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The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection toolsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting. Methods: This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol impl...
Source: Trials - November 20, 2009 Category: Journals (General) Authors: Laurie MorrisonSandro RizoliBrian SchwartzShawn RindMerita SimitciuTyrone PerreiraRussell MacDonaldAnna TrompeoDonald StussSandra BlackAlex KissAndrew Baker Source Type: journals

Cost-effectiveness of postural exercise therapy versus physiotherapy in computer screen-workers with early non-specific work-related upper limb disorders (WRULD); a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Although our trial failed to find significant differences in VAS, QALYs and ICERs based on VAS and QALYs at one-year follow-up, CEACs suggest that postural exercise therapy according to Mensendieck / Cesar has a higher probability of being cost-effective compared to regular physiotherapy; however further research is required.Trial registration: ISRCTN 15872455 (Source: Trials)
Source: Trials - November 17, 2009 Category: Journals (General) Authors: Marjon van Eijsden-BesselingSylvia GerhardsRob de BieJohan Severens Source Type: journals

Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant womenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Preeclampsia (PE) is a common maternal disease that complicates 5 to 10% of pregnancies and remains as the major cause of maternal and neonatal mortality. Cost-effective interventions aimed at preventing the development of preeclampsia are urgently needed. However, the pathogenesis of PE is not well known. Multiple mechanisms such as oxidative stress, endothelial dysfunction and insulin resistance may contribute to its development. Regular aerobic exercise recovers endothelial function; improves insulin resistance and decreases oxidative stress. Therefore the purpose of this clinical trial is to determine the e...
Source: Trials - November 17, 2009 Category: Journals (General) Authors: Robinson Ramirez-VelezAna AguilarMildrey MosqueraRonald GarciaLaura ReyesPatricio Lopez-Jaramillo Source Type: journals

Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trialsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods: We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by hig...
Source: Trials - November 9, 2009 Category: Journals (General) Authors: Xin SunMatthias BrielJason BusseElie AklJohn YouFilip MejzaMalgorzata BalaNatalia Diaz-GranadosDirk BasslerDominik MertzSadeesh SrinathanPer Olav VandvikGerman MalagaMohamed AlshurafaPhilipp DahmPablo Alonso-CoelloDiane Heels-AnsdellNeera BhatnagarBradley Source Type: journals

The impact of networks on clinical trials in the United KingdomEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The conduct of clinical trials in the UK has been affected by the recent introduction of managed clinical networks, clinical research networks and rigorous governance regulations. This commentary considers the challenges that these changes have posed for clinical triallists in the UK, based on experiences derived in the conduct of a multicentre neonatal clinical trial under the conditions that now prevail. We conclude that the considerable skills and knowledge that are now required to be an effective Principal Investigator should be recognised and that application processes, including issuing honorary contracts, should be ...
Source: Trials - November 4, 2009 Category: Journals (General) Authors: Sze May NgAlan Michael Weindling Source Type: journals

The impact of networks on clinical trials in the United KingdomomEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The conduct of clinical trials in the UK has been affected by the recent introduction of managed clinical networks, clinical research networks and rigorous governance regulations. This commentary considers the challenges that these changes have posed for clinical triallists in the UK, based on experiences derived in the conduct of a multicentre neonatal clinical trial under the conditions that now prevail. We conclude that the considerable skills and knowledge that are now required to be an effective Principal Investigator should be recognised and that application processes, including issuing honorary contracts, should be ...
Source: Trials - November 4, 2009 Category: Journals (General) Authors: Sze May NgAlan Michael Weindling Source Type: journals

Efficacies of the new Paclitaxel-eluting Coroflex PleaseTM Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex PleaseTM and TaxusTM (ECO-PLEASANT) trial: study rationale and designEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex PleaseTM versus Taxus LiberteTM stent. On the basis of this trial, we will be able to find out whether the Coroflex PleaseTM stent is non-inferior to Taxus LiberteTM stent or not.Trial registration: ClinicalTrials.gov number, NCT00699543. (Source: Trials)
Source: Trials - October 22, 2009 Category: Journals (General) Authors: Jae-Bin SeoHee-Kyung ChunKyung-Woo ParkJong-Sun ParkJang-Ho BaeSang-Ook KimKeon-Woong MoonJae-Woong ChoiSang-Gon LeeWoo-Young ChungTae-Jin YounSoo-Joong KimDoo-Il KimByung-Ok KimMin-Soo HyunKeum-Soo ParkTae-Joon ChaHweung-Kon HwangSeung-Ho HurHyo-Soo Kim Source Type: journals

Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: Results of this trial will help clarify the value of two types of massage therapy for chronic low back pain.Trial registration: Clinical Trials.gov NCT 00371384. (Source: Trials)
Source: Trials - October 19, 2009 Category: Journals (General) Authors: Daniel CherkinKaren ShermanJanet KahnJanet ErroRichard DeyoSebastien HaneuseAndrea Cook Source Type: journals

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe. (Source: Trials)
Source: Trials - October 15, 2009 Category: Journals (General) Authors: Christine KubiakFernando de Andres-TrellesWolfgang KuchinkeKarl-Heinz HuemerSteffen ThirstrupKate WhitfieldChristian LibersaBeatrice BarraudXina GrahlertGabriele DreierRuth GrychtolZsuzsa TemesvariGyorgy BlaskoGabriella KardosTimothy O'BrienMargaret Coone Source Type: journals

IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisciplinary settingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThis is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy.Trial registration: ClinicalTrials NCT00732979 (Source: Trials)
Source: Trials - October 12, 2009 Category: Journals (General) Authors: Nuh RahbariJohannes ZimmermannMoritz KochThomas BrucknerThomas SchmidtHeike ElbersChristoph ReissfelderMarkus WeigandMarkus BuchlerJurgen Weitz Source Type: journals

IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisclipinary settingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThis is a randomised controlled patient and observer blinded two-group parallel trial designed to assess efficacy and safety of infrahepatic IVC clamping during elective hepatectomy.Trial registration: ClinicalTrials NCT00732979 (Source: Trials)
Source: Trials - October 12, 2009 Category: Journals (General) Authors: Nuh RahbariJohannes ZimmermannMoritz KochThomas BrucknerThomas SchmidtHeike ElbersChristoph ReissfelderMarkus WeigandMarkus BuchlerJurgen Weitz Source Type: journals

A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings of arterial bypass anastomoses.Trial registrationNCT00837954 (Source: Trials)
Source: Trials - September 28, 2009 Category: Journals (General) Authors: Petra BaumannHardy SchumacherJohannes HusingSteffen LuntzHanns-Peter Knaebel Source Type: journals

Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspirationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study has been designed to investigate whether intracoronary bolus administration of abciximab is more effective than intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration. Methods: The Comparison of IntraCoronary versus intravenous abciximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction (CICERO) trial is a single-center, prospective, randomized open-label trial with blinded evaluation of endpoints. A total of 530 patients wi...
Source: Trials - September 27, 2009 Category: Journals (General) Authors: Youlan GuMarieke FokkemaMarthe KampingaBart de SmetEng TanAd van den HeuvelFelix Zijlstra Source Type: journals

The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal techniqueEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain.MethodSThe TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia r...
Source: Trials - September 24, 2009 Category: Journals (General) Authors: Giel KoningHans de SchipperHenk OostvogelMichiel VerhofstadPieter GerritsenKees van LaarhovenPatrick Vriens Source Type: journals

The Irish DAFNE Study Protocol: A cluster randomised trial of group versus individual follow-up after structured education for Type 1 diabetesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThis pragmatic clinical trial evaluating group follow-up after a structured education programme has been designed to have broad generalisability. The results should inform how best to manage the well educated patient with Type 1 diabetes in the real world of clinical practiceTrial registration: Current Controlled Trials ISRCTN79759174 (Source: Trials)
Source: Trials - September 22, 2009 Category: Journals (General) Authors: Sean DinneenMary Clare O' HaraMolly ByrneJohn NewellLisa DalyDonal O' SheaDiarmuid SmithIrish DAFNE Study Group Source Type: journals

