominal CT in HSJD. Computed tomography should be preferably performed of routine in portal phase and the late from 5 minutes in patients with abdominal trauma, contributing in this phase as much information regarding the extent of abdominal injury [es

A Comparative Study On The Action Potential Simulation (APS Therapy And The Routine Physiotherapy Protocol In Knee Osteoarthritisin Elderly People

Directory of Open Access Journals (Sweden)

Abbas Rahimi

2012-04-01

Full Text Available Background and Aim: Knee osteoarthritis is the most common cause for which the elderly people refere to physiotherapy outpatient clinics. This study aimed to investigate the effects of the Action Potential Stimulation (APS Therapy and the routine physiotherapy (PT protocol on relieving pain and swelling as well as the duration of the relief period in patients with knee osteoarthritis. Materials and Methods: 69 patients (62 females & 7 males with knee osteoarthritis were recruited in this study. The subjects were divided into two groups including APS Therapy (n=37, mean age: 55±13 years old and the routine PT protocol (n=32, mean age: 61±14 years old groups. A 10-session treatment period was carried out for each group; and their pain and swelling were measured at the first, fifth and tenth sessions and also one-month after the last session (follow up. The swelling was measured using measuring the circumference of the knee on the patella, 5 Cm above and 5 Cm below the patella. The routine PT protocol consisted of hot pack, ultrasound, TENS and exercise; and the APS therapy protocol included hot pack, APS Therapy and the same exercise. During the follow up, 50 out of 61 subjects were called on the phone and any pain changes were recorded.Results: In terms of swelling, the results showed significant reduction just on the patella only in the APS Therapy group (P<0.05. Visual Analogue Pain Scale (VAPS indicated a significant pain reduction in both groups. However, the APS Therapy group showed significantly pain reduction at the end of sessions five, ten and the follow up session (P<0.05. It was also revealed that while routine PT subjects showed no significant pain changes between the tenth and the follow up session, a gradual pain reduction was seen in the APS therapy group during this period (P<0.05. A gradual dosage reduction was recorded only in the APS therapy group, indicating a slight correlation with pain reduction (r=0.4.Conclusion: The

Using generalizability theory to develop clinical assessment protocols.

Science.gov (United States)

Preuss, Richard A

2013-04-01

Clinical assessment protocols must produce data that are reliable, with a clinically attainable minimal detectable change (MDC). In a reliability study, generalizability theory has 2 advantages over classical test theory. These advantages provide information that allows assessment protocols to be adjusted to match individual patient profiles. First, generalizability theory allows the user to simultaneously consider multiple sources of measurement error variance (facets). Second, it allows the user to generalize the findings of the main study across the different study facets and to recalculate the reliability and MDC based on different combinations of facet conditions. In doing so, clinical assessment protocols can be chosen based on minimizing the number of measures that must be taken to achieve a realistic MDC, using repeated measures to minimize the MDC, or simply based on the combination that best allows the clinician to monitor an individual patient's progress over a specified period of time.

PATIENT-CENTRED SCREENING FOR PRIMARY IMMUNODEFICIENCY, A MULTI-STAGE DIAGNOSTIC PROTOCOL DESIGNED FOR NONIMMUNOLOGISTS: 2011 UPDATE

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E. de Vries

2013-01-01

Full Text Available Abstract. Members of the European Society for Immunodeficiencies (ESID and other colleagues have updated themulti-stage expert-opinion-based diagnostic protocol for non-immunologists incorporating newly defined primary immunodeficiency diseases (PIDs. The protocol presented here aims to increase the awareness of PIDs among doctors working in different fields. Prompt identification of PID is important for prognosis, but this may not be an easy task. The protocol therefore starts from the clinical presentation of the patient. Because PIDs may present at all ages, this protocol is aimed at both adult and paediatric physicians. The multi-stage design allows cost-effective screening for PID of the large number of potential cases in the early phases, with more expensive tests reserved for definitive classification in collaboration with a specialist in the field of immunodeficiency at a later stage.

A protocol for patients with cardiovascular implantable devices undergoing magnetic resonance imaging (MRI): should defibrillation threshold testing be performed post-(MRI).

Science.gov (United States)

Burke, Peter Thomas; Ghanbari, Hamid; Alexander, Patrick B; Shaw, Michael K; Daccarett, Marcos; Machado, Christian

2010-06-01

Magnetic resonance imaging (MRI) in patients with Cardiovascular Implantable Electronic Devices (CIED) has not been approved by the Food and Drug Administration. Recent data suggests MRI as a relative rather than absolute contraindication in CIED patients. Recently, the American Heart Association has recommended defibrillation threshold testing (DFTT) in implantable cardioverter defibrillator (ICD) patients undergoing MRI. We evaluated the feasibility and safety of a protocol for MRI in CIED patients, incorporating the new recommendations on DFTT. Consecutive patients with CIED undergoing MRI were included. The protocol consisted of continuous monitoring during imaging, device interrogation pre- and post-MRI, reprogramming of the pacemaker to an asynchronous mode in pacemaker-dependent (PMD) patients and a non-tracking/sensing mode for non-PMD patients. All tachyarrhythmia therapies were disabled. Devices were interrogated for lead impedance, battery life, pacing, and sensing thresholds. All patients with ICD underwent DFTT/defibrillator safety margin testing (DSMT) post-MRI. A total of 92 MRI's at 1.5 Tesla were performed in 38 patients. A total of 13 PMD patients, ten ICD patients, four cardiac resynchronization therapy with defibrillator (CRT-D) patients, and 11 non-PMD patients were scanned from four major manufacturers. No device circuitry damage, programming alterations, inappropriate shocks, failure to pace, or changes in sensing, pacing, or defibrillator thresholds were found on single or multiple MRI sessions. Our protocol for MRI in CIED patients appears safe, feasible, and reproducible. This is irrespective of the type of CIED, pacemaker dependancy or multiple 24-h scanning sessions. Our protocol addresses early detection of potential complications and establishes a response system for potential device-related complications. Our observation suggests that routine DFTT/DSMT post-MRI may not be necessary.

Home-based Neurologic Music Therapy for Upper Limb Rehabilitation with Stroke Patients at Community Rehabilitation Stage - a Feasibility Study Protocol.

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Alex J Street

2015-09-01

Full Text Available Background: Impairment of upper limb function following stroke is more common than lower limb impairment and is also more resistant to treatment. Several lab-based studies with stroke patients have produced statistically significant gains in upper limb function when using musical instrument playing and techniques where rhythm acts as an external time-keeper for the priming and timing of upper limb movements. Methods: For this feasibility study a small sample size of 14 participants (3 – 60 months post stroke has been determined through clinical discussion between the researcher and study host in order to test for management, feasibility and effects, before planning a larger trial determined through power analysis. A cross-over design with five repeated measures will be used, whereby participants will be randomized into either a treatment (n=7 or wait list control (n=7 group. Intervention will take place twice weekly over 6 weeks. The ARAT and 9HPT will be used to measure for quantitative gains in arm function and finger dexterity, pre/post treatment interviews will serve to investigate treatment compliance and tolerance. A lab based EEG case comparison study will be undertaken to explore audio-motor coupling, brain connectivity and neural reorganization with this intervention, as evidenced in similar studies. Discussion: Before evaluating the effectiveness of a home-based intervention in a larger scale study, it is important to assess whether implementation of the trial methodology is feasible. This study investigates the feasibility, efficacy and patient experience of a music therapy treatment protocol comprising a chart of 12 different instrumental exercises and variations, which aims at promoting measurable changes in upper limb function in hemiparetic stroke patients. The study proposes to examine several new aspects including home-based treatment and dosage, and will provide data on recruitment, adherence and variability of outcomes.

Home-based neurologic music therapy for upper limb rehabilitation with stroke patients at community rehabilitation stage-a feasibility study protocol.

Science.gov (United States)

Street, Alexander J; Magee, Wendy L; Odell-Miller, Helen; Bateman, Andrew; Fachner, Jorg C

2015-01-01

Impairment of upper limb function following stroke is more common than lower limb impairment and is also more resistant to treatment. Several lab-based studies with stroke patients have produced statistically significant gains in upper limb function when using musical instrument playing and techniques where rhythm acts as an external time-keeper for the priming and timing of upper limb movements. For this feasibility study a small sample size of 14 participants (3-60 months post stroke) has been determined through clinical discussion between the researcher and study host in order to test for management, feasibility and effects, before planning a larger trial determined through power analysis. A cross-over design with five repeated measures will be used, whereby participants will be randomized into either a treatment (n = 7) or wait list control (n = 7) group. Intervention will take place twice weekly over 6 weeks. The ARAT and 9HPT will be used to measure for quantitative gains in arm function and finger dexterity, pre/post treatment interviews will serve to investigate treatment compliance and tolerance. A lab based EEG case comparison study will be undertaken to explore audio-motor coupling, brain connectivity and neural reorganization with this intervention, as evidenced in similar studies. Before evaluating the effectiveness of a home-based intervention in a larger scale study, it is important to assess whether implementation of the trial methodology is feasible. This study investigates the feasibility, efficacy and patient experience of a music therapy treatment protocol comprising a chart of 12 different instrumental exercises and variations, which aims at promoting measurable changes in upper limb function in hemiparetic stroke patients. The study proposes to examine several new aspects including home-based treatment and dosage, and will provide data on recruitment, adherence and variability of outcomes.

Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain

NARCIS (Netherlands)

van der Roer, N.; van Tulder, M.; van Mechelen, W.; de Vet, H.C.W.

2008-01-01

STUDY DESIGN. Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. OBJECTIVE. To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with

Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol.

Science.gov (United States)

Pérula, Luis A; Bosch, Josep M; Bóveda, Julia; Campiñez, Manuel; Barragán, Nieves; Arboniés, Juan C; Prados, Jose A; Martín, Enrique; Martín, Remedios; Massons, Josep; Criado, Margarita; Ruiz, Roger; Fernández, José A; Buitrago, Francisco; Olaya, Inmaculada; Pérez, Modesto; Ruiz, Joaquin

2011-11-05

The non-pharmacological approach to cholesterol control in patients with hyperlipidemia is based on the promotion of a healthy diet and physical activity. Thus, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns, and that include brief advice and counseling services. Within this context, Motivational Interviewing has proven to be effective in changing health behaviors in specific cases. However, more robust evidence is needed on the effectiveness of Motivational Interviewing in treating chronic pathologies -such as dyslipidemia- in patients assisted by general practitioners. This article describes a protocol to assess the effectiveness of MI as compared with general practice (brief advice), with the aim of improving lipid level control in patients with dyslipidemia assisted by a general practitioner. An open, two-arm parallel, multicentre, cluster, controlled, randomized, clinical trial will be performed. A total of 48-50 general practitioners from 35 public primary care centers in Spain will be randomized and will recruit 436 patients with dyslipidemia. They will perform an intervention based either on Motivational Interviewing or on the usual brief advice. After an initial assessment, follow-ups will be performed at 2, 4, 8 and 12 months. Primary outcomes are lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) and cardiovascular risk. The study will assess the degree of dietary and physical activity improvement, weight loss in overweight patients, and adherence to treatment guidelines. Motivational interview skills constitute the primary strategies GPs use to treat their patients. Having economical, simple, effective and applicable techniques is essential for primary care professionals to help

Identification of a research protocol to study orthodontic tooth movement

Directory of Open Access Journals (Sweden)

Annalisa Dichicco

2014-06-01

Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

Stress-first protocol for myocardial perfusion SPECT imaging with semiconductor cameras: high diagnostic performances with significant reduction in patient radiation doses

International Nuclear Information System (INIS)

Perrin, Mathieu; Claudin, Marine; Veran, Nicolas; Morel, Olivier; Besseau, Cyril; Boutley, Henri; Djaballah, Wassila; Poussier, Sylvain; Verger, Antoine; Moulin, Frederic; Imbert, Laetitia; Karcher, Gilles; Marie, Pierre-Yves

2015-01-01

Effective doses of 14 mSv or higher are currently being attained in patients having stress and rest myocardial perfusion imaging (MPI) single photon emission computed tomography (SPECT) performed on the same day with conventional protocols. This study aimed to assess the actual reduction in effective doses as well as diagnostic performances for MPI routinely planned with: (1) high-sensitivity cadmium zinc telluride (CZT) cameras, (2) very low injected activities and (3) a stress-first protocol where the normality of stress images may lead to avoiding rest imaging. During a 1-year period, 2,845 patients had MPI on a CZT camera, a single-day stress-first protocol and low injected activities (120 MBq of 99m Tc-sestamibi at stress for 75 kg body weight and threefold higher at rest). The ability to detect > 50 % coronary stenosis was assessed in a subgroup of 149 patients who also had coronary angiography, while the normalcy rate was assessed in a subgroup of 128 patients with a low pretest likelihood of coronary artery disease (<10 %). Overall, 33 % of patients had abnormal MPI of which 34 % were women and 34 % were obese. The mean effective doses and the percentage of exams involving only stress images were: (1) 3.53 ± 2.10 mSv and 37 % in the overall population, (2) 4.83 ± 1.56 mSv and 5 % in the subgroup with angiography and (3) 1.96 ± 1.52 mSv and 71 % in the low-probability subgroup. Sensitivity and global accuracy for identifying the 106 patients with coronary stenosis were 88 and 80 %, respectively, while the normalcy rate was 97 %. When planned with a low-dose stress-first protocol on a CZT camera, MPI provides high diagnostic performances and a dramatic reduction in patient radiation doses. This reduction is even greater in low-risk subgroups with high rates of normal stress images, thus allowing the mean radiation dose to be balanced against cardiac risk in targeted populations. (orig.)

Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial.

Science.gov (United States)

González Rueda, Vanessa; López de Celis, Carlos; Barra López, Martín Eusebio; Carrasco Uribarren, Andoni; Castillo Tomás, Sara; Hidalgo García, Cesar

2017-09-05

Mechanical neck pain is a highly prevalent problem in primary healthcare settings. Many of these patients have restricted mobility of the cervical spine. Several manual techniques have been recommended for restoring cervical mobility, but their effectiveness in these patients is unknown. The aim of the present study is to compare the effectiveness of two types of specific techniques of the upper neck region: the pressure maintained suboccipital inhibition technique (PMSIT) and the translatory dorsal glide mobilization (TDGM) C0-C1 technique, as adjuncts to a protocolized physiotherapy treatment of the neck region in subjects with chronic mechanical neck pain and rotation deficit in the upper cervical spine. A randomized, prospective, double-blind (patient and evaluator) clinical trial. The participants (n = 78) will be randomly distributed into three groups. The Control Group will receive a protocolized treatment for 3 weeks, the Mobilization Group will receive the same protocolized treatment and 6 sessions (2 per week) of the TDGM C0-C1 technique, and the Pressure Group will receive the same protocolized treatment and 6 sessions (2 per week) of the PMSIT technique. The intensity of pain (VAS), neck disability (NDI), the cervical range of motion (CROM), headache intensity (HIT-6) and the rating of clinical change (GROC scale) will be measured. The measurements will be performed at baseline, post-treatment and 3 months after the end of treatment, by the same physiotherapist blinded to the group assigned to the subject. We believe that an approach including manual treatment to upper cervical dysfunction will be more effective in these patients. Furthermore, the PMSIT technique acts mostly on the musculature, while the TDGM technique acts on the joint. We expect to clarify which component is more effective in improving the upper cervical mobility. ClinicalTrials.gov NCT02832232 . Registered on July 13th, 2016.

The cumulative effect of multiple critical care protocols on length of stay in a geriatric trauma population.

Science.gov (United States)

Frederickson, Tiffany A; Renner, Catherine Hackett; Swegle, James R; Sahr, Sheryl M

2013-01-01

The elderly individuals are the most rapidly growing cohort within the US population, and a corresponding increase is being seen in elderly trauma patients. Elderly patients are more likely to have a hospital length of stay (LOS) in excess of 10 days. They account for 60% of total ICU days. Length of stay is frequently used as a proxy measure for improvement in injury outcomes, changes in quality of care, and hospital outcomes. Patient care protocols are typically created from evidence-based guidelines that serve to reduce variation in care from patient to patient. Patient care protocols have been found to positively impact patient care with reduced duration of mechanical ventilation, shorter LOS in the ICU and shorter overall hospitalization time, reduced mortality, and reduced health care costs. The following study was designed to assess the impact of the implementation of 4 patient care protocols within an elderly trauma population. We hypothesized that the implementation of these protocols would have a beneficial impact on patient care that could be measured by a decrease in hospital LOS. An archival, retrospective pretest/posttest study was performed on elderly trauma patients. The new protocols helped guide practical changes in care that resulted in a 32% decrease in LOS for our elderly trauma patients which exceeds the 25% decrease found in other studies. Additionally, the "Other" category for each variable was less frequently used in the post-protocol phase than in the pre-protocol phase, suggesting a spillover effect on the level of detail recorded in the patient chart. With less variation in practices in the post-protocol phase, Injury Severity score, and admission systolic blood pressure emerged as significant predictors of LOS.

Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

Science.gov (United States)

González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

2015-10-31

Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been

A protocol of histone modification-based mechanistic study of acupuncture in patients with stable angina pectoris.

