Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: Results from the TOTEM randomized trial.

PURPOSE: To investigate whether intensive follow-up (INT) after surgery for endometrial cancer impact health-related quality of life (HRQoL) and healthcare costs compared to minimalist follow-up (MIN), in the absence of evidence supporting any benefit on 5-year overall survival. METHODS: In the TOTEM trial, HRQoL was assessed using the SF-12 and the Psychological General Well-Being (PGWB) questionnaires at baseline, after 6 and 12 months and then annually up to 5 years of follow-up. Costs were analyzed after 4 years of follow-up from a National Health Service perspective, stratified by risk level. The probability of missing data was analyzed for both endpoints. RESULTS: 1847 patients were included in the analyses. The probability of missing data was not influenced by the study arms (MIN vs INT OR: 0.97 95%CI: 0.87-1.08). Longitudinal changes in HRQoL scores did not differ between the two follow-up regimens (MIN vs INT SF-12 PCS: -0.573, CI95%: -1.31; 0.16; SF-12 MCS: -0.243, CI95%: -1.08; 0.59; PGWB: -0.057, CI95%: -0,88; 0,77). The mean cost difference between the intensive and minimalist arm was €531 for low-risk patients and €683 for high-risk patients. CONCLUSION: In the follow-up of endometrial cancer after surgery, a minimalist treatment regimen did not affect quality of life and was cost-saving in both low-risk and high-risk recurrence patients. As previous results showed no survival benefit, a minimalist approach is justified. The relevant proportion of missing data on secondary outcomes of interest could be a critical point that deserves special attention.

[Cystic fibrosis carrier screening: a Health technology assessment.] / Lo screening del portatore di fibrosi cistica: una valutazione di Health technology assessment.

This project of Health technology assessment was aimed at defining the impacts of offering a cystic fibrosis (CF) carrier screening to the general population, compared to the current situation, where the test is offered to individuals at high-risk to give birth to a child with CF. Results revealed: i) a lack of robust and updated data; ii) a return on investment up to six years from the screening's introduction, despite important economic and organizational efforts; iii) a general positive attitude of healthcare professionals, people with CF, families and general population; iv) possible issues related to the social impact.

Effectiveness of preconceptional and prenatal cystic fibrosis carrier screening: a systematic review

BACKGROUND: genetic testing for cystic fibrosis (CF) has been offered to people with higher risk of being carrier. OBJECTIVES: to assess the effectiveness of population-based CF carrier screening for adults of reproductive age and its optimal organizational features. DESIGN: systematic review. SETTING AND PARTICIPANTS: MedLine, Embase, Cochrane Library, CINAHL and LILACS (1990-2022) were searched to retrieve primary and secondary studies on adults (16 years and older), with no clinical indication or genetic risk, eligible for genetic testing for CF carrier status. MAIN OUTCOMES MEASURES: attitude to screening, uptake of screening offered, informed reproductive choices. RESULTS: a total of 3,326 records were screened and 292 potentially eligible full-text publications assessed. The review included 71 publications, corresponding to 3 reviews, 40 cohort studies (11 comparative, 29 single-arm), and 6 model studies, published between 1992 and 2021 (median 1998). Only one study compared screening or no screening. This study suggested an association between carrier screening and a lower incidence of CF. Comparative studies examined different approaches for invitation and testing, i.e., settings, target population (individuals/couples, prenatal/preconceptional), how invitations are organized (primary care/maternal hospitals), and format and content of the pre-test information. However, no firm conclusions can be drawn on the impact of these features on informed reproductive choices, uptake, and attitude, because of the limitations of the evidence collected. CONCLUSIONS: the broad heterogeneity of the studies, methodological weaknesses, and the limited transferability of the results mean there is still uncertainty about the effectiveness of preconceptional and prenatal CF carrier screening in the general population.

Public and patient involvement: a survey on knowledge, experience and opinions among researchers within a precision oncology European project.

