Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials

被引：39

作者：

Blencowe, N. S. ^{[1
,2
]}

Boddy, A. P. ^{[3
]}

Harris, A. ^{[4
]}

Hanna, T. ^{[5
,6
]}

Whiting, P. ^{[1
]}

Cook, J. A. ^{[7
]}

Blazeby, J. M. ^{[1
,2
]}

机构：

[1] Univ Bristol, Sch Social & Community Med, Surg Res Ctr, Bristol BS8 2PS, Avon, England

[2] Univ Hosp Bristol NHS Fdn Trust, Bristol Royal Infirm, Div Surg Head & Neck, Bristol, Avon, England

[3] Leicester Royal Infirm, Univ Hosp Leicester NHS Trust, Dept Surg, Leicester, Leics, England

[4] Univ London Imperial Coll Sci Technol & Med, Dept Surg & Canc, London, England

[5] Royal Liverpool & Broadgreen Univ Hosp, Natl Inst Hlth Res, Pancreas Biomed Res Unit, Liverpool, Merseyside, England

[6] Univ Liverpool, Liverpool L69 3BX, Merseyside, England

[7] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Ctr Stat Med, Oxford, England

来源：

BRITISH JOURNAL OF SURGERY | 2015年 / 102卷 / 09期

基金：

美国国家卫生研究院;

关键词：

GENTAMICIN-COLLAGEN SPONGE; ARTERY-BYPASS SURGERY; QUALITY-OF-LIFE; CONSORT STATEMENT; FIBRIN SEALANT; GASTRIC BYPASS; RADIOFREQUENCY ABLATION; DUODENAL SWITCH; TERM OUTCOMES; MESH FIXATION;

D O I：

10.1002/bjs.9808

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

BackgroundSurgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials (RCTs) within the context of explanatory and pragmatic study designs. MethodsSystematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments (CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed. ResultsOf 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (806 per cent) were provided. Standardization was mentioned for 47 (294 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 344 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory. ConclusionThe lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice. Inadequate information in many surgical trials

引用

页码：1037 / 1047

页数：11

共 97 条

[1] Randomized clinical trial comparing the cost and effectiveness of bipolar vessel sealers versus clips and vascular staplers for laparoscopic colorectal resection [J].

Adamina, M. ;

Champagne, B. J. ;

Hoffman, L. ;

Ermlich, M. B. ;

Delaney, C. P. .

BRITISH JOURNAL OF SURGERY, 2011, 98 (12) :1703-1712

[2] A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele [J].

Adzick, N. Scott ;

Thom, Elizabeth A. ;

Spong, Catherine Y. ;

Brock, John W., III ;

Burrows, Pamela K. ;

Johnson, Mark P. ;

Howell, Lori J. ;

Farrell, Jody A. ;

Dabrowiak, Mary E. ;

Sutton, Leslie N. ;

Gupta, Nalin ;

Tulipan, Noel B. ;

D'Alton, Mary E. ;

Farmer, Diana L. .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (11) :993-1004

[3] Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse [J].

Altman, Daniel ;

Vayrynen, Tapio ;

Engh, Marie Ellstrom ;

Axelsen, Susanne ;

Falconer, Christian .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (19) :1826-1836

[4]

Altman DG, 1996, BRIT MED J, V313, P570

[5] Mediastinoscopy vs Endosonography for Mediastinal Nodal Staging of Lung Cancer A Randomized Trial [J].

Annema, Jouke T. ;

van Meerbeeck, Jan P. ;

Rintoul, Robert C. ;

Dooms, Christophe ;

Deschepper, Ellen ;

Dekkers, Olaf M. ;

De Leyn, Paul ;

Braun, Jerry ;

Carroll, Nicholas R. ;

Praet, Marleen ;

de Ryck, Frederick ;

Vansteenkiste, Johan ;

Vermassen, Frank ;

Versteegh, Michel I. ;

Veselic, Maud ;

Nicholson, Andrew G. ;

Rabe, Klaus F. ;

Tournoy, Kurt G. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (20) :2245-2252

[6]

[Anonymous], J CITATION REPORTS W

[7] Understanding surgical interventions in RCTs: the need for better methodology [J].

Avery, K. N. ;

Barham, C. P. ;

Berrisford, R. ;

Blazeby, J. M. ;

Blencowe, N. S. ;

Donovan, J. ;

Elliott, J. ;

Falk, S. J. ;

Goldin, R. ;

Hanna, G. ;

Hollowood, A. D. ;

Metcalfe, C. ;

Noble, S. ;

Sanders, G. ;

Streets, C. G. ;

Titcomb, D. R. ;

Wheatley, T. .

LANCET, 2013, 381 (9860) :27-28

[8] Standards of reporting of randomized controlled trials in general surgery - Can we do better? [J].

Balasubramanian, Sabapathy P. ;

Wiener, Martin ;

Alshameeri, Zeiad ;

Tiruvoipati, Ravindranath ;

Elbourne, Diana ;

Reed, Malcolm W. .

ANNALS OF SURGERY, 2006, 244 (05) :663-667

[9] Gentamicin-Collagen Sponge for Infection Prophylaxis in Colorectal Surgery [J].

Bennett-Guerrero, Elliott ;

Pappas, Theodore N. ;

Koltun, Walter A. ;

Fleshman, James W. ;

Lin, Min ;

Garg, Jyotsna ;

Mark, Daniel B. ;

Marcet, Jorge E. ;

Remzi, Feza H. ;

George, Virgilio V. ;

Newland, Kerstin ;

Corey, G. R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (11) :1038-1049

[10] Effect of an Implantable Gentamicin-Collagen Sponge on Sternal Wound Infections Following Cardiac Surgery A Randomized Trial [J].

Bennett-Guerrero, Elliott ;

Ferguson, T. Bruce, Jr. ;

Lin, Min ;

Garg, Jyotsna ;

Mark, Daniel B. ;

Scavo, Vincent A., Jr. ;

Kouchoukos, Nicholas ;

Richardson, John B., Jr. ;

Pridgen, Rence L. ;

Corey, G. R. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (07) :755-762

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