Science.gov (United States)

Wang, Ning; Lu, Sheng-Feng; Chen, Hui; Wang, Jian-Fei; Fu, Shu-Ping; Hu, Chen-Jun; Yang, Yi; Liang, Fan-Rong; Zhu, Bing-Mei

2015-04-30

Angina pectoris (Angina) is a medical condition related to myocardial ischemia. Although acupuncture has been widely accepted as a clinical approach for angina, there is no sufficient evidence of its effectiveness against this syndrome, and its mechanisms have not yet been well elucidated. We develop this protocol to confirm the clinical efficacy of electro-acupuncture on stable angina pectoris by needling on acupoint Neiguan (PC6). Furthermore, we employ high-throughput sequencing technology to investigate the gene expression profiling and determine involvement of histone modifications in the regulation of genes after electro-acupuncture treatment. A randomized, controlled, double-blinded (assessor and patients) trial will be carried out. Sixty participants will be randomly assigned to two acupuncture treatment groups and one control group in a 1:1:1 ratio. Participants in acupuncture groups will receive 12 sessions of electro-acupuncture treatment across 4 weeks, followed by a 12-week randomization period. The acupuncture groups are divided into Neiguan (PC6) on Pericardium Meridian of Hand-jueyin or a non-acupoint. The primary clinical measure of effect is the frequency of angina attacks between these groups for four weeks after randomization. RNAs are extracted from peripheral neutrophils collected from all participants on day 0, day 30, and week 16, and are processed to RNA-Seq. We then investigate profiles of histone modifications by ChIP-Seq, for H3 Lysine 4 (H3K4me) and acetylation of H3 Lysine 27 (H3K27ac), in the presence or absence of acupuncture treatment. This study determines the efficacy and mechanisms of electro-acupuncture on stable angina pectoris. We focus on effectiveness of acupuncture on alleviating symptoms of myocardial ischemia and the gene regulation and the chromatin remodeling marks, including H3K4me1, H3K4me2, and H3K27ac, which could be key factors for regulating gene expressions caused by electro-acupuncture treatment at Neiguan. This

Low-dose single acquisition rest 99mTc/stress 201Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

International Nuclear Information System (INIS)

Dey, Thomas; Backus, Barbra E.; Romijn, R.Leo; Wieczorek, Herfried; Verzijlbergen, J.F.

2014-01-01

We developed and tested a single acquisition rest 99m Tc-sestamibi/stress 201 Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress 99m Tc and rest 99m Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected 201 Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the 201 Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and 99m Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the 99m Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients no relevant clinical follow

Study of Coronary Flow Reserve with Intravenous Use of Microbubbles (Contrast Echocardiography and Adenosine: Protocol for Clinical Application in Patients Suspected of Having Coronary Heart Disease

Directory of Open Access Journals (Sweden)

Morcerf Fernando

2002-01-01

Full Text Available OBJECTIVE: To test the feasibility, safety and accuracy of the adenosine protocol in the study of myocardial perfusion with microbubbles contrast echocardiography. METHODS: 81 pts (64 male, 60+11 years were submitted to contrast echocardiography with PESDA (sonicated solution of albumin 20%-1ml, dextrose 5%-12ml and deca-fluorobutane gas-8ml to study the myocardial perfusion at rest and after bolus injection of adenosine (6 to 18mg and to coronary angiography within 1 month each other. For each patient 3 left ventricle perfusion beds were considered (total of 243 territories. 208 territories were analyzed and 35 territories were excluded. PESDA was continuously infused (1-2ml/min, titrated for best myocardial contrast. Triggered (1:1 second harmonic imaging was used. RESULTS: Coronary angiography showed 70 flow limiting (> 75% lesions and 138 no flow limiting lesions. At rest an obvious myocardium contrast enhancement was seen in at least 1 segment of a territory in all patients. After adenosine injection an unquestionable further increase in myocardial contrast was observed in 136 territories (99% related to no flow limiting lesions, lasting < 10 s, and a myocardial perfusion defect was detected in 68 territories (97% related to flow limiting lesions. It was observed only 4 false results. There were no serious complications. CONCLUSION: Myocardial perfusion study with PESDA and adenosine protocol is a practical, safe and accurate method to analyze the coronary flow reserve.

An example of the treatment protocol in the case of a patient who has received a radioactive product

International Nuclear Information System (INIS)

Izambard, N.

2011-01-01

At the end of 2009, the Radiation Protection Unit at Rouen University Hospital (Rouen CHU), took part in discussions initiated by the hospital's protocol review board (Nursing Care Directorate) regarding management of all hospital waste produced during health care activities (including activities involving radioactive materials) with a view to complying with French National Authority for Health requirements. Moreover, these new provisions had to incorporate management procedures relative to radioactive waste from the radio analysis laboratory at the hospital's Clinical Biology Institute in accordance with the Order of 23 July 2008. To this end, a study was carried out on the university hospital departments in question, in conjunction with the nuclear medicine department of the neighbouring Henry-Becquerel Regional Cancer Centre (CRLCC), the major producer of radioactive waste. This document presents the new protocol that takes into account the feedback experience from Rouen CHU and the CRLCC. This protocol is based on a better writing down and availability of all the information concerning the treatment received by the patient during his stay at the hospital. This protocol will allow a better identification of the waste and as a consequence a better optimization of its disposal

Development and validation of a remote home safety protocol.

Science.gov (United States)

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

Development of low-dose protocols for thin-section CT assessment of cystic fibrosis in pediatric patients.

LENUS (Irish Health Repository)

O'Connor, Owen J

2010-12-01

To develop low-dose thin-section computed tomographic (CT) protocols for assessment of cystic fibrosis (CF) in pediatric patients and determine the clinical usefulness thereof compared with chest radiography.

Health care in patients 1 year post-stroke in general practice : research on the utilisation of the Dutch Transmural Protocol transient ischaemic attack/cerebrovascular accident

NARCIS (Netherlands)

de Weerd, L.; Rutgers, A.W.F.; Groenier, K.H.; van der Meer, K.

2012-01-01

This study evaluates the kind of aftercare that ischaemic stroke patients receive and the extent that aftercare fulfils the criteria of the 'Dutch Transmural Protocol transient ischaemic attack/cerebrovascular accident'. Fifty-seven patients were interviewed 1 year post-stroke about secondary

A protocol for resuscitation of severe burn patients guided by transpulmonary thermodilution and lactate levels: a 3-year prospective cohort study.

Science.gov (United States)

Sánchez, Manuel; García-de-Lorenzo, Abelardo; Herrero, Eva; Lopez, Teresa; Galvan, Beatriz; Asensio, María; Cachafeiro, Lucia; Casado, Cesar

2013-08-15

The use of urinary output and vital signs to guide initial burn resuscitation may lead to suboptimal resuscitation. Invasive hemodynamic monitoring may result in over-resuscitation. This study aimed to evaluate the results of a goal-directed burn resuscitation protocol that used standard measures of mean arterial pressure (MAP) and urine output, plus transpulmonary thermodilution (TPTD) and lactate levels to adjust fluid therapy to achieve a minimum level of preload to allow for sufficient vital organ perfusion. We conducted a three-year prospective cohort study of 132 consecutive critically burned patients. These patients underwent resuscitation guided by MAP (>65 mmHg), urinary output (0.5 to 1 ml/kg), TPTD and lactate levels. Fluid therapy was adjusted to achieve a cardiac index (CI) >2.5 L/minute/m² and an intrathoracic blood volume index (ITBVI) >600 ml/m2, and to optimize lactate levels. Statistical analysis was performed using mixed models. We also used Pearson or Spearman methods and the Mann-Whitney U-test. A total of 98 men and 34 women (mean age, 48 ± 18 years) was studied. The mean total body surface area (TBSA) burned was 35% ± 22%. During the early resuscitation phase, lactate levels were elevated (2.58 ± 2.05 mmol/L) and TPTD showed initial hypovolemia by the CI (2.68 ± 1.06 L/minute/m²) and the ITBVI (709 ± 254 mL/m²). At 24 to 32 hours, the CI and lactic levels were normalized, although the ITBVI remained below the normal range (744 ± 276 ml/m²). The mean fluid rate required to achieve protocol targets in the first 8 hours was 4.05 ml/kg/TBSA burned, which slightly increased in the next 16 hours. Patients with a urine output greater than or less than 0.5 ml/kg/hour did not show differences in heart rate, mean arterial pressure, CI, ITBVI or lactate levels. Initial hypovolemia may be detected by TPTD monitoring during the early resuscitation phase. This hypovolemia might not be reflected by blood pressure and hourly urine output. An

The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

Science.gov (United States)

Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

2017-01-01

Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

Dosimetry study on the conventional and three dimensional conformal radiation treatment planning protocols for rectal cancer

International Nuclear Information System (INIS)

Cai Yong; He Yuxiang; Han Shukui; Wu Hao; Gong Jian; Xu Bo

2007-01-01

Objective: To compare the dose distribution of clinical target volume (CTV), in normal tissues and organs for patients with rectal cancer on the conventional radiotherapy (2D) and three dimension- al conformal radiation treatment (3DCRT). Methods: The CT image data of 36 rectal cancer patients treated with 3DCRT were studied. The CTV, small bowel, colon, bladder, pelvic bone marrow, and femoral head and neck were contoured on consecutive axial slices of CT images. Two 3DCRT and three conventional treatment planning protocols were simulated using three dimensional treatment planning system (CMS Focus 2.31), were defined as 3D-3, 3D-4, 2D-2, 2D-3, 2D-4. The difference of five treatment planning protocols on the CTV and normal structure by analysis of dose-volume histograms (DVHs) were compared. Results: The D 95 and V 95 of these five protocols all exceeded 97%. The conformity index(CI) of 3D was obviously larger than that of 2D protocol. The dose inhomogeneity(DI) in 4 DCRT was less than that of 3 DCRT. The 3D as compared with the 2D, significantly reduced the mean dose of 45 Gy to the small bowel and colon. The 3D-3 as compared with the 2D-3, the 3D-4 as compared with the 2D-4, the mean dose of small bowel and colon was reduced by 28.5% and 25.7%, respectively. The 3D-3 as compared with the 2D-2, the 3D-3 as compared with the 2D-3 and the 3D4 as compared with the 2D-4, the percentage volume of small bowel and colon which received 45 Gy was reduced by 80.8% , 51.1% and 54.7% , respectively. Either the mean dose, or the percentage volume receiving 35 Gy and 45 Gy to the pelvic bone and bladder, the 3D planning protocols had advanage over the 2D planning protocols. The V 45 of bladder in 2D-2 planning proto- col was the highest in all planning protocols, exceeding 98%, but the highest V 45 of bladder was only 50% in the other planning protocols. Conclusions: Even though the difference in pelvic CTV of rectal cancer patients between the conventional radiotherapy and 3

Efficacy of an extravascular lung water-driven negative fluid balance protocol.

