| Literature DB >> 30086766 |
Salome Adam1,2, Anita Feller3, Sabine Rohrmann1, Volker Arndt4,5.
Abstract
The original article [1] contains errors whereby some information provided in Tables 2 and 5 in the online version is missing in the PDF version; in addition, some details regarding the study by Mols et al., Johnstone et al. and Fransson et al. (2008) in Tables 1 and 5 require correction.Entities:
Year: 2018 PMID: 30086766 PMCID: PMC6081813 DOI: 10.1186/s12955-018-0968-x
Source DB: PubMed Journal: Health Qual Life Outcomes ISSN: 1477-7525 Impact factor: 3.186
Summary table of study characteristics
| Characteristic | Frequency | |||||
|---|---|---|---|---|---|---|
| Study Design | Randomized controlled trial | 3 | ||||
| Recruitment | Monocentric hospital-based | 9 | ||||
| Comparison: Intervention vs. general population* | RP | EBRT | ADT | WW | AS | |
| X | 2 | |||||
| X1a | 5 | |||||
| X | 1 | |||||
| X | 1 | |||||
| X | 1 | |||||
| Comparison between different interventions* | RP | EBRT | ADT | WW | AS | |
| X | X | X | 1 | |||
| X | Xd | 1 | ||||
| X | X | 1 | ||||
| X vs. Xc | 1 | |||||
| Xc | X | 1 | ||||
| X | X | 1 | ||||
| X | X | 1 | ||||
| X | X | X | X | 1 | ||
| X | Xe | X | 1 | |||
| X | Xf | 1 | ||||
| Sample sizes (total population) | <100 | 6 | ||||
| Years since diagnosis/randomization | Long-term survivors (5-10 years after diagnosis) | 10 | ||||
| Stage at diagnosis | Localized (T1/T2) PC | 3 | ||||
| Recurrent PC survivors | No information | 10 | ||||
| Progressive PC survivors | No information | 5 | ||||
aSome studies had multiple comparisons
b“Plus ADT and/or clinical progression”
cplus ADT
dBrachytherapy
eEBRT-C — Conventional radiation; EBRT-HD — High-dose mixed-beam radiation; EBRT-LD — Low-dose mixed-beam radiation; EBRT-MB — Standard protocol/mixed-beam radiation; EBRT-PB — Proton beam radiation
fBrachytherapy
gExcluded because they died
Main findings on HRQoL in observational studies
| Comp. | Study | Key Findings | Potential Limitation(s) |
|---|---|---|---|
| S1a | Thong, M S/ 2010 [47] | Comparison: AS vs. EBRT, follow-up timeb: 7.8 years, mean aged: 75.8 years | - No baseline data available |
| S2 | Namiki, S/ 2011 [44] | Comparison: RP vs. EBRT, follow-up timeb: 5 years, meane: 69.5 years | - Sample size <70 in all study arms |
| S3a | Berg, A/ 2007 [35] | Comparison: EBRT + ADT/clinical progression vs. controls from the general population, follow-up timeb: 10-16 years, median agee: 66 years | - Sample size <100 in all study arms |
| S3a | Fransson, P/ 2008 [38] | Comparison: EBRT vs. controls from the general population, follow-up timec: 15 years, mean aged: 78.1 years | - Sample size <100 in study arms |
| S3 | Fransson, P/ 2009 [39] | Comparison: EBRT vs. WW, follow-up timec: 10 years, median aged: 78 years | - Sample size <100 in both study arms |
| S3 | Johnstone, P A S/ 2000 [42] | Comparison: EBRT (plus ADT) vs. controls from the general population, follow-up timec: 13.9 years, median aged: 80 years | - Sample size <70 in study arm |
| S3 | Mols, F/ 2006 [43] | Comparison: RP vs. EBRT (plus ADT) vs. ADT vs. WW, follow-up timeb: 5-10 years, aged: average 80 years | - Sample size <70 in two (ADT & WW) out of 4 study arms in general analyses |
| S3 | Namiki, S/ 2014 [45] | Comparison: RP vs. controls from the general population, follow-up timec: 8.3 years, mean aged: 63.9 years | - Sample size <70 in study arms |
| S3a | Shinohara, N/ 2013 [46] | Comparison: EBRT vs. RP, localized and locally advanced PC, follow-up time: 5 years, mean/median age: 68 years | - Sample size <70 in all study arms |
| X | Galbraith, M E/ 2005 [30] | Comparison: EBRT – LDg, EBRT – Cg vs. WW, follow-up timec: 5.5 years, aged: average 69.7 years | - Sample size <70 in all study arms |
Comp. Comparison group
S1: HRQoL by primary intervention in long-term survivors with localized PC; S2: HRQoL by intervention in long-term survivors with locally advanced PC; S3: HRQoL by intervention in long-term survivors with localized or locally advanced PC; X: No assignment possible as study revealed no information about cancer stage
Studies were ordered by stage information and within each group alphabetically.
