APPENDIX 1: Detailed Review Methods · A-2 HTIS - Portable Ultrasound Devices in Emergency Departments DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS OR CTS-285 OR CTS-385 OR CTS-485

HTIS - Portable Ultrasound Devices in Emergency Departments A-1

APPENDIX 1: Detailed Review Methods Literature Search Strategies Guide to Search Syntax (DIALOGP® P) ! Explode the search term (i.e., retrieve the search concept plus all narrower terms ? Truncation symbol. Retrieves plural and variant endings. (w) Proximity operator. Words must be adjacent. () Proximity operator. Words must be adjacent. (n) Proximity operator. Words must be adjacent, in any order. (l) Proximity operator. Words in subject heading adjacent to the subheading. ab Search in article abstracts. de Descriptor i.e. subject heading (a controlled, thesaurus term in DIALOGP® P). dt Document type. nd Device name (EMBASEP®P). ti Search in article titles. Literature Search for Clinical Studies

DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS DIALOGP® BIOSIS PreviewsP® MEDLINEP® EMBASEP® PASCAL

1990- English

(ultrasonography! Or ultrasonics)/de from [MEDLINEP®P] OR echography/de from [EMBASEP®P] OR (ultrasonography or ultrasound or echography)/de from [BIOSIS PreviewsP®P] OR (ultrasonography or echography or echotomography or ultrasonic()tomography or ultrasonics or ultrasound or sonography)/ti,ab AND ((portable or emergency or ED or mobile or point(w)care or point-of-care or bedside or bed()side or compact) or (cart(2w)(mount or mounted)))/ti,ab OR point-of-care systems/de from [MEDLINEP®P] OR ND=(Masters()Gateway()2000 OR Tosbee Power Vision 7000 or Sonoline Elegra OR Acuson 128()XP10 OR SiteRite OR cypress or SSD-500 OR SSD-900 OR Merlin 1101 OR Caris OR Caris Plus OR Concept\D OR Concept\G OR Concept\MC OR Concept\ML OR Concept\S OR UF-4000 OR UF-4100 OR UF-4200R OR UF-4300R OR UF-5800A OR Logiq 100 Pro OR Logiq Book OR EUB-405 OR HS-2000 OR HS-3000 OR Sigma 330 Master OR My Sono 201 OR SonoAce 600 Eureka OR OptiGo OR Falco OR Picus OR CTS-200


DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS OR CTS-285 OR CTS-385 OR CTS-485 OR SDU-350XL OR Terason 2000 OR Just Vision 200 OR SDU-1200 OR SDU-2200 OR SDU-450XL OR Aplio OR Aquila OR UF-750XT OR Sonata) from [EMBASEP®P] OR (Masters()Gateway()2000 OR Tosbee()Power()Vision()7000 or Sonoline()Elegra OR Acuson()128()XP10 OR SiteRite OR cypress or SSD()500 OR SSD()900 OR Merlin() 1101 OR Caris OR Caris()Plus OR Concept()D OR Concept()G OR Concept()MC OR Concept()ML OR Concept()S OR UF()4000 OR UF()4100 OR UF()4200R OR UF()4300R OR UF()5800A OR Logiq()100()Pro OR Logiq() Book OR EUB()405 OR HS()2000 OR HS()3000 OR Sigma()330()Master OR My()Sono()201 OR SonoAce()600 Eureka OR OptiGo OR Falco OR Picus OR CTS()200 OR CTS()285 OR CTS()385 OR CTS()485 OR SDU()350XL OR Terason()2000 OR Just()Vision()200 OR SDU()1200 OR SDU()2200 OR SDU()450XL OR Aplio OR Aquila OR UF()750XT OR Sonata)/ti,ab AND Aortic Aneurysm, Abdominal/de from [MEDLINEP®P] OR abdominal aorta aneurysm/de from [EMBASEP®P] OR abdominal aortic aneurysm/de from [BIOSIS PreviewsP®P] OR (abdominal()aortic()aneurysm? Or abdominal()aorta()aneurysm? Or AAA)/ti,ab OR ((abdominal OR abdomen OR aorta OR aortic) AND aneurysm?)/ti,ab OR abdominal injuries!/de from [MEDLINEP®P] OR abdomen(l)ultrasonography/de from [MEDLINEP®P] OR abdominal ultrasonography /de from [BIOSIS PreviewsP®P] OR abdominal injury/de from [EMBASEP®P] OR (traumatic injury/de from [BIOSIS PreviewsP®P] OR (trauma? Or wound or injur?)/ti,ab) AND (abdominal or abdomen)/ti,ab OR pregnancy, ectopic/de from [MEDLINEP®P] OR


DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS ectopic pregnancy/de from [EMBASEP®P],[BIOSIS PreviewsP®P] OR ((ectopic or ovarian or tubal or ovary or abdominal or uterine()tube)(1w)(pregnanc?))/ti,ab AND dt=(meta-analysis OR controlled clinical trial OR randomized controlled trial OR multicenter study OR clinical trial OR clinical trial, phase i OR clinical trial, phase ii OR clinical trial, phase iii OR clinical trial, phase iv OR review OR review, multicase) from [MEDLINEP®P] OR (clinical trials! OR comparative study OR epidemiologic research design! OR epidemiologic studies! OR evaluation studies OR random allocation)/de from [MEDLINEP®P] OR (Clinical study! OR controlled study! OR comparative study OR evidence based medicine OR cohort analysis OR crossover procedure)/de from [EMBASEP®P] OR (clinical trial OR clinical study OR clinical studies OR case-control study OR case-control studies OR randomized trial OR prospective study OR retrospective study OR randomized controlled trial OR multicenter study OR randomized clinical trial OR meta-analysis OR evidence-based medicine OR cohort study OR epidemiological studies OR comparative study)/de from [BIOSIS PreviewsP®P] OR (random? OR controlled()trial? OR controlled()clinical()trial? OR double()blind? Or rct?)/ti,ab OR (single()blind? OR triple()blind? OR treble()blind? OR open()label()stud? OR open()label()trial?)/ti,ab OR s (retrospective()stud? OR prospective()stud? OR sham)/ti,ab OR (meta()analy? OR metaanaly? OR meta-analysis)/ti,ab OR s (cohort()stud? OR case()control()stud? OR epidemiologic()stud?)/ti,ab OR ((research or quantitative or methodologic or systematic)(w)(review or reviews or overview or overviews))/ti,ab OR (research()integration OR integrative()research OR


DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS quantitative()synthes?s OR comparative()stud?)/ti,ab OR (evidence-based()medicine OR evidence()based()medicine)/ti,ab OR (follow-up()stud? OR evaluation()stud?)/ti,ab OR (case()series OR case-series OR cross-over OR crossover)/ti,ab OR (multi-center OR multicenter OR multi-centre OR multicentre)/ti,ab Performed: May 13, 2005 Total hits=398 records

PubMed Cochrane Library

1990- present Same MeSH headings and keywords as the original DIALOGP®P MEDLINEP®P search. Searches performed May 17, 2005; last update August 2005.

Search of HTA, near-HTA websites for published, in-progress and planned reports

e.g., INAHTA, AHRQ, University of York NHS Centre for Reviews and Dissemination (CRD) databases, NCCHTA, NICE, WHO, etc.

Literature Search for Training and Credentialing

DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS DIALOGP® BIOSIS PreviewsP® MEDLINEP® EMBASEP® PASCAL

1990- English

(ultrasonography! Or ultrasonics)/de from [MEDLINEP®P] OR echography/de from [EMBASEP®P] OR (ultrasonography or ultrasound or echography)/de from [BIOSIS PreviewsP®P] OR (ultrasonography or echography or echotomography or ultrasonic()tomography or ultrasonics or ultrasound or sonography)/ti,ab AND ((portable or emergency or ED or mobile or point(w)care or point-of-care or bedside or bed()side or compact) or (cart(2w)(mount or mounted)))/ti,ab OR point-of-care systems/de from [MEDLINEP®P]


DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS AND (credentialing or accreditation! Or certification!)/de from [MEDLINEP®P] OR (education or training or teaching)/de from [MEDLINEP®P],[BIOSIS PreviewsP®P] OR (education or accreditation or certification or teaching)/de from [EMBASEP®P] OR (credential? Or accreditation? Or certification? Or training? Or learn?)/ti,ab OR (ultrasonography(l)education or ultrasonography(l)standards)/de from [MEDLINEP®P] AND (emergencies or emergency service, hospital or emergency medical services or emergency medicine or after-hours-care)/de from [MEDLINEP®P] OR (emergency department or emergency medicine or emergency room)/de from [BIOSIS PreviewsP®P] OR (emergency medicine or emergency ward or emergency health service)/de from [EMBASEP®P] OR hospitalists/de from [MEDLINEP®P] OR (general practitioner or hospital physician or resident or surgeon)/de from [EMBASEP®P] OR ((emergency or ED or ER)()(physician? Or practitioner? Or doctor?))/ti,ab OR ((general or family)()(practitioner? Or doctor?))/ti,ab OR (resident? Or surgeon?)/ti,ab Performed: May 24, 2005 Total hits=270 records


DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS PubMed Cochrane Library

1995- present Same MeSH headings and keywords as the original DIALOGP®P MEDLINEP®P search. Searches performed May 24, 2005; last update August 2005.

Search of HTA, near-HTA websites for published, in-progress and planned reports

e.g., INAHTA, AHRQ, University of York NHS Centre for Reviews and Dissemination (CRD) databases, NCCHTA, NICE, WHO, etc.


APPENDIX 2: Hierarchy of Evidence for Test Accuracy Studies4 Level 1 – a blind comparison with reference standard among an appropriate broadly defined sample of consecutive patients. Level 2 – any one of the following: • narrow population spectrum • differential use of reference standard • reference standard not blinded • case control study design. Level 3 – any two of the following: • narrow population spectrum • differential use of reference standard • reference standard not blinded • case control study design. Level 4 – any three or more of the following: • narrow population spectrum • differential use of reference standard • reference standard not blinded • case control study design. Level 5 – expert opinion with no explicit critical appraisal, based on physiology, bench research or first principles.


APPENDIX 3: Trial Characteristics (abdominal trauma)

Author Study Type Patients Indication(s) Staff and Machine

Comparators or Gold Standards

Outcomes Documentation Training

Kimura15 Case series; prospective; non-consecutive sample

N=72; 6 to 80 years old; 82% male, 18% female

Trauma – ac of U/S detection of hemoperitoneum in blunt abdominal trauma

Various physicians from postgraduate years 2 to 9; Hitachi EUB-400

Repeated U/S if negative or equivocal results, but intra-abdominal injury still suspected; positive U/S results – lap

ss=0.87; sp=1.00; ac=0.97; FN=2 (1 underwent lap)

Jehle16 Case series; retrospective; unknown if consecutive sample

N=44; 15 years or older

Trauma – rule out intraperitoneal hemorrhage

EP or surgeon; portable model unspecified

DPL or lap ss=0.82; sp=0.94; ac=0.91; FN=2 (2 needed surgical repair); FP=2

2-hour lecture, 2 weeks supervision

Liu17 Comparative study; prospective; non-consecutive sample

N=55; 17 to 78 years, 80% male, 20% female; U/S, CT and DPL performed on each patient

Trauma – compared ac of DPL, CT (by radiologist), and U/S for blunt abdominal trauma, in detecting solid organ injury or hemoperitoneum

Trauma team leader; Toshiba SSA-240A

CT and DPL; surgical findings used to verify accuracy of 3 diagnostic techniques

UU/S: ss=0.92; sp=0.95; TP=33; FP=1; TN=18; FN=3; ac=0.93. UDPL: ss=1.00; sp=0.84; TP=36; FP=3; TN=16; FN=0; ac=0.95. UCT: ss=0.97; sp=0.95; TP=35; FP=1; TN=18; FN=1; ac=0.96.