Science.gov (United States)

Díaz-Rubia, L; Ramos-Sáez, S; Vázquez-Guillamet, R; Guerrero-López, F; Pino-Sánchez, F; García-Delgado, M; Gómez-Jiménez, F J; Fernández-Mondéjar, E

2015-01-01

To analyze the efficacy of negative fluid balance in hypoxemic patients with an elevated extravascular lung water index (EVLWI). A retrospective observational study was made. Intensive Care Unit of Virgen de las Nieves Hospital (Spain). Forty-four patients participated in the study. We analyzed our database of hypoxemic patients covering a period of 11 consecutive months. We included all hemodynamically stable and hypoxemic patients with EVLWI>9ml/kg. The protocol dictates a negative fluid balance between 500 and 1500ml/day. We analyzed the impact of this negative fluid balance strategy upon pulmonary, hemodynamic, and renal function. Demographic data, severity scores, clinical, hemodynamic, pulmonary, metabolic and renal function data. Thirty-three patients achieved negative fluid balance (NFB group) and 11 had a positive fluid balance (PFB group). In the former group, PaO2/FiO2 improved from 145 (IQR 106, 200) to 210mmHg (IQR 164, 248) (pPFB group, EVLWI also decreased from 11 (10, 14) to 10ml/kg (8, 14) at the end of the protocol (p=0.004). For these patients there were no changes in oxygenation, with a PaO2/FiO2 of 216mmHg (IQR 137, 260) at the beginning versus 205mmHg (IQR 99,257) at the end of the study (p=0.08). Three out of four hypoxic patients with elevated EVLWI tolerated the NFB protocol. In these subjects, the improvement of various analyzed physiological parameters was greater and faster than in those unable to complete the protocol. Patients who did not tolerate the protocol were usually in more severe condition, though a larger sample would be needed to detect specific characteristics of this group. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

Science.gov (United States)

Daniels, Ruby A; Torres, David; Reeser, Cathy

2016-01-01

Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol.

Science.gov (United States)

Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu

2015-06-01

To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.

Advanced dementia pain management protocols.

Science.gov (United States)

Montoro-Lorite, Mercedes; Canalias-Reverter, Montserrat

Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero» for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Tinnitus in patients with temporo-mandibular joint disorder: Proposal for a new treatment protocol.

Science.gov (United States)

Attanasio, Giuseppe; Leonardi, Alessandra; Arangio, Paolo; Minni, Antonio; Covelli, Edoardo; Pucci, Resi; Russo, Francesca Yoshie; De Seta, Elio; Di Paolo, Carlo; Cascone, Piero

2015-06-01

The present study was designed to verify the correlation between tinnitus and temporomandibular joint dysfunction.86 consecutive patients were enrolled in the study, all affected by subjective tinnitus without hearing impairment, from both genders, age between 18 and 60 years old. The final number of patients included in the study was 55. All patients received a temporo-mandibular joint examination. All the patients were asked to rate the severity of their symptoms before and after treatment using a VAS scale and the Tinnitus Handicap Inventory (THI) and they followed a standardized protocol for the investigation of tinnitus. All the subjects were monitored by the same researcher and they underwent the same splint treatment. The comparison between pre- and posttreatment phase scores showed in patients with predisposition of TMD and with TMD a statistically significant decrease of THI and VAS values. The characteristics of tinnitus and the degree of response to treatment confirmed the relationship between tinnitus and TMD. The authors believe that, when the most common causes of tinnitus, such as otologic disorders and neurological diseases are excluded, it is correct to evaluate the functionality of the temporo-mandibular joint and eventually treat its pathology to obtain tinnitus improvement or even resolution. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

Directory of Open Access Journals (Sweden)

Stacey Dawn

2012-11-01

Full Text Available Abstract Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©. Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a establishing an advisory knowledge user team in each of three targeted settings; (b assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c adapting protocols for local use, ensuring fidelity of the content; (d selecting intervention strategies to overcome known barriers and implementing the protocols; (e conducting think-aloud usability testing; (f evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing

Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

Science.gov (United States)

Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2018-05-15

There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

Avascular necrosis of the femoral head in patients treated for leukaemia. Assessment of the need for a diagnostic protocol.

Science.gov (United States)

Alguacil Pinel, J; Vila Vives, P; Salom Taverner, M

To evaluate the incidence of avascular necrosis of the hip in leukaemia patients treated in our hospital with high doses of corticosteroids in order to evaluate the necessity for an early detection protocol. Observational-descriptive and retrospective study from 2005 to 2016 of 253 patients diagnosed with paediatric leukaemia. Patients with musculoskeletal pathology were identified and patients with avascular necrosis were analysed. A total of 26 patients (10%) had musculoskeletal symptoms. Three patients with avascular necrosis (1.2%) were analysed. One girl, 7 years old, was treated conservatively with traction - suspension and discharge. Two boys, an 11 and a 15.4 year-old,who developed graft-versus-host disease secondary to bone marrow transplantation, and whose treatment included high doses of corticosteroids, developed avascular necrosis of the hip. One was treated with bisphosphonates and forage and the other ended up with a total hip arthroplasty. The occurrence of musculoskeletal symptoms during the treatment of leukaemia is different according to the bibliographic series (0.43 -12.6%). Some authors observe an increased risk in female patients between the ages of 10 and 17. A retrospective study reveals that there is a delay of 3.9 months in the diagnosis of CAP since the onset of pain. Other authors relate NAV to loading joints, age and high doses of corticosteroids. Based on the low incidence of avascular necrosis of the hip in our 14-year-old population treated for leukaemia, the creation of diagnostic protocols seems not to be necessary. However, close monitoring of patients with potential risk factors recognized in the literature, is advisable. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Outcome of patients with stage III or inoperable WT treated on the second United Kingdom WT protocol (UKWT2); a United Kingdom Children's Cancer Study Group (UKCCSG) study.

Science.gov (United States)

Grundy, R G; Hutton, C; Middleton, H; Imeson, J; Pritchard, J; Kelsey, A; Marsden, H B; Vujanic, G M; Taylor, R E

2004-04-01

The aims of UKWT2 included consolidating the results for stage III patients obtained in UKWT1 and improving the outcome for patients with inoperable tumours by giving vincristine, actinomycin-D and doxorubicin in an intensive schedule (Intensive AVA). The second UK WT trial (UKWT2) ran between July 1986 and September 1991 accruing 448 patients. One hundred and six patients were diagnosed and treated for stage III disease. Six had clear cell sarcoma of the kidney (CCSK) and seven had rhabdoid tumours of the kidney (RTK) and are analysed separately. One other patient was excluded from overall analysis. Ninety-two patients were followed for a median of 115 months. Seventy-five received standard chemotherapy and abdominal radiotherapy according to protocol. Seventeen had stage III disease at immediate nephrectomy, but radiotherapy was omitted by physician choice. Thirty-three patients had inoperable disease at diagnosis and received pre-nephrectomy chemotherapy. Overall survival (OS) at 4 years for stage III favourable histology (FH) patients receiving abdominal RT was 83% (CI: 73-89). For children with stage III disease in whom RT was omitted the OS was 82% (CI: 59-97) and for inoperable disease 94% (CI: 78-98). The overall and event-free survival (EFS) of children with stage III CCSK was 100% and was achieved with the majority of patients not receiving radiotherapy (CI: 48-100). Three of seven children with RTK are alive EFS and OS 43% (CI: 10-73). For patients treated by abdominal radiotherapy the overall local control rate was 94.4% (CI: 86.4-98.5*%), 96.7% (CI: 88.5-99.6%) for flank RT and 83.3% (51.6-98.0%) for whole abdominal radiotherapy (WRT). The outcome for stage III FH disease was similar to that reported for UKWT1 and NWTS-3. The combination of abdominal RT together with 3-drug chemotherapy achieves a high abdominal tumour control rate. Flank RT is probably sufficient for localised tumour rupture. The high cure rates for children in this trial with

Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

Science.gov (United States)

Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

2013-05-07

It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more

The studsvik BNCT project: structure and the proposed protocols

International Nuclear Information System (INIS)

Capala, J.; Stenstam, B.H.; Skoeld, K.; Henriksson, R.; Salford, L.; Carlsson, J.

