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    Appendix A: Methods and literature search strategy

    Methods and literature search strategy 

    NICE has identified studies and reviews relevant to laparoscopic insertion of an inactive implant for gastro-oesophageal reflux disease from the medical literature. Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. 

    Search strategy design and peer review 

    This search report is informed by the Preferred Reporting Items for Systematic reviews and Meta-Analyses literature search extension (PRISMA-S). A NICE information specialist ran the literature searches on 03 June 2024. See the search strategy history for the full search strategy for each database. The principal search strategy was developed in MEDLINE ALL (Ovid interface). It was adapted for use in each of the databases listed in table 4a, taking into account the database's size, search functionality and subject coverage. The MEDLINE ALL strategy was quality assured by a NICE senior information specialist. All translated search strategies were peer reviewed to ensure their accuracy. The quality assurance and peer review procedures were adapted from the Peer Review of Electronic Search Strategies (PRESS) 2015 evidence-based checklist

    Review management 

    The search results were managed in EPPI Reviewer version 5 (EPPIR5). Duplicates were removed in EPPIR5 using a 2-step process. First, automated deduplication was done using a high-value algorithm. Second, manual deduplication was used to assess low-probability matches. All decisions about inclusion, exclusion and deduplication were recorded and stored. 

    Limits and restrictions 

    The search was not limited by date or language. The CENTRAL database search removed trial registry records and conference material. The limit to remove animal studies in the searches is standard NICE practice, which has been adapted from Dickersin K, Scherer R, Lefebvre C (1994) Systematic Reviews: Identifying relevant studies for systematic reviews. BMJ 309(6964): 1286

    Main search

    Table 4a Main search results 

    Database 

    Date searched 

    Database platform 

    Database segment or version 

    Number of results downloaded 

    Cochrane Central Register of Controlled Trials (CENTRAL) 

     03/06/2024 

    Wiley 

    Issue 6 of 12, June 2024 

    218 

    Cochrane Database of Systematic Reviews (CDSR) 

     

    Protocols  

    03/06/2024 

    Wiley 

    Issue 6 of 12, June 2024 

     

     

     

     

     

    Embase 

     

     

     

    Embase Conferences  

    03/06/2024 

    Ovid 

     

     

     

    Ovid 

     

    1974 to 2024 May 31 

     

    335 

     

     

     

     

     

    171 

    INAHTA International HTA Database  

    03/06/2024 

     https://database.inahta.org/ 

    141 

    MEDLINE ALL 

    03/06/2024 

    Ovid 

    1946 to May 30, 2024 

    833 

     

    Search strategy history  

    MEDLINE ALL search strategy 

    1 , exp Gastroesophageal Reflux/ , 29,987  

    2 , ((gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) adj4 reflux*).tw. , 32,987  

    3 , Esophageal Motility Disorders/ , 2,261  

    4 , ((oesophag* or esophag*) adj4 (motilit* or dysmotilit* or disorder* or funct*)).tw. , 9,274  

    5 , (gord or gerd).tw. , 11,641  

    6 , Heartburn/ , 2,323  

    7 , ((heart adj1 burn) or heartburn or pyros?s or (water adj1 brash) or waterbrash or (acid adj1 brash) or acidbrash).tw. , 6,183  

    8 , Barrett Esophagus/ , 8,880  

    9 , (barrett* adj4 (esophag* or oesophag* or dysplas* or syndrom*)).tw. , 10,274  

    10 , Esophageal Sphincter, Lower/ , 1,907  

    11 , (lower adj4 (gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) adj4 sphincter*).tw. , 6,003  

    12 , (gastric adj4 (reflux* or regurgitat* or acid* or juice*)).tw. , 25,048  

    13 , ((acid or bile) adj4 (reflux* or indigest* or flow-back or flowback or back-flow or backflow)).tw. , 5,523  

    14 , Dyspepsia/ , 9,412  

    15 , dyspepsi*.tw. , 12,815  

    16 , Hernia, Hiatal/ , 7,001  

    17 , ((oesophag* or esophag* or para?esophag* or hiat*) adj4 hernia*).tw. , 8,844  