BACKGROUND: Patient and Public Involvement (PPI) is slowly but steadily being implemented in all phases of clinical research. As part of the European project "Building Data Rich Clinical Trials" a survey was launched to investigate the knowledge, experiences and opinions on this topic of clinicians and researchers from seven European clinical and non-clinical centers (Cancer Core Europe). METHODS: An invitation to take part in a cross-sectional web survey was sent to 199 clinicians and researchers working in the field of precision oncology. The questionnaire was developed ad hoc because no existing questionnaires met the purpose of this study. The analysis takes account of whether respondents had experience on PPI or not. RESULTS: On a total of 101 respondents, this survey reveals that 76.2% of them knew about PPI before answering the questionnaire, 54.5% had experience in the previous five years and 86.1% were interested in a training course on this topic. PPI knowledge grew together with career seniority (peak of 86.5% for established career professionals), while the group most interested in a course was the early-career professionals (100.0%). Finally, the majority of respondents stated they had no training or education on PPI (67.3% of experienced and 82.6% of not-experienced respondents). CONCLUSIONS: This survey shows that most cancer researchers knew the term PPI, even if only a little more than half of them had any relative experience. Opinions on PPI benefits, negative effects, barriers and requirements differed between the groups of PPI experienced and not-experienced respondents, showing that experience itself can influence respondents' opinions. Most of respondents reported they would prefer a training course based on practical rather than theoretical tools.

Psychosocial Impact of Virtual Cancer Care through Technology: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

This meta-analysis of RCTs aimed to determine whether replacing face-to-face hospital care with telemedicine deteriorates psychosocial outcomes of adult cancer patients, in terms of quality of life (QoL), anxiety, distress, and depression. RCTs on interventions aimed at improving patient psychosocial outcomes were excluded. MEDLINE, EmBASE, and PsycInfo were searched on 13 May 2022 without language or date restrictions. In total, 1400 records were identified and 8 RCTs included (4434 subjects). Study methodological quality was moderate. Statistically significant improvements were observed in favor of the intervention for QoL (SMD = 0.22, 95% CI 0.01 to 0.43, p = 0.04), anxiety (SMD = -0.17, 95% CI -0.30 to -0.04, p < 0.01), and global distress (SMD = -0.38, 95% CI -0.51 to -0.25, p < 0.01). A meta-analysis on depression could not be performed. In subgroup analyses, the intervention appeared to be more beneficial for patients receiving active treatment vs. follow-up, for "other cancer types" vs. breast cancer, and for "other modes of administration" vs. telephone. Given the many potential advantages of being assisted at home, telemedicine appears to be a viable option in oncology. However, more research is necessary to determine the types of patients who may benefit the most from these alternative care modalities.

Knowledge and attitudes towards clinical trials among women with ovarian cancer: results of the ACTO study.

BACKGROUND: Despite several initiatives by research groups, regulatory authorities, and scientific associations to engage citizens/patients in clinical research, there are still obstacles to participation. Among the main discouraging aspects are incomplete understanding of the concepts related to a clinical trial, and the scant, sometimes confused, explanations given. This observational, cross-sectional multicenter study investigated knowledge, attitudes and trust in clinical research. We conducted a survey among women with ovarian cancer at their first follow-up visit or first therapy session, treated in centers belonging to the Mario Negri Gynecologic Oncology (MaNGO) and Multicenter Italian Trials in Ovarian Cancer (MITO) groups. A questionnaire on knowledge, attitudes and experience was assembled ad hoc after a literature review and a validation process involving patients of the Alliance against Ovarian Cancer (ACTO). RESULTS: From 25 centers 348 questionnaire were collected; 73.5% of responders were 56 years or older, 54.8% had a high level of education, more than 80% had no experience of trial participation. Among participants 59% knew what clinical trials were and 71% what informed consent was. However, more than half did not know the meaning of the term randomization. More than half (56%) were in favor of participating in a clinical trial, but 35% were not certain. Almost all responders acknowledged the doctor's importance in decision-making. Patients' associations were recognized as having a powerful role in the design and planning of clinical trials. CONCLUSIONS: This study helps depict the knowledge and attitudes of women with ovarian cancer in relation to clinical trials, suggesting measures aimed at improving trial "culture", literacy and compliance, and fresh ways of communication between doctors and patients.

