Module

Uitkomst raming

Toelichting

Module Trachea-, bronchus- en oesophagusletsel

Geen financiële gevolgen

Uit de toetsing volgt dat de aanbeveling(en) niet breed toepasbaar zijn (<5000 patiënten) en zal daarom naar verwachting geen substantiële financiële gevolgen hebben voor de collectieve uitgaven.

GRADE

Definitie

Hoog

• er is hoge zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
• het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Redelijk

• er is redelijke zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
• het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Laag

• er is lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
• er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Zeer laag

• er is zeer lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
• de literatuurconclusie is zeer onzeker.

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. 

Cluster/richtlijn: Thoracale letsels na trauma – UV4 Trachea, bronchus en oesofagus letsel

Uitgangsvraag/modules: What is the value of a wait and see policy in comparison with scopy and/or CT with oral contrast regarding the diagnostic accuracy of trachea, main bronchus and/or oesophageal injuries in patients with suspected tracheal, broncheal and/or oesophageal injury based on unexplained mediastinal emphysema or persistent air leak despite chest drain?

Database(s): Embase.com, Ovid/Medline

Datum: 29-11-2023

Periode:  geen restrictie

Talen: geen restrictie

Literatuurspecialist: Esther van der Bijl

Rayyan review: https://rayyan.ai/reviews/858428

BMI-zoekblokken: voor verschillende opdrachten wordt (deels) gebruik gemaakt van de zoekblokken van BMI-Online https://blocks.bmi-online.nl/ Bij gebruikmaking van een volledig zoekblok zal naar de betreffende link op de website worden verwezen.

Toelichting:

Voor deze vraag is gezocht op de elementen:

• trachea, hoofdbronchus of oesofagus letsels
• afwachtend beleid
• sensitiviteit/ specificiteit filter

→ Zoals besproken vallen de sleutelartikelen PMID16782296, PMID11312194 , PMID31164915 en PMID26680145 met deze search uit, omdat deze over CT/ scopie gaan en niet over afwachtend beleid.

Te gebruiken voor richtlijntekst:

In de databases Embase.com en Ovid/Medline is op 29-11-2023 systematisch gezocht naar systematische reviews, RCTs en observationele studies over afwachtend beleid bij trachea, bronchus en oesofagus letsel. De literatuurzoekactie leverde 462 unieke treffers op.

EMBASE

OVID/MEDLINE

Ontdubbeld

SR

26

23

49

RCT

62

27

85

Observationeel

112

235

328

Totaal

200

285

462*

No.

Query

Results

#1

'trachea injury'/exp OR 'bronchus perforation'/exp OR 'bronchus injury'/exp OR 'esophagus injury'/exp OR 'bronchus rupture'/exp OR (('trachea'/exp OR 'esophagus'/exp OR 'upper gastrointestinal tract'/exp OR 'tracheobronchial tree'/exp OR 'bronchus'/exp OR 'airway'/exp) AND 'injury'/exp) OR ((('trachea*' OR 'esophag*' OR 'oesophag*' OR 'upper gastrointestinal tract' OR 'airway tree' OR 'bronch* tree' OR 'pulmonary tree' OR 'tracheobronchial system' OR 'tracheobronchial tree' OR 'bronch*' OR 'airway') NEAR/3 ('injur*' OR 'rupture' OR 'laceration*' OR 'perforation*' OR 'damage' OR 'trauma' OR 'infiltration')):ti,ab,kw)

58391

#2

'conservative treatment'/exp OR 'watchful waiting'/exp OR 'active surveillance'/exp OR (((conservative OR observative) NEAR/2 (management OR treatment*)):ti,ab,kw) OR expectative*:ti,ab,kw OR expectantly:ti,ab,kw OR 'watchful waiting':ti,ab,kw OR 'wait and see':ti,ab,kw OR 'wait & see':ti,ab,kw OR 'no treatment':ti,ab,kw OR 'natural course':ti,ab,kw OR observation*:ti,ab,kw OR 'no intervention':ti,ab,kw OR 'active surveillance':ti,ab,kw

2232282

#3

'sensitivity and specificity'/de OR sensitivity:ab,ti OR specificity:ab,ti OR predict*:ab,ti OR 'roc curve':ab,ti OR 'receiver operator':ab,ti OR 'receiver operators':ab,ti OR likelihood:ab,ti OR 'diagnostic error'/exp OR 'diagnostic accuracy'/exp OR 'diagnostic test accuracy study'/exp OR 'inter observer':ab,ti OR 'intra observer':ab,ti OR interobserver:ab,ti OR intraobserver:ab,ti OR validity:ab,ti OR kappa:ab,ti OR reliability:ab,ti OR reproducibility:ab,ti OR ((test NEAR/2 're-test'):ab,ti) OR ((test NEAR/2 'retest'):ab,ti) OR 'reproducibility'/exp OR accuracy:ab,ti OR 'differential diagnosis'/exp OR 'validation study'/de OR 'measurement precision'/exp OR 'diagnostic value'/exp OR 'reliability'/exp OR 'predictive value'/exp OR ppv:ti,ab,kw OR npv:ti,ab,kw OR (((false OR true) NEAR/3 (negative OR positive)):ti,ab)

6248993

#4

#1 AND #2 AND #3

689

#5

#4 NOT ('conference abstract'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp)

