WorldWideScience

Sample records for trial patients offered

  1. Ethical acceptability of offering financial incentives for taking antipsychotic depot medication: Patients' and clinicians' perspectives after a 12-month randomized controlled trial

    NARCIS (Netherlands)

    E.L. Noordraven (Ernst); M.H.N. Schermer (Maartje); P. Blanken (Peter); C.L. Mulder (Niels); A.I. Wierdsma (André)

    2017-01-01

    textabstractBackground: A randomized controlled trial 'Money for Medication'(M4M) was conducted in which patients were offered financial incentives for taking antipsychotic depot medication. This study assessed the attitudes and ethical considerations of patients and clinicians who participated in

  2. New Therapies Offer Valuable Options for Patients with Melanoma

    Science.gov (United States)

    Two phase III clinical trials of new therapies for patients with metastatic melanoma presented in June at the 2011 ASCO conference confirmed that vemurafenib and ipilimumab (Yervoy™) offer valuable new options for the disease.

  3. Offers

    CERN Multimedia

    Staff Association

    2012-01-01

    L'Occitane en Provence proposes the following offer: 10 % discount on all products in all L'Occitane shops in Metropolitan France upon presentation of your Staff Association membership card and a valid ID. This offer is valid only for one person, is non-transferable and cannot be combined with other promotions.

  4. Offers

    CERN Multimedia

    Staff Association

    2011-01-01

    Special offers for our members       Go Sport in Val Thoiry is offering 15% discount on all purchases made in the shop upon presentation of the Staff Association membership card (excluding promotions, sale items and bargain corner, and excluding purchases using Go Sport  and Kadéos gift cards. Only one discount can be applied to each purchase).  

  5. Offer

    CERN Multimedia

    Staff Association

    2016-01-01

    CERN was selected and participated in the ranking "Best Employers" organized by the magazine Bilan. To thank CERN for its collaboration, the magazine offers a reduction to the subscription fee for all employed members of personnel. 25% off the annual subscription: CHF 149.25 instead of CHF 199 .— The subscription includes the magazine delivered to your home for a year, every other Wednesday, as well as special editions and access to the e-paper. To benefit from this offer, simply fill out the form provided for this purpose. To get the form, please contact the secretariat of the Staff Association (Staff.Association@cern.ch).

  6. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

    New offers : Discover the theater Galpon in Geneva. The Staff Association is happy to offer to its members a discount of 8.00 CHF on a full-price ticket (tickets of 15.00 CHF instead of 22.00 CHF) so do not hesitate anymore (mandatory reservation by phone + 4122 321  21 76 as tickets are quickly sold out!). For further information, please see our website: http://staff-association.web.cern.ch/fr/content/th%C3%A9%C3%A2tre-du-galpon  

  7. Offers

    CERN Multimedia

    Association du personnel

    2013-01-01

    SPECIAL OFFER FOR OUR MEMBERS Prices Spring and Summer 2013 Day ticket: same price weekends, public holidays and weekdays: – Children from 5 to 15 years old: 30 CHF instead of 39 CHF – Adults from 16 years old: 36 CHF instead of 49 CHF – Bonus! Free for children under 5 Tickets available at the Staff Association Secretariat.

  8. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    SPECIAL OFFER FOR OUR MEMBERS Prices Spring and Summer 2013 Day ticket: same price weekends, public holidays and weekdays: Children from 5 to 15 years old: 30 CHF instead of 39 CHF Adults from 16 years old: 36 CHF instead of 49 CHF Bonus! Free for children under 5 Tickets available at the Staff Association Secretariat.

  9. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    The theater season will start again, so do not hesitate to benefit from our discount: Théâtre de Carouge : Discount for all shows and on various season tickets. La Comédie : reduction on various tickets, on annual subscriptions and on discounted card. For further information, see our website: http://staff-association.web.cern.ch/sociocultural/offers

  10. Offers

    CERN Multimedia

    Staff Association

    2015-01-01

    New offer for our members. The Staff Association CERN staff has recently concluded a framework agreement with AXA Insurance Ltd, General-Guisan-Strasse 40, 8401 Winterthur. This contract allows you to benefit from a preferential tariff and conditions for insurances: Motor vehicles for passenger cars and motorcycles of the product line STRADA: 10% discount Household insurance (personal liability and household contents) the product line BOX: 10% discount Travel insurance: 10% discount Buildings: 10% discount Legal protection: 10% discount AXA is number one on the Swiss insurance market. The product range encompasses all non-life insurance such as insurance of persons, property, civil liability, vehicles, credit and travel as well as innovative and comprehensive solutions in the field of occupational benefits insurance for individuals and businesses. Finally, the affiliate AXA-ARAG (legal expenses insurance) completes the offer. Armed with your staff association CERN card, you can always get the off...

  11. Offers

    CERN Document Server

    Staff Association

    2012-01-01

    proposes the following offer: 15% discount for the Staff Association members who enroll their children in summer FUTUREKIDS activities. Extracurricular Activities For Your Children The FUTUREKIDS Geneva Learning Center is open 6 days a week and offers a selection of after-school extracurricular activities for children and teenagers (ages 5 to 16). In addition to teaching in its Learning Centers, Futurekids collaborates with many private schools in Suisse Romande (Florimont, Moser, Champittet, Ecole Nouvelle, etc.) and with the Département de l'Instruction Publique (DIP) Genève. Courses and camps are usually in French but English groups can be set up on demand. FUTUREKIDS Computer Camps (during school holidays) FUTUREKIDS Computer Camps are a way of having a great time during vacations while learning something useful, possibly discovering a new hobby or even, why not, a future profession. Our computer camps are at the forefront of technology. Themes are diverse and suit all ...

  12. Offers

    CERN Multimedia

    Staff Association

    2012-01-01

    SPECIAL OFFER FOR OUR MEMBERS Single tariff Adulte/Enfant Tickets “Zone terrestre” 20 euros instead of 25 euros. Access to Aqualibi: 5 euros instead of 8 euros on presentation of your ticket SA member. Free for children under 3, with limited access to the attractions. More information on our website : http://association.web.cern.ch/association/en/OtherActivities/Walibi.html

  13. Offer

    CERN Multimedia

    Staff Association

    2011-01-01

      Special offer for members of the Staff Association and their families 10% reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20% reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * Next “vente privée” from 25th to 27th March 2011  

  14. Offer

    CERN Multimedia

    Staff Association

    2010-01-01

      Special offer for members of the Staff Association and their families 10% reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20% reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * Next “vente privée” from 22th to 29th November 2010

  15. Offers

    CERN Multimedia

    Staff Association

    2012-01-01

    SPECIAL OFFER FOR OUR MEMBERS Prices Spring and Summer 2012 Half-day ticket: 5 hours, same price weekends, public holidays and weekdays. Children from 5 to 15 years old: 26 CHF instead of 35 CHF Adults from 16 years old: 32 CHF instead of 43 CHF Bonus! Free for children under 5. Aquaparc Les Caraïbes sur Léman 1807 Le Bouveret (VS)

  16. Offer

    CERN Multimedia

    CARLSON WAGONLIT TRAVEL

    2011-01-01

    Special offer   From 14th to 28th February 2011: no CWT service fee! For any new reservation of a holiday package (flight + hotel/apartment) from a catalog “summer 2011” For any additional information our staff is at your disposal from Monday – Friday, from 8h30 to 16h30. Phone number 72763 or 72797 Carlson Wagonlit Tavel, Agence du CERN  

  17. Offers

    CERN Multimedia

    Staff Association

    2011-01-01

    Banque cantonale de Genève (BCGE) The BCGE Business partner programme devised for members of the CERN Staff Association offers personalized banking solutions with preferential conditions. The advantages are linked to salary accounts (free account keeping, internet banking, free Maestro and credit cards, etc.), mortgage lending, retirement planning, investment, credit, etc. The details of the programme and the preferential conditions are available on our website: http://association.web.cern.ch/association/en/OtherActivities/BCGE.html.  

  18. Offers

    CERN Multimedia

    Staff Association

    2012-01-01

    Special offer for members of the Staff Association and their families 10 % reduction on all products in the Sephora shop (sells perfume, beauty products etc.) in Val Thoiry all year round. Plus 20 % reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * next “vente privée” from 21st November to 1st December 2012 Please contact the Staff Association Secretariat to get the discount voucher.

  19. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

    Special offer for members of the Staff Association and their families 10 % reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Simply present your Staff Association membership card when you make your purchase. Plus 20 % reduction during their “vente privée”* three or four times a year. * Next “vente privée” from 24th September to 6th November 2014 Please contact the Staff Association Secretariat to get the discount voucher.  

  20. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    The « Théâtre de Carouge » offers a 5.- CHF discount for all shows (30.- CHF instead of 35.- CHF) and for the season tickets "Premières représentations" (132.- CHF instead of 162.- CHF) and "Classique" (150.- CHF instead of 180.- CHF). Please send your reservation by email to smills@tcag.ch via your professional email address. Please indicate the date of your reservation, your name and firstname and your telephone number A confirmation will be sent by email. Your membership card will be asked when you collect the tickets. More information on www.tcag.ch and www.tcag.ch/blog/

  1. Offers

    CERN Document Server

    Staff Association

    2012-01-01

    Special offer for members of the Staff Association and their families 10% reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20% reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * Next “vente privée” from 21st to 26th May 2012 Please contact the Staff Association Secretariat to get the discount voucher  

  2. Offers

    CERN Document Server

    Staff Association

    2013-01-01

    Special offer for members of the Staff Association and their families 10 % reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20 % reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * Next “vente privée” from 11th to 23rd November 2013 Please contact the Staff Association Secretariat to get the discount voucher.  

  3. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

    Passeport Gourmand   Are you dying for a nice meal? The “Passeport Gourmand” offers discounted prices to the members of the Staff Association (available until April 2015 and on sale in the Staff Association Secretariat): Passeport gourmand Ain / Savoie/ Haute Savoie: 56 CHF instead of 79 CHF. Passeport gourmand Geneva / neighbouring France:72 CHF instead of 95 CHF. To the members of the Staff Association: Benefit of reduced tickets: CHF 10 (instead of  18 CHF at the desk) on sale to the secretariat of the Staff Association, Building 510-R010 (in front of the Printshop).

  4. Offers

    CERN Multimedia

    Staff Association

    2015-01-01

    New season 2015-2016 The new season was revealed in May, and was warmly welcomed by the press, which is especially enthusiastic about the exceptional arrival of Fanny Ardand in September in the framework of Cassandre show. Discover the programme 2015-2016. The theatre La Comédie proposes different offers to our members Benefit from a reduction of 20 % on a full price ticket during all the season: from 38 CHF to 23 CHF ticket instead of 50 CHF to 30 CHF depending on the show. Buy two seasonal tickets at the price of one (offers valid upon availability, and until 30 september 2015) 2 Cards Libertà for 240 CHF instead of 480 CHF. Cruise freely through the season with 8 perfomances of your choice per season. These cards are transferrable, and can be shared with one or more accompanying persons. 2 Abo Piccolo for 120 CHF instead of 240 CHF. Let yourself be surprised a theatre performance with our discovery seasonal tickets, which includes 4 flagship perfomances for the season. ...

  5. Offer

    CERN Multimedia

    Staff Association

    2015-01-01

    RRP Communication organizes cultural events such as concerts, shows, sporting events. The members of the Staff Association profits from a reduction of 10 CHF per ticket. How to proceed: The ticket reservation is made by mail info@rrp.ch. You need to give the following information: Name of the show, and which date chosen Number of tickets, and category Name and surname Address Telephone number Mention “offer CERN”, and attach a photocopy of your Staff Association member card. After your reservation, you will be sent a copy with a payslip to the address mentioned above. Once paid, the members have the possibility to: pick up their ticket(s) from the cash register the evening of the show (opens 1 hour before the show) by showing their member card; receive the ticket(s) to the address indicated above, by registered mail, subject to an extra cost of 10CHF. Next show : More information at http://www.rrp.ch/

  6. Offers

    CERN Multimedia

    Staff Association

    2011-01-01

    At the UN Cultural kiosk (door C6) This offer is meant for international civil servants, members of diplomatic missions as well as official delegates under presentation of their accreditation card. Matthew Lee & 5 musiciens Du Blues, du Boogie, du Rock’n’Roll 28 octobre 2011 à 20h30 Théâtre du Léman Quai du Mont-Blanc 19 Hôtel Kempinski Genève Matthew Lee is an exciting pianist singer combining classic Rock’n’Roll with timeless ballads. He revisits the standards, being alternately Jerry Lee Lewis, Chuck Berry, Little Richards and many others... He is a showman with a soulful voice and displays virtuosity during his piano solos. Simply amazing! 20 % reduction Tickets from 32 to 68 CHF Kiosque Culturel ONU Palais des Nations Porte 6 Avenue de la Paix 8-14 1211 Genève 10 Tél. 022 917 11 11 info@kiosqueonu.ch

  7. Offer

    CERN Multimedia

    Staff Association

    2011-01-01

    DETAILS OF THE AGREEMENT WITH BCGE The BCGE Business partner programme devised for members of the CERN Staff Association offers personalized banking solutions with preferential conditions. The advantages are linked to salary accounts (free account keeping, internet banking, free Maestro and credit cards, etc.), mortgage lending, retirement planning, investment, credit, etc. The details of the programme and the preferential conditions are available on the Staff Association web site and from the secretariat (http://cern.ch/association/en/OtherActivities/BCGE.html). To benefit from these advantages, you will need to fill in the form available on our site, which must then be stamped by the Staff Association as proof that you are a paid-up member.  

  8. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    Do not hesitate to benefit of our offers in our partners: Théâtre de Carouge Discount of 5 CHF for all shows (30 CHF instead of 35 CHF) and on season tickets « first performance » ( 132 CHF instead 162 CHF) and also on « classical » ( 150 CHF instead of 180 CHF) upon presentation of your Staff Association membership card before payment. Théâtre La Comédie de Genève  20% off on tickets (full price – also available for partner): from 24 to 32 CHF a ticket instead of 30 to 40 CHF depending on the shows. 40% off on annual subscriptions (access to the best seats, pick up tickets at the last minute): 200 CHF for 9 shows (about 22 CHF a ticket instead of 30 to 40 CHF. Discounted card: 60 CHF and single price ticket of 16 CHF.

  9. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    FUTUREKIDS proposes 15% discount for the Staff Association members who enroll their children in FUTUREKIDS activities. New workshop for 12-15 year olds, on how to develop applications for Android phones. Easter activities calendar Extracurricular Activities For Your Children The FUTUREKIDS Geneva Learning Center is open 6 days a week and offers a selection of after-school extracurricular activities for children and teenagers (ages 5 to 16). In addition to teaching in its Learning Centers, Futurekids collaborates with many private schools in Suisse Romande (Florimont, Moser, Champittet, Ecole Nouvelle, etc.) and with the Département de l'Instruction Publique (DIP) Genève. Courses and camps are usually in French but English groups can be set up on demand. FUTUREKIDS Computer Camps (during school holidays) FUTUREKIDS Computer Camps are a way of having a great time during vacations while learning something useful, possibly discovering a new hobby or even, why not, a fut...

  10. Offers

    CERN Document Server

    Staff Association

    2011-01-01

    Special offer for members of the Staff Association and their families 10% reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20% reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * Next “vente privée” from 21st to 26th November 2011 New BCGE Business partner benefits As you may remember thanks to our BCGE business partner agreement you benefit from various advantages such as free annual subscription on your Silver or Gold credit card both for yourself and your partner (joint account). Please be informed that as of October 1st  2011 the below mentioned features will be added to your annual credit card subscription : MasterCard/Visa Silver and Gold: travel cancellation as well as related services such as holiday interruption best guaranteed price Only for Ma...

  11. Offer

    CERN Multimedia

    Staff Association

    2016-01-01

    The “La Comédie” theatre unveiled its programme for the season 2016–2017 in late May, and it was met with great enthusiasm by the press. Leading names of the European and Swiss theatre scenes, such as director Joël Pommerat who recently won four Molière awards, will make an appearance! We are delighted to share this brand new, rich and varied programme with you. The “La Comédie” theatre has various discounts for our members Buy 2 subscriptions for the price of 1 : 2 cards “Libertà” for CHF 240.- instead of CHF 480.- Cruise freely through the season with an 8-entry card valid for the shows of your choice. These cards are transferable and can be shared with one or more accompanying persons. 2 cards “Piccolo” for CHF 120 instead of CHF 240.- This card lets you discover 4 shows which are suitable for all audiences (offers valid while stock lasts and until October 31, 20...

  12. Resource utilisation and direct costs in patients with recently diagnosed fibromyalgia who are offered one of three different interventions in a randomised pragmatic trial

    NARCIS (Netherlands)

    van Eijk-Hustings, Yvonne; Kroese, Mariëlle; Creemers, An; Landewé, Robert; Boonen, Annelies

    2016-01-01

    The purpose of this study is to understand the course of costs over a 2-year period in a cohort of recently diagnosed fibromyalgia (FM) patients receiving different treatment strategies. Following the diagnosis, patients were randomly assigned to a multidisciplinary programme (MD), aerobic exercise

  13. Strategies of persuasion in offers to participate in cancer clinical trials I: Topic placement and topic framing.

    Science.gov (United States)

    Barton, Ellen; Eggly, Susan; Winckles, Andrew; Albrecht, Terrance L

    2014-01-01

    Clinical trials are the gold standard in medical research evaluating new treatments in cancer care; however, in the United States, too few patients enroll in trials, especially patients from minority groups. Offering patients the option of a clinical trial is an ethically-charged communicative event for oncologists. One particularly vexed ethical issue is the use of persuasion in trial offers. Based on a corpus of 22 oncology encounters with Caucasian-American (n = 11) and African-American (n = 11) patients, this discourse analysis describes oncologists' use of two persuasive strategies related to the linguistic structure of trial offers: topic placement and topic framing. Findings are presented in total and by patient race, and discussed in terms of whether these strategies may constitute ethical or unethical persuasion, particularly with respect to the ethical issue of undue influence and the social issue of underrepresentation of minorities in cancer clinical trials.

  14. Why do patients decline participation in offered pulmonary rehabilitation?

    DEFF Research Database (Denmark)

    Mathar, Helle; Fastholm, Pernille; Lange, Peter

    2017-01-01

    pulmonary rehabilitation. Each category was named using a content characteristic word. Results: This study shows that some patients do not remember or recall that they have been offered pulmonary rehabilitation during hospitalization. Especially the oldest patients perceive themselves to be too frail from...

  15. Offering memorable patient experience through creative, dynamic marketing strategy.

    Science.gov (United States)

    Purcărea, Victor Lorín; Raţíu, Monica; Purcărea, Theodor; Davila, Carol

    2008-01-01

    Creative, dynamic strategies are the ones that identify new and better ways of uniquely offering the target customers what they want or need. A business can achieve competitive advantage if it chooses a marketing strategy that sets the business apart from anyone else. Healthcare services companies have to understand that the customer should be placed in the centre of all specific marketing operations. The brand message should reflect the focus on the patient. Healthcare products and services offered must represent exactly the solutions that customers expect. The touchpoints with the patients must be well mastered in order to convince them to accept the proposed solutions. Healthcare service providers must be capable to look beyond customer's behaviour or product and healthcare service aquisition. This will demand proactive and far-reaching changes, including focusing specifically on customer preference, quality, and technological interfaces; rewiring strategy to find new value from existing and unfamiliar sources: disintegrating and radically reassembling operational processes: and restructuring the organization to accommodate new types of work and skill.

  16. Offering memorable patient experience through creative, dynamic marketing strategy

    Science.gov (United States)

    Raţiu, M; Purcărea, T

    2008-01-01

    Creative, dynamic strategies are the ones that identify new and better ways of uniquely offering the target customers what they want or need. A business can achieve competitive advantage if it chooses a marketing strategy that sets the business apart from anyone else. Healthcare services companies have to understand that the customer should be placed in the centre of all specific marketing operations. The brand message should reflect the focus on the patient. Healthcare products and services offered must represent exactly the solutions that customers expect. The touchpoints with the patients must be well mastered in order to convince them to accept the proposed solutions. Healthcare service providers must be capable to look beyond customer's behaviour or product and healthcare service aquisition. This will demand proactive and far–reaching changes, including focusing specifically on customer preference, quality, and technological interfaces; rewiring strategy to find new value from existing and unfamiliar sources; disintegrating and radically reassembling operational processes; and restructuring the organization to accommodate new typess of work and skill. PMID:20108466

  17. The Benefits of Segmentation in Trial-Offer Markets with Social Influence and Position Bias

    OpenAIRE

    Berbeglia, Franco; Berbeglia, Gerardo; Van Hentenryck, Pascal

    2015-01-01

    The purchasing behaviour of consumers is often influenced by numerous factors, including the visibility of the products and the influence of other customers through their own purchases or their recommendations. Motivated by trial-offer and freemium markets and a number of online markets for cultural products, leisure services, and retail, this paper studies the dynamics of a marketplace ran by a single firm and which is visited by heterogeneous consumers whose choice preferences can be modele...

  18. We Offer Renal Replacement Therapy to Patients Who Are Not Benefitted by It.

    Science.gov (United States)

    Holley, Jean L

    2016-07-01

    Nephrologists offer renal replacement therapy (RRT) to patients who are unlikely to benefit in part because of our discomfort discussing goals of care in the setting of an uncertain prognosis for a given individual. Permanent neurological impairment, terminal illness (life expectancy <6 months), medical conditions precluding the safe delivery of dialysis, elderly patients with poor prognosis, and those who begin "early" RRT are categories of patients for whom dialysis may not be beneficial. Successful use of time-limited trials of dialysis may reduce the number of patients who are started on RRT without significant benefit. However, clear achievable milestones and goals need to be incorporated into plans for time-limited trials to ensure that continuing RRT beyond the trial period is appropriate. The lack of information on outcomes and symptom management using a "palliative approach" to dialysis suggests this should not be a clinical option until additional study is done and efficacy data available. Clinical practice guidelines are available to assist nephrologists in the appropriate withholding of RRT. © 2016 Wiley Periodicals, Inc.

  19. Offering Patients Therapy Options in Unplanned Start (OPTiONS)

    DEFF Research Database (Denmark)

    Machowska, Anna; Alscher, Mark Dominik; Vanga, Satyanarayana Reddy

    2017-01-01

    Background: Patients with unplanned dialysis start (UPS) have worse clinical outcomes than non-UPS patients, and receive peritoneal dialysis (PD) less frequently. In the OPTiONS study of UPS patients, an educational programme (UPS-EP) aiming at improving care of UPS patients by facilitating care...... and outcomes within 12 months of follow up were analysed. Results: Among 270 UPS patients who had an unplanned start to dialysis, 214 were able to receive and 203 complete UPS-EP while 56 patients - who were older (p = 0.01) and had higher Charlson comorbidity index (CCI; p

  20. Clinical Trials Offer a Path to Better Care for AYAs with Cancer

    Science.gov (United States)

    The slow progress against adolescent and young adult cancers is due, in part, to this populations lack of participation in clinical trials. Researchers are testing innovative ways to enroll more AYAs in clinical trials—using expanded access, patient navigation, community outreach, and collaborations between academic and community doctors.

  1. Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

    Science.gov (United States)

    Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C

    2018-03-23

    US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60

  2. What can virtual patient simulation offer mental health nursing education?

    Science.gov (United States)

    Guise, V; Chambers, M; Välimäki, M

    2012-06-01

    This paper discusses the use of simulation in nursing education and training, including potential benefits and barriers associated with its use. In particular, it addresses the hitherto scant application of diverse simulation devices and dedicated simulation scenarios in psychiatric and mental health nursing. It goes on to describe a low-cost, narrative-based virtual patient simulation technique which has the potential for wide application within health and social care education. An example of the implementation of this technology in a web-based pilot course for acute mental health nurses is given. This particular virtual patient technique is a simulation type ideally suited to promoting essential mental health nursing skills such as critical thinking, communication and decision making. Furthermore, it is argued that it is particularly amenable to e-learning and blended learning environments, as well as being an apt tool where multilingual simulations are required. The continued development, implementation and evaluation of narrative virtual patient simulations across a variety of health and social care programmes would help ascertain their success as an educational tool. © 2011 Blackwell Publishing.

  3. Why might clinicians in Malawi not offer HIV testing to their patients ...

    African Journals Online (AJOL)

    In order to identify reasons clinicians in Malawi might not offer HIV testing to patients, a cross-sectional descriptive postal census with telephone and fax follow-up was conducted. Proportions were calculated for each reason given for not offering HIV testing. Multiple logistic regression was used to determine whether ...

  4. Total hip arthroplasty: what information do we offer patients on websites of hospitals?

    NARCIS (Netherlands)

    Brunnekreef, J.J.; Schreurs, B.W.

    2011-01-01

    BACKGROUND: Physicians face a new challenge; the self-educated patient. The internet is an important source that patients use to become self-educated. However, the individual choice for best treatment is difficult. The aim of this study was to investigate what kind of information is offered to total

  5. Patient satisfaction with the dental services offered by a dental Hospital in India

    Directory of Open Access Journals (Sweden)

    N Nagappan

    2014-01-01

    Full Text Available Introduction: A major component of quality of health care is patient satisfaction. Patient satisfaction is multifaceted and a very challenging outcome to define. Patient expectations of care and attitudes greatly contribute to the satisfaction; other psychosocial factors, including facilities and treatments services are also known to contribute to patient satisfaction scores. Aim: To measure patient satisfaction about facilities, services and treatments offered by a dental hospital in India. Materials and Methods: Self administrated questionnaire was distributed to outpatients reporting to the dental hospital for treatment. The questionnaire consisted of 30 items that included information about personal data of the patients and their satisfaction with the facilities, services and treatment received in the hospital. Results: About 89.9% of patients felt that the cost of dental hygiene services were reasonable, 57.6% of patients felt that drinking water facilities were enough in the hospital, 31.9% of patients felt that they have problem with scheduling appointments, 86% of patients felt that they had problem in contacting student dentist. Conclusion: The majority of the patients were satisfied with the facilities, services and treatment received at hospital except for facilities such as water supply and scheduling appointments with patient convenience.

  6. The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Brenner Alison RT

    2008-01-01

    Full Text Available Abstract Background Decision aids can improve decision making processes, but the amount and type of information that they should attempt to communicate is controversial. We sought to compare, in a pilot randomized trial, two colorectal cancer (CRC screening decision aids that differed in the number of screening options presented. Methods Adults ages 48–75 not currently up to date with screening were recruited from the community and randomized to view one of two versions of our previously tested CRC screening decision aid. The first version included five screening options: fecal occult blood test (FOBT, sigmoidoscopy, a combination of FOBT and sigmoidoscopy, colonoscopy, and barium enema. The second discussed only the two most frequently selected screening options, FOBT and colonoscopy. Main outcomes were differences in screening interest and test preferences between groups after decision aid viewing. Patient test preference was elicited first without any associated out-of-pocket costs (OPC, and then with the following costs: FOBT-$10, sigmoidoscopy-$50, barium enema-$50, and colonoscopy-$200. Results 62 adults participated: 25 viewed the 5-option decision aid, and 37 viewed the 2-option version. Mean age was 54 (range 48–72, 58% were women, 71% were White, 24% African-American; 58% had completed at least a 4-year college degree. Comparing participants that viewed the 5-option version with participants who viewed the 2-option version, there were no differences in screening interest after viewing (1.8 vs. 1.9, t-test p = 0.76. Those viewing the 2-option version were somewhat more likely to choose colonoscopy than those viewing the 5-option version when no out of pocket costs were assumed (68% vs. 46%, p = 0.11, but not when such costs were imposed (41% vs. 42%, p = 1.00. Conclusion The number of screening options available does not appear to have a large effect on interest in colorectal cancer screening. The effect of offering differing

  7. Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

    Science.gov (United States)

    Kelvin, Elizabeth A; George, Gavin; Mwai, Eva; Nyaga, Eston; Mantell, Joanne E; Romo, Matthew L; Odhiambo, Jacob O; Starbuck, Lila; Govender, Kaymarlin

    2018-01-01

    We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

  8. Impact on informed choice of offering antenatal sickle cell and thalassaemia screening in primary care: a randomized trial

    Science.gov (United States)

    Brown, Katrina; Dormandy, Elizabeth; Reid, Erin; Gulliford, Martin; Marteau, Theresa

    2011-01-01

    Objectives Offering antenatal sickle cell and thalassaemia (SCT) screening early in pregnancy can maximize the range of post-screening choices available, however these benefits should not be obtained at the expense of informed choice.  This study examined whether offering this screening in primary care at the time of pregnancy confirmation compromises women making informed choices. Design Partial factorial, cluster randomized controlled trial. Setting 25 general practices in two socially deprived UK areas. Participants 464 pregnant women offered antenatal SCT screening. Intervention Practices were randomly allocated to offer pregnant women screening:  i) in primary care at time of pregnancy confirmation, with parallel partner testing (n = 191), ii) in primary care at time of pregnancy confirmation, with sequential partner testing (n = 158), or iii) in secondary care by midwives, with sequential partner testing (standard care, n = 115). Main outcome Informed choice – a classification based on attitudes, knowledge and test uptake. Results 91% of woman underwent screening. About a third (30.6%) made an informed choice to accept or decline screening: 34% in primary care parallel group; 23.4% in primary care sequential and 34.8% in secondary care sequential. Allowing for adjustments, rates of informed choice did not vary by intervention group: secondary care versus primary care with parallel partner testing OR 1.07 (95% CI 0.56 to 2.02); secondary care versus primary care with sequential partner testing OR 0.67 (95% CI 0.36 to 1.25).  Uninformed choices were generally attributable to poor knowledge (65%). Conclusion Offering antenatal SCT screening in primary care did not reduce the likelihood that women made informed choices. Rates of informed choice were low and could be increased by improving knowledge. PMID:21852698

  9. Are Comic Books Appropriate Health Education Formats to Offer Adult Patients?

    Science.gov (United States)

    Ashwal, Gary; Thomas, Alex

    2018-02-01

    Physicians who recommend patient education comics should consider that some patients might question the appropriateness of this format, especially in the US, where a dominant cultural view of comics is that they are juvenile and intended to be funny. In this case, Dr. S might have approached communication with Mrs. T differently, even without knowing her attitude toward comics as a format for delivering health information. Dr. S could acknowledge that though some people might not expect useful medical information in a comic format, it has unique aspects and new research on patient education comics shows that even adults are finding this medium to be effective, educational, and engaging. Offering comics to patients, however, does potentially require patient educators to invest additional time to review and assess their accuracy and relevance. © 2018 American Medical Association. All Rights Reserved.

  10. Active offer of vaccinations during hospitalization improves coverage among splenectomized patients: An Italian experience.

    Science.gov (United States)

    Gallone, Maria Serena; Martino, Carmen; Quarto, Michele; Tafuri, Silvio

    2017-08-01

    In 2014, an Italian hospital implemented a protocol for pneumococcal, meningococcal, and Haemophilus influenzae type b vaccines offer to splenectomized patients during their hospitalization. After 1 year, coverage for recommended vaccinations increased from 5.7%-66.7% and the average time between splenectomy and vaccines administration decreased from 84.7-7.5 days. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  11. Benefits and challenges perceived by patients with cancer when offered a nurse navigator

    Directory of Open Access Journals (Sweden)

    Marianne Kirstine Thygesen

    2011-10-01

    Full Text Available Introduction: Lack of communication, care and respect from healthcare professionals can be challenges for patients in trajectories of cancer, possibly accompanied by experienced fragmentation of the care, anxiety and worries. One way to try to improve delivery of care is additional help from Nurse Navigators (NN offered in a predefined shorter or longer period, but patients´ experiences with this have seldom been investigated. Aims: To explore patients´ experiences of an NN offered in a short period of a longer trajectory of cancer. Methods: NN worked from the hospital side in the transition between primary care and a university hospital before admission. A phenomenological-hermeneutical longitudinal study was performed from referral and until two months after discharge from the hospital. Semi-structured interviews provided data for the analysis, which started open-minded. Results:  Affectional bonds were made to NN and patients felt that they benefited from her presence and her help, which they requested until one month after discharge. They were deeply disappointed and felt rejected when the contact to the NN stopped. Conclusion: In efforts to increase quality of care for patients with cancer we recommend paying special attention to critical periods in their trajectories, as well as to the theory of attachment to supplement thoughts of continuity of care and coordination in the care for women. In short, it is fine to offer additional help to those who can use it, but in practice as well as in research we call attention to awareness on how and when to stop the help, to prevent patients from feeling hurt.

  12. The Ethics of Fertility Preservation for Paediatric Cancer Patients: From Offer to Rebuttable Presumption.

    Science.gov (United States)

    McDougall, Rosalind

    2015-11-01

    Given advances in the science of fertility preservation and the link between fertility choices and wellbeing, it is time to reframe our ethical thinking around fertility preservation procedures for children and young people with cancer. The current framing of fertility preservation as a possible offer may no longer be universally appropriate. There is an increasingly pressing need to discuss the ethics of failing to preserve fertility, particularly for patient groups for whom established techniques exist. I argue that the starting point for deliberating about a particular patient should be a rebuttable presumption that fertility preservation ought to be attempted. Consideration of the harms applicable to that specific patient may then override this presumption. I outline the benefits of attempting fertility preservation; these justify a presumption in favour of the treatment. I then discuss the potential harms associated with fertility preservation procedures, which may justify failing to attempt fertility preservation in an individual patient's particular case. Moving from a framework of offer to one of rebuttable presumption in favour of fertility preservation would have significant implications for medical practice, healthcare organizations and the state. © 2015 John Wiley & Sons Ltd.

  13. Longer term clinical and economic benefits of offering acupuncture care to patients with chronic low back pain.

    Science.gov (United States)

    Thomas, K J; MacPherson, H; Ratcliffe, J; Thorpe, L; Brazier, J; Campbell, M; Fitter, M; Roman, M; Walters, S; Nicholl, J P

    2005-08-01

    To test whether patients with persistent non-specific low back pain, when offered access to traditional acupuncture care alongside conventional primary care, gained more long-term relief from pain than those offered conventional care only, for equal or less cost. Safety and acceptability of acupuncture care to patients, and the heterogeneity of outcomes were also tested. A pragmatic, two parallel group, randomised controlled trial. Patients in the experimental arm were offered the option of referral to the acupuncture service comprising six acupuncturists. The control group received usual care from their general practitioner (GP). Eligible patients were randomised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested. Three non-NHS acupuncture clinics, with referrals from 39 GPs working in 16 practices in York, UK. Patients aged 18-65 years with non-specific low back pain of 4-52 weeks' duration, assessed as suitable for primary care management by their general practitioner. The trial protocol allowed up to ten individualised acupuncture treatments per patient. The acupuncturist determined the content and the number of treatments according to patient need. The Short Form 36 (SF-36) Bodily Pain dimension (range 0-100 points), assessed at baseline, and 3, 12 and 24 months. The study was powered to detect a 10-point difference between groups at 12 months post-randomisation. Cost--utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions (EQ-5D) and a preference-based single index measure derived from the SF-36 (SF-6D). Secondary outcomes included the McGill Present Pain Index (PPI), Oswestry Pain Disability Index (ODI), all other SF-36 dimensions, medication use, pain-free months in the past year, worry about back pain, satisfaction with care received, and safety and acceptability of acupuncture care. A total of 159 patients were in the 'acupuncture offer' arm and 80 in the 'usual care' arm. All 159 patients

  14. When and Why Should Mental Health Professionals Offer Traditional Psychodynamic Therapy to Cancer Patients?

    Science.gov (United States)

    Yuppa, David P; Meyer, Fremonta

    2017-05-01

    Given the recent studies promoting time-limited manualized therapies in the oncology setting, clinicians may be reluctant to offer traditional psychodynamic therapy to cancer patients. However, there are no studies directly comparing psychodynamic therapy and other therapy modalities in this patient population and no data suggesting harm from psychodynamic approaches. Therefore, it is inappropriate to draw the conclusion that psychodynamic therapy is inferior to manualized therapy from existing evidence. Manualized treatment, such as cognitive behavioral therapy, is generally short term and therefore may reduce the practitioner's own anxiety stemming from exposure to patients facing grave disability and death. However, manualized treatment is not fully effective in specific clinical scenarios. We present a case reflecting these limitations and advocate for a flexible treatment approach incorporating elements of psychodynamic therapy. © 2017 American Medical Association. All Rights Reserved.

  15. Factors associated with a clinician's offer of screening HIV-positive patients for sexually transmitted infections, including syphilis.

    Science.gov (United States)

    Heller, R; Fernando, I; MacDougall, M

    2011-06-01

    This retrospective study assessed whether Quality Improvement Scotland national standards for the sexual health care offered to HIV-positive individuals are being met by the Edinburgh genitourinary (GU) medicine clinic; specifically whether HIV-positive patients are offered: (a) sexually transmitted infection (STI) screening annually and (b) syphilis testing six-monthly. The study also reviewed what factors were associated with a clinician's offer of STI screening and syphilis testing. Of the 509 patients seen within the study period, case notes documented that 64% were offered STI screens, and 69% were offered syphilis testing, results consistent with audits of services elsewhere. Sexual orientation (P offer of STI screening, while gender (P offer of syphilis testing. Our results suggest that one explanation for clinicians failing to offer STI screens and syphilis serology testing is their (implicit) risk assessment that STI testing is not required in individual patients.

  16. Introducing high-cost health care to patients: dentists' accounts of offering dental implant treatment.

    Science.gov (United States)

    Vernazza, Christopher R; Rousseau, Nikki; Steele, Jimmy G; Ellis, Janice S; Thomason, John Mark; Eastham, Jane; Exley, Catherine

    2015-02-01

    The decision-making process within health care has been widely researched, with shared decision-making, where both patients and clinicians share technical and personal information, often being cited as the ideal model. To date, much of this research has focused on systems where patients receive their care and treatment free at the point of contact (either in government-funded schemes or in insurance-based schemes). Oral health care often involves patients making direct payments for their care and treatment, and less is known about how this payment affects the decision-making process. It is clear that patient characteristics influence decision-making, but previous evidence suggests that clinicians may assume characteristics rather than eliciting them directly. The aim was to explore the influences on how dentists' engaged in the decision-making process surrounding a high-cost item of health care, dental implant treatments (DITs). A qualitative study using semi-structured interviews was undertaken using a purposive sample of primary care dentists (n = 25). Thematic analysis was undertaken to reveal emerging key themes. There were differences in how dentists discussed and offered implants. Dentists made decisions about whether to offer implants based on business factors, professional and legal obligations and whether they perceived the patient to be motivated to have treatment and their ability to pay. There was evidence that assessment of these characteristics was often based on assumptions derived from elements such as the appearance of the patient, the state of the patient's mouth and demographic details. The data suggest that there is a conflict between three elements of acting as a healthcare professional: minimizing provision of unneeded treatment, trying to fully involve patients in shared decisions and acting as a business person with the potential for financial gain. It might be expected that in the context of a high-cost healthcare intervention for which

  17. Variation in examination and treatment offers to patients with allergic diseases in general practice

    DEFF Research Database (Denmark)

    Hansen, Dorte Gilså; Jarbøl, Dorte Ejg; Munck, Anders Peter

    2010-01-01

    disorders. SETTING: General practice in Denmark. RESULTS: In 2005, 895 (64.3%) of 1391 randomly selected general practitioners (GPs) participated in this survey. The extent of treatment offered and the involvement of staff were strongly associated with having a nurse on the practice team. Guideline...... recommendations for preparedness for anaphylactic shock in connection with allergy vaccine therapy were not fully implemented. CONCLUSION: General practice is substantially involved in the examination and treatment of patients with allergic diseases. There is room for further involvement of staff members...

  18. A scoping review and thematic classification of patient complexity: offering a unifying framework

    Directory of Open Access Journals (Sweden)

    Alexis K. Schaink

    2012-10-01

    Full Text Available The path to improving healthcare quality for individuals with complex health conditions is complicated by a lack of common understanding of complexity. Modern medicine, together with social and environmental factors, has extended life, leading to a growing population of patients with chronic conditions. In many cases, there are social and psychological factors that impact treatment, health outcomes, and quality of life. This is the face of complexity. Care challenges, burden, and cost have positioned complexity as an important health issue. Complex chronic conditions are now being discussed by clinicians, researchers, and policy-makers around such issues as quantification, payment schemes, transitions, management models, clinical practice, and improved patient experience. We conducted a scoping review of the literature for definitions and descriptions of complexity. We provide an overview of complex chronic conditions, and what is known about complexity, and describe variations in how it is understood. We developed a Complexity Framework from these findings to guide our approach to understanding patient complexity. It is critical to use common vernacular and conceptualization of complexity to improve service and outcomes for patients with complex chronic conditions. Many questions still persist about how to develop this work with a health and social care lens; our framework offers a foundation to structure thinking about complex patients. Further insight into patient complexity can inform treatment models and goals of care, and identify required services and barriers to the management of complexity.

  19. Mineral inadequacy of oral diets offered to patients in a Brazilian hospital.

    Science.gov (United States)

    Moreira, D C F; de Sá, J S M; Cerqueira, I B; Oliveira, A P F; Morgano, M A; Amaya-Farfan, J; Quintaes, K D

    2012-01-01

    While enteral diets for hospitalized patients normally follow nutrient composition guidelines, more than 90% of hospitalized patients receive oral diets with unknown mineral composition. To evaluate the mineral contents and adequacy of three types of oral diets (regular, blend and soft) and complementary snacks offered to patients of a Brazilian hospital. The amount of minerals was determined in two non-consecutive days in duplicate samples of breakfast, collation, lunch, snack, dinner, supper and a complementary snack meal. Dietary Reference Intakes (DRIs) were used to determine the adequacy of the daily amounts served to patients. The regular diet met the RDA (Recommended Dietary Allowances) requirements only for Mn, P and Se, while the blend diet was deficient in Ca, K and Mg, and the soft diet met RDA requirements only for P and Zn. Iron was below the RDA requirement in all diets for women in fertile age, and Na was above the safe limit of intake (UL) in all the diets. The use of complementary snack was effective in meeting RDA requirements for Cu in the regular diet, and Mn and Se in the soft diet, but promoted overconsumption of Na. Evident nutritional imbalances have been detected at a key interphase between nutrition and public health services, but a solution does not appear to be insurmountable. A permanent nutritional evaluation of hospital oral diets should be an integral part of routine health care in order to speed the recovery of the hospitalized patient and dispel eventual risks due to critical mineral imbalances.

  20. Patient narratives in Yelp reviews offer insight into opioid experiences and the challenges of pain management.

    Science.gov (United States)

    Graves, Rachel L; Goldshear, Jesse; Perrone, Jeanmarie; Ungar, Lyle; Klinger, Elissa; Meisel, Zachary F; Merchant, Raina M

    2018-03-01

    To characterize Yelp reviews about pain management and opioids. We manually coded and applied natural language processing to 836 Yelp reviews of US hospitals mentioning an opioid medication. Yelp reviews by patients and caregivers describing experiences with pain management and opioids had lower ratings compared with other reviews. Negative descriptions of pain management and opioid-related experiences were more commonly described than positive experiences, and the number of themes they reflected was more diverse. Yelp reviews offer insights into pain management and opioid use that are not assessed by traditional surveys. As a free, highly utilized source of unstructured narratives, Yelp may allow ongoing assessment of policies related to pain management and opioid use.

  1. Transient dynamics in trial-offer markets with social influence: Trade-offs between appeal and quality.

    Science.gov (United States)

    Altszyler, Edgar; Berbeglia, Franco; Berbeglia, Gerardo; Van Hentenryck, Pascal

    2017-01-01

    We study a trial-offer market where consumers may purchase one of two competing products. Consumer preferences are affected by the products quality, their appeal, and their popularity. While the asymptotic convergence or stationary states of these, and related dynamical systems, has been vastly studied, the literature regarding the transitory dynamics remains surprisingly sparse. To fill this gap, we derive a system of Ordinary Differential Equations, which is solved exactly to gain insight into the roles played by product qualities and appeals in the market behavior. We observe a logarithmic tradeoff between quality and appeal for medium and long-term marketing strategies: The expected market shares remain constant if a decrease in quality is followed by an exponential increase in the product appeal. However, for short time horizons, the trade-off is linear. Finally, we study the variability of the dynamics through Monte Carlo simulations and discover that low appeals may result in high levels of variability. The model results suggest effective marketing strategies for short and long time horizons and emphasize the significance of advertising early in the market life to increase sales and predictability.

  2. Transient dynamics in trial-offer markets with social influence: Trade-offs between appeal and quality

    Science.gov (United States)

    Altszyler, Edgar; Berbeglia, Franco; Van Hentenryck, Pascal

    2017-01-01

    We study a trial-offer market where consumers may purchase one of two competing products. Consumer preferences are affected by the products quality, their appeal, and their popularity. While the asymptotic convergence or stationary states of these, and related dynamical systems, has been vastly studied, the literature regarding the transitory dynamics remains surprisingly sparse. To fill this gap, we derive a system of Ordinary Differential Equations, which is solved exactly to gain insight into the roles played by product qualities and appeals in the market behavior. We observe a logarithmic tradeoff between quality and appeal for medium and long-term marketing strategies: The expected market shares remain constant if a decrease in quality is followed by an exponential increase in the product appeal. However, for short time horizons, the trade-off is linear. Finally, we study the variability of the dynamics through Monte Carlo simulations and discover that low appeals may result in high levels of variability. The model results suggest effective marketing strategies for short and long time horizons and emphasize the significance of advertising early in the market life to increase sales and predictability. PMID:28746334

  3. Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

    2017-02-01

    Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Telomerase level increase is related to n-3 polyunsaturated fatty acid efficacy in first episode schizophrenia: Secondary outcome analysis of the OFFER randomized clinical trial.

    Science.gov (United States)

    Pawełczyk, Tomasz; Grancow-Grabka, Marta; Trafalska, Elżbieta; Szemraj, Janusz; Żurner, Natalia; Pawełczyk, Agnieszka

    2018-04-20

    Schizophrenia is associated with shortening of the lifespan mainly due to cardiovascular events, cancer and chronic obstructive pulmonary disease. Both telomere attrition and decrease of telomerase levels were observed in schizophrenia. Polyunsaturated fatty acids (PUFA) influence multiple biochemical mechanisms which are postulated to accelerate telomere shortening and limit the longevity of patients with schizophrenia. Intervention studies based on add-on therapy with n-3 polyunsaturated fatty acids (n-3 PUFA) in patients with schizophrenia did not assess the changes in telomerase levels. A randomized placebo-controlled trial named OFFER was designed to compare the efficacy of a 26-week intervention composed of either 2.2g/day of n-3 PUFA or olive oil placebo with regard to symptom severity in first-episode schizophrenia patients. The secondary outcome measure of the study was to describe the association between the clinical effect of n-3 PUFA and changes in telomerase levels. Seventy-one patients aged 16-35 were enrolled in the study and randomly assigned to the study arms. The Positive and Negative Syndrome Scale (PANSS) was used to assess the change in symptom severity. Telomerase levels of peripheral blood mononuclear cells (PBMC) were assessed at three points: at baseline and at weeks 8 and 26 of the intervention. A significantly greater increase in PBMC telomerase levels in the intervention group compared to placebo was observed (p<0.001). Changes in telomerase levels significantly and inversely correlated with improvement in depressive symptoms and severity of the illness. The efficacy of a six-month intervention with n-3 PUFA observed in first-episode schizophrenia may be related to an increase in telomerase levels. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development......BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed...... consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...

  6. Comparison of patients' expectations and experiences at traditional pharmacies and pharmacies offering enhanced advanced pharmacy practice experiences.

    Science.gov (United States)

    Kassam, Rosemin; Collins, John B; Berkowitz, Jonathan

    2010-06-15

    To compare patients' expectations and experiences at pharmacies offering traditional APPE learning opportunities with those offering enhanced APPEs that incorporate pharmaceutical care activities. A survey of anchored measures of patient satisfaction was conducted in 2 groups of APPE- affiliated community pharmacies: those participating in an enhanced APPE model versus those participating in the traditional model. The enhanced intervention included preceptor training, a comprehensive student orientation, and an extended experience at a single pharmacy rather than the traditional 2 x 4-week experience at different pharmacies. While patient expectations were similar in both traditional and enhanced APPE pharmacies, patients in enhanced pharmacies reported significantly higher in-store satisfaction and fewer service gaps. Additionally, satisfaction was significantly higher for patients who had received any form of consultation, from either pharmacist or students, than those reporting no consultations. Including provision of pharmaceutical care services as part of APPEs resulted in direct and measurable improvements in patient satisfaction.

  7. Patients' views of teamwork in the emergency department offer insights about team performance.

    Science.gov (United States)

    Henry, Beverly W; McCarthy, Danielle M; Nannicelli, Anna P; Seivert, Nicholas P; Vozenilek, John A

    2016-06-01

    Research into efforts to engage patients in the assessment of health-care teams is limited. To explore, through qualitative methods, patient awareness of teamwork-related behaviours observed during an emergency department (ED) visit. Researchers used semi-structured question guides for audio-recorded interviews and analysed their verbatim transcripts. Researchers conducted individual phone interviews with 6 teamwork subject matter experts (SMEs) and held 5 face-to-face group interviews with patients and caregivers (n = 25) about 2 weeks after discharge from the emergency department (ED). SMEs suggested that a range of factors influence patient perspectives of teams. Many patients perceived the health-care team within the context of their expectations of an ED visit and their treatment plan. Four themes emerged: (i) patient-centred views highlight gaps in coordination and communication; (ii) team processes do concern patients; (iii) patients are critical observers of ways that team members present their team roles; (iv) patients' observations of team members relate to patients' views of team effectiveness. Analysis also indicated that patients viewed health-care team members' interactions with each other as proxy for how team members actually felt about patients. Results from both sets of interviews (SME and patient) indicated that patient observations of teamwork could add to assessment of team processes/frameworks. Patients' understanding about teamwork organization seemed helpful and witnessed interteam communication appeared to influence patient confidence in the team. Patients perspectives are an important part of assessment in health care and suggest potential areas for improvement through team training. © 2013 John Wiley & Sons Ltd.

  8. Special Offers

    CERN Multimedia

    Association du personnel

    2011-01-01

    Walibi Rhône-Alpes is open until 31 October. Reduced prices for children and adults at this French attraction park in Les Avenières. For more information about all these offers, please consult our web site: http://association.web.cern.ch/association/en/OtherActivities/Offers.html

  9. Preventing heavy alcohol use in adolescents (PAS): cluster randomized trial of a parent and student intervention offered separately and simultaneously

    NARCIS (Netherlands)

    Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.

    2009-01-01

    Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19

  10. Special offers

    CERN Multimedia

    Staff Association

    2011-01-01

    Are you a member of the Staff Association? Did you know that as a member you can benefit from the following special offers: BCGE (Banque Cantonale de Genève): personalized banking solutions with preferential conditions. TPG: reduced rates on annual transport passes for active and retired staff. Aquaparc: reduced ticket prices for children and adults at this Swiss waterpark in Le Bouveret. FNAC: 5% reduction on FNAC vouchers. For more information about all these offers, please consult our web site: http://association.web.cern.ch/association/en/OtherActivities/Offers.html

  11. Special Offers

    CERN Multimedia

    Association du personnel

    2011-01-01

    Are you a member of the Staff Association? Did you know that as a member you can benefit from the following special offers: BCGE (Banque Cantonale de Genève): personalized banking solutions with preferential conditions. TPG: reduced rates on annual transport passes for active and retired staff. Aquaparc: reduced ticket prices for children and adults at this Swiss waterpark in Le Bouveret. Walibi: reduced prices for children and adults at this French attraction park in Les Avenières. FNAC: 5% reduction on FNAC vouchers. For more information about all these offers, please consult our web site: http://association.web.cern.ch/association/en/OtherActivities/Offers.html

  12. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  13. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

    Science.gov (United States)

    Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A

    2017-12-02

    Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the

  14. Offers INTERSOCCER

    CERN Multimedia

    Staff Association

    2014-01-01

      Summer Football camps   New offer to the members of the Staff Association – INTERSOCCER: 12% discount on summer football camps and courses for children (bilingual) so do not hesitate anymore!    

