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Published in: BMC Health Services Research 1/2012

Open Access 01-12-2012 | Study protocol

The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial

Authors: Kris Vanhaecht, Walter Sermeus, Jan Peers, Cathy Lodewijckx, Svin Deneckere, Fabrizio Leigheb, Steven Boonen, An Sermon, Paulo Boto, Rita Veloso Mendes, Massimiliano Panella, EQCP study group

Published in: BMC Health Services Research | Issue 1/2012

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Abstract

Background

Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP) study on PFF (NCT00962910) was designed to determine how care pathways (CP) for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome.

Methods/Design

An international cluster-randomized controlled trial (cRCT) will be performed in Belgium, Ireland, Italy and Portugal. Based on power analyses, a sample of 44 hospital teams and 437 patients per arm will be included in the study. In the control arm, usual care will be provided. Experimental teams will implement a care pathway which will include three active components: a formative evaluation of quality and organization of the care setting, a set of evidence-based key interventions, and support of the development and implementation of the CP. Main outcome will be the six-month mortality rate.

Discussion

The EQCP study constitutes the first international cRCT on care pathways. The EQCP project was designed as both a research and a quality improvement project and will provide a real-world framework for process evaluation to improve our understanding of why and when CP can really work.

Trial registration number

NCT00962910
Appendix
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Literature
1.
go back to reference Kanis JA, Johnell O, Oden A, Jonsson B, De Laet C, Dawson A: Risk of hip fracture according to the World Health Organization criteria for osteopenia and osteoporosis. Bone. 2000, 27: 585-590. 10.1016/S8756-3282(00)00381-1.CrossRefPubMed Kanis JA, Johnell O, Oden A, Jonsson B, De Laet C, Dawson A: Risk of hip fracture according to the World Health Organization criteria for osteopenia and osteoporosis. Bone. 2000, 27: 585-590. 10.1016/S8756-3282(00)00381-1.CrossRefPubMed
2.
go back to reference Boonen S, Autier P, Barette M, Vanderschueren D, Lips P, Haentjens P: Functional outcome and quality of life following hip fracture in elderly women: a prospective controlled study. Osteoporos Int. 2004, 15: 87-94. 10.1007/s00198-003-1515-z.CrossRefPubMed Boonen S, Autier P, Barette M, Vanderschueren D, Lips P, Haentjens P: Functional outcome and quality of life following hip fracture in elderly women: a prospective controlled study. Osteoporos Int. 2004, 15: 87-94. 10.1007/s00198-003-1515-z.CrossRefPubMed
3.
go back to reference Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, et al: Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010, 152: 380-390.CrossRefPubMedPubMedCentral Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, et al: Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010, 152: 380-390.CrossRefPubMedPubMedCentral
4.
go back to reference Vestergaard P, Rejnmark L, Mosekilde L: Increased mortality in patients with a hip fracture-effect of pre-morbid conditions and post-fracture complications. Osteoporos Int. 2007, 18: 1583-1593. 10.1007/s00198-007-0403-3.CrossRefPubMed Vestergaard P, Rejnmark L, Mosekilde L: Increased mortality in patients with a hip fracture-effect of pre-morbid conditions and post-fracture complications. Osteoporos Int. 2007, 18: 1583-1593. 10.1007/s00198-007-0403-3.CrossRefPubMed
5.
go back to reference Vanhaecht K, Panella M, Van Zelm RT, Sermeus W: An overview on the concept and history of care pathways as complex interventions. Int J Care Pathw. 2010, 14: 117-123. 10.1258/jicp.2010.010019.CrossRef Vanhaecht K, Panella M, Van Zelm RT, Sermeus W: An overview on the concept and history of care pathways as complex interventions. Int J Care Pathw. 2010, 14: 117-123. 10.1258/jicp.2010.010019.CrossRef