358

#6

'meta analysis'/exp OR 'meta analysis (topic)'/exp OR metaanaly*:ti,ab OR 'meta analy*':ti,ab OR metanaly*:ti,ab OR 'systematic review'/de OR 'cochrane database of systematic reviews'/jt OR prisma:ti,ab OR prospero:ti,ab OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab) OR ((systemic* NEAR/1 review*):ti,ab) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab) OR (((literature NEAR/3 review*):ti,ab) AND (search*:ti,ab OR database*:ti,ab OR 'data base*':ti,ab)) OR (('data extraction':ti,ab OR 'data source*':ti,ab) AND 'study selection':ti,ab) OR ('search strategy':ti,ab AND 'selection criteria':ti,ab) OR ('data source*':ti,ab AND 'data synthesis':ti,ab) OR medline:ab OR pubmed:ab OR embase:ab OR cochrane:ab OR (((critical OR rapid) NEAR/2 (review* OR overview* OR synthes*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synthes*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynthes*:ti,ab OR 'meta synthes*':ti,ab

982665

#7

'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomised controlled trial':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti

3928132

#8

'major clinical study'/de OR 'clinical study'/de OR 'case control study'/de OR 'family study'/de OR 'longitudinal study'/de OR 'retrospective study'/de OR 'prospective study'/de OR 'comparative study'/de OR 'cohort analysis'/de OR ((cohort NEAR/1 (study OR studies)):ab,ti) OR (('case control' NEAR/1 (study OR studies)):ab,ti) OR (('follow up' NEAR/1 (study OR studies)):ab,ti) OR (observational NEAR/1 (study OR studies)) OR ((epidemiologic NEAR/1 (study OR studies)):ab,ti) OR (('cross sectional' NEAR/1 (study OR studies)):ab,ti)

7961438

#9

'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('major clinical study'/de OR 'clinical study'/de OR 'cohort analysis'/de OR 'observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab)))

14630504

#10

#5 AND #6 – SR’s

26

#11

#5 AND #7 NOT #10 – RCT’s

62

#12

#5 AND (#8 OR #9) NOT (#10 OR #11) – Observationeel

112

#13

#10 OR #11 OR #12

200

#

Searches

Results

1

exp Esophageal Perforation/ or ((exp Trachea/ or exp Esophagus/ or exp Upper Gastrointestinal Tract/ or exp Bronchi/) and exp "Wounds and Injuries"/) or ((trachea* or 'esophag*' or oesophag* or upper gastrointestinal tract or airway tree or bronch* tree or pulmonary tree or tracheobronchial system or tracheobronchial tree or bronch* or airway) adj3 (injur* or rupture or laceration* or perforation* or damage or trauma or infiltration)).ti,ab,kf.

33962

2

exp Conservative Treatment/ or exp Watchful Waiting/ or ((conservative or observative) adj2 (management or treatment)).ti,ab,kf. or expectative*.ti,ab,kf. or expectantly.ti,ab,kf. or watchful waiting.ti,ab,kf. or "wait and see".ti,ab,kf. or wait & see.ti,ab,kf. or no treatment.ti,ab,kf. or natural course.ti,ab,kf. or no intervention.ti,ab,kf. or active surveillance.ti,ab,kf.

134015

3

exp "Sensitivity and Specificity"/ or (sensitivity or specificity).ti,ab. or (predict* or ROC-curve or receiver-operator*).ti,ab. or (likelihood or LR*).ti,ab. or exp Diagnostic Errors/ or (inter-observer or intra-observer or interobserver or intraobserver or validity or kappa or reliability).ti,ab. or reproducibility.ti,ab. or (test adj2 (re-test or retest)).ti,ab. or "Reproducibility of Results"/ or accuracy.ti,ab. or Diagnosis, Differential/ or Validation Study/ or ((false or true) adj3 (negative or positive)).ti,ab.

4956366

4

1 and 2 and 3

66

5

1 and 2

815

6

5 not (comment/ or editorial/ or letter/) not ((exp animals/ or exp models, animal/) not humans/)

780

7

meta-analysis/ or meta-analysis as topic/ or (metaanaly* or meta-analy* or metanaly*).ti,ab,kf. or systematic review/ or cochrane.jw. or (prisma or prospero).ti,ab,kf. or ((systemati* or scoping or umbrella or "structured literature") adj3 (review* or overview*)).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data-base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 review*) and (search* or database* or data-base*)).ti,ab,kf. or (("data extraction" or "data source*") and "study selection").ti,ab,kf. or ("search strategy" and "selection criteria").ti,ab,kf. or ("data source*" and "data synthesis").ti,ab,kf. or (medline or pubmed or embase or cochrane).ab. or ((critical or rapid) adj2 (review* or overview* or synthes*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synthes*)) and (search* or database* or data-base*)).ab. or (metasynthes* or meta-synthes*).ti,ab,kf.

711024

8

exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw.

2663888

9

Epidemiologic studies/ or case control studies/ or exp cohort studies/ or Controlled Before-After Studies/ or Case control.tw. or cohort.tw. or Cohort analy$.tw. or (Follow up adj (study or studies)).tw. or (observational adj (study or studies)).tw. or Longitudinal.tw. or Retrospective*.tw. or prospective*.tw. or consecutive*.tw. or Cross sectional.tw. or Cross-sectional studies/ or historically controlled study/ or interrupted time series analysis/ [Onder exp cohort studies vallen ook longitudinale, prospectieve en retrospectieve studies]

4596101

10

Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or ((exp cohort studies/ or epidemiologic studies/ or multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.))

5570297

11

6 and 7 – SR’s

23

12

(6 and 8) not 11 – RCT’s

27

13

(6 and (9 or 10)) not (11 or 12) – Observationeel

235

14

11 or 12 or 13

285