Appendix A. Search terms
Psychological Harms Search terms (Medline)Prostate Cancer 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 (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 Stenosis (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])
Overdiagnosis Search terms (Medline)Prostate Cancer (“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 Stenosis (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])
Appendix B. Selected screening services and USPSTF recommendations
Screening Service (Year of Most Recent USPSTF Review)
USPSTF Recommendations
Prostate Cancer (2011) D: Recommends against PSA-based screening for prostate cancer.
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.
Abdominal Aortic Aneurysm (2014) 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
Osteoporosis (2010) 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.
Carotid Artery Stenosis (2014)* D: Recommends against screening for carotid artery stenosis in the general adult population.
*Draft evidence report
Appendix C. Study characteristics for 5 screening services
Psychological Harms of Prostate Cancer ScreeningSource Subjects Study Type Outcomes of Interest
(Instrument or Data Source)Comparisona (Time Points) Frequency/
Burdenb
Screening Test/WorkupArcher and Hayter, 20061
7 men aged 50-69 years, from a general practice
Qualitative Men’s reactions to an equivocal PSA result (Interviews)
None Burden
Bratt et al., 20032 57 men aged 40-73 years, from families with history of PrCa
Longitudinal Anxiety, depression, & cancer-related distress (HADS; IES)
Change over time (day of screening; 4-6 weeks later)
Both
Brindle et al., 20063
569 men aged 50–69 years, recruited for ProtecT
Longitudinal Anxiety, depression, and HRQoL (HADS; SF-36)
Change over time (before screening and before biopsy)
Both
Carlsson et al., 20074
1,781 men aged ≥50 years, enrolled in ERSPC
Longitudinal Anxiety (items on study-specific questionnaire)
Change over time (before PSA results; awaiting biopsy)
Both
Chapple et al., 20075
50 men aged 52-75 years, recruited from urologists, general practitioners & support groups
Qualitative Men’s experiences before, during, & after biopsy (Interviews)
None Burden
Cormier et al., 20026
220 brothers or sons of men with PrCa
Longitudinal HRQoL; anxiety (SF-36; STAI) Change over time (before PSA test; before results; after normal result)
Both
Evans et al., 20077
28 men aged 40-75 years, from 6 Welsh general practices
Qualitative Men’s responses to screening process (Interviews)
None Burden
Macefield et al., 2010c 8
330 men aged 50-69 years, participating in ProtecT
Longitudinal Distress (POMS-SF; IES) Change over time (PSA screening; during clinic visit for biopsy; after receiving normal biopsy result; 12 weeks after negative result)
Both
Macefield et al., 20099
4,198 men aged 50–69 years, recruited for ProtecT
Longitudinal Anxiety (HADS) Change over time (PSA test; time of biopsy)
Burden
Medd et al., 200510
31 men, aged 47-91 years, referred to biopsy clinic
Cross-sectional/ qualitative
Men’s experiences before, during, & after biopsy (Study-specific questionnaire and interviews)
None Both
Oliffe, 2004d 11 14 men aged 46-74 years, recruited from support groups or advertising
Qualitative Experiences of testing, work-up and diagnosis (Interviews)
None Burden
Taylor et al., 200212
136 men, mean age 58.5 years, registered for free screening at 2 hospital-based sites
Longitudinal Avoidant or intrusive cancer-related thoughts (IES; MHI-5)
Change over time (before screening; 1 week after normal result)
Both
False-Positive ResultsFowler 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) Age- and gender-adjusted SF-36 Japanese national norms, pluschange over time within subjects(before biopsy; after results)
Burden
Katz et al., 200715 210 men, aged 52-70 years, from university hospitals and primary care practices
Cross-sectional
Anxiety; HRQoL; PrCa-related worry and perceived susceptibility (SF-36; SAI-6; study-specific items)
Primary care patients with PSAfindings in the reference range
Burden
McGovern et al., 200416
16 men, aged 55-74 years, enrolled in the PLCO
Qualitative Responses to a false-positive screening test (Focus groups)
