Appendix A. Search terms
Psychological Harms
Prostate Cancer
Lung Cancer
Search terms (Medline)
Prostate cancer*[tw] OR prostatic cancer*[tw] OR Prostatic
Neoplasms[Mesh] OR prostate specific antigen[tw] OR PSA[tw]) AND
(screening*[tw] OR early diagnosis[tw] OR early detection[tw] OR
biops*[tw] OR surveillance[tw] OR watchful waiting[tw]) AND
(depress*[tw] OR distress[tw] OR stress*[tw] OR worry[tw] OR fear*[tw]
OR anxiet*[tw] OR quality of life[tw] OR mental health[tw] OR mental
disorders[tw] OR psycholog*[tw] OR psychosocial[tw] OR well being[tw]
OR uncertainty[tw] OR emotion*[tw] OR false positive*[tw] OR harm*[tw]
OR adverse effect*[tw] OR complication*[tw])
(Lung cancer*[tw] OR Lung Neoplasms[Mesh]) AND (screening*[tw] OR
early diagnosis[tw] OR early detection[tw] OR biops*[tw] OR
surveillance[tw] OR watchful waiting[tw]) AND (depress*[tw] OR
distress[tw] OR stress*[tw] OR worry[tw] OR fear*[tw] OR anxiet*[tw]
OR quality of life[tw] OR mental health[tw] OR mental disorders[tw] OR
psycholog*[tw] OR psychosocial[tw] OR wellbeing[tw] OR well-being[tw]
OR uncertainty[tw] OR emotion*[tw] OR false positive*[tw] OR harm*[tw]
OR adverse effect*[tw] OR complication*[tw])
Abdominal Aortic Aneurysm
(Abdominal aortic aneurysm[tw] OR Aortic Aneurysm,
Abdominal[Mesh]) AND (screening*[tw] OR early diagnosis[tw] OR early
detection[tw] OR biops*[tw] OR surveillance[tw] OR watchful
waiting[tw]) AND (depress*[tw] OR distress[tw] OR stress*[tw] OR
worry[tw] OR fear*[tw] OR anxiet*[tw] OR quality of life[tw] OR mental
health[tw] OR mental disorders[tw] OR psycholog*[tw] OR
psychosocial[tw] OR well being[tw] OR uncertainty[tw] OR false
positive*[tw] OR emotion*[tw] OR harm*[tw] OR adverse effect*[tw] OR
complication*[tw])
Osteoporosis
((osteoporosis[tw] OR osteopenia[tw] OR bone density[tw] OR bone
mineral density[tw]) AND (screen*[tw] OR early diagnosis[tw] OR early
detection[tw] OR densitometry[tw]OR absorptiometry[tw] OR DEXA[tw]
OR DXA[tw]) AND (depress*[tw] OR stress*[tw] OR distress [tw] OR
worry[tw] OR fear*[tw] OR anxiet*[tw] OR quality of life[tw] OR mental
health[tw] OR mental disorders[tw] OR psycholog*[tw] OR well being[tw]
OR psychosocial[tw] OR uncertainty[tw] OR emotion*[tw])) NOT
(animals NOT humans)
(Carotid artery stenos*[tw] OR carotid stenos*[tw] OR Carotid
Stenosis[Mesh]) AND (screening*[tw] OR early diagnosis[tw] OR early
detection[tw] OR biops*[tw] OR surveillance[tw] OR watchful
waiting[tw]) AND (depress*[tw] OR distress[tw] OR stress*[tw] OR
worry[tw] OR fear*[tw] OR anxiet*[tw] OR quality of life[tw] OR mental
health[tw] OR mental disorders[tw] OR psycholog*[tw] OR
psychosocial[tw] OR well being[tw] OR uncertainty[tw] OR false
positive*[tw] OR emotion*[tw] OR harm*[tw] OR adverse effect*[tw] OR
complication*[tw])
Carotid Artery Stenosis
Overdiagnosis
Prostate Cancer
Search terms (Medline)
(“Prostatic neoplasms”[Mesh] OR “prostate cancer”[tw])
AND (screening[tw] OR mass screening[Mesh] OR early diagnosis[tw]
OR prostate specific antigen[tw]) OR PSA [tw]
AND (overdiagnos*[tw] OR over-diagnos*[tw] OR overdetect*[tw] OR
over-detect*[tw])
Lung Cancer
(Lung cancer*[tw] OR Lung Neoplasms[Mesh]) AND (screening[tw] OR
mass screening[Mesh] OR early diagnosis[tw] OR prostate specific
antigen[tw] OR PSA [tw] OR biops*[tw]) AND (overdiagnos*[tw] OR over
diagnos*[tw] OR overdetect*[tw] OR over detect*[tw] OR
insignifican*[tw]) AND (rate[tw] OR frequency[tw] OR incidence[tw] OR
prevalence[tw] OR epidemiology[subheading])
Abdominal Aortic Aneurysm
(Abdominal aortic aneurysm[tw] OR Aortic Aneurysm,
Abdominal[Mesh]) AND (screening[tw] OR mass screening[Mesh] OR
early diagnosis[tw] OR biops*[tw]) AND (overdiagnos*[tw] OR over
diagnos*[tw] OR overdetect*[tw] OR over detect*[tw] OR
insignifican*[tw]) AND (rate[tw] OR frequency[tw] OR incidence[tw] OR
prevalence[tw] OR epidemiology[subheading])
Osteoporosis
(osteoporosis [MeSH] OR osteoporosis[tw] OR osteopenia[tw]) AND
(overdiagnos*[tw] OR over diagnos*[tw] OR overdetect*[tw] OR over