2000-01-01

The BNCT facility at Studsvik is now ready for clinical trials. Scientific operations of the Studsvik BNCT project are overseen by the Scientific Advisory Board comprised of representatives of all major universities in Sweden. Furthermore, special task groups for clinical and preclinical studies have been formed to facilitate collaboration with academia and to assure the quality of the research. Proposed clinical Phase II trials for glioblastoma are sponsored by the Swedish National Neuro-Oncology Group and, initially, will involve two protocols: Protocol no.1. BNCT for glioblastoma patients who have not received any therapy other than surgery (including stereotactic biopsy only). Protocol no.2. BNCT as a palliative treatment for patients with recurrent glioblastoma following conventional therapies or BNCT. In both protocols, BPA, administered by a 6 hour i.v. infusion, will be used as the boron delivery agent. (author)

Implementation of enteral feeding protocol in an intensive care unit

DEFF Research Database (Denmark)

Padar, Martin; Uusvel, Gerli; Starkopf, Liis

2017-01-01

AIM: To determine the effects of implementing an enteral feeding protocol on the nutritional delivery and outcomes of intensive care patients. METHODS: An uncontrolled, observational before-and-after study was performed in a tertiary mixed medical-surgical intensive care unit (ICU). In 2013......, a nurse-driven enteral feeding protocol was developed and implemented in the ICU. Nutrition and outcome-related data from patients who were treated in the study unit from 2011-2012 (the Before group) and 2014-2015 (the After group) were obtained from a local electronic database, the national Population...... the groups. Patients in the After group had a lower 90-d (P = 0.026) and 120-d (P = 0.033) mortality. In the After group, enteral nutrition was prescribed less frequently (P = 0.039) on day 1 but significantly more frequently on all days from day 3. Implementation of the feeding protocol resulted in a higher...

Efficacy of a sedo-analgesia protocol in pre-hospital trauma treatment

Directory of Open Access Journals (Sweden)

Savino Occhionorelli

2013-06-01

Full Text Available Pre-hospital trauma treatment is an important situation in which pain should be appropriately assessed and treated, but there is a great lack of studies about it. Literature has widely pointed out that the underanalgesia problem is spread to all groups of patients. The objective of the study is to verify the efficacy of a sedation-analgesia protocol based on the use of NSAIDs, Fentanyl and Midazolam, for prehospital treatment of trauma patients. The protocol was tested in three Emergency Medical Services for a four month period, in which 30 patients were included in the study. Results evidenced a good management of both pain and anxiety in the majority of patients treated, with the achievement of analgesia target in 80% of the patients and sedation target in 100% of the patients.

Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial.

Science.gov (United States)

Cao, Hui-Juan; Liu, Jian-Ping; Hu, Hui; Wang, Nissi S

2014-07-10

Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality. This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).

The Use Of Spikes Protocol In Cancer: An Integrative Review

Directory of Open Access Journals (Sweden)

Fernando Henrique de Sousa

2017-03-01

Full Text Available This is an integrative review which aimed to evaluate the use of the SPIKES protocol in Oncology. We selected articles published in Medline and CINAHL databases between 2005-2015, in English, with the descriptors defined by the Medical Subject Headings (MeSH:cancer, neoplasms, plus the uncontrolled descriptor: protocol spikes.  Six articles met the inclusion criteria and were analyzed in full, three thematic categories were established: aspects inherent to the health care professional; Aspects related to the patient and aspects related to the protocol. The main effects of the steps of SPIKES protocol can provide the strengthening of ties between health professionals and patients, and ensure the maintenance and quality of this relationship.  The results indicate an important limiting factor for effective doctor-patient relationship, the little training provided to medical professionals communication of bad news, verified by the difficulty reported in this moment through interviews in the analyzed studies.

Comparison of Different Dosing Protocols of Anti-Snake Venom (ASV) in Snake Bite Cases.

Science.gov (United States)

Daswani, B R; Chandanwale, A S; Kadam, D B; Ghongane, B B; Ghorpade, V S; Manu, H C

2017-09-01

Considering the cost of Anti-Snake Venom (ASV) and irregularity in its supply, there is often a need to curtail doses of ASV, despite guidelines for management of snake bite. During June 2013 to September 2013, when ASV was in short supply, our institutional committee reviewed the overall hospital statistics of snake bite cases as well as scientific literature and formulated a working modified protocol that used low dose of ASV in snake bite cases. To retrospectively analyse and compare the modified ASV protocol versus conventional ASV protocol with respect to outcome, number of ASV vials required, duration of stay in the hospital/ ICU, and additional supportive interventions needed. This was a retrospective study conducted at a tertiary care teaching hospital, Maharashtra, India. Hospital records of inpatients admitted for snake bite during June 2013 to September 2013 (since introduction of the modified protocol) as well as during June 2012 to September 2012, (when patients received conventional protocol-historical controls) were retrospectively analysed to assess the number of ASV vials received by the patients during the stay, need for supportive therapy, duration of stay and outcome of the patients. There was a significant reduction in average number of ASV vials per patient, required vide the modified protocol compared to their historical controls (10.74±0.95 vs 28.17±2.75 pcost of management of each patient reduced by approximately 11974.41 INR per treated patient, based on the requirement of ASV. The modified ASV protocol used in this study is more cost effective as compared to the conventional protocol, deserves prospective evaluation and may be followed at least during prime time of scarcity of ASV.

The challenges of treating paraganglioma patients with 177Lu-DOTATATE PRRT: Catecholamine crises, tumor lysis syndrome and the need for modification of treatment protocols

International Nuclear Information System (INIS)

Makis, William; Mccann, Karey; Mcewan, Alexander J. B.

2015-01-01

A high percentage of paragangliomas express somatostatin receptors that can be utilized for targeted radioisotope therapy. The aim of this study was to describe and discuss the challenges of treating these tumors with 177 Lu-[DOTA0,Tyr3]octreotate (DOTATATE) radioisotope therapy using established protocols. Three paraganglioma patients were treated with 4–5 cycles of 177 Lu-DOTATATE and were evaluated for side effects and response to therapy. Two of the three patients developed severe adverse reactions following their first 177 Lu-DOTATATE treatment. One patient developed a catecholamine crisis and tumor lysis syndrome within hours of treatment, requiring intensive care unit (ICU) support, and another developed a catecholamine crisis 3 days after treatment, requiring hospitalization. The treatment protocols at our institution were subsequently modified by increasing the radioisotope infusion time from 15 to 30 min, as recommended in the literature, to 2–4 h and by reducing the administered dose of 177 Lu-DOTATATE. Subsequent 177 Lu-DOTATATE treatments utilizing the modified protocols were well tolerated, and response to therapy was achieved in all three patients, resulting in significantly improved quality of life. 177 Lu-DOTATATE is an exciting new therapeutic option in the management of paragangliomas; however, current treatment protocols described in the literature may need to be modified by lengthening the infusion time and/or lowering the initial treatment dose to prevent or reduce the severity of adverse reactions

Comparison of Three Prehospital Cervical Spine Protocols for Missed Injuries

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Rick Hong

2014-07-01

Full Text Available Introduction: We wanted to compare 3 existing emergency medical services (EMS immobilization protocols: the Prehospital Trauma Life Support (PHTLS, mechanism-based; the Domeier protocol (parallels the National Emergency X-Radiography Utilization Study [NEXUS] criteria; and the Hankins’ criteria (immobilization for patients 65 years, those with altered consciousness, focal neurologic deficit, distracting injury, or midline or paraspinal tenderness.To determine the proportion of patients who would require cervical immobilization per protocol and the number of missed cervical spine injuries, had each protocol been followed with 100% compliance. Methods: This was a cross-sectional study of patients ≥18 years transported by EMS post-traumatic mechanism to an inner city emergency department. Demographic and clinical/historical data obtained by physicians were recorded prior to radiologic imaging. Medical record review ascertained cervical spine injuries. Both physicians and EMS were blinded to the objective of the study. Results: Of 498 participants, 58% were male and mean age was 48 years. The following participants would have required cervical spine immobilization based on the respective protocol: PHTLS, 95.4% (95% CI: 93.1-96.9%; Domeier, 68.7% (95% CI: 64.5-72.6%; Hankins, 81.5% (95% CI: 77.9-84.7%. There were 18 cervical spine injuries: 12 vertebral fractures, 2 subluxations/dislocations and 4 spinal cord injuries. Compliance with each of the 3 protocols would have led to appropriate cervical spine immobilization of all injured patients. In practice, 2 injuries were missed when the PHTLS criteria were mis-applied. Conclusion: Although physician-determined presence of cervical spine immobilization criteria cannot be generalized to the findings obtained by EMS personnel, our findings suggest that the mechanism-based PHTLS criteria may result in unnecessary cervical spine immobilization without apparent benefit to injured patients. PHTLS

Development of a protocol for the kinematic analysis of movement in patients with total hip arthroplasty

OpenAIRE

Mateu Pla, Joan

2015-01-01

The aim of this final degree project is to study and analyze the kinematics of the human body lower limbs. First of all, it is extremely important to establish a protocol in order to compare two patients operated with two different techniques of total hip arthroplasty. The three usual movements that are employed to make this comparison are gait, sit-to-stand and stairs climbing. A three-dimensional full body model is implemented and the kinematic parameters (angles) necessary for the st...

