Background The main objectives of this study were to identify the number of randomized controlled trials (RCTs) that have included a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate completeness of PRO reporting according to the CONSORT PRO extension. Methods RCTs with a PRO endpoint, conducted across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated based on previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing RCT Risk of Bias. Analyses were also conducted by type of PRO endpoint (primary versus secondary) and by cancer disease site. Results A total of 56,696 potentially eligible records were scrutinized and 557 RCTs with a PRO evaluation, enrolling overall 254,677 patients, were identified. PROs were most frequently used in RCTs of breast (N=123), lung (N=85) and colorectal (N=66) cancer. Overall, PROs were secondary endpoint in 421 (76%) RCTs. Four out of six CONSORT PRO items evaluated were documented in less than 50% of the RCTs. Level of reporting was higher in RCTs with PRO as a primary endpoint. Presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PRO as primary (β=0.19; P=0.001) or secondary endpoint (β=0.30; P<0.001). Conclusion Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute in revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.
Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results. Patient summary In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results.
In this study we examined whether differences in the habitual use of mindfulness skills were associated with specific well-being and neuroticism aspects. Two hundred eleven volunteers aged 21–84 years completed measures of mindfulness, neuroticism, psychological well-being (PWB), and subjective well-being (SWB). Describing, observing, and acting with awareness (i.e., the mindfulness “what” skills) were positively correlated with personal growth, purpose in life, and autonomy (i.e., the “core” eudaimonic components of PWB). Nonreactivity and nonjudging (i.e., the mindfulness “how” skills) were negatively associated with neuroticism aspects, such as withdrawal (e.g., depression) and volatility (e.g., anger). Describing and nonreactivity were the only mindfulness skills significantly correlated with the SWB measures. Acting with awareness mediated the effect of both withdrawal and volatility on eudaimonic well-being outcomes. Describing had consistent mediation effects across all well-being measures, but only for the withdrawal aspect. Nonreactivity and nonjudging did not mediated withdrawal when considering eudaimonic well-being as outcomes. Mediation effects for nonjudging and nonreactivity were found between volatility and SWB markers as well as between volatility and self-acceptance, environmental mastery, and positive relations with others (i.e., the “other” eudaimonic PWB components). In sum, the mindfulness “what” skills were important for eudaimonic well-being, especially for internalizing individuals. Authors discuss the usefulness of a facet-level analysis of mindfulness for examining incremental validity of some facets over others in accounting for different well-being outcomes measures. Clinical implications are also discussed.
This multicenter study investigates the efficacy of the guided disclosure protocol in promoting post-traumatic growth, through meaning reconstruction, in cancer patients after adjuvant chemotherapy. Participants will be randomized to guided disclosure protocol or to an active control condition. Both conditions consist of three 20-minute writing sessions. Experimental participants verbalize emotions, describe events, and reflect on trauma effects. Control participants write about their past week's daily routine. Patients, blinded to treatment assignment, will complete questionnaires at pre-intervention, post-intervention, and 6-month follow-up. This study will improve knowledge concerning the effects of writing interventions on psychological health and well-being in cancer patients.
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