  15. Mild Hypothermia May Offer Some Improvement to Patients with MODS after CPB Surgery

    Directory of Open Access Journals (Sweden)

    Xiaoqi Zhao

    Full Text Available ABSTRACT Objective: To summarize the effect of mild hypothermia on function of the organs in patients with multiple organ dysfunction syndrome after cardiopulmonary bypass surgery. Methods: The patients were randomly divided into two groups, northermia group (n=71 and hypothermia group (n=89. We immediately began cooling the hypothermia group when test results showed multiple organ dysfunction syndrome, meanwhile all patients of two groups were drawn blood to test blood gas, liver and kidney function, blood coagulation function, and evaluated the cardiac function using echocardiography from 12 to 36 hours. We compared the difference of intra-aortic balloon pump, extracorporeal membrane oxygenation rate and mortality within one month after intensive care unit admission. Results: Among the 160 patients, 36 died, 10 (11.24% patients were from the hypothermia group and 26 (36.6% from the northermia group (P 0.05. But the platelet count has significantly difference between the two groups at the 36th hour (P <0.05. The aspartate transaminase, alanine transaminase and creatinine were improved significantly in the hypothermia group, and they were significantly better than the northermia group (P <0.05. Conclusion: Mild hypothermia is feasible and safe for patients with multiple organ dysfunction syndrome after cardiopulmonary bypass surgery.

  16. Special Offers

    CERN Multimedia

    Association du personnel

    2011-01-01

    Are you a member of the Staff Association? Did you know that as a member you can benefit from the following special offers: BCGE (Banque Cantonale de Genève): personalized banking solutions with preferential conditions.     TPG: reduced rates on annual transport passes for active and retired staff.     Aquaparc: reduced ticket prices for children and adults at this Swiss waterpark in Le Bouveret.     Walibi: reduced prices for children and adults at this French attraction park in Les Avenières.       FNAC: 5% reduction on FNAC vouchers.       For more information about all these offers, please consult our web site: http://association.web.cern.ch/association/en/OtherActivities/Offers.html

  17. Special Offers

    CERN Multimedia

    Staff Association

    2011-01-01

    Are you a member of the Staff Association? Did you know that as a member you can benefit from the following special offers: BCGE (Banque Cantonale de Genève): personalized banking solutions with preferential conditions.     TPG: reduced rates on annual transport passes for all active and retired staff.     Aquaparc: reduced ticket prices for children and adults at this Swiss waterpark in Le Bouveret.     Walibi: reduced prices for children and adults at this French attraction park in Les Avenières.       FNAC: 5% reduction on FNAC vouchers.       For more information about all these offers, please consult our web site: http://association.web.cern.ch/association/en/OtherActivities/Offers.html

  18. Motivation for physical activity of psychiatric patients when physical activity was offered as part of treatment.

    Science.gov (United States)

    Sørensen, M

    2006-12-01

    This study examined motivation variables, self-determination and self-schema, in relation to physical activity, among psychiatric patients with experience with physical activity as part of their treatment. Participants were patients (N=109) from 15 psychiatric hospitals or day-care institutions. Data were collected by questionnaires. A positive relationship between physical activity level, positive experiences of the activity and higher degree of self-determination and exercise self-schema was expected. Intrinsically regulated motives (motivated by the experience of the activity in itself) were positively and significantly related to physical activity level and the experience of decrease in symptoms during physical activity, and extrinsically regulated motives were negatively correlated with physical activity level. Intrinsically regulated motives gave an odds ratio of 20.0 for being physically active rather than inactive. Holding an exercise self-schema gave an odds ratio of 6.1 for being physically active. The majority of the patients (57.4%) reported that physical activity decreased their illness symptoms, but a few (11.9%) reported negative effects. The findings demonstrated that psychiatric patients do not differ from the normal population in relation to motivational mechanisms, even if they may experience more barriers to physical activities because of their illness. Therefore, in trying to motivate psychiatric patients, it is important to make physical activity as intrinsically motivating as possible by focusing on the positive experiences of the activity itself, as well as helping to develop an exercise self-schema.

  19. Benefits and challenges perceived by patients with cancer when offered a nurse navigator

    DEFF Research Database (Denmark)

    Thygesen, Marianne K; Pedersen, Birthe D; Kragstrup, Jakob

    2011-01-01

    Lack of communication, care and respect from healthcare professionals can be challenges for patients in trajectories of cancer, possibly accompanied by experienced fragmentation of the care, anxiety and worries. One way to try to improve delivery of care is additional help from nurse navigators (NN...

  20. Variation in examination and treatment offers to patients with allergic diseases in general practice

    DEFF Research Database (Denmark)

    Hansen, Dorte Gilså; Jarbøl, Dorte Ejg; Munck, Anders Peter

    2010-01-01

    recommendations for preparedness for anaphylactic shock in connection with allergy vaccine therapy were not fully implemented. CONCLUSION: General practice is substantially involved in the examination and treatment of patients with allergic diseases. There is room for further involvement of staff members...

  1. "Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1 trials in the UK

    Directory of Open Access Journals (Sweden)

    Woolhead Gillian

    2007-03-01

    Full Text Available Abstract Background The n-of-1 trial offers a more methodologically sound approach to determining optimum treatment for an individual patient than "trials of therapy" routinely conducted in clinical practice. However, such methodology is rarely used in the UK. This pilot study explores the acceptability of n-of-1 trials to patients in the UK. Methods Patients with osteoarthritis of the knee were recruited to their own 12-week n-of-1 trial comparing either two knee supports or an NSAID with simple analgesic. Patients were interviewed at the start and completion of their trial to explore reasons for participation, understanding of the trial design and experiences of participation. Daily diaries were completed to inform future treatment. Results Nine patients participated (5 supports, 4 drugs. Patients were keen to participate, believing that the trial may lead to personal gains such as improved symptom control and quality of life. However, recruitment to the pharmacological comparison was more difficult since this could also entail risk. All patients were eager to complete the trial, even when difficulties were encountered. Completing the daily diary provided some patients with greater insight into their condition, which allowed them to improve their self-management. The n-of-1 trial design was viewed as a 'logical' design offering an efficient method of reaching a personalised treatment decision tailored to suit individual needs and preferences. Conclusion This pilot study suggests that patients perceive the n-of-1 trial as an acceptable approach to the individualisation of treatment. In addition, further benefits over and above any gained from the interventions can be derived from involvement in such a study.

  2. A critical evaluation of Web sites offering patient information on tinnitus.

    LENUS (Irish Health Repository)

    Kieran, Stephen M

    2012-02-01

    The Internet is a vast information resource for both patients and healthcare professionals. However, the quality and content often lack formal scrutiny, so we examined the quality of patient information regarding tinnitus on the Internet. Using the three most popular search engines (google.com, yahoo.com, and msn.com), we found pertinent Web sites using the search term tinnitus. Web sites\\' accountability and authorship were evaluated using previously published criteria. The quality of patient information about tinnitus was assessed using a new 10-point scale, the Tinnitus Information Value (TIV). Statistical analysis was performed using the independent sample t-test (p patients.

  3. A critical evaluation of Web sites offering patient information on tinnitus.

    Science.gov (United States)

    Kieran, Stephen M; Skinner, Liam J; Donnelly, Martin; Smyth, David A

    2010-01-01

    The Internet is a vast information resource for both patients and healthcare professionals. However, the quality and content often lack formal scrutiny, so we examined the quality of patient information regarding tinnitus on the Internet. Using the three most popular search engines (google.com, yahoo.com, and msn.com), we found pertinent Web sites using the search term tinnitus. Web sites' accountability and authorship were evaluated using previously published criteria. The quality of patient information about tinnitus was assessed using a new 10-point scale, the Tinnitus Information Value (TIV). Statistical analysis was performed using the independent sample t-test (p patients.

  4. Special offer

    CERN Multimedia

    Staff Association

    2010-01-01

    Special offer for members of the Staff Association and their families 10% reduction on all products in the SEPHORA shop (sells perfume, beauty products etc.) in Val Thoiry ALL YEAR ROUND. Plus 20% reduction during their “vente privée”* three or four times a year. Simply present your Staff Association membership card when you make your purchase. * next “vente privée” from 24th to 29th May 2010  

  5. Special offer

    CERN Document Server

    Staff Association

    2011-01-01

    SPECIAL OFFER FOR OUR MEMBERS Tarif unique Adulte/Enfant Entrée Zone terrestre 19 euros instead of 23 euros Entrée “Zone terrestre + aquatique” 24 euros instead of 31 euros Free for children under 3, with limited access to the attractions. Walibi Rhône-Alpes is open daily from 22 June to 31 August, and every week end from 3 September until 31 October. Closing of the “zone aquatique” 11 September.

  6. Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Boone, Peter; Camara, Alpha; Eble, Alex; Elbourne, Diana; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; Lenin, Maitri; Silva, Ana Filipa

    2015-12-16

    Low education levels are endemic in much of the developing world, particularly in rural areas where traditional government-provided public services often have difficulty reaching beneficiaries. Providing trained para-teachers to teach regular after-school remedial education classes has been shown to improve literacy and numeracy in children of primary school age residing in such areas in India. This trial investigates whether such an intervention can also be effective in a West African setting with similarly low learning levels and difficult geographic access. cluster-randomized controlled trial. Clusters: villages or groups of villages with 15-300 households and at least 15 eligible children in the Lower River and North Bank Regions of The Gambia. children born between 1 September 2007 and 31 August 2009 planning to enter the first grade, for the first time, in the 2015-2016 school year in eligible villages. We anticipate enrolling approximately 150 clusters of villages with approximately 6000 children as participants. a program providing remedial after-school lessons, focusing on literacy and numeracy, 5 to 6 days a week for 3 years to eligible children, based on the intervention evaluated in the Support To Rural India's Public Education System (STRIPES) trial (PLoS ONE 8(7):e65775). both the intervention and control groups will receive small bundles of useful materials during annual data collection as recompense for their time. If the education intervention is shown to be cost-effective at raising learning levels, it is expected that the control group villages will receive the intervention for several years after the trial results are available. the primary outcome of the trial is a composite mathematics and language test score. Secondary outcomes include school attendance, enrollment, performance on nationally administered exams, parents' spending on education, spillover learning to siblings and family members, and school-related time use of parents and

  7. Burden Experienced by Family Caregivers of Patients at the End of Life: What do General Practice Teams Offer?

    Science.gov (United States)

    Krug, K; Bölter, R; Ballhausen, R A; Engeser, P; Peters-Klimm, F

    2016-09-01

    The aim of the study: was to determine how far general practice teams are prepared to relieve family caregivers of palliative patients from their caregiving burden, the support they actually offer, and where they identify needs for improvement. Method: Focus groups and interviews on the issues of identification and support of family caregivers were conducted with practice teams (general practitioners, GPs, and medical assistants, MAs) and the results qualitatively analyzed. Results: 21 participants (14 GPs, 7 MAs) from 13 practices identified burdened family caregivers, thereupon offered support and provided contact details to local consultation services. They suggested to family caregivers that they should use their social network to create room for meeting their own needs. Conclusions: Practice teams use a multitude of individualized and unsystematic approaches to support family caregivers. In further studies within the framework of this project, systematic approaches will be identified and tried out. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Clinical Trials

    Medline Plus

    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  9. When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL.

    Science.gov (United States)

    Vale, Claire L; Cragg, William J; Cromarty, Ben; Hanley, Bec; South, Annabelle; Stephens, Richard; Sturgeon, Kate; Gafos, Mitzy

    2018-02-07

    Patient and public involvement (PPI) in clinical trials aims to ensure that research is carried out collaboratively with patients and/or members of the public. However, current guidance on involving clinical trial participants in PPI activities is not consistent. We reviewed the concept of participant involvement, based on our experience. Two workshops were held at the MRCCTU at UCL with the aim of defining participant involvement, considering its rationale; benefits and challenges; and identifying appropriate models for participant involvement in clinical trials. We considered how participant involvement might complement the involvement of other public contributors. Both workshops were attended by two patient representatives and seven staff members with experience of PPI in trials. Two of the staff members had also been involved in studies that had actively involved participants. They shared details of that work to inform discussions. We defined trial participants as individuals taking part in the study in question, including those who had already completed their trial treatment and/or follow-up. Because of their direct experience, involving participants may offer advantages over other public contributors; for example, in studies of new interventions or procedures, and where it is hard to identify or reach patient or community groups that include or speak for the study population. Participant involvement is possible at all stages of a trial; however, because there are no participants to involve during the design stage of a trial, prior to enrolment, participant involvement should complement and not replace involvement of PPI stakeholders. A range of models, including those with managerial, oversight or responsive roles are appropriate for involving participants; however, involvement in data safety and monitoring committees may not be appropriate where there is a potential risk of unblinding. Involvement of participants can improve the trial experience for other

  10. Acceptability of offering financial incentives to achieve medication adherence in patients with severe mental illness: a focus group study.

    Science.gov (United States)

    Priebe, Stefan; Sinclair, Julia; Burton, Alexandra; Marougka, Stamatina; Larsen, John; Firn, Mike; Ashcroft, Richard

    2010-08-01

    Offering financial incentives to achieve medication adherence in patients with severe mental illness is controversial. To explore the views of different stakeholders on the ethical acceptability of the practice. Focus group study consisting of 25 groups with different stakeholders. Eleven themes dominated the discussions and fell into four categories: (1) 'wider concerns', including the value of medication, source of funding, how patients would use the money, and a presumed government agenda behind the idea; (2) 'problems requiring clear policies', comprising of practicalities and assurance that incentives are only one part of a tool kit; (3) 'challenges for research and experience', including effectiveness, the possibility of perverse incentives, and impact on the therapeutic relationship; (4) 'inherent dilemmas' around fairness and potential coercion. The use of financial incentives is likely to raise similar concerns in most stakeholders, only some of which can be addressed by empirical research and clear policies.

  11. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

    2015-02-27

    Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

  12. Offering assisted peritoneal dialysis is a cost-effective alternative to the current care pathway in frail elderly Dutch patients.

    Science.gov (United States)

    Laplante, Suzanne; Krepel, Harmen; Simons, Bregje; Nijhoff, Aafke; van Liere, Rens; Simons, Michel

    2013-04-01

    With the Dutch population aging, the number of individuals 75 years old or more needing dialysis is growing. This analysis assessed the cost-effectiveness of adding nurse-assisted peritoneal dialysis (aPD) to the usual care pathway in frail Dutch end-stage renal disease (ESRD) patients. THE CURRENT DUTCH TREATMENT PATHWAY (CONSERVATIVE MANAGEMENT, CM: 40% and PD in nursing home, nhPD: 60%) was compared in a decision-tree model with a new approach where the proportion of patients on dialysis would increase to 80% (i.e. CM: 20%; nhPD: 20%; and aPD: 60%). In-center hemodialysis was added in a secondary analysis. Inputs included survival (from literature), utility (from literature), and costs (2009 official tariffs). A healthcare payer's perspective was used with a 5-year horizon. The new approach was almost cost neutral in the primary analysis (despite more patients on dialysis) and dominant (more effective and less expensive) in the secondary analysis. The incremental cost-effectiveness ratio was only €52/QALY. In the sensitivity analyses (primary and secondary analyses), the new approach was either dominant or cost-effective in approximately 75% of the simulations. Despite the investment required, offering aPD to frail elderly ESRD patients is a cost-effective alternative to the current pathway for Dutch healthcare payers.

  13. If we offer it, will they accept? Factors affecting patient use intentions of personal health records and secure messaging.

    Science.gov (United States)

    Agarwal, Ritu; Anderson, Catherine; Zarate, Jesus; Ward, Claudine

    2013-02-26

    Personal health records (PHRs) are an important tool for empowering patients and stimulating health action. To date, the volitional adoption of publicly available PHRs by consumers has been low. This may be partly due to patient concerns about issues such as data security, accuracy of the clinical information stored in the PHR, and challenges with keeping the information updated. One potential solution to mitigate concerns about security, accuracy, and updating of information that may accelerate technology adoption is the provision of PHRs by employers where the PHR is pre-populated with patients' health data. Increasingly, employers and payers are offering this technology to employees as a mechanism for greater patient engagement in health and well-being. Little is known about the antecedents of PHR acceptance in the context of an employer sponsored PHR system. Using social cognitive theory as a lens, we theorized and empirically tested how individual factors (patient activation and provider satisfaction) and two environment factors (technology and organization) influence patient intentions to use a PHR among early adopters of the technology. In technology factors, we studied tool empowerment potential and value of tool functionality. In organization factors, we focused on communication tactics deployed by the organization during PHR rollout. We conducted cross-sectional analysis of field data collected during the first 3 months post go-live of the deployment of a PHR with secure messaging implemented by the Air Force Medical Service at Elmendorf Air Force Base in Alaska in December 2010. A questionnaire with validated measures was designed and completed by 283 participants. The research model was estimated using moderated multiple regression. Provider satisfaction, interactions between environmental factors (communication tactics and value of the tool functionality), and interactions between patient activation and tool empowerment potential were significantly

  14. At Your Request(®) room service dining improves patient satisfaction, maintains nutritional status, and offers opportunities to improve intake.

    Science.gov (United States)

    Doorduijn, Astrid S; van Gameren, Yvonne; Vasse, Emmelyne; de Roos, Nicole M

    2016-10-01

    Malnutrition in hospitals may be combatted by improving the meal service. To evaluate whether At Your Request(®), a meal service concept by Sodexo with a restaurant style menu card and room service, improved patient satisfaction, nutritional status, and food intake compared to the traditional 3-meals per day service. We prospectively collected data in Hospital Gelderse Vallei (Ede, the Netherlands) before (2011/2012; n = 168, age 63 ± 15 y) and after (2013/2014; n = 169, 66 ± 15 y) implementing At Your Request(®). Patient satisfaction increased after implementing At Your Request(®) from 7.5 to 8.1 (scale 1-10) and from 124.5 to 132.9 points on a nutrition-related quality of life questionnaire (p improved in 18 patients in both periods. With At Your Request(®) 0.92 g protein per kg (g/kg) bodyweight was ordered. Protein intake based on food records from patients on an energy and protein enriched diet was 0.84 g/kg during At Your Request(®) (n = 38) versus 0.91 g/kg during the traditional meal service (n = 34). At Your Request(®) is a highly rated hospital menu concept that helps patients to maintain nutritional status. The concept offers options for improving the intake of specific nutrients and foods, which should be evaluated in further studies. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  15. A double-blind clinical trial of griseofulvin in patients with Raynaud's phenomenon

    Science.gov (United States)

    Sabri, S.; Roberts, V. C.; Higgins, R. F.; Cotton, L. T.; Williams, D. I.; Wilson, L. C.

    1973-01-01

    Twenty-four patients with Raynaud's phenomenon were treated with griseofulvin and a placebo in a double-blind cross-over clinical trial. The results were assessed subjectively and plotted sequentially. The number of patients able to distinguish the active from the placebo treatment was statistically significant (P=0·05). There were indications that the response was dose dependent. Further studies are needed to establish whether griseofulvin offers useful clinical improvement in this condition. PMID:4596620

  16. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    Science.gov (United States)

    Taylor, Holly A; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patients. Seven patients were women and all but one white. The mean age was 48 years. During the 4‐month enrolment period, only three patients with EIA were identified; six patients with longer duration of symptoms were also interviewed. Most patients were able to express the primary aim of a hypothetical prevention trial presented. Factors cited by patients favouring enrolment were potential for direct medical benefit and knowledge that they would be withdrawn from the trial if they developed symptoms. Factors cited by patients against enrolment were the inclusion of a placebo and general uncertainty regarding treatment required by the RCT design. Pending larger‐scale empirical projects to explore patients' attitudes about prevention trials, small‐scale formative research in advance of such trials ought to be conducted. PMID:16984939

  17. Chlamyweb Study II: a randomised controlled trial (RCT) of an online offer of home-based Chlamydia trachomatis sampling in France.

    Science.gov (United States)

    Kersaudy-Rahib, Delphine; Lydié, Nathalie; Leroy, Chloé; March, Laura; Bébéar, Cécile; Arwidson, Pierre; de Barbeyrac, Bertille

    2017-05-01

    The number of cases of Chlamydia trachomatis (Ct) diagnosed has increased in the past 15 years in France as well as in other European countries. This paper reports a randomised controlled trial (RCT) to evaluate whether the offer of home-based testing over the internet increased the number of young people tested for chlamydia compared with the current testing strategy and to estimate the number and risks factors of the infected population. This RCT took place as an element of the Chlamyweb Study-a study aiming to evaluate an intervention (the Chlamyweb Intervention) involving the offer of a free self-sampling kit online to sexually active men and women aged 18-24 years in France. Participants in the Chlamyweb RCT (n=11 075) received either an offer of a free self-sampling kit (intervention group) or were invited to be screened in primary care settings (control group). Risks ratios were used to compare screening rates between the intervention and control groups. Risk factors were analysed for infected people in the intervention group. The screening frequency was about three times higher among young people who received a self-sampling kit than those who only received a tailored recommendation to be screened (29.2% vs 8.7%). Although rates of screening among men were lower than among women (23.9% vs 33.9%), the intervention effect was greater among men (adjusted risk ratios (aRR)=4.55 vs aRR=2.94). Ct positivity (6.8%) was similar to that observed in STI clinics. It was higher in women (8.3%) than in men (4.4%). These results invite us to consider the establishment of a large home-based screening programme, although additional studies including economic assessments are needed to evaluate the most appropriate combination of strategies in the French context. AFFSAPS n° IDRCB 0211-A01000-41; 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/.

  18. Cognitive rehabilitation in patients with gliomas : a randomized, controlled trial

    NARCIS (Netherlands)

    Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H.; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

    2009-01-01

    PURPOSE: Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients

  19. Video Helps Prepare Patients to Participate in Cancer Trials

    Science.gov (United States)

    Patients who took part in a tailored, video-based educational program had a better understanding of and fewer concerns about participating in clinical trials than patients who received text-based educational.

  20. Facilitating recruitment of patients with schizophrenia to a clinical trial

    DEFF Research Database (Denmark)

    Grønbech, Bettina Ellen; Aagaard, Jørgen; Jensen, Svend Eggert

    People with severe mental illness, such as schizophrenia have higher rates of mortality especially due to cardiovascular disease. We have established a clinical trial named “Coronary artery disease and schizophrenia”. However, patients with schizophrenia have cognitive disturbances, which make re...... recruitment of patients challenging. The purpose of this study is to understand which type of recruitment strategy is needed in clinical trials....

  1. Protons Offer Reduced Normal-Tissue Exposure for Patients Receiving Postoperative Radiotherapy for Resected Pancreatic Head Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Nichols, Romaine C., E-mail: rnichols@floridaproton.org [University of Florida Proton Therapy Institute, Jacksonsville, FL (United States); Huh, Soon N. [University of Florida Proton Therapy Institute, Jacksonsville, FL (United States); Prado, Karl L.; Yi, Byong Y.; Sharma, Navesh K. [Department of Radiation Oncology, University of Maryland, Baltimore, MD (United States); Ho, Meng W.; Hoppe, Bradford S.; Mendenhall, Nancy P.; Li, Zuofeng [University of Florida Proton Therapy Institute, Jacksonsville, FL (United States); Regine, William F. [Department of Radiation Oncology, University of Maryland, Baltimore, MD (United States)

    2012-05-01

    Purpose: To determine the potential role for adjuvant proton-based radiotherapy (PT) for resected pancreatic head cancer. Methods and Materials: Between June 2008 and November 2008, 8 consecutive patients with resected pancreatic head cancers underwent optimized intensity-modulated radiotherapy (IMRT) treatment planning. IMRT plans used between 10 and 18 fields and delivered 45 Gy to the initial planning target volume (PTV) and a 5.4 Gy boost to a reduced PTV. PTVs were defined according to the Radiation Therapy Oncology Group 9704 radiotherapy guidelines. Ninety-five percent of PTVs received 100% of the target dose and 100% of the PTVs received 95% of the target dose. Normal tissue constraints were as follows: right kidney V18 Gy to <70%; left kidney V18 Gy to <30%; small bowel/stomach V20 Gy to <50%, V45 Gy to <15%, V50 Gy to <10%, and V54 Gy to <5%; liver V30 Gy to <60%; and spinal cord maximum to 46 Gy. Optimized two- to three-field three-dimensional conformal proton plans were retrospectively generated on the same patients. The team generating the proton plans was blinded to the dose distributions achieved by the IMRT plans. The IMRT and proton plans were then compared. A Wilcoxon paired t-test was performed to compare various dosimetric points between the two plans for each patient. Results: All proton plans met all normal tissue constraints and were isoeffective with the corresponding IMRT plans in terms of PTV coverage. The proton plans offered significantly reduced normal-tissue exposure over the IMRT plans with respect to the following: median small bowel V20 Gy, 15.4% with protons versus 47.0% with IMRT (p = 0.0156); median gastric V20 Gy, 2.3% with protons versus 20.0% with IMRT (p = 0.0313); and median right kidney V18 Gy, 27.3% with protons versus 50.5% with IMRT (p = 0.0156). Conclusions: By reducing small bowel and stomach exposure, protons have the potential to reduce the acute and late toxicities of postoperative chemoradiation in this setting.

  2. Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial.

    Science.gov (United States)

    Hardy, Pollyanna; Bell, Jennifer L; Brocklehurst, Peter

    2016-07-15

    A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once data are returned can reduce the cost-burden of this approach, with possible further cost-savings if the offer were restricted to reminder letters only. This study aimed to evaluate the effect of promising a monetary incentive at first mailout versus a promise on reminder letters only. This was a randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an epidural. The follow-up questionnaire asked for information on the women's health, wellbeing and health service use one year following the birth of their baby. Women who consented to be contacted were randomised to a promise of a monetary incentive at first mailout or a promise on reminder letters only. Women were given an option of completing the questionnaire on paper or on online. The incentive was posted out on receipt of a completed questionnaire. The primary outcome was the overall return rate, and secondary outcomes were the return rate without any chasing from the study office, and the total cost of the vouchers. A total of 1,029 women were randomised, 508 to the first mailout group and 518 to the reminder group. There was no evidence to suggest a difference between groups in the overall return rate (adjusted RR 1.03 (95 % CI 0.96 to 1.11), however the proportion returned without chasing was higher in the first mailout group (adjusted RR 1.22, 95 % CI 1.07 to 1.39). The total cost of the vouchers per participant was higher in the first mailout group (mean difference £4.56, 95 % CI £4.02 to £5.11). Offering a monetary incentive when a reminder is required could be cost-effective depending on the sample size of the study and the resources available to administer the reminder letters. The

  3. Motivation and frustration in cardiology trial participation: the patient perspective.

    Science.gov (United States)

    Meneguin, Silmara; Cesar, Luiz Antônio Machado

    2012-01-01

    The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration. Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period. Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment. Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

  4. The PACT trial: PAtient Centered Telerehabilitation

    Directory of Open Access Journals (Sweden)

    Andreas Stefan Rothgangel

    2015-01-01

    Discussion: Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.

  5. Genetic Polymorphisms in the Long Noncoding RNA MIR2052HG Offer a Pharmacogenomic Basis for the Response of Breast Cancer Patients to Aromatase Inhibitor Therapy.

    Science.gov (United States)

    Ingle, James N; Xie, Fang; Ellis, Matthew J; Goss, Paul E; Shepherd, Lois E; Chapman, Judith-Anne W; Chen, Bingshu E; Kubo, Michiaki; Furukawa, Yoichi; Momozawa, Yukihide; Stearns, Vered; Pritchard, Kathleen I; Barman, Poulami; Carlson, Erin E; Goetz, Matthew P; Weinshilboum, Richard M; Kalari, Krishna R; Wang, Liewei

    2016-12-01

    Genetic risks in breast cancer remain only partly understood. Here, we report the results of a genome-wide association study of germline DNA from 4,658 women, including 252 women experiencing a breast cancer recurrence, who were entered on the MA.27 adjuvant trial comparing the aromatase inhibitors (AI) anastrozole and exemestane. Single-nucleotide polymorphisms (SNP) of top significance were identified in the gene encoding MIR2052HG, a long noncoding RNA of unknown function. Heterozygous or homozygous individuals for variant alleles exhibited a ∼40% or ∼63% decrease, respectively, in the hazard of breast cancer recurrence relative to homozygous wild-type individuals. Functional genomic studies in lymphoblastoid cell lines and ERα-positive breast cancer cell lines showed that expression from MIR2052HG and the ESR1 gene encoding estrogen receptor-α (ERα) was induced by estrogen and AI in a SNP-dependent manner. Variant SNP genotypes exhibited increased ERα binding to estrogen response elements, relative to wild-type genotypes, a pattern that was reversed by AI treatment. Further, variant SNPs were associated with lower expression of MIR2052HG and ERα. RNAi-mediated silencing of MIR2052HG in breast cancer cell lines decreased ERα expression, cell proliferation, and anchorage-independent colony formation. Mechanistic investigations revealed that MIR2052HG sustained ERα levels both by promoting AKT/FOXO3-mediated ESR1 transcription and by limiting ubiquitin-mediated, proteasome-dependent degradation of ERα. Taken together, our results define MIR2052HS as a functionally polymorphic gene that affects risks of breast cancer recurrence in women treated with AI. More broadly, our results offer a pharmacogenomic basis to understand differences in the response of breast cancer patients to AI therapy. Cancer Res; 76(23); 7012-23. ©2016 AACR. ©2016 American Association for Cancer Research.

  6. Permitting patients to pay for participation in clinical trials: the advent of the P4 trial.

    Science.gov (United States)

    Shaw, David; de Wert, Guido; Dondorp, Wybo; Townend, David; Bos, Gerard; van Gelder, Michel

    2017-06-01

    In this article we explore the ethical issues raised by permitting patients to pay for participation (P4) in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

  7. Does an offer for a free on-line continuing medical education (CME) activity increase physician survey response rate? A randomized trial.

    Science.gov (United States)

    Viera, Anthony J; Edwards, Teresa

    2012-03-07

    Achieving a high response rate in a physician survey is challenging. Monetary incentives increase response rates but obviously add cost to a survey project. We wondered whether an offer of a free continuing medical education (CME) activity would be effective in improving survey response rate. As part of a survey of a national sample of physicians, we randomized half to an offer for a free on-line CME activity upon completion of a web-based survey and the other half to no such offer. We compared response rates between the groups. A total of 1214 out of 8477 potentially eligible physicians responded to our survey, for an overall response rate of 14.3%. The response rate among the control group (no offer of CME credit) was 16.6%, while among those offered the CME opportunity, the response rate was 12.0% (p offer for a free on-line CME activity did not improve physician survey response rate. On the contrary, the offer for a free CME activity actually appeared to worsen the response rate. © 2011 Viera et al; licensee BioMed Central Ltd.

  8. Patient information in phase 1 trials

    DEFF Research Database (Denmark)

    Gad, Katrine Toubro; Lassen, Ulrik; Mau-Søerensen, Morten

    2018-01-01

    OBJECTIVE: To review what is known about cancer patients' decisions to enter a phase 1 trial and how they and their relatives perceive the information they receive when they are invited to participate. METHODS: This systematic review is based on the principles of "preferred reporting items...... for systematic reviews and meta-analyses." A systematic search was performed in the PubMed, Embase, and PsycInfo databases, supplemented by a search for unpublished literature. RESULTS: We identified 37 studies for inclusion in this review. Patients' decisions to participate in a phase 1 trial were influenced...... by the drug being tested, information procedures, physician-related factors, and the patient's individual approach to decision making. Patients have difficulties correctly repeating the purpose of a phase 1 trial. In several studies, most patients expressed expectations of personal benefit from participating...

  9. Effectiveness of strategies to encourage general practitioners to accept an offer of free access to online evidence-based information: a randomised controlled trial.

    Science.gov (United States)

    Buchan, Heather; Lourey, Emma; D'Este, Catherine; Sanson-Fisher, Rob

    2009-10-20

    This study examined the effectiveness of seven different interventions designed to increase the proportion of general practitioners (GPs) accepting an offer of free access to an online evidence-based resource. Australian GPs (n = 14,000) were randomly selected and assigned to seven intervention groups, with each receiving a different letter. Seven different strategies were used to encourage GPs to accept an offer of two years free access to an online evidence-based resource (BMJ Clinical Evidence). The first group received a standard letter of offer with no experimental demands. Groups two to seven received a standard letter of offer outlining the requirements of the study. They were asked to complete an initial online questionnaire, agree to complete a 12-month follow-up questionnaire, and agree to having data about their usage of the online evidence-based resource provided to researchers. Groups three to seven also had additional interventions included in the letter of offer: access to an online tutorial in use of the resource (group three); provision of a pamphlet with statements from influential opinion leaders endorsing the resource (group four); offer of eligibility to receive professional development points (group five); offer of eligibility for a prize of $500 for registration at a medical conference of their choice (group six); and a combination of some of the above interventions (group seven). In the group with no research demands, 27% accepted the offer. Average acceptance across all other groups was 10%. There was no advantage in using additional strategies such as financial incentives, opinion leader support, offer of professional development points, or an educational aid over a standard letter of offer to increase acceptance rates. This study showed low acceptance rates of the offer of access to the online resource when there was an associated requirement of response to a short online questionnaire and non-obtrusive monitoring of GP behaviour in terms

  10. DEMO-II trial. Aerobic exercise versus stretching exercise in patients with major depression-a randomised clinical trial.

    Science.gov (United States)

    Krogh, Jesper; Videbech, Poul; Thomsen, Carsten; Gluud, Christian; Nordentoft, Merete

    2012-01-01

    The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined. Outpatients with major depression (DSM-IV) were allocated to supervised aerobic or stretching exercise groups during a three months period. The primary outcome was the Hamilton depression score (HAM-D(17)). Secondary outcomes were cognitive function, cardiovascular risk markers, and employment related outcomes. 56 participants were allocated to the aerobic exercise intervention versus 59 participants to the stretching exercise group. Post intervention the mean difference between groups was -0.78 points on the HAM-D(17) (95% CI -3.2 to 1.6; P = .52). At follow-up, the participants in the aerobic exercise group had higher maximal oxygen uptake (mean difference 4.4 l/kg/min; 95% CI 1.7 to 7.0; P = .001) and visuospatial memory on Rey's Complex Figure Test (mean difference 3.2 points; 95% CI 0.9 to 5.5; P = .007) and lower blood glucose levels (mean difference 0.2 mmol/l; 95% CI 0.0 to 0.5; P = .04) and waist circumference (mean difference 2.2 cm; 95% CI 0.3 to 4.1; P = .02) compared with the stretching exercise group. The results of this trial does not support any antidepressant effect of referring patients with major depression to a three months aerobic exercise program. Due to lower recruitment than anticipated, the trial was terminated prior to reaching the pre-defined sample size of 212 participants; therefore the results should be interpreted in that context. However, the DEMO-II trial does suggest that an exercise program for patients with depression offer positive short-term effects on maximal oxygen uptake, visuospatial memory, fasting glucose levels, and waist circumference. ClinicalTrials.gov NCT00695552.

  11. A 12-week interdisciplinary rehabilitation trial in patients with gliomas

    DEFF Research Database (Denmark)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek

    2018-01-01

    %) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive...... that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences...

  12. Methods to improve patient recruitment and retention in stroke trials

    DEFF Research Database (Denmark)

    Berge, Eivind; Stapf, Christian; Al-Shahi Salman, Rustam

    2016-01-01

    by health services only when delivered within clinical trials. The literature review revealed that few methods have been formally evaluated. The top five priorities for evaluation identified in the workshop were as follows: short and illustrated patient information leaflets, nonwritten consent......Background: The success of randomized-controlled stroke trials is dependent on the recruitment and retention of a sufficient number of patients, but fewer than half of all trials meet their target number of patients. Methods: We performed a search and review of the literature, and conducted...... a survey and workshop among 56 European stroke trialists, to identify barriers, suggest methods to improve recruitment and retention, and make a priority list of interventions that merit further evaluation. Results: The survey and workshop identified a number of barriers to patient recruitment...

  13. At Your Request((R)) room service dining improves patient satisfaction, maintains nutritional status, and offers opportunities to improve intake

    NARCIS (Netherlands)

    Doorduijn, A.S.; Gameren, Y. van; Vasse, E.; Roos, N.M. de

    2016-01-01

    BACKGROUND: Malnutrition in hospitals may be combatted by improving the meal service. AIM: To evaluate whether At Your Request((R)), a meal service concept by Sodexo with a restaurant style menu card and room service, improved patient satisfaction, nutritional status, and food intake compared to the

  14. Trends in the utilization of medical imaging from 2003 to 2011: clinical encounters offer a complementary patient-centered focus.

    Science.gov (United States)

    Dodoo, Martey S; Duszak, Richard; Hughes, Danny R

    2013-07-01

    The aim of this study was to investigate trends in utilization and spending for medical imaging, using medical visits resulting in imaging as a novel metric of utilization. Utilization and spending for medical imaging were examined using (1) Medicare Part B claims data from 2003 to 2011 to measure per-enrollee spending and (2) household component events data on the elderly Medicare-age population from the Medical Expenditure Panel Survey from 2003 to 2010 to measure utilization as a function of clinical encounters. Annual health spending and Medicare payments for imaging for the elderly population grew from $294 per enrollee in 2003 to $418 in 2006 and had declined to $390 by 2011. Over this entire time, however, annual medical visits by a similar Medicare-age (≥ 65 years old) population resulting in imaging trended consistently downward, from 12.8% in 2003 to 10.6% in 2011. Despite early growth and then more recent declines in average Medicare spending per enrollee since 2003, the percentage of patient encounters resulting in medical imaging has significantly and consistently declined nationwide. Spending alone is thus an incomplete measure of changes in the role and utilization of medical imaging in overall patient care. As policymakers focus on medical imaging, a thoughtful analysis of payment policy influencing imaging utilization, and its role in concurrent and downstream patient care, will be critical to ensure appropriate patient access. Copyright © 2013 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  15. Does mitral valve repair offer an advantage over replacement in patients undergoing aortic valve replacement?

    Science.gov (United States)

    Thourani, Vinod H; Suri, Rakesh M; Rankin, J Scott; He, Xia; O'Brien, Sean M; Badhwar, Vinay; Ailawadi, Gorav; Vassileva, Christina M; Shults, Christian C; Svensson, Lars G; Gammie, James S

    2014-08-01

    Concomitant aortic and mitral valve (MV) operations have more than doubled over the past decade. We utilized the Society of Thoracic Surgeons Adult Cardiac Surgery Database (ACSD) to evaluate outcomes for patients undergoing combined aortic valve replacement (AVR) and MV repair or replacement. From 1993 to 2007, 23,404 patients undergoing concomitant AVR+MV surgery were identified. Patients with mitral stenosis, emergent or salvage status, and endocarditis were excluded. Outcomes were expressed as unadjusted operative mortality, adjusted odds ratio (OR) for mortality, and a composite of mortality and major complications. The MV repair was performed in 46.0% and replacement in 54.0% of AVR patients. The rate of MV repair increased from 22.5% in 1993 to 59.1% in 2007 (panalysis included the following: age (OR 1.21, p<0.0001); concomitant CABG (OR 1.49, p<0.0001); diabetes mellitus (OR 1.56, p<0.0001); reoperation (OR 1.53, p<0.0001); and renal failure with dialysis (OR 3.57, p<0.0001). Patients undergoing MV repair had a lower independent risk of operative mortality (OR 0.61, p<0.0001), and mortality also independently improved over time (2003 to 2007 vs 1993 to 1997, OR 0.79, p<0.002). When feasible, MV repair remains the most optimal method of correcting mitral regurgitation during concomitant AVR. Continued efforts to improve MV repair rates in this setting seem warranted. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  16. Hypnotherapy in radiotherapy patients: A randomized trial

    NARCIS (Netherlands)

    Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT

  17. Hypnotherapy in radiotherapy patients: A randomized trial

    International Nuclear Information System (INIS)

    Stalpers, Lukas J.A.; Costa, Hanna C. da; Merbis, Merijn A.E.; Fortuin, Andries A.; Muller, Martin J.; Dam, Frits van

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. Results: No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p < 0.05) and overall (p < 0.05) well-being. Conclusion: Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect

  18. Clinical trial enrollment, patient characteristics, and survival differences in prospectively registered metastatic colorectal cancer patients

    DEFF Research Database (Denmark)

    Sorbye, Halfdan; Pfeiffer, Per; Cavalli-Björkman, Nina

    2009-01-01

    BACKGROUND: Trial accrual patterns were examined to determine whether metastatic colorectal cancer (mCRC) patients enrolled in trials are representative of a general cancer population concerning patient characteristics and survival. METHODS: A total of 760 mCRC patients referred for their first...... oncological consideration at 3 hospitals in Scandinavia covering defined populations were registered consecutively during 2003 to 2006. Clinical trial enrollment, patient characteristics, and treatment were recorded prospectively, and the follow-up was complete. RESULTS: Palliative chemotherapy was initiated...... was then only 2.1 months. The median survival for all 760 nonresectable mCRC patients was 10.7 months. CONCLUSIONS: mCRC patients enrolled into clinical trials differ in characteristics from patients receiving chemotherapy outside protocol and have better survival, even when given the same treatment. Although...

  19. Different spontaneous breathing trials in patients with atrial fibrillation

    Directory of Open Access Journals (Sweden)

    Y.-H. Tseng

    2015-09-01

    Full Text Available Introduction: Weaning from mechanical ventilation is one of the most important and challenging problems for most intensive care unit (ICU patients. Spontaneous breathing trial (SBT is the most common method used to evaluate patients’ ability to breathe by themselves and plays an important role in decision making for weaning. The aim of our study was to investigate the effect of different methods of SBT in respiratory care unit (RCU patients with atrial fibrillation (AF on weaning outcome. Methods: We retrospectively analyzed different methods of SBT in patients with and without AF. We enrolled RCU patients who required mechanical ventilation and had undergone transthoracic echocardiography from January 2011 to January 2012. Results: There was a higher SBT passing rate among AF patients who received pressure support ventilation (PSV trial than in those who received T-piece trail (92.5% vs. 73.1%, p = 0.041. The weaning rates between these two groups were not significantly different (83.8% vs. 94.7%, p = 0.403. Total ventilator days were longer in T-piece group than in PSV group (median 40.0, IQR: 18.2–125.1 days vs. 33.0, IQR: 29.6–51.0 days respectively, p = 0.580, but this difference was not statistically significant. These results were not found in patients without AF. Conclusions: The use of PSV trial might be considered first instead of T-piece trial for SBT when AF patients were ready to wean. Keywords: Atrial fibrillation (AF, Intensive care unit (ICU, Mechanical ventilation, Spontaneous breathing trial (SBT, Ventilator weaning

  20. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  1. Intensive care unit research ethics and trials on unconscious patients.

    Science.gov (United States)

    Gillett, G R

    2015-05-01

    There are widely acknowledged ethical issues in enrolling unconscious patients in research trials, particularly in intensive care unit (ICU) settings. An analysis of those issues shows that, by and large, patients are better served in units where research is actively taking place for several reasons: i) they do not fall prey to therapeutic prejudices without clear evidential support, ii) they get a chance of accessing new and potentially beneficial treatments, iii) a climate of careful monitoring of patients and their clinical progress is necessary for good clinical research and affects the care of all patients and iv) even those not in the treatment arm of a trial of a new intervention must receive best current standard care (according to international evidence-based treatment guidelines). Given that we have discovered a number of 'best practice' regimens of care that do not optimise outcomes in ICU settings, it is of great benefit to all patients (including those participating in research) that we are constantly updating and evaluating what we do. Therefore, the practice of ICU-based clinical research on patients, many of whom cannot give prospective informed consent, ticks all the ethical boxes and ought to be encouraged in our health system. It is very important that the evaluation of protocols for ICU research should not overlook obvious (albeit probabilistic) benefits to patients and the acceptability of responsible clinicians entering patients into well-designed trials, even though the ICU setting does not and cannot conform to typical informed consent procedures and requirements.

  2. Could we offer mitochondrial donation or similar assisted reproductive technology to South African patients with mitochondrial DNA disease?

    Science.gov (United States)

    Meldau, Surita; Riordan, Gillian; Van der Westhuizen, Francois; Elson, Joanna L; Smuts, Izelle; Pepper, Michael S; Soodyall, Himla

    2016-02-02

    The decision of the UK House of Commons in 2015 to endorse the use of pioneering in vitro fertilisation techniques to protect future generations from the risk of mitochondrial DNA (mtDNA) disease has sparked worldwide controversy and debate. The availability of such technologies could benefit women at risk of transmitting deleterious mutations. MtDNA disease certainly occurs in South Africa (SA) in all population groups. However, diagnostic strategies and practices for identifying individuals who would benefit from technologies such as IVF have in the past been suboptimal in this country. New developments in the molecular diagnostic services available to SA patients, as well as better education of referring clinicians and the implementation of more structured, population-appropriate diagnostic strategies, may open the floor to this debate in SA.

  3. The Challenges of Recruiting Patients into a Sham Surgery Trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer Borbjerg; Lohmander, Stefan; Roos, Ewa M.

    the challenges in recruiting patients into a placebo controlled surgical trial of arthroscopic partial meniscectomy. Materials and Methods Results presented are from an ongoing RCT where patients aged 35-55 with an MRI confirmed degenerative medial meniscus tear were randomized to arthroscopic partial...... a meniscus lesion. Only when MRI confirmed a meniscus lesion were the patients finally included. Findings / Results 261 patients have been screened. 109 had clinical signs of a medial meniscus lesion. 13 declined to receive the patient information, 39 declined after reviewing the patient material and 55...... agreed to participate. 2 patients underwent MRI which was negative before being informed of the study. All 55 patients who were willing to participate underwent MRI. Of these only 34 had a medial meniscus tear confirmed by MRI (2 pending). In total 25 patients were finally included from the 261 initially...

  4. Stroke outcome in clinical trial patients deriving from different countries.

    Science.gov (United States)

    Ali, Myzoon; Atula, Sari; Bath, Philip M W; Grotta, James; Hacke, Werner; Lyden, Patrick; Marler, John R; Sacco, Ralph L; Lees, Kennedy R

    2009-01-01

    Stroke incidence and outcome vary widely within and across geographical locations. We examined whether differences in index stroke severity, stroke risk factors, mortality, and stroke outcome across geographical locations remain after adjusting for case mix. We analyzed 3284 patients from the Virtual International Stroke Trials Archive (VISTA). We used logistic regression to examine the incidence of mild index stroke, functional, and neurological outcomes after accounting for age, medical history, year of trial recruitment, and initial stroke severity in the functional and neurological outcome analyses. We examined mortality between geographical regions using a Cox proportional hazards model, accounting for age, initial stroke severity, medical history, and year of trial recruitment. Patients enrolled in the USA and Canada had the most severe index strokes. Those recruited in Austria and Switzerland had the best functional and neurological outcomes at 90 days (P<0.05), whereas those enrolled in Germany had the worst functional outcome at 90 days (P=0.013). Patients enrolled in Austria, Switzerland, Belgium, Netherlands, Finland, Germany, Greece, Israel, Spain, and Portugal had a significantly better survival rate when compared with those enrolled in USA and Canada. Patients enrolled in trials after 1998 had more severe index strokes, with no significant difference in outcome compared with those enrolled before 1998. We identified regional variations in index stroke severity, outcome, and mortality for patients enrolled in ischemic stroke clinical trials over the past 13 years that were not fully explained by case mix. Index stroke severity was greater in patients enrolled after 1998, with no significant improvement in outcomes compared to those enrolled before 1998.

  5. Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial.

    Science.gov (United States)

    Labhardt, Niklaus D; Ringera, Isaac; Lejone, Thabo I; Klimkait, Thomas; Muhairwe, Josephine; Amstutz, Alain; Glass, Tracy R

    2018-03-20

    Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART). To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa. Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group. Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter. Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment. Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care

  6. Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

    Science.gov (United States)

    Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

    2017-06-15

    Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

  7. Reasons why patients fail screening in Indian breast cancer trials

    Directory of Open Access Journals (Sweden)

    P Mahajan

    2015-01-01

    Full Text Available Introduction: An increased number of screen failure patients in a clinical trial increases time and cost required for the recruitment. Assessment of reasons for screen failure can help reduce screen failure rates and improve recruitment. Materials and Methods: We collected retrospective data of human epidermal growth factor receptor (HER2 positive Indian breast cancer patients, who failed screening for phase 3 clinical trials and ascertained their reasons for screen failure from screening logs. Statistical comparison was done to ascertain if there are any differences between private and public sites. Results: Of 727 patients screened at 14 sites, 408 (56.1% failed screening. The data on the specific reasons for screen failures was not available at one of the public sites (38 screen failures out of 83 screened patients. Hence, after excluding that site, further analysis is based on 644 patients, of which 370 failed screening. Of these, 296 (80% screen failure patients did not meet selection criteria. The majority -266 were HER2 negative. Among logistical issues, 39 patients had inadequate breast tissue sample. Sixteen patients withdrew their consent at private sites as compared to six at public sites. The difference between private and public sites for the above three reasons was statistically significant. Conclusion: Use of prescreening logs to reduce the number of patients not meeting selection criteria and protocol logistics, and patient counseling to reduce consent withdrawals could be used to reduce screen failure rate.

  8. Almond supplementation reduces serum uric acid in coronary artery disease patients: a randomized controlled trial.

    Science.gov (United States)

    Jamshed, Humaira; Gilani, Anwar-Ul-Hassan; Sultan, Fateh Ali Tipoo; Amin, Faridah; Arslan, Jamshed; Ghani, Sumaira; Masroor, Madiha

    2016-08-19

    Elevated serum uric acid (UA), a biomarker of renal insufficiency, is also an independent prognostic marker for morbidity in coronary artery disease (CAD) and poses serious health risks. This study reports the effect of almond consumption on UA in CAD patients. A randomized controlled clinical trial was conducted with three groups: no-intervention (NI), Pakistani almonds (PA) or American almonds (AA). Patients were recruited from the Cardiology Clinics, Aga Khan University Hospital. Two follow-ups were scheduled at week-6 and week-12. 150 patients were randomly divided in three groups (50 per group). NI was not given almonds, whereas the PA and AA were given Pakistani and American almond varieties (10 g/day), respectively; with instruction to soak overnight and eat before breakfast. Almonds supplementation significantly reduced (p < 0.05) serum UA among groups, and over time. At week-6, UA concentrations were -13 to -16 % less in PA and AA; at week-12 the concentrations were -14 to -18 % less, compared to NI. Systolic and diastolic blood pressure and body weights of the participants remained fairly constant among all the groups. Almonds (10 g/day), eaten before breakfast, reduces serum UA in CAD patients. Prevention of hyperuricemia can confer protection from kidney and vascular damage and if extrapolated for general population, dietary almonds can offer grander health benefit. Trial is registered at Australian New Zealand Clinical trial registry as ACTRN12614000036617.

  9. Representativeness of Honeypot Trial Participants to Australasian PD Patients.

    Science.gov (United States)

    Zhang, Lei; Badve, Sunil V; Pascoe, Elaine M; Beller, Elaine; Cass, Alan; Clark, Carolyn; de Zoysa, Janak; Isbel, Nicole M; Liu, Xusheng; McTaggart, Steven; Morrish, Alicia T; Playford, Geoffrey; Scaria, Anish; Snelling, Paul; Vergara, Liza A; Hawley, Carmel M; Johnson, David W

    2017-01-01

    The HONEYPOT trial failed to establish the superiority of exit-site application of Medihoney compared with nasal mupirocin prophylaxis for the prevention of peritonitis in peritoneal dialysis (PD) patients. This study aimed to assess the representativeness of the patients in the HONEYPOT trial to the Australian and New Zealand PD population. This study compared baseline characteristics of the 371 PD patients in the HONEYPOT trial with those of 6,085 PD patients recorded on the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. Compared with the PD population, the HONEYPOT sample was older (standardized difference [ d ] = 0.19, p = 0.003), more likely to be treated with automated PD ( d = 0.58, p < 0.001), had higher residual renal function ( d = 0.26, p < 0.001) and a higher proportion of participants with end-stage kidney disease due to polycystic kidney disease ( d = 0.17) and lower proportion due to diabetes ( d = -0.17) and glomerulonephritis ( d = -0.18) ( p < 0.001), and lower proportions of indigenous people ( d = -0.17, p < 0.001), current smokers ( d = -0.10, p < 0.001), and people with prior histories of hemodialysis ( d = -0.16, p < 0.001), diabetes mellitus ( d = -0.18, p < 0.001), and coronary artery disease ( d = -0.15, p < 0.001). HONEYPOT trial participants tended to be healthier than the Australian and New Zealand PD patient population. Although the differences between the groups were generally modest, it is possible that their cumulative effect may have had some impact on external generalizability, which is not an uncommon occurrence in clinical trials. Copyright © 2017 International Society for Peritoneal Dialysis.