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

OpenAIRE

van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

2008-01-01

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapist...

Study and development of a remote biometric authentication protocol

OpenAIRE

Bistarelli, Stefano; Claudio, Viti

2003-01-01

This paper reports the phases of study and implementation of a remote biometric authentication protocol developed during my internship at the I.i.t. of the C.n.r. in Pisa. Starting from the study of authentication history we had a look from the first system used since the 60ies to the latest technology; this helped us understand how we could realize a demonstration working protocol that could achieve a web remote authentication granting good reliability: to do this we choosed to modify the SS...

Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol.

Science.gov (United States)

Gimbel, Ronald; Shi, Lu; Williams, Joel E; Dye, Cheryl J; Chen, Liwei; Crawford, Paul; Shry, Eric A; Griffin, Sarah F; Jones, Karyn O; Sherrill, Windsor W; Truong, Khoa; Little, Jeanette R; Edwards, Karen W; Hing, Marie; Moss, Jennie B

2017-03-06

Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei). ©Ronald Gimbel, Lu Shi, Joel E Williams, Cheryl J Dye, Liwei Chen, Paul Crawford, Eric A Shry, Sarah F Griffin, Karyn O Jones, Windsor W Sherrill, Khoa Truong, Jeanette R Little, Karen W Edwards, Marie Hing, Jennie B Moss. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2017.

Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol

Directory of Open Access Journals (Sweden)

Pérula Luis A

2011-11-01

Full Text Available Abstract Background The non-pharmacological approach to cholesterol control in patients with hyperlipidemia is based on the promotion of a healthy diet and physical activity. Thus, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns, and that include brief advice and counseling services. Within this context, Motivational Interviewing has proven to be effective in changing health behaviors in specific cases. However, more robust evidence is needed on the effectiveness of Motivational Interviewing in treating chronic pathologies -such as dyslipidemia- in patients assisted by general practitioners. This article describes a protocol to assess the effectiveness of MI as compared with general practice (brief advice, with the aim of improving lipid level control in patients with dyslipidemia assisted by a general practitioner. Methods/Design An open, two-arm parallel, multicentre, cluster, controlled, randomized, clinical trial will be performed. A total of 48-50 general practitioners from 35 public primary care centers in Spain will be randomized and will recruit 436 patients with dyslipidemia. They will perform an intervention based either on Motivational Interviewing or on the usual brief advice. After an initial assessment, follow-ups will be performed at 2, 4, 8 and 12 months. Primary outcomes are lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and cardiovascular risk. The study will assess the degree of dietary and physical activity improvement, weight loss in overweight patients, and adherence to treatment guidelines. Discussion Motivational interview skills constitute the primary strategies GPs use to treat their patients. Having economical, simple, effective and

An Hourly Dose-Escalation Desensitization Protocol for Aspirin-Exacerbated Respiratory Disease.

Science.gov (United States)

Chen, Justin R; Buchmiller, Brett L; Khan, David A

2015-01-01

Aspirin desensitization followed by maintenance therapy effectively improves symptom control in patients with aspirin exacerbated respiratory disease (AERD). The majority of current desensitization protocols use 3-hour dosing intervals and often require 2 to 3 days to complete. We evaluated hourly dose escalations in a subset of patients with chronic rhinosinusitis, nasal polyps, and asthma who historically reacted to aspirin within 1 hour or were avoiding aspirin with the goal of developing a safe and efficient desensitization protocol. Fifty-seven aspirin desensitizations were performed under the hourly protocol. All patients had refractory nasal polyposis as an indication for aspirin desensitization. The clinical characteristics of each subject were analyzed in relation to aspects of his or her reactions during the procedure. Ninety-eight percent of study patients were successfully treated under the hourly protocol, including those with a history of severe reactions and intubation. None required further medication than is available in an outpatient allergy clinic. A total of 96% of reactors recorded a bronchial or naso-ocular reaction within 1 hour of the preceding dose. Of the total patients on this protocol, 40% were able to complete the procedure in a single day, and 60% within 2 days. Patients with AERD who have a history of symptoms less than 1 hour after aspirin exposure can be safely desensitized with a 1-hour dose-escalation protocol that can often be completed in a single day. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Targeted agents for patients with advanced/metastatic pancreatic cancer: A protocol for systematic review and network meta-analysis.

Science.gov (United States)

Di, Baoshan; Pan, Bei; Ge, Long; Ma, Jichun; Wu, Yiting; Guo, Tiankang

2018-03-01

Pancreatic cancer (PC) is a devastating malignant tumor. Although surgical resection may offer a good prognosis and prolong survival, approximately 80% patients with PC are always diagnosed as unresectable tumor. National Comprehensive Cancer Network's (NCCN) recommended gemcitabine-based chemotherapy as efficient treatment. While, according to recent studies, targeted agents might be a better available option for advanced or metastatic pancreatic cancer patients. The aim of this systematic review and network meta-analysis will be to examine the differences of different targeted interventions for advanced/metastatic PC patients. We will conduct this systematic review and network meta-analysis using Bayesian method and according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) statement. To identify relevant studies, 6 electronic databases including PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), Web of science, CNKI (Chinese National Knowledge Infrastructure), and CBM (Chinese Biological Medical Database) will be searched. The risk of bias in included randomized controlled trials (RCTs) will be assessed using the Cochrane Handbook version 5.1.0. And we will use GRADE approach to assess the quality of evidence from network meta-analysis. Data will be analyzed using R 3.4.1 software. To the best of our knowledge, this systematic review and network meta-analysis will firstly use both direct and indirect evidence to compare the differences of different targeted agents and targeted agents plus chemotherapy for advanced/metastatic pancreatic cancer patients. This is a protocol of systematic review and meta-analysis, so the ethical approval and patient consent are not required. We will disseminate the results of this review by submitting to a peer-reviewed journal.

Conventional and advanced implant treatment in the type II diabetic patient: surgical protocol and long-term clinical results.

Science.gov (United States)

Tawil, Georges; Younan, Roland; Azar, Pierre; Sleilati, Ghassan

2008-01-01

To investigate the effect of type-2 diabetes on implant survival and complication rate. Prospective study enrolling type-2 diabetic patients suffering from edentulism, having a mean perioperative HbA1c level of 7.2%, and compliant with a maintenance program. All the patients underwent dental and periodontal examinations and had laboratory testing for HbA1c, fasting plasma glucose, blood lipids, and microalbuminuria. Nondiabetic patients matched for implant treatment indication served as controls. The influence of clinical diabetes-related factors and periodontal parameters (Plaque Index, bleeding on probing, probing depth) on implant survival were assessed via univariate then multivariate methods. Forty-five diabetic patients, followed for 1 to 12 years, mean age 64.7 years, received 255 implants: 143 following a classical protocol and 112 in cases of sinus floor elevation, immediate loading, and guided bone regeneration. Forty-five nondiabetic control patients received 244 implants: 142 following a classical protocol and 102 in cases of advanced surgery. Implant survival following conventional or advanced implant therapy was not statistically different between the well-controlled (HbA1c diabetic group was 97.2% (control 98.8%) and was not significantly different for age, gender, diabetes duration, smoking, or type of hypoglycemic therapy. The mean peri-implant bone loss was 0.41 +/- 0.58 mm (control, 0.49 +/- 0.64 mm). PI and BOP fairly correlated with postoperative complications. HbA1c was the only multivariate independent factor affecting the complication rate (P = .04). No statistically significant difference was found for patients (P = .81) or for implants (P = .66) for the advanced surgery cases or the conventional approach in diabetic patients compared to nondiabetic patients.

Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

Science.gov (United States)

Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

2017-01-01

For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

Study on Cloud Security Based on Trust Spanning Tree Protocol

Science.gov (United States)

Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

2015-09-01

Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

Cost savings using a protocol approach to manage anemia in a hemodialysis unit.

Science.gov (United States)

Charlesworth, Emily C; Richardson, Robert M; Battistella, Marisa

2014-01-01

National guidelines recommend using anemia management protocols to guide treatment. The objective of this study was to determine if an anemia management protocol would improve hemoglobin (Hgb) indices in hemodialysis patients and to measure whether the protocol would reduce the use and cost of darbepoetin alfa (DBO) and intravenous (IV) iron in hemodialysis patients. An anemia management protocol was created and implemented for hemodialysis patients at our institution. A retrospective observational review of the use of DBO and IV iron as well as changes in Hgb, transferrin saturation and ferritin in 174 patients was conducted 6 months before and after implementation of the anemia protocol. The number of Hgb measurements in the target range increased from 44.3 to 46.0% (p = 0.48) after protocol implementation. The mean weekly dose of DBO was reduced from 34.56 ± 31.12 to 31.11 ± 28.64 μg post-protocol implementation (p = 0.011), which translated to a cost savings of USD 41,649 over 6 months. The mean monthly IV iron dose also decreased from 139.56 ± 98.83 to 97.65 ± 79.05 mg (p DBO and iron agents while increasing the number of patients in the target Hgb range, which led to significant cost savings in the treatment of anemia.

Nursing Music Protocol and Postoperative Pain.

