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Items: 1 to 20 of 88

1.

The Brief Pain Inventory and its "pain at its worst in the last 24 hours" item: clinical trial endpoint considerations.

Atkinson TM, Mendoza TR, Sit L, Passik S, Scher HI, Cleeland C, Basch E.

Pain Med. 2010 Mar;11(3):337-46. doi: 10.1111/j.1526-4637.2009.00774.x. Epub 2010 Jan 15.

2.

Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.

Clark MJ, Harris N, Griebsch I, Kaschinski D, Copley-Merriman C.

Health Qual Life Outcomes. 2014 Jul 4;12:104. doi: 10.1186/s12955-014-0104-5.

3.

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health.

Health Qual Life Outcomes. 2006 Oct 11;4:79.

4.

Pain palliation measurement in cancer clinical trials: the US Food and Drug Administration perspective.

Basch E, Trentacosti AM, Burke LB, Kwitkowski V, Kane RC, Autio KA, Papadopoulos E, Stansbury JP, Kluetz PG, Smith H, Justice R, Pazdur R.

Cancer. 2014 Mar 1;120(5):761-7. doi: 10.1002/cncr.28470. Epub 2013 Dec 5.

5.

Validation of a modified version of the brief pain inventory for painful diabetic peripheral neuropathy.

Zelman DC, Gore M, Dukes E, Tai KS, Brandenburg N.

J Pain Symptom Manage. 2005 Apr;29(4):401-10.

PMID:
15857744
6.

The validity and utility of the BPI interference measures for evaluating the impact of osteoarthritic pain.

Williams VS, Smith MY, Fehnel SE.

J Pain Symptom Manage. 2006 Jan;31(1):48-57.

PMID:
16442482
7.

Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

Ramasamy A, Martin ML, Blum SI, Liedgens H, Argoff C, Freynhagen R, Wallace M, McCarrier KP, Bushnell DM, Hatley NV, Patrick DL.

Pain Med. 2017 Jun 1;18(6):1098-1110. doi: 10.1093/pm/pnw357.

PMID:
28340111
8.

Validation of a modified version of the Brief Pain Inventory for painful diabetic peripheral neuropathy.

Zelman DC, Gore M, Dukes E, Tai KS, Brandenburg N.

J Vasc Nurs. 2005 Sep;23(3):97-104.

PMID:
16125633
10.

Responsiveness and minimal important differences for patient reported outcomes.

Revicki DA, Cella D, Hays RD, Sloan JA, Lenderking WR, Aaronson NK.

Health Qual Life Outcomes. 2006 Sep 27;4:70.

11.

Patient-reported outcomes supporting anticancer product approvals.

Rock EP, Kennedy DL, Furness MH, Pierce WF, Pazdur R, Burke LB.

J Clin Oncol. 2007 Nov 10;25(32):5094-9. Review.

PMID:
17991927
12.

Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

Nixon A, Kerr C, Breheny K, Wild D.

Health Qual Life Outcomes. 2013 Mar 11;11:38. doi: 10.1186/1477-7525-11-38. Review.

13.

Brief pain inventory--facial minimum clinically important difference.

Sandhu SK, Halpern CH, Vakhshori V, Mirsaeedi-Farahani K, Farrar JT, Lee JY.

J Neurosurg. 2015 Jan;122(1):180-90. doi: 10.3171/2014.8.JNS132547.

PMID:
25361481
14.

Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels.

Willke RJ, Burke LB, Erickson P.

Control Clin Trials. 2004 Dec;25(6):535-52. Review.

PMID:
15588741
15.

Outcome measurement in female sexual dysfunction clinical trials: review and recommendations.

Althof SE, Rosen RC, DeRogatis L, Corty E, Quirk F, Symonds T.

J Sex Marital Ther. 2005 Mar-Apr;31(2):153-66. Review.

PMID:
15859374
16.

What is sufficient evidence for the reliability and validity of patient-reported outcome measures?

Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group;.

Value Health. 2007 Nov-Dec;10 Suppl 2:S94-S105.

17.

Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards.

Cleeland CS, Sloan JA; ASCPRO Organizing Group.

J Pain Symptom Manage. 2010 Jun;39(6):1077-85. doi: 10.1016/j.jpainsymman.2009.05.025. Review.

PMID:
20538189
18.

Patient-reported outcome instrument selection: designing a measurement strategy.

Snyder CF, Watson ME, Jackson JD, Cella D, Halyard MY; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group.

Value Health. 2007 Nov-Dec;10 Suppl 2:S76-85.

19.

Greek brief pain inventory: validation and utility in cancer pain.

Mystakidou K, Mendoza T, Tsilika E, Befon S, Parpa E, Bellos G, Vlahos L, Cleeland C.

Oncology. 2001;60(1):35-42.

PMID:
11150906
20.

Validation of the Short Form of the Brief Pain Inventory (BPI-SF) in Spanish Patients with Non-Cancer-Related Pain.

de Andrés Ares J, Cruces Prado LM, Canos Verdecho MA, Penide Villanueva L, Del Valle Hoyos M, Herdman M, Traseira Lugilde S, Velázquez Rivera I.

Pain Pract. 2015 Sep;15(7):643-53. doi: 10.1111/papr.12219. Epub 2014 Apr 28.

PMID:
24766769

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