References
- CherubiniADel SignoreSOuslanderJSemlaTMichelJPFighting against age discrimination in clinical trialsJ Am Geriatr Soc20105891791179620863340
- BroekhuizenKPothofAde CraenAJMooijaartSPCharacteristics of randomized controlled trials designed for elderly: a systematic reviewPLoS One2015105e012670925978312
- Le QuintrecJLBussyCGolmardJLHervéCBaulonAPietteFRandomized controlled drug trials on very elderly subjects: descriptive and methodological analysis of trials published between 1990 and 2002 and comparison with trials on adultsJ Gerontol A Biol Sci Med Sci200560334034415860471
- van DeudekomFJPostmusIvan der HamDJExternal validity of randomized controlled trials in older adults, a systematic reviewPLoS One2017123e0174053e017405828346503
- WrobelPDehlinger-KremerMKlingmannIEthical challenges in clinical research at both ends of lifeDrug Inf J201145189105
- DienerLHugonot-DienerLAlvinoSGuidance synthesis. Medical research for and with older people in Europe: proposed ethical guidance for good clinical practice: ethical considerationsJ Nutr Health Aging201317762562723933874
- WithamMDMcMurdoMEHow to get older people included in clinical studiesDrugs Aging200724318719617362048
- ToerienMBrookesSTMetcalfeCA review of reporting of participant recruitment and retention in RCTs in six major journalsTrials200910111219128475
- DaviesLCookJPriceABeardDWhat are the methodological challenges in the design and conduct of orthopaedic randomised controlled trials comparing surgery and non-operative interventions? A systematic reviewTrials201718Suppl 1O65
- PercivalTMedical Ethics or A Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and SurgeonsManchesterS. Russell1803
- American Medical AssociationCode of Medical Ethics of the American Medical Association Originally Adopted at the Adjourned Meeting of the National Medical Convention in PhiladelphiaChicagoAmerican Medical Association Press1897 Available from: https://babel.hathitrust.org/cgi/pt?id=ien.35558005316472;view=1up;seq=3Accessed January 22, 2019
- BeauchampTLInformed consent: its history, meaning, and present challengesCamb Q Healthc Ethics201120451552321843382
- WillJFA brief historical and theoretical perspective on patient autonomy and medical decision making: part II: the autonomy modelChest201113961491149721652559
- LombardoPAPhantom tumors and hysterical women: revising our view of the Schloendorff caseJ Law Med Ethics200533479180116686248
- Anweisung an die Vorsteher Der Kliniken, Polikliniken und sonstigen Krankenanstalten über medizinische Eingriffe zu anderen ALS zu diagnostischen, Heilund Immunisierungszwecken vom 29 Dezember 1900Zentralblatt für die gesamte Unterrichtsverwaltung Preußen 1901 Available from: http://goobiweb.bbf.dipf.de/Accessed December 18, 2018
- MitscherlichAMielkeFMedizin Ohne Menschlichkeit Dokumente Des Nürnberger ÄrzteprozessesFrankfurt aMFischer Taschenb1989
- TröhlerU R-TSThe Nuremberg Code: The Proceedings in the Medical Case, the Ten Principles of Nuremberg, and the Lasting Effect of the Nuremberg CodeAldershot, UKAshgate Publishing Ltd1998
- World Medical AssociationDeclaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland61964 Available from: http//www.cirp.org/library/ethics/helsinki/Accessed January 22, 2019
- BeecherHKEthics and clinical researchN Engl J Med196627424135413605327352
- PappworthMHHuman Guinea Pigs: Experimentation on ManHarmondsworthPenguin Books1969
- CDC [homepage on the Internet] U.S. Public Health Service Syphilis Study at Tuskegee Available from: http://www.cdc.gov/tuskegee/timeline.htmAccessed July 8, 2018
- Public law 93-348-Juli 12, 1974 88-Stat. National Research Act Available from: http://history.nih.gov/research/downloads/PL93-348.pdfAccessed July 8, 2018
- HHS.gov [homepage on the Internet]The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Available from: http://www.hhs.gov/ohrp/humansubjectAccessed April 18, 1979
- ICH Harmonised Tripartite GuidelineGuideline for good clinical prac-tice E6(R1). ICH Harmonised Tripartite Guideline199619964i53 Available from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdfAccessed January 22, 2019
- WomenPFe-HInvolved N Code of federal regulations title 45 department of health and Human services part 46 Protection of human subjects2009 Available from: https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/ohrpregulations.pdfAccessed January 22, 2019
- Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the test. Available from: https://publications.europa.eu/en/publication-detail/-/publication/98ea0b12-c69c-4608-a406-001e48ed29a5/language-enAccessed January 22, 2019
- KochHGReiter-TheilSHHInformed Consent in Psychiatry European Perspectives of Ethics, Law and Clinical PracticeBaden-BadenNomos Verlagagesellschaft1997
- KimSYHAppelbaumPSJesteDVOlinJTProxy and surrogate consent in geriatric neuropsychiatric research: update and recommendationsAm J Psychiatry2004161579780615121642
- DuguetAMBoyer-BeviereBConsent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer diseaseMed Law201130461362722397184