Psychosocial Care for Adult Cancer Patients: Guidelines of the Italian Medical Oncology Association.

Psychosocial morbidity can have negative consequences for cancer patients, including maladaptive coping, poor treatment adherence, and lower quality of life. Evidence shows that psychosocial interventions can positively impact quality of life, as well as symptoms and side effects; however, they are not always offered to patients who might benefit from them. These guidelines were produced by a multidisciplinary panel of 16 experts, including patients, following GRADE methodology. The panel framed clinical questions and voted on outcomes to investigate. Studies identified by rigorous search strategies were assessed to rate certainty of evidence, and recommendations were formulated by the panel. Although the quality of the evidence found was generally moderate, interventions could be recommended aimed at improving patient information, communication with healthcare professionals and involvement in decision-making; detecting and managing patient psychosocial needs, particularly with non-pharmacological therapy; and supporting families of patients with advanced cancer. The role of nurses as providers of information and psychosocial care is stressed. Most recommended interventions do not appear to necessitate new services or infrastructures, and therefore do not require allocation of additional resources, but predominantly involve changes in clinical staff behavior and/or ward organization. Patients should be made aware of psychosocial care standards so that they can expect to receive them.

["Donnainformata-mammografia": a decision aid developed and validated in the Italian setting]. / Donnainformata-mammografia: un decision aid costruito e validato nel setting italiano.

The decision aid "Donnainformata-mammografia" (https://www.donnainformata-mammografia.it/en/) has been developed with the aim of providing clear information on the benefits and harms of breast cancer screening, and the controversies on the relationship between mortality reduction and overdiagnosis. It was evaluated in a randomized clinical trial showing it increases informed choice and does not decrease participation in screening.This article describes the framework, the guiding principles, and the operational phases of the tool development.The project was developed within the national screening programme. The promoters decided to state their placement, to start from the information needs of women and what is already known, and to balance spontaneous navigation with "nudging" to key contents. Three focus groups with 18 women and 4 interviews were organized. Participants expressed a favourable attitude towards screening, and no knowledge of the debate on screening efficacy and overdiagnosis. A literature review and a comparison of decision aids were conducted. The online tool included the results of these steps. The home page presents key information with links to relevant topics, so that the person can decide to stop there having an overview or to continue. The «ready to decide¼ button, which leads to the section of decision support, can be clicked on every page. Here, the person can evaluate a list of key points on the basis of her values, in order to decide to participate in screening or not.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.

BACKGROUND: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA). METHODS: A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA. RESULTS: Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%). CONCLUSION: DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT03097653.

Choosing Wisely Italy: online survey on opinions and behaviors of 1006 people and 355 volunteers of healthcare advocacy associations.

BACKGROUND: In the framework of 'Doing more does not mean doing better - Choosing Wisely Italy' health professionals, general population and healthcare advocacy associations are widely involved. PartecipaSalute-Mario Negri IRCCS and Altronconsumo organized a survey in order to assess the opinions and behaviors of people toward unnecessary tests and drugs. METHODS: An online survey was distributed by Altroconsumo to a voluntary panel of 6304 Italian citizens covering the whole of the country and by PartecipaSalute-Mario Negri IRCCS through the PartecipaSalute website, e-mail lists, website articles, lay journals and Facebook. RESULTS: In all 1006 people reached by Altroconsumo, and 355 volunteers of healthcare advocacy associations reached by PartecipaSalute responded. Respondents usually decides on their treatment together with the physician, respectively 50% for general population and 64% for volunteers of healthcare advocacy associations. The respondents are aware of the question of over-use of drugs and tests (80%), more often among the volunteers of healthcare advocacy associations (86%). Over-use is considered a problem mostly for economic reasons among the general population, while in the advocacy associations the risks for patients' health is considered more important. CONCLUSION: These findings suggest that patients do not always ask for more, especially if they receive an answer to their questions and clarifications about unnecessary treatments. There is a need for further understanding of the factors influencing decision-making aimed at achieving good care. Engaging the public and patients at all levels of healthcare is essential for a valuable use of health resources.

