- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06506669
Kaihi monitoroidun anestesiahoidon (MAC) toteutettavuuspilottitutkimus (CaTNAPS-1)
Kahden normaalin lähestymistavan vertailu kaihileikkauksen menettelylliseen rauhoitukseen: mahdollinen toteutettavuuspilottitutkimus
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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California
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San Francisco, California, Yhdysvallat, 94143
- University of California, San Francisco
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
- ≥ 65 vuotta vanha
- Pystyy antamaan tietoisen suostumuksen ja suorittamaan opiskelutoimenpiteet englanniksi
- Pystyy antamaan suostumuksensa itselleen
- Pystyy seuraamaan ohjeita
- Pystyy kiipeämään yhtä portaita pysähtymättä lepäämään
- Sinulla on uusi kaihidiagnoosi
- Suunnittele kaihileikkausta silmälle seuraavan 6 kuukauden aikana
Poissulkemiskriteerit:
- Aikaisempi kaihileikkaus
- Pääsy sairaalaan viimeisen 30 päivän aikana
- Vaikeus saada rauhoittavaa muiden pienten avohoitotoimenpiteiden tai kuvantamistutkimusten aikana
- Allergia tai resistenssi paikallispuudutettaville aineille
- Ei voi makaa selälläsi ilman oireita (esim. hengitysvaikeuksia, voimakasta selkäkipua jne.)
- Aiempi vakava ahdistuneisuus, joka edellyttää bentsodiatsepiinien rutiininomaista käyttöä
- Vaikea läppäsairaus (esim. kriittinen aorttastenoosi)
- Sydänsairaudet, jotka edellyttävät istutettua sydänlaitetta, kuten sydämentahdistin, defibrillaattori tai vasemman kammion apulaite (rytmihäiriö, kongestiivinen sydämen vajaatoiminta jne.)
- Hoitamaton rintakipu tai angina
- Potilaat, joilla on liikehäiriöitä (esim. Parkinsonin tauti)
- Aivoverisuonionnettomuuden (CVA), ohimenevän iskeemisen hyökkäyksen (TIA) tai kohtausten historia
- Vaadi kodin happea (O2) levossa tai rasituksessa
- Dialyysihoitoa vaativa loppuvaiheen munuaissairaus (ESRD).
- Sairaasta liikalihavuus (BMI>35)
- Potilas, jolle tehdään kaihileikkaus yhdessä minkä tahansa muun oftalmologisen toimenpiteen kanssa
- Potilas, joka tarvitsee yleisanestesia kaihileikkauksen aikana olemassa olevan kaihien taustalla olevien ominaisuuksien ja/tai suunnitellun toimenpiteen monimutkaisuuden vuoksi
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Interventio
Potilaille annetaan suun kautta tapahtuvaa sedaatiota ennen toimenpidettä.
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Suun kautta annettava anksiolyysihoito ennen leikkausta
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Placebo Comparator: Plasebo
Potilaille annetaan suun kautta otettava plasebopilleri ennen toimenpidettä.
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Lumepilleri ilman vaikuttavia aineita annettuna ennen leikkausta
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants With High Satisfaction (ISAS Score ≥ 2)
Aikaikkuna: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants Meeting Eligibility Criteria at Screening
Aikaikkuna: At screening (prior to enrollment)
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Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility
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At screening (prior to enrollment)
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Number of Participants Completing All Study Surveys at Each Timepoint
Aikaikkuna: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm
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30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Number of Participants Who Completed All Required Study Procedures
Aikaikkuna: From enrollment through final study follow-up (POD7)
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Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) |
From enrollment through final study follow-up (POD7)
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Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up
Aikaikkuna: From enrollment through 30 days after surgery
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Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study
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From enrollment through 30 days after surgery
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Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS)
Aikaikkuna: 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
|
The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. |
30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7)
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Quality of Recovery-15 (QoR-15) Total Score After Surgery
Aikaikkuna: 1 day and 7 days after surgery
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The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence.
Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150.
Higher scores indicate better recovery.
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1 day and 7 days after surgery
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Functional Recovery Index (FRI) Total Score After Surgery
Aikaikkuna: 1 day and 7 days after surgery
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The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living.
Each item is scored and summed to produce a total score ranging from 0 to 100.
Lower scores indicate better functional recovery.
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1 day and 7 days after surgery
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Catherine L Chen, M.D., University of California, San Francisco
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
- Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Developed in collaboration with the American College of Surgeons, American Society of Anesthesiologists, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists, and Society of Vascular Medicine Endorsed by the Society of Hospital Medicine. J Nucl Cardiol. 2015 Feb;22(1):162-215. doi: 10.1007/s12350-014-0025-z. No abstract available.
- Partridge JS, Harari D, Dhesi JK. Frailty in the older surgical patient: a review. Age Ageing. 2012 Mar;41(2):142-7. doi: 10.1093/ageing/afr182.
- Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.
- Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.
