Clinical trial NCT05221866: Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Official title: Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Opioid Dependence
Opioid Misuse
Post-Surgical Complication
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 711
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The patient-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design.
Primary purpose: TREATMENT

Brief summary: Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed research seeks to test a provider-facing decision support tool and a patient-facing smartphone app to reduce the amounts of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery.

Detailed description: Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, patients will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or patients.

Eligibility criteria: Inclusion Criteria:

1. \>19-89 years old
2. Access to a smartphone (iOS or Android)
3. inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home

Exclusion Criteria:

1. Patients re-hospitalized within 30 days of previous hospitalization
2. Pregnant patients
3. Patients not able to read the English language
4. Patients discharged to a post-acute care facility
5. Patients with contraindications to opioids, acetaminophen, or NSAIDs
6. Patients meeting the AHRQ definition of long-term opioid therapy (opioid use on most days \>3 months) prior to surgery.

Primary outcomes:
measure: Cumulative weekly opioid intake after discharge
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Assessment-Pain Intensity
timeFrame: 4 weeks
measure: Pain Assessment-Pain Interference
timeFrame: 4 Weeks
measure: Opioid prescription on day of discharge
timeFrame: 4 Weeks
measure: Opioids prescribed from "day of discharge + 1" until 28 days after discharge
timeFrame: 4 Weeks
measure: Opioid disposal
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Karsten Bartels, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guy GP Jr, Zhang K, Bohm MK, Losby J, Lewis B, Young R, Murphy LB, Dowell D. Vital Signs: Changes in Opioid Prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Jul 7;66(26):697-704. doi: 10.15585/mmwr.mm6626a4.
citation: Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
citation: Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.
citation: Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
citation: Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
citation: Nooromid MJ, Blay E Jr, Holl JL, Bilimoria KY, Johnson JK, Eskandari MK, Stulberg JJ. Discharge prescription patterns of opioid and nonopioid analgesics after common surgical procedures. Pain Rep. 2018 Feb 6;3(1):e637. doi: 10.1097/PR9.0000000000000637. eCollection 2018 Jan.
citation: Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
citation: Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436.
citation: Khorfan R, Shallcross ML, Yu B, Sanchez N, Parilla S, Coughlin JM, Johnson JK, Bilimoria KY, Stulberg JJ. Preoperative patient education and patient preparedness are associated with less postoperative use of opioids. Surgery. 2020 May;167(5):852-858. doi: 10.1016/j.surg.2020.01.002. Epub 2020 Feb 20.
citation: Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
citation: Frieden TR, Houry D. Reducing the Risks of Relief--The CDC Opioid-Prescribing Guideline. N Engl J Med. 2016 Apr 21;374(16):1501-4. doi: 10.1056/NEJMp1515917. Epub 2016 Mar 15. No abstract available.
citation: Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
citation: Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med. 2020 Feb 1;180(2):301-309. doi: 10.1001/jamainternmed.2019.5459.
citation: Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
citation: Carrico JA, Mahoney K, Raymond KM, McWilliams SK, Mayes LM, Mikulich-Gilbertson SK, Bartels K. Predicting Opioid Use Following Discharge After Cesarean Delivery. Ann Fam Med. 2020 Mar;18(2):118-126. doi: 10.1370/afm.2493.
citation: Bartels K, Mahoney K, Raymond KM, McWilliams SK, Fernandez-Bustamante A, Schulick R, Hopfer CJ, Mikulich-Gilbertson SK. Opioid and non-opioid utilization at home following gastrointestinal procedures: a prospective cohort study. Surg Endosc. 2020 Jan;34(1):304-311. doi: 10.1007/s00464-019-06767-1. Epub 2019 Apr 3.
citation: Tighe P, Buckenmaier CC 3rd, Boezaart AP, Carr DB, Clark LL, Herring AA, Kent M, Mackey S, Mariano ER, Polomano RC, Reisfield GM. Acute Pain Medicine in the United States: A Status Report. Pain Med. 2015 Sep;16(9):1806-26. doi: 10.1111/pme.12760. Epub 2015 Jun 10.
citation: Howard R, Fry B, Gunaseelan V, Lee J, Waljee J, Brummett C, Campbell D Jr, Seese E, Englesbe M, Vu J. Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. JAMA Surg. 2019 Jan 1;154(1):e184234. doi: 10.1001/jamasurg.2018.4234. Epub 2019 Jan 16.