detect*[tw] OR diagnostic errors[mesh] OR misdiagnos*[tw] OR
misinterpret*[tw]) AND (rate[tw] OR frequency[tw] OR incidence[tw] OR
prevalence[tw] OR epidemiology[subheading])
(Carotid artery stenos*[tw] OR carotid stenos*[tw] OR Carotid
Stenosis[Mesh]) AND (screening[tw] OR mass screening[Mesh] OR
early diagnosis[tw] OR biops*[tw]) AND (overdiagnos*[tw] OR over
diagnos*[tw] OR overdetect*[tw] OR over detect*[tw] OR
insignifican*[tw]) AND (rate[tw] OR frequency[tw] OR incidence[tw] OR
prevalence[tw] OR epidemiology[subheading])
Carotid Artery Stenosis
Appendix B. Selected screening services and USPSTF recommendations
Screening Service (Year of Most Recent
USPSTF Review)
Prostate Cancer (2011)
USPSTF Recommendations
Lung Cancer (2013)
B: Recommends annual screening for lung cancer
with low-dose computed tomography (LDCT) in
persons at high risk for lung cancer based on age
and smoking history.
B: Recommends one-time screening for
abdominal aortic aneurysm (AAA) by
ultrasonography in men aged 65 to 75 who have
ever smoked. C: No recommendation for or against
screening in men aged 65-75 who have never
smoked. D: Recommends against screening in
women
B: Recommends screening for osteoporosis in
women aged 65 years or older and in younger
women whose fracture risk is equal to or greater
than that of a 65-year-old white woman who has no
additional risk factors. I: Insufficient evidence to
assess screening in men.
D: Recommends against screening for carotid
artery stenosis in the general adult population.
Abdominal Aortic Aneurysm (2014)
Osteoporosis (2010)
Carotid Artery Stenosis (2014)*
*Draft evidence report
D: Recommends against PSA-based screening for
prostate cancer.
Appendix C. Study characteristics for 5 screening services
Psychological Harms of Prostate Cancer Screening
Study Type
Outcomes of Interest
(Instrument or Data Source)
Comparisona (Time Points)
Frequency/
Burdenb
Qualitative
Men’s reactions to an equivocal
PSA result (Interviews)
Anxiety, depression, & cancerrelated distress (HADS; IES)
Anxiety, depression, and HRQoL
(HADS; SF-36)
Anxiety (items on study-specific
questionnaire)
Men’s experiences before,
during, & after biopsy
(Interviews)
HRQoL; anxiety (SF-36; STAI)
None
Burden
Change over time (day of
screening; 4-6 weeks later)
Change over time (before
screening and before biopsy)
Change over time (before PSA
results; awaiting biopsy)
None
Both
Cormier et al.,
20026
7 men aged 50-69 years, from a
general practice
57 men aged 40-73 years, from
families with history of PrCa
569 men aged 50–69 years,
recruited for ProtecT
1,781 men aged ≥50 years,
enrolled in ERSPC
50 men aged 52-75 years, recruited
from urologists, general
practitioners & support groups
220 brothers or sons of men with
PrCa
Both
Evans et al.,
20077
Macefield et al.,
2010c 8
28 men aged 40-75 years, from 6
Welsh general practices
330 men aged 50-69 years,
participating in ProtecT
Qualitative
Longitudinal
Men’s responses to screening
process (Interviews)
Distress (POMS-SF; IES)
Change over time (before PSA
test; before results; after normal
result)
None
Both
Macefield et al.,
20099
Medd et al.,
200510
4,198 men aged 50–69 years,
recruited for ProtecT
31 men, aged 47-91 years, referred
to biopsy clinic
Longitudinal
Anxiety (HADS)
Crosssectional/
qualitative
Oliffe, 2004d
14 men aged 46-74 years, recruited
from support groups or advertising
136 men, mean age 58.5 years,
registered for free screening at 2
hospital-based sites
Qualitative
Men’s experiences before,
during, & after biopsy (Studyspecific questionnaire and
interviews)
Experiences of testing, work-up
and diagnosis (Interviews)
Avoidant or intrusive cancerrelated thoughts (IES; MHI-5)
Change over time (PSA screening;
during clinic visit for biopsy; after
receiving normal biopsy result; 12
weeks after negative result)
Change over time (PSA test; time
of biopsy)
None
None
Burden
Change over time (before
screening; 1 week after normal
result)
Both
Source
Subjects
Screening Test/Workup
Archer and
Hayter, 20061