Goletti18 Case series; prospective; consecutive sample


Trauma – detecting abdominal lesions and free fluid collections in blunt abdominal trauma

Trauma surgeon; SAL 32 or SAL 77 device

Inconclusive U/S or unstable patient with negative U/S results=CT or DPL performed

UDetecting free fluid: ss=0.98; sp=0.99; PPV=1.00. UDetecting site ofU abdominal lesions: ss=0.87; PPV=0.93. Unnecessary lap. rate: 2.44%

U/S scans performed by surgeon with >2 years experience in performing ED U/S





Ingeman19 Case series; prospective; non-consecutive sample

N=97; 73% males, 24% females

Detecting free fluid EP; Ultramark 5 portable unit

CT, DPL, lap ss=0.75; sp=0.96; ac=0.91; PPV=0.86; NPV=0.92; FP=3; FN=6

Data sheet (including interpretation of detection of fluid, hard copies of each view, time to complete scan, results of CT/DPL or lap, and radiologist’s interpretation of hard copies)

1-hour didactic session, 1 hour of practice on human volunteers

Chiu20 Case series; prospective; non-consecutive sample

N=722; 68% male, 32% female

Trauma – utility of FAST in management of blunt trauma victim who presents with abdominal injury without hemoperitoneum

Trauma attending surgeon or trauma fellow performed and interpreted; Siemens Sonoline SI-400)

CT, DPL, exploratory lap or observation

15 of 52 patients with abdominal injury did not have hemoperitoneum; all 15 had negative FAST results

FAST findings recorded as no fluid (0), minimal fluid (1), large fluid (2), or poorly visualized (X). Positive: 1 point; negative: 0 points





McElveen21 Case series; prospective; consecutive sample

N=82; 77% male, 23% female

Trauma – establish ac of U/S compared with gold standards (DPL, CT, observation, lap) and ability of surgeons to perform U/S to detect free fluid or organ injuries

Surgeons; Johnson & Johnson U/S 280SL machine

CT (71), serial examinations (6), DPL (3), lap (2)

ss=0.88; sp=0.98; ac=0.96; PV=0.97; PPV=0.93; FN=2 (no surgery needed); FP=1

Immediate interpretation of U/S recorded

1995 Eastern Association for the Surgery of Trauma U/S course, and 15 examinations of normal patients; chief resident-classroom instruction by attending surgeon followed by 15 supervised examinations of normal patients and 10 supervised examinations of trauma patients

Thomas22 Case series; prospective; unknown if consecutive sample

N=832 Trauma – initial experience with U/S program in detecting free fluid

Trauma surgeon or fellow; Aloka SSD-500

CT, DPL, lap or observation

ss=0.87; sp=1.00; ac=0.99; FP=4 (2 underwent non-therapeutic surgery); FN=7; TN=773; TP=48

Four views photographed and filed with patients’ demographic data, brief history and physical examination findings, U/S results and time to complete U/S examinations

8-hour course; instruction and hands-on U/S evaluation of human models (normal and 1 with positive finding)





Rozycki23 Case series; prospective; unknown if consecutive sample

N=1,227, patients with blunt abdominal trauma; range 15 to 84 years old; 73% male, 27% female

Trauma – to detect free intraperitoneal fluid

Surgeons; Panther U/S Scanner Type 2002

Negative U/S: serial physical examinations; positive U/S: CT or celiotomy; poor quality U/S image: CT or DPL

ss=0.78; sp=1.00; PPV=0.97; NPV=0.99; TN=1151; TP=58; FP=2 (1 underwent unnecessary surgery); FN=16 (12 underwent surgical repair, 1 died)

Training course included didactics, videotapes, practice session, written test, and supervision during first 50 examinations.

Shih24 Case series; prospective; unknown if consecutive sample

170 patients with trauma

Detecting free fluid or organ injury

Attending surgeons; Toshiba SSA-240A

CT, operative findings, clinical follow-up

Intraperitoneal injury: ss=0.96; sp=0.98; PPV=0.93; NPV=0.98; ac=0.97

Miletic25 Case series; retrospective; non-consecutive sample

N=242; 18 to 83 years old; 69.8% male, 30.2% female

Trauma – evaluate emergent U/S in detection of hemoperitoneum in civil conditions

Specialists (>3 years experience and >1,000 U/S); Esaote Biomedica C7000

Positive U/S results confirmed by surgery or CT

UCivil conditions:U ss=0.88; sp=1.00; ac=0.95; PPV=0.95; NPV=0.91; FN=12

Shackford26 Case series; prospective; unknown if consecutive sample


Trauma – FAST examination error during initial experience of non-radiologist clinicians in detecting hemoperitoneum