- Ianchulev T, Litoff D, Ellinger D, Stiverson K, Packer M. Office-Based Cataract Surgery: Population Health Outcomes Study of More than 21 000 Cases in the United States. Ophthalmology. 2016 Apr;123(4):723-8. doi: 10.1016/j.ophtha.2015.12.020. Epub 2016 Jan 22.
- Glisson C, Landsverk J, Schoenwald S, Kelleher K, Hoagwood KE, Mayberg S, Green P; Research Network on Youth Mental Health. Assessing the organizational social context (OSC) of mental health services: implications for research and practice. Adm Policy Ment Health. 2008 Mar;35(1-2):98-113. doi: 10.1007/s10488-007-0148-5. Epub 2007 Dec 18.
- Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846.
- McIsaac DI, MacDonald DB, Aucoin SD. Frailty for Perioperative Clinicians: A Narrative Review. Anesth Analg. 2020 Jun;130(6):1450-1460. doi: 10.1213/ANE.0000000000004602.
- Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372.
- Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
- Norregaard, J. C. Results from the International Cataract Surgery Outcomes Study. Acta Ophthalmologica Scandinavica 85, 5-32, doi:10.1111/j.1600-0420.2007.00937.x (2007).
- Kent, C. Cataract Surgery: Is an anesthesiologist necessary?, <https://www.reviewofophthalmology.com/article/cataract-surgery-is-an-anesthesiologist-necessary> (2009).
- Andrews, M. Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery, <https://khn.org/news/anthem-calls-on-eye-surgeons-to-monitor-anesthesia-during-cataract-surgery/> (2018).
- Zakrzewski PA, Friel T, Fox G, Braga-Mele R. Monitored anesthesia care provided by registered respiratory care practitioners during cataract surgery: a report of 1957 cases. Ophthalmology. 2005 Feb;112(2):272-7. doi: 10.1016/j.ophtha.2004.08.016.
- Kent-Smith BT, Wallace GM. Routine cataract surgery without the presence of an anaesthetist. Clin Exp Ophthalmol. 2007 Aug;35(6):589. doi: 10.1111/j.1442-9071.2007.01553.x. No abstract available.
- Murray P, Adams K, Haddad P, Murray N, O'Rourke M. The routine requirement for anaesthetists in local anaesthetic cataract surgery. Clin Exp Ophthalmol. 2007 Mar;35(2):195-6. doi: 10.1111/j.1442-9071.2006.01441.x. No abstract available.
- Zakrzewski PA, Banashkevich AV, Friel T, Braga-Mele R. Monitored anesthesia care by registered respiratory therapists during cataract surgery: an update. Ophthalmology. 2010 May;117(5):897-902. doi: 10.1016/j.ophtha.2009.10.005. Epub 2010 Jan 15.
- Basta B, Gioia L, Gemma M, Dedola E, Bianchi I, Fasce F, Beretta L. Systemic adverse events during 2005 phacoemulsifications under monitored anesthesia care: a prospective evaluation. Minerva Anestesiol. 2011 Sep;77(9):877-83.
- Koolwijk J, Fick M, Selles C, Turgut G, Noordergraaf JI, Tukkers FS, Noordergraaf GJ. Outpatient cataract surgery: incident and procedural risk analysis do not support current clinical ophthalmology guidelines. Ophthalmology. 2015 Feb;122(2):281-7. doi: 10.1016/j.ophtha.2014.08.030. Epub 2014 Oct 22.
- Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD. Injectable versus topical anesthesia for cataract surgery: patient perceptions of pain and side effects. The Study of Medical Testing for Cataract Surgery study team. Ophthalmology. 2000 Nov;107(11):2054-60. doi: 10.1016/s0161-6420(00)00359-6.
- Katz J, Feldman MA, Bass EB, Lubomski LH, Tielsch JM, Petty BG, Fleisher LA, Schein OD; Study of Medical Testing for Cataract Surgery Study Team. Adverse intraoperative medical events and their association with anesthesia management strategies in cataract surgery. Ophthalmology. 2001 Oct;108(10):1721-6. doi: 10.1016/s0161-6420(01)00704-7.
- Fukuoka H, Afshari NA. The impact of age-related cataract on measures of frailty in an aging global population. Curr Opin Ophthalmol. 2017 Jan;28(1):93-97. doi: 10.1097/ICU.0000000000000338.
- American Society of Anesthesiologists. ASA Calls on Anthem to Rescind Its New Policy on Anesthesia for Cataract Surgery, <https://www.asahq.org/advocacy-and-asapac/fda-and-washington-alerts/washington-alerts/2018/02/asa-calls-on-anthem-to-rescind-its-new-policy-on-anesthesia-for-cataract-surgery?&ct=fd2b35b6cdb74e0b126f4539b73b56360091233e85002bc197d8049fa56b7a4253b022b37557ad25186cfc15475fa96cd09811e97c66fe62b04a1ec1298f82ef> (2018).
- American Academy of Ophthalmology. Pressure on Anthem Grows; Academy Keeps Pushing for Cataract-Surgery Anesthesia Coverage, 2018).
