References
- LaineCDavidoffFPatient-centered medicine. A professional evolutionJAMA19962751521568531314
- LipkinMShared decision makingJAMA Intern Med20131731204120523712307
- PorterMEWhat is value in health care?N Engl J Med20103632477248121142528
- TinettiMEBaschEPatients’ responsibility to participate in decision making and researchJAMA20133092331233223700165
- LloydKWhiteJDemocratizing clinical researchNature201147427727821677725
- ThorntonSBeyond rhetoric: we need a strategy for patient involvement in the health serviceBMJ2014348g407224957899
- DomecqJPPrutskyGElraiyahTPatient engagement in research: a systematic reviewBMC Health Serv Res2014148924568690
- Caron-FlintermanJFBroerseJEBundersJFThe experiential knowledge of patients: a new resource for biomedical research?Soc Sci Med2005602575258415814182
- HanleyBTruesdaleAKingAElbourneDChalmersIInvolving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire surveyBMJ200132251952311230065
- van der ScheerLGarciaEvan der LaanALvan der BurgSBoeninkMThe benefits of patient involvement for translational researchHealth Care Anal Epub20141224
- JenksSThe public applauds cancer research but not how research priorities are setJ Natl Cancer Inst1997893503519082045
- ElwynGCroweSFentonMIdentifying and prioritizing uncertainties: patient and clinician engagement in the identification of research questionsJ Eval Clin Pract20101662763120482747
- FleurenceRLForsytheLPLauerMEngaging patients and stakeholders in research proposal review: the patient-centered outcomes research instituteAnn Intern Med201416112213025023251
- ChalmersIAtkinsonPFentonMFirkinsLCroweSCowanKTackling treatment uncertainties together: the evolution of the James Lind Initiative, 2003–2013J R Soc Med201310648249123824330
- Petit-ZemanSFirkinsLScaddingJWThe James Lind Alliance: tackling research mismatchesLancet201037666766920801389
- ChalmersIGlasziouPAvoidable waste in the production and reporting of research evidenceLancet2009374868919525005
- VayenaEThe next step in the patient revolution: patients initiating and leading researchBMJ2014349g431824986856
- KayeJCurrenLAndersonNFrom patients to partners: participant-centric initiatives in biomedical researchNat Rev Genet20121337137622473380
- SwanMCrowdsourced health research studies: an important emerging complement to clinical trials in the public health research ecosystemJ Med Internet Res2012142e4622397809
- SoxHCGreenfieldSComparative effectiveness research: a report from the Institute of MedicineAnn Intern Med200915120320519567618
- BarrPJElwynGMeasurement challenges in shared decision making: putting the ‘patient’ in patient-reported measuresHealth Expect Epub2015625
- MullinsCDVandigoJZhengZWicksPPatient-centeredness in the design of clinical trialsValue Health20141747147524969009
- MuradMHShahNDVan HoutenHKIndividuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferencesJ Clin Epidemiol20116474374821109401
- BaschEToward patient-centered drug development in oncologyN Engl J Med201336939740023822654
- LindenmeyerAHearnshawHSturtJOrmerodRAitchisonGAssessment of the benefits of user involvement in health research from the Warwick Diabetes Care Research User Group: a qualitative case studyHealth Expect20071026827717678515
- AliKRoffeCCromePWhat patients want: consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute strokeStroke20063786587116456122
- de WitMAbmaTKoelewijn-van LoonMCollinsSKirwanJInvolving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferencesBMJ Open201335e002241
- U.S. Department of Health and Human Services Food and Drug AdministrationGuidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling ClaimsSilver Spring, MDU.S. Department of Health and Human Services Food and Drug Administration2009
- DinanMAComptonKLDhillonJKUse of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trialsMed Care20114941541921368680
- GandhiGYMuradMHFujiyoshiAPatient-important outcomes in registered diabetes trialsJAMA20082992543254918523223
- RahimiKMalhotraABanningAPJenkinsonCOutcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic reviewBMJ2010341c570721041324