  10. Automated patient and medication payment method for clinical trials

    Directory of Open Access Journals (Sweden)

    Yawn BP

    2013-01-01

    Full Text Available Barbara P Yawn,1 Suzanne Madison,1 Susan Bertram,1 Wilson D Pace,2 Anne Fuhlbrigge,3 Elliot Israel,3 Dawn Littlefield,1 Margary Kurland,1 Michael E Wechsler41Olmsted Medical Center, Department of Research, Rochester, MN, 2UCDHSC, Department of Family Medicine, University of Colorado Health Science Centre, Aurora, CO, 3Brigham and Women's Hospital, Pulmonary and Critical Care Division, Boston, MA, 4National Jewish Medical Center, Division of Pulmonology, Denver, CO, USABackground: Published reports and studies related to patient compensation for clinical trials focus primarily on the ethical issues related to appropriate amounts to reimburse for patient's time and risk burden. Little has been published regarding the method of payment for patient participation. As clinical trials move into widely dispersed community practices and more complex designs, the method of payment also becomes more complex. Here we review the decision process and payment method selected for a primary care-based randomized clinical trial of asthma management in Black Americans.Methods: The method selected is a credit card system designed specifically for clinical trials that allows both fixed and variable real-time payments. We operationalized the study design by providing each patient with two cards, one for reimbursement for study visits and one for payment of medication costs directly to the pharmacies.Results: Of the 1015 patients enrolled, only two refused use of the ClinCard, requesting cash payments for visits and only rarely a weekend or fill-in pharmacist refused to use the card system for payment directly to the pharmacy. Overall, the system has been well accepted by patients and local study teams. The ClinCard administrative system facilitates the fiscal accounting and medication adherence record-keeping by the central teams. Monthly fees are modest, and all 12 study institutional review boards approved use of the system without concern for patient

  11. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

    OpenAIRE

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-01-01

    Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...

  12. An economic evaluation alongside a randomised controlled trial on psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia.

    Science.gov (United States)

    Turkstra, Erika; Mihala, Gabor; Scuffham, Paul A; Creedy, Debra K; Gamble, Jenny; Toohill, Jocelyn; Fenwick, Jennifer

    2017-03-01

    The rate of caesarean section continues to increase, and there is evidence that childbirth fear is a contributing factor. Insufficient evidence is available on the impact of reducing childbirth fear on health-related quality of life and health service use. We undertook an economic evaluation of a psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia. Pregnant women (n = 339) with high childbirth fear were randomised to a midwife-led psycho-education intervention for childbirth fear or to usual care. This paper presents the economic evaluation of the intervention based on health-related quality of life and health service use from recruitment to six weeks postpartum (n = 184). The changes in health-related quality of life after birth (EQ-5D-3L: 0.016 vs. 0.010, p = 0.833, for usual care and intervention) and total health care use cost (AUS$10,110 vs. AUS$9980, p = 0.819) were similar between groups. The intervention did not increase costs; however, in a post hoc analysis, the interventions might be cost-effective for those women with very high childbirth fear. This brief psycho-education intervention by midwives did not improve the health-related quality of life of women, and had no impact on overall cost. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. DEMO-II trial. Aerobic exercise versus stretching exercise in patients with major depression-a randomised clinical trial.

    Directory of Open Access Journals (Sweden)

    Jesper Krogh

    Full Text Available The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined.Outpatients with major depression (DSM-IV were allocated to supervised aerobic or stretching exercise groups during a three months period. The primary outcome was the Hamilton depression score (HAM-D(17. Secondary outcomes were cognitive function, cardiovascular risk markers, and employment related outcomes.56 participants were allocated to the aerobic exercise intervention versus 59 participants to the stretching exercise group. Post intervention the mean difference between groups was -0.78 points on the HAM-D(17 (95% CI -3.2 to 1.6; P = .52. At follow-up, the participants in the aerobic exercise group had higher maximal oxygen uptake (mean difference 4.4 l/kg/min; 95% CI 1.7 to 7.0; P = .001 and visuospatial memory on Rey's Complex Figure Test (mean difference 3.2 points; 95% CI 0.9 to 5.5; P = .007 and lower blood glucose levels (mean difference 0.2 mmol/l; 95% CI 0.0 to 0.5; P = .04 and waist circumference (mean difference 2.2 cm; 95% CI 0.3 to 4.1; P = .02 compared with the stretching exercise group.The results of this trial does not support any antidepressant effect of referring patients with major depression to a three months aerobic exercise program. Due to lower recruitment than anticipated, the trial was terminated prior to reaching the pre-defined sample size of 212 participants; therefore the results should be interpreted in that context. However, the DEMO-II trial does suggest that an exercise program for patients with depression offer positive short-term effects on maximal oxygen uptake, visuospatial memory, fasting glucose levels, and waist circumference.ClinicalTrials.gov NCT00695552.

  14. Innovative gas offers

    International Nuclear Information System (INIS)

    Sala, O.; Mela, P.; Chatelain, F.

    2007-01-01

    New energy offers are progressively made available as the opening of gas market to competition becomes broader. How are organized the combined offers: gas, electricity, renewable energies and energy services? What are the marketing strategies implemented? Three participants at this round table present their offer and answer these questions. (J.S.)

  15. Human papilloma virus (HPV) infection leads to the development of head and neck lesions but offers better prognosis in malignant Indian patients.

    Science.gov (United States)

    Sarkar, Shreya; Alam, Neyaz; Chakraborty, Jayanta; Biswas, Jaydip; Mandal, Syam Sundar; Roychoudhury, Susanta; Panda, Chinmay Kumar

    2017-06-01

    Head and neck cancers constitute a multifactorial global disease burden and are associated with human papilloma virus (HPV) as a possible risk factor. The aim of the study is to understand the relationship between HPV and the development of head and neck lesions in Indian patients. To this end, frequency of HPV was assessed in relation to different demographic and etiological features and correlated with patient survival. The prevalence of HPV significantly increased from mild dysplastic lesions (43.6%) to head and neck squamous cell carcinoma (HNSCC) stage IV (68.5%) with HPV 16 being pre-dominant in both dysplasia (43.8%) and HNSCC (61.5%). Similar trend was observed in increasing grades of the tumour. In invasive lesions, patients aged below the median age of onset showed significantly higher occurrence of HPV than those above it. Patients harbouring HPV showed a significantly better survival irrespective of age of onset. Likewise, better survival was observed in tobacco habit negative/HPV-positive patients, and as reflected in both univariate and multivariate analysis. Majority of the HPV 16-positive samples showed moderate/high nuclear expression of HPV E6 and E7 proteins in tumours and respective basal layer of adjacent normal tissues. Thus, our data indicate that frequent HPV infection, along with tobacco habit, is a pre-requisite factor for the development of HNSCC of Indian patients but offers a better survival even during tobacco usage, implicating its diagnostic and prognostic importance.

  16. Cytoreductive surgery and HIPEC offers similar outcomes in patients with rectal peritoneal metastases compared to colon cancer patients: a matched case control study.

    Science.gov (United States)

    Simkens, Geert A; van Oudheusden, Thijs R; Braam, Hidde J; Wiezer, Marinus J; Nienhuijs, Simon W; Rutten, Harm J; van Ramshorst, Bert; de Hingh, Ignace H

    2016-04-01

    The effect of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with rectal peritoneal metastases (PM) is unclear. This case-control study aims to assess the results of cytoreduction and HIPEC in patients with rectal PM compared to colon PM patients. Colorectal PM patients treated with complete macroscopic cytoreduction and HIPEC were included. Two colon cancer patients were case-matched for each rectal cancer patient, based on prognostic factors (T stage, N stage, histology type, and extent of PM). Short- and long-term outcomes were compared between both groups. From 317 patients treated with complete macroscopic cytoreduction and HIPEC, 29 patients (9.1%) had rectal PM. Fifty-eight colon cases were selected as control patients. Baseline characteristics were similar between groups. Major morbidity was 27.6% and 34.5% in the rectal and colon group, respectively (P = 0.516). Median disease-free survival was 13.5 months in the rectal group and 13.6 months in the colon group (P = 0.621). Two- and five-year overall survival rates were 54%/32% in rectal cancer patients, and 61%/24% in colon cancer patients (P = 0.987). Cytoreduction and HIPEC in selected patients with rectal PM is feasible and provides similar outcomes as in colon cancer patients. Rectal PM should not be regarded a contra-indication for cytoreduction and HIPEC in selected patients. J. Surg. Oncol. 2016;113:548-553. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  17. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial.

    Science.gov (United States)

    Edinger, Jack D; Wohlgemuth, William K; Krystal, Andrew D; Rice, John R

    2005-11-28

    Insomnia is common and debilitating to fibromyalgia (FM) patients. Cognitive-behavioral therapy (CBT) is effective for many types of patients with insomnia, but has yet to be tested with FM patients. This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms. This randomized clinical trial enrolled 47 FM patients with chronic insomnia complaints. The study compared CBT, sleep hygiene (SH) instructions, and usual FM care alone. Outcome measures were subjective (sleep logs) and objective (actigraphy) total sleep time, sleep efficiency, total wake time, sleep latency, wake time after sleep onset, and questionnaire measures of global insomnia symptoms, pain, mood, and quality of life. Forty-two patients completed baseline and continued into treatment. Sleep logs showed CBT-treated patients achieved nearly a 50% reduction in their nocturnal wake time by study completion, whereas SH therapy- and usual care-treated patients achieved only 20% and 3.5% reductions on this measure, respectively. In addition, 8 (57%) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 (17%) of 12 SH therapy recipients and 0% of the usual care group. Comparable findings were noted for similar actigraphic improvement criteria. The SH therapy patients showed favorable outcomes on measures of pain and mental well-being. This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies. Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients. Larger clinical trials of this intervention with FM patients seem warranted.

  18. Talking About Trials: Overcoming Bottlenecks in Clinical Communication

    Science.gov (United States)

    Participation in clinical trials by adult patients is dismally low. No one knows how many patients are offered the opportunity to enroll in trials. NCI researchers are studying how patients hear about trials, whether they discuss enrollment with their providers, and the roles they play in deciding to participate in a trial.

  19. Understanding clinicians' decisions to offer intravenous thrombolytic treatment to patients with acute ischaemic stroke: a protocol for a discrete choice experiment.

    Science.gov (United States)

    De Brún, Aoife; Flynn, Darren; Joyce, Kerry; Ternent, Laura; Price, Christopher; Rodgers, Helen; Ford, Gary A; Lancsar, Emily; Rudd, Matthew; Thomson, Richard G

    2014-07-09

    Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patients meeting specific criteria. Approximately 12% of eligible patients in England, Wales and Northern Ireland received thrombolysis in the first quarter of 2013, yet as many as 15% are eligible to receive treatment. Suboptimal use of thrombolysis may have been largely attributable to structural factors; however, with the widespread implementation of 24/7 hyper acute stroke services, continuing variation is likely to reflect differences in clinical decision-making, in particular the influence of ambiguous areas within the guidelines, licensing criteria and research evidence. Clinicians' perceptions about thrombolysis may now exert a greater influence on treatment rates than structural/service factors. This research seeks to elucidate factors influencing thrombolysis decision-making by using patient vignettes to identify (1) patient-related and clinician-related factors that may help to explain variation in treatment and (2) associated trade-offs in decision-making based on the interplay of critical factors. A discrete choice experiment (DCE) will be conducted to better understand how clinicians make decisions about whether or not to offer thrombolysis to patients with acute ischaemic stroke. To inform the design, exploratory work will be undertaken to ensure that (1) all potentially influential factors are considered for inclusion; and (2) to gain insights into the 'grey areas' of patient factors. A fractional factorial design will be used to combine levels of patient factors in vignettes, which will be presented to clinicians to allow estimation of the variable effects on decisions to offer thrombolysis. Ethical approval for this study was obtained from the Newcastle University Research Ethics Committee. The results will be disseminated in peer review publications and at national conferences. Findings will be translated into continuing professional development activities

  20. A Plutocratic Proposal: an ethical way for rich patients to pay for a place on a clinical trial.

    Science.gov (United States)

    Masters, Alexander; Nutt, Dominic

    2017-11-01

    Many potential therapeutic agents are discarded before they are tested in humans. These are not quack medications. They are drugs and other interventions that have been developed by responsible scientists in respectable companies or universities and are often backed up by publications in peer-reviewed journals. These possible treatments might ease suffering and prolong the lives of innumerable patients, yet they have been put aside. In this paper, we outline a novel mechanism-the Plutocratic Proposal-to revive such neglected research and fund early phase clinical trials. The central idea of the Proposal is that any patient who rescues a potential therapeutic agent from neglect by funding early phase clinical trials (either entirely or in large part) should be offered a place on the trial. 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/.

  1. Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial.

    Science.gov (United States)

    Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M

    2017-04-01

    Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

  2. Patient safety in elderly hip fracture patients: design of a randomised controlled trial.

    NARCIS (Netherlands)

    Merten, H.; Lubberding, S.; Wagtendonk, I. van; Johannesma, P.C.; Wagner, C.

    2011-01-01

    BACKGROUND: The clinical environment in which health care providers have to work everyday is highly complex; this increases the risk for the occurrence of unintended events. The aim of this randomised controlled trial is to improve patient safety for a vulnerable group of patients that have to go

  3. Patient safety in elderly hip fracture patients: design of a randomised controlled trial

    NARCIS (Netherlands)

    Merten, H.; Lubberding, S.; van Wagtendonk, I.; Johannesma, P.C.; Wagner, C.

    2011-01-01

    Background: The clinical environment in which health care providers have to work everyday is highly complex; this increases the risk for the occurrence of unintended events. The aim of this randomised controlled trial is to improve patient safety for a vulnerable group of patients that have to go

  4. Internet Presentation of Departments of Pediatric Surgery in Germany and Their Compliance with Recommended Criteria for Promoting Services and Offering Professional Information for Patients.

    Science.gov (United States)

    Farhat, Naim; Zoeller, Christoph; Petersen, Claus; Ure, Benno

    2016-08-01

    Introduction The presentation of health institutions in the internet is highly variable concerning marketing features and medical information. We aimed to investigate the structure and the kind of information provided on the Web sites of all departments of pediatric surgery in Germany. Furthermore, we aimed to identify the degree to which these Web sites comply with internet marketing recommendations for generating business. Method The Web sites of all pediatric surgery units referred to as departments on the official Web site of the German Society of Pediatric Surgery (GSPS) were assessed. The search engine Google was used by entering the terms "pediatric surgery" and the name of the city. Besides general data eight content characteristics focusing on ranking, accessibility, use of social media, multilingual sites, navigation options, selected images, contact details, and medical information were evaluated according to published recommendations. Results A total of 85 departments of pediatric surgery were included. On Google search results 44 (52%) ranked number one and 34 (40%) of the department's homepages were accessible directly through the homepage link of the GSPS. A link to own digital and/or social media was offered on 11 (13%) homepages. Nine sites were multilingual. The most common navigation bar item was clinical services on 74 (87%) homepages. Overall, 76 (89%) departments presented their doctors and 17 (20%) presented other staff members with images of doctors on 53 (62%) and contact data access from the homepage on 68 (80%) Web sites. On 25 (29%) Web sites information on the medical conditions treated were presented, on 17 (20%) details of treating concepts, and on 4 (5%) numbers of patients with specific conditions treated in the own department per year. Conclusion We conclude that numerous of the investigated online presentations do not comply with recommended criteria for offering professional information for patients and for promoting

  5. Exercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol

    Directory of Open Access Journals (Sweden)

    Tilvis Reijo S

    2010-10-01

    Full Text Available Abstract Background Besides cognitive decline, Alzheimer's disease (AD leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. Methods During years 2008-2010, patients with AD (n = 210 living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1 tailored home-based exercise twice weekly 2 group-based exercise twice weekly in rehabilitation center 3 control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36. Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. Discussion To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. Trial registration ACTRN12608000037303

  6. The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study.

    Science.gov (United States)

    Jensen, Kamilla B; Morthorst, Britt R; Vendsborg, Per B; Hjorthøj, Carsten R; Nordentoft, Merete

    2015-04-14

    Studies show a high and growing prevalence of mental disorders in the population worldwide. 25% of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills. The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional care. An investigation of the effect of MHFA offered a Danish population is needed. The design is a randomized waitlist-controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated to be "mental health first-aiders" following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out. Outcomes measured are sensitive to interpretation, hence a challenge to uniform. This trial will add to the use of a mixed-methods design and exemplify how it can strengthen the analysis and take up the challenge of a sensitive outcome. https://clinicaltrials.gov identifier NCT02334020.

  7. The deceptive concept of hypoparathyroidism and recurrence after parathyroidectomy in dialysis patients: are we offering a Procrustean bed to some patients?

    Directory of Open Access Journals (Sweden)

    FABIO LUIZ DE MENEZES MONTENEGRO

    Full Text Available ABSTRACT Objective: to analyze the frequency of hypoparathyroidism and of its recurrence after parathyroidectomy in dialysis patients according to different existing classifications. Methods: we conducted a retrospective study of 107 consecutive dialysis patients undergoing total parathyroidectomy with immediate autograft in a tertiary hospital from 2006 to 2010. We studied the changes in PTH levels in the postoperative period over time. Were grouped patients according to different PTH levels targets recommended according to the dosage method and by the American and Japanese Nephrology Societies, and by an International Experts Consortium. Results: after parathyroidectomy, there was sustained reduction in serum calcium and phosphatemia. The median value of PTH decreased from 1904pg/ml to 55pg/ml in 12 months. Depending on the considered target level, the proportion of patients below the target ranged between 17% and 87%. On the other hand, the proportion of patients with levels above the target ranged from 3% to 37%. Conclusion: the application of different recommendations for PTH levels after parathyroidectomy in dialysis patients may lead to incorrect classifications of hypoparathyroidism or recurrent hyperparathyroidism and resultin discordant therapeutic conducts.

  8. Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens.

    Science.gov (United States)

    Maloney, Cristine; Lyons, Kathleen Doyle; Li, Zhongze; Hegel, Mark; Ahles, Tim A; Bakitas, Marie

    2013-04-01

    ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. To gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation. A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. The benefits of the intervention and the positive aspects of trial participation outweighed trial "burdens". This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?

  9. Assessment of Perceived Cost to the Patient and Other Barriers to Clinical Trial Participation

    Science.gov (United States)

    Weckstein, Douglas J.; Thomas, Christian A.; Emery, Ivette F.; Shea, Barbara F.; Fleury, Alison; White, Margaret E.; Chase, Elizabeth; Robinson, Cindy; Frazier, Stacey; Pilar, Christine

    2011-01-01

    Purpose: Less than 5% of patients with cancer participate in trials. Few studies have specifically addressed the role of cost to the patient as an influence on trial participation. Our main purpose was to determine the importance of added cost as a barrier to clinical trial participation in the community setting. Our secondary goal was to determine the most prevalent barriers to trial participation for patients. Patients and Methods: Four community practices in New England issued surveys to consecutive cohorts of patients with cancer. Patients were assessed for eligibility for clinical trials at their practice site. Trial-eligible patients who declined participation were asked to select reasons that contributed to their decision. Results: Surveys were issued to 1,755 patients. Seventy-one percent of all trial-eligible patients returned surveys. Forty-four percent of nonparticipating trial-eligible patients did not recall hearing about clinical trials from their provider. The most common reasons cited by trial-eligible patients for declining trial participation were fear of adverse effects (50%) and discomfort with random assignment (44%). Twenty-eight percent cited concerns about added cost, and 12% noted cost as the most important factor in their decision. Conclusion: Concerns about adverse effects and random assignment were the most common reasons cited by patients declining trial participation in four community oncology practices in New England. Cost considerations were important for a significant proportion of these patients. Many patients eligible for trial participation were not informed by their provider about the availability of research trials. PMID:22211132

  10. Proactive palliative care for patients with COPD (PROLONG): a pragmatic cluster controlled trial

    NARCIS (Netherlands)

    Duenk, R.G.; Verhagen, C.A.; Bronkhorst, E.M.; Mierlo, P. van; Broeders, M.E.A.C.; Collard, S.M.; Dekhuijzen, P.N.R.; Vissers, K.C.P.; Heijdra, Y.F.; Engels, Y.

    2017-01-01

    BACKGROUND AND AIM: Patients with advanced chronic obstructive pulmonary disease (COPD) have poor quality of life. The aim of this study was to assess the effects of proactive palliative care on the well-being of these patients. TRIAL REGISTRATION: This trial is registered with the Netherlands Trial

  11. Geographic Differences in Patients in a Global Acute Heart Failure Clinical Trial (from the ASCEND-HF Trial)

    NARCIS (Netherlands)

    Metra, Marco; Mentz, Robert J.; Hernandez, Adrian F.; Heizer, Gretchen M.; Armstrong, Paul W.; Clausell, Nadine; Corbalan, Ramon; Costanzo, Maria Rosa; Dickstein, Kenneth; Dunlap, Mark E.; Ezekowitz, Justin A.; Howlett, Jonathan G.; Komajda, Michel; Krum, Henry; Lombardi, Carlo; Fonarow, Gregg C.; McMurray, John J. V.; Nieminen, Markku S.; Swedberg, Karl; Voors, Adriaan A.; Starling, Randall C.; Teerlink, John R.; O'Connor, Christopher M.

    2016-01-01

    A growing number of countries and geographical regions are involved in major clinical trials. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure is the largest trial in acutely decompensated heart failure (HF) with patients from 5 geographical regions: North America

  12. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

    NARCIS (Netherlands)

    Lin, Carol Alice; Bhandari, Mohit; Guyatt, Gordon; Walter, Stephen D.; Schemitsch, Emil H.; Swiontkowski, Marc; Sanders, David; Tornetta, Paul; Sanders, David W.; Walter, Stephen; Sprague, Sheila; Heels-Ansdell, Diane; Buckingham, Lisa; Leece, Pamela; Viveiros, Helena; Mignott, Tashay; Ansell, Natalie; Sidorkewicz, Natalie; Agel, Julie; Bombardier, Claire; Berlin, Jesse A.; Bosse, Michael; Browner, Bruce; Gillespie, Brenda; Jones, Alan; O'Brien, Peter; Poolman, Rudolf; Macleod, Mark D.; Carey, Timothy; Leitch, Kellie; Bailey, Stuart; Gurr, Kevin; Konito, Ken; Bartha, Charlene; Low, Isolina; MacBean, Leila V.; Ramu, Mala; Reiber, Susan; Strapp, Ruth; Tieszer, Christina; Kreder, Hans J.; Stephen, David J. G.; Axelrod, Terry S.; Yee, Albert J. M.; Richards, Robin R.; Finkelstein, Joel; Gofton, Wade; Murnaghan, John; Schatztker, Joseph; Ford, Michael; Bulmer, Beverly; Conlan, Lisa; Laflamme, G. Yves; Berry, Gregory; Beaumont, Pierre; Ranger, Pierre; Laflamme, Georges-Henri; Gagnon, Sylvain; Malo, Michel; Fernandes, Julio; Poirier, Marie-France; McKee, Michael D.; Waddell, James P.; Bogoch, Earl R.; Daniels, Timothy R.; McBroom, Robert R.; Vicente, Milena R.; Storey, Wendy; Wild, Lisa M.; McCormack, Robert; Perey, Bertrand; Goetz, Thomas J.; Pate, Graham; Penner, Murray J.; Panagiotopoulos, Kostas; Pirani, Shafique; Dommisse, Ian G.; Loomer, Richard L.; Stone, Trevor; Moon, Karyn; Zomar, Mauri; Webb, Lawrence X.; Teasdall, Robert D.; Birkedal, John Peter; Martin, David Franklin; Ruch, David S.; Kilgus, Douglas J.; Pollock, David C.; Harris, Mitchel Brion; Wiesler, Ethan Ron; Ward, William G.; Shilt, Jeffrey Scott; Koman, Andrew L.; Poehling, Gary G.; Kulp, Brenda; Creevy, William R.; Stein, Andrew B.; Bono, Christopher T.; Einhorn, Thomas A.; Brown, T. Desmond; Pacicca, Donna; Sledge, John B.; Foster, Timothy E.; Voloshin, Ilva; Bolton, Jill; Carlisle, Hope; Shaughnessy, Lisa; Obremskey, William T.; LeCroy, C. Michael; Meinberg, Eric G.; Messer, Terry M.; Craig, William L.; Dirschl, Douglas R.; Caudle, Robert; Harris, Tim; Elhert, Kurt; Hage, William; Jones, Robert; Piedrahita, Luis; Schricker, Paul O.; Driver, Robin; Godwin, Jean; Kregor, Philip James; Tennent, Gregory; Truchan, Lisa M.; Sciadini, Marcus; Shuler, Franklin D.; Driver, Robin E.; Nading, Mary Alice; Neiderstadt, Jacky; Vap, Alexander R.; Vallier, Heather A.; Patterson, Brendan M.; Wilber, John H.; Wilber, Roger G.; Sontich, John K.; Moore, Timothy Alan; Brady, Drew; Cooperman, Daniel R.; Davis, John A.; Cureton, Beth Ann; Mandel, Scott; Orr, R. Douglas; Sadler, John T. S.; Hussain, Tousief; Rajaratnam, Krishan; Petrisor, Bradley; Drew, Brian; Bednar, Drew A.; Kwok, Desmond C. H.; Pettit, Shirley; Hancock, Jill; Cole, Peter A.; Smith, Joel J.; Brown, Gregory A.; Lange, Thomas A.; Stark, John G.; Levy, Bruce A.; Swiontkowski, Marc F.; Garaghty, Mary J.; Salzman, Joshua G.; Schutte, Carol A.; Tastad, Linda; Vang, Sandy; Seligson, David; Roberts, Craig S.; Malkani, Arthur L.; Sanders, Laura; Dyer, Carmen; Heinsen, Jessica; Smith, Langan; Madanagopal, Sudhakar; Frantz-Bush, Linda; Coupe, Kevin J.; Tucker, Jeffrey J.; Criswell, Allen R.; Buckle, Rosemary; Rechter, Alan Jeffrey; Sheth, Dhiren Shaskikant; Urquart, Brad; Trotscher, Thea; Anders, Mark J.; Kowalski, Joseph M.; Fineberg, Marc S.; Bone, Lawrence B.; Phillips, Matthew J.; Rohrbacher, Bernard; Stegemann, Philip; Mihalko, William M.; Buyea, Cathy; Augustine, Stephen J.; Jackson, William Thomas; Solis, Gregory; Ero, Sunday U.; Segina, Daniel N.; Berrey, Hudson B.; Agnew, Samuel G.; Fitzpatrick, Michael; Campbell, Lakina C.; Derting, Lynn; McAdams, June; Goslings, J. Carel; Ponsen, Kees Jan; Luitse, Jan; Kloen, Peter; Joosse, Pieter; Winkelhagen, Jasper; Duivenvoorden, Raphaël; Teague, David C.; Davey, Joseph; Sullivan, J. Andy; Ertl, William J. J.; Puckett, Timothy A.; Pasque, Charles B.; Tompkins, John F.; Gruel, Curtis R.; Kammerlocher, Paul; Lehman, Thomas P.; Puffinbarger, William R.; Carl, Kathy L.; Weber, Donald W.; Jomha, Nadr M.; Goplen, Gordon R.; Masson, Edward; Beaupre, Lauren A.; Greaves, Karen E.; Schaump, Lori N.; Jeray, Kyle J.; Goetz, David R.; Westberry, David E.; Broderick, J. Scott; Moon, Bryan S.; Tanner, Stephanie L.; Powell, James N.; Buckley, Richard E.; Elves, Leslie; Connolly, Stephen; Abraham, Edward P.; Steele, Trudy; Ellis, Thomas; Herzberg, Alex; Brown, George A.; Crawford, Dennis E.; Hart, Robert; Hayden, James; Orfaly, Robert M.; Vigland, Theodore; Vivekaraj, Maharani; Bundy, Gina L.; Miclau, Theodore; Matityahu, Amir; Coughlin, R. Richard; Kandemir, Utku; McClellan, R. Trigg; Lin, Cindy Hsin-Hua; Karges, David; Cramer, Kathryn; Watson, J. Tracy; Moed, Berton; Scott, Barbara; Beck, Dennis J.; Orth, Carolyn; Puskas, David; Clark, Russell; Jones, Jennifer; Egol, Kenneth A.; Paksima, Nader; France, Monet; Wai, Eugene K.; Johnson, Garth; Wilkinson, Ross; Gruszczynski, Adam T.; Vexler, Liisa

    2016-01-01

    To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Retrospective review of prospectively collected data from a large clinical trial. Six level-1 international trauma centers. We compared rates and timing of reoperation in a subset of

  13. The deceptive concept of hypoparathyroidism and recurrence after parathyroidectomy in dialysis patients: are we offering a Procrustean bed to some patients?

    Science.gov (United States)

    Montenegro, Fabio Luiz DE Menezes; Brescia, Marilia D'Elboux Guimaraes; Nascimento, Climério Pereira; Massoni, Ledo Mazzei; Arap, Sérgio Samir; Santos, Stênio Roberto Castro Lima; Goldenstein, Patrícia Taschner; Bueno, Rodrigo Oliveira; Custodio, Melani Ribeiro; Jorgetti, Vanda; Moyses, Rosa Maria Affonso

    2016-01-01

    to analyze the frequency of hypoparathyroidism and of its recurrence after parathyroidectomy in dialysis patients according to different existing classifications. we conducted a retrospective study of 107 consecutive dialysis patients undergoing total parathyroidectomy with immediate autograft in a tertiary hospital from 2006 to 2010. We studied the changes in PTH levels in the postoperative period over time. Were grouped patients according to different PTH levels targets recommended according to the dosage method and by the American and Japanese Nephrology Societies, and by an International Experts Consortium. after parathyroidectomy, there was sustained reduction in serum calcium and phosphatemia. The median value of PTH decreased from 1904pg/ml to 55pg/ml in 12 months. Depending on the considered target level, the proportion of patients below the target ranged between 17% and 87%. On the other hand, the proportion of patients with levels above the target ranged from 3% to 37%. the application of different recommendations for PTH levels after parathyroidectomy in dialysis patients may lead to incorrect classifications of hypoparathyroidism or recurrent hyperparathyroidism and resultin discordant therapeutic conducts. analisar as frequências de hipoparatireoidismo e de recidiva do hiperparatireoidismo após paratireoidectomia em pacientes dialíticos de acordo com diferentes classificações existentes. estudo retrospectivo de 107 pacientes dialíticos consecutivamente submetidos à paratireoidectomia total com autoenxerto imediato em um hospital terciário no período de 2006 a 2010. A variação dos níveis de PTH no pós-operatório foi estudada ao longo do tempo. Os pacientes foram agrupados de acordo com diferentes metas de níveis de PTH recomendados de acordo com o método de dosagem e pelas sociedades de nefrologia americana, japonesa e de um consórcio internacional de especialistas. após a paratireoidectomia, houve redução sustentada da calcemia e

  14. The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation.

    Science.gov (United States)

    Fanning, Laura; Ilomäki, Jenni; Bell, J Simon; Dārziņš, Pēteris

    2017-11-01

    Trials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF. A cross-sectional study was undertaken. All patients discharged with AF between 2012 and 2015 from a large public hospital network in Melbourne, Australia, were identified. Inclusion and exclusion criteria from the DOAC trials were applied. The proportions of hospitalized patients with AF who would have been eligible for the dabigatran (RE-LY), rivaroxaban (ROCKET-AF) and apixaban (ARISTOTLE) trials were estimated, as was pooled eligibility for all three trials. Characteristics of eligible and ineligible patients were compared. For the 4734 patients, application of the inclusion and exclusion criteria resulted in 60.5, 52.6 and 35.8% eligibility for the trials of apixaban, dabigatran and rivaroxaban, respectively. Pooled eligibility across all three trials demonstrated that 33.4% of the patients would have been eligible for all three trials but 36.7% ineligible for any trial. Ineligible patients who met exclusion criteria were older and experienced more comorbidities. The apixaban and dabigatran trials may be the most representative of hospitalized patients with AF. The DOAC trial results can readily be extrapolated to, and guide prescribing for, at least two thirds of patients discharged from a large metropolitan health service in Australia.

  15. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  16. The use and reporting of patient-reported outcomes in phase III breast cancer trials.

    Science.gov (United States)

    Brim, Remy L; Pearson, Steven D

    2013-04-01

    Public and government attention to patient-centered research outcomes has been increasing, evidenced by the recent formation of the Patient Centered Outcomes Research Institute. Drug development clinical trials can be made more patient-centered by collecting patient-reported outcome measures that can inform decision making by patients and their health-care providers. Patient-reported outcomes are important to collect in trials of breast cancer therapeutics, which encompass a wide range of treatment regimens and side effects. We sought to determine recent trends in the use of patient-reported outcomes in drug trials for the treatment of breast cancer and evaluate the reporting of these data in study publications. We searched ClinicalTrials.gov for phase III breast cancer drug trials, recording information on start date, primary completion date, primary outcome measure, primary sponsor, stage of cancer, and patient-reported outcome use. To assess the reporting of patient-reported outcome data, Google.com and PubMed.gov were searched for all publications resulting from included trials. We found 236 eligible trials, starting between May 1989 and December 2011. Of these trials, 83 (35%) stipulated patient-reported outcome use. The rate of patient-reported outcome use in recent years has shown no increase over earlier time periods: 37% (1989-2000) versus 36% (2004-2007) versus 30% (2008-2011) (p = 0.8). Trials with sponsorship led by the pharmaceutical industry and trials including patients with locally advanced or metastatic disease had the highest rates of patient-reported outcome use (40/87 (46%) and 44/102 (43%), respectively). Among the 83 trials that collected patient-reported outcome measures, 36 were completed a minimum of 2 years before our analysis; of these 36 studies, 19 (53%) had published patient-reported outcome data. Data were limited to self-reported descriptions of trials listed on the ClinicalTrial.gov database, which is the best compendium of trial

  17. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial.

    Science.gov (United States)

    Wahidi, Momen M; Reddy, Chakravarthy; Yarmus, Lonny; Feller-Kopman, David; Musani, Ali; Shepherd, R Wesley; Lee, Hans; Bechara, Rabih; Lamb, Carla; Shofer, Scott; Mahmood, Kamran; Michaud, Gaetane; Puchalski, Jonathan; Rafeq, Samaan; Cattaneo, Stephen M; Mullon, John; Leh, Steven; Mayse, Martin; Thomas, Samantha M; Peterson, Bercedis; Light, Richard W

    2017-04-15

    Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allow patients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined. To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis. Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter. The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34-83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms. Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).

  18. Meta-analysis of randomized clinical trials in the era of individual patient data sharing.

    Science.gov (United States)

    Kawahara, Takuya; Fukuda, Musashi; Oba, Koji; Sakamoto, Junichi; Buyse, Marc

    2018-01-12

    Individual patient data (IPD) meta-analysis is considered to be a gold standard when the results of several randomized trials are combined. Recent initiatives on sharing IPD from clinical trials offer unprecedented opportunities for using such data in IPD meta-analyses. First, we discuss the evidence generated and the benefits obtained by a long-established prospective IPD meta-analysis in early breast cancer. Next, we discuss a data-sharing system that has been adopted by several pharmaceutical sponsors. We review a number of retrospective IPD meta-analyses that have already been proposed using this data-sharing system. Finally, we discuss the role of data sharing in IPD meta-analysis in the future. Treatment effects can be more reliably estimated in both types of IPD meta-analyses than with summary statistics extracted from published papers. Specifically, with rich covariate information available on each patient, prognostic and predictive factors can be identified or confirmed. Also, when several endpoints are available, surrogate endpoints can be assessed statistically. Although there are difficulties in conducting, analyzing, and interpreting retrospective IPD meta-analysis utilizing the currently available data-sharing systems, data sharing will play an important role in IPD meta-analysis in the future.

  19. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

    Science.gov (United States)

    Pacik, Peter T; Geletta, Simon

    2017-06-01

    pain-free intercourse as noted by patient communications and serial female sexual function studies. Further studies are indicated to better understand the individual components of this multimodal treatment program. Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med 2017;5:e114-e123. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Enrollment of Patients With Lung and Colorectal Cancers Onto Clinical Trials

    OpenAIRE

    Fouad, Mona N.; Lee, Jeannette Y.; Catalano, Paul J.; Vogt, Thomas M.; Zafar, Syed Yousuf; West, Dee W.; Simon, Christian; Klabunde, Carrie N.; Kahn, Katherine L.; Weeks, Jane C.; Kiefe, Catarina I.

    2012-01-01

    Both practice environment and patient clinical and demographic characteristics are associated with cancer clinical trial enrollment; simultaneous intervention may be required when trying to increase enrollment rates.

  1. Offers for our members

    CERN Document Server

    Staff Association

    2013-01-01

    The Courir shops propose the following offer: 15% discount on all articles (not on sales) in the Courir shops (Val Thoiry, Annemasse and Neydens) and 5% discount on sales upon presentation of your Staff Association membership card and an identity card before payment. Summer is here, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 21 € instead of 26 €. Access to Aqualibi: 5 € instead of 8 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Car park free. * * * * * Aquaparc : Day ticket: – Children: 30 CHF instead of 39 CHF – Adults : 36 CHF instead of 49 CHF Bonus! Free for children under 5.

  2. Offers for our members

    CERN Multimedia

    Staff Association

    2017-01-01

    Summer is here, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 24 € instead of 30 €. Access to Aqualibi: 5 € instead of 6 € on presentation of your SA member ticket. Free for children under 100 cm. Car park free. * * * * * Aquaparc : Day ticket: – Children: 33 CHF instead of 39 CHF – Adults : 33 CHF instead of 49 CHF Bonus! Free for children under 5.

  3. Offers for our members

    CERN Multimedia

    Staff Association

    2017-01-01

    Summer is coming, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 24 € instead of 30 €. Access to Aqualibi: 5 € instead of 6 € on presentation of your SA member ticket. Free for children under 100 cm. Car park free. * * * * * Aquaparc : Day ticket: – Children: 33 CHF instead of 39 CHF – Adults : 33 CHF instead of 49 CHF Bonus! Free for children under 5.

  4. Ameliorating Patient Stigma Amongst Staff Working With Personality Disorder: Randomized Controlled Trial of Self-Management Versus Skills Training.

    Science.gov (United States)

    Clarke, Sue; Taylor, Georgina; Bolderston, Helen; Lancaster, Joanna; Remington, Bob

    2015-11-01

    Patients diagnosed with a personality disorder (PD) are often stigmatized by the healthcare staff who treat them. This study aimed to compare the impact on front-line staff of a self-management Acceptance and Commitment Therapy-based training intervention (ACTr) with a knowledge- and skills-based Dialectical Behaviour Training intervention (DBTr). A service-based randomized controlled trial was conducted comparing the effects of 2-day ACTr (N = 53) and DBTr (N = 47) staff workshops over 6 months. Primary outcome measures were staff attitudes towards patients and staff-patient relationships. For both interventions, staff attitudes, therapeutic relationship, and social distancing all improved pre- to postintervention, and these changes were maintained at 6-month follow-up. Although offering different resources to staff, both ACTr and DBTr were associated with an improved disposition towards PD patients. Future research could evaluate a combined approach, both for staff working with PD patients and those working with other stigmatized groups.

  5. Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial

    Science.gov (United States)

    Kulshreshtha, Ambar; Kvedar, Joseph C.; Goyal, Abhinav; Halpern, Elkan F.; Watson, Alice J.

    2010-01-01

    Remote monitoring (RM) of homebound heart failure (HF) patients has previously been shown to reduce hospital admissions. We conducted a pilot trial of ambulatory, non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting. Eligible patients from Massachusetts General Hospital (n = 150) were randomized to a control group (n = 68) or to a group that was offered RM (n = 82). The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study. Participants in the RM program had a lower all-cause per person readmission rate (mean = 0.64, SD ± 0.87) compared to the usual care group (mean = 0.73, SD ± 1.51; P-value = .75) although the difference was not statistically significant. HF-related readmission rate was similarly reduced in participants. This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates. PMID:20508741

  6. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....

  7. Induction chemotherapy with paclitaxel and cisplatin followed by radiotherapy for larynx organ preservation in advanced laryngeal and hypopharyngeal cancer offers moderate late toxicity outcome (DeLOS-I-trial).

    Science.gov (United States)

    Dietz, Andreas; Rudat, Volker; Dreyhaupt, Jens; Pritsch, Maria; Hoppe, Florian; Hagen, Rudolph; Pfreundner, Leo; Schröder, Ursula; Eckel, Hans; Hess, Markus; Schröder, Michael; Schneider, Petra; Jens, Bünzel; Zenner, Hans P; Werner, Jochen A; Engenhardt-Cabillic, Rita; Vanselow, Bernhard; Plinkert, Peter; Niewald, Marcus; Kuhnt, Thomas; Budach, Wilfried; Flentje, Michael

    2009-08-01

    A prospective multicenter phase-II trial (12 centers) was performed by the German larynx organ preservation group (DeLOS) to evaluate the effect of induction chemotherapy (ICHT) with paclitaxel/cisplatin (TP), followed by accelerated-hyperfractionated (concomitant boost) radiotherapy (RT) in responders. The trial was focused on larynx preservation, tumor control, survival, salvage surgery and late toxicity in patients with advanced larynx/hypopharynx carcinoma eligible for total laryngectomy (LE). Seventy-one patients (40 larynx, 87.5% St. III, IV; 31 hypopharynx, 93.4% St. III, IV) were enrolled into the study and treated with ICHT (200 mg/m(2) paclitaxel, 100 mg/m(2) cisplatin; day 1, 22) according to the DeLOS protocol. Patients with complete or partial tumor response proceeded to RT (69.9 Gy in 5.5 weeks). Non-responders received a LE followed by postoperative RT (56-70 Gy in 5.5-7 weeks). The response rate to ICHT for larynx cancer was 69.6% (7.1% complete, 62.5% partial response) and for hypopharyngeal cancer was 84.3% (6.9% complete, 77.4% partial response). Overall survival after 36 months was 60.3% (95% CI, 48.4-72.2%), after 42 months was 56.5% (95% CI, 44.2-68.8%). Laryngectomy-free survival was as follows: after 36 months, 43.0% (95% CI, 30.9-55.0%); after 42 months, 41.3% (95% CI, 29.3-53.3%). Both parameters did not show different outcomes after distinguishing larynx from hypopharynx. LE was indicated in 15 non-responders after ICHT. Five of the 15 non-responders refused the laryngectomy. Two of the five received RT instead and had no evidence of disease 42 months after RT. Late toxicity (dysphagia III, IV LENT SOMA score in laryngectomy-free survivors: after 6 months, 1.8%; 12 months, 11.4%; 18 months, 14.5%; 24 months, 8.1%; 36 months, 16%) and salvage surgery (4 pharyngocutaneous fistulas in 27 operations) were tolerable. In a large portion of patients eligible for LE, the larynx could be preserved with satisfying functional outcome. Good

  8. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  9. Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review.

    Science.gov (United States)

    Gaudry, Stéphane; Messika, Jonathan; Ricard, Jean-Damien; Guillo, Sylvie; Pasquet, Blandine; Dubief, Emeline; Boukertouta, Tanissia; Dreyfuss, Didier; Tubach, Florence

    2017-12-01

    Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other). Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge. Patient-important outcomes are rarely primary

  10. Birth weight differences between those offered financial voucher incentives for verified smoking cessation and control participants enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), employing an intuitive approach and a Complier Average Causal Effects (CACE) analysis.

    Science.gov (United States)

    McConnachie, Alex; Haig, Caroline; Sinclair, Lesley; Bauld, Linda; Tappin, David M

    2017-07-20

    The Cessation in Pregnancy Incentives Trial (CPIT), which offered financial incentives for smoking cessation during pregnancy showed a clinically and statistically significant improvement in cessation. However, infant birth weight was not seen to be affected. This study re-examines birth weight using an intuitive and a complier average causal effects (CACE) method to uncover important information missed by intention-to-treat analysis. CPIT offered financial incentives up to £400 to pregnant smokers to quit. With incentives, 68 women (23.1%) were confirmed non-smokers at primary outcome, compared to 25 (8.7%) without incentives, a difference of 14.3% (Fisher test, p financial incentives to quit. Viewed in this way, the overall birth weight gain with incentives is attributable only to potential quitters. We compared an intuitive approach to a CACE analysis. Mean birth weight of potential quitters in the incentives intervention group (who therefore quit) was 3338 g compared with potential quitters in the control group (who did not quit) 3193 g. The difference attributable to incentives, was 3338 - 3193 = 145 g (95% CI -617, +803). The mean difference in birth weight between the intervention and control groups was 21 g, and the difference in the proportion who managed to quit was 14.3%. Since the intervention consisted of the offer of incentives to quit smoking, the intervention was received by all women in the intervention group. However, "compliance" was successfully quitting with incentives, and the CACE analysis yielded an identical result, causal birth weight increase 21 g ÷ 0.143 = 145 g. Policy makers have great difficulty giving pregnant women money to stop smoking. This study indicates that a small clinically insignificant improvement in average birth weight is likely to hide an important clinically significant increase in infants born to pregnant smokers who want to stop but cannot achieve smoking cessation without the addition of financial

  11. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

    Science.gov (United States)

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-04-06

    In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were

  12. Offers for our members

    CERN Multimedia

    Staff Association

    2016-01-01

    Summer is here, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 23 € instead of 29 €. Access to Aqualibi: 5 € instead of 6 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12:00 p.m. Free for children under 3, with limited access to the attractions. Car park free. * * * * * Aquaparc : Day ticket: – Children: 33 CHF instead of 39 CHF – Adults : 33 CHF instead of 49 CHF Bonus! Free for children under 5.

  13. Offers for our members

    CERN Multimedia

    Staff Association

    2015-01-01

    Summer is here, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 21,50 € instead of 27 €. Access to Aqualibi: 5 € instead of 6 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12:00 p.m. Free for children under 3, with limited access to the attractions. Car park free. * * * * * Aquaparc : Day ticket: – Children: 33 CHF instead of 39 CHF – Adults : 33 CHF instead of 49 CHF Bonus! Free for children under 5.

  14. Offers for our members

    CERN Multimedia

    Staff Association

    2013-01-01

    Summer is here, enjoy our offers for the aquatic parcs! Walibi : Tickets "Zone terrestre": 21 € instead of 26 €. Access to Aqualibi: 5 € instead of 8 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Car park free. * * * * * Aquaparc : Day ticket: – Children: 30 CHF instead of 39 CHF – Adults : 36 CHF instead of 49 CHF Bonus! Free for children under 5.

  15. Offers for our members

    CERN Multimedia

    Staff Association

    2017-01-01

    Summer is here, enjoy our offers for the water parks! Walibi: Tickets "Zone terrestre": 24 € instead of 30 €. Access to Aqualibi: 5 € instead of 6 € on presentation of your ticket purchased at the Staff Association. Bonus! Free for children under 100 cm, with limited access to the attractions. Free car park. *  *  *  *  *  *  *  * Aquaparc: Day ticket: -  Children: 33 CHF instead of 39 CHF -  Adults : 33 CHF instead of 49 CHF Bonus! Free for children under 5 years old.

  16. The effects of crisis plans for patients with psychotic and bipolar disorders: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Roosenschoon BJ

    2009-07-01

    , insight into illness, recovery style, social support, locus of control, service engagement and coping with crises situations. The interviews take place before randomisation, nine month later and finally eighteen months after randomisation. Discussion This study examines the effects of two types of crisis plans. In addition, the results offer an understanding of the way these advance statements work and whether it is more effective to include a patients' advocate in the process of creating a psychiatric advance statement. These statements may be an intervention to prevent crises and the use of compulsion in mental health care. The strength and limitations of this study are discussed. Trial registration Current Controlled Trails NTR1166.

  17. Offering Financial Incentives to Increase Adherence to Antipsychotic Medication

    Science.gov (United States)

    Highton-Williamson, Elizabeth; Barnicot, Kirsten; Kareem, Tarrannum; Priebe, Stefan

    2015-01-01

    Abstract Financial incentives for medication adherence in patients with psychotic disorders are controversial. It is not yet known whether fears expressed by clinicians are borne out in reality. We aimed to explore community mental health clinicians’ experiences of the consequences of giving patients with psychotic disorders a financial incentive to take their depot medication. We implemented descriptive and thematic analyses of semistructured interviews with the clinicians of patients assigned to receive incentives within a randomized controlled trial. Fifty-nine clinicians were interviewed with regard to the effect of the incentives on 73 of the 78 patients allocated to receive incentives in the trial. Most commonly, the clinicians reported benefits for clinical management including improved adherence, contact, patient monitoring, communication, and trust (n = 52). Positive effects on symptoms, insight, or social functioning were reported for some (n = 33). Less commonly, problems for patient management were reported (n = 19) such as monetarization of the therapeutic relationship or negative consequences for the patient (n = 15) such as increased drug and alcohol use. Where requests for increased money occurred, they were rapidly resolved. It seems that, in most cases, the clinicians found that using incentives led to benefits for patient management and for patient health. However, in 33% of cases, some adverse effects were reported. It remains unclear whether certain clinical characteristics are associated with increased risk for adverse effects of financial incentives. The likelihood of benefit versus the smaller risk for adverse effects should be weighed up when deciding whether to offer incentives to individual patients. PMID:25692797

  18. Comparing conVEntional RadioTherapy with stereotactIC body radiotherapy in patients with spinAL metastases: study protocol for an randomized controlled trial following the cohort multiple randomized controlled trial design

    International Nuclear Information System (INIS)

    Velden, Joanne M. van der; Verkooijen, Helena M.; Seravalli, Enrica; Hes, Jochem; Gerlich, A. Sophie; Kasperts, Nicolien; Eppinga, Wietse S. C.; Verlaan, Jorrit-Jan; Vulpen, Marco van

    2016-01-01

    Standard radiotherapy is the treatment of first choice in patients with symptomatic spinal metastases, but is only moderately effective. Stereotactic body radiation therapy is increasingly used to treat spinal metastases, without randomized evidence of superiority over standard radiotherapy. The VERTICAL study aims to quantify the effect of stereotactic radiation therapy in patients with metastatic spinal disease. This study follows the ‘cohort multiple Randomized Controlled Trial’ design. The VERTICAL study is conducted within the PRESENT cohort. In PRESENT, all patients with bone metastases referred for radiation therapy are enrolled. For each patient, clinical and patient-reported outcomes are captured at baseline and at regular intervals during follow-up. In addition, patients give informed consent to be offered experimental interventions. Within PRESENT, 110 patients are identified as a sub cohort of eligible patients (i.e. patients with unirradiated painful, mechanically stable spinal metastases who are able to undergo stereotactic radiation therapy). After a protocol amendment, also patients with non-spinal bony metastases are eligible. From the sub cohort, a random selection of patients is offered stereotactic radiation therapy (n = 55), which patients may accept or refuse. Only patients accepting stereotactic radiation therapy sign informed consent for the VERTICAL trial. Non-selected patients (n = 55) receive standard radiotherapy, and are not aware of them serving as controls. Primary endpoint is pain response after three months. Data will be analyzed by intention to treat, complemented by instrumental variable analysis in case of substantial refusal of the stereotactic radiation therapy in the intervention arm. This study is designed to quantify the treatment response after (stereotactic) radiation therapy in patients with symptomatic spinal metastases. This is the first randomized study in palliative care following the cohort multiple Randomized

  19. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial.

    Science.gov (United States)

    Fernández-de-Las-Peñas, César; Alonso-Blanco, Cristina; Morales-Cabezas, Matilde; Miangolarra-Page, Juan Carlos

    2005-06-01

    control group, the improvement in tragus to wall distance (P=0.009) and in lumbar side flexion (P=0.02) was statistically significant. Although the rest of the outcomes also improved, they did not reach a significant level (P>0.05). In the experimental group, the improvement in all the clinical measures of the BASMI index (P<0.01) and in the BASFI index (P=0.003) was statistically significant. The intergroup comparison between the improvement (prepost scores) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index, except in tragus to wall distance, as well as in the BASFI index. The experimental protocol developed by our research group, based on the GPR method and specific strengthening and flexibility exercises of the muscle chains, offers promising results in the management of patients suffering from AS. Further trials on this topic are required.