Bratt et al., 20032
Brindle et al.,
20063
Carlsson et al.,
20074
Chapple et al.,
20075
Taylor et al.,
200212
11
False-Positive Results
Longitudinal
Longitudinal
Longitudinal
Qualitative
Longitudinal
Longitudinal
Both
Both
Burden
Burden
Burden
Both
Fowler et al.,
200613
285 men, mean age 61 years, from
3 hospital primary practices
Longitudinal
PrCA-related thoughts and
worry (Study-specific
questionnaire)
Change over time (6 weeks, 6
months, and 1 year after normal
PSA test or normal biopsy)
Both
Ishihara et al.,
2006c 14
141 men aged ≥50 years, enrolled
from hospital outpatient list
Longitudinal
HRQoL (SF-36)
Burden
Katz et al.,
200715
210 men, aged 52-70 years, from
university hospitals and primary
care practices
Crosssectional
McGovern et al.,
200416
16 men, aged 55-74 years, enrolled
in the PLCO
Qualitative
Anxiety; HRQoL; PrCa-related
worry and perceived
susceptibility (SF-36; SAI-6;
study-specific items)
Responses to a false-positive
screening test (Focus groups)
Age- and gender-adjusted SF-36
Japanese national norms, plus
change over time within subjects
(before biopsy; after results)
Primary care patients with PSA
findings in the reference range
None
Burden
McNaughtonCollins et al.,
200417
Perczek et al.,
2002c 18
400 men, mean age 60 years, from
3 hospital primary care practices
Crosssectional
PrCA-related thoughts and worry
(Study-specific questionnaire)
Primary care patients with PSA
findings in the reference range
Both
101 men, mean age 66.7 years, at
VA Medical Centers
Longitudinal
Distress (POMS)
Change over time (before & after
biopsy)
Burden
Change over time (6-months
intervals, up to 5 years after
diagnosis)
None
Burden
Age-matched controls attending
urology clinic but w/o PrCa dx
Age-matched population controls
Burden
Age-standardized suicide rate in
the general population
Scores were compared to
published criteria for “caseness”
Frequency
Normative HADS data from a large
non-clinical sample
Both
Burden
Diagnosis (Labeling)
Arredondo et al.,
200419
383 men, largely >55 years old,
enrolled in CaPSURE
Longitudinal
HRQoL during WW (RAND SF36)
Bailey et al.,
200720
10 men, aged 64-88 years,
attending urology clinic at a tertiary
care medical center
60 men awaiting treatment & 21
controls; aged 49-74 years
72,613 men with PrCa (mean age
at study entry 71.1 years) and
217,839 age-matched men without
PrCa
128 suicides among 77,439 men
with PrCa
88 men aged 48-78 years,
attending a joint urology/oncology
clinic
100 men (mean age 67.1 years)
from outpatient clinics
Qualitative
Uncertainty during WW
(Interviews)
Crosssectional
Longitudinal
PrCA-specific QoL (FACT-P
validation study)
Psychiatric hospitalization;
outpatient visits; use of
antidepressant medication
(Swedish registry data)
Suicide (Swedish registry data)
Batista-Miranda
et al., 200321
Bill-Axelson et
al., 201122
Bill-Axelson et
al., 201023
Bisson et al.,
200224
Burnet et al.,
200725
Longitudinal
Crosssectional
Crosssectional
Depression; anxiety; distress;
QoL (GHQ30; HADS; IES;
EORTC-QOL-30)
Anxiety & depression during AS
(HADS)
Burden
Frequency
Frequency
Daubenmeier et
al., 200626
93 men (mean age intervention
group 64.8 years, controls 66.5
years) enrolled in RCT on effects of
lifestyle changes on PrCa
progression
10 men, aged >55 years, from
urology/endocrinology clinics
136 suicides among 168,584 men
with PrCa (mean age at diagnosis
73.4 years), out of 4,305,358 men
followed 1961-2004
148 suicides among 342,497 men
(mean age at diagnosis 70.2 years)
with PrCa
27 men, aged 65-88 years at study
entry, with localized disease,
recruited for RCT comparing WW to
RT
7 men, aged 62-69 years, selected
from a PrCa registry
Longitudinal
HRQoL during AS (SF-36;
Perceived Stress Scale)
Change over time (baseline & 12
months later)
Burden
Qualitative
None
Burden
Longitudinal
Reactions to diagnosis
(Interviews)
Suicide (Swedish registry data)
Men without PrCa
Frequency
Longitudinal
Suicide (National Death Index)
Frequency
Longitudinal
HRQoL (EORTC-QLQ-30)
during WW
