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Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority)

Identifieur interne : 000163 ( Pascal/Corpus ); précédent : 000162; suivant : 000164

Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority)

Auteurs : Katharina Biester ; Guido Skipka ; Rebecca Jahn ; Barbara Buchberger ; Volker Rohde ; Stefan Lange

Source :

RBID : Pascal:12-0153781

Descripteurs français

English descriptors

Abstract

OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
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A03   1    @0 BJU int. : (Print)
A05       @2 109
A06       @2 5
A08 01  1  ENG  @1 Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority)
A11 01  1    @1 BIESTER (Katharina)
A11 02  1    @1 SKIPKA (Guido)
A11 03  1    @1 JAHN (Rebecca)
A11 04  1    @1 BUCHBERGER (Barbara)
A11 05  1    @1 ROHDE (Volker)
A11 06  1    @1 LANGE (Stefan)
A14 01      @1 Institute for Quality and Efficiency in Health Care @2 Cologne @3 DEU @Z 1 aut. @Z 2 aut. @Z 6 aut.
A14 02      @1 Institute for Health Care Management and Research, University of Duisburg @2 Essen @3 DEU @Z 3 aut. @Z 4 aut.
A14 03      @1 Helios Agnes Karll Hospital @2 Bad Schwartau @3 DEU @Z 5 aut.
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A44       @0 0000 @1 © 2012 INIST-CNRS. All rights reserved.
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C01 01    ENG  @0 OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.
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Format Inist (serveur)

NO : PASCAL 12-0153781 INIST
ET : Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority)
AU : BIESTER (Katharina); SKIPKA (Guido); JAHN (Rebecca); BUCHBERGER (Barbara); ROHDE (Volker); LANGE (Stefan)
AF : Institute for Quality and Efficiency in Health Care/Cologne/Allemagne (1 aut., 2 aut., 6 aut.); Institute for Health Care Management and Research, University of Duisburg/Essen/Allemagne (3 aut., 4 aut.); Helios Agnes Karll Hospital/Bad Schwartau/Allemagne (5 aut.)
DT : Publication en série; Niveau analytique
SO : BJU international : (Papier); ISSN 1464-4096; Royaume-Uni; Da. 2012; Vol. 109; No. 5; Pp. 722-730; Bibl. 35 ref.
LA : Anglais
EA : OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.
CC : 002B14D02; 002B20B02
FD : Adénome de la prostate; Article synthèse; Revue bibliographique; Chirurgie; Traitement; Voie transurétrale; Equivalence; Voie abord; Résection chirurgicale; Prostate; Norme; Etalon; Néphrologie; Urologie
FG : Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire; Tumeur bénigne; Pathologie de la prostate; Appareil urogénital
ED : Benign prostatic hyperplasia; Review; Bibliographic review; Surgery; Treatment; Transurethral route; Equivalence; Surgical approach; Surgical resection; Prostate; Standards; Standard; Nephrology; Urology
EG : Male genital diseases; Urinary system disease; Benign neoplasm; Prostate disease; Urogenital system
SD : Hiperplasia prostática benigna; Artículo síntesis; Revista bibliográfica; Cirugía; Tratamiento; Via transuretral; Equivalencia; Vía abordaje; Resección quirúrgica; Prostata; Norma; Marco; Nefrología; Urología
LO : INIST-1050.354000502845880130
ID : 12-0153781