Science.gov (United States)

Poulsen, Michael J; Coto, Jeffrey

2018-04-01

Pain has always been a major concern for patients and nurses during the postoperative period. Therapies, medicines, and protocols have been developed to improve pain and anxiety but have undesirable risks to the patient. Complementary and alternative medicine therapies have been studied but have not been applied as regular protocols in the hospital setting. Music is one type of complementary and alternative medicine therapy that has been reported to have favorable results on reducing postoperative pain, anxiety, and opioid usage. However, music lacks a protocol that nurses can implement during the perioperative process. This paper is an in-depth literature review assessing a best practice recommendation and protocol that establishes a consensus in the use of music therapy. The results suggest that music therapy may consist of calming, soft tones of 60-80 beats per minute for at least 15-30 minutes at least twice daily during the pre- and postoperative periods. It is suggested that music only be used in conjunction with standards of care and not as the primary intervention of pain or anxiety. This evidence suggests that proper use of music therapy can significantly reduce surgical pain. Implementing these protocols and allowing the freedom of nursing staff to use them may lead to greater reductions in surgical pain and anxiety and a reduction in opioid use. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Safety of a dedicated brain MRI protocol in patients with a vagus nerve stimulator.

Science.gov (United States)

de Jonge, Jeroen C; Melis, Gerrit I; Gebbink, Tineke A; de Kort, Gérard A P; Leijten, Frans S S

2014-11-01

Although implanted metallic devices constitute a relative contraindication to magnetic resonance imaging (MRI) scanning, the safety of brain imaging in a patient with a vagus nerve stimulator (VNS) is classified as "conditional," provided that specific manufacturer guidelines are followed when a transmit and receive head coil is used at 1.5 or 3.0 Tesla. The aim of this study was to evaluate the safety of performing brain MRI scans in patients with the VNS. From September 2009 until November 2011, 101 scans were requested in 73 patients with the VNS in The Netherlands. Patients were scanned according to the manufacturer's guidelines. No patient reported any side effect, discomfort, or pain during or after the MRI scan. In one patient, a lead break was detected based on device diagnostics after the MRI-scan. However, because no system diagnostics had been performed prior to MR scanning in this patient, it is unclear whether MR scanning was responsible for the lead break. The indication for most scans was epilepsy related. Twenty-six scans (26%) were part of a (new) presurgical evaluation and could probably better have been performed prior to VNS implantation. Performing brain MRI scans in patients with an implanted VNS is safe when a modified MRI protocol is followed. Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

Evaluation of a protocol for the non-operative management of perforated peptic ulcer.

Science.gov (United States)

Marshall, C; Ramaswamy, P; Bergin, F G; Rosenberg, I L; Leaper, D J

1999-01-01

The non-operative management of perforated peptic ulcer has previously been shown to be both safe and effective although it remains controversial. A protocol for non-operative management was set up in this hospital in 1989. Adherence to the guidelines in the protocol has been audited over a 6-year period with a review of outcome. The case-notes of patients with a diagnosis of perforated peptic ulcer were reviewed. Twelve guidelines from the protocol were selected for evaluation of compliance to the protocol. Forty-nine patients underwent non-operative treatment initially. Eight patients failed to respond and underwent operation. Complications included abscess formation (seven patients), renal failure (one), gastric ileus (one), chest infection (two), and cardiac failure and stroke (one). Four deaths occurred in this group. Adherence to certain protocol guidelines was poor, notably those concerning prevention of thromboembolism, use of antibiotics, use of contrast examination to confirm the diagnosis and referral for follow-up endoscopy. Two gastric cancers were detected on subsequent endoscopy. This experience demonstrates that non-operative treatment can be used successfully in a general hospital. Adherence to protocol guidelines was found to be variable and the protocol has therefore been simplified. This study highlights the need for an accurate diagnosis and the importance of follow-up endoscopy.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

Science.gov (United States)

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease – study protocol for a randomised controlled trial [ISRCTN11611768

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Zaugg Christian

2004-08-01

Full Text Available Abstract Background Physical exercise has become a cornerstone of management of chronic obstructive pulmonary disease (COPD because it leads to clinically relevant improvements of exercise capacity and health-related quality of life (HRQL. Despite the scarcity of randomised trials directly comparing exercise protocols, current guidelines recommend high intensity continuous exercise for lower extremities as the probably most effective exercise modality. However, for patients admitted to inpatient respiratory rehabilitation programmes, it is often difficult to initiate such an exercise programme because they are severely limited by dyspnoea and leg fatigue and therefore unable to perform continuous exercise at higher intensities and for periods longer than 30 minutes. Interval exercise may be an attractive alternative for these COPD patients because it allows high intensity exercise with recovery periods. The aim of this study is to assess if interval exercise compared to high intensity continuous exercise is not of inferior effectiveness in terms of HRQL and exercise capacity improvements but associated with better exercise tolerance in patients with moderate to severe COPD at the beginning of a respiratory rehabilitation. Methods/Design We will assign patients with moderately severe to severe COPD to either continuous exercise or interval exercise using a stratified randomisation. Patients will follow 12–15 exercise sessions during a comprehensive inpatient respiratory rehabilitation. Primary end point for effectiveness is HRQL as measured by the Chronic Respiratory Questionnaire (CRQ two weeks after the end of rehabilitation and secondary endpoints include additional clinical outcomes such as functional exercise capacity, other HRQL measures, patients' experience of physical exercise as well as physiological measures of the effects of physical exercise such as cardiopulmonary exercise testing. Including expected drop-outs, we will need 52

Low-dose single acquisition rest {sup 99m}Tc/stress {sup 201}Tl myocardial perfusion SPECT protocol: phantom studies and clinical validation

Energy Technology Data Exchange (ETDEWEB)

Dey, Thomas [RWTH Aachen University, Institute of Imaging and Computer Vision, Aachen (Germany); Backus, Barbra E.; Romijn, R.Leo [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Wieczorek, Herfried [Philips Research, Eindhoven (Netherlands); Verzijlbergen, J.F. [St. Antonius Hospital, Department of Nuclear Medicine, Nieuwegein (Netherlands); Erasmus Medical Center, Department of Nuclear Medicine, Rotterdam (Netherlands)

2014-03-15

We developed and tested a single acquisition rest {sup 99m}Tc-sestamibi/stress {sup 201}Tl dual isotope protocol (SDI) with the intention of improving the clinical workflow and patient comfort of myocardial perfusion single photon emission computed tomography (SPECT). The technical feasibility of SDI was evaluated by a series of anthropomorphic phantom studies on a standard SPECT camera. The attenuation map was created by a moving transmission line source. Iterative reconstruction including attenuation correction, resolution recovery and Monte Carlo simulation of scatter was used for simultaneous reconstruction of dual tracer distribution. For clinical evaluation, patient studies were compared to stress {sup 99m}Tc and rest {sup 99m}Tc reference images acquired in a 2-day protocol. Clinical follow-up examinations like coronary angiography (CAG) and fractional flow reserve (FFR) were included in the assessment if available. Phantom studies demonstrated the technical feasibility of SDI. Artificial lesions inserted in the phantom mimicking ischaemia could be clearly identified. In 51/53 patients, the image quality was adequate for clinical evaluation. For the remaining two obese patients with body mass index > 32 the injected {sup 201}Tl dose of 74 MBq was insufficient for clinical assessment. In answer to this the {sup 201}Tl dose was adapted for obese patients in the rest of the study. In 31 patients, SDI and {sup 99m}Tc reference images resulted in equivalent clinical assessment. Significant differences were found in 20 patients. In 18 of these 20 patients additional examinations were available. In 15 patients the diagnosis based on the SDI images was confirmed by the results of CAG or FFR. In these patients the SDI images were more accurate than the {sup 99m}Tc reference study. In three patients minor ischaemic lesions were detected by SDI but were not confirmed by CAG. In one of these cases this was probably caused by pronounced apical thinning. For two patients

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

Directory of Open Access Journals (Sweden)

Hatz Rudolf

2010-05-01

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

Cost effectiveness of a protocol using palivizumab in preterm infants

Directory of Open Access Journals (Sweden)

Yolanda Hernández-Gago

2017-03-01

Full Text Available Objective: The main objective was to evaluate the cost-effectiveness of protocol use of palivizumab in premature established by consensus in our Hospital comparing it based on the recommendations of various Scientific Societies. As a secondary objective risk factors and severity of hospitalized patients attending the established protocol in our Hospital were analyzed. Methods: The study period was 4 seasons with the expanded protocol (retrospective data versus 2 with restricted or agreed protocol (prospective data. The perspective of the study was the Health System, including the costs of hospitalization and palivizumab our center. The calculation of the effectiveness was determined with the admission rate of premature patients stratified by weeks of gestational age <29, <32; and <35. For the analysis of risk factors and severity in patients admitted seasons with the new protocol are collected prospectively clinical data and environmental and social factors. Results: In the range of gestational age <29 years old and <32 greater effectiveness of the extended protocol was not demonstrated against the consensus. Only more effective for EG <35 in the accumulated data and comparing seasons 12/13 and 08/09 to 13/14 for individual data was observed. This range has an associated incremental cost effectiveness ratio of € 53 250,07 (range: € 14 793,39 to € 90 446,47 for singles data and € 50 525,53 (€ 28 688.22 to € 211 575,65 for accumulated. The establishment of this protocol in our center meant an average saving per season € 169 911,51. A cost- effectiveness of the extended protocol appropriate relationship is found if the cost of palivizumab per patient was less than € 1 206,67 (calculated for maximum use of the vial and a higher rate of hospitalization of 9.21%. Children entering the season with the new protocol (season 12/13 and 13/14 are 63.4% in children under 3 months and 90% are term infants who do not belong to any population at

An evidence based blunt trauma protocol

NARCIS (Netherlands)

Vugt, R. van; Kool, D.R.; Lubeek, S.F.K.; Dekker, H.M.; Brink, M.; Deunk, J.; Edwards, M.J.R.