Age-, calendar period-, and statematched suicide rates from the
general population
Change over time (between 4 & 10
years of follow-up)
Qualitative
Worry, fear, & uncertainty during
WW (Interviews)
None
Burden
Johansson et al.,
201132
167 men, aged 45-75 years,
randomly assigned to WW in
SPCG-4
Longitudinal
QoL; anxiety; depression (Studyspecific questionnaire)
Both
Kelly, 200933
14 men, aged 59-83 years, from
outpatient clinics
Qualitative
Impact of diagnosis on body
image (Interviews)
Population-based control group
matched for region and age; also
within-subjects change at 2 followup points 9 years apart
None
Korfage et al.,
200634
52 men, aged 60–74 years,
enrolled in ERSPC
Longitudinal
HRQoL (SF-36; EQ-5D)
Change over time (before & after
diagnosis)
Burden
Kronenwetter et
al., 200535
26 men, aged 50-85 years,
participating in the Prostate Cancer
Lifestyle Trial (PCLT)
25 men, aged 48-77 years, referred
by physicians
Qualitative
Reactions to diagnosis
(Interviews)
None
Burden
Qualitative
AS-related uncertainty
(Interviews)
None
Burden
35 men, aged 46-87 years,
recruited from PrCa support groups
or advertising
Qualitative
Reactions to diagnosis
(Interviews)
None
Burden
Ervik et al.,
201027
Fall et al., 200928
Fang et al.,
201029
Fransson et al.,
200930
Hedestig et al.,
200331
Oliffe et al.,
200936
Oliffe, 200637
Burden
Burden
Reeve et al.,
201238
163 Medicare beneficiaries, mean
age 75.1 years
Longitudinal
HRQoL & major depression
during conservative
management (SF-36; Diagnostic
Interview Schedule items from
MHOS)
Cancer-specific QoL during WW
(EORTC-QLQ-30+3)
Matched non-cancer controls
Both
Siston et al.,
200339
39 men, aged 47-84 years, from 5
VA Medical Centers
Longitudinal
Change over time (after dx, 3
months & 12 months later)
Burden
Thong et al.,
200940
71 men, aged ≥50 years, identified
from a cancer registry
Crosssectional
HRQoL during AS (SF-36;
Quality of Life – Cancer
Survivors)
Norms for Dutch adult males
Burden
van den Bergh et
al., 201041
129 men, median age 64.6 years at
diagnosis, participating in a
prospective protocol-based AS
program
Longitudinal
Anxiety & depression (CES-D,
MAX-PC)
Change over time (2 time points
during AS)
Both
Vasarainen et al.,
201142
75 men, aged 60-69 years, enrolled
in a prospective AS study (PRIAS)
Longitudinal
HRQoL (RAND-36)
Previously published norms for
Finnish adult males
Burden
Notes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency of harm as the number of people who suffer a specific harm per
1,000 people exposed to the possibility of that harm, or sufficient data to estimate the proportion. We defined burden as an indication of the physical or psychological effects experienced by the patient or
family, such as its severity, anticipated duration, treatability, or effect on daily functioning. cAlso includes evidence on harms of diagnosis. dAlso includes evidence on harms of false positive results.
Abbreviations (and type of instrument): (GENERAL) BDI = Beck Depression Inventory; CES-D = Center for Epidemiologic Studies Depression Scale; EQ-5D = A simple health outcomes survey
devised by the EuroQol Group; GHQ30 = General Health Questionnaire; GTUS = Growth Through Uncertainty Scale; HADS = Hospital Anxiety & Depression Scale; HAI = Health Anxiety Inventory; MHI5 = Mental Health Inventory; MHOS = Medicare Health Outcomes Survey; MUIS-C = Mishel Uncertainty in Illness Scale Community Form; POMS-SF = Profile of Mood States—Short Form; QoL =
Quality of Life; RAND-36 = RAND 36-item Health Survey; SAI-6 = State Anxiety Index, short-form version; SF-36 = 36-Item Short Form Health Survey; STAI = State-Trait Anxiety Inventory. (CANCER –
SPECIFIC) EORTC-QLQ-30 & EORTC-QLQ-30+3 = European Organization for Research and Treatment of Cancer Quality of Life questionnaire; FACT-P = Functional Assessment of Cancer Therapy—
Prostate; IES = Impact of Event Scale; MAX-PC = Memorial Anxiety Scale for Prostate Cancer; QLI = Ferrans & Powers Quality of Life Index-Cancer Version; UCLA-PCI = UCLA Prostate Cancer Index.