    18 , deglutition disorder/ , 24,703  

    19 , (Deglutit* adj4 disord*).tw. , 341  

    20 , dysphag*.tw. , 36,177  

    21 , or/1-20 , 143,991  

    22 , "Prostheses and Implants"/ , 50,486  

    23 , Prosthesis Implantation/ , 15,741  

    24 , Prosthesis Design/ , 61,937  

    25 , (prosthe* adj4 (design* or implant*)).tw. , 22,984  

    26 , (implantable adj2 device).tw. , 2,961  

    27 , ((anti-reflux or non-active) adj4 implant*).tw. , 24  

    28 , or/22-27 , 138,552  

    29 , 21 and 28 , 870  

    30 , refluxstop.tw. , 6  

    31 , 29 or 30 , 873  

    32 , animals/ not humans/ , 5,192,576  

    33 , 31 not 32 , 833 

     

    Embase search strategy 

    1, exp gastroesophageal reflux/, 80,534 

    2, ((gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) adj4 reflux*).tw., 51,332 

    3, esophagus function disorder/, 3,016 

    4, ((oesophag* or esophag*) adj4 (motilit* or dysmotilit* or disorder* of funct*)).tw., 8,340 

    5, (gord or gerd).tw., 24,694 

    6, heartburn/, 17,717 

    7, ((heart adj1 burn) or heartburn or pyros?s or (water adj1 brash) or waterbrash or (acid adj1 brash) or acidbrash).tw., 11,398 

    8, Barrett esophagus/, 20,102 

    9, (barrett* adj4 (esophag* or oesophag* or dysplas* or syndrom*)).tw., 17,658 

    10, lower esophagus sphincter/, 14,133 

    11, (lower adj4 (gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) adj4 sphincter*).tw., 9,433 

    12, (gastric adj4 (reflux* or regurgitat* or acid* or juice*)).tw., 29,181 

    13, ((acid or bile) adj4 (reflux* or indigest* or flow-back or flowback or back-flow or backflow)).tw., 9,349 

    14, Dyspepsia/, 40,639 

    15, dyspepsi*.tw., 20,118 

    16, hiatus hernia/, 15,657 

    17, ((oesophag* or esophag* or para?esophag* or hiat*) adj4 hernia*).tw., 13,006 

    18, dysphagia/, 95,461 

    19, (Deglutit* adj4 disord*).tw., 356 

    20, dysphag*.tw., 63,413 

    21, or/1-20, 283,966 

    22, prosthesis/, 34,291 

    23, prosthesis implantation/, 3,383 

    24, prosthesis design/, 8,182 

    25, (prosthes* adj4 (design* or implant*)).tw., 20,535 

    26, (implantable adj2 device).tw., 4,797 

    27, ((anti-reflux or non-active) adj4 implant*).tw., 35 

    28, or/22-27, 65,776 

    29, 21 and 28, 499 

    30, refluxstop.tw,dv,dm., 25 

    31, 29 or 30, 514 

    32, Nonhuman/ not human/, 5,456,142 

    33, 31 not 32, 506 

    34, (conference abstract* or conference review or conference paper or conference proceeding).db,pt,su., 5,959,494 

    35, 33 not 34, 335 

    36, 33 and 34, 171 

     
    (CDSR and CENTRAL) search strategy 

    #1 MeSH descriptor: [Gastroesophageal Reflux] explode all trees 2561  

    #2 ((gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) near/4 reflux*) 6553  

    #3 MeSH descriptor: [Esophageal Motility Disorders] explode all trees 2794  

    #4 ((oesophag* or esophag*) near/4 (motilit* or dysmotilit* or disorder* of funct*)) 11154  

    #5 (gord or gerd) 2471  

    #6 MeSH descriptor: [Heartburn] explode all trees 467  

    #7 ((heart near/1 burn) or heartburn or pyros?s or (water near/1 brash) or waterbrash or (acid near/1 brash) or acidbrash) 2937  

    #8 MeSH descriptor: [Barrett Esophagus] explode all trees 347  

    #9 (barrett* near/4 (esophag* or oesophag* or dysplas* or syndrom*)) 798  

    #10 MeSH descriptor: [Esophageal Sphincter, Lower] explode all trees 101  

    #11 (lower near/4 (gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) near/4 sphincter*) 1018  

    #12 gastric near/4 (reflux* or regurgitat* or acid* or juice*) 4362  

    #13 ((acid or bile) near/4 (reflux* or indigest* or flow-back or flowback or back-flow or backflow)) 1107  

