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Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making. European Urology, 66(3), 416-427. Efficace, F., Feuerstein, M., Fayers, P., Cafaro, V., Eastham, J., Pusic, A., … & EORTC Quality of Life Group. (2014).

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.

Patient-Reported Outcomes in Randomized Controlled Trials of Colorectal Cancer: An Analysis Determining the Availability of Robust Data that Informs Clinical Decision-Making. Journal of Cancer Research and Clinical Oncology, 141(12), 2181-2192. Rees, J. R., Whale, K., Fish, D., Fayers, P., Cafaro, V., Pusic, A., Blazeby, J.M., Efficace, F. (2015)

Purpose: Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. Methods: A systematic review from January 2004-February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research-patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. Results: Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. Conclusions: Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings.

Quality of Patient-Reported Outcome (PRO) Reporting Across Cancer Randomized Controlled Trials According to the CONSORT PRO Extension: A Pooled Analysis of 557 Trials. Cancer, 121(18), 3335-3342. Efficace, F., Fayers, P., Pusic, A., Cemal, Y., Yanagawa, J., Jacobs, M., La Sala, A., Cafaro., V., Whale, K., Rees, J., Blazeby, J. (2015).

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). Conclusions: 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.

Promoting posttraumatic growth in cancer patients: A study protocol for a randomized controlled trial of guided written disclosure. Journal of health psychology24(2), 240-253, Cafaro, V., Iani, L., Costantini, M., Di Leo, S. (2019)

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.

Dimensions of mindfulness and their relations with psychological well-being and neuroticism. Mindfulness, 1-13. Iani, L., Lauriola, M., Cafaro, V., & Didonna, F. (2017).

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.

The assessment of mindfulness skills: the “what” and the “how”. Journal of Mental Health, 1-8. Iani, L., Lauriola, M. & Cafaro, V. (2017).

Background: The five facets mindfulness questionnaire-short form (FFMQ-SF) is a new, brief measure for the assessment of mindfulness skills in clinical and nonclinical samples. The construct validity of the FFMQ-SF has not been previously assessed in community samples. Aims: The present study investigated the factor structure of the Italian version of the FFMQ-SF. Method: Structured equation modeling was used to test the fit of three alternative models in a sample of highly educated adults (n = 211). Results: A hierarchical model with a single second-order factor loaded by observing, describing, and acting with awareness (i.e. the mindfulness “what” skills) performed slightly better than both a five-factor model with correlated factors and a hierarchical model with a general second-order factor. The FFMQ-SF scores were significantly higher than those reported in both Dutch depressed patients and Australian undergraduate students for all facets (but nonreactivity for the Australian sample). Conclusions: Data support the multifaceted nature of mindfulness skills. Because of its brevity and simplicity of use, the FFMQ-SF is a promising questionnaire in longitudinal and clinical research. This questionnaire can serve as a guideline to help clinicians assess and monitor mindfulness skills acquisition, strengthening, and generalization, and prioritize mindfulness skills that need immediate attention.