Property:Additional Notes
This is a property of type Text.
W
Wyatt et al. (2012): Health-Related Quality-of-Life Outcomes: A Reflexology Trial With Patients With Advanced-Stage Breast Cancer +
PRO:
Large, multicenter sample;
Statistical model with repeated measures (no multiple testing), intention-to-treat analysis and covariates (group differences from baseline in depression and anxiety were controlled);
Survey of NW not with CTCAE, but systematically with own criteria
CONTRA:
No blinding when conducting the study, although this would have been possible (subjective outcomes)
Dyspnoea, which is also the mediator for the effects of physical function (outcome 4), was itself only measured with a single item (internal validity).
No indication of the specific results of the group comparisons between arm A and arm B (i.e. the comparisons with the active control group), except for the one significant effect on dyspnoea (reduced reporting) +
Wyatt et al. (2017): A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment +
'''Mediators analysed'''
* Perception of social support with Multidimensional Scale of Perceived Social Support (MSPSS) in study weeks 1, 5, 11: no significant differences between the arms (p=0.99)
* Quality of the patient-study partner relationship with the Quality Relationship Tool in study weeks 1, 5, 11: no significant differences between the arms (p=0.08)
PRO:
* Large, multicenter sample
* The comparability of the groups was comprehensively checked (including the reference to the partner who carried out the reflex therapy, comorbidities, etc.) and the difference in age was controlled. In addition, statistical model with repeated measures (no multiple testing)
CONTRA:
* Reliability and validity of the short form of the Patient-Reported Outcomes Measurements Information System PROMIS has not yet been sufficiently tested
* No idea what exactly the control group did (“attention”)
* High drop-out, but equally distributed in both arms and intention-to-treat analysis carried out (nevertheless influence on external validity)
* NI about the effect sizes and the clinical relevance range +
Z
Zalat et al. (2020): Evaluation of the cardioprotective effects of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy +
PRO:
* Ethical approval
* Study protocol
* Baseline comparison
CONTRA:
* No blinding
* Simple randomization: Even numbers assigned to carnitine and odd numbers to silymarin arm; unclear how the control group was randomized and no additional details on randomization
* Statistical methods opaque: No group comparison despite planned ANOVA with group comparison
* Unclear process for patient inclusion and unclear timing of randomization (patients were "recruited" after randomization); exclusion reasons in text differ from those in the figure
* High risk of bias as 14 patients in the intervention groups dropped out due to non-compliance with the protocol and no ITT analysis was conducted
* No information on adverse events
* Change in silymarin arm over 6 months from 66.7 ± 0.045 to 68.56 ± 0.031 is highly significant (p = 0.003), despite a very small difference +