Non-radiologist clinicians; Medison 6000

DPL, CT, lap, serial physical examinations

ss=0.68; sp=0.98; PPV=0.92; NPV=0.92; LR(+)=42.6; NLR(–)=0.3; FN=16; FP=3; initial error rate=17%; error rate after 10 examinations=5%

>8 hours education on didactic and hands-on training; >10 normal examinations for practice sessions; 50 supervised scans on patients





Corbett27 Case series; prospective; non-consecutive sample

N=47;





Jang30 Comparative study; retrospective; unknown if consecutive sample

698 patients with traumatic abdominal pain

Review of FAST for abdominal trauma, to evaluate if 10 examinations sufficient for clinicians to maintain capability of adequately performing FAST examinations to detect free fluid

Emergency medicine residents; Aloka SSD-1400

Formal U/S, CT, or surgical findings

For EPs with 11 to 20 examinations: ss=0.74; sp=0.99. For EPs with 21 to 30 examinations: ss=1.00, sp=0.97. For EPs with ≥31 examinations: ss=0.95, sp=0.99. Significant difference found between 11 to 20 examinations and ≥31 examinations in regard to ss.

Residents participated in large group lecture and demonstration done annually by attending physicians with residency training in FAST examinations.

Suthers31 Case series; prospective; unknown if consecutive sample

120 children, mean age 9.8±5 years old, 80 males, 40 females; 118 patients included for analysis

Trauma: to detect hemoperitoneum

Surgeons and surgical residents;Hitachi EUB-2000 or SonoSite 180 Plus

CT, lap ss=0.70; sp=1.00; PPV=1.00; NPV=0.92; FN=8; FP=0

All staff instructed by surgeon certified as U/S instructor; training included didactic and practical sessions; 50 initial FAST examinations proctored by instructor present at time of examination or by further CT evaluation

ss=sensitivity; sp=specificity; ac=accuracy; PPV=positive predictive value; NPV=negative predictive value; FN=false-negatives; TN=true-negatives; FP=false-positives; TP=true positives; LOS=length of stay; LR(+)=positive likelihood ratio; LR(–)=negative likelihood ratio; lap=laparotomy; DPL=diagnostic peritoneal lavage, ED=emergency department, FAST=focused abdominal sonography for trauma, U/S=ultrasonography, CT=computed tomography.


APPENDIX 4: Trial Characteristics (AAA)

Author Study Type Patients Indication(S) Staff and Machine

Comparators Or Gold Standards


Tayal10 Case series; prospective; consecutive sample

n=125; 54% male, 46% female

AAA: whether ED U/S can accurately determine presence of AAA and guide ED disposition

EPs; Shimadzu 400 and Shimadzu 450 machine

Radiology U/S (28 of 125), CT (95 of 125), magnetic resonance imaging (1 of 125).

ss=1.00; sp=0.98; PPV (27 of 29)=0.93; NPV (96 of 96)=1.00; FP=2

Data sheet; measurements entered into U/S database

U/S training at department EM for faculty and residents; senior EM resident and EM attending physicians minimum introductory emergency U/S education and performed ≥50 emergency U/S before study

ss=sensitivity; sp=specificity; ac=accuracy; PPV=positive predictive value; NPV=negative predictive value; FP=false positives; EM=emergency medicine; AAA=abdominal aortic aneurysm; ED=emergency department; U/S=ultrasonography.


APPENDIX 5: Trial Characteristics (ectopic pregnancy)




Mateer32

Case series; prospective; non-consecutive sample

n=152; 4 lost to follow-up; 18 years and older

Ectopic pregnancy: evaluate protocol of endovaginal sonography

EPs; AU530 machine

Reviewing consultant gynecologist, or final diagnosis

Based on n=118 (patients with no definite IUP and βhCG





Shih 13 Comparative study; prospective; non-consecutive sample

n=127; 74 in EPPPS group

Ectopic pregnancy

EP; Corometrics Aloka 620

Obstetrics-gynecology consultation, or radiologist-performed formal U/S

6 ectopic in EPPPS group detected, 4 detected in non-EPPPS group; no FN or FP diagnoses of ectopic pregnancy; ss for IUP in EPPPS group 94%; sp for IUP in EPPPS group 100%

Hard copies printed 24-hour didactic and hands-on instruction by radiologists and technologists in U/S department; 10 studies in pelvic, aortic, and gallbladder imaging proctored through real-time or hard copy studies