6.
go back to reference Panella M, Marchisio S, Di Stanislao F: Reducing clinical variations with clinical pathways: do pathways work?. Int J Qual Health Care. 2003, 15: 509-521. 10.1093/intqhc/mzg057.CrossRefPubMed Panella M, Marchisio S, Di Stanislao F: Reducing clinical variations with clinical pathways: do pathways work?. Int J Qual Health Care. 2003, 15: 509-521. 10.1093/intqhc/mzg057.CrossRefPubMed
7.
go back to reference Pearson SD, Goulart-Fisher D, Lee TH: Critical pathways as a strategy for improving care: problems and potential. Ann Intern Med. 1995, 123: 941-948.CrossRefPubMed Pearson SD, Goulart-Fisher D, Lee TH: Critical pathways as a strategy for improving care: problems and potential. Ann Intern Med. 1995, 123: 941-948.CrossRefPubMed
9.
go back to reference Vanhaecht K, De Witte K, Panella M, Sermeus W: Do pathways lead to better organized care processes?. J Eval Clin Pract. 2009, 15: 782-788. 10.1111/j.1365-2753.2008.01068.x.CrossRefPubMed Vanhaecht K, De Witte K, Panella M, Sermeus W: Do pathways lead to better organized care processes?. J Eval Clin Pract. 2009, 15: 782-788. 10.1111/j.1365-2753.2008.01068.x.CrossRefPubMed
10.
go back to reference Vanhaecht K, De Witte K, Depreitere R, Sermeus W: Clinical pathway audit tools: a systematic review. J Nurs Manag. 2006, 14: 529-537. 10.1111/j.1365-2934.2006.00705.x.CrossRefPubMed Vanhaecht K, De Witte K, Depreitere R, Sermeus W: Clinical pathway audit tools: a systematic review. J Nurs Manag. 2006, 14: 529-537. 10.1111/j.1365-2934.2006.00705.x.CrossRefPubMed
11.
go back to reference Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F: Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009, 18: 369-373. 10.1136/qshc.2008.026559.CrossRefPubMed Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F: Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009, 18: 369-373. 10.1136/qshc.2008.026559.CrossRefPubMed
12.
go back to reference Vanhaecht K, Sermeus W, Peers J, Decramer M, Lodewijckx C, Leigheb F, et al: A cluster randomized trial on the effect of care pathways for COPD patients. Rational & design of the EQCP study. Trials. 2011, 11: 111.CrossRef Vanhaecht K, Sermeus W, Peers J, Decramer M, Lodewijckx C, Leigheb F, et al: A cluster randomized trial on the effect of care pathways for COPD patients. Rational & design of the EQCP study. Trials. 2011, 11: 111.CrossRef
13.
go back to reference Lemmens L, Van Zelm RT, Vanhaecht K, Kerkkamp H: Systematic review: indicators to evaluate effectiveness of clinical pathways for gastrointestinal surgery. J Eval Clin Pract. 2008, 14: 880-887. 10.1111/j.1365-2753.2008.01079.x.CrossRefPubMed Lemmens L, Van Zelm RT, Vanhaecht K, Kerkkamp H: Systematic review: indicators to evaluate effectiveness of clinical pathways for gastrointestinal surgery. J Eval Clin Pract. 2008, 14: 880-887. 10.1111/j.1365-2753.2008.01079.x.CrossRefPubMed
15.
go back to reference Vanhaecht K, De Witte K, Sermeus W: The impact of clinical pathways on the organisation of care processes. 2007, Leuven: ACCO Vanhaecht K, De Witte K, Sermeus W: The impact of clinical pathways on the organisation of care processes. 2007, Leuven: ACCO
16.
go back to reference Panella M, Vanhaecht K: Is there still need for confusion about pathways?. Int J Care Pathw. 2010, 14: 1-3. 10.1258/jicp.2010.010008.CrossRef Panella M, Vanhaecht K: Is there still need for confusion about pathways?. Int J Care Pathw. 2010, 14: 1-3. 10.1258/jicp.2010.010008.CrossRef
17.
go back to reference Panella M, Marchisio S, Gardini A, Di Stanislao F: A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007, 7: 179-10.1186/1472-6963-7-179.CrossRefPubMedPubMedCentral Panella M, Marchisio S, Gardini A, Di Stanislao F: A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007, 7: 179-10.1186/1472-6963-7-179.CrossRefPubMedPubMedCentral
18.