citation: Ossiander EM. Using textual cause-of-death data to study drug poisoning deaths. Am J Epidemiol. 2014 Apr 1;179(7):884-94. doi: 10.1093/aje/kwt333. Epub 2014 Feb 11.
citation: Banta-Green CJ, Merrill JO, Doyle SR, Boudreau DM, Calsyn DA. Measurement of opioid problems among chronic pain patients in a general medical population. Drug Alcohol Depend. 2009 Sep 1;104(1-2):43-9. doi: 10.1016/j.drugalcdep.2009.03.022. Epub 2009 May 26.
citation: Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use United States, 2008-2011. JAMA Intern Med. 2014 May;174(5):802-3. doi: 10.1001/jamainternmed.2013.12809. No abstract available.
citation: Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
citation: Bartels K, Binswanger IA, Hopfer CJ. Sources of Prescription Opioids for Nonmedical Use. J Addict Med. 2016 Mar-Apr;10(2):134. doi: 10.1097/ADM.0000000000000192. No abstract available.
citation: Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend. 2006 Feb 1;81(2):103-7. doi: 10.1016/j.drugalcdep.2005.05.009. Epub 2005 Jul 14.
citation: Harris K, Curtis J, Larsen B, Calder S, Duffy K, Bowen G, Hadley M, Tristani-Firouzi P. Opioid pain medication use after dermatologic surgery: a prospective observational study of 212 dermatologic surgery patients. JAMA Dermatol. 2013 Mar;149(3):317-21. doi: 10.1001/jamadermatol.2013.1871.
citation: Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 Feb;185(2):551-5. doi: 10.1016/j.juro.2010.09.088. Epub 2010 Dec 18.
citation: Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20.
citation: Inciardi JA, Surratt HL, Cicero TJ, Beard RA. Prescription opioid abuse and diversion in an urban community: the results of an ultrarapid assessment. Pain Med. 2009 Apr;10(3):537-48. doi: 10.1111/j.1526-4637.2009.00603.x.
citation: Volkow ND, McLellan TA. Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. JAMA. 2011 Apr 6;305(13):1346-7. doi: 10.1001/jama.2011.369. No abstract available.
citation: Hill MV, Stucke RS, Billmeier SE, Kelly JL, Barth RJ Jr. Guideline for Discharge Opioid Prescriptions after Inpatient General Surgical Procedures. J Am Coll Surg. 2018 Jun;226(6):996-1003. doi: 10.1016/j.jamcollsurg.2017.10.012. Epub 2017 Nov 30.
citation: Overton HN, Hanna MN, Bruhn WE, Hutfless S, Bicket MC, Makary MA; Opioids After Surgery Workgroup. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. doi: 10.1016/j.jamcollsurg.2018.07.659. Epub 2018 Aug 14.
citation: Glod SA. The Other Victims of the Opioid Epidemic. N Engl J Med. 2017 Jun 1;376(22):2101-2102. doi: 10.1056/NEJMp1702188. No abstract available.
citation: Nair BG, Newman SF, Peterson GN, Wu WY, Schwid HA. Feedback mechanisms including real-time electronic alerts to achieve near 100% timely prophylactic antibiotic administration in surgical cases. Anesth Analg. 2010 Nov;111(5):1293-300. doi: 10.1213/ANE.0b013e3181f46d89. Epub 2010 Sep 14.
citation: Abrams BA, Murray KA, Mahoney K, Raymond KM, McWilliams SK, Nichols S, Mahmoudi E, Mayes LM, Fernandez-Bustamante A, Mitchell JD, Meguid RA, Zanotti G, Bartels K. Postdischarge Pain Management After Thoracic Surgery: A Patient-Centered Approach. Ann Thorac Surg. 2020 Nov;110(5):1714-1721. doi: 10.1016/j.athoracsur.2020.04.048. Epub 2020 Jun 1.
citation: Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.
citation: Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.
citation: Bouwsma EVA, Huirne JAF, van de Ven PM, Vonk Noordegraaf A, Schaafsma FG, Schraffordt Koops SE, van Kesteren PJM, Brolmann HAM, Anema JR. Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation. BMJ Open. 2018 Jan 30;8(1):e017781. doi: 10.1136/bmjopen-2017-017781.