Wong33 Case series; prospective; non-consecutive sample

N=151 Ectopic pregnancy: efficacy of U/S in identifying ectopic pregnancy in ED

EP; Aloka SD-500

Final assessment of gynaecologist

Presence or absence IUP: ss=0.82; sp=0.92; agreement between junior and senior ED doctors=81%; using either no definite IUP or other findings: ss=0.80; sp=0.78; PPV=0.12; NPV=0.99

U/S findings printed and appended to patient’s record and study form

On the job training for junior staff

Durston34 Case series; retrospective; unknown if consecutive sample

N=120, ectopic pregnancy seen in ED before or at point of diagnosis

Ectopic pregnancy: quality of ED performing transabdominal U/S

Epoch 1 and epoch 2:U U/S technicians performed; Acuson XP-128 machine; UEpoch 3: U EPs; first six months, General Electric RT3200; replaced with GE Logiq400

ED U/S: ruling out IUP; compared or confirmed by surgical pathology, repeat U/S or clinical follow-up

UDetecting IUPU: ss=0.98; sp=1.00; ac (excluding indeterminate scans) =0.99; ac (including indeterminate scan) =0.90. Quality indicator: (% patients documented to have absence of IUP at first ED visit): epoch 1: 76%; epoch 2: 88%; epoch 3: 96%

Medical records housed in database

10 EPs attended 3-day class: 12 hours didactic teaching and 12 hours of practice on live models; 1 EP had 1-month U/S elective during residency





Rodgerson 14 Comparative study; retrospective; non-consecutive sample

n=37; 16 right upper quadrant ED U/S (group I) and 21 formal U/S in radiology (group II)

Ectopic pregnancy: whether time to diagnosis and treatment for patients with ruptured ectopic pregnancy for those who had ED U/S compared with U/S in radiology

EM faculty or senior EM residents supervised by EM faculty; HP Sonos 100 or Aloka 1450.

Formal U/S UTime to diagnosis: group I: 58 minutes; group II: 197 minutes. UTime to operative treatment: group I: 111 minutes; group II: 322 minutes

EM faculty 14 years experience with locating hemoperitoneum; annual 10-hour didactic course and hands-on training with FAST and some cardiac examination aspects.

ss=sensitivity; sp=specificity; ac=accuracy; PPV=positive predictive value; NPV=negative predictive value; FN=false negatives; FP=false positives; IUP=intrauterine pregnancy; EPPPS=EP-performed pelvic U/S; EM=emergency medicine; EP=emergency physician; IUP=intrauterine pregnancy; U/S=ultrasonography; ED=emergency department.


APPENDIX 6: Trial Characteristics (multiple indications)

Author Study Type Patients Indication(S) Staff and Machine

Comparators or Gold

Standards


Schlager35 Case series; prospective

167 patients Pregnancy-related pelvic U/S studies; AAA

EP; Aloka SSD-620 Formal U/S, surgical postoperative report

Pregnancy-related U/S: ss=1.00; sp=1.00; PPV=1.00; NPV=1.00. AAA: ss=1.00; sp=1.00; PPV=1.00; NPV=1.00

Physicians required to write study interpretation on patient chart, and attach a representative laser-print copy of scan

Hands-on orientation and instruction, followed by four mornings in medical imaging working with U/S technologist

Rowland36 Case series; prospective

221 scans including intraperitoneal fluid (66); AAA (33)

To detect any free fluid and dilated aorta

EP; Aloka SSD 1100

CT, DPL, lap, formal U/S, or autopsy

Free fluid: ss=0.64; sp=0.85; PPV=0.47; NPV=0.92; ac=0.82. AAA: ss=1.00; sp=1.00; PPV=1.00; NPV=1.00; ac=1.00

Data sheet including U/S findings

3 days of didactic presentations, review of U/S images, and 4 hours daily of hands-on training

Jones37 Case series; prospective

111 patients with trauma, 58 patients with AAA

To evaluate a credentialing program; to detect any free fluid and dilated aorta

Non-radiologists; B-K Medical Cheetah 2003 U/S system

CT, DPL, lap, formal U/S, or autopsy

Free fluid: ss=0.72; sp=0.97; PPV=0.89; NPV=0.91; ac=0.90. AAA: ss=0.98; sp=1.00; PPV=1.00; NPV=0.96; ac=0.99