Links to Exploration step

Pascal:12-0153781

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<div type="abstract" xml:lang="en">OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.</div>
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<s1>Helios Agnes Karll Hospital</s1>
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<s0>OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.</s0>
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<s5>11</s5>
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<s0>Resección quirúrgica</s0>
<s5>11</s5>
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<s5>12</s5>
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<fC03 i1="10" i2="X" l="ENG">
<s0>Prostate</s0>
<s5>12</s5>
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<s0>Prostata</s0>
<s5>12</s5>
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<s5>17</s5>
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<s5>18</s5>
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<s5>19</s5>
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<s5>37</s5>
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<s5>37</s5>
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<s0>Urinary system disease</s0>
<s5>38</s5>
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<s5>39</s5>
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<s5>41</s5>
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<NO>PASCAL 12-0153781 INIST</NO>
<ET>Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority)</ET>
<AU>BIESTER (Katharina); SKIPKA (Guido); JAHN (Rebecca); BUCHBERGER (Barbara); ROHDE (Volker); LANGE (Stefan)</AU>
<AF>Institute for Quality and Efficiency in Health Care/Cologne/Allemagne (1 aut., 2 aut., 6 aut.); Institute for Health Care Management and Research, University of Duisburg/Essen/Allemagne (3 aut., 4 aut.); Helios Agnes Karll Hospital/Bad Schwartau/Allemagne (5 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>BJU international : (Papier); ISSN 1464-4096; Royaume-Uni; Da. 2012; Vol. 109; No. 5; Pp. 722-730; Bibl. 35 ref.</SO>
<LA>Anglais</LA>
<EA>OBJECTIVE • To assess the potential additional benefit of non-standard vs standard surgical treatments for benign prostatic hyperplasia (BPH) and to present a new methodological approach to investigate therapeutic equivalence (non-inferiority) regarding symptom reduction. PATIENTS AND METHODS • We conducted a systematic review and searched MEDLINE, Embase and the Cochrane Library (last search: 10/2009) for randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). • Eligible studies were those that included patients with symptomatic BPH requiring surgical treatment and which compared non-standard procedures (e.g. minimally invasive technologies) with standard ones (e.g. transurethral resection of the prostate, TURP). In addition, only studies analysing patient-relevant outcomes were considered (e.g. irritative and obstructive symptoms, length of hospital stay, quality of life and adverse events). • The main outcome of interest for the present analysis was superiority or non-inferiority for symptom reduction. • As no trial investigated non-inferiority, we defined a non-inferiority threshold (0.25 standard deviation) on the basis of published literature. If a non-standard procedure showed non-inferiority for symptom reduction, additional outcomes were assessed. Meta-analyses were conducted if feasible and meaningful. RESULTS • In all, 43 mainly low-quality trials (RCTs only) compared nine non-standard surgical treatments with standard ones. • Mean follow-up ranged from 6 to 84 months. • No non-standard procedure was superior for symptom reduction. Non-inferiority for symptom reduction was shown in patients who had undergone holmium laser resection of the prostate (HoLRP) or thulium laser resection of the prostate (TmLRP). • As procedural advantages (e.g. no occurrence of transurethral resection syndrome) and other advantages (e.g. shortened hospital stay) were found, an indication of an additional benefit of HoLRP and TmLRP was determined. CONCLUSIONS • No proof of superiority for symptom reduction has been shown for non-standard surgical treatments in patients with BPH. • There is a lack of high-quality RCTs and trials designed to investigate non-inferiority. • Future studies should define a non-inferiority threshold (ideally, uniform) a priori, so that results of individual studies are interpretable and comparable, and future systematic reviews should consider this issue.</EA>
<CC>002B14D02; 002B20B02</CC>
<FD>Adénome de la prostate; Article synthèse; Revue bibliographique; Chirurgie; Traitement; Voie transurétrale; Equivalence; Voie abord; Résection chirurgicale; Prostate; Norme; Etalon; Néphrologie; Urologie</FD>
<FG>Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire; Tumeur bénigne; Pathologie de la prostate; Appareil urogénital</FG>
<ED>Benign prostatic hyperplasia; Review; Bibliographic review; Surgery; Treatment; Transurethral route; Equivalence; Surgical approach; Surgical resection; Prostate; Standards; Standard; Nephrology; Urology</ED>
<EG>Male genital diseases; Urinary system disease; Benign neoplasm; Prostate disease; Urogenital system</EG>
<SD>Hiperplasia prostática benigna; Artículo síntesis; Revista bibliográfica; Cirugía; Tratamiento; Via transuretral; Equivalencia; Vía abordaje; Resección quirúrgica; Prostata; Norma; Marco; Nefrología; Urología</SD>
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<ID>12-0153781</ID>
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