- GainottiSFusari ImperatoriSSpila-AlegianiSHow are the interests of incapacitated research participants protected through legislation? An Italian study on legal agency for dementia patientsPLoS One201056e1115020585400
- GaleottiFVanacoreNGainottiSHow legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementiaDrugs Aging201229860761422574633
- United Nations educational, scientific and cultural organization, report of the International bioethics Committee of UNESCO (IBC) on consent, social and human sciences sector, division of ethics of science and technology, bioethics section, SHS/EST/CIB08 Available from: https://unesdoc.unesco.org/ark:/48223/pf000178124Accessed January 22, 2019
- WalaszekAClinical ethics issues in geriatric psychiatryPsychiatr Clin North Am200932234335919486818
- KimSYHCaineEDUtility and limits of the Mini Mental State Examination in evaluating consent capacity in Alzheimer’s diseasePsychiatr Serv200253101322132412364686
- KarlawishJMeasuring decision-making capacity in cognitively impaired individualsNeurosignals2008161919818097164
- MarsonDCIngramKKCodyHAHarrellLEAssessing the competency of patients with Alzheimer’s disease under different legal standards. A prototype instrumentArch Neurol199552109499547575221
- SchaeferLAMacArthur Competence Assessment ToolsKreutzerJSDeLucaJCaplanBEncyclopedia of Clinical NeuropsychologySpringerNew York, NY2011
- World Health OrganizationMen, Ageing and HealthGenevaWorld Health Organization2001163
- RiemSHartwigEHartwigJAlterstraumatologieOrthopädie und Unfallchirurgie up2date2012703187205
- (GMWP) EGMWPMedical Research For and With Older People in Europe2013127 Available from: http://efgcp.organica.eu.com/EFGCP/documents/EFGCPGMWPResearchGuidelinesFinaledited2013052770.pdfAccessed January 21, 2019
- International Council for HarmonizationE7 Studies in Support of Special Populations: Geriatrics Questions & Answers Current Version E7 Q & As Document History. ICH2010 Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm189544.pdfAccessed January 22, 2019
- PRISMA transparent reporting of systematic reviews and meta-analyses [homepage on the Internet] Available from: http://www.prisma-statement.org/Accessed December 20, 2018
- IvashkovYvan NormanGAInformed consent and the ethical management of the older patientAnesthesiol Clin200927356958019825493
- European Medicines Agency [homepage on the Internet]CPMP/ICH/135/95, ICH topic e 6 (R1) Guideline for Good Clinical Practice2002 Available from: www.ema.europa.eu/pdfs/human/ich/013595en.pdfAccessed July 8, 2018
- The European Parliament and the Council of the European UnionRegulation (EU) 536/2014 of the European Parliament and of The Council of 16 April 2014on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC2014 Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdfAccessed January 22, 2019
- SAMW/ASSM medical-ethical guidelinesMedical treatment and care of people with disabilities2008 (updated 2013). Available from: https://www.samw.ch/en/Publications/Medical-ethical-Guidelines.htmlAccessed July 8, 2018
- FolsteinMFFolsteinSEMcHughPR“Mini-mental state”. A practical method for grading the cognitive state of patients for the clinicianJ Psychiatr Res19751231891981202204
- CullenBO’NeillBEvansJJCoenRFLawlorBAA review of screening tests for cognitive impairmentJ Neurol Neurosurg Psychiatry200778879079917178826
- BundesversammlungDEidgenossenschaftDSSchweizerisches Zivilgesetzbuch2011 Available from: https://www.admin.ch/opc/de/classified-compilation/19070042/201901010000/210.pdfAccessed January 25, 2019
- InouyeSKWestendorpRGJSaczynskiJSDelirium in elderly peopleLancet2014383992091192223992774
- HomeierDAging: physiology, disease, and abuseClin Geriatr Med201430467168625439635
- ConroySElliottAThe frailty syndromeMedicine20174511518
- InouyeSKCharpentierPAPrecipitating factors for delirium in hos-pitalized elderly personsJAMA1996275118528596223
- SchuurmansMJDuursmaSAShortridge-BaggettLMCleversGJPel-LittelRElderly patients with a hip fracture: the risk for deliriumAppl Nurs Res2003162758412764718
- SmithTOCooperAPeryerGGriffithsRFoxCCrossJFactors predicting incidence of post-operative delirium in older people following hip fracture surgery: a systematic review and meta-analysisInt J Geriatr Psychiatry201732438639628093812
- BlondellRDPowellGEDoddsHNLooneySWLukanJKAdmission characteristics of trauma patients in whom delirium developsAm J Surg2004187333233715006560
- HjermstadMJFayersPMHaugenDFStudies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature reviewJ Pain Symptom Manage20114161073109321621130
- FinkASProchazkaAVHendersonWGEnhancement of surgical informed consent by addition of repeat back: a multicenter, randomized controlled clinical trialAnn Surg20102521273620562609
- JesteDVDunnLBPalmerBWA collaborative model for research on decisional capacity and informed consent in older patients with schizophrenia: bioethics unit of a geriatric psychiatry intervention research centerPsychopharmacology20031711687412768273
- BarryMJEdgman-LevitanSShared decision making – the pinnacle of patient-centered careN Engl J Med Overseas Ed20123669780781