Hard copies of scans printed

4 to 16 hours emergency U/S courses, minimum 15 to 25 accurate scans

ss=sensitivity; sp=specificity; ac=accuracy; PPV=positive predictive value; NPV=negative predictive value; FN=false negatives; TN=true negatives; FP=false positives; TP=true positives; lap=laparotomy; EP=emergency physician; AAA=abdominal aortic aneurysm; U/S=ultrasonography; DPL=diagnostic peritoneal lavage; CT=computerized tomography.


APPENDIX 7: Results from Systematic Reviews and Clinical Practice Guidelines

Author Study Type Patients Strength of Evidence, Quality of Study

Gold Standards

Conclusions

Pearl58 Systematic review of prospective trials

11 trials; patients with blunt abdominal trauma

Moderate quality of selected studies (some selection bias, or lack of independent gold standards, or good observational study but not randomized or controlled)

CT, DPL, lap All trials concluded that U/S was valuable for assessment of blunt intraperitoneal trauma. None determined therapeutic effect or patient outcome (most U/S exams performed by surgeons or other non-radiologists)

EAST54 CPG that included clinical trials

Patients with blunt abdominal trauma

Included studies were class I (prospective)

DPL, CT Level II recommendation: FAST may be considered as initial diagnostic modality to exclude hemoperitoneum; repeated FAST is required in hemodynamically stable patients with indeterminate initial FAST results. Level III recommendation: FAST is indicated for patient with abnormal mentation, equivocal finds on physical examination, multiple injuries, concomitant chest injury or hematuria. Drawbacks: injuries unassociated with hemoperitoneum may not be detected by FAST; ureliable for excluding hollow visceral injury; cannot be used to reliably grade solid organ injuries. Accuracy of FAST is independent of practitioner performing study

Stengel57 Systematic review of diagnostic studies

Trauma patients; 30 trials, 9,047 patients

Moderate to poor quality of evidence available; (significant bias inherent in most studies, such as patient selection, use of gold standard examinations to verify accuracy of ultrasonographic findings)

CT, DPL, lap, clinical observation

U/S has high specificity but low sensitivity for detection of free fluid and organ lesions. Other effective assessment should be performed in clinically suspected abdominal trauma, regardless of initial U/S findings (article did not indicate who performed U/S scans)

ACEP55 CPG that included various primary studies

Patients with acute blunt abdominal trauma

Used systematic review approach, assessed studies including prospective cohort using criterion standard, retrospective observational studies, case series, case report

CT, DPL Level B recommendation (recommendations that reflects moderate clinical certainty): FAST is useful as an initial screening examination to detect hemoperitoneum in blunt abdominal trauma patients (article did not indicate who performed the U/S scans)

Stengel56 Systematic review of RCTs or quasi-RCTs

5 trials; patients with blunt abdominal trauma

Details of study populations sparse or missing, difficult to estimate degree and direction of bias

CT, DPL, clinical monitoring

No significant difference found between groups with respect to mortality, use of CT or DPL, reduction in lap rates, or length of hospital stay; insufficient evidence from RCTs to justify promotion of U/S-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma (performed by radiologists, non-radiologist clinicians, or U/S technicians)

lap=laparatomy; CT=computerized tomography; DPL=diagnostic peritoneal lavage; CPG=clinical practice guideline; U/S=ultrasonography; FAST=focused abdominal sonography for trauma.


APPENDIX 8: Included and Excluded Studies Studies Inclusion, or Reason for Exclusion