  20. Evaluation of the interdisciplinary PSYMEPHY treatment on patients with fibromyalgia: a randomized control trial.

    Science.gov (United States)

    Martín, Josune; Torre, Fernando; Aguirre, Urko; González, Nerea; Padierna, Angel; Matellanes, Begoña; Quintana, José Ma

    2014-04-01

    Fibromyalgia (FM) is a chronic disorder that can have a devastating effect on patients' lives. This study assessed the efficacy of a 6-week interdisciplinary treatment that combines coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) compared with standard pharmacologic care. The study was a randomized controlled trial (54 participants in the PSYMEPHY group and 56 in the control group [CG] ) with follow-up at 6 months. PSYMEPHY patients were also assessed at 12 months. The main outcomes were changes in total Fibromyalgia Impact Questionnaire (FIQ) score, pain, fatigue, morning tiredness, anxiety, and use of pain coping strategies as measured by the FIQ, the visual analog scale, and the Coping with Chronic Pain Questionnaire. After the 6-month assessment, patients in the CG were offered the PSYMEPHY treatment, and completed all of the instruments immediately after treatment, and at 6- and 12-month follow-up visits (N = 93). Subjects received therapy at two different outpatient clinical locations. Fibromyalgia patients. Six months after the intervention, significant improvements in total FIQ score (P = 0.04), and pain (P = 0.03) were seen in the PSYMEPHY group compared with controls. Twelve months after the intervention, all patients in the PSYMEPHY group maintained statistically significant improvements in total FIQ score, and pain, and showed an improvement in fatigue, rested, anxiety, and current pain compared with baseline. Data from the control patients who underwent the PSYMEPHY intervention corroborated the initial results. This study highlights the beneficial effects of an interdisciplinary treatment for FM patients in a hospital pain management unit. A 6-week interdisciplinary intervention showed significant improvement in key domains of fibromyalgia, as quality of life, pain, fatigue, rested, and anxiety at 12 months. Wiley Periodicals, Inc.

  1. Our trial to improve patient positioning during mammography

    International Nuclear Information System (INIS)

    Nakayama, Takashi; Kotsuma, Yoshikazu; Hiramatsu, Sawako

    2007-01-01

    For effective breast cancer screening, reading of high-quality mammograms is essential, and for this purpose proper patient positioning during mammography is important. At our Shin-Osaka Mammography Seminar, which includes eight institutions, a physician and nine radiology technicians get together weekly in order to critically review mammogram reading and techniques for obtaining good mammograms. We have recognized that patient positioning has a great effect on mammogram quality, particularly for women in their 40 s who have dense mammary glands, and we have adopted a digital mammography system, or comparative mammography for such patients. Since July 2005, we have critically reviewed positioning every 3 or 4 months with the aim of improving our technique. Eight institutions have participated in this trial, each contributing mammograms taken recently from 20 to 30 consecutive participants, and the grade of positioning has been determined according to the Institutional Mammogram Estimation Standard (6 items, each scoring a maximum of 4 points, total 24 points) proposed by the Central Committee for Quality Control of Mammography Screening. The estimation has been done by both ourselves and committee members. When a total of 20 points or more is obtained and all 6 items score 3 points or more, it is considered that the positioning has been good, and this is termed ''Positioning A'' (P-A). On the other hand, if the total score is less than 20 points, and any one of the 6 items scores less than 3 points, it is considered that positioning has been inadequate, and this is termed ''Positioning-D'' (P-D). At the first review meeting, which was held before our critical study, P-A accounted for 48% of cases, and this had improved to 72% at the second meeting, and to 66% at the third. P-D accounted for 41% of cases at the first meeting, 20% at the second, and 21% at the third. Thus our trial involving discussion between a physician and technicians to critically review good

  2. BNCT clinical trials of skin melanoma patients in Argentina

    International Nuclear Information System (INIS)

    Roth, Berta M.; Bonomi, Marcelo R.; Gonzalez, Sara J.

    2006-01-01

    The clinical outcome of six skin melanoma BNCT irradiations is presented. Three patients (A, B and C), with multiple subcutaneous skin metastases progressed to chemotherapy were infused with ∼14 g/m 2 of boronophenylalanine ( 10 BPA)-fructose and irradiated in the hyperthermal neutron beam of the RA-6 reactor. Patient A received two one fraction irradiations in different areas of the leg, B received one fraction and C was irradiated in three consecutive fields at the calf, heel and foot sole. The maximum prescribed dose to normal skin ranged from 16.5 to 24 Gy-Eq. With a minimum follow-up of 10 months there was a G1 acute epithelitis in A and B and a G3 in C. No late toxicity was observed. Due to the in-field tumor-growth-delay and the absence of severe acute and/or late toxicity observed during the follow-up period, a dose-escalation trial is ongoing. (author)

  3. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  4. Survival after relapse in patients with endometrial cancer : results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    Objective. The aim of this study was to determine the rates of local control and survival after relapse in patients with stage I endometrial cancer treated in the multicenter randomized PORTEC trial. Methods, The PORTEC trial included 715 patients with stage I endometrial cancer, either grade I or 2

  5. Patient Selection in Heart Failure With Preserved Ejection Fraction Clinical Trials

    NARCIS (Netherlands)

    Kelly, Jacob P.; Mentz, Robert J.; Mebazaa, Alexandre; Voors, Adriaan A.; Butler, Javed; Roessig, Lothar; Fiuzat, Mona; Zannad, Faiez; Pitt, Bertram; O'Connor, Christopher M.; Lam, Carolyn S. P.

    2015-01-01

    Recent clinical trials in patients with heart failure with preserved ejection fraction (HFpEF) have provided important insights into participant selection strategies. Historically, HFpEF trials have included patients with relatively preserved left ventricular ejection fraction ranging from 40% to

  6. Intrathecal Trialing of Continuous Infusion Combination Therapy With Hydromorphone and Bupivacaine in Failed Back Surgery Patients.

    Science.gov (United States)

    Galica, Ryan J; Hayek, Salim M; Veizi, Elias; McEwan, Matthew T; Katta, Sivakanth; Ali, Omar; Aziz, Nida; Sondhi, Nidhi

    2017-12-05

    Intrathecal (IT) trial is a prognostic interventional pain management procedure employed to determine the potential success of treating intractable pain with an implantable infusion device system. There is a dearth of data regarding trials with continuous infusion of combination therapy (e.g. opioid combined with local anesthetic). The objective of the this study was to determine the overall outcomes of continuous infusion IT trials and factors influencing long-term success of IT therapy in patients with chronic intractable pain post-laminectomy. This is a retrospective analysis of all patients with lumbar failed back surgery syndrome (FBSS) who were trialed with a combination of hydromorphone and bupivacaine with a temporary externalized IT catheter from March 2007 to June 2014. From a cohort of 62 patients fulfilling the inclusion criteria, 54 (87.10%) patients had successful IT trials. No significant differences were found between successful and failed trial patients with regards to age, sex, pre-trial pain numeric rating scale scores, pre-trial morphine equivalent daily dose, or trial dosages. Significant positive correlations were found between pretrial oral opioid intake and end of trial hydromorphone dose and hydromorphone dose escalation at 12 months and 24 months. Patients with refractory low back pain due to FBSS who underwent successful combination IT trial with hydromorphone and bupivacaine infused through a temporary IT catheter had significantly improved pain intensity scores following permanent implant. Higher pre-trial MEDD was correlated with higher trial and post-implant opioid doses and higher rates of opioid dose escalation post-implant. © 2017 International Neuromodulation Society.

  7. Offer for our members

    CERN Multimedia

    Staff Association

    2017-01-01

    The Staff Association CERN staff has recently concluded a framework agreement with AXA Insurance Ltd, General-Guisan-Strasse 40, 8401 Winterthur. This contract allows you to benefit from a preferential tariff and conditions for insurances: Motor vehicles for passenger cars and motorcycles of the product line STRADA: 10% discount Household insurance (personal liability and household contents) the product line BOX: 10% discount Travel insurance: 10% discount Buildings: 10% discount Legal protection: 10% discount AXA is number one on the Swiss insurance market. The product range encompasses all non-life insurance such as insurance of persons, property, civil liability, vehicles, credit and travel as well as innovative and comprehensive solutions in the field of occupational benefits insurance for individuals and businesses. Finally, the affiliate AXA-ARAG (legal expenses insurance) completes the offer. For those of you already insured with the company, contact your current advisor. Others may contact a counsel...

  8. Offers for our members

    CERN Multimedia

    Staff Association

    2013-01-01

    The warm weather arrives, it's time to take advantage of our offers Walibi and Aquapark! Walibi : Tickets "Zone terrestre": 21 € instead of 26 € Access to Aqualibi: 5 € instead of 8 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Car park free. * * * * * Aquaparc : Half-day ticket (5 hours): – Children: 26 CHF instead of 35 CHF – Adults : 32 CHF instead of 43 CHF Day ticket: – Children: 30 CHF instead of 39 CHF – Adults : 36 CHF instead of 49 CHF Free for children under 5.

  9. Offers for our members

    CERN Multimedia

    Association du personnel

    2013-01-01

    La banque LCL propose aux membres de l’Association du personnel les avantages suivants : – Un barème Privilège sur le Prêt immobilier – Des avantages tarifaires sur l’épargne, notamment l’assurance-vie. – Un taux préférentiel de prêt à la consommation. En outre, jusqu’au 30 septembre 2013, elle offre 50€ à tous les nouveaux clients, membres de l'Association du personnel. Summer is here, enjoy our offers for the aquatic parcs! Tickets "Zone terrestre" : 21 € instead of de 26 €. Access to Aqualibi : 5 euros instead of 8 euros on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Free car park. * * * * * * * Full day ticket: – Children : 30 CHF instead of 39 CHF &...

  10. Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients.

    Science.gov (United States)

    Krieger, Janice L; Neil, Jordan M; Strekalova, Yulia A; Sarge, Melanie A

    2017-03-01

    Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. © The Author 2016. Published by Oxford University Press.

  11. External validity of the ARISTOTLE trial in real-life atrial fibrillation patients.

    Science.gov (United States)

    Hägg, Lovisa; Johansson, Cecilia; Jansson, Jan-Håkan; Johansson, Lars

    2014-10-01

    Our primary objective was to determine the proportion of patients with atrial fibrillation (AF) eligible for enrollment in a randomized controlled trial for a novel oral anticoagulant, the ARISTOTLE trial. A secondary objective was to describe the reasons for trial ineligibility. We performed a cross-sectional study of an unselected population including 2274 patients in Skellefteå, Sweden with at least one verified episode of AF on or before December 31, 2010. Patients were classified as suitable or unsuitable for anticoagulant treatment according to current guidelines. The enrollment criteria from the ARISTOTLE trial were extracted from the original publication and applied to the population. Among all patients with AF, 1579 were classified as suitable for anticoagulant treatment. Of these, only 658 patients (42%) were eligible for participation in the ARISTOTLE trial. Among the 921 patients ineligible for participation, 498 did not meet the ECG criteria, 272 had psychosocial problems, and in addition, 78 patients were excluded due to both of these criteria. Our study shows that a majority of the patients in an unselected population with AF suitable for anticoagulant treatment were ineligible for participation in the ARISTOTLE trial. The applicability of the ARISTOTLE trial is therefore unknown for a considerable proportion of patients with AF in real life. © 2014 John Wiley & Sons Ltd.

  12. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

  13. Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Asehnoune Karim

    2011-10-01

    Full Text Available Abstract Background Traumatic brain injury (TBI is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP add to the morbidity and mortality of traumatic brain-injured patients. In one study, hydrocortisone for treatment of traumatic-induced corticosteroid insufficiency (CI in multiple injured patients has prevented HAP, particularly in the sub-group of patients with severe TBI. Fludrocortisone is recommended in severe brain-injured patients suffering from acute subarachnoid hemorrhage. Whether an association of hydrocortisone with fludrocortisone protects from HAP and improves neurological recovery is uncertain. The aim of the current study is to compare corticotherapy to placebo for TBI patients with CI. Methods The CORTI-TC (Corticotherapy in traumatic brain-injured patients trial is a multicenter, randomized, placebo controlled, double-blind, two-arms study. Three hundred and seventy six patients hospitalized in Intensive Care Unit with a severe traumatic brain injury (Glasgow Coma Scale ≤ 8 are randomized in the first 24 hours following trauma to hydrocortisone (200 mg.day-1 for 7 days, 100 mg on days 8-9 and 50 mg on day-10 with fludrocortisone (50 μg for 10 days or double placebo. The treatment is stopped if patients have an appropriate adrenal response. The primary endpoint is HAP on day-28. The endpoint of the ancillary study is the neurological status on 6 and 12 months. Discussion The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery. Trial registration NCT01093261

  14. Regulatory barriers to clinical trial enrollment of adolescent and young adult oncology patients.

    Science.gov (United States)

    Felgenhauer, Judy; Hooke, Mary C

    2014-06-01

    Adolescent and young adult (AYA) patients with cancer may face unique challenges if they and their families wish to participate in clinical oncology trials. Regulatory guidelines and funding requirements put in place to protect patients may actually raise barriers to enrollment in clinical trials. Hospital age guidelines may need to be readdressed to better suit the needs of AYA patients. Finally, the creation of the National Clinical Trials Network will provide new opportunities for pediatric and medical oncologists to collaborate in the care of AYA patients. Copyright © 2014 by the American Academy of Pediatrics.

  15. Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC with carbon ion radiotherapy: The PROMETHEUS-01 trial

    Directory of Open Access Journals (Sweden)

    Jäkel Oliver

    2011-02-01

    Full Text Available Abstract Background Treatment options for patients with advanced hepatocellular carcinoma (HCC are often limited. In most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months. Radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. However, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE, which can be calculated between 2 and 3 depending on the HCC cell line as well as the endpoint analyzed. Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with HCC. Methods/Design In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for patients with advanced HCC. The study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control. Primary endpoint is toxicity, secondary endpoint is progression-free survival and response. Discussion The Prometheus-01 trial ist the first trial evaluating carbon ion radiotherapy delivered by intensity-modulated rasterscanning for the treatment of HCC. Within this Phase I dose escalation study, the optimal dose of carbon ion radiotherapy will be determined. Trial registration NCT 01167374

  16. Randomized Multi-site Trial of the Job Seekers’ Workshop in Patients with Substance Use Disorders

    Science.gov (United States)

    Svikis, Dace S.; Keyser-Marcus, Lori; Stitzer, Maxine; Rieckmann, Traci; Safford, Lauretta; Loeb, Peter; Allen, Tim; Luna-Anderson, Carol; Back, Sudie E.; Cohen, Judith; DeBernardi, Michael A.; Dillard, Bruce; Forcehimes, Alyssa; Jaffee, William; Killeen, Therese; Kolodner, Ken; Levy, Michael; Pallas, Diane; Perl, Harold I.; Potter, Jennifer Sharpe; Provost, Scott; Reese, Karen; Sampson, Royce R.; Sepulveda, Allison; Snead, Ned; Wong, Conrad J.; Zweben, Joan

    2012-01-01

    Background Unemployment is associated with negative outcomes both during and after drug abuse treatment. Interventions designed to increase rates of employment may also improve drug abuse treatment outcomes. The purpose of this multi-site clinical trial was to evaluate the Job Seekers’ Workshop (JSW), a three session, manualized program designed to train patients in the skills needed to find and secure a job. Method Study participants were recruited through the NIDA Clinical Trials Network (CTN) from six psychosocial counseling (n=327) and five methadone maintenance (n=301) drug treatment programs. Participants were randomly assigned to either standard care (program-specific services plus brochure with local employment resources) (SC) or standard care plus JSW. Three 4-hr small group JSW sessions were offered weekly by trained JSW facilitators with ongoing fidelity monitoring. Results JSW and SC participants had similar 12- and 24-week results for the primary outcome measure (i.e., obtaining a new taxed job or enrollment in a training program), Specifically, one-fifth of participants at 12 weeks (20.1 – 24.3%) and nearly one-third at 24 weeks (31.4–31.9%) had positive outcomes, with “obtaining a new taxed job” accounting for the majority of cases. Conclusion JSW group participants did not have higher rates of employment/training than SC controls. Rates of job acquisition were modest for both groups, suggesting more intensive interventions may be needed. Alternate targets (e.g., enhancing patient motivation, training in job-specific skills) warrant further study as well. PMID:21802222

  17. Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

    Science.gov (United States)

    Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

    2017-04-01

    contract. Contract renegotiation occurs in response to cyclical changes within the trust relationship throughout trial participation. The Integrated Model of Trust offers a novel framework to interrogate the process by which diverse populations and clinical trial teams build trust. To our knowledge, this is the first model of trust-building in clinical trials that frames trust development through integrated clinical and business perspectives. By focusing on the process, rather than outcomes of trust-building diverse trial participants, clinical trials teams, participants, and cancer centers may be able to better understand, measure, and manage their trust relationships in real time. Ultimately, this may foster increased recruitment and retention of diverse populations to clinical trials.

  18. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    2014-01-01

    to include the required number of participants into the RCT. Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation. RESULTS: A total of 476 patients entered the screening group, of which 190 patients......BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo...... component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial...

  19. Are postoperative intravenous fluids in patients undergoing elective laparoscopic cholecystectomy a necessity? A randomized clinical trial.

    Science.gov (United States)

    Henriques, Jessimara Ribeiro; Correia, Maria Isabel Toulson Davisson

    2018-04-01

    Intravenous (IV) fluid therapy should be individualized according to each patient's weight, disease, and comorbidities, as well as the type and duration of the operative procedure. Laparoscopic cholecystectomy represents one of the most common, short-duration operations; thus, the aim of this study was to assess the necessity of postoperative administration of IV fluids. A randomized clinical trial with patients undergoing elective laparoscopic cholecystectomy was performed. Patients were randomly assigned to control group (IV fluids at the surgeon's discretion) and study group (no IV fluids after the operation). Body weight and composition, total intravenous fluids, urinary output, creatinine levels, and the presence of thirst and hunger were assessed. Costs related to the administration of postoperative IV fluids were measured. The study and control groups were similar with regard to sex distribution, age, and general characteristics. There was a significant difference in the amount of infused IV fluids (1,600 mL vs 3,000 mL), directly related to the amount offered postoperatively to the control group. Weight, extracellular water, and urinary output (1,257 ± 736 mL vs 888 ± 392 mL; P fluids (r = 0.333). There were no differences in creatinine levels, thirst, hunger, and well-being features. An average of 10.7 minutes per patient of nursing time was required for IV administration. Cost related to IV fluids was increased in the control group. Postoperative intravenous fluids are not necessary in patients undergoing laparoscopic cholecystectomy, and their use is associated with increased nursing time and costs. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. The Effect of Music Therapy in Patients with Huntington's Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    van Bruggen-Rufi, Monique C H; Vink, Annemieke C; Wolterbeek, Ron; Achterberg, Wilco P; Roos, Raymund A C

    2017-01-01

    Music therapy may have beneficial effects on improving communication and expressive skills in patients with Huntington's disease (HD). Most studies are, however, small observational studies and methodologically limited. Therefore we conducted a multi-center randomized controlled trial. To determine the efficacy of music therapy in comparison with recreational therapy in improving quality of life of patients with advanced Huntington's disease by means of improving communication. Sixty-three HD-patients with a Total Functional Capacity (TFC) score of ≤7, admitted to four long-term care facilities in The Netherlands, were randomized to receive either group music therapy or group recreational therapy in 16 weekly sessions. They were assessed at baseline, after 8, 16 and 28 weeks using the Behaviour Observation Scale for Huntington (BOSH) and the Problem Behaviour Assessment-short version (PBA-s). A linear mixed model with repeated measures was used to compare the scores between the two groups. Group music therapy offered once weekly for 16 weeks to patients with Huntington's disease had no additional beneficial effect on communication or behavior compared to group recreational therapy. This was the first study to assess the effect of group music therapy on HD patients in the advanced stages of the disease. The beneficial effects of music therapy, recorded in many, mainly qualitative case reports and studies, could not be confirmed with the design (i.e. group therapy vs individual therapy) and outcome measures that have been used in the present study. A comprehensive process-evaluation alongside the present effect evaluation is therefore performed.

  1. Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McDowell Jenny

    2010-02-01

    adherence and/or persistence with antihypertensive medications. The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service, control for the 'Hawthorne effect' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG, a strategy that is expected to improve retention. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12609000705280

  2. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Emanuelsson, Frida; Skou Thomsen, Ann Sofia

    2014-01-01

    . There was a larger effect size difference in 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control...

  3. A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis

    DEFF Research Database (Denmark)

    Sørensen, Per; Birket-Smith, M; Wattar, U

    2011-01-01

    Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim of this ......Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim...... of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist...

  4. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

    Directory of Open Access Journals (Sweden)

    Norio Sugawara

    Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

  5. Diamorphine for pain relief in labour : a randomised controlled trial comparing intramuscular injection and patient-controlled analgesia.

    Science.gov (United States)

    McInnes, Rhona J; Hillan, Edith; Clark, Diana; Gilmour, Harper

    2004-10-01

    To compare the efficacy of diamorphine administered by a patient-controlled pump (patient-controlled analgesia) with intramuscular administration for pain relief in labour. Randomised controlled trial. The South Glasgow University Hospitals NHS Trust. Primigravidae and multigravidae in labour at term (37-42 weeks). Women were randomised in labour to the study (patient-controlled analgesia) or control group (intramuscular). Randomisation was achieved through a random permuted block design stratified by parity. Study group women were given a loading dose of 1.2 mg diamorphine intravenously and then attached to the pump. Control group women received intramuscular diamorphine as per hospital protocol. Participants were also given 3 mg of buccal Stemetil. Data were collected throughout labour and at six postnatal weeks. Analgesia requirements during labour and women's satisfaction with the method of pain relief. Women in the study group (patient-controlled analgesia) used significantly less diamorphine than women in the control group (intramuscular) but were significantly more likely to state that they were very dissatisfied with their use of diamorphine and were significantly more likely to opt out of the trial before the birth of the baby. The majority of women in both groups used other analgesia concurrent with diamorphine such as Entonox, aromatherapy or TENS. Patient-controlled analgesia administration of diamorphine for the relief of pain in labour offers no significant advantages over intramuscular administration. The results also suggest that diamorphine is a poor analgesic for labour pain irrespective of the mode of administration.

  6. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: Results of the Compass pilot randomised trial.

    Science.gov (United States)

    Canfell, Karen; Caruana, Michael; Gebski, Val; Darlington-Brown, Jessica; Heley, Stella; Brotherton, Julia; Gertig, Dorota; Jennett, Chloe J; Farnsworth, Annabelle; Tan, Jeffrey; Wrede, C David; Castle, Philip E; Saville, Marion

    2017-09-01

    Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%). Compass is an open-label randomised trial of 5-yearly HPV screening versus 2.5-yearly liquid-based cytology (LBC) screening. In the first phase, consenting women aged 25-64 years presenting for routine screening at 47 primary practices in Victoria, Australia, provided a cervical sample and were randomised at a central laboratory at a 1:2:2 allocation to (i) image-read LBC screening with HPV triage of low-grade cytology ('LBC screening'), (ii) HPV screening with those HPV16/18 positive referred to colposcopy and with LBC triage for other oncogenic (OHR) types ('HPV+LBC triage'), or (iii) HPV screening with those HPV16/18 positive referred to colposcopy and with dual-stained cytology triage for OHR types ('HPV+DS triage'). A total of 5,006 eligible women were recruited from 29 October 2013 to 7 November 2014 (recruitment rate 58%); of these, 22% were in the group age-eligible for vaccination. Data on 4,995 participants were analysed after 11 withdrawals; 998 were assigned to, and 995 analysed (99.7%) in, the LBC-screened group; 1,996 assigned to and 1,992 analysed (99.8%) in the HPV+LBC triage group; and 2,012 assigned to and 2,008 analysed (99.8%) in the HPV+DS triage group. No serious trial-related adverse events were reported. The main outcomes were colposcopy referral and detected CIN2+ rates at baseline screening, assessed on an intention

  7. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: Results of the Compass pilot randomised trial.

    Directory of Open Access Journals (Sweden)

    Karen Canfell

    2017-09-01

    Full Text Available Using primary human papillomavirus (HPV testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+] compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%.Compass is an open-label randomised trial of 5-yearly HPV screening versus 2.5-yearly liquid-based cytology (LBC screening. In the first phase, consenting women aged 25-64 years presenting for routine screening at 47 primary practices in Victoria, Australia, provided a cervical sample and were randomised at a central laboratory at a 1:2:2 allocation to (i image-read LBC screening with HPV triage of low-grade cytology ('LBC screening', (ii HPV screening with those HPV16/18 positive referred to colposcopy and with LBC triage for other oncogenic (OHR types ('HPV+LBC triage', or (iii HPV screening with those HPV16/18 positive referred to colposcopy and with dual-stained cytology triage for OHR types ('HPV+DS triage'. A total of 5,006 eligible women were recruited from 29 October 2013 to 7 November 2014 (recruitment rate 58%; of these, 22% were in the group age-eligible for vaccination. Data on 4,995 participants were analysed after 11 withdrawals; 998 were assigned to, and 995 analysed (99.7% in, the LBC-screened group; 1,996 assigned to and 1,992 analysed (99.8% in the HPV+LBC triage group; and 2,012 assigned to and 2,008 analysed (99.8% in the HPV+DS triage group. No serious trial-related adverse events were reported. The main outcomes were colposcopy referral and detected CIN2+ rates at baseline screening, assessed on an intention

  8. The effect of a patient-oriented treatment decision aid for risk factor management in patients with diabetes (PORTDA-diab: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Denig Petra

    2012-11-01

    Full Text Available Abstract Background To improve risk factor management in diabetes, we need to support effective interactions between patients and healthcare providers. Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes, and is intended to empower patients in taking a proactive role in their disease management. Important features are: (1 involving patients in setting goals together with their provider; (2 encourage them to prioritise on treatments that maximise relevant outcomes; and (3 integration of the decision aid in the practice setting and workflow. As secondary aim, we want to evaluate the impact of different presentation formats, and learn more from the experiences of the healthcare providers and patients with the decision aid. Methods and design We will conduct a randomised trial comparing four formats of the decision aid in a 2×2 factorial design with a control group. Patients with type 2 diabetes managed in 18 to 20 primary care practices in The Netherlands will be recruited. Excluded are patients with a recent myocardial infarction, stroke, heart failure, angina pectoris, terminal illness, cognitive deficits, >65 years at diagnosis, or not able to read Dutch. The decision aid is offered to the patients immediately before their quarterly practice consultation. The same decision information will be available to the healthcare provider for use during consultation. In addition, the providers receive a set of treatment cards, which they can use to discuss the benefits and risks of different options. Patients in the control group will receive care as usual. We will measure the effect of the intervention on patient empowerment, satisfaction with care, beliefs about medication, negative emotions, health status, prescribed medication, and predicted cardiovascular risk. Data will be collected with questionnaires and automated extraction from medical records in 6 months before and

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

    Science.gov (United States)

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

    2016-01-01

    Introduction Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. Methods ESTEEM is a multi-site, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient-centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure and need for additional treatment. Results The final study design was implemented in November 2013 across 8 clinical sites in the Pelvic Floor Disorders Network. As of February 27, 2016, 433 total /472 targeted participants have been randomized. Conclusions We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision-making. PMID:27287818

  10. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... Enhanced participation by minorities in these trials is necessary to assess the effectiveness of advances in breast cancer care among major subpopulations and to ensure equity in the distribution of research benefits...

  11. Practical aspects of conducting a pragmatic randomised trial in primary care : Patient recruitment and outcome assessment

    NARCIS (Netherlands)

    Van Der Windt, Danielle A.W.M.; Koes, Bart W.; Van Aarst, M.; Heemskerk, Monique A.M.B.; Bouter, Lex M.

    2000-01-01

    Background. Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. Aim. To address the difficulties involved in patient recruitment and to present

  12. Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms

    Directory of Open Access Journals (Sweden)

    Kasper S

    2017-03-01

    Full Text Available Siegfried Kasper,1 Angelika Dienel2 1Universitätsklinik für Psychiatrie und Psychotherapie, Medizinische Universität Wien, Wien, Austria; 2Dr Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany Purpose: This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated with Rhodiola rosea. The reported capacity of R. rosea to strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment with R. rosea dry extract in this target group.Methods: The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mg R. rosea extract (WS® 1375, Rosalin was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales. Results: The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to

  13. Antitumor activity of rapamycin in a Phase I trial for patients with recurrent PTEN-deficient glioblastoma.

    Directory of Open Access Journals (Sweden)

    Tim F Cloughesy

    2008-01-01

    Full Text Available There is much discussion in the cancer drug development community about how to incorporate molecular tools into early-stage clinical trials to assess target modulation, measure anti-tumor activity, and enrich the clinical trial population for patients who are more likely to benefit. Small, molecularly focused clinical studies offer the promise of the early definition of optimal biologic dose and patient population.Based on preclinical evidence that phosphatase and tensin homolog deleted on Chromosome 10 (PTEN loss sensitizes tumors to the inhibition of mammalian target of rapamycin (mTOR, we conducted a proof-of-concept Phase I neoadjuvant trial of rapamycin in patients with recurrent glioblastoma, whose tumors lacked expression of the tumor suppressor PTEN. We aimed to assess the safety profile of daily rapamycin in patients with glioma, define the dose of rapamycin required for mTOR inhibition in tumor tissue, and evaluate the antiproliferative activity of rapamycin in PTEN-deficient glioblastoma. Although intratumoral rapamycin concentrations that were sufficient to inhibit mTOR in vitro were achieved in all patients, the magnitude of mTOR inhibition in tumor cells (measured by reduced ribosomal S6 protein phosphorylation varied substantially. Tumor cell proliferation (measured by Ki-67 staining was dramatically reduced in seven of 14 patients after 1 wk of rapamycin treatment and was associated with the magnitude of mTOR inhibition (p = 0.0047, Fisher exact test but not the intratumoral rapamycin concentration. Tumor cells harvested from the Ki-67 nonresponders retained sensitivity to rapamycin ex vivo, indicating that clinical resistance to biochemical mTOR inhibition was not cell-intrinsic. Rapamycin treatment led to Akt activation in seven patients, presumably due to loss of negative feedback, and this activation was associated with shorter time-to-progression during post-surgical maintenance rapamycin therapy (p < 0.05, Logrank test

  14. Trial Characteristics as Contextual Factors when Evaluating Targeted Therapies in Patients with Psoriatic Disease

    DEFF Research Database (Denmark)

    Ballegaard, Christine; Jørgensen, Tanja S; Skougaard, Marie

    2018-01-01

    characteristics in stratified and meta-regression analyses. Odds ratios (OR) were calculated and compared among the trial eligibility criteria via the Ratio of Odds Ratios (ROR). RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons, 17,737 patients) were eligible. Overall retention was OR 2.16 (1.70 to 2.......75) with higher odds for PsA trials compared with psoriasis trials (ROR = 2.55 [1.64 to 3.97]). The eligibility criteria "targeted therapy history", "minimum required disease duration", "required negative rheumatoid factor", and "required CASPAR criteria" were of importance for achieving ACR20 in Ps...

  15. Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun

    2017-09-01

    Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

  16. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: Results of the Compass pilot randomised trial

    Science.gov (United States)

    Canfell, Karen; Gebski, Val; Heley, Stella; Brotherton, Julia; Gertig, Dorota; Jennett, Chloe J.; Farnsworth, Annabelle; Castle, Philip E.; Saville, Marion

    2017-01-01

    Background Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia’s HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%–77%). Methods and findings Compass is an open-label randomised trial of 5-yearly HPV screening versus 2.5-yearly liquid-based cytology (LBC) screening. In the first phase, consenting women aged 25–64 years presenting for routine screening at 47 primary practices in Victoria, Australia, provided a cervical sample and were randomised at a central laboratory at a 1:2:2 allocation to (i) image-read LBC screening with HPV triage of low-grade cytology (‘LBC screening’), (ii) HPV screening with those HPV16/18 positive referred to colposcopy and with LBC triage for other oncogenic (OHR) types (‘HPV+LBC triage’), or (iii) HPV screening with those HPV16/18 positive referred to colposcopy and with dual-stained cytology triage for OHR types (‘HPV+DS triage’). A total of 5,006 eligible women were recruited from 29 October 2013 to 7 November 2014 (recruitment rate 58%); of these, 22% were in the group age-eligible for vaccination. Data on 4,995 participants were analysed after 11 withdrawals; 998 were assigned to, and 995 analysed (99.7%) in, the LBC-screened group; 1,996 assigned to and 1,992 analysed (99.8%) in the HPV+LBC triage group; and 2,012 assigned to and 2,008 analysed (99.8%) in the HPV+DS triage group. No serious trial-related adverse events were reported. The main outcomes were colposcopy referral and detected CIN2+ rates at

  17. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial.

    Science.gov (United States)

    Dauvilliers, Yves; Bassetti, Claudio; Lammers, Gert Jan; Arnulf, Isabelle; Mayer, Geert; Rodenbeck, Andrea; Lehert, Philippe; Ding, Claire-Li; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2013-11-01

    Narcolepsy is characterised by excessive daytime sleepiness (EDS) and cataplexy. Histamine neurons are crucial to maintain wakefulness. We assessed the safety and efficacy of pitolisant (previously called BF2.649), a selective histamine H3 receptor inverse agonist that activates these neurons, in patients with narcolepsy. For this double-blind, randomised, parallel-group controlled trial, we recruited patients with narcolepsy from 32 sleep disorder centres in five European countries. Patients were eligible if they were aged 18 years or older, had not taken psychostimulants for at least 14 days, and had EDS (defined as an Epworth Sleepiness Scale [ESS] score of at least 14). Using a computer-generated randomisation sequence, we randomly allocated patients to receive pitolisant, modafinil, or placebo (1:1:1). Treatment lasted 8 weeks: 3 weeks of flexible dosing according to investigator's judgment (10 mg, 20 mg, or 40 mg a day of pitolisant; 100 mg, 200 mg or 400 mg a day of modafinil) followed by 5 weeks of stable dosing. Patients took four tablets a day in a double-dummy design to ensure masking. For the primary analysis, assessed in the intention-to-treat population, we assessed the superiority of pitolisant versus placebo, and the non-inferiority of pitolisant versus modafinil. This trial is registered with ClinicalTrials.gov, number NCT01067222. Between May 26, 2009, and June 30, 2010, we screened 110 patients, 95 of whom were eligible and randomly assigned to treatment: 30 to placebo, 32 to pitolisant, and 33 to modafinil. Over the 8-week treatment period, mean ESS score reductions were -3·4 (SD 4·2) in the placebo group, -5·8 (6·2) in the pitolisant group, and -6·9 (6·2) in the modafinil group. Our primary analysis of between-group differences in mean ESS score at endpoint (adjusted for baseline) showed pitolisant to be superior to placebo (difference -3·0, 95% CI -5·6 to -0·4; p=0·024), but not non-inferior to modafinil (difference 0·12, 95% CI -2

  18. Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

    NARCIS (Netherlands)

    Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

    2009-01-01

    OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

  19. Improving Breast Cancer Research Through Automated Matching of Patients to Clinical Trials

    National Research Council Canada - National Science Library

    Hall, Lawrence

    2004-01-01

    .... It allows for cost preferences to be entered. Therefore, the system user can choose to rule patients out of trials as quickly as possible without regard to the cost of tests necessary to do this...

  20. Improving Breast Cancer Research Through Automated Matching of Patients to Clinical Trials

    National Research Council Canada - National Science Library

    Hall, Lawrence

    2003-01-01

    .... It allows for cost preferences to be entered. Therefore, the system user can choose to rule patients out of trials as quickly as possible without regard to the cost of tests necessary to do this...

  1. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet).

  2. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  3. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  4. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  5. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  6. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  7. Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation

    DEFF Research Database (Denmark)

    Gade, Josephine; Beck, Anne Marie; Bitz, Christian

    2018-01-01

    . Protein supplementation can preserve muscle mass and/or strength and, combining this with resistance exercise training (RT), may have additional benefits. Therefore, this study investigates the effect of protein supplementation as an addition to offering RT among older adults while admitted...... to the geriatric ward and after discharge. This has not previously been investigated. METHODS AND ANALYSIS: In a block-randomised, double-blind, multicentre intervention study, 165 older adults above 70 years, fulfilling the eligibility criteria, will be included consecutively from three medical departments...... (blocks of n=20, stratified by recruitment site). After inclusion, participants will be randomly allocated (1:1) to receive either ready-to-drink, protein-enriched, milk-based supplements (a total of 27.5 g whey protein/day) or isoenergetic placebo products (

  8. Pierre Bourdieu's Theory of Practice offers nurses a framework to uncover embodied knowledge of patients living with disabilities or illnesses: A discussion paper.

    Science.gov (United States)

    Oerther, Sarah; Oerther, Daniel B

    2018-04-01

    To discuss how Bourdieu's theory of practice can be used by nurse researchers to better uncover the embodied knowledge of patients living with disability and illness. Bourdieu's theory of practice has been used in social and healthcare researches. This theory emphasizes that an individual's everyday practices are not always explicit and mediated by language, but instead an individual's everyday practices are often are tacit and embodied. Discussion paper. Ovid MEDLINE, CINAHL and SCOPUS were searched for concepts from Bourdieu's theory that was used to understand embodied knowledge of patients living with disability and illness. The literature search included articles from 2003 - 2017. Nurse researchers should use Bourdieu's theory of practice to uncover the embodied knowledge of patients living with disability and illness, and nurse researchers should translate these discoveries into policy recommendations and improved evidence-based best practice. The practice of nursing should incorporate an understanding of embodied knowledge to support disabled and ill patients as these patients modify "everyday practices" in the light of their disabilities and illnesses. Bourdieu's theory enriches nursing because the theory allows for consideration of both the objective and the subjective through the conceptualization of capital, habitus and field. Uncovering individuals embodied knowledge is critical to implement best practices that assist patients as they adapt to bodily changes during disability and illness. © 2017 John Wiley & Sons Ltd.

  9. Assessment of clinical trial participant patient satisfaction: a call to action.

    Science.gov (United States)

    Pflugeisen, Bethann Mangel; Rebar, Stacie; Reedy, Anne; Pierce, Roslyn; Amoroso, Paul J

    2016-10-06

    As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

  10. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    OpenAIRE

    Ferreira, Giovanni E.; Barreto, Rodrigo G. P.; Robinson, Caroline C.; Plentz, Rodrigo D. M.; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Ri...

  11. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A treatment

    Science.gov (United States)

    We sought to determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A. DESIGN: Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received ...

  12. Bias towards dementia: are hip fracture trials excluding too many patients? A systematic review

    NARCIS (Netherlands)

    Hebert-Davies, Jonah; Laflamme, G.-Yves; Rouleau, Dominique; Bhandari, Mohit; Devereaux, Philip J.; Guyatt, Gordon; Heetveld, Martin J.; Jeray, Kyle; Liew, Susan; Richardson, Martin J.; Schemitsch, Emil H.; Swiontkowski, Marc; Tornetta, Paul; Walter, Stephen; Mohit, Bhandari; Sprague, Sheila; Viveiros, Helena; Simunovic, Nicole; Swinton, Marilyn; Heels-Ansdell, Diane; Buckingham, Lisa; Duraikannan, Aravin; Swiontkowski, Marc F.; Agel, Julie; van Lieshout, Esther M. M.; Zielinski, Stephanie M.; Goslings, J. Carel; Haverlag, Robert; Ponsen, M. J.; de Rijcke, P. A. R.; Koppert, C. L.; Buijk, Steven E.; Groenendijk, Richard P. R.; Dawson, I.; de Rycke, P. A. R.; Tetteroo, G. W. M.; Bruijninckx, M. M. M.; Doornebosch, P.; deGraaf, E. J. R.; Patka, Peter; Eversdijk, Martin; Peters, Rolf; van Waes, Oscar; den Hartog, Dennis; van Waes, O.; Oprel, P.; Gasthuis, Kennemer; Visser, Gijs A.; Stockmann, Heyn; Silvis, Rob; Snellen, J. P.; Rybroek, A.; Scheepers, J. J. G.; Vermeulen, Erik G. J.; Siroen, M. P. C.; Vuylsteke, Ronald; Brom, H. L. F.; Ryna, H.; van Laarhoven, H. A. J.; Haag, Den; Rhemrev, S.; Bosman, C. H. R.; van Otterloo, Alexander Mol; Hoogendoorn, Jochem; Idenburg, Floris; de Vries, A. C.; Meylaerts, S. A. G.; Roukema, Gert R.; Josaputra, H.; Keller, Paul; de Rooij, P. P.; Kuiken, H.; Boxma, H.; Cleffken, B. I.; Liem, Ronald; Poolman, Rudolf W.; Simons, Maarten P.; van der Heijden, F. H. W. M.; Willems, W. J.; de Meulemeester, Frank R. A. J.; van der Hart, Cor; Tarkan, K.; Festen, S.; de Nies, F.; Out, N. J. M.; Bosma, J.; de Graaf Gasthuis, Reinier; van der Elst, Maarten; van der Pol, Carmen C.; van't Reit, Martyne; Karsten, T. M.; de Vries, M. R.; Stassen, P. S.; Schep, N.; Schmidt, Ben; Hoffman, W. H.; Segers, J. M.; Zijl, Jacco; Verhoeven, Bart; Smits, Anke; Theunissen, Evert B. M.; Wille, J.; Govaert, Lonnek; Wittich, Phillippe; Brauw, Maurits; Wille, Jan; Ritchie, Ewan D.; Wittish, H.; Wessel, R. N.; Hammacher, E. R.; Ziekenhuis, Elisabeth; Verhofstad, Michiel H. J.; Meijer, Joast M. R.; van Egmond, Teun; van den Heijden, F. H. W. M.; Campo, Martin; Verhagen, Ronald; van Kampen, A.; Biert, J.; van Vugt, Arie B.; Edwards, Michael; Blokhuis, Taco; Frolke, Jan Paul M.; Geeraidts, L.; de Waal Malefyt, M. C.; Schreurs, B.; Simmermacher, Roger K. J.; van Mulken, Jeroen; van Gaalen, Steven M.; Bronovo, Ziekenhuis; Bronkhorst, Maarten W. G. A.; Guicherit, O. R.; Frihagen, Frede; Nordsletten, Lars; Kibsgaard, Thomas; Haug, Knut Jorgen; Lona, Tariei; Ugland, Stein; Nilsen, Kenneth; Brekke, Anne Christin; Vesterhus, Elise Berg; Tetsworth, Kevin; Weinrauch, Patrick; Pincus, Paul; Donald, Geoff; yang, Steven; Halliday, Brett; Gervais, Trevor; Holt, Michael; Flynn, Annette; Pirpiris, Marinis; Love, David; Bucknill, Andrew; Farrugia, Richard J.; Dowrick, Adam; Donohue, Craig; Bedi, Harvinder; Li, Doug; Edwards, Elton; Csonguray, Steven; Miller, Russell; Wang, Otis; Chia, Andrew; Jain, Arvind; Mammen, Mathan; Moaveni, Ash; Murdock, Zoe; Sage, Claire; Bahadur, Tegh; Jain, Anil Kumar; Pankaj, Amite; Pesantez, Rodrigo; Martinez, Adriana; Novoa, Catherine; Buckley, Richard E.; Duffy, Paul; Korley, Robert; Johnston, Kelly; Puloski, Shannon; Carcary, Kimberly; Avram, Victoria; Bicknell, Ryan; Yach, Jeff; Bardana, Davide; Wood, Gavin; Lambert, Sue; Sanders, David W.; Howard, Jamie; Macleod, Mark; Lawendy, Abdel; Bartley, Debra; Laney, Tim; Tieszer, Christina; Peterson, Devin; Zalzal, Paul; Naumetz, Victor; Brien, Heather; Weening, Brad; Wai, Eugene K.; Papp, Steven; Roffey, Darren; McCormack, Robert; Stone, Trevor; Perey, Bertrand; Viskontas, Darius; Boyer, Dory; Moola, Farhad; Zomar, Mauri; Moon, Karyn; McKee, Michael; Hall, Jeremy; Ahn, Henry; Vicente, Milena R.; Wild, Lisa M.; Kreder, Hans J.; Stephen, David J. G.; Nousianinen, Markku; Kunz, Monica; Syed, Khalid; Azad, Tania; Coles, Chad; Leighton, Ross; Johnstone, David; Glazebrook, Mark; Alexander, David; Coady, Cathy; Trask, Kelly; Dobbin, Gwendolyn; Oliver, Todd M.; Jones, Vicky; Ronan, James; Brown, Desmond T.; Carlilse, Hope; Shaughnessy, Lisa; Schwappach, John; Davis, Craig A.; Weingarten, Peter; Weinerman, Stewart; Newman, Heike; Baker, Janell; Browner, Kieran; Hurley, Meghan; Payton, Krystal; Zura, Robert; Manson, Maria J.; Goetz, David; Broderick, Scott J.; Porter, Scott; Pace, Thomas; Tanner, Stephanie L.; Snider, Becky; Schmidt, Andrew H.; Haas, Jonathan; Templeman, David; Westberg, Jerald R.; Mullis, Brian; Ertl, J. P.; Shively, Karl; Frizzel, Valda; Moore, Molly M.; Marcantonio, Andrew J.; Iorio, Richard; Lobo, Margaret; Kain, Michael; Specht, Lawrence; Tilzey, John; Garfi, John; Prayson, Michael J.; Laughlin, Richard; Rubino, Joe; Lawless, Mathew; DiPaola, Matt; Gayton, Chris; Dulaney-Cripe, Liz; Vallier, Heather A.; Wilber, John; Wilber, Roger G.; Sontich, John H.; Patterson, Brendan; Dolenc, Andrea; Robinson, Chalitha; DePaolo, Charles J.; Alosky, Rachel; Shell, E.; Keeve, Jonathan P.; Anderson, Chris; McDonald, Michael; Hoffman, Jodi; Baele, Joseph; Weber, Tim; Edison, Matt; Musapatika, Dana; Jones, Clifford; Ringler, James; Endres, Terrance; Gelbke, Martin; Jabara, Michael; Sietsema, Debra L.; Engerman, Susan M.; Switzer, Julie A.; Li, Mangnai; Marston, Scott; Cole, Peter; Vang, Sandy X.; Ly, Thuan; Anderson, Sarah; Foley, Amy; McBeth, Jessica; Comstock, Curt; Ziran, Navid; Shaer, James; Hileman, Barbara; Karges, David; Cannada, Lisa; Kuldjanov, Djoldas; Watson, John Tracy; Mills, James Jackman Emily; Hill, Leslie; Simon, Tiffanya; Abdelgawad, Amr; Shunia, Juan; Jenkins, Mark; Zumwalt, Mimi; Romero, Amanda West; Lowe, Jason; Goldstein, Jessica; Zamorano, David P.; Lawson, Deanna; Archdeacon, Michael; Wyrick, John; Hampton, Shelley; Lewis, Courtland G.; Ademi, Arben; Sullivan, Raymond; Caminiti, Stephanie; Graves, Matthew; Smith, Lori; Della Rocca, Gregory J.; Crist, Brett D.; Murtha, Yvonne; Anderson, Linda K.; Kliewer, Toni K.; McPherson, Melinda K.; Sullivan, Kelly M.; Jarrett, Sharon L.; Sagebien, Carlos; Seuffert, Patricia; Mehta, Samir; Esterhai, John; Ahn, Jaimo; Tjoumakaris, Fotios; Horan, Annamarie D.; Kaminski, Christine; Tarkin, Ivan; Siska, Peter; Luther, Arlene; Irrgang, James; Farrell, Dana J.; Gorczyca, John T.; Gross, Jonathan M.; Kates, Stephen Lloyd; Colosi, Jen; Hibsch, Nancy; Noble, Krista; Neu, Sarah; Agarwal, Animesh; Wright, Rebecca; Hsu, Joseph R.; Randall, Gayle M.; Ficke, James R.; Charlton, Michael; Fan, Mary; Garcia, Socorro H.; Obremskey, William T.; Richards, Justin Edward; Robinson, Kenya; Carroll, Eben; Kulp, Brenda; Guyatt, Gordon H.; Devereaux, Philip James; Einhorn, Thomas A.; Koval, Ken J.; Tetsworth, Kevin D.; Culgin, Sarah; Desjardin, Heather; Beimers, Lijkele; de Vries, Jasper; Zurcher, Arthur W.; Albers, G. H. Rob; Rademakers, Maarten; Breugem, Stefan; van der Haven, Ibo; Damen, Peter Jan; Bulstra, Gythe H.; Somford, P.; Haverkamp, Daniël; Gasthuis, Onze Lieve Vrouwe; Molekamp, Willem Jan Kleyn; Kleipool, E. B.; Keizer, Stefan B.; Swen, Jan-Willem A.; Nelissen, Eelco M.; Hollander, Peter H. C. den; Metsaars, Weineke; Thomassen, J. W.; Fontijne, W. Peter J.; Wiersma, Saskia C.; Boetes, Bastiaan; JT, Edgar; Ziekenhuis, Spaarne; Nolte, Peter A.; de Jong, Tjitte; van Noort, Arthur; Vergroesen, Diederik A.; van den Bekerom, Michel P. J.; Schutte, Bernard G.; Schuman, Lein; Hillen, Robert Jan; Cheung, John; van der Heide, Huub J. L.; Nagels, Jochem; Krips, Rover; Mullers, J. Bernard; Schüller, Hans; Ziekenhuis, Amphia; van den Hout, Joost A. A. M.; Joosten, Adrianus J. P.; van der Broek, Chris M.; Bolder, Stefan B. T.; Eygendaal, Denise; Moonen, Adrianus F. C. M.; van Geenen, Rutger C. I.; Hoebink, Eric A.; Wagenmakers, Robert; van Helden, Wouter; Kooijman, Rob; Postema, Roelf R.; Lampe, Harald I. H.; Ziekenhuizen, Gelre; Bolhuis, Hugo W.; Bullens, Pieter H. J.; Hogervorst, Mike; de Kroon, Karin E.; Jansen, Rob H.; Raven, Eric E. J.; van Jonbergen, Hans-Peter W.; Reuver, Joost M.; Barnaart, Alexander F. W.; Roerdink, W. Herbert; van Erve, Ruud H. G. P.; Koorevaar, Rinco; Frima, Anthony Hans; Flikweert, Elvira R.; Falke, Mark L. M.; Kurek, Frans J.; Slingerland, Adrianus C. H.; Vallei, Gelderse; van Dijk, Jan P.; van Helden, Wouter H.; Mauer-Hansen, Espen; Boee, Berte; Clarke-Jensen, Jon; Brekke, Anne Christine; Vestergaard, Elise Berg; Carr, Ashley; Russ, Matthias; Li, Douglas; Doig, Stephen; Laflamme, Yves; Fernandes, Julio C.; Poirier, Marie-France; Bogoch, Earl; Kreder, Hans; Axelrod, Terry; Jenkinson, Richard; Wadey, Veronica; Nousiainen, Markku; Stephen, David; Macnevin, Melanie; Richardson, Glen C.; Biddulph, Michael; Gross, Michael; Dunbar, Michael; Dobbin, Gwen; Zarin, Jeffrey; Parvataneni, Hari; Baker, Janell K.; Roberson, James R.; Erens, Greg; Montelione, Anita; Woodard, Shawndra; Ertl, Janos; Cummings, Judd; Worman, Ripley; Webster, Mark; Parr, Andrew; Frizzell, Valda; Moore, Molly; Wilk, Richard; Torchia, Michael; Cross, William; Sems, Andrew; Taunton, Michael; Sanchez-Satelo, Joaquin; Sierrz, Rafsel; Timm, Kimberly; Foreman, Barbara; DePaolo, Charles; Hill, Rocky; Lewis, Coutland; Srivastava, Ajay; Bakeman, James; Sietsema, Deb; Strathy, Gregg; Johnson, Paul; Peter, Kathleen; Morton, Maeghan E.; Parvizi, Javad; Austin, Matthew; Morrison, Tiffany; Mont, Michael; Copeland, Carol; Delanois, Ronald; Khanuja, Harpal; Weddington, Shaquita; Bacon, Madeline; Mullen, Marylou; Kanlic, Enes; Abdelgawad, Amr Atef; Shunia, Juan Gerardo; Horan, Annamarie

    2012-01-01

    Patients with hip fractures are older and often present many co-morbidities, including dementia. These patients cannot answer quality of life questionnaires and are generally excluded from trials. We hypothesized that a significant number of patients are being excluded from these studies and this

  13. Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.

    2016-01-01

    Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma

  14. 48 CFR 570.303-3 - Late offers, modifications of offers, and withdrawals of offers.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Late offers, modifications of offers, and withdrawals of offers. 570.303-3 Section 570.303-3 Federal Acquisition Regulations... PROPERTY Contracting Procedures for Leasehold Interests in Real Property 570.303-3 Late offers...

  15. Researchers offer up a mnemonic tool to guide clinicians who must assess decision-making capacity in patients during emergency situations.