go back to reference Panella M, Marchisio S, Barbieri A, Di Stanislao F: A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008, 8: 223-10.1186/1472-6963-8-223.CrossRefPubMedPubMedCentral Panella M, Marchisio S, Barbieri A, Di Stanislao F: A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008, 8: 223-10.1186/1472-6963-8-223.CrossRefPubMedPubMedCentral
19.
go back to reference Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al: Designing and evaluating complex interventions to improve health care. BMJ. 2007, 334: 455-459. 10.1136/bmj.39108.379965.BE.CrossRefPubMedPubMedCentral Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, et al: Designing and evaluating complex interventions to improve health care. BMJ. 2007, 334: 455-459. 10.1136/bmj.39108.379965.BE.CrossRefPubMedPubMedCentral
20.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008, 337: a1655-10.1136/bmj.a1655.CrossRefPubMedPubMedCentral Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008, 337: a1655-10.1136/bmj.a1655.CrossRefPubMedPubMedCentral
21.
22.
go back to reference A framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. 2000, Medical Research Council A framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. 2000, Medical Research Council
23.
go back to reference Deneckere S, Robyns N, Vanhaecht K, Euwema M, Panella M, Lodewijckx C, et al: Indicators for follow-up of multidisciplinary teamwork in care processes: results of an international expert panel. Evaluation & the Health Professional 2010 [Epub ahead of print]. 2010, [Epub ahead of print]. Deneckere S, Robyns N, Vanhaecht K, Euwema M, Panella M, Lodewijckx C, et al: Indicators for follow-up of multidisciplinary teamwork in care processes: results of an international expert panel. Evaluation & the Health Professional 2010 [Epub ahead of print]. 2010, [Epub ahead of print].
24.
go back to reference Van Herck P, Vanhaecht K, Deneckere S, Bellemans J, Panella M, Barbieri A, et al: Key interventions and outcomes in joint arthroplasty clinical pathways: a systematic review. J Eval Clin Pract. 2010, 16: 39-49. 10.1111/j.1365-2753.2008.01111.x.CrossRefPubMed Van Herck P, Vanhaecht K, Deneckere S, Bellemans J, Panella M, Barbieri A, et al: Key interventions and outcomes in joint arthroplasty clinical pathways: a systematic review. J Eval Clin Pract. 2010, 16: 39-49. 10.1111/j.1365-2753.2008.01111.x.CrossRefPubMed
25.
go back to reference Rotter T, Kinsman L, James E, Machotta A, Gothe H, Willis J, et al: Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst Rev. 2010, Art. No: CD006632. Rotter T, Kinsman L, James E, Machotta A, Gothe H, Willis J, et al: Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs. Cochrane Database Syst Rev. 2010, Art. No: CD006632.
26.
go back to reference Pawson R, Tilley N: Realistic evaluation. 1997, London: SAGE Publications Ltd Pawson R, Tilley N: Realistic evaluation. 1997, London: SAGE Publications Ltd
27.
go back to reference Lodewijckx C, Sermeus W, Vanhaecht K, Panella M, Deneckere S, Leigheb F, et al: Inhospital management of COPD exacerbations: a systematic review of the literature with regard to adherence to international guidelines. J Eval Clin Pract. 2009, 15: 1101-1110. 10.1111/j.1365-2753.2009.01305.x.CrossRefPubMed Lodewijckx C, Sermeus W, Vanhaecht K, Panella M, Deneckere S, Leigheb F, et al: Inhospital management of COPD exacerbations: a systematic review of the literature with regard to adherence to international guidelines. J Eval Clin Pract. 2009, 15: 1101-1110. 10.1111/j.1365-2753.2009.01305.x.CrossRefPubMed
28.
go back to reference Panella M, Brambilla R, Marchisio S, Di Stanislao F: Reducing stroke in-hospital mortality: organized care is a complex intervention. Stroke. 2008, 39: e186-10.1161/STROKEAHA.108.533877.CrossRefPubMed Panella M, Brambilla R, Marchisio S, Di Stanislao F: Reducing stroke in-hospital mortality: organized care is a complex intervention. Stroke. 2008, 39: e186-10.1161/STROKEAHA.108.533877.CrossRefPubMed
29.
