link.springer.com10.1007/... · Web viewNotes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency

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)


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


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


(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


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


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


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


Yankelevitz et al., 200378

Pathology/Imaging 87 cases of Stage I lung cancer in the MLP and MSK studies


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


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



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


2 2 2


N/A

Health-related quality of life

Cross-sectional

5(31-210)

2 2 1


7 3 1

Qualitative 1(16)

N/A

Hospitalization, Suicide

Longitudinal 4(registry data)

N/A

Screening Service



range)


Lung Cancer

Anxiety

Cross-sectional

0 0 0 0


1 3 0

Qualitative 2(12,16)

N/A


1(98)

1 0 0

Longitudinal 0 0 0 0

Qualitative 0 N/A


Cross-sectional

1(98)

1 0 0


0 7 0


N/A


Cross-sectional

0 0 0 0


4 2 0


N/A

Prescription of antidepressant medications

Longitudinal 1(4,104)

N/A

Screening Service



range)


Abdominal Aortic Aneurysm Anxiety

Cross-sectional

1(365)

1 0 0


2 0 0

Qualitative 0 N/A


1(365)

1 0 0


2 0 0

Qualitative 0 N/A


Cross-sectional

1(23)

0 1 0


Qualitative 2(3,10)

N/A


Cross-sectional

1(365)

1 0 0


4 0 0

Qualitative 2(3,10)

N/A

Screening Service



range)


Osteoporosis

Anxiety

Cross-sectional

0 0 0 0

Longitudinal 1(298)

0 0 1

Qualitative 0 N/A


1(62)

1 0 0

Longitudinal 1(298)

1 0 0

Qualitative 0 N/A


Cross-sectional

0 0 0 0

Longitudinal 1(298)

0 1 0


N/A


Cross-sectional

1(62)

0 1 0

Longitudinal 1(642)

1 0 0


N/A

Screening Service



range)


Carotid Artery Stenosis Worry, Intrusive

thoughts, Distress, Fear, Uncertainty, Perceived risk, General reactions

Cross-sectional

1(27)

0 1 0


Qualitative 0 N/A

link.springer.com10.1007/... · Web viewNotes: aUnless otherwise noted, in this column “change over time” refers to repeated measures within subjects. bWe defined frequency

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