    Science.gov (United States)

    2015-03-01

    Clinicians from Johns Hopkins University School of Medicine have developed a mnemonic-driven tool to help clinicians quickly assess whether patients have decision-making capacity during emergency situations. The approach uses the mnemonic "CURVES" to guide physicians to first consider whether patients have decision-making capacity, and then to determine whether treatment can be commenced-without informed consent. The first four letters of the mnemonic "CURVES'" stand for: choose and' communicate, understanding, reason, and value. The authors rote that these four qualities/abilities need to be present to establish decision-making capacity. The last two letters of the pneumonic stand for emergency and surrogate, prompting physicians to consider whether the patient is at immninent risk and whether there is a surrogate decision-maker available. The authors note that while the issues represented by the CURVES pneumonic should be very familiar to clinicians, effective use of the tool requires training and practice.

  16. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Silcock Jonathan

    2011-07-01

    Full Text Available Abstract Background The participant information sheet (PIS provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16. Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p p Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in

  17. Phase i study evaluating the treatment of patients with hepatocellular carcinoma (HCC) with carbon ion radiotherapy: the PROMETHEUS-01 trial.

    Science.gov (United States)

    Combs, Stephanie E; Habermehl, Daniel; Ganten, Tom; Schmidt, Jan; Edler, Lutz; Burkholder, Iris; Jäkel, Oliver; Haberer, Thomas; Debus, Jürgen

    2011-02-12

    Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often limited. In most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months.Radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. However, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date.Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 3 depending on the HCC cell line as well as the endpoint analyzed.Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with HCC. In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for patients with advanced HCC. The study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control.Primary endpoint is toxicity, secondary endpoint is progression-free survival and response. The Prometheus-01 trial ist the first trial evaluating carbon ion radiotherapy delivered by intensity-modulated rasterscanning for the treatment of HCC. Within this Phase I dose escalation study, the optimal dose of carbon ion radiotherapy will be determined. NCT 01167374.

  18. Series: Pragmatic trials and real world evidence: Paper 3. Patient selection challenges and consequences.

    Science.gov (United States)

    Oude Rengerink, Katrien; Kalkman, Shona; Collier, Susan; Ciaglia, Antonio; Worsley, Sally D; Lightbourne, Alison; Eckert, Laurent; Groenwold, Rolf H H; Grobbee, Diederick E; Irving, Elaine A

    2017-09-01

    This paper addresses challenges of identifying, enrolling, and retaining participants in a trial conducted within a routine care setting. All patients who are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice, this can be best achieved by including-within the selected sites-all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling) or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrollment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Offers

    CERN Multimedia

    Staff Association

    2015-01-01

    Tickets "Zone terrestre": 21 € instead of 27 €. Access to Aqualibi: 5 € instead of 8 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Car park free.

  20. Offers

    CERN Multimedia

    Staff association

    2014-01-01

        Envie de soirée au théâtre, n’hésitez pas à bénéficier de nos offres pour nos membres ! Théâtre de Carouge : Réduction de 5 CHF pour tous les spectacles (30 CHF au lieu de 35 CHF) Le théâtre de Carouge vous présente sa nouvelle pièce : La double insconstance Du vedredi 21 mars au dimanche 6 avril 2014 De Marivaux Mise en scène de Philippe Mentha Audio-description le mardi 1er avril et le samedi 5 avril 2014 Il règne un doux mélange de révoltes et de séductions, de ruses et de fatalité dans cette Double Inconstance de Marivaux que met en scène Philippe Mentha, membre fondateur du Théâtre de Carouge et directeur depuis plus de trente ans du Théâtre Kléber-Méleau. L’allure d...

  1. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

      Bénéficiez du tarif spécial de 35 CHF/personne + 1 accompagnant au Théâtre de Carouge  en étant membre de l’Association du personnel.  Envoyez votre réservation par mail à smills@tcag.ch via votre adresse mail professionnelle. Indiquez la date de votre réservation, votre nom, prénom et numéro de téléphone. Une confirmation de réservation vous sera retournée par mail. La présentation de votre carte de membre sera demandée lors du retrait des billets.   De Molière – Mise en scène de Jean Liermier Argan, veuf, remarié avec Béline qui n’attend que la mort de son mari pour hériter, multiplie saignées, purges et autres ingestions de remèdes. Angélique, sa fille, vuet &a...

  2. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

    To our members 5% discount on Fnac vouchers Vouchers of 50.-, 100.- et 200. - CHF Valid in the 4 shops in Switzerland without restriction on purchases. On sale in the office of Secretariat of the staff Association.

  3. OFFERS

    CERN Multimedia

    Staff Association

    2014-01-01

    Nouveau partenaire - Joy’s Club   Venez profiter des remises au Joy’s Club / Minigolf à Divonne-les-bains en tant que membre de l’Association ! Sur présentation de votre carte membre, vous bénéficierez d’une remise immédiate telle que : - Pour une partie adulte : 6 euros au lieu de 7 euros - Pour une partie enfant : 4 euros au lieu de 5 euros - Pour le mini Park : 6 euros au lieu de 7 euros Pour plus de renseignements, n’hésitez pas à demander au Secrétariat de l’Association ou à consulter notre site web: http://staff-association.web.cern.ch/fr/socioculturel/offres  

  4. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    Tickets "Zone terrestre": 21.50 € instead of 27 €. Access to Aqualibi: 5 € instead of 8 € on presentation of your SA member ticket. Free for children (3-11 years old) before 12 h 00. Free for children under 3, with limited access to the attractions. Car park free.

  5. Offers

    CERN Multimedia

    Staff Association

    2014-01-01

    12 % discount on football camps and courses for children from 3 to 13 years old, with bilingual coaches.   Now also courses during the autumn holidays! In order to get the discount you need to register online, then send a mail to info@intersoccer.ch with a scan of your membership card to recieve a refund of the discount.

  6. Offers

    CERN Multimedia

    Staff Association

    2012-01-01

    Si cette offre vous intéresse, merci d’envoyer un mail à mh.boulanger@comedie.ch avec le détail de votre réservation via votre adresse mail professionnelle. Le retrait des places se fait à la billetterie sur présentation de votre carte de membre de l’Association du personnel. Pour toute commande d’abonnement ou de carte de réduction par courrier ou internet, cocher le tarif collectif en indiquant le nom de l’entreprise et en joignant un justificatif nominatif. Pour tout renseignement, n’hésitez pas à contacter Marie-Hélène Boulanger : –  Tel. : 022 809 60 86 –  email : mh.boulanger@comedie.ch

  7. Offer

    CERN Multimedia

    Staff Association

    2015-01-01

    Le parc ouvre ses portes le samedi 4 avril 2015!   La Chasse aux Oeufs du 4 au 26 avril En plus de ses 25 attractions et spectacles, le parc proposera aux enfants de 3 à 12 ans de relever le challenge d’une course aux oeufs dans un jardin de Pâques reconstitué ! Autant de petits oeufs à trouver dans un temps limite ; tout cela au milieu de lapins, poules, fleurs et autres oeufs géants pour repartir avec des gourmandises en chocolat de la marque Revillon Chocolatier.   Profitez de notre offre spéciale pour nos membres : Tarif unique Adulte/Enfant Entrée Zone terrestre 21,50 euros au lieu de 27 euros Accès à l’Aqualibi : 5 euros au lieu de 8 euros sur présentation du billet d’entrée au tarif membre AP. Entrée gratuite pour les enfants de moins de 3 ans, avec accès limité aux attractions. Les billet...

  8. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    Concert Scoop music tour sur le parc Walibi ! Vendredi 12 Juillet Vous trouverez la présentation de l’événement et les vidéos des artistes attendus avec leurs titres faisant vibrer les radios en ce moment sur le site internet http://www.walibi.com/rhone-alpes/fr-fr/evenements/scoop-music-tour. Le concert est gratuit et débute à la fermeture du parc avec une première partie surprise. Profitez donc d’une belle journée sur le parc et finissez en beauté avec le concert de l’été !

  9. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    Découvrez les plus belles tables de Suisse romande et de France voisine en bénéficiant des réductions suivantes sur chaque repas, pendant une année : 50 % pour 2 personnes / 40 % pour 3 personnes / 30 % pour 4 personnes / 20 % pour 5 à 6 personnes. Comment ça marche ? Faites votre choix parmi les 110 restaurants de votre région et réservez votre table pour 2, 3, 4, 5 ou 6 personnes. Présentez votre Passeport Gourmand dès votre arrivée. Savourez votre repas et profitez d’une réduction exceptionnelle sur votre addition (hors boissons, menu du jour et business lunch). Quels sont vos avantages ? Profitez du prix préférentiel pour les membres de l’association du CERN : – Passeport Gourmand Genève : CHF 75.- (au lieu de CHF 95.-) – Passeport Gourmand Ain/Savoie/Haute-Savoie : CHF 59.- (au lieu de...

  10. Offers

    CERN Multimedia

    Staff Association

    2013-01-01

    Découvrez les plus belles tables de Suisse romande et de France voisine en bénéficiant des réductions suivantes sur chaque repas, pendant une année : 50 % pour 2 personnes, 40 % pour 3 personnes, 30 % pour 4 personnes, 20 % pour 5 à 6 personnes. Comment ça marche ? Faites votre choix parmi les 110 restaurants de votre région et réservez votre table pour 2, 3, 4, 5 ou 6 personnes. Présentez votre Passeport Gourmand dès votre arrivée. Savourez votre repas et profitez d’une réduction exceptionnelle sur votre addition (hors boissons, menu du jour et business lunch). Quels sont vos avantages ? Profitez du prix préférentiel pour les membres de l’association du CERN : – Passeport Gourmand Genève : CHF 75.- (au lieu de CHF 95.-) – Passeport Gourmand Ain/Savoie/Haute-Savoie : CHF 59.- (au lieu de CH...

  11. Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Thorup, Anne; Petersen, Lone

    2006-01-01

    Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

  12. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials

    NARCIS (Netherlands)

    Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

    2015-01-01

    The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting

  13. Cycle ergometer and inspiratory muscle training offer modest benefit compared with cycle ergometer alone: a comprehensive assessment in stable COPD patients.

    Science.gov (United States)

    Wang, Kai; Zeng, Guang-Qiao; Li, Rui; Luo, Yu-Wen; Wang, Mei; Hu, Yu-He; Xu, Wen-Hui; Zhou, Lu-Qian; Chen, Rong-Chang; Chen, Xin

    2017-01-01

    Cycle ergometer training (CET) has been shown to improve exercise performance of the quadriceps muscles in patients with COPD, and inspiratory muscle training (IMT) may improve the pressure-generating capacity of the inspiratory muscles. However, the effects of combined CET and IMT remain unclear and there is a lack of comprehensive assessment. Eighty-one patients with COPD were randomly allocated to three groups: 28 received 8 weeks of CET + IMT (combined training group), 27 received 8 weeks of CET alone (CET group), and 26 only received 8 weeks of free walking (control group). Comprehensive assessment including respiratory muscle strength, exercise capacity, pulmonary function, dyspnea, quality of life, emotional status, nutritional status, and body mass index, airflow obstruction, and exercise capacity index were measured before and after the pulmonary rehabilitation program. Respiratory muscle strength, exercise capacity, inspiratory capacity, dyspnea, quality of life, depression and anxiety, and nutritional status were all improved in the combined training and CET groups when compared with that in the control group ( P Inspiratory muscle strength increased significantly in the combined training group when compared with that in the CET group (ΔPI max [maximal inspiratory pressure] 5.20±0.89 cmH 2 O vs 1.32±0.91 cmH 2 O; P 0.05). Patients with weakened respiratory muscles in the combined training group derived no greater benefit than those without respiratory muscle weakness ( P >0.05). There were no significant differences in these indices between the patients with malnutrition and normal nutrition after pulmonary rehabilitation program ( P >0.05). Combined training is more effective than CET alone for increasing inspiratory muscle strength. IMT may not be useful when combined with CET in patients with weakened inspiratory muscles. Nutritional status had slight impact on the effects of pulmonary rehabilitation. A comprehensive assessment approach can be more

  14. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta...

  15. Do new cancer drugs offer good value for money? The perspectives of oncologists, health care policy makers, patients, and the general population.

    Science.gov (United States)

    Dilla, Tatiana; Lizan, Luís; Paz, Silvia; Garrido, Pilar; Avendaño, Cristina; Cruz-Hernández, Juan J; Espinosa, Javier; Sacristán, José A

    2016-01-01

    In oncology, establishing the value of new cancer treatments is challenging. A clear definition of the different perspectives regarding the drivers of innovation in oncology is required to enable new cancer treatments to be properly rewarded for the value they create. The aim of this study was to analyze the views of oncologists, health care policy makers, patients, and the general population regarding the value of new cancer treatments. An exploratory and qualitative study was conducted through structured interviews to assess participants' attitudes toward cost and outcomes of cancer drugs. First, the participants were asked to indicate the minimum survival benefit that a new treatment should have to be funded by the Spanish National Health System (NHS). Second, the participants were requested to state the highest cost that the NHS could afford for a medication that increases a patient's quality of life (QoL) by twofold with no changes in survival. The responses were used to calculate incremental cost-effectiveness ratios (ICERs). The minimum improvement in patient survival means that justified inclusions into the NHS were 5.7, 8.2, 9.1, and 10.4 months, which implied different ICERs for oncologists (€106,000/quality-adjusted life year [QALY]), patients (€73,520/QALY), the general population (€66,074/QALY), and health care policy makers (€57,471/QALY), respectively. The costs stated in the QoL-enhancing scenario were €33,167, €30,200, €26,000, and €17,040, which resulted in ICERs of €82,917/QALY for patients, €75,500/QALY for the general population, €65,000/QALY for oncologists, and €42,600/QALY for health care policy makers, respectively. All estimated ICER values were higher than the thresholds previously described in the literature. Oncologists most valued gains in survival, whereas patients assigned a higher monetary value to treatments that enhanced QoL. Health care policy makers were less likely to pay more for therapeutic

  16. Investigating the relationship between ageism and some demographic aspects in offering nursing care to elder patients of Al-zahra hospital, Isfahan

    Directory of Open Access Journals (Sweden)

    Bahareh Afarigan

    2016-12-01

    Full Text Available Objective and domain: patient care quality is influenced by many factors one of which can be nurse’s attitude toward the elderly. The present study conducted aiming at specifying the relationship between ageism and some demographic aspects of nursing care toward elder patients hospitalized at Alzahra hospital. Method: the present study is a co relational descriptive research. The statistical population includes all nurses who work in different units of Alzahra hospital of Isfahan (except those working in pediatric and NICU units, as they have no contact with elder patients in 2015. Through availability sampling 275 nurses were selected; 93 male and182 female nurses. Instrument of this study was a questionnaire on ageism designed by researcher. In order for analyzing the data, the researcher used independent T test, variance analysis test and Cross call Valise test. Findings: in investigating knowledge related to elder people, findings of this study shows that this knowledge was in a low level in 11.6 % of nurses and high in 32.7% of them. Attitudes toward elder patients were in 8.4%of nurses negative in 81.8% of them neuter and 9.8% of nurses have got positive attitudes toward the elderly. Also results demonstrated that this attitude was meaningfully more negative in male nurses than females. But in other aspects like age, educational level, income, educational time, ethnicity, living with elderly people and presence of an elder person in their family or relatives, no meaningful difference was seen. Discussion and conclusion: In general, this study showed that sex, occupational record, having passed educational term time are factors influencing ageism. But other demographic characteristics played no meaningful role in nurses’ ageism and these are to be paid more attention in order to decrease ageism.

  17. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making....

  18. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten

    2005-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  19. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, CM; Als-Nielsen, B; Damgaard, M

    2006-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five...... Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks...

  20. Attitudes and expectations of patients with neuromuscular diseases about their participation in a clinical trial.

    Science.gov (United States)

    Gargiulo, M; Herson, A; Michon, C C; Hogrel, J Y; Doppler, V; Laloui, K; Herson, S; Payan, C; Eymard, B; Laforêt, P

    2013-01-01

    This study aimed to gain a better understanding of the psychological impact of participating in a clinical trial for patients with Pompe disease (Acid Maltase Deficiency). Attitudes and expectations of adult patients with neuromuscular diseases regarding medical trials are as yet unreported. In order to learn about the psychological consequences of participating in a clinical trial, we conducted a prospective assessment of patients with late-onset Pompe Disease, a rare genetic condition, for which no treatment had been available before. This psychological study was carried out as an ancillary study to the randomized double-blind placebo-controlled trial described elsewhere (van der Ploeg et al., 2010). We assessed patients (n=8) at inclusion, and at 12 and 18 months for six psychological dimensions: depression (Beck Depression Inventory, BDI), hopelessness (Beck Hopelessness Scale, BHS), anxiety (STAI A-B), quality of life (Whoqol-26), social adjustment (S.A.S-self-report) and locus of control (IPC Levenson). We produced a self-administered questionnaire in order to assess the attitudes, motivations and expectations of patients during the trial. At 12 months, mean social adjustment (SAS-SR, P=0.02) had improved, and at 18 months mean depression score had improved as well (BDI, P=0.03). The quality of life of patients (Whoqol-26) remained unchanged. Throughout the study, patients were more likely to have an internal locus of control than an external one (IPC Levenson). The self-administered questionnaire showed that patients' expectations were disproportionate compared to the medical information they had received starting the trial. For all patients, the first motivation for being enrolled in a clinical trial was "to help research", for half of them the motivation was to "improve their health". Whether patients believed to be part of one group or another (placebo or treatment) depended on their subjective perception of improvement during the trial. Given the small

  1. Effectiveness of intensive smoking reduction counselling plus combination nicotine replacement therapy in promoting long-term abstinence in patients with chronic obstructive pulmonary disease not ready to quit smoking: Protocol of the REDUQ trial

    Directory of Open Access Journals (Sweden)

    Petra Hagens

    2017-12-01

    Discussion: The outcomes of the REDUQ trial will advance knowledge on treatment of smoking COPD patients not ready to quit. If (cost-effective, the smoking reduction intervention can be offered to this difficult-to-treat target group as a valuable adjunct to smoking cessation treatment.

  2. Urinary Metabolite Profiling Offers Potential for Differentiation of Liver-Kidney Yin Deficiency and Dampness-Heat Internal Smoldering Syndromes in Posthepatitis B Cirrhosis Patients

    Directory of Open Access Journals (Sweden)

    Xiaoning Wang

    2015-01-01

    Full Text Available Zheng is the basic theory and essence of traditional Chinese medicine (TCM in diagnosing diseases. However, there are no biological evidences to support TCM Zheng differentiation. In this study we elucidated the biological alteration of cirrhosis with TCM “Liver-Kidney Yin Deficiency (YX” or “Dampness-Heat Internal Smoldering (SR” Zheng and the potential of urine metabonomics in TCM Zheng differentiation. Differential metabolites contributing to the intergroup variation between healthy controls and liver cirrhosis patients were investigated, respectively, and mainly participated in energy metabolism, gut microbiota metabolism, oxidative stress, and bile acid metabolism. Three metabolites, aconitate, citrate, and 2-pentendioate, altered significantly in YX Zheng only, representing the abnormal energy metabolism. Contrarily, hippurate and 4-pyridinecarboxylate altered significantly in SR Zheng only, representing the abnormalities of gut microbiota metabolism. Moreover, there were significant differences between two TCM Zhengs in three metabolites, glycoursodeoxycholate, cortolone-3-glucuronide, and L-aspartyl-4-phosphate, among all differential metabolites. Metabonomic profiling, as a powerful approach, provides support to the understanding of biological mechanisms of TCM Zheng stratification. The altered urinary metabolites constitute a panel of reliable biological evidence for TCM Zheng differentiation in patients with posthepatitis B cirrhosis and may be used for the potential biomarkers of TCM Zheng stratification.

  3. Cycle ergometer and inspiratory muscle training offer modest benefit compared with cycle ergometer alone: a comprehensive assessment in stable COPD patients

    Directory of Open Access Journals (Sweden)

    Wang K

    2017-09-01

    Full Text Available Kai Wang,1,* Guang-qiao Zeng,2,* Rui Li,1,* Yu-wen Luo,1 Mei Wang,1 Yu-he Hu,1 Wen-hui Xu,1 Lu-qian Zhou,2 Rong-chang Chen,2 Xin Chen1 1Department of Respiratory Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, China; 2Department of Respiratory Medicine, The State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China *These authors contributed equally to this work Background: Cycle ergometer training (CET has been shown to improve exercise performance of the quadriceps muscles in patients with COPD, and inspiratory muscle training (IMT may improve the pressure-generating capacity of the inspiratory muscles. However, the effects of combined CET and IMT remain unclear and there is a lack of comprehensive assessment.Materials and methods: Eighty-one patients with COPD were randomly allocated to three groups: 28 received 8 weeks of CET + IMT (combined training group, 27 received 8 weeks of CET alone (CET group, and 26 only received 8 weeks of free walking (control group. Comprehensive assessment including respiratory muscle strength, exercise capacity, pulmonary function, dyspnea, quality of life, emotional status, nutritional status, and body mass index, airflow obstruction, and exercise capacity index were measured before and after the pulmonary rehabilitation program.Results: Respiratory muscle strength, exercise capacity, inspiratory capacity, dyspnea, quality of life, depression and anxiety, and nutritional status were all improved in the combined training and CET groups when compared with that in the control group (P<0.05 after pulmonary rehabilitation program. Inspiratory muscle strength increased significantly in the combined training group when compared with that in the CET group (ΔPImax [maximal inspiratory pressure] 5.20±0.89 cmH2O vs 1.32±0.91 cmH2O

  4. Parotid salivary parameters in bulimic patients – a controlled clinical trial.

    OpenAIRE

    Elżbieta Paszyńska; Agnieszka Słopień; Monika Węglarz; Roger W.A. Linden

    2015-01-01

    Objectives The aim of this study was to determine whether patients with purging-type bulimia and/or non-bulimic patients, treated with serotonin reuptake inhibitor SI-5-HT (fluoxetine), have dental erosion and changes in selected buffer components of parotid saliva (bicarbonates, phosphates, urea), compared with the healthy population. Methods A controlled clinical trial was designed for three, age-matched, female groups of 94 patients: 1) bulimic patients treated with fluoxetin...

  5. Antipyretic therapy in critically ill patients with established sepsis: a trial sequential analysis.

    Directory of Open Access Journals (Sweden)

    Zhongheng Zhang

    Full Text Available antipyretic therapy for patients with sepsis has long been debated. The present study aimed to explore the beneficial effect of antipyretic therapy for ICU patients with sepsis.systematic review and trial sequential analysis of randomized controlled trials.Pubmed, Scopus, EBSCO and EMBASE were searched from inception to August 5, 2014.Mortality was dichotomized as binary outcome variable and odds ratio (OR was chosen to be the summary statistic. Pooled OR was calculated by using DerSimonian and Laird method. Statistical heterogeneity was assessed by using the statistic I2. Trial sequential analysis was performed to account for the small number of trials and patients.A total of 6 randomized controlled trials including 819 patients were included into final analysis. Overall, there was no beneficial effect of antipyretic therapy on mortality risk in patients with established sepsis (OR: 1.02, 95% CI: 0.50-2.05. The required information size (IS was 2582 and our analysis has not yet reached half of the IS. The Z-curve did not cross the O'Brien-Fleming α-spending boundary or reach the futility, indicating that the non-significant result was probably due to lack of statistical power.our study fails to identify any beneficial effect of antipyretic therapy on ICU patients with established diagnosis of sepsis. Due to limited number of total participants, more studies are needed to make a conclusive and reliable analysis.

  6. Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations.

    Science.gov (United States)

    Vaduganathan, Muthiah; Butler, Javed; Roessig, Lothar; Fonarow, Gregg C; Greene, Stephen J; Metra, Marco; Cotter, Gadi; Kupfer, Stuart; Zalewski, Andrew; Sato, Naoki; Filippatos, Gerasimos; Gheorghiade, Mihai

    2015-07-01

    With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF?

  7. Efficacy of Plai Cream in Adult Patients with Muscle Strain: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Cheechareoan, Sukrom; Pathanawiriyasirikul, Thanate; Manmee, Charuwan; Janpol, Kanya

    2016-02-01

    Nonsteroidal anti-inflammatory drugs are a standard treatment option for muscle strain; however, side effects persist. This clinical trial was designed to compare the efficacy of Plai cream compared to placebos in adult patients with muscle strain. In this randomized, double-blind, placebo-controlled trial, 140 participants aged over 18 years with muscle strain were randomized to receive either Plai cream (n = 70 patients, treatment group) or placebos (n = 70 patients, control group) . Outcome assessments included the visual analog scale (VAS), quality of life (QoL), the amount of remaining cream, and the number of acetaminophen tablets used. After 2 weeks, the mean pain scores following treatment with both Plai cream and placebos in patients with muscle strain decreased from baseline to the end of the study at week 2. However, no significant difference for VA S score was found. The QoL of the two groups showed improvements in QoL as witnessed by increased mean QoL scores from baseline to week 2; however, these differences were not statistically significant. In general, mean QoL scores above 50 indicate good quality of life. The amount of Plai cream used reduced from baseline to week 2, but no significant difference in the amount of cream remaining was found between the two groups at each visit. Similarly, the number of acetaminophen tablets used was not statistically different between the treatment and control groups. There was no difference in pain reduction in the 2-week period between patients with muscle strain using Plai cream and those given placebos, but Plai cream tended to reduce pain in the long term. No side effects were found from Plai cream, so this non-invasive treatment may be offered to patients.

  8. Patient centric approach for clinical trials: Current trend and new opportunities.

    Science.gov (United States)

    Sharma, Neha Shankar

    2015-01-01

    The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.

  9. Patient centric approach for clinical trials: Current trend and new opportunities

    Directory of Open Access Journals (Sweden)

    Neha Shankar Sharma

    2015-01-01

    Full Text Available The clinical research industry today is undergoing a major facelift. Companies are continuously looking to adopt and implement effective and innovative ways to accelerate drug launches in the market. Companies today are more open and do not view patients as mere "subjects" who generate data, - but as informed collaborators whose participation is "core" to the overall success of trials leading to the emergence of the concept of "patient-centric trials." This paper is intended to highlight the current trends and new opportunities that can be seen in industry -indicative of crucial role patients today play in their own health care using technology, social media and self education.

  10. A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    2008-04-01

    Full Text Available BACKGROUND: There have been increasing concerns regarding the safety and efficacy of neuroleptics in people with dementia, but there are very few long-term trials to inform clinical practice. The aim of this study was to determine the impact of long-term treatment with neuroleptic agents upon global cognitive decline and neuropsychiatric symptoms in patients with Alzheimer disease. METHODS AND FINDINGS: DESIGN: Randomised, blinded, placebo-controlled parallel two-group treatment discontinuation trial. SETTING: Oxfordshire, Newcastle and Gateshead, London and Edinburgh, United Kingdom. PARTICIPANTS: Patients currently prescribed the neuroleptics thioridazine, chlorpromazine, haloperidol trifluoperazine or risperidone for behavioural or psychiatric disturbance in dementia for at least 3 mo. INTERVENTIONS: Continue neuroleptic treatment for 12 mo or switch to an identical placebo. OUTCOME MEASURES: Primary outcome was total Severe Impairment Battery (SIB score. Neuropsychiatric symptoms were evaluated with the Neuropsychiatric Inventory (NPI. RESULTS: 165 patients were randomised (83 to continue treatment and 82 to placebo, i.e., discontinue treatment, of whom 128 (78% commenced treatment (64 continue/64 placebo. Of those, 26 were lost to follow-up (13 per arm, resulting in 51 patients per arm analysed for the primary outcome. There was no significant difference between the continue treatment and placebo groups in the estimated mean change in SIB scores between baseline and 6 mo; estimated mean difference in deterioration (favouring placebo -0.4 (95% confidence interval [CI] -6.4 to 5.5, adjusted for baseline value (p = 0.9. For neuropsychiatric symptoms, there was no significant difference between the continue treatment and placebo groups (n = 56 and 53, respectively in the estimated mean change in NPI scores between baseline and 6 mo; estimated mean difference in deterioration (favouring continue treatment -2.4 (95% CI -8.2 to 3.5, adjusted for

  11. The Aliskiren Trial to Minimize OutcomeS in Patients with HEart failure trial (ATMOSPHERE)

    DEFF Research Database (Denmark)

    Krum, Henry; McMurray, John J V; Abraham, William T

    2015-01-01

    diabetes at baseline in ATMOSPHERE. RESULTS: A total of 7063 patients were randomized into ATMOSPHERE April 2009-April 2014 at 755 sites in 43 countries. Their average age was 63 years and 78% were men. ATMOSPHERE patients were generally similar to those in PARADIGM-HF although fewer had diabetes, renal...... dysfunction, and were treated with a mineralocorticoid receptor antagonist. In ATMOSPHERE, patients with diabetes differed in numerous ways from those without. Patients with diabetes were older and had worse heart failure status but a similar left ventricular ejection fraction (mean 28%); they had a higher......AIMS AND METHODS: To: (i) describe the baseline characteristics of patients in ATMOSPHERE and the changes in the planned analysis of ATMOSPHERE resulting from the mandated discontinuation of study treatment in patients with diabetes; (ii) compare the baseline characteristics of patients...

  12. Co-morbidity of 'clinical trial' versus 'real-world' patients using cardiovascular drugs

    NARCIS (Netherlands)

    Wieringa, N.F.; Vos, Reinder; van der Werf, G.T.; van der Veen, W.J.; de Graeff, P.A.

    2000-01-01

    Purpose - To examine discrepancies between co-morbidity of patients included in pre marketing clinical trials of cardiovascular drugs and patients from daily practice, representing the actual users after marketing, and to investigate the availability of data regarding co-morbidity in registration

  13. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  14. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  15. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71)

  16. Of Guinea pigs and gratitude: the difficult discourse of clinical trials from the cancer patient perspective.

    Science.gov (United States)

    Thorne, S; Taylor, K; Stephens, J M L; Kim-Sing, C; Hislop, T G

    2013-09-01

    In an ongoing longitudinal qualitative cohort study of cancer patients' needs and preferences across the cancer journey, we harvested a subset of accounts pertaining to conversations between patients and their clinicians around clinical trials. Recognising these conversations as a departure from the more routine discourses of clinical care, in that they enter into new dimensions of investment and motivation on the part of clinicians, we engaged in both secondary analysis of banked data and focussed interviewing of cancer patients to better understand how cancer patients describe communications in relation to decisions pertaining to clinical trials participation. Using constant comparative techniques informed by the interpretive description approach to applied qualitative methodology to guide a systematic analysis of this set of data, we documented patterns and themes across patient accounts. The resulting thematic depiction of clinical trials discourses from a patient perspective contrasts with assumptions apparent in the professional literature relating to the clinical advantage of trials participation, and illuminates aspects of patient-clinician interaction that are particularly amenable to disruption within this delicate and nuanced discourse. Findings from this study have implications for our understanding of the complexities of cancer communication at the delicate intersection of patient care and knowledge generation. © 2013 John Wiley & Sons Ltd.

  17. Effect of Administration Route on the Pharmacokinetics of Cobalamin in Elderly Patients: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Monique P.H. Tillemans, PharmD

    2014-12-01

    Conclusions: The pharmacokinetics of intranasal and intramuscular cobalamin administration in elderly, cobalamin-deficient patients differ significantly. However, the estimated 2% bioavailability of cobalamin after intranasal administration makes intranasal cobalamin administration a potentially interesting administration route for elderly patients. Netherlands Trial Registry identifier: NTR 3005.

  18. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    DEFF Research Database (Denmark)

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

    2014-01-01

    Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

  19. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  20. Biotin ameliorates muscle cramps of hemodialysis patients: a prospective trial.

    Science.gov (United States)

    Oguma, Shiro; Ando, Itiro; Hirose, Takuo; Totsune, Kazuhito; Sekino, Hiroshi; Sato, Hiroshi; Imai, Yutaka; Fujiwara, Masako

    2012-07-01

    Patients with renal failure undergoing hemodialysis often have muscle cramps during and after the dialysis therapy. Muscle cramps are defined as the sudden onset of a prolonged involuntary muscle contraction accompanied with severe pain, resulting in early termination of a HD session and inadequate dialysis. The etiology of the cramps is unknown and effective anti-cramp medicine is not available. We have hypothesized that water-soluble vitamins are deficient in HD patients. Accordingly, we administrated biotin to 14 patients who had frequent muscle cramps during HD sessions. Oral administration of 1 mg/day biotin promptly reduced the onset and the severity of cramps in 12 patients both during and after HD. Then, the plasma biotin levels were measured by an enzyme-linked immunosorbent assay method (ELISA) in HD patients, including 14 patients with cramps and 13 patients without cramps, and 11 healthy volunteers. Plasma biotin levels were elevated in 27 HD patients at baseline compared with healthy volunteers [451 (377 - 649) vs. 224 (148 - 308) ng/l, median (lower-upper quartiles); p cramp patients, the biotin levels were significantly higher in biotin-ineffective 7 patients than biotin-effective 7 patients [1,064 (710 - 1,187) vs. 445 (359 - 476) ng/l; p cramps regardless of their elevated plasma biotin levels.

  1. Simulating clinical trial visits yields patient insights into study design and recruitment

    Directory of Open Access Journals (Sweden)

    Lim SS

    2017-07-01

    Full Text Available S Sam Lim,1 Alan J Kivitz,2 Doug McKinnell,3 M Edward Pierson,4 Faye S O’Brien4 1Division of Rheumatology, Department of Medicine, Emory University, Atlanta, GA, USA; 2Altoona Center for Clinical Research, Altoona, PA, USA; 3Deloitte Life Sciences Advisory, Basel, Switzerland; 4Clinical Operations, Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA Purpose: We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.Patients and methods: Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE/lupus nephritis (LN were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.Results: The Atlanta study involved 6 African-American patients (5 female aged 27–60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32–75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1 information, communication, and education; 2 responsiveness to needs; 3 access to care; and 4 coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in

  2. A randomised controlled trial of patient led training in medical education: protocol

    Directory of Open Access Journals (Sweden)

    Watt Ian

    2010-12-01

    Full Text Available Abstract Background Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety. Methods/Design A randomised cluster controlled trial will be conducted. The intervention will be incorporated into the mandatory training of junior doctors training programme on patient safety. The study will be conducted in the Yorkshire and Humber region in the North of England. Patients who have experienced a safety incident in the NHS will be recruited. Patients will be identified through National Patient Safety Champions and local Trust contacts. Patients will receive training and be supported to talk to small groups of trainees about their experiences. The primary aim of the patient-led teaching module is to increase the awareness of patient safety issues amongst doctors, allow reflection on their own attitudes towards safety and promote an optimal culture among the doctors to improve safety in practice. A mixture of qualitative and quantitative methods will be used to evaluate the impact of the intervention, using the Attitudes to Patient Safety Questionnaire (APSQ as our primary quantitative outcome, as well as focus groups and semi-structured interviews. Discussion The research team face a number of challenges in developing the intervention, including integrating a new method of teaching into an existing curriculum, facilitating effective patient involvement and identifying suitable outcome measures. Trial Registration Current controlled Trials

  3. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient).

    Science.gov (United States)

    Yoshimura, Shinichi; Uchida, Kazutaka; Daimon, Takashi; Takashima, Ryuzo; Kimura, Kazuhiro; Morimoto, Takeshi

    2017-11-01

    Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available. We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days. A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups ( P =0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53-1.3; P =0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups. Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02549846. © 2017 American Heart Association, Inc.

  4. Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Dorleijn Desirée MJ

    2011-12-01

    Full Text Available Abstract Background Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed. The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. Methods/Design This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics. Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. Discussion This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. Trial Registration This

  5. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    Directory of Open Access Journals (Sweden)

    Rousseau Sally

    2010-10-01

    Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT

  6. Final year nursing students in Nigeria; How knowledgeable and prepared are they to offer medical care to patients with chronic kidney disease?

    Science.gov (United States)

    Okwuonu, Chimezie Godswill; Kanu, Hannah Sylvanus; Odigie, Ojeh-Oziegbe

    2017-01-01

    Nurses play an important role in the management of chronic kidney disease (CKD) patients at primary, secondary, and tertiary levels of care. In other to perform their functions, it is pertinent that they have a good understanding of kidney functions and CKD. We do not know if the current educational curriculum prepares them adequately for this role. To assess the knowledge level of kidney functions and diseases among final year nursing students in Abia State Nigeria. This was a cross sectional study involving final year diploma and Bachelor of nursing (B.Nursing) students who were randomly chosen. Structured, self-administered questionnaire containing 18 items was the tool for data collection. A score of one was given for each correctly answered question on functions of the kidney, symptoms, signs, causes, and complications of CKD. A score of 50% and above was regarded as good knowledge. Two hundred questionnaires were distributed, but 186 were returned (response rate of 93%). Male:female ratio was 1:14.5. One hundred and seventeen (62.9%) knew the correct definition of CKD, but only 69 (37.1%) knew the normal range of glomerular filtration rate. Eighty-one percent had good knowledge of kidney functions while 39 (21%) had good knowledge of CKD. Overall, 42 (22.6%) had good knowledge of kidney functions and CKD. Students who rotated through the dialysis unit during their clinical posting had higher mean knowledge score than others (P = 0.03). There was no significant difference in the mean knowledge scores of the diploma and B.Nursing students (P = 0.76). The majority of the final year students had poor knowledge of CKD. There is need to expand the current teaching curriculum so as to increase the knowledge of these future nurses on the basic concepts of CKD to improve outcomes of patient management. Résumé Contexte: Les infirmiers jouent un rôle important dans le suivi des personnes souffrant de la maladie rénale chronique (MRC) aux premiers, deuxièmes et

  7. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

  8. Targeting cancer patients' quality of life through social comparison : A randomised trial

    NARCIS (Netherlands)

    Brakel, Thecla M.; Dijkstra, Arie; Buunk, Abraham P.

    2014-01-01

    Objective: Former cancer patients' quality of life can be improved by offering social comparison information. Whether patients, however, benefit from the information may depend on how negative they perceive their present and their future. Design: We conducted a randomised experimental field study

  9. Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

    Science.gov (United States)

    Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

    2016-01-01

    Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

  10. Exercise rehabilitation on home-dwelling patients with Alzheimer's disease--a randomized, controlled trial. Study protocol.

    Science.gov (United States)

    Pitkala, Kaisu H; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Kautiainen, Hannu; Strandberg, Timo E

    2010-10-06

    Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. During years 2008-2010, patients with AD (n = 210) living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1) tailored home-based exercise twice weekly 2) group-based exercise twice weekly in rehabilitation center 3) control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36). Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. ACTRN12608000037303.

  11. Sociodemographic analysis of patients in radiation therapy oncology group clinical trials

    International Nuclear Information System (INIS)

    Chamberlain, Robert M.; Winter, Kathryn A.; Vijayakumar, Srinivasan; Porter, Arthur T.; Roach, M.; Streeter, Oscar; Cox, James D.; Bondy, Melissa L.

    1998-01-01

    Purpose: To assess the degree to which the sociodemographic characteristics of patients enrolled in Radiation Therapy Oncology Group (RTOG) clinical trails are representative of the general population. Methods and Materials: Sociodemographic data were collected on 4016 patients entered in 33 open RTOG studies between July 1991 and June 1994. The data analyzed included educational attainment, age, gender, and race. For comparison, we obtained similar data from the U.S. Department of Census. We also compared our RTOG data with Surveillance Epidemiology and End Results (SEER) data for patients who received radiation therapy, to determine how RTOG patients compared with cancer patients in general, and with patients with cancers at sites typically treated with radiotherapy. Results: Overall, the sociodemographic characteristics of patients entered in RTOG trials were similar to those of the Census data. We found that, in every age group of African-American men and at nearly every level of educational attainment, the proportion of RTOG trial participants mirrored the proportion in the census data. Significant differences were noted only in the youngest category of African-American men, where the RTOG accrues more in the lower educational categories and fewer with college experience. For African-American women, we found a similar pattern in every age group and at each level of educational attainment. As with men, RTOG trials accrued a considerably larger proportion of younger, less educated African-American women than the census reported. Using SEER for comparison, the RTOG enrolled proportionately more African-American men to trials all cancer sites combined, and for prostate and head and neck cancer. In head and neck trials, the RTOG enrolled nearly twice as many African-American men than would be predicted by SEER data. In lung cancer trials, RTOG underrepresented African-American men significantly; however, there was no difference for brain cancer trials. There were

  12. Who am I? Reflections on self-image among patients with cancer in clinical trials.

    Science.gov (United States)

    Ulrich, Connie M

    2013-12-01

    Patients with cancer who participate in research face difficult challenges. Their lives change in many ways, and they often question their self-image. Self-image includes how patients see themselves and who they want to become. The current commentary addresses the issue of self-image in patients with cancer who participate in clinical trials and how their sense of who they were changes as they shift from patients with cancer to research participants. Patients with cancer who participate in research may suffer from multiple identity transitions, ranging from physical alterations in appearance and bodily capabilities to psychological burdens of job loss and the inability to contribute financially to their families. The author aims to provide insight as to how researchers can help patients find meaning in their lives during the process of participation in clinical trials as they undergo identity transitions.

  13. Statistical analysis plan for the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial

    DEFF Research Database (Denmark)

    Billot, Laurent; Venkatesh, Balasubramanian; Myburgh, John

    2017-01-01

    BACKGROUND: The Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL) trial, a 3800-patient, multicentre, randomised controlled trial, will be the largest study to date of corticosteroid therapy in patients with septic shock. OBJECTIVE: To describe a statistic...

  14. Offering Incentives from the Outside

    DEFF Research Database (Denmark)

    Emmanuel, Nikolas G.

    2017-01-01

    Incentives offer a good deal of underexplored opportunities to help manage conflict by encouraging political bargaining. This study has two primary objectives. First, it furthers the discussion of how external third parties can help manage conflicts. Second, it offers a typology of the available ...

  15. The Challenges of Recruiting Patients into a Sham Surgery Trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer Borbjerg; Lohmander, Stefan; Roos, Ewa M.

    meniscectomy or placebo surgery. Patients referred from general practitioners were screened. If eligible, oral and written information about the study including a 10 minute video was given to the patients and they were subsequently invited to participate. If willing they were referred to an MRI to confirm...

  16. Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.

    Science.gov (United States)

    DeVito Dabbs, Annette; Song, Mi-Kyung; Myers, Brad; Hawkins, Robert P; Aubrecht, Jill; Begey, Alex; Connolly, Mary; Li, Ruosha; Pilewski, Joseph M; Bermudez, Christian A; Dew, Mary Amanda

    2013-01-01

    Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. Our purpose is to describe the protocol to evaluate Pocket PATH (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial (RCT) to evaluate health IT intended for patient use. An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies are described to maintain equipoise, to monitor data safety and intervention fidelity, and to keep pace with changing technology during such trials. The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care, and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting RCTs and include strategies to address the unique issues associated with the evaluation of health IT for patient use.

  17. The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.

    Science.gov (United States)

    Sen, Anando; Goldstein, Andrew; Chakrabarti, Shreya; Shang, Ning; Kang, Tian; Yaman, Anil; Ryan, Patrick B; Weng, Chunhua

    2017-09-13

    The population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics. Sixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial duration and trial metadata were statistically analyzed. A focused analysis with only phase 2 and 3 interventional trials was also conducted. A total of 869 of 1691 trials (51.4%) and 412 of 776 phase 2 and 3 interventional trials (53.1%) had a population representativeness of representativeness was significantly correlated with the representativeness of the Hba1c criterion. The greater the number of criteria or the shorter the trial, the less the representativeness. Among the trial metadata, phase, recruitment status, and start year were found to have a statistically significant effect on population representativeness. For phase 2 and 3 interventional trials, only start year was significantly associated with representativeness. Our study quantified the representativeness of multiple type 2 diabetes trials. The common low representativeness of type 2 diabetes trials could be attributed to specific study design requirements of trials or safety concerns. Rather than criticizing the low representativeness, we contribute a method for increasing the transparency of the representativeness of clinical trials. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics

  18. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

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

    Science.gov (United States)

    Bekelman, David B; Plomondon, Mary E; Sullivan, Mark D; Nelson, Karin; Hattler, Brack; McBryde, Connor; Lehmann, Kenneth G; Potfay, Jonathan; Heidenreich, Paul; Rumsfeld, John S

    2013-07-09

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

  20. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  1. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer

    DEFF Research Database (Denmark)

    Grønvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette

    2017-01-01

    Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients...

  2. Psychiatric treatment following participation in the CapOpus randomized trial for patients with comorbid cannabis use disorder and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Orlovska, Sonja; Fohlmann, Allan

    2013-01-01

    Randomized trials targeting cannabis use disorders in patients with psychosis have generally been unsuccessful. One of the largest such trials was the CapOpus trial, which had an impact on the number of monthly joints used, but not on the number of days with cannabis use or positive or negative...

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

    Science.gov (United States)

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

    2016-06-01

    The 'gold standard' for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design. It is widely accepted that second-generation antipsychotics are the therapy of choice in the treatment of schizophrenia. However, their general superiority over first-generation antipsychotics could not be demonstrated in recent randomised controlled trials. Furthermore, we are becoming increasingly aware that the experimental conditions of randomised controlled trials, as in the European First Episode Schizophrenia Trial and Clinical Antipsychotic Trials of Intervention Effectiveness Phase 1 studies, may be inappropriate for psychiatric treatments. The high heterogeneity in the patient population produces discrepancies between daily clinical perception and randomised controlled trials results. The patient-oriented approach in the Cost Utility of the Latest Antipsychotic drugs in Schizophrenia Study reflects everyday clinical practice. The results, however, are highly dependent on the physicians' preferences. The goal of the design described here is to take an intermediate path between randomised controlled trials and clinical studies such as Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study, combining the advantages of both study types. The idea is to randomise two treatment pairs each consisting of one first-generation antipsychotic and one second-generation antipsychotic in a first step and subsequently, to involve the investigators in deciding for a pair most appropriate to the patients' needs and then to randomise the allocation to one drug (first-generation antipsychotic or second-generation antipsychotic) of that chosen pair. This idea was first implemented in the

  4. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants

    DEFF Research Database (Denmark)

    Holmskov, J; Licht, R W; Andersen, K

    2017-01-01

    OBJECTIVE: In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. METHOD: A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.......8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. RESULTS: The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years...

  5. Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

    Science.gov (United States)

    Kearney, Anna; Williamson, Paula; Young, Bridget; Bagley, Heather; Gamble, Carrol; Denegri, Simon; Muir, Delia; Simon, Natalie A; Thomas, Stephen; Elliot, Jim T; Bulbeck, Helen; Crocker, Joanna C; Planner, Claire; Vale, Claire; Clarke, Mike; Sprosen, Tim; Woolfall, Kerry

    2017-12-01

    Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. A modified Delphi process including a two round online survey and a stakeholder consensus meeting. In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  6. Factors associated with willingness to participate in a vaccine clinical trial among elderly Hispanic patients

    Directory of Open Access Journals (Sweden)

    Sharon Rikin

    2017-09-01

    Full Text Available A population specific understanding of barriers and facilitators to participation in clinical trials could improve recruitment of elderly and minority populations. We investigated how prior exposure to clinical trials and incentives were associated with likelihood of participation in a vaccine clinical trial through a questionnaire administered to 200 elderly patients in an academic general internal medicine clinic. Wilcoxon signed rank sum test compared likelihood of participation with and without monetary incentives. Logistic regression evaluated characteristics associated with intent to participate in an influenza vaccine trial, adjusted for age, gender, language, and education history. When asked about likelihood of participation if there was monetary compensation, there was a 12.2% absolute increase in those reporting that they would not participate, with a significant difference in the distribution of likelihood before and after mentioning a monetary incentive (Wilcoxon signed rank test, p = 0.001. Those with previous knowledge of clinical trials (54.4% were more likely to report they would participate vs. those without prior knowledge (OR 2.5, 95% CI [1.2, 5.2]. The study highlights the importance of pre-testing recruitment materials and incentives in key group populations prior to implementing clinical trials. Keywords: Geriatrics, Clinical trials, Research design, Disparities

  7. Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial.

    Science.gov (United States)

    ter Huurne, Elke D; de Haan, Hein A; Postel, Marloes G; van der Palen, Job; VanDerNagel, Joanne E L; DeJong, Cornelis A J

    2015-06-18

    Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders. A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants' self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant's eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest. A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F97=63.07, Peffect sizes between d=.34 to d=.49

  8. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

    2008-01-01

    BACKGROUND: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health......-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients. HYPOTHESIS: The primary hypothesis is that daily recombinant......, and HRQoL, and has a favorable safety profile. DESIGN/MEASUREMENTS: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20...

  9. Communicating BRCA research results to patients enrolled in international clinical trials

    DEFF Research Database (Denmark)

    Pulford, David J; Harter, Philipp; Floquet, Anne

    2016-01-01

    pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study......BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS......: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because...

  10. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Christensen, Anton Wulf; Tarp, Simon; Furst, Daniel E

    2015-01-01

    . Odds ratios (ORs) were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR). RESULTS: Sixty-two trials (19,923 RA patients) were included in the primary analyses...... using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI) 3.41 to 4.60). The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower......OBJECTIVE: To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs...

  11. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial)

    DEFF Research Database (Denmark)

    Toft, Palle; Olsen, Hanne Tanghus; Jørgensen, Helene Korvenius

    2014-01-01

    BACKGROUND: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted......-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients......-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium...

  12. Does adding cognitive-behavioural physiotherapy to exercise improve outcome in patients with chronic neck pain? A randomised controlled trial.

    Science.gov (United States)

    Thompson, D P; Oldham, J A; Woby, S R

    2016-06-01

    To determine whether adding a physiotherapist-led cognitive-behavioural intervention to an exercise programme improved outcome in patients with chronic neck pain (CNP). Multicentre randomised controlled trial. Four outpatient physiotherapy departments. Fifty-seven patients with CNP. Follow-up data were provided by 39 participants [57% of the progressive neck exercise programme (PNEP) group and 79% of the interactive behavioural modification therapy (IBMT) group]. Twenty-eight subjects were randomised to the PNEP group and 29 subjects were randomised to the IBMT group. IBMT is underpinned by cognitive-behavioural principles, and aims to modify cognitive risk factors through interactive educational sessions, graded exercise and progressive goal setting. The main outcome measure was disability, measured by the Northwick Park Questionnaire (NPQ). Secondary outcomes were the Numeric Pain Rating Scale (NPRS), Pain Catastrophising Scale, Tampa Scale for Kinesiophobia (TSK), Chronic Pain Self-efficacy Scale (CPSS) and the Pain Vigilance and Awareness Questionnaire. No significant between-group differences in disability were observed (mean NPQ change: PNEP=-7.2, IBMT=-10.2). However, larger increases in functional self-efficacy (mean CPSS change: PNEP=1.0, IBMT=3.2) and greater reductions in pain intensity (mean NPRS change: PNEP=-1.0, IBMT=-2.2; Pphysiotherapy in all patients with CNP. However, superior outcomes were observed for several secondary measures, and IBMT may offer additional benefit in some patients. ISRCTN27611394. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  13. Physician recruitment of patients to non-therapeutic oncology clinical trials: ethics revisited

    Directory of Open Access Journals (Sweden)

    Lee eBlack

    2013-03-01

    Full Text Available Tailoring medical treatment to individual patients requires a strong foundation in research to provide the data necessary to understand the relationship between the disease, the patient, and the type of treatment advocated for. Non-therapeutic oncology clinical trials studying therapeutic resistance require the participation of patients, yet only a small percentage enroll. Treating physicians are often relied on to recruit patients, but they have a number of ethical obligations that might be perceived as barriers to recruiting. Concepts such as voluntariness of consent and conflicts of interest can have an impact on whether physicians will discuss clinical trials with their patients and how patients perceive the information. However, these ethical obligations should not be prohibitive to physician recruitment of patients—precautions can be taken to ensure that patients’ consent to research participation is fully voluntary and devoid of conflict, such as the use of other members of the research team than the treating physician to discuss the trial and obtain consent, and better communication between researchers, clinicians and patients. These can ensure that research benefits are maximized for the good of patients and society.