citation: Horstman MJ, Mills WL, Herman LI, Cai C, Shelton G, Qdaisat T, Berger DH, Naik AD. Patient experience with discharge instructions in postdischarge recovery: a qualitative study. BMJ Open. 2017 Feb 22;7(2):e014842. doi: 10.1136/bmjopen-2016-014842.
citation: Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12195.
citation: Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. doi: 10.1002/14651858.CD001431.pub3.
citation: Shojania KG, Jennings A, Mayhew A, Ramsay CR, Eccles MP, Grimshaw J. The effects of on-screen, point of care computer reminders on processes and outcomes of care. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD001096. doi: 10.1002/14651858.CD001096.pub2.
citation: Reilly BM, Evans AT. Translating clinical research into clinical practice: impact of using prediction rules to make decisions. Ann Intern Med. 2006 Feb 7;144(3):201-9. doi: 10.7326/0003-4819-144-3-200602070-00009.
citation: Moons KG, Royston P, Vergouwe Y, Grobbee DE, Altman DG. Prognosis and prognostic research: what, why, and how? BMJ. 2009 Feb 23;338:b375. doi: 10.1136/bmj.b375. No abstract available.
citation: Kansagara D, Englander H, Salanitro A, Kagen D, Theobald C, Freeman M, Kripalani S. Risk prediction models for hospital readmission: a systematic review. JAMA. 2011 Oct 19;306(15):1688-98. doi: 10.1001/jama.2011.1515.
citation: Justice AC, Covinsky KE, Berlin JA. Assessing the generalizability of prognostic information. Ann Intern Med. 1999 Mar 16;130(6):515-24. doi: 10.7326/0003-4819-130-6-199903160-00016.
citation: Moons KG, Altman DG, Vergouwe Y, Royston P. Prognosis and prognostic research: application and impact of prognostic models in clinical practice. BMJ. 2009 Jun 4;338:b606. doi: 10.1136/bmj.b606. No abstract available.
citation: Ryan R, Santesso N, Hill S, Lowe D, Kaufman C, Grimshaw J. Consumer-oriented interventions for evidence-based prescribing and medicines use: an overview of systematic reviews. Cochrane Database Syst Rev. 2011 May 11;(5):CD007768. doi: 10.1002/14651858.CD007768.pub2.
citation: Sessler DI, Myles PS. Novel Clinical Trial Designs to Improve the Efficiency of Research. Anesthesiology. 2020 Jan;132(1):69-81. doi: 10.1097/ALN.0000000000002989.
citation: Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
citation: Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.
citation: Fernandez-Bustamante A, Bartels K, Clavijo C, Scott BK, Kacmar R, Bullard K, Moss AFD, Henderson W, Juarez-Colunga E, Jameson L. Preoperatively Screened Obstructive Sleep Apnea Is Associated With Worse Postoperative Outcomes Than Previously Diagnosed Obstructive Sleep Apnea. Anesth Analg. 2017 Aug;125(2):593-602. doi: 10.1213/ANE.0000000000002241.
citation: Krause M, McWilliams SK, Bullard KJ, Mayes LM, Jameson LC, Mikulich-Gilbertson SK, Fernandez-Bustamante A, Bartels K. Neostigmine Versus Sugammadex for Reversal of Neuromuscular Blockade and Effects on Reintubation for Respiratory Failure or Newly Initiated Noninvasive Ventilation: An Interrupted Time Series Design. Anesth Analg. 2020 Jul;131(1):141-151. doi: 10.1213/ANE.0000000000004505.
citation: Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
citation: Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
citation: Bartels K, Kaizer A, Jameson L, Bullard K, Dingmann C, Fernandez-Bustamante A. Hypoxemia Within the First 3 Postoperative Days Is Associated With Increased 1-Year Postoperative Mortality After Adjusting for Perioperative Opioids and Other Confounders. Anesth Analg. 2020 Aug;131(2):555-563. doi: 10.1213/ANE.0000000000004553.
citation: Bookman K, West D, Ginde A, Wiler J, McIntyre R, Hammes A, Carlson N, Steinbruner D, Solley M, Zane R. Embedded Clinical Decision Support in Electronic Health Record Decreases Use of High-cost Imaging in the Emergency Department: EmbED study. Acad Emerg Med. 2017 Jul;24(7):839-845. doi: 10.1111/acem.13195. Epub 2017 May 11.