go back to reference Vanhaecht K, Sermeus W, Peers J, Deneckere S, Lodewijckx C, Leigheb F, et al: The European Quality of Care Pathway (EQCP) study: history, project management & approach. Int J Care Pathw. 2010, 14: 52-56. 10.1258/jicp.2010.010015.CrossRef Vanhaecht K, Sermeus W, Peers J, Deneckere S, Lodewijckx C, Leigheb F, et al: The European Quality of Care Pathway (EQCP) study: history, project management & approach. Int J Care Pathw. 2010, 14: 52-56. 10.1258/jicp.2010.010015.CrossRef
30.
go back to reference Rotter T, Kugler J, Koch R, Gothe H, Twork S, van Oostrum JM, et al: A systematic review and meta-analysis of the effects of clinical pathways on length of stay, hospital costs and patient outcomes. BMC Health Serv Res. 2008, 8: 265-10.1186/1472-6963-8-265.CrossRefPubMedPubMedCentral Rotter T, Kugler J, Koch R, Gothe H, Twork S, van Oostrum JM, et al: A systematic review and meta-analysis of the effects of clinical pathways on length of stay, hospital costs and patient outcomes. BMC Health Serv Res. 2008, 8: 265-10.1186/1472-6963-8-265.CrossRefPubMedPubMedCentral
31.
go back to reference Neuman MD, Archan S, Karlawish JH, Schwartz JS, Fleisher LA: The relationship between short-term mortality and quality of care for hip fracture: a meta-analysis of clinical pathways for hip fracture. J Am Geriatr Soc. 2009, 57: 2046-2054. 10.1111/j.1532-5415.2009.02492.x.CrossRefPubMed Neuman MD, Archan S, Karlawish JH, Schwartz JS, Fleisher LA: The relationship between short-term mortality and quality of care for hip fracture: a meta-analysis of clinical pathways for hip fracture. J Am Geriatr Soc. 2009, 57: 2046-2054. 10.1111/j.1532-5415.2009.02492.x.CrossRefPubMed
32.
go back to reference Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR: Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005, 20: 1019-1025. 10.1111/j.1525-1497.2005.00219.x.CrossRefPubMedPubMedCentral Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR: Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005, 20: 1019-1025. 10.1111/j.1525-1497.2005.00219.x.CrossRefPubMedPubMedCentral
33.
go back to reference Cameron I, Crotty M, Currie C, Finnegan T, Gillespie L, Gillespie W, et al: Geriatric rehabilitation following fractures in older people: a systematic review. Health Technol Assess. 2000, 4: 1-111. Cameron I, Crotty M, Currie C, Finnegan T, Gillespie L, Gillespie W, et al: Geriatric rehabilitation following fractures in older people: a systematic review. Health Technol Assess. 2000, 4: 1-111.
34.
go back to reference Chudyk AM, Jutai JW, Petrella RJ, Speechley M: Systematic review of hip fracture rehabilitation practices in the elderly. Arch Phys Med Rehabil. 2009, 90: 246-262. 10.1016/j.apmr.2008.06.036.CrossRefPubMed Chudyk AM, Jutai JW, Petrella RJ, Speechley M: Systematic review of hip fracture rehabilitation practices in the elderly. Arch Phys Med Rehabil. 2009, 90: 246-262. 10.1016/j.apmr.2008.06.036.CrossRefPubMed
35.
go back to reference Vanhaecht K, Bollmann M, Bower K, Gallagher C, Gardini A, Guezo J, et al: Prevalence and use of clinical pathways in 23 countries—an international survey by the European Pathway Association E-P-A.org. J Integr Care Pathw. 2006, 10: 28-34.CrossRef Vanhaecht K, Bollmann M, Bower K, Gallagher C, Gardini A, Guezo J, et al: Prevalence and use of clinical pathways in 23 countries—an international survey by the European Pathway Association E-P-A.org. J Integr Care Pathw. 2006, 10: 28-34.CrossRef
36.
go back to reference Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al: Framework for design and evaluation of complex interventions to improve health. BMJ. 2000, 321: 694-696. 10.1136/bmj.321.7262.694.CrossRefPubMedPubMedCentral Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al: Framework for design and evaluation of complex interventions to improve health. BMJ. 2000, 321: 694-696. 10.1136/bmj.321.7262.694.CrossRefPubMedPubMedCentral
37.