Other abbreviations: AS = Active Surveillance; CaPSURE = Cancer of the Prostate Strategic Urological Research Endeavor Health Survey; ERSPC = European Randomised Study of Screening for
Prostate Cancer; HRQoL = Health-Related Quality of Life; PrCa = Prostate Cancer; PLCO = Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial; PRIAS = Prostate Cancer Research
International: Active Surveillance study; ProtecT = Prostate Testing for Cancer and Treatment study; PSA = Prostate Serum Antigen test; RP = Radical prostatectomy; RT = Radiotherapy; SEER =
Surveillance, Epidemiology and End Results program; SPCG-4 = Scandinavian Prostate Cancer Group Study Number 4; WW = Watchful Waiting
Overdiagnosis of Prostate Cancer
Author, Year
Study Type
Data/Population
Outcome(s) of Interest
Ciatto et al., 200543
Follow-up of 2
pilot studies
6890 participants in pilot screening studies from 1991 to
1994
Observed excess incidence in screened subjects
Davidov & Zelin,
200444
Modeling
Hypothetical; assumes that screened population is a
random sample from general population
Probability of overdiagnosis
Draisma et al.,
200945
Modeling
SEER 9 population aged 50 – 84 years during 1985 – 2000
Overdiagnosis rate
Graif et al., 200746
Pathology/Imaging
2,126 men with clinical stage T1c PCa treated with RRP
from 1989 to 2005
Possible overdiagnosis, defined as tumor volume less
than 0.5 cm3, Gleason less than 7, clear surgical
margins, and organ confined disease in the RRP
specimen
Gulati et al., 201047
Modeling
Prostate Cancer Prevention Trial (PCPT) data
Percent overdiagnosed at 2 different PSA cut-offs
Heijnsdijk et al.,
200948
Modeling
Simulated cohort of 100 000 men (European standard
population)
Cases overdetected per 100 screened men
Pashayan et al.,
200949
Modeling
ProtecT study plus UK national statistics and cancer
registry data
Probability of overdiagnosis
Pelzer et al., 200850
Pathology/Imaging
1445 patients undergoing radical prostatectomy and with a
PSA level <10 ng/mL
Over-diagnosis, defined as a pathological stage of
pT2a and a Gleason score of <7 with no positive
surgical margins
Telesca et al.,
200851
Modeling
SEER data, plus literature values for other parameters
Age- and ethnicity-specific overdiagnosis estimates
Tsodikov et al.,
200652
Modeling
SEER data from nine areas of the U.S.
Estimates of overdiagnosis by birth cohort
Welch & Albertsen,
200953
Ecological
SEER and U.S. Census data
Percent overdiagnosed
Wu et al., 201254
Modeling
Finnish arm of ERSPC
Absolute risk of overdetection
Abbreviations: ERSPC = European Randomized Study of Screening for Prostate Cancer; PrCA = Prostate cancer; PSA = Prostate Serum Antigen test; RRP = Radical Retropubic Prostactemy; SEER
= Surveillance, Epidemiology and End Results program
Psychological Harms of Osteoporosis Screening
Subjects
Study Type
Outcomes of Interest
(Instrument or Data Source)
Comparisona
(Time Points)
Frequency/
Burden?b
Emmett et al.,
201255
31 women, aged ≥70-85 years,
participating in screening arm of an RCT
Qualitative
Responses to screening
(Interviews)
None
Burden
Green et al.,
200656
24 women, aged 45-64 years, whose
clinical consultations were recorded; 10
follow-up interviews
Qualitative
Responses to screening
(Recorded clinical consultations;
interviews)
None
Burden
Rimes et al.,
200257
298 women, aged 32-73 years, recruited
by advertising or word of mouth to
participate in bone density measurement
research
Longitudinal
Health anxiety; depression;
perceived osteoporosis risk (HAI,
STAI, BDI & osteoporosis-specific
questionnaire)
Change over time (before
scanning, after results, and at
1 week and 3 month followup)
Burden
Source
Screening Test
Diagnosis (Labeling)
Bianchi et al.,
200558
62 women, aged 50-85 years, with
uncomplicated primary OP
Crosssectional
HRQoL & depression
(QUALEFFO-41; Zung Depression
Scale)
Women of comparable age
with another chronic disease
(hypothyroidism)
Both
Dennison et al.,
201059
642 men (mean age 64.6 years) &
women (mean age 66.6 years) traced
through health services registry &
enrolled in longitudinal study
30 women, aged 70-85 years, purposively
sampled from an RCT, recently screened,
& told they were at higher risk of fracture
(not formally diagnosed with OP)
Longitudinal
HRQoL (SF-36)
Both
Qualitative
“Risk-of-illness” experience
(Interviews)
Osteoporotic, osteopenia,
and normal subjects,
compared before screening
& 4 years later
None
Salter et al.,
201160
Burden
Notes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency of harm as the number of people who suffer a specific harm per
1,000 people exposed to the possibility of that harm, or sufficient data for estimation of the proportion. We defined burden as an indication of the physical or psychological effects experienced by the
patient or family, such as its severity, anticipated duration, treatability, or effect on daily functioning. Abbreviations (and type of instrument): (GENERAL) BARS = Beck Anxiety Rating Scale; BDI =
Beck Depression Inventory; HADS = Hospital Anxiety & Depression Scale; HAI = Health Anxiety Inventory; HDRS = Hamilton Depression Rating Scale; SF-36 = 36-Item Short Form Health Survey (SF36); STAI = State-Trait Anxiety Inventory. (OSTEOPOROSIS–SPECIFIC) Mini-OQOL = Osteoporosis Quality of Life scale; QUALEFFO-41 = Quality of life questionnaire of the European Foundation for
Osteoporosis. Other abbreviations: HRQoL = Health-related quality of life; OP = osteoporosis; VFX = vertebral fracture