As potential limitations, the following criteria were considered: (1) sample size 100 per study arm for studies using EORTC-C30 and 70 for studies using SF-36 70 (2) adjustment for attrition error (3) statistical significance tests performed (4) adjustment for attrition error (only prospective cohort studies) (5) baseline data available (6) reporting of appropriate results.
Definition of clinically meaningful difference: EORTC QLQ-C30: min. 10 points difference; SF-36: min. 5 points difference in general health dimension, min 6.5 points in physical dimension, 7.9 points in mental health dimension.
aInlcusion of PC survivors with disease progression
bTime since diagnosis
cTime since enrolment in study
dAge at survey
eAge at enrollment in study
fNot reported, but clinically meaningful difference
gEBRT-LD — Low-dose mixed-beam radiation, EBRT-C — Conventional radiation
Characteristics of included studies
| At survey ≥ 5 years | Mean/ Median (Range)a | At diagnosisg | ||||
|---|---|---|---|---|---|---|
| First Author/ Year, Country | Study Design | Sample | Intervention (%) | Age at survey (years) | Follow-up timef | Cancer Stage (%) |
| Berg, A/ 2007, Norway [35] | Hospital-based observational prospective monocentric cohort study | 64 | EBRT (100) [+ADT (44.0)]e | 66c (48-81) | 11 (10 – 16) | Localized PC (33.0) |
| Brundage, M/ 2015, UK and US [36] | Hospital-based mulitcentric randomized controlled trial | 85-111d | 1. ADT (50.0)c | 69.7c (65.5 – 73.5) | (5 – 8) | Locally advanced PC (100.0) |
| Donovan, J L / 2016, UK [37] | Population-based multicentric randomized controlled trial | 1413-1463d | 1. AS (33.2) | 62c | (5 – 6) | Localized PC (100.0) |
| Fransson, P/ 2008, Sweden [38] | Hospital-based observational prospective monocentric cohort study | 64 | 1. EBRT (42.2) +ADT (20.3) | 78.1 (62 – 87) | 14.7 (13.5 – 16.4) | Localized PC (89.9) |
| Fransson, P/ 2009, Sweden [39] | Hospital-based observational monocentric retrospective cohort study | 54 | 1. EBRT (50.0) | 78 (54 – 88) | 9.6 (6.4 – 16.3) | Local PC (100.0) |
| Galbraith, M E/ 2005, US [40] | Hospital-based observational prospective monocentric cohort study | 137 | 1. WW (11.5)c | 69.9c | 5.5 | No information |
| Giberti, C/ 2009, Italy [41] | Hospital-based monocentric randomized controlled trial | 174 | 1. RP (44.5) | 65.3c (56 – 74)c | 5 | Localized PC (100.0) |
| Johnstone, P A S/ 2000, US [42] | Hospital based observational monocentric prospective cohort study | 46 | EBRT (100.0) | 80 (62 – 90) | 13.9 (10 – 23) | Localized PC |
| Mols, F/ 2006, Denmark [43] | Population-based observational retrospective cohort study | 780 | 1. RP (32.9) | 75 | (5-10) | Localized PC (76.0) |
| Namiki, S/ 2011, Japan [44] | Hospital-based observational prospective monocentric cohort study | 111 | 1. RP (43.2) + ADT (48) | 69.5c (53 – 84) | 5 | Locally Advanced PC (100.0) |
| Namiki, S/ 2014, Japan [45] | Hospital-based observational prospective monocentric cohort study | 91 | RP (100.0) | 63.9c | 8.5 (7.1 – 10.25) | Localized PC (94.5) |
| Shinohara, N/ 2013, Japan [46] | Hospital-based observational monocentric prospective cohort study | 67 | 1. EBRT (32.4) | 682 (53 – 79) | 5 | Localized PC (93.4) |
| Thong, M S/ 2010, Netherlands [47] | Population-based observational retrospective cohort study | 142 | 1. AS (50.0) [+ ADT (2.8)/ +RP (1.4)/ + EBRT (7)/ + EBRT + ADT (1.4)]e | 75.8 | 7.8 | Localized PC (100) |
RP Radical Prostatectomy, EBRT External Beam Radiotherapy (refers to the external delivery of any type of radiation), BT Brachytherapy, WW Watchful Waiting, AS Active Surveillance, ADT Androgen Deprivation Therapy
aMean/Medians for total sample
bEBRT-C — Conventional radiation; EBRT-HD — High-dose mixed-beam radiation; EBRT-LD — Low-dose mixed-beam radiation; EBRT-MB — Standard protocol/mixed-beam radiation; EBRT-PB — Proton beam radiation
cSample size/Age at enrolment in study or randomisation
dSample sizes at different time points ≥ 5 years
eSecondary intervention(s)
fEither time since diagnosis or time since randomization
gCategorization: local PC – T1 & T2, locally advanced PC T3 & T4