citation: Wellek S, Blettner M. On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2012 Apr;109(15):276-81. doi: 10.3238/arztebl.2012.0276. Epub 2012 Apr 13.
citation: Turner RM, White IR, Croudace T; PIP Study Group. Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med. 2007 Jan 30;26(2):274-89. doi: 10.1002/sim.2537.
citation: Reich NG, Myers JA, Obeng D, Milstone AM, Perl TM. Empirical power and sample size calculations for cluster-randomized and cluster-randomized crossover studies. PLoS One. 2012;7(4):e35564. doi: 10.1371/journal.pone.0035564. Epub 2012 Apr 27.
citation: Arnup SJ, McKenzie JE, Hemming K, Pilcher D, Forbes AB. Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial. Trials. 2017 Aug 15;18(1):381. doi: 10.1186/s13063-017-2113-2.
citation: Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004 Mar;94(3):423-32. doi: 10.2105/ajph.94.3.423.
citation: Milani RV, Franklin NC. The Role of Technology in Healthy Living Medicine. Prog Cardiovasc Dis. 2017 Mar-Apr;59(5):487-491. doi: 10.1016/j.pcad.2017.02.001. Epub 2017 Feb 11.
citation: Krebs P, Duncan DT. Health App Use Among US Mobile Phone Owners: A National Survey. JMIR Mhealth Uhealth. 2015 Nov 4;3(4):e101. doi: 10.2196/mhealth.4924.
citation: Liu VX, Rosas E, Hwang J, Cain E, Foss-Durant A, Clopp M, Huang M, Lee DC, Mustille A, Kipnis P, Parodi S. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surg. 2017 Jul 19;152(7):e171032. doi: 10.1001/jamasurg.2017.1032. Epub 2017 Jul 19.
citation: Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19.
citation: Barozzi N, Tett SE. Perceived barriers to paracetamol (acetaminophen) prescribing, especially following rofecoxib withdrawal from the market. Clin Rheumatol. 2009 May;28(5):509-19. doi: 10.1007/s10067-008-1077-8. Epub 2009 Jan 9.
citation: Sirey JA, Banerjee S, Marino P, Bruce ML, Halkett A, Turnwald M, Chiang C, Liles B, Artis A, Blow F, Kales HC. Adherence to Depression Treatment in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Nov 1;74(11):1129-1135. doi: 10.1001/jamapsychiatry.2017.3047.
citation: Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055.
citation: Dong Y, Wang P, Dai Z, Liu K, Jin Y, Li A, Wang S, Zheng J. Increased self-care activities and glycemic control rate in relation to health education via Wechat among diabetes patients: A randomized clinical trial. Medicine (Baltimore). 2018 Dec;97(50):e13632. doi: 10.1097/MD.0000000000013632.
citation: Attum B, Rodriguez-Buitrago A, Harrison N, Evans A, Obremskey W, Sethi MK, Jahangir AA. Opioid Prescribing Practices by Orthopaedic Trauma Surgeons After Isolated Femur Fractures. J Orthop Trauma. 2018 Mar;32(3):e106-e111. doi: 10.1097/BOT.0000000000001046.
citation: Dhumane PW, Diana M, Leroy J, Marescaux J. Minimally invasive single-site surgery for the digestive system: A technological review. J Minim Access Surg. 2011 Jan;7(1):40-51. doi: 10.4103/0972-9941.72381.
citation: Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
citation: Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.
citation: White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ. 2011 Feb 7;342:d40. doi: 10.1136/bmj.d40.
citation: Brainard J, Scott BK, Sullivan BL, Fernandez-Bustamante A, Piccoli JR, Gebbink MG, Bartels K. Heated humidified high-flow nasal cannula oxygen after thoracic surgery - A randomized prospective clinical pilot trial. J Crit Care. 2017 Aug;40:225-228. doi: 10.1016/j.jcrc.2017.04.023. Epub 2017 Apr 19.
citation: Teja BJ, Sutherland TN, Barnett SR, Talmor DS. Cost-Effectiveness Research in Anesthesiology. Anesth Analg. 2018 Nov;127(5):1196-1201. doi: 10.1213/ANE.0000000000003334.