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocolEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting.Trial Registration Number: NCT00830622 (Source: Trials)
Source: Trials - September 21, 2009 Category: Journals (General) Authors: Richard LesterEdward MillsAntony KaririPaul RitvoMichael ChungWilliam JackJames HabyarimanaSarah KaranjaSamson BarasaRosemary NgutiBenson EstambaleElizabeth NgugiT Blake BallLehana ThabaneJoshua KimaniLawrence GelmonMarta AckersFrancis Plummer Source Type: journals

QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and MaliEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. Methods: This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health per...
Source: Trials - September 17, 2009 Category: Journals (General) Authors: Alexandre DumontPierre FournierWilliam FraserSlim HaddadMamadou TraoreIdrissa DiopMouhamadou GueyeAlioune GayeFrancois CouturierJean-Charles PasquierFrancois BeaudoinAndre LalondeMarie HatemMichal Abrahamowicz Source Type: journals

Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionIn contrast to former trials on information programs on the ICU-stay our intervention will take place in the ICU itself. This approach will ensure to compensate for memory effects due to anesthesia or preoperative stress. Further the results will be applicable to non-elective ICU-patients.Trial RegistrationClinicalTrials NCT00764933 (Source: Trials)
Source: Trials - September 13, 2009 Category: Journals (General) Authors: Steffen FleischerAlmuth BergThomas NeubertMichael KollerJohann BehrensRalf BeckerAnnegret HorbachJoachim RadkeMatthias RothmundOliver Kuss Source Type: journals

REFINE (Reducing Falls in In-Patient Elderly) - a randomised controlled trial.Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff.ISRCTN trial number : ISRCTN44972300. (Source: Trials)
Source: Trials - September 9, 2009 Category: Journals (General) Authors: Catherine VassOpinder SahotaAvril DrummondDenise KendrickJohn GladmanTracey SachMark AvisMatthew Grainge Source Type: journals

Cost-minimization analysis in a blind randomized trial on small-incision versus laparoscopic cholecystectomy from a societal perspective: sick leave outweighs efforts in hospital savingsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Based on differences in costs, small-incision cholecystectomy seems to be the preferred operative technique over the laparoscopic technique both from a hospital and societal cost perspective. Sick leave associated with convalescence after cholecystectomy in employed patients results in considerable costs to society.Trial registration ISRCTN Register, number ISRCTN67485658. (Source: Trials)
Source: Trials - September 3, 2009 Category: Journals (General) Authors: Frederik KeusTrudy de JongeHein GooszenErik BuskensCornelis van Laarhoven Source Type: journals

Performance-based readability testing of participant information for a Phase 3 IVF trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: The original participant information sheet may not have enabled patients fully to give valid consent. Participants seeing the revised sheet were better able to understand the trial. Those who write information for trial participants should take account of good practice in information design. Performance-based User Testing may be a useful method to indicate strengths and weaknesses in trial information. (Source: Trials)
Source: Trials - August 31, 2009 Category: Journals (General) Authors: Peter KnappD k RaynorJonathan SilcockBrian Parkinson Source Type: journals

Psychoeducation versus treatment as usual in diabetic patients with subthreshold depression: preliminary results of a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: Psycho-educational treatment appears to be beneficial in diabetic patients with mild to moderate depressive symptoms, but its effects are comparable with the non-specific support given to the subjects in the control group.Trial registration: Current Controlled Trials ISRCTN58745372 (Source: Trials)
Source: Trials - August 25, 2009 Category: Journals (General) Authors: Mirjana Pibernik-OkanovicDrazen BegicDea AjdukovicNatasa AndrijasevicZeljko Metelko Source Type: journals

The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 - with specific consideration on ethics: a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study will hopefully assist in contributing to the question of the efficacy of the timing of surgery in traumatic thoracolumbar SCI.RCT registration number: ISRCTN61263382 (Source: Trials)
Source: Trials - August 23, 2009 Category: Journals (General) Authors: Vafa Rahimi-MovagharSoheil SaadatAlexander VaccaroSeyed Mohammad GhodsiMohammad SamadianArya SheykhmozaffariSeyed Mohammad SafdariBahram Keshmirian Source Type: journals

Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy.Trial registration number: Clinical Trials.gov Identifier: NCT00599677. (Source: Trials)
Source: Trials - August 22, 2009 Category: Journals (General) Authors: Hui ZhengXiao-ping TianYing LiFan-rong LiangShu-guang YuXu-guang LiuYong TangXu-guang YangJie YanGuo-jie SunXiao-rong ChangHong-xing ZhangTing-ting MaShu-yuan Yu Source Type: journals

Barriers encountered during enrollment in an internet-mediated randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.Trial Registration: ClinicalTrials.gov NCT00729040 (Source: Trials)
Source: Trials - August 22, 2009 Category: Journals (General) Authors: Lorraine BuisAdrienne JanneyMichael HessSilas CulverCaroline Richardson Source Type: journals

Efficacy and safety of bilateral continuous theta burst stimulation (cTBS) for the treatment of chronic tinnitus: design of a three-armed randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Tinnitus, the perception of sound and noise in absence of an auditory stimulus, has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex. Transient modulation of tinnitus by repetitive transcranial magnetic stimulation (rTMS) indicated that this area is critically involved in the pathophysiology of tinnitus and suggested new treatment strategies. However, the therapeutic efficacy of rTMS in tinnitus is still unclear, individual response is variable, and the optimal stimulation area disputable. Recently, continuous Theta burst stimulation (cTBS...
Source: Trials - August 20, 2009 Category: Journals (General) Authors: Carola ArfellerReinhard VontheinStefan PlontkeChristian Plewnia Source Type: journals

A phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoningEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: Our findings suggest use of moderate doses of clonidine in acute organophosphate poisoning can be used without causing frequent clinical problems but that higher doses are associated with a high incidence of hypotension requiring intervention. Further studies are needed to study the efficacy of clonidine as an antidote in organophosphate poisoning.Trial registration: Current Controlled Trial ISRCTN89917816. (Source: Trials)
Source: Trials - August 19, 2009 Category: Journals (General) Authors: Polwattage PereraShaluka JayamannaRaja HettiarachchiChandana AbeysingheHarindra KarunatilakeAndrew DawsonNick Buckley Source Type: journals

Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patientsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study will help to answer the question whether the "early total care" or the damage control" concept is associated with better outcome.Trial registration: Current Controlled Trials ISRCTN10321620 (Source: Trials)
Source: Trials - August 18, 2009 Category: Journals (General) Authors: Dieter RixenEva SteinhausenStefan SauerlandRolf LeferingMatthias MeierMarc MaegeleBertil BouillonEdmund Neugebauer Source Type: journals

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorisation for a pharmacotherapy.Design/MethodsWe will conduct a non-inferiority randomised trial of rapid reduction versus standard abrupt cessation among smokers who want to stop smoking. In the r...
Source: Trials - August 13, 2009 Category: Journals (General) Authors: Nicola LindsonPaul AveyardJackie IngramJennie InglisJane BeachRobert WestSusan Michie Source Type: journals

Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome indexEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments.Trial Registration: Current Controlled Trials ISRCTN52023186 (Source: Trials)
Source: Trials - August 13, 2009 Category: Journals (General) Authors: Emilio Perea-MillaLuis Carlos Silva AycaguerJoan Carles March CerdaFrancisco Gonzalez SaizFrancisco Rivas-RuizAlina DanetManuel Romero VallecilloEugenia Oviedo-Joekes Source Type: journals

Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach') with standard care ('clinic only') to improve access to and success of National Health Service smoking cessation services. Methods: This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in w...
Source: Trials - August 13, 2009 Category: Journals (General) Authors: Rachna BeghPaul AveyardPenney UptonRaj BhopalMartin WhiteAmanda AmosRobin PrescottRaman BediPelham BartonMonica FletcherParamjit GillQaim ZaidiAziz Sheikh Source Type: journals

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care.Trial registration number: ISRCTN08601529. (Source: Trials)
Source: Trials - August 12, 2009 Category: Journals (General) Authors: Frank Peters-KlimmStephen CampbellThomas Muller-TaschDieter SchellbergGotz GelbrichWolfgang HerzogJoachim Szecsenyi Source Type: journals