None Burden
McNaughton-Collins et al., 200417
400 men, mean age 60 years, from 3 hospital primary care practices
Cross-sectional
PrCA-related thoughts and worry (Study-specific questionnaire)
Primary care patients with PSAfindings in the reference range
Both
Perczek et al., 2002c 18
101 men, mean age 66.7 years, at VA Medical Centers
Longitudinal Distress (POMS) Change over time (before & after biopsy)
Burden
Diagnosis (Labeling)Arredondo et al., 200419
383 men, largely >55 years old, enrolled in CaPSURE
Longitudinal HRQoL during WW (RAND SF-36)
Change over time (6-months intervals, up to 5 years after diagnosis)
Burden
Bailey et al., 200720
10 men, aged 64-88 years, attending urology clinic at a tertiary care medical center
Qualitative Uncertainty during WW (Interviews)
None Burden
Batista-Miranda et al., 200321
60 men awaiting treatment & 21 controls; aged 49-74 years
Cross-sectional
PrCA-specific QoL (FACT-P validation study)
Age-matched controls attending urology clinic but w/o PrCa dx
Burden
Bill-Axelson et al., 201122
72,613 men with PrCa (mean age at study entry 71.1 years) and 217,839 age-matched men without PrCa
Longitudinal Psychiatric hospitalization; outpatient visits; use of antidepressant medication (Swedish registry data)
Age-matched population controls Frequency
Bill-Axelson et al., 201023
128 suicides among 77,439 men with PrCa
Longitudinal Suicide (Swedish registry data) Age-standardized suicide rate in the general population
Frequency
Bisson et al., 200224
88 men aged 48-78 years, attending a joint urology/oncology clinic
Cross-sectional
Depression; anxiety; distress; QoL (GHQ30; HADS; IES; EORTC-QOL-30)
Scores were compared to published criteria for “caseness”
Frequency
Burnet et al., 200725
100 men (mean age 67.1 years) from outpatient clinics
Cross-sectional
Anxiety & depression during AS (HADS)
Normative HADS data from a large non-clinical sample
Both
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
Longitudinal HRQoL during AS (SF-36; Perceived Stress Scale)
Change over time (baseline & 12 months later)
Burden
Ervik et al., 201027
10 men, aged >55 years, from urology/endocrinology clinics
Qualitative Reactions to diagnosis (Interviews)
None Burden
Fall et al., 200928 136 suicides among 168,584 men with PrCa (mean age at diagnosis 73.4 years), out of 4,305,358 men followed 1961-2004
Longitudinal Suicide (Swedish registry data) Men without PrCa Frequency
Fang et al., 201029
148 suicides among 342,497 men (mean age at diagnosis 70.2 years) with PrCa
Longitudinal Suicide (National Death Index) Age-, calendar period-, and state-matched suicide rates from the general population
Frequency
Fransson et al., 200930
27 men, aged 65-88 years at study entry, with localized disease, recruited for RCT comparing WW to RT
Longitudinal HRQoL (EORTC-QLQ-30) during WW
Change over time (between 4 & 10 years of follow-up)
Burden
Hedestig et al., 200331
7 men, aged 62-69 years, selected from a PrCa registry
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 (Study-specific questionnaire)
Population-based control group matched for region and age; also within-subjects change at 2 follow-up points 9 years apart
Both
Kelly, 200933 14 men, aged 59-83 years, from outpatient clinics
Qualitative Impact of diagnosis on body image (Interviews)
None Burden
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)
Qualitative Reactions to diagnosis (Interviews)
None Burden
Oliffe et al., 200936
25 men, aged 48-77 years, referred by physicians
Qualitative AS-related uncertainty (Interviews)
None Burden
Oliffe, 200637 35 men, aged 46-87 years, recruited from PrCa support groups or advertising
Qualitative Reactions to diagnosis (Interviews)
None 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)
Matched non-cancer controls Both
Siston et al., 200339
39 men, aged 47-84 years, from 5 VA Medical Centers
Longitudinal Cancer-specific QoL during WW (EORTC-QLQ-30+3)
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
Cross-sectional