citation: Carias C, Chesson HW, Grosse SD, Li R, Meltzer MI, Miller GF, Murphy LB, Nurmagambetov TA, Pike JJ, Whitham HK. Recommendations of the Second Panel on Cost Effectiveness in Health and Medicine: A Reference, Not a Rule Book. Am J Prev Med. 2018 Apr;54(4):600-602. doi: 10.1016/j.amepre.2017.11.013. Epub 2018 Jan 12. No abstract available.
citation: Wang H, Li T, Siahpush M, Chen LW, Huberty J. Cost-Effectiveness of Ready for Recess to Promote Physical Activity in Children. J Sch Health. 2017 Apr;87(4):278-285. doi: 10.1111/josh.12495.
citation: Neary KC, Mormino MA, Wang H. Suture Button Fixation Versus Syndesmotic Screws in Supination-External Rotation Type 4 Injuries: A Cost-Effectiveness Analysis. Am J Sports Med. 2017 Jan;45(1):210-217. doi: 10.1177/0363546516664713. Epub 2016 Sep 30.
citation: Grimsrud C, Killen C, Murphy M, Wang H, McGarry S. Long-Term Outcomes of Rotationplasty patients in the treatment of lower extremity sarcomas with cost analysis. J Clin Orthop Trauma. 2020 Feb;11(Suppl 1):S149-S152. doi: 10.1016/j.jcot.2019.06.003. Epub 2019 Jun 5.
citation: Young L, Zimmerman L, Pozehl B, Barnason S, Wang H. Cost-effectiveness of a symptom management intervention: improving physical activity in older women following coronary artery bypass surgery. Nurs Econ. 2012 Mar-Apr;30(2):94-103.
citation: Wang H, Qiu F, Boilesen E, Nayar P, Lander L, Watkins K, Watanabe-Galloway S. Rural-Urban Differences in Costs of End-of-Life Care for Elderly Cancer Patients in the United States. J Rural Health. 2016 Sep;32(4):353-362. doi: 10.1111/jrh.12160. Epub 2015 Nov 20.
citation: Wang H, Gregg A, Qiu F, Kim J, Chen B, Wan N, Su D, Michaud T, Chen LW. Breast Cancer Screening for Patients of Rural Accountable Care Organization Clinics: A Multi-Level Analysis of Barriers and Facilitators. J Community Health. 2018 Apr;43(2):248-258. doi: 10.1007/s10900-017-0412-x.
citation: McClure NS, Sayah FA, Xie F, Luo N, Johnson JA. Instrument-Defined Estimates of the Minimally Important Difference for EQ-5D-5L Index Scores. Value Health. 2017 Apr;20(4):644-650. doi: 10.1016/j.jval.2016.11.015. Epub 2017 Jan 10.
citation: Pickard AS, Law EH, Jiang R, Pullenayegum E, Shaw JW, Xie F, Oppe M, Boye KS, Chapman RH, Gong CL, Balch A, Busschbach JJV. United States Valuation of EQ-5D-5L Health States Using an International Protocol. Value Health. 2019 Aug;22(8):931-941. doi: 10.1016/j.jval.2019.02.009. Epub 2019 May 25.
citation: Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003.
citation: Schwarzer R, Rochau U, Saverno K, Jahn B, Bornschein B, Muehlberger N, Flatscher-Thoeni M, Schnell-Inderst P, Sroczynski G, Lackner M, Schall I, Hebborn A, Pugner K, Fehervary A, Brixner D, Siebert U. Systematic overview of cost-effectiveness thresholds in ten countries across four continents. J Comp Eff Res. 2015 Sep;4(5):485-504. doi: 10.2217/cer.15.38.
citation: Claxton K, Sculpher M, McCabe C, Briggs A, Akehurst R, Buxton M, Brazier J, O'Hagan T. Probabilistic sensitivity analysis for NICE technology assessment: not an optional extra. Health Econ. 2005 Apr;14(4):339-47. doi: 10.1002/hec.985.
citation: Cantor SB. Cost-effectiveness analysis, extended dominance, and ethics: a quantitative assessment. Med Decis Making. 1994 Jul-Sep;14(3):259-65. doi: 10.1177/0272989X9401400308.