Psychological Harms of Lung Cancer Screening
Subjects
Study Type
Outcomes of Interest
(Instrument or Data Source)
Comparisona
(Time Points)
Frequency/
Burdenb
3,925 men and women, mean age 57
years, participating in the Danish Lung
Cancer Screening Trial (DLCST)
Longitudinal
Cancer-specific and lung cancerspecific psychosocial
consequences of screening (COS;
COS-LC)
Burden
Byrne et al.,
200862
341 men and women, mean age 60
years, enrolled in Pittsburgh Lung
Screening Study
(PLuSS)
Longitudinal
Anxiety; fear and perceived risk of
lung cancer (STAI; 3 items
adapted from the PCQ)
Kaerlev et al.,
201263
4,104 men and women, mean age 57
years, participating in DLCST
Longitudinal
Prescription of antidepressant or
anxiolytic medication
Sinicrope et al.,
201064
60 initial respondents, male and female,
mean age 52 years
Longitudinal
Lung cancer-related concern (4
items adapted from previously
published questionnaire
Group randomized to
screening vs. group
randomized to control; also
change over time (COS
before randomization &
before first screening round;
COS-LC at a subsequent
screening round a year later)
Change over time (before
initial CT screening; within 2
weeks of receiving screening
results; 6 months and 12
months later
Group randomized to
screening vs. group
randomized to control; 3-year
follow-up
Change over time (before
screening; 1 month after
receipt of result; 6 months
post-study, after follow-up
with pulmonologist
Qualitative
and
Longitudinal
Psychosocial consequences of
abnormal and false positive lung
cancer screening results (Group
interviews and COS)
Dimensionality, objectivity,
and reliability of scale
Burden
McGovern et
al., 2004c 16
Interviews: 9 women and 7 men, aged 5366 years, recruited in the prevalence
round of the DLCST; 3 and 2 participated
in field test of instrument. 195 initial
subjects for survey.
12 men and women, aged 55-74 years,
enrolled in the PLCO
Qualitative
Responses to a false-positive
screening test (Focus groups)
None
Burden
van den Bergh
et al., 201166
1,466 men and women, aged 50-75
years, participating in the NELSON trial
Longitudinal
HRQoL; anxiety, and lung cancerspecific distress (SF-12; EQ-5D;
STAI-6; IES)
Group randomized to
screening vs. group
randomized to control; also
change over time (before
randomization; 2 months after
baseline scan for those with a
negative or indeterminate
scan result; at 2-year
assessment)
Burden
Source
Screening Test
Aggestrup et
al., 201261
Burden
Frequency
Both
False-Positive Results
Brodersen et
al., 201065
van den Bergh
et al., 201067
733 men and women, aged 50-75 years,
participating in the NELSON trial
Longitudinal
HRQoL; anxiety, and lung cancerspecific distress (SF-12; EQ-5D;
STAI-6; IES)
Vierikko et al.,
200968
601 asbestos-exposed workers, mean
age 65 years
Longitudinal
Health anxiety and worry about
lung cancer (Study-specific
questionnaire)
Diagnosis (Labeling)
Chapple et al.,
45 patients with lung cancer, recruited
200469
through various sources; aged 40+ years
Qualitative
Steinberg et al.,
200970
Crosssectional
Experiences of lung cancer-related
stigma, shame and blame
(Interviews)
Distress, depression, nervousness
(Distress Thermometer; ESAS)
98 men and women newly diagnosed with
lung cancer, mean age 63 years
Change over time (before
randomization; 1 week before
baseline scan; 2 months after
baseline scan for those with a
negative or indeterminate
scan result)
Change over time (at study
outset and 1 year later) in
both negative and false
positive groups
Burden
None
Burden
None
Frequency
Burden
Notes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency of harm as the number of people who suffer a specific harm per
1,000 people exposed to the possibility of that harm, or sufficient data for estimation of the proportion. We defined burden as an indication of the physical or psychological effects experienced by the
patient or family, such as its severity, anticipated duration, treatability, or effect on daily functioning. cAlso includes evidence on harms of diagnosis. Abbreviations (and type of instrument):
(GENERAL) ; EQ-5D = EuroQol questionnaire; HADS = Hospital Anxiety & Depression Scale; HAI = Health Anxiety Inventory; HDRS = Hamilton Depression Rating Scale; SF-12 = 12-Item Short Form
Health Survey; SF-36 = 36-Item Short Form Health Survey (SF-36); STAI = State-Trait Anxiety Inventory. (CANCER–SPECIFIC) COS = Consequence of Screening questionnaire; COS-LC =
Consequence of Screening in Lung Cancer questionnaire; ESAS = Edmonton Symptom Assessment Scale; IES = Impact of Event Scale; PCQ = Psychological Consequences Questionnaire. Other
abbreviations: HRQoL = Health-related quality of life
Overdiagnosis of Lung Cancer
Author, Year
Study Type
Data/Population
Outcome(s) of Interest
Dominioni et al.,
201271
Pathology/Imaging
1,244 smokers (mean age 56.6 years) with 21 screendetected cancers, from general practices in Varese
Province, Italy
Percent overdiagnosed, defined as screen-detected
cancers with volume doubling time > 300 days
Hazelton et al.,
201272
Modeling
Model calibrated to data from 6878 heavy smokers
without asbestos exposure in the control arm of CARET;
and to 3,642 subjects with comparable smoking histories
in PLuSS. Calibration checked using data from the New
York University Lung Cancer Biomarker Center (n =
1,021) and Moffitt
Cancer Center cohorts (n = 677).