Australasian College for Emergency Medicine40 included ACEP policy statement39 included ACEP guideline55 included AIUM guideline41 included Akgür 77 performed by radiologists Akkersdijk 78 performer and U/S model unknown Al Salamah 79 unknown U/S model Ali 45 included Arrillaga 80 performed by technicians Bakker 81 performed by radiologists Ballard 82 inclusion criteria not met – indication Bailey 52 included Barnhart 83 performed by radiologists Blackbourne 9 included Bode 84 performed by radiologists Boulanger 85 inclusion criteria not met – U/S model Boulanger 86 inclusion criteria not met – U/S model Branney 87 unknown model Brooks 88 inclusion criteria not met – U/S model Burgher 89 insufficient data Burgher 90 inclusion criteria not met – indication Buzzas 91 inclusion criteria not met – U/S model CEUS43,44 included Chen 92 performer unknown Chen 93 inclusion criteria not met – outcome Chiu 20 included Coley 94 performed by radiologists Corbett 27 included Costantino 95 inclusion criteria not met – outcome Dewitz 96 insufficient data Dolich 75 performed by technicians Durham 12 included Durston 97 inclusion criteria not met – U/S model Durston 34 included EAST guideline 54 included ED Echo course (R. Wiss, personal communication, 2005) included The Royal College of Radiologists 42 included Förster 98 unknown U/S model Frezza 99 unknown U/S model Frezza 100 inclusion criteria not met – program Glaser 101 mixed results of trauma Goletti 18 included Goodwin 74 performed by radiologists Hoffmann 102 unknown U/S model Holmes 103 performed by sonographers


Studies Inclusion, or Reason for Exclusion

Ingeman 19 included Jang 30 included Jehangir 70 performed by radiologists Jehle 16 included Jones 37 included Jones 104 inclusion criteria not met – indication Kaplan 105 performed by radiologists Katz 106 performed by radiologists Kern 107 inclusion criteria not met – U/S model Kimura 15 included Knaut 108 inclusion criteria not met – outcome Krupnick 109 performed by technicians Kuhn 49 included Lanoix 110 insufficient data Lanoix 46,47 included Lentz 111 performed by technicians Liger 112 inclusion criteria not met – U/S model Lingawi 113 performed by radiologists Liu 17 included Luks 73 performed by radiologists Ma 114 penetrating injuries >20% Ma 115 penetrating injuries >20% Ma 116 insufficient data Ma 117 penetrating injuries >20% Ma 118 inclusion criteria not met – U/S model Mandavia 119 insufficient data Mandavia 120 insufficient data Mandavia 50 included Massarutti 121 performed by radiologists Mateer 38 included Mateer 32 included Mateer 11 included McElveen 21 included McGahan 122 performed by sonographers McKenney 71 performed by radiologists McKenney 72 performed by technicians McKenney 123 inclusion criteria not met – U/S model McNeil 124 insufficient data Melniker 125 insufficient data Melniker 126 insufficient data Miletic 25 included Murphy 127 insufficient data Mutabagani 128 performed by radiologists Naseem 129 performed by radiologists Nural 130 performed by radiologists Partrick 131 inclusion criteria not met – outcome Pearl 58 included


Studies Inclusion, or Reason for Exclusion

Polk 132 not in ed setting Porter 133 performed by technicians Price 51 included Richards 134 performed by sonographers Richards 135 performed by sonographers Richards 136 performed by sonographers Richards 137 performed by sonographers Richards 138 performed by sonographers Rodgerson 14 included Rodgerson 139 insufficient data Roepke 140 insufficient data Rose 141 insufficient data Rosen 142 insufficient data Röthlin 143 mixed results of trauma Rowland 36 included Rozycki 144 inclusion criteria not met – U/S model Rozycki 145 inclusion criteria not met – U/S model Rozycki 23 included Salen 146 insufficient data Salen 53 included Schlager 35 included Shackford 26 included Shalev 147 unknown U/S model Shapiro 148 very small patient group Shih 13 included Shih 24 included Sisley 48 included Stassen 28 included Stengel 57 included Stengel 56 included Suthers 31 included Tayal 149 insufficient data Tayal 10 included Tayal 150 inclusion criteria not met – indication Thomas 22 included Thourani 151 unknown U/S model Tso 152 inclusion criteria not met – U/S model Udobi 153 penetrating injuries Vassiliadis 29 included Walker 154 case report Wherrett 155 inclusion criteria not met – U/S model Wong 33 included Yeo 156 inclusion criteria not met – U/S model

U/S=ultrasonography

Documents

APPENDIX 1: Detailed Review Methods · A-2 HTIS - Portable Ultrasound Devices in Emergency Departments DATABASES LIMITS SUBJECT HEADINGS/KEYWORDS OR CTS-285 OR CTS-385 OR CTS-485