Table 3.
GRADE analysis: quality of the overall literature pool by population/intervention type for studies assessing three cluster components
| Condition | Number of participants of completed (number studies) | Confidence in estimate of effect GRADE | Magnitude of estimate of effect GRADE | Safety GRADE | GRADE recommendation | Comments |
|---|---|---|---|---|---|---|
| Metastatic (n=1) | ||||||
| Psychosocial* | – | – | – | – | – | – |
| Non-metastatic (n=5) | ||||||
| Behavioral | 70 (2) | C | ND | 0 | No recommendation | Some promise for sleep, mixed for fatigue, neither statistically significant on depression. Both poor quality (−, −) studies and under-powered. |
| Pharmacological | 558 (2) | B | ND | 0 | Weak recommendation in favor | Promising for sleep, mixed for fatigue, and neither statistically significant for depression. Mixed quality studies (+, −). |
| CAM* | – | – | – | – | – | – |
| Mixed (n=3) | ||||||
| Psychosocial | 237 (2) | B | ND | 0 | Weak recommendation in favor | Promising for sleep, mixed for depression and not statistically significant for fatigue. Adequate quality studies (+,+). |
| Pharmacological* | – | – | – | – | – | – |
| Survivors (n=3) | ||||||
| Pharmacological | 145 (2) | B | ND | 0 | No recommendation | Promising for sleep, no evidence for depression or fatigue. Mixed quality studies (+,−). |
| CAM* | – | – | – | – | – | – |
Notes:
Due to the small number of studies in these categories, four studies35,40,42,43 were not assessed via the GRADE; There are four major domains that comprise the core of the modified GRADE methodology: (1) confidence in the estimate of the effect was categorized into the following groups using pre-defined criteria: A) High: further research is very unlikely to change confidence in the estimate of effect; several high quality RCTs with consistent results or in special cases, or one large, high quality, multi-center RCT; B) Moderate: further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate; one high quality RCT or several RCTs with some limitations; C) Low: further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate; one or more RCTs with severe limitations; D) Very Low: any estimate of effect is very uncertain; expert opinion, no direct research evidence or one or more RCTs with severe limitations. (2) magnitude of the effect was categorized into five levels of none (<0.2), small (0.2–0.5), moderate (0.5–0.8), large (>0.8), or not described (authors did not describe or report effect size for this review’s outcomes of interest due to the lack of author reporting). (3) safety grade is dependent on the frequency and severity of adverse events and interactions. Safety was categorized into one of the following grades: +2, appears safe with infrequent adverse events and interactions; +1, appears relatively safe but with frequent but not serious adverse events and interactions; 0, safety not well understood or conflicting; −1, appears to have safety concerns that include infrequent but serious adverse events and/or interactions or; −2, has serious safety concerns that include frequent and serious adverse events and/or interactions. (4) strength of the recommendation can be determined using the following categories and criteria: strong recommendation in favor of or against – very certain that benefits do, or do not, outweigh risks and burdens; no recommendation – no recommendations can be made or; weak recommendation in favor of or against – benefits and risks and burdens are finely balanced, or appreciable uncertainty exists about the magnitude of benefits and risks.
Abbreviations: CAM, complementary/alternative medicine; GRADE, Grading of Recommendation Assessment, Development and Evaluation; RCT, randomized controlled trial.