- GnanasakthyAMordinMClarkMDeMuroCFehnelSCopley-MerrimanCA review of patient-reported outcome labels in the United States: 2006 to 2010Value Health20121543744222583453
- WillkeRJBurkeLBEricksonPMeasuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labelsControl Clin Trials20042553555215588741
- CoonsSJKothariSMonzBUBurkeLBThe patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claimsClin Pharmacol Ther20119074374821993428
- GarrattAPatient reported outcome measures in trialsBMJ2009338a259719139137
- VietaABadiaXSacristanJAA systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitusClin Ther2011331225124521856000
- VietaABadiaXÁlvarezESacristánJAWhich nontraditional outcomes should be measured in healthcare decision-making in schizophrenia? A systematic reviewPerspect Psychiatr Care20124819820723005587
- WolpertMFordTTrustamEPatient-reported outcomes in child and adolescent mental health services (CAMHS): use of idiographic and standardized measuresJ Ment Health20122116517322559827
- McCartneyMHow do we know whether medical apps work?BMJ2013346f181123516158
- KamerowDRegulating medical apps: which ones and how much?BMJ2013347f600924103694
- HarrisJScientific research is a moral dutyJ Med Ethics20053124224815800367
- The Patient Access to Cancer Care Excellence (PACE) [homepage on the Internet] Available from: https://pacenetwork.com/Accessed September 28, 2015
- GiffordALCunninghamWEHeslinKCHIV Cost and Services Utilization Study ConsortiumParticipation in research and access to experimental treatments by HIV-infected patientsN Engl J Med20023461373138211986412
- UngerJMHershmanDLAlbainKSPatient income level and cancer clinical trial participationJ Clin Oncol20133153654223295802
- GelijnsACGabrielSELooking beyond translation – integrating clinical research with medical practiceN Engl J Med20123661659166122551126
- SacristanJAClinical research and medical care: towards effective and complete integrationBMC Med Res Methodol201515425575454
- SacristánJASotoJGalendeIHylanTRRandomized database studies: a new method to assess drugs’ effectiveness?J Clin Epidemiol1998517137159731918
- LauerMSD’AgostinoRBSrThe randomized registry trial – the next disruptive technology in clinical research?N Engl J Med20133691579158123991657
- SacristanJADillaTNo big data without small data: learning health care systems begin and end with the individual patientJ Eval Clin Pract20152161014101725832820
- Paasche-OrlowMKTaylorHABrancatiFLReadability standards for informed-consent forms as compared with actual readabilityN Engl J Med200334872172612594317
- TaylorHEBramleyDEAn analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New ZealandAnaesth Intensive Care20124099599823194208
- HereuPPérezEFuentesIVidalXSuñéPArnauJMConsent in clinical trials: what do patients know?Contemp Clin Trials20103144344620462521
- TamNTHuyNTThoa leTBParticipants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysisBull World Health Organ201593186H198H25883410
- DreyfussDIs it better to consent to an RCT or to care? Muetadeltaepsilonnu alphagammaalphanu (“nothing in excess”)Intensive Care Med20053134535515605232
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
- HendersonGEChurchillLRDavisAMClinical trials and medical care: defining the therapeutic misconceptionPLoS Med20074e32418044980
- AgrawalMGradyCFaircloughDLMeropolNJMaynardKEmanuelEJPatients’ decision-making process regarding participation in phase I oncology researchJ Clin Oncol2006244479448416983117
- VistGEBryantDSomervilleLBirminghemTOxmanADOutcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participateCochrane Database Syst Rev20083MR00000918677782
- KoopsLLindleyRIThrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trialBMJ200232541512193356
- VillenNRedondoSFontRQuintanaSPerfil de los miembros no sanitarios de los comités éticos de investigación clínica y comités de ética asistencial de Cataluña [Profile of lay members of ethics committees in Catalonia (Spain)]Med Clin2012138296299 Spanish
- PletcherMJLoBGradyDInformed consent in randomized quality improvement trials: a critical barrier for learning health systemsJAMA Intern Med201417466867024615554