  14. The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent; Gluud, Christian; Jobes, David A; Nordentoft, Merete

    2014-05-29

    In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective

  15. A randomised controlled trial of patient led training in medical education: protocol.

    Science.gov (United States)

    Winterbottom, Anna E; Jha, Vikram; Melville, Colin; Corrado, Oliver; Symons, Jools; Torgerson, David; Watt, Ian; Wright, John

    2010-12-03

    Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety. A randomised cluster controlled trial will be conducted. The intervention will be incorporated into the mandatory training of junior doctors training programme on patient safety. The study will be conducted in the Yorkshire and Humber region in the North of England. Patients who have experienced a safety incident in the NHS will be recruited. Patients will be identified through National Patient Safety Champions and local Trust contacts. Patients will receive training and be supported to talk to small groups of trainees about their experiences. The primary aim of the patient-led teaching module is to increase the awareness of patient safety issues amongst doctors, allow reflection on their own attitudes towards safety and promote an optimal culture among the doctors to improve safety in practice. A mixture of qualitative and quantitative methods will be used to evaluate the impact of the intervention, using the Attitudes to Patient Safety Questionnaire (APSQ) as our primary quantitative outcome, as well as focus groups and semi-structured interviews. The research team face a number of challenges in developing the intervention, including integrating a new method of teaching into an existing curriculum, facilitating effective patient involvement and identifying suitable outcome measures. Current controlled Trials: ISRCTN94241579.

  16. The effect of resistance training during radiotherapy on spinal bone metastases in cancer patients - a randomized trial.

    Science.gov (United States)

    Rief, Harald; Petersen, Lina C; Omlor, Georg; Akbar, Michael; Bruckner, Thomas; Rieken, Stefan; Haefner, Matthias F; Schlampp, Ingmar; Förster, Robert; Debus, Jürgen; Welzel, Thomas

    2014-07-01

    To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy (RT) as combined treatment in patients with spinal bone metastases. Secondly, to quantify pathological fractures after combined treatment. In this randomized trial, 60 patients were allocated from September 2011 until March 2013 into one of the two groups: resistance training (group A) or passive physical therapy (group B) with thirty patients in each group during RT. Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline, 3 and 6 months after RT. Bone density in all metastases increased significantly by 28.3% (IQR 11.4-139.0) and 80.3% (IQR 32.6-250.6) after 3 and 6 months in group A (both p < 0.01). The bone density in group A was significantly increased compared to control group after 3 and 6months (both p < 0.01, median 59.7; IQR 21.1-98.3 and median 62.9; IQR -9.7 to 161.7). The bone density data in group B showed no significant increase over the course of time (p = 0.289, median 5.5, IQR 0.0-62.2 and p = 0.057, median 52.1, IQR 0.0-162.7). 23.3% of the patients in group A and 30.0% of the patients in group B had pathological fractures, no fracture was assigned to intervention, and no difference between groups after 3 and 6 months was observed (p = 0.592 and p = 0.604). Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases. This combined treatment is effective, practicable, and without side effects for patients. Importantly, the pathological fracture rate in the intervention group was not increased. The results offer a rationale for future large controlled investigations to confirm these findings. Clinical trial identifier NCT01409720. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ...

  18. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Giovanni E. Ferreira

    2016-01-01

    Full Text Available ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed, EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  19. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Science.gov (United States)

    Ferreira, Giovanni E.; Barreto, Rodrigo G. P.; Robinson, Caroline C.; Plentz, Rodrigo D. M.; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions. PMID:27437710

  20. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ferreira, Giovanni E; Barreto, Rodrigo G P; Robinson, Caroline C; Plentz, Rodrigo D M; Silva, Marcelo F

    2016-04-01

    To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration's Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  1. Can Team-Based Care Improve Patient Satisfaction? A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Wen, Jin; Schulman, Kevin A.

    2014-01-01

    Background Team-based approaches to patient care are a relatively recent innovation in health care delivery. The effectiveness of these approaches on patient outcomes has not been well documented. This paper reports a systematic review of the relationship between team-based care and patient satisfaction. Methods We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, and PSYCHOINFO for eligible studies dating from inception to October 8, 2012. Eligible studies reported (1) a randomized controlled trial, (2) interventions including both team-based care and non-team-based care (or usual care), and (3) outcomes including an assessment of patient satisfaction. Articles with different settings between intervention and control were excluded, as were trial protocols. The reference lists of retrieved papers were also evaluated for inclusion. Results The literature search yielded 319 citations, of which 77 were screened for further full-text evaluation. Of these, 27 articles were included in the systematic review. The 26 trials with a total of 15,526 participants were included in this systematic review. The pooling result of dichotomous data (number of studies: 10) showed that team-based care had a positive effect on patient satisfaction compared with usual care (odds ratio, 2.09; 95% confidence interval, 1.54 to 2.84); however, combined continuous data (number of studies: 7) demonstrated that there was no significant difference in patient satisfaction between team-based care and usual care (standardized mean difference, −0.02; 95% confidence interval, −0.40 to 0.36). Conclusions Some evidence showed that team-based care is better than usual care in improving patient satisfaction. However, considering the pooling result of continuous data, along with the suboptimal quality of included trials, further large-scale and high-quality randomized controlled trials comparing team-based care and usual care are needed. PMID:25014674

  2. Marketing of initial public offering

    Directory of Open Access Journals (Sweden)

    Denčić-Mihajlov Ksenija

    2013-01-01

    Full Text Available The initial public offering offers the ability to obtain additional capital through the mechanism of the primary capital market and represents an important milestone in the life-cycle of privately-held corporations. The value and the number of realized IPO transactions at the global level are increasing. At the same time, due to IPO underpricing problem, the companies that are going public fail to collect requested amount of capital to fund future growth. Given the limited importance granted to marketing, and especially promotion, in the theory and practice in the process of evaluating and trading securities, the author addresses two subjects in this paper. Firstly, the author emphasizes the importance of defining and implementing appropriate marketing strategies in the initial public offering process, and secondly, discusses the impact of marketing expenditures in various instruments to reduce IPO underpricing and create value for shareholders of the company that is going public through the initial public offering.

  3. Ethical Considerations for Deep Brain Stimulation Trials in Patients with Early-Onset Alzheimer's Disease.

    Science.gov (United States)

    Viaña, John Noel M; Bittlinger, Merlin; Gilbert, Frederic

    2017-01-01

    Several studies of deep brain stimulation (DBS) of the fornix or the nucleus basalis of Meynert have been recently conducted in people with Alzheimer's disease, with several recruiting participants early-onset Alzheimer's disease (EOAD). Although EOAD accounts for less than 5.5% of AD cases, ethical considerations must still be made when performing DBS trials including these participants since a portion of people with EOAD, especially those possessing autosomal-dominant mutations, have an atypical and more aggressive disease progression. These considerations include appropriate patient selection and signing of an informed consent for genetic testing; appropriate study design; potential outcomes that people with EOAD could expect; and accurate interpretation and balanced discussion of trial results. Finally, recommendations for future DBS for AD trials will be made to ensure that EOAD patients will not experience avoidable harms should they be enrolled in these experimental studies.

  4. Clinical Trials of Adult Stem Cell Therapy in Patients with Ischemic Stroke.

    Science.gov (United States)

    Bang, Oh Young

    2016-01-01

    Stem cell therapy is considered a potential regenerative strategy for patients with neurologic deficits. Studies involving animal models of ischemic stroke have shown that stem cells transplanted into the brain can lead to functional improvement. With current advances in the understanding regarding the effects of introducing stem cells and their mechanisms of action, several clinical trials of stem cell therapy have been conducted in patients with stroke since 2005, including studies using mesenchymal stem cells, bone marrow mononuclear cells, and neural stem/progenitor cells. In addition, several clinical trials of the use of adult stem cells to treat ischemic stroke are ongoing. This review presents the status of our understanding of adult stem cells and results from clinical trials, and introduces ongoing clinical studies of adult stem cell therapy in the field of stroke.

  5. Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial

    Directory of Open Access Journals (Sweden)

    Tracy L. Stockley

    2016-10-01

    Full Text Available Abstract Background The clinical utility of molecular profiling of tumor tissue to guide treatment of patients with advanced solid tumors is unknown. Our objectives were to evaluate the frequency of genomic alterations, clinical “actionability” of somatic variants, enrollment in mutation-targeted or other clinical trials, and outcome of molecular profiling for advanced solid tumor patients at the Princess Margaret Cancer Centre (PM. Methods Patients with advanced solid tumors aged ≥18 years, good performance status, and archival tumor tissue available were prospectively consented. DNA from archival formalin-fixed paraffin-embedded tumor tissue was tested using a MALDI-TOF MS hotspot panel or a targeted next generation sequencing (NGS panel. Somatic variants were classified according to clinical actionability and an annotated report included in the electronic medical record. Oncologists were provided with summary tables of their patients’ molecular profiling results and available mutation-specific clinical trials. Enrolment in genotype-matched versus genotype-unmatched clinical trials following release of profiling results and response by RECIST v1.1 criteria were evaluated. Results From March 2012 to July 2014, 1893 patients were enrolled and 1640 tested. After a median follow-up of 18 months, 245 patients (15 % who were tested were subsequently treated on 277 therapeutic clinical trials, including 84 patients (5 % on 89 genotype-matched trials. The overall response rate was higher in patients treated on genotype-matched trials (19 % compared with genotype-unmatched trials (9 %; p < 0.026. In a multi-variable model, trial matching by genotype (p = 0.021 and female gender (p = 0.034 were the only factors associated with increased likelihood of treatment response. Conclusions Few advanced solid tumor patients enrolled in a prospective institutional molecular profiling trial were treated subsequently on genotype

  6. The role of maintenance therapy in the treatment of elderly non-small-cell lung cancer patients: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhang L

    2017-12-01

    Full Text Available Liangzhe Zhang, Shugeng Gao, Jie He Department of Thoracic Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China Purpose: Maintenance therapy is an effective treatment strategy for advanced non-small-cell lung cancer (NSCLC. We aim to investigate whether age would affect the efficacy of maintenance therapy in the treatment of advanced NSCLC. Materials and methods: Relevant trials were identified by searching electronic databases and conference meetings. Prospective randomized controlled trials assessing maintenance therapy in elderly patients with advanced NSCLC were included. Outcomes of interest included overall survival (OS and progression-free survival (PFS in elderly patients with advanced NSCLC. Results: A total of 2,724 patients from 5 randomized controlled trials were included for analysis, with 897 patients aged ≥65 years and 1,577 patients aged <65 years. Single-agent maintenance therapy in elderly patients significantly improved PFS (hazard ratio [HR] 0.65, 95% CI: 0.43–0.98, p=0.04 and OS (HR 0.81, 95% CI: 0.68–0.97, p=0.024 when compared with placebo. In addition, doublet maintenance therapy significantly improved PFS (HR 0.81, 95% CI: 0.68–0.97, p=0.024 in comparison with single-agent maintenance therapy. However, doublet maintenance did not improve OS in comparison with single-agent maintenance therapy (HR 1.05, 95% CI: 0.60–1.83, p=0.86. Conclusions: The findings of this study suggest that single-agent maintenance therapy in elderly patients with advanced NSCLC offers an improved PFS and OS when compared with placebo. Further trials are recommended to clearly investigate the efficacy of combination maintenance therapy for advanced NSCLC in this setting. Keywords: non-small-cell lung cancer, maintenance therapy, elderly, meta-analysis, lung neoplasm, older, systematic review

  7. Induction Chemotherapy and Continuous Hyperfractionated Accelerated Radiotherapy (CHART) for Patients With Locally Advanced Inoperable Non-Small-Cell Lung Cancer: The MRC INCH Randomized Trial

    International Nuclear Information System (INIS)

    Hatton, Matthew; Nankivell, Matthew; Lyn, Ethan; Falk, Stephen; Pugh, Cheryl; Navani, Neal; Stephens, Richard; Parmar, Mahesh

    2011-01-01

    Purpose: Recent clinical trials and meta-analyses have shown that both CHART (continuous hyperfractionated accelerated radiation therapy) and induction chemotherapy offer a survival advantage over conventional radical radiotherapy for patients with inoperable non-small cell-lung cancer (NSCLC). This multicenter randomized controlled trial (INCH) was set up to assess the value of giving induction chemotherapy before CHART. Methods and Materials: Patients with histologically confirmed, inoperable, Stage I-III NSCLC were randomized to induction chemotherapy (ICT) (three cycles of cisplatin-based chemotherapy followed by CHART) or CHART alone. Results: Forty-six patients were randomized (23 in each treatment arm) from 9 UK centers. As a result of poor accrual, the trial was closed in December 2007. Twenty-eight patients were male, 28 had squamous cell histology, 34 were Stage IIIA or IIIB, and all baseline characteristics were well balanced between the two treatment arms. Seventeen (74%) of the 23 ICT patients completed the three cycles of chemotherapy. All 42 (22 CHART + 20 ICT) patients who received CHART completed the prescribed treatment. Median survival was 17 months in the CHART arm and 25 months in the ICT arm (hazard ratio of 0.60 [95% CI 0.31-1.16], p = 0.127). Grade 3 or 4 adverse events (mainly fatigue, dysphagia, breathlessness, and anorexia) were reported for 13 (57%) CHART and 13 (65%) ICT patients. Conclusions: This small randomized trial indicates that ICT followed by CHART is feasible and well tolerated. Despite closing early because of poor accrual, and so failing to show clear evidence of a survival benefit for the additional chemotherapy, the results suggest that CHART, and ICT before CHART, remain important options for the treatment of inoperable NSCLC and deserve further study.

  8. The PACOVAR-trial: A phase I/II study of pazopanib (GW786034 and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer

    Directory of Open Access Journals (Sweden)

    Schmidt Marcus

    2011-10-01

    Full Text Available Abstract Background The prognosis of patients with recurrent, platinum-resistant epithelial ovarian cancer (EOC is poor. There is no standard treatment available. Emerging evidence suggests a major role for antiangiogenic treatment modalities in EOC, in particular in combination with the metronomic application of low dose chemotherapy. The novel, investigational oral antiangiogenic agent pazopanib targeting vascular endothelial growth factor receptor (VEGFR, platelet-derived growth factor receptor (PDGFR and c-kit is currently being studied in different tumour types and is already used as first line therapy in recurrent renal cell carcinoma. A combined therapy consisting of pazopanib and metronomic oral cyclophosphamide may offer a well-tolerable treatment option to patients with recurrent, pretreated EOC. Methods/design This study is designed as a multicenter phase I/II trial evaluating the optimal dose for pazopanib (phase I as well as activity and tolerability of a combination regimen consisting of pazopanib and metronomic cyclophosphamide in the palliative treatment of patients with recurrent, platinum-resistant, pre-treated ovarian cancer (phase II. The patient population includes patients with histologically or cytologically confirmed diagnosis of EOC, cancer of the fallopian tube or peritoneal cancer which is platinumresistant or -refractory. Patients must have measurable disease according to RECIST criteria and must have failed available standard chemotherapy. Primary objectives are determination of the optimal doses for pazopanib (phase I and the overall response rate according to RECIST criteria (phase II. Secondary objectives are time to progression, overall survival, safety and tolerability. The treatment duration is until disease progression or intolerability of study drug regimen (with a maximum of 13 cycles up to 52 weeks per subject. Discussion The current phase I/II trial shall clarify the potential of the multitargeting

  9. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance.

    Science.gov (United States)

    Buchanan, Adam H; Datta, Santanu K; Skinner, Celette Sugg; Hollowell, Gail P; Beresford, Henry F; Freeland, Thomas; Rogers, Benjamin; Boling, John; Marcom, P Kelly; Adams, Martha B

    2015-12-01

    Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient satisfaction and CGC attendance from a randomized trial comparing telegenetics with in-person CGC among individuals referred to CGC in four rural oncology clinics. Participants (n = 162) were randomized to receive CGC at their local oncology clinic in-person or via telegenetics. Cost analyses included telegenetics system; mileage; and personnel costs for genetic counselor, IT specialist, and clinic personnel. CGC attendance was tracked via study database. Patient satisfaction was assessed 1 week post-CGC via telephone survey using validated scales. Total costs were $106 per telegenetics patient and $244 per in-person patient. Patient satisfaction did not differ by group on either satisfaction scale. In-person patients were significantly more likely to attend CGC than telegenetics patients (89 vs. 79 %, p = 0.03), with bivariate analyses showing an association between lesser computer comfort and lower attendance rate (Chi-square = 5.49, p = 0.02). Our randomized trial of telegenetics vs. in-person counseling found that telegenetics cost less than in-person counseling, with high satisfaction among those who attended. This study provides support for future randomized trials comparing multiple service delivery models on longer-term psychosocial and behavioral outcomes.

  10. Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hoffmann, Kristine; Sobol, Nanna A; Frederiksen, Kristian S

    2016-01-01

    Background: Studies of physical exercise in patients with Alzheimer’s disease (AD) are few and results have been inconsistent. Objective: To assess the effects of a moderate-to-high intensity aerobic exercise program in patients with mild AD. Methods: In a randomized controlled trial, we recruited...... 200 patients with mild AD to a supervised exercise group (60-min sessions three times a week for 16 weeks) or to a control group. Primary outcome was changed from baseline in cognitive performance estimated by Symbol Digit Modalities Test (SDMT) in the intention-to-treat (ITT) group. Secondary...... baseline in SDMT as compared with the control group (mean: 4.2, 95% CI 0.5 to 7.9, p = 0.028), suggesting a dose-response relationship between exercise and cognition. Conclusions: This is the first randomized controlled trial with supervised moderate-to-high intensity exercise in patients with mild AD...

  11. Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study

    Directory of Open Access Journals (Sweden)

    Jacques Medioni

    2017-09-01

    Full Text Available Introduction: Crotoxin has a broad antitumor activity but has shown frequent neurotoxic toxicity. To induce tolerance and limit this toxicity, we propose a new design with intra-patient dose escalation. Methods: A new Dose Limiting Toxicity definition was used. The concept of Target Ceiling Dose was introduced. Results: Dose Limiting Toxicity was the inability to dose escalate twice. Target Ceiling Dose was the highest planned dose to be administered to a patient and could change for patients along time. Recommended Dose was defined similarly as in a (3 + 3 conventional design. Conclusion: This innovant design was used and the clinical trial is now closed for inclusions. Results will be presented later. Keywords: Clinical trial, Phase 1, Intra-patient dose escalation, Cancer

  12. Vision related quality of life in patients with type 2 diabetes in the EUROCONDOR trial

    DEFF Research Database (Denmark)

    Trento, Marina; Durando, Olga; Lavecchia, Sonia

    2017-01-01

    To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic...... retinopathy were enrolled in a 2-year multicenter randomized controlled trial. The 25-item National Eye Institute Visual Functioning Questionnaire was used to explore 12 subscales of vision related quality of life. The patients were 62.8 ± 6.7 years old and had 11.1 ± 5.6 years known disease duration....... Diabetic retinopathy was absent in 193 (43.0 %) and mild in 256 (57.0 %). Patients without diabetic retinopathy were older, had shorter diabetes duration and used less insulin and glucose-lowering agents but did not differ by gender, best corrected visual acuity or any subscale, except vision specific...

  13. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

    Science.gov (United States)

    2013-01-01

    To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting. The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. PMID:24168680

  14. Real-life COPD patients compared to large trial populations : An UNLOCK external validity study

    NARCIS (Netherlands)

    Kruis, Annemarije; Ställberg, Bjorn; Jones, Rupert; Tsiligianni, Ioanna; Kocks, Jan Willem; Van Der Molen, Thys; Chavannes, Niels

    2013-01-01

    Objective To investigate the external validity of six large randomized controlled medication trials (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) compared to the COPD population seen in the community, and to examine the proportion of patients in the community that would be selected based on

  15. OPPORTUNITYTM: a large-scale randomized clinical trial of growth hormone in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, Joel D; Cheung, Alfred K; Christiansen, Jens Sandahl

    2011-01-01

    Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality in hypo...

  16. OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, Joel D; Cheung, Alfred K; Christiansen, Jens Sandahl

    2011-01-01

    Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality in hypo...

  17. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning

    DEFF Research Database (Denmark)

    Talley, N J; Vakil, N; Lauritsen, K

    2007-01-01

    BACKGROUND: Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment. AIM: To evaluate whether a 1-w acid suppression trial is useful for identifying true responders...

  18. Randomized Trial of Continuing Care Enhancements for Cocaine-Dependent Patients following Initial Engagement

    Science.gov (United States)

    McKay, James R.; Lynch, Kevin G.; Coviello, Donna; Morrison, Rebecca; Cary, Mark S.; Skalina, Lauren; Plebani, Jennifer

    2010-01-01

    Objective: The effects of cognitive-behavioral relapse prevention (RP), contingency management (CM), and their combination (CM + RP) were evaluated in a randomized trial with 100 cocaine-dependent patients (58% female, 89% African American) who were engaged in treatment for at least 2 weeks and had an average of 44 days of abstinence at baseline.…

  19. Rosiglitazone Decreases Plasma Levels of Osteoprotegerin in a Randomized Clinical Trial with Type 2 Diabetes Patients

    DEFF Research Database (Denmark)

    Nybo, Mads; Preil, Simone Rørdam; Juhl, Henning Friis

    2011-01-01

    regarding cardiovascular disease. The South Danish Diabetes Study, an investigator-driven, randomized, controlled clinical trial lasting 2 years, was used to test this hypothesis in patient groups with different medication strategies (insulin aspart or NPH insulin, added either metformin...

  20. A consultation leaflet to improve an older patient's involvement in general practice care: a randomized trial.

    NARCIS (Netherlands)

    Wetzels, R.V.; Wensing, M.J.P.; Weel, C. van; Grol, R.P.T.M.

    2005-01-01

    OBJECTIVE: To evaluate the effects of a programme to enhance the involvement of older patients in their consultations in general practice. DESIGN: Cluster randomized trial, in which data was collected from different cohorts. SETTING AND PARTICIPANTS: Twenty-five general practices in the south-east

  1. A Randomized Trial of a Brief Mental Health Intervention for Primary Care Patients

    Science.gov (United States)

    Lang, Ariel J.; Norman, Gregory J.; Casmar, Pollyanna V.

    2006-01-01

    This randomized trial is a first evaluation of a brief psychotherapeutic intervention for primary care patients. Sixty-two participants were randomly assigned to the intervention or to treatment as usual. As compared with treatment as usual, the intervention led to significant reductions in symptoms of anxiety and depression. The reduction was…

  2. Effects of rosuvastatin on progression of stenosis in adult patients with congenital aortic stenosis (PROCAS Trial)

    NARCIS (Netherlands)

    Linde, D. van der; Yap, S.C.; Dijk, A.P. van; Budts, W.; Pieper, P.G.; Burgh, P.H. van der; Mulder, B.J.; Witsenburg, M.; Cuypers, J.A.; Lindemans, J.; Takkenberg, J.J.; Roos-Hesselink, J.W.

    2011-01-01

    Recent trials have failed to show that statin therapy halts the progression of calcific aortic stenosis (AS). We hypothesized that statin therapy in younger patients with congenital AS would be more beneficial, because the valve is less calcified. In the present double-blind, placebo-controlled

  3. Analysis of patient-reported outcomes from the LUME-Lung 1 trial

    DEFF Research Database (Denmark)

    Novello, Silvia; Kaiser, Rolf; Mellemgaard, Anders

    2015-01-01

    INTRODUCTION: The LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and adenocarcinoma...

  4. OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, Joel D; Cheung, Alfred K; Christiansen, Jens Sandahl

    2011-01-01

    Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality...

  5. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial)

    DEFF Research Database (Denmark)

    Qayyum, Abbas Ali; Mathiasen, Anders Bruun; Mygind, Naja Dam

    2017-01-01

    We aimed to evaluate the effect of intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stromal cells (ASCs) in patients with refractory angina. MyStromalCell trial is a randomized double-blind placebo-controlled study including sixty patients with CCS/NYHA class II...... capacity compared to placebo. However, exercise capacity increased in the ASC but not in the placebo group. This trial is registered with ClinicalTrials.gov NCT01449032....

  6. Oral zinc sulphate in treatment of patients with thallium poisoning: A clinical therapeutic trial

    OpenAIRE

    Ahmed A. Al-Mohammadi; Adil A. Noaimi; Khalifa E. Sharquie; Khalil I. Al-Hamdi

    2011-01-01

    Thallium poisoning is usually associated with typical dermatological features simulating that of zinc deficiency. The aim of this study was to evaluate the role of oral zinc sulphate in the treatment of patients with thallium poisoning.Materials and methods: This clinical therapeutic trial study was conducted in Departments of Dermatology of Baghdad and Basrah Teaching Hospitals from February 2008 - February 2010, where a total of 37 patients with thallium poisoning were enrolled.A detailed h...

  7. Uncaria tomentosa for Reducing Side Effects Caused by Chemotherapy in CRC Patients: Clinical Trial

    OpenAIRE

    I. L. G. Farias; M. C. S. Araújo; J. G. Farias; L. V. Rossato; L. I. Elsenbach; S. L. Dalmora; N. M. P. Flores; M. Durigon; I. B. M. Cruz; V. M. Morsch; M. R. C. Schetinger

    2012-01-01

    To evaluate the effectiveness of Uncaria tomentosa in minimizing the side effects of chemotherapy and improving the antioxidant status of colorectal cancer (CRC) patients, a randomized clinical trial was conducted. Patients (43) undergoing adjuvant/palliative chemotherapy with 5-Fluorouracil/leucovorin + oxaliplatin (FOLFOX4) were split into two groups: the UT group received chemotherapy plus 300 mg of Uncaria tomentosa daily and the C group received only FOLFOX4 and served as a control. Bloo...

  8. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    OpenAIRE

    Adamsen, Lis; Quist, Morten; Andersen, Christina; M?ller, Tom; Herrstedt, J?rn; Kronborg, Dorte; Baadsgaard, Marie T; Vistisen, Kirsten; Midtgaard, Julie; Christiansen, Birgitte; Stage, Maria; Kronborg, Morten T; R?rth, Mikael

    2009-01-01

    Objective To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. Design Randomised controlled trial. Setting Two university hospitals in Copenhagen, Denmark. Participants 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing...

  9. Almond supplementation reduces serum uric acid in coronary artery disease patients: a randomized controlled trial

    OpenAIRE

    Jamshed, Humaira; Gilani, Anwar-ul-Hassan; Sultan, Fateh Ali Tipoo; Amin, Faridah; Arslan, Jamshed; Ghani, Sumaira; Masroor, Madiha

    2016-01-01

    Objective Elevated serum uric acid (UA), a biomarker of renal insufficiency, is also an independent prognostic marker for morbidity in coronary artery disease (CAD) and poses serious health risks. This study reports the effect of almond consumption on UA in CAD patients. Study design A randomized controlled clinical trial was conducted with three groups: no-intervention (NI), Pakistani almonds (PA) or American almonds (AA). Patients were recruited from the Cardiology Clinics, Aga Khan Univers...

  10. The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

    2015-03-08

    Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

  11. The effect of protein restriction on albuminuria in patients with type 2 diabetes mellitus: a randomized trial

    NARCIS (Netherlands)

    Pijls, L.T.J.; de Vries, H.; Donker, A.J.M.; van Eijk, J.T.M.

    1999-01-01

    Background. A randomized trial was conducted to assess whether protein restriction helps to delay the onset of renal disorders in type 2 diabetic patients. Methods. Included in the trial were 121 type 2 diabetic patients with microalbuminuria or at least detectable albuminuria, or diabetes of

  12. Perna canaliculus Lipid Complex PCSO-524™ Demonstrated Pain Relief for Osteoarthritis Patients Benchmarked against Fish Oil, a Randomized Trial, without Placebo Control

    Directory of Open Access Journals (Sweden)

    Jacek Szechinski

    2013-06-01

    Full Text Available Osteoarthritis (OA typically generates pain, reduced mobility and reduced quality of life. Most conventional treatments for osteoarthritis, such as non-steroidal anti-inflammatory drugs (NSAIDs and simple analgesics, have side effects. PCSO-524™, a non polar lipid extract from the New Zealand Green Lipped Mussel, is rich in omega-3 fatty acids and has been shown to reduce inflammation in both animal studies and patient trials. This OA trial examined pain relief changes in relation to quality of life and safety of use for OA patients who took PCSO-524™ compared with patients who took fish oil (containing an industry standard EPA-18% and DHA-12% blend. PCSO-524™ patients showed a statistically significant improvement compared with patients who took fish oil. There was an 89% decrease in their pain symptoms and 91% reported an improved quality of life. Patients treated with fish oil showed significantly less improvement and a greater level of physical discomfort during the study. These results suggest that PCSO-524™ might offer a potential alternative complementary therapy with no side effects for OA patients.

  13. Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

    Science.gov (United States)

    Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

    2017-07-11

    The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

  14. Diagnostic conversion to bipolar disorder in unipolar depressed patients participating in trials on antidepressants.

    Science.gov (United States)

    Holmskov, J; Licht, R W; Andersen, K; Bjerregaard Stage, T; Mørkeberg Nilsson, F; Bjerregaard Stage, K; Valentin, J B; Bech, P; Ernst Nielsen, R

    2017-02-01

    In unipolar depressed patients participating in trials on antidepressants, we investigated if illness characteristics at baseline could predict conversion to bipolar disorder. A long-term register-based follow-up study of 290 unipolar depressed patients with a mean age of 50.8 years (SD=11.9) participating in three randomized trials on antidepressants conducted in the period 1985-1994. The independent effects of explanatory variables were examined by applying Cox regression analyses. The overall risk of conversion was 20.7%, with a mean follow-up time of 15.2 years per patient. The risk of conversion was associated with an increasing number of previous depressive episodes at baseline, [HR 1.18, 95% CI (1.10-1.26)]. No association with gender, age, age at first depressive episode, duration of baseline episode, subtype of depression or any of the investigated HAM-D subscales included was found. The patients were followed-up through the Danish Psychiatric Central Research Register, which resulted in inherent limitations such as possible misclassification of outcome. In a sample of middle-aged hospitalized unipolar depressed patients participating in trials on antidepressants, the risk of conversion was associated with the number of previous depressive episodes. Therefore, this study emphasizes that unipolar depressed patients experiencing a relatively high number of recurrences should be followed more closely, or at least be informed about the possible increased risk of conversion. Copyright © 2016. Published by Elsevier Masson SAS.

  15. An efficacy trial of an electronic health record-based strategy to inform patients on safe medication use: The role of written and spoken communication.

    Science.gov (United States)

    Curtis, Laura M; Mullen, Rebecca J; Russell, Allison; Fata, Aimee; Bailey, Stacy C; Makoul, Gregory; Wolf, Michael S

    2016-09-01

    We tested the feasibility and efficacy of an electronic health record (EHR) strategy that automated the delivery of print medication information at the time of prescribing. Patients (N=141) receiving a new prescription at one internal medicine clinic were recruited into a 2-arm physician-randomized study. We leveraged an EHR platform to automatically deliver 1-page educational 'MedSheets' to patients after medical encounters. We also assessed if physicians counseled patients via patient self-report immediately following visits. Patients' understanding was objectively measured via phone interview. 122 patients completed the trial. Most intervention patients (70%) reported receiving MedSheets. Patients reported physicians frequently counseled on indication and directions for use, but less often for risks. In multivariable analysis, written information (OR 2.78, 95% CI 1.10-7.04) and physician counseling (OR 2.95, 95% CI 1.26-6.91) were independently associated with patient understanding of risk information. Receiving both was most beneficial; 87% of those receiving counseling and MedSheets correctly recalled medication risks compared to 40% receiving neither. An EHR can be a reliable means to deliver tangible, print medication education to patients, but cannot replace the salience of physician-patient communication. Offering both written and spoken modalities produced a synergistic effect for informing patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient ... that does the study uses the same protocol. Key information in a protocol includes how many patients ...

  17. Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

    Science.gov (United States)

    Pang, Herbert H; Wang, Xiaofei; Stinchcombe, Thomas E; Wong, Melisa L; Cheng, Perry; Ganti, Apar Kishor; Sargent, Daniel J; Zhang, Ying; Hu, Chen; Mandrekar, Sumithra J; Redman, Mary W; Manola, Judith B; Schilsky, Richard L; Cohen, Harvey J; Bradley, Jeffrey D; Adjei, Alex A; Gandara, David; Ramalingam, Suresh S; Vokes, Everett E

    2016-11-20

    Purpose Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95% CI, 0.19 to 0.25) and EDR of 1.65 (95% CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 ( P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95% CI, 0.00 to 0.06]; EDR, 1.07 [95% CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients

  18. Web-based cognitive behavioral therapy for female patients with eating disorders: Randomized controlled trial

    NARCIS (Netherlands)

    Huurne, E.D. ter; Haan, H.A. de; Postel, M.G.; Palen, J.A.M. van der; Nagel, J.E.L. van der; Jong, C.A.J. de

    2015-01-01

    Background: Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. Objective: This study evaluated the effects of a Web-based cognitive behavioral therapy

  19. Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial

    NARCIS (Netherlands)

    ter Huurne, E.D.; de Haan, H.A.; Postel, Marloes Gerda; van der Palen, Jacobus Adrianus Maria; VanDerNagel, Joanneke E.L.; de Jong, Cor A.J.

    2015-01-01

    Background: Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. Objective: This study evaluated the effects of a Web-based cognitive behavioral therapy

  20. Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial

    OpenAIRE

    ter Huurne, E.D.; de Haan, H.A.; Postel, Marloes Gerda; van der Palen, Jacobus Adrianus Maria; VanDerNagel, Joanneke E.L.; de Jong, Cor A.J.

    2015-01-01

    Background Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. Objective This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eat...

  1. A phase 2 randomised discontinuation trial of cabozantinib in patients with ovarian carcinoma.

    Science.gov (United States)

    Vergote, Ignace B; Smith, David C; Berger, Raanan; Kurzrock, Razelle; Vogelzang, Nicholas J; Sella, Avishay; Wheler, Jennifer; Lee, Yihua; Foster, Paul G; Weitzman, Ron; Buckanovich, Ronald J

    2017-09-01

    Cabozantinib (XL184), an orally bioavailable inhibitor of vascular endothelial growth factor receptor 2 and MET, was assessed in a cohort of ovarian carcinoma patients as part of a phase 2 randomised discontinuation trial (RDT) with cohorts from nine different tumour types. Patients received 100-mg cabozantinib daily. Those with stable disease (SD) per Response Evaluation Criteria in Solid Tumors at week 12 were randomised to cabozantinib or placebo. Primary end-points were objective response rate (ORR) at week 12 and progression-free survival (PFS) after random assignment. Seventy patients with ovarian carcinoma, 50% of whom were platinum refractory/resistant, were enrolled in this RDT. Median PFS from day 1 was 5.5 months for all patients. The ORR at week 12 was 21%; one patient achieved a complete response (CR), and 14 patients (20%) achieved a confirmed partial response (PR). The overall disease control rate (CR + PR + SD) at week 12 was 50%. Throughout the study, 70% of the patients with ≥1 postbaseline scan had tumour regression, and randomisation was discontinued early. For patients with SD randomised to cabozantinib, PFS was 5.9 months after randomisation. The most common grade 3/4 adverse events were diarrhoea (14%), palmar-plantar erythrodysesthesia syndrome (6%), asthenia (6%), hypertension (6%) and neutropenia (6%). Dose reductions were required in 37% of the patients during the first 12 weeks. Cabozantinib demonstrates clinical activity, with acceptable toxicities, in patients with ovarian carcinoma based on ORR and regression of tumour target lesions. This trial is registered at ClinicalTrial.gov (NCT00940225). Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis: A Meta-Epidemiological Study.

    Directory of Open Access Journals (Sweden)

    Anton Wulf Christensen

    Full Text Available To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs for rheumatoid arthritis (RA.We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3-6 and used an add-on design. Odds ratios (ORs were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR.Sixty-two trials (19,923 RA patients were included in the primary analyses using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI 3.41 to 4.60. The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower in trials including "DMARD-naïve" patients compared with trials including "DMARD inadequate responders" (ROR = 0.45, 95%CI 0.31 to 0.66 and trials including "targeted therapy inadequate responders" (0.50, 95%CI 0.29 to 0.87, test for interaction: p = 0.0002. Longer mean disease duration was associated with a higher likelihood of responding to treatment (β = 1.05, 95%CI 1.00 to 1.11 OR's per year; p = 0.03. Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings.Our results suggest that a highly selective inclusion is not associated with greater treatment effect, as might otherwise be expected. The added benefit of a targeted therapy was lower in trials including patients who were DMARD-naïve and trials including patients with shorter disease durations.

  3. Music preferences of mechanically ventilated patients participating in a randomized controlled trial.

    Science.gov (United States)

    Heiderscheit, Annie; Breckenridge, Stephanie J; Chlan, Linda L; Savik, Kay

    2014-01-01

    Mechanical ventilation (MV) is a life-saving measure and supportive modality utilized to treat patients experiencing respiratory failure. Patients experience pain, discomfort, and anxiety as a result of being mechanically ventilated. Music listening is a non-pharmacological intervention used to manage these psychophysiological symptoms associated with mechanical ventilation. The purpose of this secondary analysis was to examine music preferences of 107 MV patients enrolled in a randomized clinical trial that implemented a patient-directed music listening protocol to help manage the psychophysiological symptom of anxiety. Music data presented includes the music genres and instrumentation patients identified as their preferred music. Genres preferred include: classical, jazz, rock, country, and oldies. Instrumentation preferred include: piano, voice, guitar, music with nature sounds, and orchestral music. Analysis of three patients' preferred music received throughout the course of the study is illustrated to demonstrate the complexity of assessing MV patients and the need for an ongoing assessment process.

  4. [Efficacy of dolutegravir in treatment-experienced patients: the SAILING and VIKING trials].

    Science.gov (United States)

    Moreno, Santiago; Berenguer, Juan

    2015-03-01

    Dolutegravir is an HIV integrase inhibitor with a high genetic barrier to resistance and is active against raltegravir- and/or elvitegravir-resistant strains. The clinical development of dolutegravir for HIV infection rescue therapy is based on 3 clinical trials. In the SAILING trial, dolutegravir (5 mg once daily) in combination with 2 other antiretroviral agents was well tolerated and showed greater virological effect than raltegravir (400 mg twice daily) in the treatment of integrase inhibitor-naïve adults with virological failure infected with HIV strains with at least two-class drug resistance. The VIKING studies were designed to evaluate the efficacy of dolutegravir as rescue therapy in treatment-experienced patients infected with HIV strains with resistance mutations to raltegravir and/or elvitegravir. VIKING-1-2 was a dose-ranging phase IIb trial. VIKING-3 was a phase III trial in which dolutegravir (50 mg twice daily) formed part of an optimized regimen and proved safe and effective in this difficult-to-treat group of patients. Dolutegravir is the integrase inhibitor of choice for rescue therapy in multiresistant HIV infection, both in integrase inhibitor-naïve patients and in those previously treated with raltegravir or elvitegravir. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  5. Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial.

    Science.gov (United States)

    Dixon, Padraig; Hollinghurst, Sandra; Edwards, Louisa; Thomas, Clare; Foster, Alexis; Davies, Ben; Gaunt, Daisy; Montgomery, Alan A; Salisbury, Chris

    2016-07-01

    Depression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression. To investigate the cost-effectiveness of a telehealth intervention ('Healthlines') for patients with depression. A prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Cost-consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome. A total of 609 participants were randomised - 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI -0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a

  6. Pilates in heart failure patients: a randomized controlled pilot trial.

    Science.gov (United States)

    Guimarães, Guilherme Veiga; Carvalho, Vitor Oliveira; Bocchi, Edimar Alcides; d'Avila, Veridiana Moraes

    2012-12-01

    Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Investigate the effects of Pilates on exercise capacity variables in HF. Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P = 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P = 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P = 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P = 0.02). The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy. © 2011 Blackwell Publishing Ltd.

  7. Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers.

    Science.gov (United States)

    Smith, Allan 'Ben'; Agar, Meera; Delaney, Geoff; Descallar, Joseph; Dobell-Brown, Kelsey; Grand, Melissa; Aung, Jennifer; Patel, Pinky; Kaadan, Nasreen; Girgis, Afaf

    2018-02-01

    Clinical trials play a critical role in advancing cancer care, but international research shows that few cancer patients, particularly culturally and linguistically diverse (CALD) patients, participate in trials. This limits generalizability of trial results and increases health disparities. This study aimed to establish rates and correlates of trial participation among CALD patients in South Western Sydney Local Health District (SWSLHD), a highly culturally diverse area. Data from all cancer patients diagnosed and/or treated in SWSLHD from January 2006 to July 2016 were analyzed retrospectively. The primary outcome was trial enrolment among patients born in non-English speaking countries (CALD) versus English speaking countries (non-CALD). Multivariable logistic regression evaluated CALD status as a predictor of trial participation. Moderators of trial participation by the different CALD groups, namely those whose preferred language was English (CALD-PLE) or was not English (CALD-PLNE), were examined by testing interactions between CALD status and other demographic and clinical variables. A total of 19 453 patients were analyzed (54.9% non-CALD, 16.5% CALD-PLE, 18.5% CALD-PLNE). Overall, 7.4% of patients were enrolled in a trial. Trial participation was significantly lower in CALD patients than non-CALD patients (5.7% vs 8.4%; odds ratio [OR] = 0.80; 95% confidence interval [CI], 0.69-0.91; P = 0.001). CALD-PLNE patients were less likely to participate in trials than non-CALD (OR = 0.45; 95% CI, 0.36-0.56; P language barriers (e.g. simplified and translated multimedia participant information materials) is needed. © 2017 John Wiley & Sons Australia, Ltd.

  8. Cognitive behavioural treatment for mild Alzheimer's patients and their caregivers (CBTAC): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Forstmeier, Simon; Maercker, Andreas; Savaskan, Egemen; Roth, Tanja

    2015-11-17

    About 90 % of all persons with mild Alzheimer's disease experience neuropsychiatric symptoms, most frequently apathy, depression, anxiety and irritability. These symptoms are associated with greater morbidity, a reduced quality of life for the patient, an increased burden and depression for the caregiver, and higher costs of care and nursing home placement. Psychosocial interventions based on behaviour therapy represent the most efficacious treatment of neuropsychiatric symptoms. However, there is no study, to our knowledge, that has evaluated a multicomponent treatment programme based on comprehensive, cognitive behavioural therapy (CBT). This randomized controlled trial aims to evaluate a CBT-based treatment programme consisting of 8 modules and 25 sessions. Fifty patients with mild Alzheimer's disease alone or with mild mixed dementia (Alzheimer's disease and vascular dementia) who have any neuropsychiatric symptom will be included. A caregiver must be available. The patients and their caregivers will be randomized to either the CBT-based intervention group or to the control condition group, which receives treatment as usual. The primary outcome measure is depression in the patient with Alzheimer's disease. The secondary outcome measures for a person with Alzheimer's disease are other neuropsychiatric symptoms, quality of life and coping strategies. The secondary outcome measures for a caregiver are caregiver's burden, depression, anxiety, anger, quality of life and coping strategies. Neuropsychological testing includes tests of cognitive function and activities of daily living and a global clinical assessment of severity. Participants in both groups will be assessed before and after the treatment phase (lasting approximately 9 months). Follow-up assessments will take place 6 and 12 months after treatment. All assessments will be conducted by blinded assessors. This trial has the potential to establish an empirically based psychological treatment for non

  9. Postgraduates courses offered to nursing

    Directory of Open Access Journals (Sweden)

    Pedro Jorge Araujo

    2011-07-01

    Full Text Available Aim: To know the official masters that the Spanish Universities have offered during the academic course 2010/2011.Material and methods: Descriptive observational and transversal court study, in which it has analysed 170 university official masters and in which it has used a questionnaire with a total of 15 questions elaborated for this work.Results: 52 Spanish Universities of the 75 that there is have offered during the academic course 2010/2011 official masters that can realise for graduated in infirmary. By areas, the official masters more offered have been the ones of nutrition and alimentary security. 76,33% of the official masters have a length of 1 academic year. Almost the half of the official masters have an orientation researcher-professional and almost 40% researcher. 62,65% of the masters give of face-to-face way. In 52,1% of the official masters do not realise external practices and 86,2% has continuity with the doctorate.Conclusions: It has seen that it is necessary that expand the number of masters including other fields of study that contribute to a main specialisation of the professionals of the infirmary. An important percentage of official masters give in face-to-face modality, and there is very few offered on-line or to distance.

  10. Out Come Of Trial Of Scar In Patients With Previous Caesarean Section.

    Science.gov (United States)

    Khan, Bushra; Deeba, Farhat; Bashir, Rubina; Khan, Wajiha

    2016-01-01

    Patients who had one caesarean section were previously not given a trial of scar due to fear of increased morbidity. However, recently there has been a trend to give a trial of labour to patients with a previous caesarean section for a non-recurrent cause. Medical evidence indicates that 60-80% of women can achieve vaginal delivery after a previous lower segment caesarean section. Proper selection of patients for trial of scar and vigilant monitoring during labour will achieve successful maternal and perinatal outcome. The objective of our study is to establish the fact that vaginal delivery after one caesarean section has a high success rate in patients with previous one caesarean section for non-recurrent cause. The study was conducted in Ayub Teaching Abbottabad, Gynae-B Unit. All labouring patients, during the study period of five years, with previous one caesarean section and between 37 weeks to 41 weeks of gestation for a non-recurrent cause were included in the study. Data was recorded on special pro forma designed for the purpose. Patients who had previous classical caesarean section, more than one caesarean section, and previous caesarean section with severe wound infection, transverse lie and placenta previa in present pregnancy were excluded. Foetal macrosomia (wt>4 kg) and severe IUGR with compromised blood flow on Doppler in present pregnancy were also not considered suitable for the study. Patients who had any absolute contraindication for vaginal delivery were also excluded. There were 12505 deliveries during the study period. Total vaginal deliveries were 8790 and total caesarean sections were 3715. Caesarean section rate was 29.7%. Out of these 8790 patients, 764 patients were given a trial of scar and 535 patients delivered successfully vaginally (70%). Women who presented with spontaneous onset of labour were more likely to deliver vaginally (74.8%) as compared to induction group (27.1%). Trial of vaginal birth after caesarean (VBAC) in selected

  11. Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial.

    Science.gov (United States)

    Walsh, Timothy S; Boyd, Julia A; Watson, Douglas; Hope, David; Lewis, Steff; Krishan, Ashma; Forbes, John F; Ramsay, Pamela; Pearse, Rupert; Wallis, Charles; Cairns, Christopher; Cole, Stephen; Wyncoll, Duncan

    2013-10-01

    To compare hemoglobin concentration (Hb), RBC use, and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic (Hb≤90 g/L) critically ill patients of age≥55 years requiring≥4 days of mechanical ventilation in ICU. Parallel-group randomized multicenter pilot trial. Six ICUs in the United Kingdom participated between August 2009 and December 2010. One hundred patients (51 restrictive and 49 liberal groups). Patients were randomized to a restrictive (Hb trigger, 70 g/L; target, 71-90 g/L) or liberal (90 g/L; target, 91-110 g/L) transfusion strategy for 14 days or the remainder of ICU stay, whichever was longest. Baseline comorbidity rates and illness severity were high, notably for ischemic heart disease (32%). The Hb difference among groups was 13.8 g/L (95% CI, 11.5-16.0 g/L); pliberal group (55%) than in the restrictive group (37%); relative risk was 0.68 (95% CI, 0.44-1.05; p=0.073). This trend remained in a survival model adjusted for age, gender, ischemic heart disease, Acute Physiology and Chronic Health Evaluation II score, and total non-neurologic Sequential Organ Failure Assessment score at baseline (hazard ratio, 0.54 [95% CI, 0.28-1.03]; p=0.061). A large trial of transfusion strategies in older mechanically ventilated patients is feasible. This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice.

  12. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  13. A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience.

    Science.gov (United States)

    Arun, Banu; Austin, Taylor; Babiera, Gildy V; Basen-Engquist, Karen; Carmack, Cindy L; Chaoul, Alejandro; Cohen, Lorenzo; Connelly, Lisa; Haddad, Robin; Harrison, Carol; Li, Yisheng; Mallaiah, Smitha; Nagarathna, Raghuram; Parker, Patricia A; Perkins, George H; Reuben, James M; Shih, Ya-Chen Tina; Spelman, Amy; Sood, Anil; Yang, Peiying; Yeung, Sai-Ching J

    2017-03-01

    Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions

  14. Randomized blinded trial of standardized written patient information before total knee arthroplasty.

    Directory of Open Access Journals (Sweden)

    Benedicte Eschalier

    Full Text Available The effect of patient education before total knee arthroplasty (TKA is controversial. No consensus exists about the optimal content of educational interventions. In a previous study, we developed and validated an educational booklet on the peri-TKA management of knee osteoarthritis.Our primary purpose was to evaluate the impact of the educational booklet on knowledge among patients awaiting TKA.This randomized controlled single-blind trial evaluated standard information by the surgeon with or without delivery of the educational booklet 4-6 weeks before primary noncomplex TKA in patients aged 55-75 years with incapacitating knee osteoarthritis. Patients were enrolled at a French surgical center between June 2011 and January 2012. A patient knowledge score was determined at baseline, on the day before TKA, and 3-6 weeks after TKA, using a self-administered questionnaire developed for our previous study. The assessor was blinded to group assignment.Of 44 eligible patients, 42 were randomized, 22 to the intervention and 20 to the control group, all of whom were included in the analysis. The groups were comparable at baseline. The intervention was associated with significantly better patient knowledge scores.An educational booklet improves knowledge among patients awaiting TKA. A study assessing the impact of the booklet combined with a exercise program would be helpful.Level I, randomized controlled double-blind trial; see S1 CONSORT Checklist.clinicaltrials.gov #NCT01747759.

  15. The addition of tramadol to the standard of i.v. acetaminophen and morphine infusion for postoperative analgesia in neonates offers no clinical benefit: a randomized placebo-controlled trial.

    Science.gov (United States)

    Olischar, Monika; Palmer, Greta M; Orsini, Francesca; Davidson, Andrew J; Perkins, Elizabeth J; Lee, Katherine J; Everest, Neil J; Cranswick, Noel E; Hunt, Rod W

    2014-11-01

    Tramadol is used following neonatal cardiac and general surgery. However, its ability to opioid-spare or facilitate earlier extubation in postoperative neonates is unquantified. This randomized placebo-controlled trial aimed to assess whether tramadol's addition to standard analgesia resulted in earlier extubation or reduced analgesic/sedative requirements in postsurgical neonates. Neonates born ≥32 weeks postmenstrual age received either tramadol [T] 2 mg·kg(-1) or placebo [P] 6-hourly for up to 5 days postthoracoabdominal surgery in addition to morphine (commenced at 20 mcg·kg(-1) ·h(-1)) and 6-hourly i.v. acetaminophen. Time to extubation, morphine and midazolam amounts, hourly pain scores, and seizure activity were compared using an intention-to-treat and per-protocol analysis. Seventy-one neonates participated. Median survival time to extubation was similar between the groups (T 67 h [95% CI 51, 84] vs P 52 h [95%CI 43, 65]; P = 0.4), and similar numbers were extubated by 96 h (T 69% vs P 77%; difference -8%, 95%CI -28, 13%). Morphine and midazolam exposure was similar, with low pain scores in both groups (mean percentage of time with a pain score >5/20 during the 5 days: T 13% vs P 11%, difference in means 2.8 [95% CI -1.8, 7.6], P = 0.20). Most participants had normal cranial ultrasounds (T 86% vs P 86%); no seizures occurred clinically or electroencephalographically. Tramadol's addition to standard analgesia in this small group of postsurgical neonates did not appear to have any positive effect on time to extubation, morphine or midazolam exposure, or pain scores. This questions the benefit of tramadol for postsurgical neonates. Importantly, no seizures occurred in these ill neonates who may potentially be at greater risk of tramadol toxicity compared with adults. © 2014 John Wiley & Sons Ltd.

  16. Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients and Utility for Biomarker-Selected Clinical Trials.

    Science.gov (United States)

    Kim, Seung Tae; Kim, Kyoung-Mee; Kim, Nayoung K D; Park, Joon Oh; Ahn, Soomin; Yun, Jae-Won; Kim, Kyu-Tae; Park, Se Hoon; Park, Peter J; Kim, Hee Cheol; Sohn, Tae Sung; Choi, Dong Il; Cho, Jong Ho; Heo, Jin Seok; Kwon, Wooil; Lee, Hyuk; Min, Byung-Hoon; Hong, Sung No; Park, Young Suk; Lim, Ho Yeong; Kang, Won Ki; Park, Woong-Yang; Lee, Jeeyun

    2017-10-01

    Molecular profiling of actionable mutations in refractory cancer patients has the potential to enable "precision medicine," wherein individualized therapies are guided based on genomic profiling. The molecular-screening program was intended to route participants to different candidate drugs in trials based on clinical-sequencing reports. In this screening program, we used a custom target-enrichment panel consisting of cancer-related genes to interrogate single-nucleotide variants, insertions and deletions, copy number variants, and a subset of gene fusions. From August 2014 through April 2015, 654 patients consented to participate in the program at Samsung Medical Center. Of these patients, 588 passed the quality control process for the 381-gene cancer-panel test, and 418 patients were included in the final analysis as being eligible for any anticancer treatment (127 gastric cancer, 122 colorectal cancer, 62 pancreatic/biliary tract cancer, 67 sarcoma/other cancer, and 40 genitourinary cancer patients). Of the 418 patients, 55 (12%) harbored a biomarker that guided them to a biomarker-selected clinical trial, and 184 (44%) patients harbored at least one genomic alteration that was potentially targetable. This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase. This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase. © AlphaMed Press 2017.

