Table 5.
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 significant differences in HRQL between AS and RT on the QOL-CS scales - In multivariate models RT was significantly negatively associated with physical functioning, bodily pain dimensions, QOL-CS spiritual and total well-being scores Subgroup analyses: exclusion of clinically progressed cancer survivors - Above results remain unchanged Comparison: AS or EBRT vs. controls from the general population, follow-up timeb: 7.8 years, mean aged: 75.8 years - PC survivors reported comparable HRQL scores compared to an age-matched, normative population, except in role physical PC survivors treated with EBRT reported significantly (p < 0.05) worse mean compared to controls from the general population |
- No baseline data available |
| S2 | Namiki, S/ 2011 [44] | Comparison: RP vs. EBRT, follow-up timeb: 5 years, meane: 69.5 years - Patterns of alterations over time in intervention groups were different in physical function (p < 0.001), role physical (p < 0.001), role emotional (p < 0.001) and vitality (p = 0.027), whereas survivors treated with RP had higher scores in all domains |
- Sample size <70 in all study arms - (Repeated ANOVA-tests: only changes over time are shown) - No confounding control - No adjustment for attrition error |
| 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 - Worse clinically relevant scores for survivors in social functioning scales and higher burden with insomnia and diarrhea Comparison: EBRT vs. controls from the general population, follow-up timeb: 10-16 years, median agee: 66 years - Clinically relevant higher burden for PC survivors with diarrhea |
- Sample size <100 in all study arms - No confounding control - No significance statistical test -No adjustment for attrition error |
| S3a | Fransson, P/ 2008 [38] | Comparison: EBRT vs. controls from the general population, follow-up timec: 15 years, mean aged: 78.1 years - No significant differences were observed among intervention groups in measures of general health-related or cancer-related QoL |
- Sample size <100 in study arms - No confounding control - No adjustment for attrition error |
| S3 | Fransson, P/ 2009 [39] | Comparison: EBRT vs. WW, follow-up timec: 10 years,median aged: 78 years - No significant differences were observed between groups in measures of general health-related or cancer-related QoL |
- 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 - Clinically important differencesf but worse score for PC survivors in role emotional and vitality not statistically relevant |
- Sample size <100 in both study arms - Only results on physical and role functioning were reported for this follow-up time |
| 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 - PC survivors who underwent RP had, in general, the highest HRQoL, followed by survivors who received WW and patients who received EBRT. Survivors who received ADT had the lowest physical HRQL, in general. - Significantly different means between intervention groups in physical functioning (p < 0.001, clinical important differencef) and physical well-being (p = 0.02). Clinically important differencesf in vitality among group means, but not significantly different means. - PC survivors treated with EBRT reported a significantly (p < 0.05) worse mean in physical functioning compared to survivors treated with EBRT - Survivors treated with ADT reported a significantly (p < 0.05) worse mean in physical functioning and vitality compared to survivors treated with EBRT Subgroup analyses – age groups: <75 years vs. > = 75 years - In general, HRQL scores were higher for younger survivors than for older survivors Comparison: RP or EBRT or ADT or WW vs. general population, 5-10 years after diagnosis - PC survivors reported comparable HRQL scores compared to an age-matched, normative population group - PC survivors treated with RP, EBRT and WW reported less problems with bodily pain than population controls |
- Sample size <100 in both study arms - No intention to treat 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 - No significant differences were observed among the groups in measures of general health-related or cancer-related quality of life |
- Sample size <70 in study arms - No adjustment for attrition error |
| S3a | Shinohara, N/ 2013 [46] | Comparison: EBRT vs. RP, localized and locally advanced PC, follow-up time: 5 years, mean/median age: 68 years - No significant differences were observed among the groups in measures of general health-related or cancer-related QoL |
- Sample size <70 in all study arms - No adjustment for attrition error - No confounding control |
| X | Galbraith, M E/ 2005 [30] | Comparison: EBRT – LDg, EBRT – Cg vs. WW, follow-up timec: 5.5 years, aged: average 69.7 years - Regardless of type of intervention, health-related QOL and general health tend to decrease for prostate cancer survivors - PC survivors in WW tended to have poorer health outcomes |
- Sample size <70 in all study arms - No confounding control - For growth curve analyses plots are printed badly, so it cannot be distinguished between intervention arms - For comparisons at specific time points it is not explained which statistical tests was used - P-values are not shown for all comparisons, not explained for which reasons some results are not shown - No adjustment for attrition error |
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 results appropriate
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