Percent overdiagnosed
Lindell et al.,
200773
Pathology/Imaging
48 screen-detected cancers from 1520 high-risk
participants were evaluated for growth rate and
morphologic change
Percent overdiagnosed, defined as screen-detected
cancers with volume doubling time > 400 days
Marcus et al.,
200674
Follow-up of RCT
6101 participants in the Mayo Lung Project
Excess cases in the screened vs. unscreened arms,
after 16 years of follow-up
Pinsky et al.,
200475
Modeling
A general convolution model for disease natural history
was fitted to screening trial data from the Mayo Lung
Cancer Screening Trial
Proportion of screen-detected cases, in a population
undergoing annual screening, that would never present
clinically
Sone et al., 200776
Pathology/Imaging
45 cases from 13,037 CT scans of 5480 participants, 4074 years old at the initial CT screening in 1996
Percent overdiagnosed, defined as having expected
age of death (calculated from VDT) greater than
average Japanese life expectancy
Veronesi et al.,
201277
Pathology/Imaging
From 5203 participants (mean age of 57.7) in a 5-year CT
study, 175 study patients diagnosed with primary lung
cancer
Percent overdiagnosed, defined as screen-detected
cancers with volume doubling time > 400 days
Yankelevitz et al.,
200378
Pathology/Imaging
87 cases of Stage I lung cancer in the MLP and MSK
studies
Percent overdiagnosed, defined as screen-detected
cancers with volume doubling time > 400 days
Abbreviations: CARET = Carotene and Retinol Efficacy Trial; CT = Computed Tomography; MLP = Mayo Lung Project; MSK = Memorial Sloan-Kettering Cancer Center project; PLuSS = Pittsburgh
Lung Screening Trial;
Psychological Harms of Abdominal Aortic Aneurysm Screening
Study Type
Outcomes of Interest
(Instrument or Data Source)
Comparisona
(Time Points)
Frequency/
Burdenb
Longitudinal
Depression, anxiety, and HRQoL
(HADS; short-form state anxiety
scale of the Spielberger state-trait
anxiety scale; SF-36; EQ-5D)
Burden
10 men, aged 65+ years, under
surveillance for an abdominal aorta ≥30
mm, discovered during screening
3 male patients, aged 79-80 years, from a
subgroup of patients who suffered a
decrease in quality of life (QoL) 12
months after AAA screening & diagnosis
Qualitative
Reactions to diagnosis and
surveillance (Interviews)
Positive result vs. negative
result vs. controls (not invited
for screening (6 weeks after
screening); Positive
result/surgery vs. positive
result/surveillance (3 & 12
months after screening or
surgery)
None
Qualitative
Long-term response to diagnosis
and surveillance (Interviews)
None
Burden
De Rango et
al., 201182
178 patients, aged 50-79 years, under
surveillance for small (4.1-5.4 cm) AAAs
in the CAESAR trial
Longitudinal
HRQoL (SF-36)
Burden
Lederle et al.,
200383
567 patients, aged 50 to 79 years, under
surveillance for AAAs 4.0-5.4 cm
Longitudinal
HRQoL (SF-36)
Lesjak et al.,
201284
Screened men aged 65-74 years, 53 with
an abnormal aorta, and 130 with a normal
aorta
Longitudinal
Anxiety , depression, and QoL
(HADS; SF36)
Spencer et al.,
200485
120 screened men with AAA and 245 with
a normal aorta; mean age 65–83 years
Crosssectional
HRQoL, depression, and anxiety
(SF-36; EQ-5D; HADS)
Patients randomized to
undergo endovascular aortic
aneurysm repair; also change
over time (before
randomization, at 6 months
and yearly thereafter)
Patients randomized to
undergo endovascular aortic
aneurysm repair; also change
over time (before
randomization and at
clinic visits every 6 months
thereafter during the
8-year study)
Men with an abnormal aorta
vs. those with a normal aorta.
Also change over time
(before screening; 6 months
after screening)
Men with AAA vs. men with
normal aorta
Stanisic and
Rzepa, 201286
23 patients, mean age 73.8 years,
admitted for surgery to repair
asymptomatic AAA
Crosssectional
Reactions to diagnosis (Studyspecific questionnaire)
None
Frequency
Source
Subjects
Diagnosis (Labeling)
Ashton et al.,
67,800 men, aged 65–74 years, enrolled
200279
in the Multicentre Aneurysm Screening
Study (MASS)
Bertero et al.,
201080
Brannstrom et
al., 200981
Burden
Burden
Both
Burden
Notes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency of harm as the number of people who suffer a specific harm per
1,000 people exposed to the possibility of that harm, or sufficient data for estimation of the proportion. We defined burden as an indication of the physical or psychological effects experienced by the
patient or family, such as its severity, anticipated duration, treatability, or effect on daily functioning. Abbreviations (and type of instrument): (GENERAL) EQ-5D = EuroQol questionnaire; HADS =
Hospital Anxiety & Depression ScaleSF-36 = 36-Item Short Form Health Survey (SF-36); STAI = State-Trait Anxiety Inventory. Other abbreviations: CAESAR trial = Comparison of surveillance vs.