go back to reference Koval KJ, Skovron ML, Aharonoff GB, Zuckerman JD: Predictors of functional recovery after hip fracture in the elderly. Clin Orthop Relat Res. 1998, 348: 22-28.PubMed Koval KJ, Skovron ML, Aharonoff GB, Zuckerman JD: Predictors of functional recovery after hip fracture in the elderly. Clin Orthop Relat Res. 1998, 348: 22-28.PubMed
38.
go back to reference Partanen J, Saarenpaa I, Heikkinen T, Wingstrand H, Thorngren KG, Jalovaara P: Functional outcome after displaced femoral neck fractures treated with osteosynthesis or hemiarthroplasty: a matched-pair study of 714 patients. Acta Orthop Scand. 2002, 73: 496-501.PubMed Partanen J, Saarenpaa I, Heikkinen T, Wingstrand H, Thorngren KG, Jalovaara P: Functional outcome after displaced femoral neck fractures treated with osteosynthesis or hemiarthroplasty: a matched-pair study of 714 patients. Acta Orthop Scand. 2002, 73: 496-501.PubMed
39.
go back to reference Scriven M: Evaluation thesaurus. 1991, Newbury Park: Sage Publications, 4 Scriven M: Evaluation thesaurus. 1991, Newbury Park: Sage Publications, 4
40.
go back to reference Deming WE: Out of the crisis. 1982, Melborne: Syndicate of the University of Cambridge Deming WE: Out of the crisis. 1982, Melborne: Syndicate of the University of Cambridge
41.
go back to reference Vanhaecht K, Van Gerven E, Deneckere S, Lodewijckx C, Janssen I, Van Zelm RT: The 7-phase method to design, implement and evaluate care pathways. International Journal for Person Centered Care. 2012, . In Press. Vanhaecht K, Van Gerven E, Deneckere S, Lodewijckx C, Janssen I, Van Zelm RT: The 7-phase method to design, implement and evaluate care pathways. International Journal for Person Centered Care. 2012, . In Press.
42.
go back to reference Lewin S, Glenton C, Oxman AD: Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009, 339: b3496-10.1136/bmj.b3496.CrossRefPubMedPubMedCentral Lewin S, Glenton C, Oxman AD: Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009, 339: b3496-10.1136/bmj.b3496.CrossRefPubMedPubMedCentral
43.
go back to reference Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006, 332: 413-416. 10.1136/bmj.332.7538.413.CrossRefPubMedPubMedCentral Oakley A, Strange V, Bonell C, Allen E, Stephenson J: Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006, 332: 413-416. 10.1136/bmj.332.7538.413.CrossRefPubMedPubMedCentral
44.
go back to reference Hawe P, Shiell A, Riley T: Complex interventions: how “out of control” can a randomised controlled trial be?. BMJ. 2004, 328: 1561-1563. 10.1136/bmj.328.7455.1561.CrossRefPubMedPubMedCentral Hawe P, Shiell A, Riley T: Complex interventions: how “out of control” can a randomised controlled trial be?. BMJ. 2004, 328: 1561-1563. 10.1136/bmj.328.7455.1561.CrossRefPubMedPubMedCentral
45.
go back to reference Vanhaecht K, Bellemans J, De Witte K, Diya L, Lesaffre E, Sermeus W: Does the organisation of care process affect outcome in patients undergoing total joint arthroplasty?. J Eval Clin Pract. 2010, 16: 121-128. 10.1111/j.1365-2753.2009.01130.x.CrossRefPubMed Vanhaecht K, Bellemans J, De Witte K, Diya L, Lesaffre E, Sermeus W: Does the organisation of care process affect outcome in patients undergoing total joint arthroplasty?. J Eval Clin Pract. 2010, 16: 121-128. 10.1111/j.1365-2753.2009.01130.x.CrossRefPubMed
46.
go back to reference Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010, 8: 18-10.1186/1741-7015-8-18.CrossRefPubMedPubMedCentral Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010, 8: 18-10.1186/1741-7015-8-18.CrossRefPubMedPubMedCentral
Metadata
Title
The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial
Authors
Kris Vanhaecht
Walter Sermeus
Jan Peers
Cathy Lodewijckx
Svin Deneckere
Fabrizio Leigheb
Steven Boonen
An Sermon
Paulo Boto
Rita Veloso Mendes
Massimiliano Panella
EQCP study group
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2012
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-12-124

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