- Hubbard RE, Story DA. Patient frailty: the elephant in the operating room. Anaesthesia. 2014 Jan;69 Suppl 1:26-34. doi: 10.1111/anae.12490.
- Kim DH, Patorno E, Pawar A, Lee H, Schneeweiss S, Glynn RJ. Measuring Frailty in Administrative Claims Data: Comparative Performance of Four Claims-Based Frailty Measures in the U.S. Medicare Data. J Gerontol A Biol Sci Med Sci. 2020 May 22;75(6):1120-1125. doi: 10.1093/gerona/glz224.
- Kim DH, Schneeweiss S, Glynn RJ, Lipsitz LA, Rockwood K, Avorn J. Measuring Frailty in Medicare Data: Development and Validation of a Claims-Based Frailty Index. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):980-987. doi: 10.1093/gerona/glx229.
- Hodge W, Horsley T, Albiani D, Baryla J, Belliveau M, Buhrmann R, O'Connor M, Blair J, Lowcock E. The consequences of waiting for cataract surgery: a systematic review. CMAJ. 2007 Apr 24;176(9):1285-90. doi: 10.1503/cmaj.060962.
- Iroku-Malize T, Kirsch S. Eye Conditions in Older Adults: Cataracts. FP Essent. 2016 Jun;445:17-23.
- Owsley C, McGwin G Jr, Sloane M, Wells J, Stalvey BT, Gauthreaux S. Impact of cataract surgery on motor vehicle crash involvement by older adults. JAMA. 2002 Aug 21;288(7):841-9. doi: 10.1001/jama.288.7.841.
- Hillman, L. Phaco turns 50, <https://www.eyeworld.org/phaco-turns-50> (2017).
- Eke T, Thompson JR. Serious complications of local anaesthesia for cataract surgery: a 1 year national survey in the United Kingdom. Br J Ophthalmol. 2007 Apr;91(4):470-5. doi: 10.1136/bjo.2006.106005. Epub 2006 Nov 23.
- Jefferis JM, Clarke MP, Taylor JP, Brittain KR. Challenges for the cataract surgeon treating people with dementia: a qualitative study exploring anesthetic choices. Clin Ophthalmol. 2014 Sep 26;8:1993-9. doi: 10.2147/OPTH.S69388. eCollection 2014.
- Norregaard JC, Bernth-Petersen P, Bellan L, Alonso J, Black C, Dunn E, Andersen TF, Espallargues M, Anderson GF. Intraoperative clinical practice and risk of early complications after cataract extraction in the United States, Canada, Denmark, and Spain. Ophthalmology. 1999 Jan;106(1):42-8. doi: 10.1016/s0161-6420(99)90004-0.
- Sharwood PL, Thomas D, Roberts TV. Adverse medical events associated with cataract surgery performed under topical anaesthesia. Clin Exp Ophthalmol. 2008 Dec;36(9):842-6. doi: 10.1111/j.1442-9071.2009.01924.x.
- Stein JD, Grossman DS, Mundy KM, Sugar A, Sloan FA. Severe adverse events after cataract surgery among medicare beneficiaries. Ophthalmology. 2011 Sep;118(9):1716-23. doi: 10.1016/j.ophtha.2011.02.024. Epub 2011 Jun 2.
- Rocha G, Turner C. Safety of cataract surgery under topical anesthesia with oral sedation without anesthetic monitoring. Can J Ophthalmol. 2007 Apr;42(2):288-94.
- California Medical Association. CMA calls for investigation into Anthem restricting use of sedation during cataract surgery, <https://www.cmadocs.org/newsroom/news/view/ArticleID/21466/t/CMA-calls-for-investigation-into-Anthem-policy-restricting-use-of-sedation-during-cataract-surgery> (2018).
- Whitlock EL, Whittington RA. The Frailty Syndrome: Anesthesiologists Must Understand More and Fear Less. Anesth Analg. 2020 Jun;130(6):1445-1448. doi: 10.1213/ANE.0000000000004789. No abstract available.
- Hays, D. G. & Singh, A. A. Qualitative inquiry in clinical and educational settings. (Guilford Press, 2012).
- Francis JJ, Johnston M, Robertson C, Glidewell L, Entwistle V, Eccles MP, Grimshaw JM. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010 Dec;25(10):1229-45. doi: 10.1080/08870440903194015.
- Guest, G., MacQueen, K. M. & Namey, E., E. Applied Thematic Analysis. (Sage Publications, 2011).
- MacQueen, K. M., McLellan, E., Kay, K. & Milstein, B. Codebook Development for Team-Based Qualitative Analysis. CAM Journal 10, 31-36, doi:10.1177/1525822x980100020301 (2016).
- Hays, D. G. & Singh, A. A. in Qualitative Inquiry in Clinical and Educational Settings Ch. 10, 292-336 (Guilford Press, 2011).
- Rosenfeld, S. Monitored Anesthesia Care in Cataract Surgery, <https://www.aao.org/eyenet/article/monitored-anesthesia-care-in-cataract-surgery> (2018).
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 23-40367
- 5K23AG072035-03 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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