Potential benefits of pregnancy on endometriosis symptoms.

OBJECTIVE: To explore the potential benefits of pregnancy on endometriosis symptoms. This is a retrospective study that has been conducted at Academic department and referral center for endometriosis. STUDY DESIGN: We included all conservative women who had a live birth after at least one surgery for endometriosis and who reported pre-pregnancy moderate to severe pelvic pain symptoms (at least one among dysmenorrhea, deep dyspareunia, non menstrual pelvic pain and dyschezia). Data were collected before pregnancy and two years after delivery. The main aim of the study was comparing endometriosis-related pain symptoms before and after pregnancy. Mental health and quality of life were also assessed to investigate the possible psychological benefits of pregnancy. RESULTS: One-hundred thirty- one women were identified. Forty- nine women (37%, 95% CI: 29-47%) had a clinically relevant recurrence of symptoms requiring medical or surgical treatment. Two years after delivery, 84% of women (95% CI 77-90%) reported at least one moderate-severe pain symptom. A statistically significant improvement was observed for HADS and SF-12 scores but not for FSFI. CONCLUSION: Women with endometriosis experiencesymptoms relief during and immediately after pregnancy. However, as for hormonal medical therapy, symptoms rapidly recur in the vast majority of cases.

A stepped-care approach to symptomatic endometriosis management: a participatory research initiative.

OBJECTIVE: To assess the proportion of patients with symptomatic endometriosis satisfied with their medical treatment 12 months after enrollment in a stepped-care management protocol. DESIGN: Prospective, single-arm, self-controlled study. SETTING: Academic department. PATIENT(S): A cohort of 157 consecutive patients referred or self-referred to our center for symptomatic endometriosis. INTERVENTIONS(S): Systematic detailed information process on medical and surgical treatment followed by a shared decision to start a stepped-care protocol including three subsequent medical therapy steps (oral contraception [OC]; 2.5 mg/d norethindrone acetate [NETA]; 2 mg/d dienogest [DNG]) and a fourth surgical step. Stepping up was triggered by drug inefficacy/intolerance. MAIN OUTCOME MEASURE(S): Satisfaction with treatment was assessed according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied). Variations were measured in pain symptoms with the use of a 0-10-point numeric rating scale (NRS), in quality of life with the use of the Short Form 12 questionnaire (SF-12), and in sexual functioning with the use of the Female Sexual Function Index (FSFI). RESULT(S): At the end of the 12-month study period, 106 women were still using OC, 23 were using NETA, three were using DNG, and four had undergone surgery. Twenty-one participants (13%) dropped out from the study. In intention-to-treat analysis, excluding five drop-outs for pregnancy desire, the overall satisfaction rate with the stepped-care protocol was 62% (95/152; 95% CI 55%-70%). By 12-month follow-up, significant improvements were observed in all pain symptom scores and in SF-12 physical and mental component summary scores, whereas FSFI scores did not vary substantially. CONCLUSION(S): Most women with endometriosis-associated pelvic pain who chose a stepped-care approach were satisfied with OC and a low-cost progestin for the treatment of their symptoms. The need to step up to an expensive progestin or surgery was marginal.

Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

BACKGROUND: In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. RESULTS: Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. CONCLUSIONS: These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

Deciding on cystic fibrosis carrier screening: three citizens' juries and an online survey.

