Content and Face Validity of the Evaluation Tool of Health Information for Consumers (ETHIC): Getting Health Information Accessible to Patients and Citizens.

BACKGROUND: Health information concerns both individuals' engagement and the way services and professionals provide information to facilitate consumers' health decision making. Citizens' and patients' participation in the management of their own health is related to the availability of tools making health information accessible, thus promoting empowerment and making care more inclusive and fairer. A novel instrument was developed (Evaluation Tool of Health Information for Consumers-ETHIC) for assessing the formal quality of health information materials written in Italian language. This study reports ETHIC's content and face validity. METHODS: A convenience sample of 11 experts and 5 potential users was involved. The former were requested to evaluate relevance and exhaustiveness, the latter both readability and understandability of ETHIC. The Content Validity Index (CVI) was calculated for ETHIC's sections and items; experts and potential users' feedback were analyzed by the authors. RESULTS: All sections and most items were evaluated as relevant. A new item was introduced. Potential users provided the researchers with comments that partly confirmed ETHIC's clarity and understandability. CONCLUSIONS: Our findings strongly support the relevance of ETHIC's sections and items. An updated version of the instrument matching exhaustivity, readability, and understandability criteria was obtained, which will be assessed for further steps of the validation process.

Mindfulness-based therapies for cancer patients and families: a systematic review.

BACKGROUND: Mindfulness-based therapies (MBTs) addressed to patients with cancer have been widely studied in the last two decades, and their efficacy has been systematically reviewed and meta-analysed. Although findings from literature highlight benefits of MBTs on several patients' health outcomes, these should be appraised taking into consideration the characteristics of the selected studies. In this systematic review, we summarised the current evidence of the efficacy of MBTs in improving the quality of life of both patients with cancer and their relatives, with a focus on the methodological quality, type of MBT evaluated and population involved in existing randomised controlled trials (RCTs). METHODS: We searched English language articles published until February 2021. Couples of authors independently applied inclusion criteria and extracted findings. Thirty RCTs were included. RESULTS: Nearly half of the studies were performed in English-speaking countries outside of Europe, with females diagnosed with breast cancer. Most considered heterogeneous phases of illness; one study only was performed on relatives. In most cases, different measures were employed to evaluate the same outcome. The efficacy of MBTs has been demonstrated in 25 of the 30 included articles. The methodological quality of RCTs was acceptable. CONCLUSION: The heterogeneity of studies' characteristics makes findings on the efficacy of MBTs poorly informative with reference to different clinical and cancer-related psychological conditions. Studies on more homogeneous samples by cancer site and phase, as well as performed in different cultural contexts, could provide a basis for better evaluating and targeting MBTs' protocols for the specific needs of patients with cancer and their relatives.

Preliminary Investigation of Microlitter Pollution in Low-Energy Hydrodynamic Basins Using Sabella spallanzanii (Polychaeta: Sabellidae) Tubes.

Harbor basins are strategically important and heavily impacted water bodies according to the water framework directive. Due to constant traffic, variety of activities, and low-energy hydrodynamics, these areas can have high degrees of water pollution. This study reports the results of the preliminary investigation of anthropogenic microlitter (AM) pollution in a semi-enclosed basin (Civitavecchia harbor; northern Tyrrhenian Sea, Italy) using the tubes built by the polychaete Sabella spallanzanii. The visual inspection showed AM particles within the tube structure as a result of its building process. The total average AM abundance was 20.8 ± 3.7 AM g-1. AM abundances and flushing time as the hydrodynamic parameter of water renewal highlight the homogeneity of the sampling area. The suitability of S. spallanzanii tubes as a potential tool to investigate the AM pollution level in sheltered and polluted environments is highlighted.

The assessment of mindfulness skills: the "what" and the "how".

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.

Promoting post-traumatic growth in cancer patients: A study protocol for a randomized controlled trial of guided written disclosure.

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.

Underwater noise assessment outside harbor areas: The case of Port of Civitavecchia, northern Tyrrhenian Sea, Italy.

Underwater noise assessment is particularly important in coastal areas where a wide range of natural and anthropogenic sounds generate complex and variable soundscapes. In the last century, the number and size of noise sources has increased significantly, thereby increasing the ocean's background noise. Shipping is the main source of lower-frequency underwater noises (<500 Hz). This research aimed to provide an initial assessment of underwater noise levels in a coastal area of the northern Tyrrhenian Sea (Italy) using short-term recordings. Spatial and temporal variations in the noise level, and the type and number of ships sailing through the port were recorded. A significant correlation was found between ferry boats and sound pressure levels, indicating their role as a prevalent source of low frequency underwater noise in the project area. This research could provide the baseline for implementation of distribution and point-source underwater noise models that are required for sustainable coastal management.

Dimensions of Mindfulness and Their Relations with Psychological Well-Being and Neuroticism.

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.

Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

BACKGROUND: The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. METHODS: RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTS: A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (ß = .19, P = .001) and RCTs with PROs as secondary endpoints (ß = .30, P < .001). CONCLUSIONS: Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.

Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making.

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.

Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.

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.