    #14 MeSH descriptor: [Dyspepsia] explode all trees 1437  

    #15 dyspepsi* 6542  

    #16 MeSH descriptor: [Hernia, Hiatal] explode all trees 135  

    #17 ((oesophag* or esophag* or para?esophag* or hiat*) near/4 hernia*) 501  

    #18 MeSH descriptor: [Deglutition Disorders] explode all trees 4107  

    #19 (Deglutit* near/4  disord*) 1514  

    #20 dysphag* 6190  

    #21 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 31305  

    #22 MeSH descriptor: [Prostheses and Implants] explode all trees 25963  

    #23 MeSH descriptor: [Prosthesis Implantation] explode all trees 11818  

    #24 MeSH descriptor: [Prosthesis Design] explode all trees 3527  

    #25 (prosthes* near/4 (design* or implant*)) 9295  

    #26 (implantable near/2 device) 379  

    #27 (anti-reflux or non-active)  near/4 implant* 6  

    #28 #22 or #23 or #24 or #25 or #26 or #27 34255  

    #29 #21 AND #28 230  

    #30 refluxstop 2  

    #31 #29 or #30 231  

    #32 "conference":pt or (clinicaltrials or trialsearch):so 750874  

    #33 #31 NOT #32 227  

     

    INAHTA HTA search strategy 

    1 , "Gastroesophageal Reflux"[mhe] , 47  

    2 , ((gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) AND reflux*) , 36  

    3 , "Esophageal Motility Disorders"[mh] , 0  

    4 , (oesophag* or esophag*) AND (motilit* or dysmotilit* or disorder* of funct*)) , 21  

    5 , (gord or gerd) , 36  

    6 , "Heartburn"[mh] , 3  

    7 , (heart AND burn) or heartburn or pyros?s or (water AND brash) or waterbrash or (acid AND brash) or acidbrash) , 8  

    8 , "Barrett Esophagus"[mh] , 30  

    9 , (barrett* AND (esophag* or oesophag* or dysplas* or syndrom*)) , 38  

    10 , "Esophageal Sphincter, Lower"[mh] , 6  

    11 , (lower AND (gastro-esophag* or gastro-oesophag* or gastro?esophag* or oesophag* or esophag*) AND sphincter*) , 7  

    12 , gastric AND (reflux* or regurgitat* or acid* or juice*) , 14  

    13 , (acid or bile) AND (reflux* or indigest* or flow-back or flowback or back-flow or backflow)) , 13  

    14 , "Dyspepsia"[mh] , 16  

    15 , dyspepsi* , 29  

    16 , "Hernia, Hiatal"[mh] , 0  

    17 , (oesophag* or esophag* or para?esophag* or hiat*) AND hernia*) , 5  

    18 , "Deglutition Disorders"[mh] , 22  

    19 , (Deglutit* AND disord*) , 1  

    20 , dysphag* , 37  

    21 , #20 OR #19 OR #18 OR #17 OR #16 OR #15 OR #14 OR #13 OR #12 OR #11 OR #10 OR #9 OR #8 OR #7 OR #6 OR #5 OR #4 OR #3 OR #2 OR #1 , 183  

    22 , "Prostheses and Implants"[mh] , 154  

    23 , "Prosthesis Implantation"[mh] , 169  

    24 , "Prosthesis Design"[mh] , 39  

    25 , (prosthes* AND (design* or implant*)) , 78  

    26 , (implantable AND device) , 48  

    27 , (anti-reflux or non-active) AND implant* , 2  

    28 , #27 OR #26 OR #25 OR #24 OR #23 OR #22 , 417  

    29 , #28 AND #21 , 141  

    30 , refluxstop , 1  

    31 , #30 OR #29 , 141 

     

    Inclusion criteria 

    The following inclusion criteria were applied to the abstracts identified by the literature search. 

    • Publication type: clinical studies were included with emphasis on identifying good quality studies. Abstracts were excluded if they did not report clinical outcomes. Reviews, editorials, and laboratory or animal studies, were also excluded and so were conference abstracts, because of the difficulty of appraising study methodology, unless they reported specific adverse events not available in the published literature. 

    • People with: gastro-oesophageal reflux disease. 

    • Intervention or test: Laparoscopic insertion of an inactive implant (RefluxStop)

    • Outcome: articles were retrieved if the abstract contained information relevant to the safety, efficacy, or both. 

    If selection criteria could not be determined from the abstracts the full paper was retrieved. 

    Find out more about how NICE selects the evidence for the committee