Background: Health technology assessment and ethical issues have to be dealt with in deciding on national carrier screening for cystic fibrosis (CF)-the most frequent severe autosomal recessive disease in Caucasian populations and several stakeholders need to be involved. A citizens' jury is one way to ask citizens to deliberate on controversial topics in the interests of a society. The aims of this project were to gather opinions about CF carrier screening through citizens' jury deliberations and to match them with the findings of a large online consultation survey open to the general population, people with CF and families and health professionals. Methods: Three citizens' juries and an online survey were asked: 'Should the Health Service organize screening of the population with the aim of identifying healthy people who may have children with CF?' The jurors had no medical background and no personal or family CF history. The survey was open to people with CF, families, and healthcare professionals. Results: Jurors and survey respondents were in favour of CF carrier screening, mainly considering the severity of CF, the value of informed reproductive choices and the equality of the screening. All the citizens' juries felt positively about the health service actively offer CF carrier screening to provide women and couples of reproductive age equal access and standardized information on the pros and cons. Conclusion: Considering the favourable attitude towards CF screening, the feasibility of CF screening, in terms of best setting, target age and healthcare professionals providing it, should be tested in a clinical trial.

[Decision aid and informed decision on breast cancer screening: the "DonnaInformata-Mammografia" project.] / Decision aid e scelta informata sullo screening mammografico: il progetto DonnaInformata-Mammografia.

In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patient associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women's informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented. The contents of the DA were developed on the basis of: a) findings of three focus groups and four interviews, organized in the three Italian screening centers; b) analysis of the literature. A web-based platform (www.donnainformata-mammografia) was developed to implement the DA in a multilevel model. The impact of the DA will be evaluated in a randomized controlled trial with a one week follow-up. The women will be randomized to DA or a standard brochure via web. We will invite 8160 women to obtain the final sample size of 816 women. The primary outcome will be informed choice, measured via knowledge, attitudes and intentions on BC screening. SECONDARY OUTCOMES: participation rate and decisional conflict process. If the informed choice will be reached, the web DA will be open source and could be implemented in BC screenings. This model could be applied to other health care settings and cancer screenings.

Medical treatment or surgery for colorectal endometriosis? Results of a shared decision-making approach.

STUDY QUESTION: What is the degree of patient satisfaction in women with symptomatic colorectal endometriosis who choose medical or surgical treatment after a shared decision-making (SDM) process? SUMMARY ANSWER: The degree of satisfaction with treatment was high both in women who chose medical treatment with a low-dose oral contraceptive (OCP) or a progestin, and in those who chose to undergo surgical resection of bowel endometriosis. WHAT IS KNOWN ALREADY: Hormonal therapies and surgery for colorectal endometriosis have been investigated in non-comparative studies with inconsistent results. STUDY DESIGN, SIZE, DURATION: Parallel cohort study conducted on 87 women referring to our centre with an indication to surgery for colorectal endometriosis. A standardised SDM process was adopted, allowing women to choose their preferred treatment. Median follow-up was 40 [18-60] months in the medical therapy group and 45 [30-67] in the surgery group. PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients with endometriosis infiltrating the proximal rectum, the rectosigmoid junction, and the sigmoid, not causing severe sub-occlusive symptoms were enroled. A total of 50 patients chose treatment with an OCP (n = 12) or a progestin (n = 38), whereas 37 women confirmed their previous indication to surgery. Patient satisfaction was graded according to a 5-category scale. Variations in bowel and pain symptoms were measured by means of a 0-10 numeric rating scale. Constipation was assessed with the Knowles-Eccersley-Scott Symptom Questionnaire (KESS), health-related quality of life with the Short Form-12 questionnaire (SF-12), psychological status with the Hospital Anxiety and Depression scale (HADS) and sexual functioning with the Female Sexual Function Index (FSFI). MAIN RESULTS AND THE ROLE OF CHANCE: Six women in the medical therapy group requested surgery because of drug inefficacy (n = 3) or intolerance (n = 3). Seven major complications were observed in the surgery group (19%). At 12-month follow-up, 39 (78%) women in the medical therapy group were satisfied with their treatment, compared with 28 (76%) in the surgery group (adjusted odds ratio (OR), 1.37; 95% confidence interval (CI), 0.45-4.15; intention-to-treat analysis). Corresponding figures at final follow-up assessment were 72% in the former group and 65% in the latter one (adjusted OR, 1.74; 95% CI, 0.62-4.85). The 60-month cumulative proportion of dissatisfaction-free participants was 71% in the medical therapy group compared with 61% in the surgery group (P = 0.61); the Hazard incidence rate ratio was 1.21 (95% CI, 0.57-2.62). Intestinal complaints were ameliorated by both treatments. Significant between-group differences in favour of medical treatment were observed at 12-month follow-up in diarrhoea, dysmenorrhoea, non-menstrual pelvic pain and SF-12 physical component scores. The total HADS score improved significantly in both groups, whereas the total FSFI score improved only in women who chose medical therapy. LIMITATIONS REASONS FOR CAUTION: As treatments were not randomly assigned, selection bias and confounding are likely. The small sample size exposes to the risk of type II errors. WIDER IMPLICATIONS OF THE FINDINGS: When adequately informed and empowered through a SDM process, most patients with non-occlusive colorectal endometriosis who had already received a surgical indication, preferred medical therapy. The possibility of choosing the preferred treatment may allow maximisation of the potential effect of the interventions. STUDY FUNDING/COMPETING INTEREST(S): This study was financed by Italian fiscal contribution '5 × 1000'-Ministero dell'Istruzione, dell'Università e della Ricerca-devolved to Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy. P.V., M.P.F., R.R., D.D., A.R., P.M., O.D.G. and M.C. declare that they have no conflicts of interest. E.S. received grants from Ferring and Serono.

Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial.

BACKGROUND: In Italy women aged 50-69 are invited for a population-based breast cancer (BC) screening. Physicians, policy makers and patients associations agree on the need to inform women about the benefits and harms in order to permit an informed decision. Decision aids (DA) are an effective way to support people in their decisions about health. This trial aims to assess women's informed choices, according to their health literacy and values, on participating or not in BC screening for the first time. Benefits, harms and controversies are presented. METHODS/DESIGN: The impact of the DA will be evaluated in a randomized controlled trial with a two-week follow-up. Women will be randomized via web to DA or a standard brochure. We will invite 8160 women, to obtain a final sample of 816 women. The primary outcome will be informed choice, measured on the basis of knowledge, attitudes and intentions on BC screening. Secondary outcomes are participation rate, satisfaction on information and decisional conflict. DISCUSSION: The web DA will be open-source and implemented on BC screenings and its efficacy for increasing informed choice will be tested. This model could be applied to other healthcare settings, cancer screenings, and public health programs. TRIAL REGISTRATION: The protocol for this trial was registered with the Clinicaltrials.gov registry on March 16, 2017: NCT03097653 .

Cross-cultural validation of health literacy measurement tools in Italian oncology patients.

BACKGROUND: The aim of this study was to assess the psychometric characteristics of four Health Literacy (HL) measurement tools, viz. Newest Vital Sign (NVS), Short Test of Functional Health Literacy in Adults (STOFHLA), Single Item Literacy Screener (SILS) and Single question on Self-rated Reading Ability (SrRA) among Italian oncology patients. METHODS: The original version of the tools were translated from the English language into Italian using a standard forward-backward procedure and according to internationally recognized good practices. Their internal consistency (reliability) and validity (construct, convergent and discriminative) were tested in a sample of 245 consecutive cancer patients recruited from seven Italian health care centers. RESULTS: The internal consistency of the STOFHLA-I was Chronbach's α=0.96 and that of NVS-I was α=0.74. The STOFHLA-I, NVS-I, SILS-I and SrRA-I scores were in a good relative correlation and in all tools the discriminative known-group validity was confirmed. The reliability and validity values were similar to those obtained from other cultural context studies. CONCLUSION: The psychometric characteristics of the Italian version of NVS, STHOFLA, SILS and SrRA were found to be good, with satisfactory reliability and validity. This indicates that they could be used as a screening tool in Italian patients. Moreover, the use of the same cross-cultural tools, validated in different languages, is essential for implementing multicenter studies to measure and compare the functional HL levels across countries.