Exercise therapy, quality of life, and activities of daily living in patients with Parkinson disease: a small scale quasi-randomised trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: The findings from this small scale quasi-randomised trial showed that exercise therapy was effective in improving activities of daily living and perceived health status in patients with Parkinson's disease. Indeed, exercise therapy could be offered to patients with Parkinson disease, considering that it is low in cost and usually has no negative side effects.Trial registration: Current Controlled Trials ISRCTN98825027 (Source: Trials)
Source: Trials - August 10, 2009 Category: Journals (General) Authors: Bahram YousefiVahid TadibiAli Fathollahzadeh KhoeiAli Montazeri Source Type: journals

Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies.Trial registrationCurrent Controlled Trials ISRCTN15334496 (Source: Trials)
Source: Trials - August 1, 2009 Category: Journals (General) Authors: Jean-Noel VergnesElise ArrivePierre GourdyHelene HanaireVincent RigalleauHenri GinCyril SedaratGeorges DorignacChristophe BouMichel SixouCathy Nabet Source Type: journals

Evaluation of an online Diabetes Needs Assessment Tool (DNAT) for health professionals: a randomised controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for t...
Source: Trials - July 29, 2009 Category: Journals (General) Authors: Sara SchroterDean JenkinsRebecca PlayleKieran WalshCourtenay ProbertThomas KellnerGerhard ArnhoferDavid Owens Source Type: journals

Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocolEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionOur Cochrane review (2005) on reminiscence therapy for people with dementia did not identify any rigorous trials or economic analyses in this field.Trial Registration: ISRCTN42430123 (Source: Trials)
Source: Trials - July 29, 2009 Category: Journals (General) Authors: Robert WoodsErrollyn BruceRhiannon EdwardsBarry HounsomeJohn KeadyEsme Moniz-CookMartin OrrellIan Russell Source Type: journals

Clinical evaluation of magnetic resonance imaging in coronary heart disease: The CE-MARC studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThe CE-MARC study is a prospective, diagnostic accuracy cohort study of 750 patients assessing the performance of a multi-parametric CMR study in detecting CHD using invasive X-ray coronary angiography as the reference standard and comparing it with ETT and SPECT.Trial Registration: Current Controlled Trials ISRCTN77246133 (Source: Trials)
Source: Trials - July 28, 2009 Category: Journals (General) Authors: John GreenwoodNeil MarediaAleksandra RadjenovicJulia BrownJane NixonAmanda FarrinCatherine DickinsonJohn YoungerJohn RidgwayMark SculpherStephen BallSven Plein Source Type: journals

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research studyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities -- rather than individual themselves -- are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of r...
Source: Trials - July 27, 2009 Category: Journals (General) Authors: Monica TaljaardCharles WeijerJeremy GrimshawJudith Belle BrownAriella BinikRobert BoruchJamie BrehautShazia ChaudhryMartin EcclesAndrew McRaeRaphael SaginurMerrick ZwarensteinAllan Donner Source Type: journals

RADAR - A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosisEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Prospective, international, multi-centre, randomised (1:1) trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated glomerular filtration rate (eGFR) in patients with haemodynamically significant atherosclerotic renal artery stenosis. Methods: Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis...
Source: Trials - July 26, 2009 Category: Journals (General) Authors: Uwe SchwarzwalderMichael HaukThomas Zeller Source Type: journals

Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support. Methods: In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2)...
Source: Trials - July 26, 2009 Category: Journals (General) Authors: Tara DonkerAnnemieke van StratenHeleen RiperIsaac MarksGerhard AnderssonPim Cuijpers Source Type: journals

Perioperative management in distal pancreatectomy: results of a survey in 23 European participating centres of the DISPACT trial and a review of literatureEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusion: Most perioperative standards within the centres participating in the DISPACT trial are in accordance with current available evidence. The need for drainages requires further investigation.Clinical trial registration: ISRCTN 18452029 (Source: Trials)
Source: Trials - July 25, 2009 Category: Journals (General) Authors: Helge BrunsNuh RahbariThorsten LofflerMarkus DienerChristoph SeilerMatthias GlanemannGiovanni ButturiniChristoph SchuhmacherInga RossionMarkus BuchlerTido JunghansDispact Trial Group Source Type: journals