  17. Choosing relevant endpoints for older breast cancer patients in clinical trials: an overview of all current clinical trials on breast cancer treatment

    NARCIS (Netherlands)

    de Glas, N. A.; Hamaker, M. E.; Kiderlen, M.; de Craen, A. J. M.; Mooijaart, S. P.; van de Velde, C. J. H.; van Munster, B. C.; Portielje, J. E. A.; Liefers, G. J.; Bastiaannet, E.

    2014-01-01

    With the ongoing ageing of western societies, the proportion of older breast cancer patients will increase. For several years, clinicians and researchers in geriatric oncology have urged for new clinical trials that address patient-related endpoints such as functional decline after treatment of

  18. Imatinib discontinuation in chronic phase myeloid leukaemia patients in sustained complete molecular response : A randomised trial of the Dutch-Belgian Cooperative Trial for Haemato-Oncology (HOVON)

    NARCIS (Netherlands)

    Thielen, Noortje; van der Holt, Bronno; Cornelissen, Jan J.; Verhoef, Gregor E. G.; Gussinklo, Titia; Biemond, Bart J.; Daenen, Simon M. G.; Deenik, Wendy; Kooy, Rien van Marwijk; Petersen, Eefke; Smit, Willem M.; Valk, Peter J. M.; Ossenkoppele, Gert J.; Janssen, Jeroen J. W. M.

    2013-01-01

    Background: Tyrosine kinase inhibitors treatment in responding chronic myeloid leukaemia (CML) patients is generally continued indefinitely. In this randomised phase II trial, we investigated whether CML patients in molecular response(4.5) (MR4.5, quantitative reverse-transcription polymerase chain

  19. Imatinib discontinuation in chronic phase myeloid leukaemia patients in sustained complete molecular response: A randomised trial of the Dutch-Belgian Cooperative Trial for Haemato-Oncology (HOVON)

    NARCIS (Netherlands)

    Thielen, Noortje; van der Holt, Bronno; Cornelissen, Jan J.; Verhoef, Gregor E. G.; Gussinklo, Titia; Biemond, Bart J.; Daenen, Simon M. G.; Deenik, Wendy; van Marwijk Kooy, Rien; Petersen, Eefke; Smit, Willem M.; Valk, Peter J. M.; Ossenkoppele, Gert J.; Janssen, Jeroen J. W. M.

    2013-01-01

    Tyrosine kinase inhibitors treatment in responding chronic myeloid leukaemia (CML) patients is generally continued indefinitely. In this randomised phase II trial, we investigated whether CML patients in molecular response(4.5) (MR(4.5), quantitative reverse-transcription polymerase chain reaction

  20. Acupuncture on the day of embryo transfer: a randomized controlled trial of 635 patients

    DEFF Research Database (Denmark)

    Andersen, Dorthe; Løssl, Kristine; Nyboe Andersen, Anders

    2010-01-01

    This prospective, randomized, controlled and double-blinded trial studied whether acupuncture in relation to embryo transfer could increase the ongoing pregnancy rates and live birth rates in women undergoing assisted reproductive therapy. A total of 635 patients undergoing IVF or intracytoplasmic...... sperm injection (ICSI) were included. In 314 patients, embryo transfer was accompanied by acupuncture according to the principles of traditional Chinese medicine. In the control group, 321 patients received placebo acupuncture using a validated placebo needle. In the acupuncture group and the placebo...

  1. Clinical trials with the new antitussive levodropropizine in adult bronchitic patients.

    Science.gov (United States)

    Allegra, L; Bossi, R

    1988-08-01

    The results of 6 clinical trials involving a total of 174 patients are reported. Levodropropizine (S(-)-3-(4-phenyl-piperazin-1-yl)-propane-1,2-diol, DF 526) was compared in double-blind manner with placebo, morclofone and cloperastine. The antitussive activity and therapeutic efficacy of the drug were shown to be greater than those of placebo and morclofone and similar to those of cloperastine. Levodropropizine was effective in about 80% of patients; in responders, cough frequency was reduced by an average of 33-51%. Levodropropizine was generally well tolerated and mild side-effects were reported for only 3% of patients.

  2. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

    Science.gov (United States)

    Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-09-15

    Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover

  3. Permissive Hypotension vs. Conventional Resuscitation Strategies in Adult Trauma Patients with Hemorrhagic Shock: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Tran, Alexandre; Yates, Jeffrey; Lau, Aaron; Lampron, Jacinthe; Matar, Maher

    2018-01-24

    Aggressive fluid resuscitation in trauma promotes deleterious effects such as clot disruption, dilutional coagulopathy and hypothermia. Animal studies suggest that permissive hypotension maintains appropriate organ perfusion, reduces bleeding and improves mortality. This review assesses the efficacy and safety of permissive hypotension in adult trauma patients with hemorrhagic shock. We searched the MEDLINE and EMBASE databases from inception to May 2017 for randomized controlled trials comparing permissive hypotension vs. conventional resuscitation following traumatic injury. We included pre-operative and intraoperative resuscitation strategies. The primary outcome was 30-day or in-hospital mortality. Secondary outcomes included blood product utilization, estimated blood loss and in-hospital complications. Pooling was performed with a random-effects model. We screened 722 abstracts, from which five randomized trials evaluating 1158 patients were included. Blood pressure targets in the intervention arms varied from systolic BP 50 - 70 mmHg or MAP ≥ 50 mmHg as compared to systolic BP 65 - 100 mmHg or MAP ≥ 65 in the control arms. Two studies evaluated only patients with penetrating injury while the remaining three additionally included blunt injuries. Four trials suggested a survival benefit for 30-day or in-hospital mortality with hypotensive resuscitation, although three studies were insufficiently powered to find statistical significance. Studies were of poor to moderate quality due to poor protocol reporting and lack of blinding. The pooled odds ratio was 0.70 (95% CI 0.53 to 0.92), suggesting a survival benefit for permissive hypotension. Those patients received fewer blood products and had lesser estimated blood loss. Permissive hypotension may offer a survival benefit over conventional resuscitation for patients with hemorrhagic injury. It may additionally reduce blood loss and blood product utilization. However, the majority of studies were underpowered

  4. Chemotherapy in locally advanced nasopharyngeal carcinoma: An individual patient data meta-analysis of eight randomized trials and 1753 patients

    International Nuclear Information System (INIS)

    Baujat, Bertrand; Audry, Helene; Bourhis, Jean; Chan, Anthony T.C.; Onat, Haluk; Chua, Daniel T.T.; Kwong, Dora L.W.; Al-Sarraf, Muhyi; Chi, K.-H.; Hareyama, Masato; Leung, Sing F.; Thephamongkhol, Kullathorn; Pignon, Jean-Pierre

    2006-01-01

    Objectives: To study the effect of adding chemotherapy to radiotherapy (RT) on overall survival and event-free survival for patients with nasopharyngeal carcinoma. Methods and Materials: This meta-analysis used updated individual patient data from randomized trials comparing chemotherapy plus RT with RT alone in locally advanced nasopharyngeal carcinoma. The log-rank test, stratified by trial, was used for comparisons, and the hazard ratios of death and failure were calculated. Results: Eight trials with 1753 patients were included. One trial with a 2 x 2 design was counted twice in the analysis. The analysis included 11 comparisons using the data from 1975 patients. The median follow-up was 6 years. The pooled hazard ratio of death was 0.82 (95% confidence interval, 0.71-0.94; p = 0.006), corresponding to an absolute survival benefit of 6% at 5 years from the addition of chemotherapy (from 56% to 62%). The pooled hazard ratio of tumor failure or death was 0.76 (95% confidence interval, 0.67-0.86; p < 0.0001), corresponding to an absolute event-free survival benefit of 10% at 5 years from the addition of chemotherapy (from 42% to 52%). A significant interaction was observed between the timing of chemotherapy and overall survival (p = 0.005), explaining the heterogeneity observed in the treatment effect (p = 0.03), with the highest benefit resulting from concomitant chemotherapy. Conclusion: Chemotherapy led to a small, but significant, benefit for overall survival and event-free survival. This benefit was essentially observed when chemotherapy was administered concomitantly with RT

  5. Effect of exercise on cognitive function in chronic disease patients: a meta-analysis and systematic review of randomized controlled trials.

    Science.gov (United States)

    Cai, Hong; Li, Guichen; Hua, Shanshan; Liu, Yufei; Chen, Li

    2017-01-01

    The purpose of this study was to conduct a meta-analysis and systematic review to assess the effect of exercise on cognitive function in people with chronic diseases. PubMed, Web of Science, Embase, the Cochrane Library, CINAHL, PsycINFO, and three Chinese databases were electronically searched for papers that were published until September 2016. This meta-analysis and systematic review included randomized controlled trials that evaluated the effect of exercise on cognitive function compared with control group for people with chronic diseases. Totally, 35 studies met the inclusion criteria, with 3,113 participants. The main analysis revealed a positive overall random effect of exercise intervention on cognitive function in patients with chronic diseases. The secondary analysis revealed that aerobic exercise interventions and aerobic included exercise interventions had a positive effect on cognition in patients with chronic diseases. The intervention offering low frequency had a positive effect on cognitive function in patients with chronic diseases. Finally, we found that interventions offered at both low exercise intensity and moderate exercise intensity had a positive effect on cognitive function in patients with chronic diseases. The secondary analysis also revealed that exercise interventions were beneficial in Alzheimer's disease patients when grouped by disease type. This meta-analysis and systematic review suggests that exercise interventions positively influence cognitive function in patients with chronic diseases. Beneficial effect was independent of the type of disease, type of exercise, frequency, and the intensity of the exercise intervention.

  6. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Brian E Lacy

    Full Text Available Abdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating.This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale during the 14-day baseline period. Patients reported abdominal symptoms (including bloating and bowel symptoms daily; adverse events were monitored. The primary responder endpoint required patients to have ≥3 complete spontaneous bowel movements/week with an increase of ≥1 from baseline, for ≥9 of 12 weeks. The primary endpoint compared linaclotide 145 μg vs. placebo.The intent-to-treat population included 483 patients (mean age=47.3 years, female=91.5%, white=67.7%. The primary endpoint was met by 15.7% of linaclotide 145 μg patients vs. 7.6% of placebo patients (P<0.05. Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity. Approximately one-third of linaclotide patients (each group had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01. Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients. AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.Once-daily linaclotide (145 and 290 μg significantly improved bowel and abdominal symptoms in chronic idiopathic constipation patients with moderate-to-severe baseline abdominal bloating; in particular

  7. Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sydney Rosen

    2016-05-01

    from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3. In the rapid arm, 119/187 patients (64% initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51% in the standard arm (relative risk [RR] 1.26 [1.05-1.50]. In the rapid arm 182/187 (97% initiated ART ≤90 d, compared to 136/190 (72% in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49. Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61-1.84. The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain.Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa.ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.

  8. The Impact of Concomitant Medication Use on Patient Eligibility for Phase I Cancer Clinical Trials

    Directory of Open Access Journals (Sweden)

    Mitesh J. Borad, Kelly K. Curtis, Hani M. Babiker, Martin Benjamin, Raoul Tibes, Ramesh K. Ramanathan, Karen Wright, Amylou C. Dueck, Gayle Jameson, Daniel D. Von Hoff

    2012-01-01

    Full Text Available Concomitant medication (CM use may result in Phase I cancer clinical trial ineligibility due to concern for potential CM-investigational drug interactions or alteration of investigational drug absorption. Few studies have examined the impact of CM use on trial eligibility. Methods: We reviewed records of 274 patients on Phase I trials at a single academic institution. Demographics, CM identities and classes, CM discontinuation, reasons, and incidence of CM substitution were recorded. CM-investigational drug cytochrome P450 (CYP enzyme interactions were documented. Statistical analysis was performed using descriptive statistics. Results: 273 of 274 patients (99.6%, 95% confidence interval [CI] 98.9-100% took CM, with a median of 8 CM per patient (range 0 - 42. CM discontinuation occurred in 67 cases (25%, 95% CI 19-30%. The most common CM classes discontinued were herbal (17 cases, 25%, 95% CI 16-37% and proton pump inhibitors (15 cases, 22%, 95% CI 12-32%. CM discontinuation reasons were: protocol prohibition (32 cases, 48%, 95% CI 36-60%; potential CM-investigational drug interaction (25 cases, 37%, 95% CI 26-49%; other (10 cases, 15%, 95% CI 6-23%. A potential CM-investigational drug CYP interaction was noted in 122 cases (45%, 95% CI 39-50%. CM potentially weakly decreased investigational drug metabolism in 52 cases (43%, 95% CI 34-51%, and potentially strongly decreased investigational drug metabolism in 17 cases (14%, 95% CI 8-20%. Investigational drug potentially weakly decreased CM metabolism in 39 cases (32%, 95% CI 24-40%, and potentially strongly decreased CM metabolism in 28 cases (23%, 95% CI 15-30%. CM substitution occurred in 36/67 cases (54%, 95% CI 41-66% where CM were discontinued to allow for eventual participation in clinical trials. Overall in 2 cases (0.7%, 95% CI 0.1-2.6%, patients were protocol ineligible because CM could not be discontinued or substituted. Conclusions: This study highlights the high prevalence of

  9. Dietary Almonds Increase Serum HDL Cholesterol in Coronary Artery Disease Patients in a Randomized Controlled Trial.

    Science.gov (United States)

    Jamshed, Humaira; Sultan, Fateh Ali Tipoo; Iqbal, Romaina; Gilani, Anwar Hassan

    2015-10-01

    More than one-half of coronary artery disease (CAD) patients have low HDL cholesterol despite having well-managed LDL cholesterol. Almond supplementation has not been shown to elevate circulating HDL cholesterol concentrations in clinical trials, perhaps because the baseline HDL cholesterol of trial subjects was not low. This clinical trial was designed to test the effect of almond supplementation on low HDL cholesterol in CAD patients. A total of 150 CAD patients (50 per group), with serum LDL cholesterol ≤100 mg/dL and HDL cholesterol ≤40 mg/dL in men and ≤50 mg/dL in women, were recruited from the Aga Khan University Hospital. After recording vital signs and completing a dietary and physical activity questionnaire, patients were randomly assigned to 1 of the following 3 groups: the no-intervention group (NI), the Pakistani almonds group (PA), and the American almonds group (AA). The respective almond varieties (10 g/d) were given to patients with instructions to soak them overnight, remove the skin, and eat them before breakfast. Blood samples for lipid profiling, body weight, and blood pressure were collected, and assessment of dietary patterns was done at baseline, week 6, and week 12. Almonds significantly increased HDL cholesterol. At weeks 6 and 12, HDL cholesterol was 12-14% and 14-16% higher, respectively, in the PA and AA than their respective baselines. In line with previous reports, serum concentrations of total cholesterol, triglycerides, LDL cholesterol, and VLDL cholesterol; total-to-HDL and LDL-to-HDL cholesterol ratios, and the atherogenic index were reduced in both the PA and AA at weeks 6 and 12 compared with baseline (P almond groups. Dietary patterns, body weight, and blood pressure did not change in any of the 3 groups during the trial. A low dose of almonds (10 g/d) consumed before breakfast can increase HDL cholesterol, in addition to improving other markers of abnormal lipid metabolism in CAD patients with low initial HDL cholesterol

  10. Effectiveness of electric toothbrushing in patients with neuromuscular disability: A randomized observer-blind crossover trial.

    Science.gov (United States)

    Ikeda, Tokuhei; Yoshizawa, Kunio; Takahashi, Kazuya; Ishida, Chiho; Komai, Kiyonobu; Kobayashi, Kazuhiko; Sugiura, Shirou

    2016-01-01

    To evaluate the effectiveness of an electric toothbrush for oral care in patients with neuromuscular disability. In this randomized observer-blind crossover trial, 30 patients with neuromuscular disease performed either electric or manual toothbrushing each for 4 weeks. Plaque status (plaque control record), periodontal pocket depth, oral status (oral assessment guide), salivary bacterial count, and toothbrushing time were assessed after each period and compared between the two groups by Wilcoxon signed-rank test. Twenty-eight patients completed the study, including 18 communicative patients. Periodontal pockets were significantly shallower and toothbrushing time was significantly shorter with electric toothbrush use than with manual toothbrush use. No significant differences in oral status and salivary bacterial counts were noted between the approaches, but plaque status significantly improved after electric toothbrushing in communicative patients. Electric toothbrushing is beneficial for maintaining oral health in patients with neuromuscular disability and reducing the caregivers' oral care burden. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

  11. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Music preferences of mechanically ventilated patients participating in a randomized controlled trial

    Science.gov (United States)

    Heiderscheit, Annie; Breckenridge, Stephanie J.; Chlan, Linda L.; Savik, Kay

    2014-01-01

    Mechanical ventilation (MV) is a life-saving measure and supportive modality utilized to treat patients experiencing respiratory failure. Patients experience pain, discomfort, and anxiety as a result of being mechanically ventilated. Music listening is a non-pharmacological intervention used to manage these psychophysiological symptoms associated with mechanical ventilation. The purpose of this secondary analysis was to examine music preferences of 107 MV patients enrolled in a randomized clinical trial that implemented a patient-directed music listening protocol to help manage the psychophysiological symptom of anxiety. Music data presented includes the music genres and instrumentation patients identified as their preferred music. Genres preferred include: classical, jazz, rock, country, and oldies. Instrumentation preferred include: piano, voice, guitar, music with nature sounds, and orchestral music. Analysis of three patients’ preferred music received throughout the course of the study is illustrated to demonstrate the complexity of assessing MV patients and the need for an ongoing assessment process. PMID:25574992

  13. Ketamine rapidly relieves acute suicidal ideation in cancer patients: a randomized controlled clinical trial.

    Science.gov (United States)

    Fan, Wei; Yang, HaiKou; Sun, Yong; Zhang, Jun; Li, Guangming; Zheng, Ying; Liu, Yi

    2017-01-10

    This study was designed to examine the rapid antidepressant effects of single dose ketamine on suicidal ideation and overall depression level in patients with newly-diagnosed cancer. Forty-two patients were enrolled into the controlled trial and randomized into two groups: ketamine group and midazolam group. Patients from the two groups received a sub-anesthetic dose of racemic ketamine hydrochloride or midazolam. Suicidal ideation score, measured with the Beck Scale and suicidal part of the Montgomery-Asberg Depression Rating Scale, significantly decreased on day 1 and day 3 in ketamine-treated patients when compared to those treated with midazolam. Consistently, overall depression levels measured using the Montgomery-Asberg Depression Rating Scale indicated a significant relief of overall depression on day 1 in ketamine-treated patients. Collectively, this study provides novel information about the rapid antidepressant effect of ketamine on acute depression and suicidal ideation in newly-diagnosed cancer patients.

  14. Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arabi Yaseen M

    2012-10-01

    Full Text Available Abstract Background Nutritional support is an essential part of the management of critically ill patients. However, optimal caloric intake has not been systematically evaluated. We aim to compare two strategies of enteral feeding: permissive underfeeding versus target feeding. Method/Design This is an international multi-center randomized controlled trial in critically ill medical- surgical adult patients. Using a centralized allocation, 862 patients will be randomized to permissive underfeeding or target feeding. Patients in the permissive group receive 50% (acceptable range is 40% to 60% of the calculated caloric requirement, while those in the targeted group receive 100% (acceptable range 70% to 100% of the calculated caloric requirement. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, 28-day, and 180-day mortality as well as health care-associated infections, organ failure, and length of stay in the ICU and hospital. The trial has 80% power to detect an 8% absolute reduction in 90-day mortality assuming a baseline risk of death of 25% at an alpha level of 0.05. Discussion Patient recruitment started in November 2009 and is currently active in five centers. The Data Monitoring Committee advised continuation of the trial after the first interim analysis. The study is expected to finish by November 2013. Trial registration Current Controlled Trials ISRCTN68144998

  15. Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis

    Science.gov (United States)

    2014-01-01

    Background Parenterally administered ascorbic acid modulates sepsis-induced inflammation and coagulation in experimental animal models. The objective of this randomized, double-blind, placebo-controlled, phase I trial was to determine the safety of intravenously infused ascorbic acid in patients with severe sepsis. Methods Twenty-four patients with severe sepsis in the medical intensive care unit were randomized 1:1:1 to receive intravenous infusions every six hours for four days of ascorbic acid: Lo-AscA (50 mg/kg/24 h, n = 8), or Hi-AscA (200 mg/kg/24 h, n = 8), or Placebo (5% dextrose/water, n = 8). The primary end points were ascorbic acid safety and tolerability, assessed as treatment-related adverse-event frequency and severity. Patients were monitored for worsened arterial hypotension, tachycardia, hypernatremia, and nausea or vomiting. In addition Sequential Organ Failure Assessment (SOFA) scores and plasma levels of ascorbic acid, C-reactive protein, procalcitonin, and thrombomodulin were monitored. Results Mean plasma ascorbic acid levels at entry for the entire cohort were 17.9 ± 2.4 μM (normal range 50-70 μM). Ascorbic acid infusion rapidly and significantly increased plasma ascorbic acid levels. No adverse safety events were observed in ascorbic acid-infused patients. Patients receiving ascorbic acid exhibited prompt reductions in SOFA scores while placebo patients exhibited no such reduction. Ascorbic acid significantly reduced the proinflammatory biomarkers C-reactive protein and procalcitonin. Unlike placebo patients, thrombomodulin in ascorbic acid infused patients exhibited no significant rise, suggesting attenuation of vascular endothelial injury. Conclusions Intravenous ascorbic acid infusion was safe and well tolerated in this study and may positively impact the extent of multiple organ failure and biomarkers of inflammation and endothelial injury. Trial registration ClinicalTrials.gov identifier NCT01434121. PMID

  16. Outcome of trial of scar in patients with previous caesarean section

    International Nuclear Information System (INIS)

    Khan, B.; Bashir, R.; Khan, W.

    2016-01-01

    Medical evidence indicates that 60-80% of women can achieve vaginal delivery after a previous lower segment caesarean section. Proper selection of patients for trial of scar and vigilant monitoring during labour will achieve successful maternal and perinatal outcome. The objective of our study is to establish the fact that vaginal delivery after one caesarean section has a high success rate in patients with previous one caesarean section for non-recurrent cause. Methods: The study was conducted in Ayub Teaching Abbottabad, Gynae-B Unit. All labouring patients, during the study period of five years, with previous one caesarean section and between 37 weeks to 41 weeks of gestation for a non-recurrent cause were included in the study. Data was recorded on special proforma designed for the purpose. Patients who had previous classical caesarean section, more than one caesarean section, and previous caesarean section with severe wound infection, transverse lie and placenta previa in present pregnancy were excluded. Foetal macrosomia (wt>4 kg) and severe IUGR with compromised blood flow on Doppler in present pregnancy were also not considered suitable for the study. Patients who had any absolute contraindication for vaginal delivery were also excluded. Results: There were 12505 deliveries during the study period. Total vaginal deliveries were 8790 and total caesarean sections were 3715. Caesarean section rate was 29.7%. Out of these 8790 patients, 764 patients were given a trial of scar and 535 patients delivered successfully vaginally (70%). Women who presented with spontaneous onset of labour were more likely to deliver vaginally (74.8%) as compared to induction group (27.1%). Conclusion: Trial of vaginal birth after caesarean (VBAC) in selected cases has great importance in the present era of the rising rate of primary caesarean section. (author)

  17. Prevalence and prediction of primary sleep disorders in a clinical trial of depressed patients with insomnia.

    Science.gov (United States)

    McCall, W Vaughn; Kimball, James; Boggs, Niki; Lasater, Barbara; D'Agostino, Ralph B; Rosenquist, Peter B

    2009-10-15

    Insomnia-pharmacology clinical trials routinely exclude primary sleep disorders, such as obstructive sleep apnea (OSA) and periodic limb movement disorder (PLMD), with a single night of polysomnography (PSG). Given the expense of PSG, we examined whether a thorough clinical screening, combined with actigraphy, would successfully identify OSA and PLMD as part of baseline screening for a clinical trial of insomnia treatment in depressed patients. Of the 73 patients with a complete baseline dataset, 12 screened positive for OSA/PLMD (AHI > 15, or PLMAI > 15), while 61 "passed" the PSG screen. The OSA/PLMD+ patients were older (51.4 +/- 10.2 y) and took more naps (2.6 per week) than the OSA/PLMD- patients (41.3 +/- 12.8 y; and 1.1 naps per week). The combination of age and nap frequency produced a "good" receiver operating characteristic (ROC) model for predicting OSA/PLMD+, with the area under the curve of 0.82. There were no other demographic, sleep diary, or actigraphic variables, which differed between OSA/PLM + or -, and no other variable improved the ROC model. Still, the best model misclassified 16 of 73 persons. We conclude that while age and the presence of napping were helpful in identifying OSA and PLM in a well-screened sample of depressed insomniacs, PSG is required to definitively identify and exclude primary sleep disorders in insomnia clinical trials.

  18. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

  19. Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial.

    Science.gov (United States)

    Almufleh, Balqees; Emami, Elham; Alageel, Omar; de Melo, Fabiana; Seng, Francois; Caron, Eric; Nader, Samer Abi; Al-Hashedi, Ashwaq; Albuquerque, Rubens; Feine, Jocelyne; Tamimi, Faleh

    2018-04-01

    Clinical data regarding newly introduced laser-sintered removable partial dentures (RPDs) are needed before this technique can be recommended. Currently, only a few clinical reports have been published, with no clinical studies. This clinical trial compared short-term satisfaction in patients wearing RPDs fabricated with conventional or computer-aided design and computer-aided manufacturing (CAD-CAM) laser-sintering technology. Twelve participants with partial edentulism were enrolled in this pilot crossover double-blinded clinical trial. Participants were randomly assigned to wear cast or CAD-CAM laser-sintered RPDs for alternate periods of 30 days. The outcome of interest was patient satisfaction as measured using the McGill Denture Satisfaction Instrument. Assessments was conducted at 1, 2, and 4 weeks. The participant's preference in regard to the type of prosthesis was assessed at the final evaluation. The linear mixed effects regression models for repeated measures were used to analyze the data, using the intention-to-treat principle. To assess the robustness of potential, incomplete adherence, sensitivity analyses were conducted. Statistically significant differences were found in patients' satisfaction between the 2 methods of RPD fabrication. Participants were significantly more satisfied with laser-sintered prostheses than cast prostheses in regard to general satisfaction, ability to speak, ability to clean, comfort, ability to masticate, masticatory efficiency, and oral condition (Premovable partial dentures may lead to better outcomes in terms of patient satisfaction in the short term. The conclusion from this pilot study requires confirmation by a larger randomized controlled trial. ClinicalTrials.gov. A study about patient satisfaction with laser-sintered removable partial dentures; NCT02769715. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  20. Effect of an education programme for patients with osteoarthritis in primary care - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bjärnung Åsa

    2010-10-01

    Full Text Available Abstract Background Osteoarthritis (OA is a degenerative disease, considered to be one of the major public health problems. Research suggests that patient education is feasible and valuable for achieving improvements in quality of life, in function, well-being and improved coping. Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA. The aim of this study was to evaluate the effects of this education programme for patients with OA in primary health care in terms of self-efficacy, function and self-perceived health. Method The study was a single-blind, randomized controlled trial (RCT in which the EuroQol-5D and Arthritis self-efficacy scale were used to measure self-perceived health and self-efficacy and function was measured with Grip Ability Test for the upper extremity and five different functional tests for the lower extremity. Results We found differences between the intervention group and the control group, comparing the results at baseline and after 6 months in EuroQol-5D (p Conclusion This study has shown that patient education for patients with osteoarthritis is feasible in a primary health care setting and can improve self-perceived health as well as function in some degree, but not self-efficacy. Further research to investigate the effect of exercise performance on function, as well as self-efficacy is warranted. Trial registration The trial is registered with ClinicalTrials.gov. Registration number: NCT00979914

  1. Glasgow supported self-management trial (GSuST) for patients with moderate to severe COPD: randomised controlled trial.

    Science.gov (United States)

    Bucknall, C E; Miller, G; Lloyd, S M; Cleland, J; McCluskey, S; Cotton, M; Stevenson, R D; Cotton, P; McConnachie, A

    2012-03-06

    To determine whether supported self management in chronic obstructive pulmonary disease (COPD) can reduce hospital readmissions in the United Kingdom. Randomised controlled trial. Community based intervention in the west of Scotland. Patients admitted to hospital with acute exacerbation of COPD. Participants in the intervention group were trained to detect and treat exacerbations promptly, with ongoing support for 12 months. The primary outcome was hospital readmissions and deaths due to COPD assessed by record linkage of Scottish Morbidity Records; health related quality of life measures were secondary outcomes. 464 patients were randomised, stratified by age, sex, per cent predicted forced expiratory volume in 1 second, recent pulmonary rehabilitation attendance, smoking status, deprivation category of area of residence, and previous COPD admissions. No difference was found in COPD admissions or death (111/232 (48%) v 108/232 (47%); hazard ratio 1.05, 95% confidence interval 0.80 to 1.38). Return of health related quality of life questionnaires was poor (n=265; 57%), so that no useful conclusions could be made from these data. Pre-planned subgroup analysis showed no differential benefit in the primary outcome relating to disease severity or demographic variables. In an exploratory analysis, 42% (75/150) of patients in the intervention group were classified as successful self managers at study exit, from review of appropriateness of use of self management therapy. Predictors of successful self management on stepwise regression were younger age (P=0.012) and living with others (P=0.010). COPD readmissions/deaths were reduced in successful self managers compared with unsuccessful self managers (20/75 (27%) v 51/105 (49%); hazard ratio 0.44, 0.25 to 0.76; P=0.003). Supported self management had no effect on time to first readmission or death with COPD. Exploratory subgroup analysis identified a minority of participants who learnt to self manage; this group had a

  2. Practices, patients and (imperfect data - feasibility of a randomised controlled clinical drug trial in German general practices

    Directory of Open Access Journals (Sweden)

    Hummers-Pradier Eva

    2011-04-01

    Full Text Available Abstract Background Randomised controlled clinical (drug trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01 to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI. Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP standards as defined by the International Conference on Harmonisation (ICH in mainly inexperienced general practices. Methods This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1 successful practice recruitment, 2 sufficient patient recruitment, 3 complete and accurate data collection and 4 appropriate protection of patient safety. Results The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs were observed during the trial. Conclusions To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and

  3. The PACOVAR-trial: A phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer

    International Nuclear Information System (INIS)

    Eichbaum, Michael; Fersis, Nikos; Schmidt, Marcus; Wallwiener, Markus; Schneeweiss, Andreas; Sohn, Christof; Mayer, Christine; Eickhoff, Regina; Bischofs, Esther; Gebauer, Gerhard; Fehm, Tanja; Lenz, Florian; Fricke, Hans-Christian; Solomayer, Erich

    2011-01-01

    The prognosis of patients with recurrent, platinum-resistant epithelial ovarian cancer (EOC) is poor. There is no standard treatment available. Emerging evidence suggests a major role for antiangiogenic treatment modalities in EOC, in particular in combination with the metronomic application of low dose chemotherapy. The novel, investigational oral antiangiogenic agent pazopanib targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and c-kit is currently being studied in different tumour types and is already used as first line therapy in recurrent renal cell carcinoma. A combined therapy consisting of pazopanib and metronomic oral cyclophosphamide may offer a well-tolerable treatment option to patients with recurrent, pretreated EOC. This study is designed as a multicenter phase I/II trial evaluating the optimal dose for pazopanib (phase I) as well as activity and tolerability of a combination regimen consisting of pazopanib and metronomic cyclophosphamide in the palliative treatment of patients with recurrent, platinum-resistant, pre-treated ovarian cancer (phase II). The patient population includes patients with histologically or cytologically confirmed diagnosis of EOC, cancer of the fallopian tube or peritoneal cancer which is platinumresistant or -refractory. Patients must have measurable disease according to RECIST criteria and must have failed available standard chemotherapy. Primary objectives are determination of the optimal doses for pazopanib (phase I) and the overall response rate according to RECIST criteria (phase II). Secondary objectives are time to progression, overall survival, safety and tolerability. The treatment duration is until disease progression or intolerability of study drug regimen (with a maximum of 13 cycles up to 52 weeks per subject). The current phase I/II trial shall clarify the potential of the multitargeting antiangiogenic tyrosinkinaseinhibitor GW 786034 (pazopanib) in

  4. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Czarnetzki, Christoph; Elia, Nadia; Frossard, Jean-Louis; Giostra, Emiliano; Spahr, Laurent; Waeber, Jean-Luc; Pavlovic, Gordana; Lysakowski, Christopher; Tramèr, Martin R

    2015-08-01

    Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of erythromycin lactobionate in gastric emptying in patients undergoing emergency surgery. The Erythro-Emerge trial was a single-center, randomized, double-blinded, placebo-controlled clinical trial in patients undergoing emergency surgery under general anesthesia at Geneva University Hospitals. We included 132 patients from March 25, 2009, through April 10, 2013, and all patients completed the study. Randomization was stratified for trauma and nontrauma procedures. The randomization code was opened on April 23, 2013, and analyses were performed through July 26, 2013. We performed an intention-to-treat analysis. Patients were randomized to intravenous erythromycin lactobionate, 3 mg/kg, or placebo 15 minutes before tracheal intubation. Patients were followed up for 24 hours. The primary outcome was a clear stomach, defined as less than 40 mL of liquids and no solids and identified through endoscopy immediately after intubation. The secondary outcome was the pH level of residual gastric content. A clear stomach was diagnosed in 42 of 66 patients (64%) receiving placebo compared with 53 of 66 patients (80%) receiving erythromycin (risk ratio, 1.26 [95% CI, 1.01-1.57]). In the population undergoing surgery for nontrauma, the association between receipt of erythromycin and having a clear stomach (adjusted odds ratio [95% CI]) was statistically significant (13.4 [1.49-120]; P = .02); in the population undergoing surgery for trauma, it was not (1.81 [0.64-5.16]; P = .26). Median (interquartile range) pH of the residual gastric liquid was 2 (1-4) in 36 patients receiving placebo and 6 (3-7) in 16 receiving erythromycin (P = .002). Patients receiving erythromycin had nausea (20 [30%] vs 4 [6%]) and stomach cramps (15 [23%] vs 2 [3

  5. PREDICTORS OF PHYSICIAN REFERRAL FOR PATIENT RECRUITMENT TO ALZHEIMER DISEASE CLINICAL TRIALS

    Science.gov (United States)

    Galvin, James E.; Meuser, Thomas M.; Boise, Linda; Connell, Cathleen M

    2009-01-01

    Background Inadequate recruitment into Alzheimer disease (AD) clinical trials is an important threat to the validity and generalizability of the studies. The majority of dementia patients are first evaluated by community-based physicians; however, physician perceptions of clinical research are largely unknown. Methods A survey was distributed to 3,123 physicians in three states; 370 were returned. Survey items assessed attitudes, perceived benefits of and barriers to referral to clinical research and physicians use of the internet for medical information. Results The mean age of the respondents was 50.6 ± 10.8y; 70% were male, 78% Caucasian, 61% were primary care providers; 63% used the internet ≥3 times/week. No demographic or medical specialty differences existed between those who were likely (n=193) and unlikely (n=162) to refer patients to clinical trials. Differences were discovered in perceived benefits reported by physicians who were more likely to refer, while differences in perceived barriers existed in primary care compared with specialists. Referral to clinical trials is predicted by close proximity to a research center (OR:4.0,95%CI:1.1–15.6) and availability of internet information regarding diagnostic evaluation (OR:2.3,95%CI:1.1–4.7). Primary barriers included concerns about exposure of patients to uncomfortable procedures (OR:4.7,95%CI:1.2–18.7) and lack of time to discuss research participation (OR:6.8,95%CI:1.4–32.3). Conclusions Proximity to a research center and availability of diagnostic clinical tools are strong predictors of clinical trial referral. Concern over risks to patients and lack of time are strong barriers. These results suggest that dementia outreach education targeted to physicians should emphasize the importance of clinical trials with a focus on discussing research participation in a time-efficient manner and increasing awareness of risk reduction and the safety of research protocols. Providing easy access to up

  6. Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: Patients Perspectives.

    Science.gov (United States)

    Chalela, Patricia; Suarez, Lucina; Muñoz, Edgar; Gallion, Kipling J; Pollock, Brad H; Weitman, Steven D; Karnad, Anand; Ramirez, Amelie G

    2014-04-24

    Inclusion of minorities in clinical research is an essential step to develop novel cancer treatments, improve health care overall, understand potential differences in pharmacogenomics and address minorities' disproportionate cancer burden. However, Latinos and other minority groups continue to be critically underrepresented, particularly in early-phase clinical trials (EPCTs). The objective of the present study was to explore barriers and promoting factors influencing patients' decisions to enroll or not in early phase clinical trials (EPCTs) and identify areas for intervention to increase minority enrollment into clinical research. An interviewer-administered survey was conducted with 100 cancer patients in the predominantly Latino region of South Texas. Exploratory factor analysis was conducted to identify underlying dimensions, and multiple logistic regression assessed significant factors that promote or deter patients enrollment to EPCTs. In addition, a separate subgroup mean analysis assessed differences by enrollment status and race/ethnicity. For one standard deviation increase in the importance given to the possibility of symptoms improvement, the predicted odds of refusing enrollment were 3.20 times greater (OR=3.20, 95% CI=1.06-9.71, p 0.040). Regarding barriers, among patients who considered fear/uncertainty of the new treatment a deterrent to enrollment, one standard deviation increase in agreement with these barriers was associated with a 3.60 increase (OR=3.60, 95% CI=1.30-9.97h, p 0.014) in the odds of not being enrolled in an EPCT. In contrast, non-enrolled patients were less likely (OR=0.14, 95% CI=0.05-0.44, p 0.001) to consider fatalistic beliefs as an important barrier. This study, one of the first to identify South Texas patients' barriers to enroll in EPCTs, highlights potential focal areas to increase participation of both minority and non-minority patients in clinical research. Culturally tailored interventions promoting patient

  7. Imatinib mesylate for plexiform neurofibromas in patients with neurofibromatosis type 1: a phase 2 trial.

    Science.gov (United States)

    Robertson, Kent A; Nalepa, Grzegorz; Yang, Feng-Chun; Bowers, Daniel C; Ho, Chang Y; Hutchins, Gary D; Croop, James M; Vik, Terry A; Denne, Scott C; Parada, Luis F; Hingtgen, Cynthia M; Walsh, Laurence E; Yu, Menggang; Pradhan, Kamnesh R; Edwards-Brown, Mary K; Cohen, Mervyn D; Fletcher, James W; Travers, Jeffrey B; Staser, Karl W; Lee, Melissa W; Sherman, Marcie R; Davis, Cynthia J; Miller, Lucy C; Ingram, David A; Clapp, D Wade

    2012-12-01

    Plexiform neurofibromas are slow-growing chemoradiotherapy-resistant tumours arising in patients with neurofibromatosis type 1 (NF1). Currently, there are no viable therapeutic options for patients with plexiform neurofibromas that cannot be surgically removed because of their proximity to vital body structures. We undertook an open-label phase 2 trial to test whether treatment with imatinib mesylate can decrease the volume burden of clinically significant plexiform neurofibromas in patients with NF1. Eligible patients had to be aged 3-65 years, and to have NF1 and a clinically significant plexiform neurofibroma. Patients were treated with daily oral imatinib mesylate at 220 mg/m(2) twice a day for children and 400 mg twice a day for adults for 6 months. The primary endpoint was a 20% or more reduction in plexiform size by sequential volumetric MRI imaging. Clinical data were analysed on an intention-to-treat basis; a secondary analysis was also done for those patients able to take imatinib mesylate for 6 months. This trial is registered with ClinicalTrials.gov, number NCT01673009. Six of 36 patients (17%, 95% CI 6-33), enrolled on an intention-to-treat basis, had an objective response to imatinib mesylate, with a 20% or more decrease in tumour volume. Of the 23 patients who received imatinib mesylate for at least 6 months, six (26%, 95% CI 10-48) had a 20% or more decrease in volume of one or more plexiform tumours. The most common adverse events were skin rash (five patients) and oedema with weight gain (six). More serious adverse events included reversible grade 3 neutropenia (two), grade 4 hyperglycaemia (one), and grade 4 increases in aminotransferase concentrations (one). Imatinib mesylate could be used to treat plexiform neurofibromas in patients with NF1. A multi-institutional clinical trial is warranted to confirm these results. Novartis Pharmaceuticals, the Indiana University Simon Cancer Centre, and the Indiana University Herman B Wells Center for

  8. A selected controlled trial of supplementary vitamin E for treatment of muscle cramps in hemodialysis patients.

    Science.gov (United States)

    El-Hennawy, Adel S; Zaib, Salwat

    2010-01-01

    Muscle cramps are not uncommon complications of hemodialysis (HD) treatments and lead to early termination of HD sessions and are therefore a significant cause of under-dialysis. The etiology of cramps in dialysis patients remains a matter of debate. Many reports suggested that vitamin E (vit. E) may be effective for the prevention of HD-associated cramps. We decided to perform a selected controlled trial of supplementary vit. E for treatment of patients on HD who experience frequent attacks during and between HD sessions. The goal was to compare the number of attacks of muscle cramps with the patient's baseline over a specific period of time. In this study, 19 HD patients were randomly selected of different age groups and ethnicity. Patient must have had at least 60 attacks of muscle cramps during and between HD sessions over a 12-week period. All selected patients received vit. E at a dose of 400 international units daily for 12 weeks, and the number of attacks of muscle cramps was recorded. The frequency of muscle cramps decreased significantly during vit. E therapy, and, at the end of the trial, vit. E led to cramp reductions of 68.3%. The reduction in number of attacks of muscle cramps had no significant correlation with age, sex, etiology of end-stage renal disease, serum electrolytes, or HD duration, and it showed a statistically positive correlation (P = 0.0001) with vit. E therapy. No vit. E-related adverse effects were encountered during the trial. Short-term treatment with vit. E is safe and effective in reducing number of attacks of muscle cramps in HD patients, as shown in our study.

  9. Effects of remote, retroactive intercessory prayer on outcomes in patients with bloodstream infection: randomised controlled trial

    Science.gov (United States)

    Leibovici, Leonard

    2001-01-01

    Objective To determine whether remote, retroactive intercessory prayer, said for a group of patients with a bloodstream infection, has an effect on outcomes. Design Double blind, parallel group, randomised controlled trial of a retroactive intervention. Setting University hospital. Subjects All 3393 adult patients whose bloodstream infection was detected at the hospital in 1990-6. Intervention In July 2000 patients were randomised to a control group and an intervention group. A remote, retroactive intercessory prayer was said for the well being and full recovery of the intervention group. Main outcome measures Mortality in hospital, length of stay in hospital, and duration of fever. Results Mortality was 28.1% (475/1691) in the intervention group and 30.2% (514/1702) in the control group (P for difference=0.4). Length of stay in hospital and duration of fever were significantly shorter in the intervention group than in the control group (P=0.01 and P=0.04, respectively). Conclusions Remote, retroactive intercessory prayer said for a group is associated with a shorter stay in hospital and shorter duration of fever in patients with a bloodstream infection and should be considered for use in clinical practice. What is already known on this topicTwo randomised controlled trials of remote intercessory prayer (praying for persons unknown) showed a beneficial effect in patients in an intensive coronary care unitA recent systematic review found that 57% of the randomised, placebo controlled trials of distant healing showed a positive treatment effectWhat this study addsRemote intercessory prayer said for a group of patients is associated with a shorter hospital stay and shorter duration of fever in patients with a bloodstream infection, even when the intervention is performed 4-10 years after the infection PMID:11751349

  10. N-of-1 trials in the clinical care of patients in developing countries: a systematic review.

    Science.gov (United States)

    Alemayehu, Chalachew; Nikles, Jane; Mitchell, Geoffrey

    2018-04-23

    N-of-1 trials have a potential role in promoting patient-centered medicine in developing countries. However, there is limited academic literature regarding the use of N-of-1 trials in the clinical care of patients in resource-poor settings. To assess the extent of use, purpose and treatment outcome of N-of-1 trials in developing countries. A systematic review of clinical N-of-1 trials was conducted between 1985 and September 2015 using PubMed, Embase, CINAHL, Web of Science and the Cochrane Central Register of Controlled Trials. Grey literature databases and clinical trial registers were also searched. This review included randomized, multi-cycle, crossover within individual patient trials involving drug intervention. Quality assessment and data extraction were conducted by two independent reviewers. Out of 131 N-of-1 trials identified, only 6 (4.5%) were conducted in developing countries. The major reason that N-of-1 trials were used was to provide evidence on feasibility, effectiveness and safety of therapies. A total of 72 participants were involved in these trials. Five of the studies were conducted in China and all evaluated Chinese traditional medicine. The remaining study was conducted in Brazil. The completion rate was 93%. More than half, 46 (69%) of subjects made medication changes consistent with trial results after trial completion. A number of threats to the validity of the included evidence limited the validity of the evidence. In particular, the estimated overall effect in four of the included studies could have been affected by the "carry over" of the previous treatment effect as no adequate pharmacokinetic evidence regarding traditional medicines was presented. The prevalence and scope of N-of-1 trials in developing countries is low. A coordinated effort among government, clinicians, researchers and sponsor organizations is needed to increase their uptake and quality in developing countries. PROSPERO CRD42015026841 .

  11. Review Strategies to Recruit and Retain Rural Patient Participating Self-management Behavioral Trials.

    Science.gov (United States)

    Young, Lufei; Barnason, Susan; DO, VAN

    2015-01-01

    Self-management plays a vital role in improving health outcomes and reducing costs in patients with cardiovascular disease (CVD) and associated risk factors. Based on existing studies, rural residents with CVD and/or risk factors show low engagement in self-management behaviors. Due to low participation in behavioral intervention trials, the most promising mechanism to promote self-management among rural populations is unknown. In turn, the purpose of this article is to review the evidence that supports strategies to recruit and retain rural patients to participate in behavioral intervention trials aimed to promote self-management of CVD and its risk factors. This review is expected to assist researchers in identifying effective solutions to overcome barriers in the recruitment and retention processes when conducting intervention research studies on the self-management of CVD in rural communities.

  12. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

    DEFF Research Database (Denmark)

    Krag, Mette; Perner, Anders; Wetterslev, Jørn

    2014-01-01

    PURPOSE: To assess the effects of stress ulcer prophylaxis (SUP) versus placebo or no prophylaxis on all-cause mortality, gastrointestinal (GI) bleeding and hospital-acquired pneumonia in adult critically ill patients in the intensive care unit (ICU). METHODS: We performed a systematic review using...... meta-analysis and trial sequential analysis (TSA). Eligible trials were randomised clinical trials comparing proton pump inhibitors or histamine 2 receptor antagonists with either placebo or no prophylaxis. Two reviewers independently assessed studies for inclusion and extracted data. The Cochrane...... of bias. There was no statistically significant difference in mortality (fixed effect: RR 1.00, 95% CI 0.84-1.20; P = 0.87; I(2) = 0%) or hospital-acquired pneumonia (random effects: RR 1.23, 95% CI 0.86-1.78; P = 0.28; I(2) = 19%) between SUP patients and the no prophylaxis/placebo patients...

  13. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  14. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  15. Gastrointestinal Bleeding in Patients With Atrial Fibrillation Treated With Rivaroxaban or Warfarin: ROCKET AF Trial.

    Science.gov (United States)

    Sherwood, Matthew W; Nessel, Christopher C; Hellkamp, Anne S; Mahaffey, Kenneth W; Piccini, Jonathan P; Suh, Eun-Young; Becker, Richard C; Singer, Daniel E; Halperin, Jonathan L; Hankey, Graeme J; Berkowitz, Scott D; Fox, Keith A A; Patel, Manesh R

    2015-12-01

    Gastrointestinal (GI) bleeding is a common complication of oral anticoagulation. This study evaluated GI bleeding in patients who received at least 1 dose of the study drug in the on-treatment arm of the ROCKET AF (Rivaroxaban Once-daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial. The primary outcome was adjudicated GI bleeding reported from first to last drug dose + 2 days. Multivariable modeling was performed with pre-specified candidate predictors. Of 14,236 patients, 684 experienced GI bleeding during follow-up. These patients were older (median age 75 years vs. 73 years) and less often female. GI bleeding events occurred in the upper GI tract (48%), lower GI tract (23%), and rectum (29%) without differences between treatment arms. There was a significantly higher rate of major or nonmajor clinical GI bleeding in rivaroxaban- versus warfarin-treated patients (3.61 events/100 patient-years vs. 2.60 events/100 patient-years; hazard ratio: 1.42; 95% confidence interval: 1.22 to 1.66). Severe GI bleeding rates were similar between treatment arms (0.47 events/100 patient-years vs. 0.41 events/100 patient-years; p = 0.39; 0.01 events/100 patient-years vs. 0.04 events/100 patient-years; p = 0.15, respectively), and fatal GI bleeding events were rare (0.01 events/100 patient-years vs. 0.04 events/100 patient-years; 1 fatal events vs. 5 fatal events total). Independent clinical factors most strongly associated with GI bleeding were baseline anemia, history of GI bleeding, and long-term aspirin use. In the ROCKET AF trial, rivaroxaban increased GI bleeding compared with warfarin. The absolute fatality rate from GI bleeding was low and similar in both treatment arms. Our results further illustrate the need for minimizing modifiable risk factors for GI bleeding in patients on oral anticoagulation. Copyright © 2015 American College of Cardiology Foundation. Published by

  16. Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Cornelissen Jessica

    2010-07-01

    Full Text Available Abstract Background Non-pharmacological treatment (NPT is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA. The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse. The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137

  17. Posture and lumbar puncture headache: a controlled trial in 50 patients.

    OpenAIRE

    Handler, C E; Smith, F R; Perkin, G D; Rose, F C

    1982-01-01

    A prospective single blind trial in 50 patients was performed to investigate the effect of posture on post lumbar puncture headache (LPH). A difference between the frequency of headache at five hours between the two groups (prone for four hours, versus 30 degrees head down tilt for 30 minutes followed by supine posture for 3 1/2 hours) did not reach significance. These findings do not support the suggestion that a prone posture, by possibly reducing cerebrospinal fluid (CSF) leakage, signific...

  18. Clinical trial insurance coverage for cancer patients under the Affordable Care Act

    Directory of Open Access Journals (Sweden)

    Christine B. Mackay

    2016-04-01

    Conclusion: Three main factors limit the effectiveness of the ACA provisions in expanding clinical trial coverage: 1 ‘grandfathered’ self-funded employer plans not subject to state Employee Retirement Income Security Act (ERISA regulations, 2 Medicaid coverage limits not addressed under the ACA, 3 populations that remain uninsured. Kansas saw a negligible increase in insurance coverage as a result of the ACA thus lack of insurance coverage is likely to remain a concern for cancer patients.

  19. Predicting premature termination within a randomized controlled trial for binge-eating patients

    OpenAIRE

    Flückiger, C.; Meyer, A. H.; Wampold, B. E.; Gassmann, D.; Messerli-Bürgy, N.; Munsch, S.

    2011-01-01

    Understanding the dropout rates of efficacious forms of psychotherapy for patients with binge eating disorder (BED) is an unsolved problem within this increasing population. Up until now the role of psychotherapy process characteristics as predictors of premature termination has not been investigated in the BED literature. Within a randomized controlled trial (N=78) we investigated the degree to which early psychological process characteristics such as components of the therapeutic relationsh...