Aortic Endografting for Small Aneurysm Repair ; HRQoL = Health-related quality of life
Psychological Harms of Carotid Stenosis Screening
Source
Subjects
Diagnosis (Labeling)
Stanisic and
27 patients, mean age 66.8 years,
Rzepa, 201286
admitted for surgery to repair
asymptomatic carotid artery stenosis
Study Type
Outcomes of Interest
(Instrument or Data Source)
Comparisona
(Time Points)
Frequency/
Burdenb
Crosssectional
Reactions to diagnosis (Studyspecific questionnaire
None
Frequency
Notes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency of harm as the number of people who suffer a specific harm per
1,000 people exposed to the possibility of that harm, or sufficient data for estimation of the proportion. We defined burden as an indication of the physical or psychological effects experienced by the
patient or family, such as its severity, anticipated duration, treatability, or effect on daily functioning
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Appendix D. Numbers of studies by outcome and screening service
Screening
Service
Outcome
Studies
Design
Prostate Cancer
Crosssectional
Outcome Measures
k
(sample size
range)
4
(88-210)
General
Specific
Both
3
0
1
7
(57-4,198)
4
3
0
Anxiety
Longitudinal
Depression
Worry, Intrusive
thoughts,
Distress, Fear,
Uncertainty,
Perceived risk,
General
reactions
Health-related
quality of life
Qualitative
2
(14-16)
Crosssectional
3
(88-129)
3
Longitudinal
4
Qualitative
5
(57-569)
0
Crosssectional
5
(31-400)
0
5
0
Longitudinal
6
(57-285)
2
2
2
Qualitative
Crosssectional
Longitudinal
Qualitative
Hospitalization,
Suicide
Longitudinal
N/A
0
0
1
0
N/A
11
(7-50)
N/A
5
(31-210)
2
2
1
12
(39-569)
1
(16)
4
(registry data)
7
3
1
N/A
N/A
Screening
Service
Outcome
Studies
Design
Lung Cancer
Crosssectional
Anxiety
Longitudinal
Qualitative
Depression
Worry, Intrusive
thoughts,
Distress, Fear,
Uncertainty,
Perceived risk,
General
reactions
Health-related
quality of life
Specific
Both
0
0
0
4
(341-3,925)
1
3
0
N/A
1
(98)
1
0
0
Longitudinal
0
0
0
0
Qualitative
0
Crosssectional
Longitudinal
Qualitative
N/A
1
(98)
1
0
0
7
(60-3,925)
0
7
0
2
(12,16)
Crosssectional
Longitudinal
N/A
0
0
0
0
6
(195-3,925)
2
(12,16)
1
(4,104)
4
2
0
N/A
N/A
Studies
Design
Abdominal
Aortic
Aneurysm
General
Crosssectional
Qualitative
Screening
Service
k
(sample size
range)
0
2
(12,16)
Longitudinal
Prescription of
antidepressant
medications
Outcome
Outcome Measures
Crosssectional
Outcome Measures
k
(sample size
range)
1
(365)
General
Specific
Both
1
0
0
2
(183-1,956)
2
0
0
Anxiety
Longitudinal
Qualitative
Depression
Crosssectional
Longitudinal
0
N/A
1
(365)
1
0
0
2
(183-1,956)
2
0
0
Qualitative
Worry, Intrusive
thoughts,
Distress, Fear,
Uncertainty,
Perceived risk,
General
reactions
Health-related
quality of life
0
Crosssectional
Longitudinal
0
1
0
0
0
0
0
2
(3,10)
Crosssectional
1
(365)
1
0
0
4
(178-1,956)
2
(3,10)
4
0
0
Qualitative
Outcome
N/A
N/A
Studies
Design
Osteoporosis
1
(23)
Qualitative
Longitudinal
Screening
Service
N/A
Crosssectional
Outcome Measures
k
(sample size
range)
0
General
Specific
Both
0
0
0
1
(298)
0
0
1
Anxiety
Longitudinal
Qualitative
Depression
N/A
Crosssectional
1
(62)
1
0
0
Longitudinal
1
(298)
0
1
0
0
0
0
0
0
1
(298)
0
1
0
Qualitative
Worry, Intrusive
thoughts,
Distress, Fear,
Uncertainty,
Perceived risk,
General
reactions
Health-related
quality of life
0
Crosssectional
Longitudinal
Qualitative
Crosssectional
Longitudinal
Qualitative
N/A
3
(24-31)
N/A
1
(62)
0
1
0
1
(642)
3
(24-31)
1
0
0
N/A
Screening
Service
Outcome
Studies
Design
Carotid Artery
Stenosis
Worry, Intrusive
thoughts,
Distress, Fear,
Uncertainty,
Perceived risk,
General
reactions
Outcome Measures
k
(sample size
range)
1
(27)
General
Specific
Both
0
1
0
Longitudinal
0
0
0
0
Qualitative
0
Crosssectional
N/A