DOMINO-AD protocol: donepezil and memantine in moderate to severe Alzheimer's disease - a multicentre RCTEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
DiscussionThere is considerable debate about the clinical and cost effectiveness of anti-dementia drugs. DOMINO-AD seeks to provide clear evidence on the best treatment strategies for those managing patients at a particularly important clinical transition point.Trial registrationCurrent controlled trials ISRCTN49545035 (Source: Trials)
Source: Trials - July 23, 2009 Category: Journals (General) Authors: Rob JonesBart SheehanPatrick PhillipsEd JuszczakJessica AdamsAshley BaldwinClive BallardSube BanerjeeBob BarberPeter BenthamRichard BrownAlistair BurnsTom DeningDavid FindlayRichard GrayMary GriffinClive HolmesAlan HughesRobin JacobyTony JohnsonRoy JonesM Source Type: journals

Compliance of clinical trial registries with the World Health Organization minimum data set: a surveyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications. (Source: Trials)
Source: Trials - July 21, 2009 Category: Journals (General) Authors: Lorenzo MojaIvan MoschettiMunira NurbhaiAnna CompagnoniAlessandro LiberatiJeremy GrimshawAn-Wen ChanKay DickersinKarmela Krleza-JericDavid MoherIda SimJimmy Volmink Source Type: journals

Can you believe what you read in the papers?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The number of reports of clinical trials grows by hundreds every week. However, this does not mean that people making decisions about health care are finding it easier to obtain reliable knowledge for these decisions. Some of the information is unreliable. Systematic reviews are helping to resolve this by bringing together the research on a topic, appraising and summarising it. But the quality of these reviews depends greatly on the quality of the studies, and this usually means the quality of their reports. If there are fundamental flaws within a study, such as the use of inappropriate 'randomisation' techniques in the co...
Source: Trials - July 15, 2009 Category: Journals (General) Authors: Mike Clarke Source Type: journals

Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocolEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recordi...
Source: Trials - July 13, 2009 Category: Journals (General) Authors: Jong-In KimMyeong-Soo LeeSo-Young JungJun-Yong ChoiSanghoon LeeJeong-Min KoHong ZhaoJiping ZhaoAe-Ran KimMi-Suk ShinKyung-Won KangHee-Jung JungTae-Hun KimBaoyan LiuSun-Mi Choi Source Type: journals

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxificationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This study seeks to address this paucity by evaluating the most routinely used interventions amongst drug users within UK prisons.Methods / DesignThis study uses randomised controlled trial methodology to compare the open use of buprenorphine and methadone for opiate detoxification, given in the context of routine care, within three UK prisons. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome will be abstinence status eight days after detoxification, as determined by a urine test. Secondary outcomes will be recorded during the detoxification and then at one, three and...
Source: Trials - July 13, 2009 Category: Journals (General) Authors: Laura SheardNat WrightClive AdamsNicole BoundBruno RushforthRoger HartCharlotte Tompkins Source Type: journals

A review of reporting of participant recruitment and retention in RCTs in six major journalsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Conclusions: The majority of RCTs reported the flow of participants well after randomisation, although only two-thirds included a complete flow chart and there was great variability over the definition of "lost to follow up". Reporting of participant eligibility was poor, making assessments of recruitment practice and external validity difficult. Reporting of participant flow throughout RCTs could be improved by small changes to the CONSORT chart. (Source: Trials)
Source: Trials - July 9, 2009 Category: Journals (General) Authors: Merran ToerienSara BrookesChris MetcalfeIsabel de SalisZelda TomlinTim PetersJonathan SterneJenny Donovan Source Type: journals

Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Background: Fractures of the proximal humerus are common injuries and account for 4-5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2-10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions.We aim to compare th...
Source: Trials - July 7, 2009 Category: Journals (General) Authors: Stig BrorsonBo Sanderhoff OlsenLars Henrik FrichSteen Lund JensenHans Viggo JohannsenAnne Kathrine SorensenAsbjorn Hrobjartsson Source Type: journals