2013-01-01

OBJECTIVE: Currently CT is rapidly implemented in the evaluation of trauma patients. In anticipation of a large international multicentre trial, this study's aim was to evaluate the clinical feasibility of a new diagnostic protocol, used for the primary radiological evaluation in adult blunt

The challenges of treating paraganglioma patients with {sup 177}Lu-DOTATATE PRRT: Catecholamine crises, tumor lysis syndrome and the need for modification of treatment protocols

Energy Technology Data Exchange (ETDEWEB)

Makis, William; Mccann, Karey; Mcewan, Alexander J. B. [Dept. of Diagnostic Imaging, Cross Cancer Institute, Alberta (China)

2015-09-15

A high percentage of paragangliomas express somatostatin receptors that can be utilized for targeted radioisotope therapy. The aim of this study was to describe and discuss the challenges of treating these tumors with {sup 177}Lu-[DOTA0,Tyr3]octreotate (DOTATATE) radioisotope therapy using established protocols. Three paraganglioma patients were treated with 4–5 cycles of {sup 177}Lu-DOTATATE and were evaluated for side effects and response to therapy. Two of the three patients developed severe adverse reactions following their first {sup 177}Lu-DOTATATE treatment. One patient developed a catecholamine crisis and tumor lysis syndrome within hours of treatment, requiring intensive care unit (ICU) support, and another developed a catecholamine crisis 3 days after treatment, requiring hospitalization. The treatment protocols at our institution were subsequently modified by increasing the radioisotope infusion time from 15 to 30 min, as recommended in the literature, to 2–4 h and by reducing the administered dose of {sup 177}Lu-DOTATATE. Subsequent {sup 177}Lu-DOTATATE treatments utilizing the modified protocols were well tolerated, and response to therapy was achieved in all three patients, resulting in significantly improved quality of life. {sup 177}Lu-DOTATATE is an exciting new therapeutic option in the management of paragangliomas; however, current treatment protocols described in the literature may need to be modified by lengthening the infusion time and/or lowering the initial treatment dose to prevent or reduce the severity of adverse reactions.

Protocol of study and pursuit of the radioinduced burns

International Nuclear Information System (INIS)

Portas, Mercedes; Glustein, Daniel; Pomerane, Armando; Peragallo, Mabel; Guzman, Alejandra; Ciordia, Irma; Genovese, Jorge; Cymberknoh, Manuel; Dubner, Diana; Michelin, Severino; Perez, Maria del Rosario; Trano, Jose Luis Di; Gisone, Pablo

2001-01-01

A study of localized overexposures based on local experience and international criteria is being carried out within the framework of a cooperation agreement between the Buenos Aires Burned Hospital and the Nuclear Regulatory Authority. This protocol was designed considering separately acute and chronic reactions, including the following aspects: patient reception: clinical findings, laboratory tests, photographic recording, and multidisciplinary evaluation; dose reconstruction: evaluation of the dose distribution by biophysical and biological procedures; extension and depth estimation: telethermography, computed tomography, magnetic resonance, radioisotopic procedures, capillaroscopy and percutaneous oxymetry; therapeutic strategies: pain treatment, prevention of infections, systemic administration of pentoxiphyllin and alpha-tocopherol, local application of trolamine and antioxidants, prevention and treatment of radioinduced fibrosis. When it is indicated, surgical treatment includes partial or total excision followed by covering by graft or flap. The application of tissue-engineering techniques will be considered. Study of individual radiosensitivity: evaluation of apoptosis in peripheral lymphocytes and clonogenic assays in dermal fibroblasts 'in vitro' irradiated. (author)

Current understanding of treatment and management protocol for adult diabetic in-patients at a tertiary care hospital

International Nuclear Information System (INIS)

Waki, N.; Memon, A.; Khan, M.O.; Masood, S.; Rouf, M.; Mirza, R.

2012-01-01

Objective: To assess the current understanding of treatment and management protocols for adult diabetic in-patients at a tertiary care hospital. Methods: This cross-sectional study, conducted at the Civil Hospital Karachi from July to September 2009, involved 450 participants, who were interviewed through a well-structured questionnaire regarding the patient's demography, clinical features, past medical history, type of diabetes mellitus, duration, associated complications, and also involved patient notes for laboratory tests and management. SPSSv15.0 was used for descriptive analysis. Results: The study population of 450 diabetics had 144 (32%) males and 306 (68%) females. Of the total, 435 (96.7%) patients had type 2 diabetes. There were 231 (51%) patients using insulin, 168 (37.3%) oral hypoglycaemic drugs, and 51 (11.3%) using both. Among patients using insulin, regular insulin usage stood at 30% followed by a combination of regular insulin and NPH (26.7%) and NPH alone at 6%. The most popular drug used was metformin (27.3%) and the least used drug was glitazones (4%). In the study population, 73.3% patients controlled their diabetes with diet, and 24.7% with regular exercise. Conclusion: Majority of the study population had type 2 diabetes with a female preponderance. Insulin was prescribed for half the patients. Metformin was the most frequently used oral hypoglycaemic drug. (author)

Artery-only fingertip replantations using a controlled nailbed bleeding protocol.

Science.gov (United States)

Erken, H Yener; Takka, Semih; Akmaz, Ibrahim

2013-11-01

We report our experience, treatment protocol, and 2-year follow-up results of 24 fingertip replantations treated using the artery-only technique without vein or nerve repair. We performed a retrospective review of 24 patients who had undergone fingertip replantation at the same center between 2005 and 2011. All patients in this study had complete fingertip amputation at or distal to the distal interphalangeal joint of the fingers or interphalangeal joint of the thumb. Patients with incomplete and complete amputations who had undergone vein and/or nerve repair along with artery repair were excluded. All patients received the same protocol including removal of the nail at the surgery and intravenous heparin 70 U/kg administered at the time of arterial anastomosis. After surgery, the nailbed was mechanically made to bleed with a sterile needle and mechanically scrubbed with a heparin-saline gauze. All patients received the same postoperative medical treatment protocol until physiological outflow was restored. Successful replantation was confirmed with clinical observation. Twenty-one of the 24 fingertip replantations (88%) were successful. The mean length of hospital stay was 7 days (range, 4-9 d). Fifteen of 22 patients required blood transfusion. The average amount of blood transfusion was 1.2 U (range, 0-3 U). This study shows that the described technique and protocol reconstructed circulation without vein anastomosis and with a high success rate. Furthermore, adequate sensory recovery without any nerve repair had occurred by the 2-year follow-up. Therapeutic IV. Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Rush allergen specific immunotherapy protocol in feline atopic dermatitis: a pilot study of four cats.

Science.gov (United States)

Trimmer, Ann M; Griffin, Craig E; Boord, Mona J; Rosenkrantz, Wayne S

2005-10-01

Rush immunotherapy has been shown to be as safe as conventional immunotherapy in canine atopic patients. Rush immunotherapy has not been reported in the feline atopic patient. The purpose of this pilot study was to determine a safe protocol for rush immunotherapy in feline atopic patients. Four atopic cats diagnosed by history, physical examination and exclusion of appropriate differential diagnoses were included in the study. Allergens were identified via liquid phase immunoenzymatic testing (VARL: Veterinary Allergy Reference Labs, Pasadena, CA). Cats were premedicated with 1.5 mg triamcinolone orally 24 and 2 h prior to first injection and 10 mg hydroxyzine PO 24, 12 and 2 h prior to first injection. An intravenous catheter was placed prior to first injection. Allergen extracts (Greer Laboratories, Lenoir, North Carolina) were all administered subcutaneously at increasing protein nitrogen units (pnu) every 30 minutes for 5 h to maintenance dose of 15,000 pnus ml-1. Vital signs were assessed every 15 minutes. Two cats developed mild pruritus and the subsequent injection was delayed 30 minutes. No changes in either cat's vital signs were noted, nor was there any further pruritus. All four cats successfully completed rush immunotherapy. Two cats developed a dermal swelling on the dorsal neck one week later. In these four cats, this protocol appeared to be a safe regimen to reach maintenance therapy. A larger sample of feline patients is needed to determine the incidence of adverse reactions and to follow the success of ASIT based upon this method of induction.

Safety of a DVT chemoprophylaxis protocol following traumatic brain injury: a single center quality improvement initiative.

Science.gov (United States)

Nickele, Christopher M; Kamps, Timothy K; Medow, Joshua E