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; MHI-5 = 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 CancerAuthor, 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 overdetectionAbbreviations: 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 ScreeningSource Subjects Study Type Outcomes of Interest
(Instrument or Data Source)Comparisona
(Time Points)Frequency/Burden?b
Screening TestEmmett 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-specificquestionnaire)
Change over time (before scanning, after results, and at 1 week and 3 month follow-up)
Burden
Diagnosis (Labeling)Bianchi et al., 200558
62 women, aged 50-85 years, with uncomplicated primary OP
Cross-sectional
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
Longitudinal HRQoL (SF-36) Osteoporotic, osteopenia, and normal subjects, compared before screening & 4 years later
Both
Salter et al., 201160
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)
Qualitative “Risk-of-illness” experience (Interviews)
None 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 (SF-36); 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 ScreeningSource Subjects Study Type Outcomes of Interest
(Instrument or Data Source)Comparisona
(Time Points)Frequency/Burdenb
Screening TestAggestrup et al., 201261
3,925 men and women, mean age 57 years, participating in the Danish Lung Cancer Screening Trial (DLCST)
Longitudinal Cancer-specific and lung cancer-specific psychosocial consequences of screening (COS; COS-LC)
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)
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)
Change over time (before initial CT screening; within 2 weeks of receiving screening results; 6 months and 12 months later
Burden
Kaerlev et al., 201263
4,104 men and women, mean age 57 years, participating in DLCST
Longitudinal Prescription of antidepressant or anxiolytic medication
Group randomized to screening vs. group randomized to control; 3-year follow-up
Frequency
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
Change over time (before screening; 1 month after receipt of result; 6 months post-study, after follow-up with pulmonologist
Both
False-Positive ResultsBrodersen et al., 201065
Interviews: 9 women and 7 men, aged 53-66 years, recruited in the prevalence round of the DLCST; 3 and 2 participated in field test of instrument. 195 initial subjects for survey.
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
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 cancer-specific 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
van den Bergh et al., 201067
733 men and women, aged 50-75 years, participating in the NELSON trial
Longitudinal HRQoL; anxiety, and lung cancer-specific distress (SF-12; EQ-5D; STAI-6; IES)
Change over time (before randomization; 1 week before baseline scan; 2 months after baseline scan for those with a negative or indeterminate scan result)
Burden
Vierikko et al., 200968
601 asbestos-exposed workers, mean age 65 years
Longitudinal Health anxiety and worry about lung cancer (Study-specific questionnaire)
Change over time (at study outset and 1 year later) in both negative and false positive groups
Burden
Diagnosis (Labeling)Chapple et al., 200469
45 patients with lung cancer, recruited through various sources; aged 40+ years
Qualitative Experiences of lung cancer-related stigma, shame and blame (Interviews)
None Burden
Steinberg et al., 200970
98 men and women newly diagnosed with lung cancer, mean age 63 years
Cross-sectional
Distress, depression, nervousness (Distress Thermometer; ESAS)
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. 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 screen-detected 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 MoffittCancer 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, 40-74 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
Source Subjects Study Type Outcomes of Interest (Instrument or Data Source)
Comparisona
(Time Points)Frequency/Burdenb
Diagnosis (Labeling)Ashton et al., 200279
67,800 men, aged 65–74 years, enrolled in the Multicentre Aneurysm Screening Study (MASS)
Longitudinal Depression, anxiety, and HRQoL (HADS; short-form state anxiety scale of the Spielberger state-traitanxiety scale; SF-36; EQ-5D)
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)