  20. Management of infection in myelosuppressed patients: clinical trials and common sense.

    Science.gov (United States)

    Greene, W H

    1985-01-01

    In the past fifteen years, enormous research effort has been expended in pursuit of the "ideal" approach to the management of infection in the myelosuppressed, i.e., granulocytopenic, patient. In the welter of clinical trials, some "commonsense" fundamentals have been lost or submerged, while other ideas seem to have become "modern myths." Among those commonsense approaches that should not be forgotten are the following: Granulocytopenia often precludes even the most skilled observer from assessing whether a febrile patient is truly infected. The epidemiology of infection at the local institution should be the principal determinant of the empiric antibiotic regimen in use. There is no ideal empiric antibiotic regimen. In particular, there is no absolute necessity for antipseudomonal penicillins, for aminoglycosides or for combinations of antibiotics. Some modern myths that seem to have been widely accepted without adequate data are: Antibiotic "synergism" is an essential prerequisite to a successful outcome of infection in the granulocytopenic patient. In the febrile granulocytopenic patient who responds to treatment, antibiotics should be continued until the granulocytopenia resolves. In the febrile granulocytopenic patient who does not respond to treatment, all such patients should receive amphotericin B for empiric antifungal treatment. These and other modern myths and aspects of common sense will be discussed in light of recent clinical trials.

  1. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  2. Physical Performance and Clinical Outcomes in Dialysis Patients: A Secondary Analysis of the Excite Trial

    Directory of Open Access Journals (Sweden)

    Claudia Torino

    2014-07-01

    Full Text Available Background/Aims: Scarce physical activity predicts shorter survival in dialysis patients. However, the relationship between physical (motor fitness and clinical outcomes has never been tested in these patients. Methods: We tested the predictive power of an established metric of motor fitness, the Six-Minute Walking Test (6MWT, for death, cardiovascular events and hospitalization in 296 dialysis patients who took part in the trial EXCITE (ClinicalTrials.gov Identifier: NCT01255969. Results: During follow up 69 patients died, 90 had fatal and non-fatal cardiovascular events, 159 were hospitalized and 182 patients had the composite outcome. In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of 20 walked metres during the 6MWT was associated to a 6% reduction of the risk for the composite end-point (P=0.001 and a similar relationship existed between the 6MWT, mortality (PConclusions: Poor physical performance predicts a high risk of mortality, cardiovascular events and hospitalizations in dialysis patients. Future studies, including phase-2 EXCITE, will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population.

  3. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial.

    Science.gov (United States)

    Burns, Tom; Rugkåsa, Jorun; Molodynski, Andrew; Dawson, John; Yeeles, Ksenija; Vazquez-Montes, Maria; Voysey, Merryn; Sinclair, Julia; Priebe, Stefan

    2013-05-11

    Compulsory supervision outside hospital has been developed internationally for the treatment of mentally ill people following widespread deinstitutionalisation but its efficacy has not yet been proven. Community treatment orders (CTOs) for psychiatric patients became available in England and Wales in 2008. We tested whether CTOs reduce admissions compared with use of Section 17 leave when patients in both groups receive equivalent levels of clinical contact but different lengths of compulsory supervision. OCTET is a non-blinded, parallel-arm randomised controlled trial. We postulated that patients with a diagnosis of psychosis discharged from hospital on CTOs would have a lower rate of readmission over 12 months than those discharged on the pre-existing Section 17 leave of absence. Eligible patients were those involuntarily admitted to hospital with a diagnosis of psychosis, aged 18-65 years, who were deemed suitable for supervised outpatient care by their clinicians. Consenting patients were randomly assigned (1:1 ratio) to be discharged from hospital either on CTO or Section 17 leave. Randomisation used random permuted blocks with lengths of two, four, and six, and stratified for sex, schizophrenic diagnosis, and duration of illness. Research assistants, treating clinicians, and patients were aware of assignment to randomisation group. The primary outcome measure was whether or not the patient was admitted to hospital during the 12-month follow-up period, analysed with a log-binomial regression model adjusted for stratification factors. We did all analyses by intention to treat. This trial is registered, number ISRCTN73110773. Of 442 patients assessed, 336 patients were randomly assigned to be discharged from hospital either on CTO (167 patients) or Section 17 leave (169 patients). One patient withdrew directly after randomisation and two were ineligible, giving a total sample of 333 patients (166 in the CTO group and 167 in the Section 17 group). At 12 months

  4. Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zarbock, Alexander; Gerß, Joachim; Van Aken, Hugo; Boanta, Andreea; Kellum, John A; Meersch, Melanie

    2016-03-18

    Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort. Our plan is to randomize critically ill patients with acute kidney injury to 'early' or 'late' initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome. Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury. German Clinical Trials Register: DRKS00004367 ( www.germanctr.de ); 28 May 2013.

  5. Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

    Directory of Open Access Journals (Sweden)

    Ueda A

    2013-05-01

    Full Text Available Akira Ueda, Ayumu Hosokawa, Kohei Ogawa, Hiroki Yoshita, Takayuki Ando, Shinya Kajiura, Haruka Fujinami, Kengo Kawai, Jun Nishikawa, Kazuto Tajiri, Masami Minemura, Toshiro SugiyamaDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, JapanObjective: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.Methods: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM alone, S-1 (tegafur, gimeracil, and oteracil potassium alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible or the ineligible group (arm ineligible. We evaluated the efficacy and the safety of the chemotherapy.Results: A total of 23 patients out of 75 (31% belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS was 3.5 months, and the median overall survival (OS was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.Conclusion: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.Keywords: gemcitabine, S-1, clinical practice

  6. Nutritional education for management of osteodystrophy (NEMO) trial: Design and patient characteristics, Lebanon.

    Science.gov (United States)

    Karavetian, Mirey; Abboud, Saade; Elzein, Hafez; Haydar, Sarah; de Vries, Nanne

    2014-02-01

    THIS STUDY AIMS TO DETERMINE THE EFFECT OF A TRAINED DEDICATED DIETITIAN ON CLINICAL OUTCOMES AMONG LEBANESE HEMODIALYSIS (HD) PATIENTS: and thus demonstrate a viable developing country model. This paper describes the study protocol and baseline data. The study was a multicenter randomized controlled trial with parallel-group design involving 12 HD units: assigned to cluster A (n = 6) or B (n = 6). A total of 570 patients met the inclusion criteria. Patients in cluster A were randomly assigned as per dialysis shift to the following: Dedicated Dietitian (DD) (n = 133) and Existing Practice (EP) (n = 138) protocols. Cluster B patients (n = 299) received Trained Hospital Dietitian (THD) protocol. Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines. DD protocol included: individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change. EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study. The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities, with no set educational protocol or tools. Baseline data revealed that 40% of patients were hyperphosphatemics (> 5.5 mg/dl) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake (58.86%± 33.87% of needs) yet adequate dietary P intake (795.52 ± 366.94 mg/day). Quality of life (QOL) ranged from 48-75% of full health. Baseline differences between the 3 groups revealed significant differences in serum P, malnutrition status, adherence to diet and P chelators and in 2 factors of the QOL: physical and social functioning. The data show room for improvement in the nutritional status of the patients. The NEMO trial may be able to

  7. Patient satisfaction with occlusal scheme of conventional complete dentures: A randomised clinical trial (part I).

    Science.gov (United States)

    Moradpoor, H; Arabzade Hoseini, M; Savabi, O; Shirani, M

    2018-01-01

    Occlusal scheme can affect denture retention, stability, occlusal force distribution, aesthetics, masticatory function, patient comfort and general patient satisfaction with dentures. This study aimed to compare the patient satisfaction with 3 types of complete denture occlusion including fully bilateral balanced occlusion (FBBO), newly presented buccalised occlusion (BO) and lingualised occlusion (LO). In this parallel randomised clinical trial, new conventional complete dentures were fabricated for 86 volunteers. Participants were randomly allocated to 3 groups with 3 different occlusal schemes. All patients were recalled at 1 and 3 months after delivery for data collection. The 19-item version of Oral Health Impact Profile for Edentulous Patients questionnaire was used in this study. The visual analogue scale (VAS) was used for assessment of the prosthodontist's attitude towards denture quality, patient's attitude towards different occlusal schemes and evaluation of patient satisfaction. Data were analysed using the Wilcoxon signed rank test, the Kruskal-Wallis test and the post hoc Dunn test via SPSS version 18.0 (P ≤ .05). Eighty-six patients completed the study, and their data were analysed (mean age ± standard deviation = 57.78 ± 9.98 years). The only significant difference when comparing the 3 groups was physical pain, which was significantly higher in FBBO group. No significant differences were found for the VAS scores of patient and prosthodontist satisfaction or the domain scores among the 3 occlusal schemes either at 1 or at 3 months post-delivery. The VAS score of patient satisfaction and prosthodontist satisfaction increased at third compared to first month after delivery. The results of this randomised clinical trial provided evidence that BO is as effective as LO for the fabrication of complete dentures. © 2017 John Wiley & Sons Ltd.

  8. A review of renal, cardiovascular and mortality endpoints in antihypertensive trials in diabetic patients.

    Science.gov (United States)

    García-Donaire, J A; Segura, J; Cerezo, C; Ruilope, L M

    2011-12-01

    Renal disease is highly prevalent in people with type 2 diabetes, and co-existence with hypertension increases the risk of cardiac events and mortality. Despite many large randomized trials, controversies remain regarding optimal antihypertensive therapy in diabetic patients, including whether some classes of antihypertensive drugs have specific renal protective properties, and the relationships between renal, cardiovascular and mortality endpoints. In this article, we review landmark antihypertensive drug trials from the last two decades in patient populations composed, or including substantial proportions, of patients with type 2 diabetes. Several points emerge. Firstly, treatment effects can vary widely among different renal, cardiovascular and mortality endpoints. Secondly, combinations of antihypertensive drugs vary in their ability to prevent major renal and cardiovascular events, even if they produce similar reductions in blood pressure. Thirdly, simply adding further antihypertensive drugs may not improve outcomes, even if it produces further reductions in blood pressure. In most trials, a reduction in microalbuminuria was associated with evidence of renal protection, but further evidence is needed relating changes in proteinuria with cardiovascular risk. The study that aligns best with the current reappraisal of ESH guidelines, with regard to blood pressure goals, use of an adequate combination and simultaneously protecting the kidney and the cardiovascular system, is the ADVANCE study.

  9. Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22%) or 16% (from 30% to 46%) in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a dengue therapeutic that can

  10. Implementation of an anonymisation tool for clinical trials using a clinical trial processor integrated with an existing trial patient data information system.

    Science.gov (United States)

    Aryanto, Kadek Y E; Broekema, André; Oudkerk, Matthijs; van Ooijen, Peter M A

    2012-01-01

    To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two methods are presented for an adapted CTP test set-up. In the first method, images are pushed from the Picture Archiving and Communication System (PACS) using the DICOM protocol through a local network. In the second method, images are transferred through the internet using the HTTPS protocol. In total 25,000 images from 50 patients were moved from the PACS, anonymised and stored within roughly 2 h using the first method. In the second method, an average of 10 images per minute were transferred and processed over a residential connection. In both methods, no duplicated images were stored when previous images were retransferred. The anonymised images are stored in appropriate directories. The CTP can transfer and process DICOM images correctly in a very easy set-up providing a fast, secure and stable environment. The adapted CTP allows easy integration into an environment in which patient data are already included in an existing information system.

  11. Patient load effects on response time to critical arrhythmias in cardiac telemetry: a randomized trial.

    Science.gov (United States)

    Segall, Noa; Hobbs, Gene; Granger, Christopher B; Anderson, Amanda E; Bonifacio, Alberto S; Taekman, Jeffrey M; Wright, Melanie C

    2015-05-01

    Remotely monitored patients may be at risk for a delayed response to critical arrhythmias if the telemetry watchers who monitor them are subject to an excessive patient load. There are no guidelines or studies regarding the appropriate number of patients that a single watcher may safely and effectively monitor. Our objective was to determine the impact of increasing the number of patients monitored on response time to simulated cardiac arrest. Randomized trial. Laboratory-based experiment. Forty-two remote telemetry technicians and nurses from cardiac units. Number of patients monitored in a simulation of cardiac telemetry monitoring work. We carried out a study to compare response times to ventricular fibrillation across five patient loads: 16, 24, 32, 40, and 48 patients. The simulation replicated the work of telemetry watchers using a combination of real recorded patient electrocardiogram signals and a simulated patient experiencing ventricular fibrillation. Study participants were assigned to one of the five patient loads and completed a 4-hour monitoring session, during which they performed tasks-including event documentation and phone calls to report events-similar to real monitoring work. When the simulated patient sustained ventricular fibrillation, the time required to report this arrhythmia was recorded. As patient loads increased, there was a statistically significant increase in response times to the ventricular fibrillation. In addition, frequency of failure to meet a response time goal of less than 20 seconds was significantly higher in the 48-patient condition than in all other conditions. Task performance decreased as patient load increased. As participants monitored more patients in a laboratory setting, their performance with respect to recognizing critical and noncritical events declined. This study has implications for the design of remote telemetry work and other patient monitoring tasks in critical and intermediate care units.

  12. Evolving the multiple roles of 'patients' in health-care research: reflections after involvement in a trial of shared decision-making.

    Science.gov (United States)

    Thornton, Hazel; Edwards, Adrian; Elwyn, Glyn

    2003-09-01

    This paper offers 'consumer-led' reflections by steering group members of a patient-centred research study involving consumer advocates, patients' associations and patients, throughout the whole study, from pre- to post-study phases. ORIGINAL STUDY DESIGN: The study: 'Shared decision making and risk communication in general practice' incorporated systematic reviews, psychometric evaluation of outcome measures, and quantitative, qualitative and health economic analyses of a cluster randomized trial of professional skill development, all informed by consumer and patient engagement. The work was produced by a wide collaboration led by researchers from the Department of General Practice, University of Wales College of Medicine, Cardiff, including a consumers' advisory group and a patients' association. The study participants were 20 general practitioners from Gwent, their practice staff, and almost 800 patients at these practices. Consumers and patients contributed to several stages of the research from inception and design, securing of funding, implementation of the protocol, and interpretation and dissemination of the findings. 'Patient involvement' research initiatives that include an equally wide variety of 'user' participants as 'health-professional' participants, accountable to a 'Health in Partnership' funded project, require a user-led viewpoint to be presented and disseminated. This paper presents reflections on the processes of the research, the interpretations of study findings by the involved parties, and notes how this model is fundamental to effective research in the field of patient-centred health care if future practice, policy and research are to change.

  13. Baseline characteristics and event rates among anticoagulated patients with atrial fibrillation in practice and pivotal NOAC trials

    Directory of Open Access Journals (Sweden)

    Peter A. Noseworthy

    2017-10-01

    Full Text Available The data report details the baseline characteristics and observed outcomes among patients included in a large US administrative claims database (Optum Labs Data Warehouse and those enrolled in the pivotal phase III clinical trials examining apixaban, dabigratan, edoxaban and rivaroxaban versus warfarin for the prevention of cardio embolism (Granger et al., 2011; Cannolly et al., 2009; Patel et al., 2011; Giugliano et al., 2013 [1–4]. These data are to be interpreted in the context of the linked publication (Noseworthy et al., 2017 [5]. These data illustrate baseline characteristics in patients treated in routine practice and those enrolled in clinical trials. For instance, patients treated with apixaban in practice tended to be slightly older and we more likely to be female than those enrolled in the apixaban clinical trial. Patient treated with rivaroxaban in practice tended to have lower CHADS2 scores than those included in the rivaroxaban clinical trial. Overall, and stratified by baseline CHADS2 scores, patients treated with NOACs in routine practice had comparable or slightly lower stroke risks than those in the clinical trials. Patients treated with NOACs in routine practice had slightly higher bleeding risk in practice, particularly in high-risk patients with CHADS2 ≥ 3, compared to those in the clinical trials. These data may serve as a benchmark for realized outcomes among anticoagulated patients with atrial fibrillation in the United States and may serve as a useful comparison to other datasets or countries.

  14. Why do patients choose (not) to participate in an exercise trial during adjuvant chemotherapy for breast cancer?

    NARCIS (Netherlands)

    van Waart, Hanna; van Harten, Wim H.; Buffart, Laurien M.; Sonke, Gabe S.; Stuiver, Martijn M.; Aaronson, Neil K.

    2016-01-01

    Only between 25% and 50% of patients invited to participate in clinical trial-based physical exercise programs during cancer treatment agree to do so. The purpose of this study was to identify factors associated significantly with the decision (not) to participate in a randomized controlled trial of

  15. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

    DEFF Research Database (Denmark)

    Bosch, Jaime; Thabut, Dominique; Albillos, Agustín

    2008-01-01

    A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal...... events, were comparable between groups. CONCLUSION: Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo. Therefore, decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered, because results of this study do...

  16. A controlled trial on the effect of hypnosis on dental anxiety in tooth removal patients.

    Science.gov (United States)

    Glaesmer, Heide; Geupel, Hendrik; Haak, Rainer

    2015-09-01

    Empirical evidence concerning the efficacy of hypnosis to reduce anxiety in dental patients is limited. Hence we conducted a controlled trial in patients undergoing tooth removal. The study aims at assessing patient's attitude toward hypnosis and comparing the course of dental anxiety before, during and subsequent to tooth removal in patients with treatment as usual (TAU) and patients with treatment as usual and hypnosis (TAU+HYP). 102 patients in a dental practice were assigned to TAU or TAU+HYP. Dental anxiety was assessed before, during and after treatment. All patients were asked about their experiences and attitudes toward hypnosis. More than 90% of patients had positive attitudes toward hypnosis. Dental anxiety was highest before treatment, and was decreasing across the three assessment points in both groups. The TAU+HYP group reported significantly lower levels of anxiety during treatment, but not after treatment compared with TAU group. Our findings confirm that hypnosis is beneficial as an adjunct intervention to reduce anxiety in patients undergoing tooth removal, particularly with regard to its no-invasive nature. The findings underline that hypnosis is not only beneficial, but also highly accepted by the patients. Implementation of hypnosis in routine dental care should be forwarded. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... IRB is an independent committee created by the institution that sponsors a clinical trial. IRB members are ... provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research- ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit ... public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical trials at ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... IRBs, develop educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board ...

  4. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Louise Dudley

    Full Text Available Patient and public involvement (PPI is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact.Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation.We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups and managerial (e.g. trial management groups roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees.Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials.

  5. Oral zinc sulphate in treatment of patients with thallium poisoning: A clinical therapeutic trial

    Directory of Open Access Journals (Sweden)

    Ahmed A. Al-Mohammadi

    2011-06-01

    Full Text Available Thallium poisoning is usually associated with typical dermatological features simulating that of zinc deficiency. The aim of this study was to evaluate the role of oral zinc sulphate in the treatment of patients with thallium poisoning.Materials and methods: This clinical therapeutic trial study was conducted in Departments of Dermatology of Baghdad and Basrah Teaching Hospitals from February 2008 - February 2010, where a total of 37 patients with thallium poisoning were enrolled.A detailed history was taken from all patients and complete clinical examination was performed. All patients received zinc sulphate in a dose of 5 mg/kg three times a day few days before confirming the diagnosis of thallium poisoning. Thallium in urine had been measured using the colorimetric method and was positive in all patients. After confirming the diagnosis of thallium poisoning, thallium antidotes Prussian blue was given to 32 patients.Results: Age range of 37 patients was 5-33 (24±5.3 years. The dermatological findings were mainly: anagen hair loss affected the scalp and limbs. Also, dusky ecchymotic red dermatitis like rash was observed on the face and dorsum of hands and legs, while neurological manifestations were mainly of peripheral neuropathy, were reported in 21 (55% patients. All patients but two responded promptly to a trial of zinc sulphate within few days.Conclusion: Oral Zinc sulphate appears to be an effective and safe treatment for thallium poisoning particularly for skin and hair features and in reducing its lethal progression and complications. J Clin Exp Invest 2011;2(2:133-7

  6. Comparison of electronic health record system functionalities to support the patient recruitment process in clinical trials.

    Science.gov (United States)

    Schreiweis, Björn; Trinczek, Benjamin; Köpcke, Felix; Leusch, Thomas; Majeed, Raphael W; Wenk, Joachim; Bergh, Björn; Ohmann, Christian; Röhrig, Rainer; Dugas, Martin; Prokosch, Hans-Ulrich

    2014-11-01

    Reusing data from electronic health records for clinical and translational research and especially for patient recruitment has been tackled in a broader manner since about a decade. Most projects found in the literature however focus on standalone systems and proprietary implementations at one particular institution often for only one singular trial and no generic evaluation of EHR systems for their applicability to support the patient recruitment process does yet exist. Thus we sought to assess whether the current generation of EHR systems in Germany provides modules/tools, which can readily be applied for IT-supported patient recruitment scenarios. We first analysed the EHR portfolio implemented at German University Hospitals and then selected 5 sites with five different EHR implementations covering all major commercial systems applied in German University Hospitals. Further, major functionalities required for patient recruitment support have been defined and the five sample EHRs and their standard tools have been compared to the major functionalities. In our analysis of the site's hospital information system environments (with four commercial EHR systems and one self-developed system) we found that - even though no dedicated module for patient recruitment has been provided - most EHR products comprise generic tools such as workflow engines, querying capabilities, report generators and direct SQL-based database access which can be applied as query modules, screening lists and notification components for patient recruitment support. A major limitation of all current EHR products however is that they provide no dedicated data structures and functionalities for implementing and maintaining a local trial registry. At the five sites with standard EHR tools the typical functionalities of the patient recruitment process could be mostly implemented. However, no EHR component is yet directly dedicated to support research requirements such as patient recruitment. We

  7. [Motivation of patients to participate in clinical trials. An explorative survey].

    Science.gov (United States)

    Gaul, Charly; Malcherczyk, Annett; Schmidt, Thomas; Helm, Jürgen; Haerting, Johannes

    2010-02-01

    Difficulties in recruiting patients for clinical trials lead to increasing costs, and prolonged implementation of evidences into medical practice. Knowledge about motivation and barriers in potential participants would be helpful to develop successful recruitment strategies. Currently, no systematic research of determining factors affecting the decision to participate in clinical studies is available from German samples. After been given details about a potential participation in a clinical or diagnostic study in nine study centers, patients were recruited for an additional structured questionnaire survey concerning motivation and barriers to participation. 62 patients were included into the survey. 95.1% did not have any experience with clinical studies before. 66.1% met the physician explaining the study and asking for informed consent for the first time. Despite this, 96.6% judged the physician to be competent. Family and friends were important for decision-making about the participation in a study. Gender was only of marginal influence. The majority of patients (91.4%) expected advantages of the study for their own. 88% of the patients denominated potential advantages for other patients as an additional motivator. The possibility of adverse events was inferior for patients in decision-making about participation in a clinical trial. Physicians recruiting patients for clinical studies should be well prepared about details of the study and should have adequate time for an introductory conversation in a quiet environment. Including relatives into the introductory conversation may enhance the motivation and therefore the success of recruitment. Potential advantages of a participation for the own treatment and additionally for other patients should be highlighted. Possible side effects should be explained in a realistic manner.

  8. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Whitlock, Richard P; Devereaux, P J; Teoh, Kevin H; Lamy, Andre; Vincent, Jessica; Pogue, Janice; Paparella, Domenico; Sessler, Daniel I; Karthikeyan, Ganesan; Villar, Juan Carlos; Zuo, Yunxia; Avezum, Álvaro; Quantz, Mackenzie; Tagarakis, Georgios I; Shah, Pallav J; Abbasi, Seyed Hesameddin; Zheng, Hong; Pettit, Shirley; Chrolavicius, Susan; Yusuf, Salim

    2015-09-26

    Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00427388. Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared

  9. Treatment of patients with atypical meningiomas Simpson grade 4 and 5 with a carbon ion boost in combination with postoperative photon radiotherapy: The MARCIE Trial

    Directory of Open Access Journals (Sweden)

    Unterberg Andreas

    2010-11-01

    Full Text Available Abstract Background Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50% and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE, which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed. First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising. Methods/design The Phase II-MARCIE-Study will evaluate a carbon ion boost applied to the macroscopic tumor in conjunction with photon radiotherapy in patients with atypical menigiomas after incomplete resection or biopsy. Primary endpoint is progression-free survival, secondary endpoints are overall survival, safety and toxicity. Discussion Based on published data on the treatment of atypical meningiomas with carbon ions at GSI, the present study will evaluate this treatment concept in a larger patient population and will compare outcome to current standard photon treatment. Trial registration NCT01166321

  10. Rivaroxaban in the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation: Clinical Implications of the ROCKET AF Trial and Its Subanalyses.

    Science.gov (United States)

    Spencer, Ryan J; Amerena, John V

    2015-12-01

    Atrial fibrillation (AF) is an increasingly common cause of stroke and systemic embolism. While warfarin has been the mainstay of stroke prevention in patients with AF, newer novel oral anticoagulant medications are now available. Rivaroxaban, a direct factor Xa inhibitor with a rapid onset and offset after oral administration, offers potential advantages over warfarin, predominantly due to its predictable pharmacokinetics across wide patient populations. It requires no coagulation monitoring, and only two different doses are needed (20 mg daily for patients with normal renal function and 15 mg daily in those with reduced renal function). A large randomized trial (ROCKET AF) has shown non-inferiority to warfarin for preventing stroke or systemic embolism in the per-protocol population and superiority to warfarin in the on-treatment safety population. Several subanalyses confirm that the treatment effect of rivaroxaban is consistent across different patient subgroups, including those with reduced renal function. The tolerability of rivaroxaban appears similar to that of warfarin, with comparable overall bleeding rates in clinical trials. In ROCKET AF, significantly lower rates of fatal and intracranial bleeding were seen with rivaroxaban, while lower rates of gastrointestinal bleeding were seen with warfarin. Important contraindications to rivaroxaban include valvular AF, the presence of a prosthetic valve (mechanical or bioprosthetic) or valve repair, the need for concurrent dual antiplatelet therapy, and creatinine clearance <30 ml/min. Once-daily dosing and the lack of coagulation monitoring may increase utilization and adherence compared with warfarin, potentially decreasing the large burden of care associated with stroke secondary to AF. Overall, rivaroxaban offers a useful alternative to warfarin for stroke prevention in patients with AF.

  11. Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial.

    Science.gov (United States)

    Michalsen, Andreas; Bock, Silke; Lüdtke, Rainer; Rampp, Thomas; Baecker, Marcus; Bachmann, Jürgen; Langhorst, Jost; Musial, Frauke; Dobos, Gustav J

    2009-06-01

    We investigated the effectiveness of cupping, a traditional method of treating musculoskeletal pain, in patients with carpal tunnel syndrome (CTS) in an open randomized trial. n = 52 outpatients (58.5 +/- 8.0 years) with neurologically confirmed CTS were randomly assigned to either a verum (n = 26) or a control group (n = 26). Verum patients were treated with a single application of wet cupping, and control patients with a single local application of heat within the region overlying the trapezius muscle. Patients were followed up on day 7 after treatment. The primary outcome, severity of CTS symptoms (VAS), was reduced from 61.5 +/- 20.5 to 24.6 +/- 22.7 mm at day 7 in the cupping group and from 67.1 +/- 20.2 to 51.7 +/- 23.9 mm in the control group [group difference -24.5mm (95%CI -36.1; -2.9, P cupping therapy may be effective in relieving the pain and other symptoms related to CTS. The efficacy of cupping in the long-term management of CTS and related mechanisms remains to be clarified. The results of a randomized trial on the clinical effects of traditional cupping therapy in patients with carpal tunnel syndrome are presented. Cupping of segmentally related shoulder zones appears to alleviate the symptoms of carpal tunnel syndrome.

  12. Impact of a patient decision aid on care among patients with nonvalvular atrial fibrillation: a cluster randomized trial

    Science.gov (United States)

    McAlister, Finlay A.; Man-Son-Hing, Malcolm; Straus, Sharon E.; Ghali, William A.; Anderson, David; Majumdar, Sumit R.; Gibson, Paul; Cox, Jafna L.; Fradette, Miriam

    2005-01-01

    Background Too few patients with nonvalvular atrial fibrillation (NVAF) receive appropriate antithrombotic therapy. We tested the short-term (primary outcome) and long-term (secondary outcome) effect of a patient decision aid on the appropriateness of antithrombotic therapy among patients with NVAF. Methods We conducted a cluster randomized trial with blinded outcome assessment involving 434 NVAF patients from 102 community-based primary care practices. Patients in the intervention group received a self-administered booklet and audiotape decision aid tailored to their personal stroke risk profile. Patients in the control group received usual care. The primary outcome measure was change in antithrombotic therapy at 3 months. Appropriateness of therapy was defined using the American College of Chest Physicians (ACCP) recommendations. Results The mean patient age was 72 years, and the median duration of NVAF was 5 years. In the control group, there was a 3% decrease over 3 months in the number of patients receiving therapy appropriate to their risk of stroke (40% [85/215] at baseline v. 37% [79/215] at 3 months). In the intervention group, the number of patients receiving therapy appropriate to their stroke risk increased by 9% (32% [69/219] at baseline v. 41% [89/219] at 3 months). Although the proportion of patients whose therapy met the ACCP treatment recommendations did not differ between study arms at baseline (p = 0.11) or 3 months (p = 0.44), there was a 12% absolute improvement in the number of patients receiving appropriate care in the intervention group compared with the control group at 3 months (p = 0.03). The beneficial effect of the decision aid did not persist (p = 0.44 for differences between study arms after 12 months). Interpretation There was short-term improvement in the appropriateness of antithrombotic care among patients with NVAF who were exposed to a decision aid, but the improvement did not persist. PMID:16129870

  13. Effectiveness of newspaper advertising for patient recruitment into a clinical trial

    Science.gov (United States)

    Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

    2014-01-01

    Aims To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Methods Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. Results The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Conclusions Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. PMID:24283948

  14. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  15. Effectiveness of newspaper advertising for patient recruitment into a clinical trial.

    Science.gov (United States)

    Hapca, Adrian; Jennings, Claudine G; Wei, Li; Wilson, Adam; MacDonald, Thomas M; Mackenzie, Isla S

    2014-06-01

    To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice. © 2013 The British Pharmacological Society.

  16. Motivation and treatment engagement intervention trial (MotivaTe-IT): the effects of motivation feedback to clinicians on treatment engagement in patients with severe mental illness

    Science.gov (United States)

    2012-01-01

    Background Treatment disengagement and non-completion poses a major problem for the successful treatment of patients with severe mental illness. Motivation for treatment has long been proposed as a major determinant of treatment engagement, but exact mechanisms remain unclear. This current study serves three purposes: 1) to determine whether a feedback intervention based on the patients’ motivation for treatment is effective at improving treatment engagement (TE) of severe mentally ill patients in outpatient psychiatric treatment, 2) to gather insight into motivational processes and possible mechanisms regarding treatment motivation (TM) and TE in this patient population and 3) to determine which of three theories of motivation is most plausible for the dynamics of TM and TE in this population. Methods/design The Motivation and Treatment Engagement Intervention Trial (MotivaTe-IT) is a multi-center cluster randomized trial investigating the effectiveness of feedback generated by clinicians regarding their patients’ treatment motivation upon the patients’ TE. The primary outcome is the patients’ TE. Secondary outcomes are TM, psychosocial functioning and quality of life. Patients whose clinicians generate monthly motivation feedback (additional to treatment as usual) will be compared to patients who receive treatment as usual. An estimated 350 patients, aged 18 to 65 years, with psychotic disorders and/or severe personality disorders will be recruited from outpatient community mental health care. The randomization will be performed by a computerized randomization program, with an allocation ratio of 1:1 (team vs. team or clinician vs. clinician) and patients, but not clinicians, will be blind to treatment allocation at baseline assessment. Due to the nature of the trial, follow-up assessment can not be blinded. Discussion The current study can provide important insights regarding motivational processes and the way in which motivation influences the treatment

  17. Motivation and treatment engagement intervention trial (MotivaTe-IT: the effects of motivation feedback to clinicians on treatment engagement in patients with severe mental illness

    Directory of Open Access Journals (Sweden)

    Jochems Eline C

    2012-11-01

    Full Text Available Abstract Background Treatment disengagement and non-completion poses a major problem for the successful treatment of patients with severe mental illness. Motivation for treatment has long been proposed as a major determinant of treatment engagement, but exact mechanisms remain unclear. This current study serves three purposes: 1 to determine whether a feedback intervention based on the patients’ motivation for treatment is effective at improving treatment engagement (TE of severe mentally ill patients in outpatient psychiatric treatment, 2 to gather insight into motivational processes and possible mechanisms regarding treatment motivation (TM and TE in this patient population and 3 to determine which of three theories of motivation is most plausible for the dynamics of TM and TE in this population. Methods/design The Motivation and Treatment Engagement Intervention Trial (MotivaTe-IT is a multi-center cluster randomized trial investigating the effectiveness of feedback generated by clinicians regarding their patients’ treatment motivation upon the patients’ TE. The primary outcome is the patients’ TE. Secondary outcomes are TM, psychosocial functioning and quality of life. Patients whose clinicians generate monthly motivation feedback (additional to treatment as usual will be compared to patients who receive treatment as usual. An estimated 350 patients, aged 18 to 65 years, with psychotic disorders and/or severe personality disorders will be recruited from outpatient community mental health care. The randomization will be performed by a computerized randomization program, with an allocation ratio of 1:1 (team vs. team or clinician vs. clinician and patients, but not clinicians, will be blind to treatment allocation at baseline assessment. Due to the nature of the trial, follow-up assessment can not be blinded. Discussion The current study can provide important insights regarding motivational processes and the way in which motivation

  18. Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

    Science.gov (United States)

    Takahashi, Fumihiro; Morita, Satoshi

    2018-02-08

    Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

  19. Study of multiparameter respiratory pattern complexity in surgical critically ill patients during weaning trials

    Directory of Open Access Journals (Sweden)

    Maglaveras Nikos K

    2011-01-01

    Full Text Available Abstract Background Separation from mechanical ventilation is a difficult task, whereas conventional predictive indices have not been proven accurate enough, so far. A few studies have explored changes of breathing pattern variability for weaning outcome prediction, with conflicting results. In this study, we tried to assess respiratory complexity during weaning trials, using different non-linear methods derived from theory of complex systems, in a cohort of surgical critically ill patients. Results Thirty two patients were enrolled in the study. There were 22 who passed and 10 who failed a weaning trial. Tidal volume and mean inspiratory flow were analyzed for 10 minutes during two phases: 1. pressure support (PS ventilation (15-20 cm H2O and 2. weaning trials with PS: 5 cm H2O. Sample entropy (SampEn, detrended fluctuation analysis (DFA exponent, fractal dimension (FD and largest lyapunov exponents (LLE of the two respiratory parameters were computed in all patients and during the two phases of PS. Weaning failure patients exhibited significantly decreased respiratory pattern complexity, reflected in reduced sample entropy and lyapunov exponents and increased DFA exponents of respiratory flow time series, compared to weaning success subjects (p 0.1, SampEn and LLE predicted better weaning outcome compared with RSBI, P0.1 and RSBI* P0.1 (conventional model, R2 = 0.874 vs 0.643, p Conclusions We suggest that complexity analysis of respiratory signals can assess inherent breathing pattern dynamics and has increased prognostic impact upon weaning outcome in surgical patients.

  20. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    Science.gov (United States)

    Allet, L; Armand, S; de Bie, R A; Golay, A; Monnin, D; Aminian, K; Staal, J B; de Bruin, E D

    2010-03-01

    Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. This was a randomised controlled trial (n=71) with an intervention (n=35) and control group (n=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up. The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (pbalance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down. Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients' physical activity levels and quality of life. ClinicalTrials.gov NCT00637546 This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/

  1. A kidney offer acceptance decision tool to inform the decision to accept an offer or wait for a better kidney.

    Science.gov (United States)

    Wey, Andrew; Salkowski, Nicholas; Kremers, Walter K; Schaffhausen, Cory R; Kasiske, Bertram L; Israni, Ajay K; Snyder, Jon J

    2018-04-01

    We developed a kidney offer acceptance decision tool to predict the probability of graft survival and patient survival for first-time kidney-alone candidates after an offer is accepted or declined, and we characterized the effect of restricting the donor pool with a maximum acceptable kidney donor profile index (KDPI). For accepted offers, Cox proportional hazards models estimated these probabilities using transplanted kidneys. For declined offers, these probabilities were estimated by considering the experience of similar candidates who declined offers and the probability that declining would lead to these outcomes. We randomly selected 5000 declined offers and estimated these probabilities 3 years post-offer had the offers been accepted or declined. Predicted outcomes for declined offers were well calibrated (offers been accepted, the probabilities of graft survival and patient survival were typically higher. However, these advantages attenuated or disappeared with higher KDPI, candidate priority, and local donor supply. Donor pool restrictions were associated with worse 3-year outcomes, especially for candidates with high allocation priority. The kidney offer acceptance decision tool could inform offer acceptance by characterizing the potential risk-benefit trade-off associated with accepting or declining an offer. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

  2. Improving awareness of cancer clinical trials among Hispanic patients and families: audience segmentation decisions for a media intervention.

    Science.gov (United States)

    Quinn, Gwendolyn P; McIntyre, Jessica; Gonzalez, Luis E; Antonia, Teresita Muñoz; Antolino, Prado; Wells, Kristen J

    2013-01-01

    Clinical trials hold great promise for cancer treatment; yet, Hispanic cancer patients have low rates of clinical trial participation. Lack of awareness and knowledge of clinical trials and language barriers may account for low participation rates. Patient education through audiovisual materials can improve knowledge of and attitudes toward clinical trials among Hispanic populations. In this study, 36 Hispanic cancer patients/survivors and caregivers in Florida and Puerto Rico participated in focus groups to aid in developing a Spanish-language DVD and booklet intervention designed to increase knowledge about clinical trials. Focus group results showed (a) low levels of knowledge about clinical trials, (b) uncertainty about why a physician would expect a patient to make a choice about treatment, and (c) desire for family participation in decision making. Respondents expressed various preferences for aspects of the DVD such as showing extended family in the DVD and physician explanations about key terms. On the basis of these preferences, the authors developed a creative brief for a DVD. The content of the DVD was reviewed by Hispanic community leaders and key stakeholders. A final DVD was created, in Spanish, using Hispanic patients and physicians, which contained the information deemed important from the focus groups and stakeholder interviews. The DVD is complete with companion booklet and currently undergoing a randomized control trial.

  3. A prospective randomized trial of perioperative seizure prophylaxis in patients with intraparenchymal brain tumors.

    Science.gov (United States)

    Wu, Adam S; Trinh, Victoria T; Suki, Dima; Graham, Susan; Forman, Arthur; Weinberg, Jeffrey S; McCutcheon, Ian E; Prabhu, Sujit S; Heimberger, Amy B; Sawaya, Raymond; Wang, Xuemei; Qiao, Wei; Hess, Kenneth; Lang, Frederick F

    2013-04-01

    Seizures are a potentially devastating complication of resection of brain tumors. Consequently, many neurosurgeons administer prophylactic antiepileptic drugs (AEDs) in the perioperative period. However, it is currently unclear whether perioperative AEDs should be routinely administered to patients with brain tumors who have never had a seizure. Therefore, the authors conducted a prospective, randomized trial examining the use of phenytoin for postoperative seizure prophylaxis in patients undergoing resection for supratentorial brain metastases or gliomas. Patients with brain tumors (metastases or gliomas) who did not have seizures and who were undergoing craniotomy for tumor resection were randomized to receive either phenytoin for 7 days after tumor resection (prophylaxis group) or no seizure prophylaxis (observation group). Phenytoin levels were monitored daily. Primary outcomes were seizures and adverse events. Using an estimated seizure incidence of 30% in the observation arm and 10% in the prophylaxis arm, a Type I error of 0.05 and a Type II error of 0.20, a target accrual of 142 patients (71 per arm) was planned. The trial was closed before completion of accrual because Bayesian predictive probability analyses performed by an independent data monitoring committee indicated a probability of 0.003 that at the end of the study prophylaxis would prove superior to observation and a probability of 0.997 that there would be insufficient evidence at the end of the trial to choose either arm as superior. At the time of trial closure, 123 patients (77 metastases and 46 gliomas) were randomized, with 62 receiving 7-day phenytoin (prophylaxis group) and 61 receiving no prophylaxis (observation group). The incidence of all seizures was 18% in the observation group and 24% in the prophylaxis group (p = 0.51). Importantly, the incidence of early seizures (observation group compared with 10% in the prophylaxis group (p = 1.0). Likewise, the incidence of clinically

  4. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomised clinical trial

    DEFF Research Database (Denmark)

    de Vos, Cecile C; Meier, Kaare; Zaalberg, Paul Brocades

    2014-01-01

    Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our......D questionnaires also showed that patients in the SCS group, unlike those in the control group, experienced reduced pain and improved health and quality of life after 6 months of treatment. In patients with refractory painful diabetic neuropathy, spinal cord stimulation therapy significantly reduced...... knowledge, ours is the first multicentre randomized controlled trial investigating the effectiveness of SCS in patients with PDN. Sixty patients with PDN in the lower extremities refractory to conventional medical therapy were enrolled and followed for 6 months. They were randomized 2:1 to best conventional...

  5. Electrolyte and Metabolic Disturbances in Ebola Patients during a Clinical Trial, Guinea, 2015

    Science.gov (United States)

    Bah, Elhadj Ibrahima; Haba, Nyankoye; Delamou, Alexandre; Camara, Bienvenu Salim; Olivier, Kadio Jean-Jacques; De Clerck, Hilde; Nordenstedt, Helena; Semple, Malcolm G.; Van Herp, Michel; Buyze, Jozefien; De Crop, Maaike; Van Den Broucke, Steven; Lynen, Lutgarde; De Weggheleire, Anja

    2016-01-01

    By using data from a 2015 clinical trial on Ebola convalescent-phase plasma in Guinea, we assessed the prevalence of electrolyte and metabolic abnormalities at admission and their predictive value to stratify patients into risk groups. Patients underwent testing with a point-of-care device. We used logistic regression to construct a prognostic model and summarized the predictive value with the area under the receiver operating curve. Abnormalities were common among patients, particularly hypokalemia, hypocalcemia, hyponatremia, raised creatinine, high anion gap, and anemia. Besides age and PCR cycle threshold value, renal dysfunction, low calcium levels, and low hemoglobin levels were independently associated with increased risk for death. A prognostic model using all 5 factors was highly discriminatory (area under the receiver operating curve 0.95; 95% CI 0.90–0.99) and enabled the definition of risk criteria to guide targeted care. Most patients had a very low (80%) risk for death. PMID:27869610

  6. A randomized, controlled trial of physician postures when breaking bad news to cancer patients.

    Science.gov (United States)

    Bruera, Eduardo; Palmer, J Lynn; Pace, Ellen; Zhang, Karen; Willey, Jie; Strasser, Florian; Bennett, Michael I

    2007-09-01

    Medical training teaches physicians to sit when breaking bad news, though there have been no controlled studies to support this advice. We aimed to establish cancer patients' preference for physician posture when physicians break bad news using a randomized controlled crossover trial in a department of palliative care at a large US cancer center. Referred patients were blind to the hypothesis and watched video sequences of a sitting or standing physician breaking bad news to a cancer patient and 168 of 173 participants (88 female) completed the study. Sitting physicians were preferred and viewed as significantly more compassionate than standing physicians (P importance than posture. In summary, cancer patients, especially females, prefer physicians to sit when breaking bad news and rate physicians who adopt this posture as more compassionate. However, sitting posture alone is unlikely to compensate for poor communication skills and lack of other respectful gestures during a consultation.

  7. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

    Science.gov (United States)

    Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

    2015-09-15

    The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. © 2015 American Cancer Society.

  8. The Effects of Inhalation Aromatherapy on Anxiety in Patients With Myocardial Infarction: A Randomized Clinical Trial

    Science.gov (United States)

    Najafi, Zahra; Taghadosi, Mohsen; Sharifi, Khadijeh; Farrokhian, Alireza; Tagharrobi, Zahra

    2014-01-01

    Background: Anxiety is an important mental health problem in patients with cardiac disease. Anxiety reduces patients’ quality of life and increases the risk of different cardiac complications. Objectives: The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infarction. Patients and Methods: This was a randomized clinical trial conduced on 68 patients with myocardial infarction hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in 2013. By using the block randomization technique, patients were randomly assigned to experimental (33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days) and control (35 patients receiving routine care of study setting including no aromatherapy) groups. At the beginning of study and twenty minutes after each aromatherapy session, anxiety state of patients was assessed using the Spielberger’s State Anxiety Inventory. Data was analyzed using SPSS v. 16.0. We used Chi-square, Fisher’s exact, independent-samples T-test and repeated measures analysis of variance to analyze the study data. Results: The study groups did not differ significantly regarding baseline anxiety mean and demographic characteristics. However, after the administration of aromatherapy, anxiety mean in the experimental group was significantly lower than the control group. Conclusions: Inhalation aromatherapy with lavender aroma can reduce anxiety in patients with myocardial infarction. Consequently, healthcare providers, particularly nurses, can use this strategy to improve postmyocardial infarction anxiety management. PMID:25389481

  9. Depression screening with patient-targeted feedback in cardiology: DEPSCREEN-INFO randomised clinical trial.

    Science.gov (United States)

    Löwe, Bernd; Blankenberg, Stefan; Wegscheider, Karl; König, Hans-Helmut; Walter, Dirk; Murray, Alexandra M; Gierk, Benjamin; Kohlmann, Sebastian

    2017-02-01

    International guidelines advocate depression screening in patients with coronary heart disease (CHD) and other chronic illnesses, but evidence is lacking. To test the differential efficacy of written patient-targeted feedback v. no written patient feedback after depression screening. Patients with CHD or hypertension from three cardiology settings were randomised and screened for depression (ClinicalTrials.gov Identifier: NCT01879111). Compared with the control group, where only cardiologists received written feedback, in the intervention group both cardiologists and patients received written feedback regarding depression status. Depression severity was measured 1 month (primary outcome) and 6 months after screening. The control group (n = 220) and the patient-feedback group (n = 155) did not differ in depression severity 1 month after screening. Six months after screening, the patient-feedback group showed significantly greater improvements in depression severity and was twice as likely to seek information about depression compared with the control group. Patient-targeted feedback in addition to screening has a significant but small effect on depression severity after 6 months and may encourage patients to take an active role in the self-management of depression. © The Royal College of Psychiatrists 2017.

  10. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial.

    Science.gov (United States)

    Teri, Linda; Gibbons, Laura E; McCurry, Susan M; Logsdon, Rebecca G; Buchner, David M; Barlow, William E; Kukull, Walter A; LaCroix, Andrea Z; McCormick, Wayne; Larson, Eric B

    2003-10-15

    Exercise training for patients with Alzheimer disease combined with teaching caregivers how to manage behavioral problems may help decrease the frailty and behavioral impairment that are often prevalent in patients with Alzheimer disease. To determine whether a home-based exercise program combined with caregiver training in behavioral management techniques would reduce functional dependence and delay institutionalization among patients with Alzheimer disease. Randomized controlled trial of 153 community-dwelling patients meeting National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for Alzheimer disease, conducted between June 1994 and April 1999. Patient-caregiver dyads were randomly assigned to the combined exercise and caregiver training program, Reducing Disability in Alzheimer Disease (RDAD), or to routine medical care (RMC). The RDAD program was conducted in the patients' home over 3 months. Physical health and function (36-item Short-Form Health Survey's [SF-36] physical functioning and physical role functioning subscales and Sickness Impact Profile's Mobility subscale), and affective status (Hamilton Depression Rating Scale and Cornell Depression Scale for Depression in Dementia). At 3 months, in comparison with the routine care patients, more patients in the RDAD group exercised at least 60 min/wk (odds ratio [OR], 2.82; 95% confidence interval [CI], 1.25-6.39; P =.01) and had fewer days of restricted activity (OR, 3.10; 95% CI, 1.08-8.95; PExercise training combined with teaching caregivers behavioral management techniques improved physical health and depression in patients with Alzheimer disease.

  11. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial.

    Science.gov (United States)

    Sturkenboom, Ingrid H W M; Graff, Maud J L; Hendriks, Jan C M; Veenhuizen, Yvonne; Munneke, Marten; Bloem, Bastiaan R; Nijhuis-van der Sanden, Maria W

    2014-06-01

    There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson's disease. We did a multicentre, assessor-masked, randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals (ParkinsonNet), with assessment at 3 months and 6 months. Patients with Parkinson's disease with self-reported difficulties in daily activities were included, along with their primary caregivers. Patients were randomly assigned (2:1) to the intervention or control group by a computer-generated minimisation algorithm. The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines; control individuals received usual care with no occupational therapy. The primary outcome was self-perceived performance in daily activities at 3 months, assessed with the Canadian Occupational Performance Measure (score 1-10). Data were analysed using linear mixed models for repeated measures (intention-to-treat principle). Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months. This trial is registered with ClinicalTrials.gov, NCT01336127. Between April 14, 2011, and Nov 2, 2012, 191 patients were randomly assigned to the intervention group (n=124) or the control group (n=67). 117 (94%) of 124 patients in the intervention group and 63 (94%) of 67 in the control group had a participating caregiver. At baseline, the median score on the Canadian Occupational Performance Measure was 4·3 (IQR 3·5-5·0) in the intervention group and 4·4 (3·8-5·0) in the control group. At 3 months, these scores were 5·8 (5·0-6·4) and 4·6 (4·6-6·6), respectively. The adjusted mean difference in score between groups at 3 months was in favour of the intervention group (1·2; 95% CI 0·8-1·6

  12. Quality assessment of delineation and dose planning of early breast cancer patients included in the randomized Skagen Trial 1

    DEFF Research Database (Denmark)

    Francolini, Giulio; Thomsen, Mette S; Yates, Esben S

    2017-01-01

    BACKGROUND AND PURPOSE: To report on a Quality assessment (QA) of Skagen Trial 1, exploring hypofractionation for breast cancer patients with indication for regional nodal radiotherapy. MATERIAL AND METHODS: Deviations from protocol regarding target volume delineations and dose parameters (Dmin...

  13. [Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial

    NARCIS (Netherlands)

    Kruis, A.L.; Boland, M.R.; Assendelft, W.J.J.; Gussekloo, J.; Tsiachristas, A.; Stijnen, T.; Blom, C.; Sont, J.K.; Rutten-van Molken, M.P.; Chavannes, N.H.

    2015-01-01

    OBJECTIVE: To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. DESIGN: 24 month, multicentre, pragmatic cluster randomised controlled trial,

  14. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial

    NARCIS (Netherlands)

    Kruis, A.L.; Boland, M.R.; Assendelft, W.J.J.; Gussekloo, J.; Tsiachristas, A.; Stijnen, T.; Blom, C.; Sont, J.K.; Rutten-van Molken, M.P.; Chavannes, N.H.

    2014-01-01

    OBJECTIVE: To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. DESIGN: 24 month, multicentre, pragmatic cluster randomised controlled trial

  15. Chronic obstructive pulmonary disease in patients with atrial fibrillation: Insights from the ARISTOTLE trial.

    Science.gov (United States)

    Durheim, Michael T; Cyr, Derek D; Lopes, Renato D; Thomas, Laine E; Tsuang, Wayne M; Gersh, Bernard J; Held, Claes; Wallentin, Lars; Granger, Christopher B; Palmer, Scott M; Al-Khatib, Sana M

    2016-01-01

    Comorbid chronic obstructive pulmonary disease (COPD) is associated with poor outcomes among patients with cardiovascular disease. The risks of stroke and mortality associated with COPD among patients with atrial fibrillation are not well understood. We analyzed patients from ARISTOTLE, a randomized trial of 18,201 patients with atrial fibrillation comparing the effects of apixaban versus warfarin on the risk of stroke or systemic embolism. Using Cox proportional hazards models, we assessed the associations between comorbid COPD and risk of stroke or systemic embolism and of mortality, adjusting for treatment allocation, smoking history and other risk factors. COPD was present in 1950 (10.8%) of 18,134 patients with data on pulmonary disease history. After multivariable adjustment, COPD was not associated with risk of stroke or systemic embolism (adjusted HR 0.85 [95% CI 0.60, 1.21], p=0.356). However, COPD was associated with a higher risk of all-cause mortality (adjusted HR 1.60 [95% CI 1.36, 1.88], p<0.001) and both cardiovascular and non-cardiovascular mortality. The benefit of apixaban over warfarin on stroke or systemic embolism was consistent among patients with and without COPD (HR 0.92 [95% CI 0.52, 1.63] versus 0.78 [95% CI 0.65, 0.95], interaction p=0.617). COPD was independently associated with increased risk of cardiovascular and non-cardiovascular mortality among patients with atrial fibrillation, but was not associated with risk of stroke or systemic embolism. The effect of apixaban on stroke or systemic embolism in COPD patients was consistent with its effect in the overall trial population. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), an