- BrehautJCFergussonDAKimmelmanJShojaniaKGSaginurRElwynGUsing decision aids may improve informed consent for researchContemp Clin Trials20103121822020156597
- GilliesKSkeaZCCampbellMKDecision aids for randomised controlled trials: a qualitative exploration of stakeholders’ viewsBMJ Open20144e005734
- TallonDMulliganJWilesNInvolving patients with depression in research: survey of patients’ attitudes to participationBr J Gen Pract20116113414121439170
- KostRGLeeLMYessisJCollerBSHendersonDKResearch Participant Perception Survey Focus Group SubcommitteeAssessing research participants’ perceptions of their clinical research experiencesClin Trans Sci20114403413
- KostRGLeeLMYessisJWesleyRAHendersonDKCollerBSAssessing participant-centered outcomes to improve clinical researchN Engl J Med20133692179218124304050
- WendlerDKrohmalBEmanuelEJGradyCESPRIT GroupWhy patients continue to participate in clinical researchArch Intern Med20081681294129918574086
- HolmbergCKarnerJJRappeneckerJWittCMClinical trial participants’ experiences of completing questionnaires: a qualitative studyBMJ Open20144e004363
- PartridgeAHBursteinHJGelmanRSMarcomPKWinerEPDo patients participating in clinical trials want to know study results?J Natl Cancer Inst20039549149212644548
- MacNeilSDFernandezCVAttitudes of research ethics board chairs towards disclosure of research results to participants: results of a national surveyJ Med Ethics20073354955317761827
- PartridgeAHWinerEPInforming clinical trial participants about study resultsJAMA200228836336512117402
- Dal-ReRCostaJInformación de los resultados a los participantes de los ensayos clínicos [Informing clinical trials participants about the results]Med Clin2007128375378 Spanish
- ShalowitzDIMillerFGDisclosing individual results of clinical research: implications of respect for participantsJAMA200529473774016091577
- World Medical AssociationWorld Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjectsJAMA20133102191219424141714
- DalalHWinghamJPritchardCCommunicating the results of research: how do participants of a cardiac rehabilitation RCT prefer to be informed?Health Expect20101332333019906214
- AvinsALBentSPadulaAStacconeSBaduaEGoldbergHInitial experience with a group presentation of study results to research participantsTrials200891618355417
- DorseyERBeckCAAdamsMHuntington Study Group TREND-HD InvestigatorsCommunicating clinical trial results to research participantsArch Neurol2008651590159519064746
- RichardsTMontoriVMGodleeFLapsleyPPaulDLet the patient revolution beginBMJ2013346f261423674136
- BalasEABorenSAYearbook of Medical Informatics: Managing Clinical Knowledge for Health Care ImprovementGermanySchattauer Verlagsgesellscaft mbH20006570
- CoulterALocockLZieblandSCalabreseJCollecting data on patient experience is not enough: they must be used to improve careBMJ2014348g222524671966
- ThompsonIMJrLeachRJAnkerstDPFocusing PSA testing on detection of high-risk prostate cancers by incorporating patient preferences into decision makingJAMA201431299599625090603
- RosenblattMJainSHCahillMSharing of clinical trial data: benefits, risks, and uniform principlesAnn Intern Med201516230630725622304
- RossJSKrumholzHMUshering in a new era of open science through data sharing: the wall must come downJAMA20133091355135623508736
- GoodmanSNClinical trial data sharing: what do we do now?Ann Intern Med201516230830925621467
- LoBSharing clinical trial data: maximizing benefits, minimizing riskJAMA201531379379425594500
- BoniniSEichlerHGWathionNRasiGTransparency and the European Medicines Agency – sharing of clinical trial dataN Engl J Med20143712452245525539105
- ElberseJECaron-FlintermanJFBroerseJEPatient-expert partnerships in research: how to stimulate inclusion of patient perspectivesHealth Expect20111422523921176013
- CordierJFThe expert patient: towards a novel definitionEur Respir J20144485385725271227
- ChakradharSTraining on trials: patients taught the language of drug developmentNat Med20152120921025742451
- ElberseJEPittensCAde Cock BuningTBroerseJEPatient involvement in a scientific advisory process: setting the research agenda for medical productsHealth Policy201210723124222739128