Burden
Bertero et al., 201080
10 men, aged 65+ years, under surveillance for an abdominal aorta ≥30 mm, discovered during screening
Qualitative Reactions to diagnosis and surveillance (Interviews)
None Burden
Brannstrom et al., 200981
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 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) Patients randomized to undergo endovascular aortic aneurysm repair; also change over time (before randomization, at 6 months and yearly thereafter)
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) Patients randomized to undergo endovascular aortic aneurysm repair; also change over time (before randomization and atclinic visits every 6 months thereafter during the8-year study)
Burden
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)
Men with an abnormal aorta vs. those with a normal aorta. Also change over time (before screening; 6 months after screening)
Both
Spencer et al., 200485
120 screened men with AAA and 245 with a normal aorta; mean age 65–83 years
Cross-sectional
HRQoL, depression, and anxiety (SF-36; EQ-5D; HADS)
Men with AAA vs. men with normal aorta
Burden
Stanisic and Rzepa, 201286
23 patients, mean age 73.8 years, admitted for surgery to repair asymptomatic AAA
Cross-sectional
Reactions to diagnosis (Study-specific 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. 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 ScreeningSource Subjects Study Type Outcomes of Interest
(Instrument or Data Source)Comparisona
(Time Points)Frequency/Burdenb
Diagnosis (Labeling)Stanisic and Rzepa, 201286
27 patients, mean age 66.8 years, admitted for surgery to repair asymptomatic carotid artery stenosis
Cross-sectional
Reactions to diagnosis (Study-specific 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 Outcome Measures
Design k(sample size
range)
General Specific Both
Prostate Cancer
Anxiety
Cross-sectional
4(88-210)
3 0 1
Longitudinal 7(57-4,198)
4 3 0
Qualitative 2(14-16)
N/A
DepressionCross-sectional
3(88-129)
30 0
Longitudinal 5(57-569)
4 1 0
Qualitative 0 N/A
Worry, Intrusive thoughts, Distress, Fear, Uncertainty, Perceived risk, General reactions
Cross-sectional
5(31-400)
0 5 0
Longitudinal 6(57-285)
2 2 2
Qualitative 11(7-50)
N/A
Health-related quality of life
Cross-sectional
5(31-210)
2 2 1
Longitudinal 12(39-569)
7 3 1
Qualitative 1(16)
N/A
Hospitalization, Suicide
Longitudinal 4(registry data)
N/A
Screening Service
Outcome Studies Outcome Measures
Design k(sample size
range)
General Specific Both
Lung Cancer
Anxiety
Cross-sectional
0 0 0 0
Longitudinal 4(341-3,925)
1 3 0
Qualitative 2(12,16)
N/A
DepressionCross-sectional
1(98)
1 0 0
Longitudinal 0 0 0 0
Qualitative 0 N/A
Worry, Intrusive thoughts, Distress, Fear, Uncertainty, Perceived risk, General reactions
Cross-sectional
1(98)
1 0 0
Longitudinal 7(60-3,925)
0 7 0
Qualitative 2(12,16)
N/A
Health-related quality of life
Cross-sectional
0 0 0 0
Longitudinal 6(195-3,925)
4 2 0
Qualitative 2(12,16)
N/A
Prescription of antidepressant medications
Longitudinal 1(4,104)
N/A
Screening Service
Outcome Studies Outcome Measures
Design k(sample size
range)
General Specific Both
Abdominal Aortic Aneurysm Anxiety
Cross-sectional
1(365)
1 0 0
Longitudinal 2(183-1,956)
2 0 0
Qualitative 0 N/A
DepressionCross-sectional
1(365)
1 0 0
Longitudinal 2(183-1,956)
2 0 0
Qualitative 0 N/A
Worry, Intrusive thoughts, Distress, Fear, Uncertainty, Perceived risk, General reactions
Cross-sectional
1(23)
0 1 0
Longitudinal 0 0 0 0
Qualitative 2(3,10)
N/A
Health-related quality of life
Cross-sectional
1(365)
1 0 0
Longitudinal 4(178-1,956)
4 0 0
Qualitative 2(3,10)
N/A
Screening Service
Outcome Studies Outcome Measures
Design k(sample size
range)
General Specific Both
Osteoporosis
Anxiety
Cross-sectional
0 0 0 0
Longitudinal 1(298)
0 0 1
Qualitative 0 N/A
DepressionCross-sectional
1(62)
1 0 0
Longitudinal 1(298)
1 0 0
Qualitative 0 N/A
Worry, Intrusive thoughts, Distress, Fear, Uncertainty, Perceived risk, General reactions
Cross-sectional
0 0 0 0
Longitudinal 1(298)
0 1 0
Qualitative 3(24-31)
N/A
Health-related quality of life
Cross-sectional
1(62)
0 1 0
Longitudinal 1(642)
1 0 0
Qualitative 3(24-31)
N/A