Pain as bad as you can imagine or extremely severe pain? A randomized controlled trial comparing two pain scale anchors.

BACKGROUND: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity. METHODS: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity. RESULTS: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005). CONCLUSION: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms.

GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESS©): psychometric properties and clinically meaningful thresholds as assessed in the Phase 3 DeFi randomized controlled clinical trial.

PURPOSE: The GODDESS© tool was developed to assess Desmoid Tumor/Aggressive Fibromatosis (DT/AF) symptom severity and impact on patients' lives. This study evaluated GODDESS©'s cross-sectional and longitudinal measurement properties. METHODS: The Phase 3, randomized placebo-controlled, DeFi study (NCT03785964) of nirogacestat in DT/AF was used to assess GODDESS©'s reliability, construct validity, responsiveness, and estimate of meaningful change thresholds (MCTs). Other patient-reported outcome (PRO) measures included Patient Global Impression of Severity (PGIS) in DT/AF symptoms, EORTC QLQ-C30, Brief Pain Inventory Short Form, and PROMIS Physical Function short-form 10a v2.0 plus 3 items. RESULTS: DeFi participants (N = 142) had a median age of 34 years (range: 18-76) and were mostly female (64.8%), with extra-abdominal (76.8%) or intra-abdominal tumors (23.2%). The GODDESS© symptom/impact scales showed internal consistency at baseline, cycles 4 and 7 (Cronbach's α > 0.70) and test-retest reliability (intra-class correlation coefficient > 0.85). GODDESS© scales correlated moderately to highly with PRO measures capturing similar content and differentiated among PGIS and Eastern Cooperative Oncology Group groups. GODDESS© scales detected improvement over time. For the total symptom score, a 1.30-point decrease was estimated as the within-person MCT and a 1.00-point decrease as the between-group MCT. For the physical functioning impact score, estimated within- and between-group MCTs were 0.60-point and 0.50-point decreases, respectively. Few participants exhibited symptom worsening. CONCLUSION: GODDESS© was found to be reliable, valid, responsive, and interpretable as a clinical trial endpoint in the pooled sample of DT/AF patients. Estimated MCTs can be used to define responders and assess group-level differences in future, unblinded, efficacy analyses. TRIAL REGISTRATION NUMBER AND REGISTRATION DATE: NCT03785964; December 24, 2018.

International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.

In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field.

Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03.

PURPOSE: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI). METHODS: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14-70 (T2), and 71-112 (T3) days following randomization. RESULTS: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness. CONCLUSION: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making.

Suggestions for modifications to the Female Sexual Function Index based on cognitive interviews with sexual and gender minority individuals and cisgender, heterosexual persons.

BACKGROUND: Patient-reported outcome measures for sexual health were often designed for research studies that included only heterosexual, partnered, and cisgender participants; as such, they may have limited applicability for clinical use among sexual and gender minority (SGM) individuals or those without a partner. AIM: We aimed to conduct cognitive interviews with SGM persons and heterosexual women to determine the readability, comprehension, and applicability of questionnaire items to assess sexual function among diverse sexual and gender identities. METHODS: We conducted 4 rounds of cognitive interviews with 52 participants (28 SGM; 24 cisgender, heterosexual) who provided feedback on the comprehension and wording of questionnaire items and response scales. We used items from the Female Sexual Function Index (FSFI) and focused on establishing content validity of a modified measure. Participants made recommendations for changes to the questionnaire, which was iteratively revised between interview rounds. Two independent coders analyzed the transcripts using structural coding based on 5 predefined codes: satisfaction with item, specificity/language change needed, missing/suggested item, patient definitions of concepts, and confusion with item. OUTCOMES: Content validity. RESULTS: After 3 rounds of cognitive interviews and revisions to the questionnaire, participants found the final version acceptable and understandable, thereby reaching thematic saturation and establishing content validity of the modified FSFI. Modifications included the following: replacing all instances of "sexual stimulation" and "intercourse" with "sexual activity (alone or with a partner)," broadening the definition of "vaginal penetration" beyond penile-vaginal penetration, and adding skip logic to include the option "no sexual activity." Participants identified missing concepts important to their sexual health, such as use of an external lubricant. CLINICAL IMPLICATIONS: The FSFI and similar questionnaires need to be adapted to broader clinical practice populations such that all persons' experiences are accurately reflected and assessed, ensuring that sexual health needs can be met more inclusively. STRENGTH AND LIMITATIONS: A strength of the study was using cognitive interviews engaging patient perspectives, which is considered the gold standard for establishing content validity. One limitation is that participants included predominantly White and highly educated women. CONCLUSION: Feedback from interviews supports modifying FSFI items and further psychometric testing, and future studies should evaluate the measure among racially and educationally diverse groups.

Association of patient activity bio-profiles with health-related quality of life in patients with newly diagnosed multiple myeloma: a prospective observational cohort study.

Background: Due to the nature of their disease, patients with multiple myeloma (MM) often have bone disease-related pain that limits physical activity and diminishes health-related quality of life (HRQOL). Digital health technology with wearables and electronic patient reported outcome (ePRO) tools can provide insights into MM HRQoL. Methods: In this prospective observational cohort study conducted at Memorial Sloan Kettering Cancer in NY, NY, USA, patients with newly diagnosed MM (n = 40) in two cohorts (Cohort A - patients <65 years; Cohort B - patients ≥65 years) were passively remote-monitored for physical activity at baseline and continuously for up to 6 cycles of induction therapy from Feb 20, 2017 to Sep 10, 2019. The primary endpoint of the study was to determine feasibility of continuous data capture, defined as 13 or more patients of each 20-patient cohort compliant with capturing data for ≥16 h of a 24-hr period in ≥60% of days of ≥4 induction cycles. Secondary aims explored activity trends with treatment and association to ePRO outcomes. Patients completed ePRO surveys (EORTC - QLQC30 and MY20) at baseline and after each cycle. Associations between physical activity measurements, QLQC30 and MY20 scores, and time from the start of treatment were estimated using a linear mixed model with a random intercept. Findings: Forty patients were enrolled onto study, and activity bioprofiles were compiled among 24/40 (60%) wearable user participants (wearing the device for at least one cycle). In an intention to treat feasibility analysis, 21/40 (53%) patients [12/20 (60%) Cohort A; 9/20 (45%) Cohort B] had continuous data capture. Among data captured, overall activity trended upward cycle over cycle for the entire study cohort (+179 steps/24 h per cycle; p = 0.0014, 95% CI: 68-289). Older patients (age ≥65 years) had higher increases in activity (+260 steps/24 h per cycle; p < 0.0001, 95% CI: -154 to 366) compared to younger patients (+116 steps/24 h per cycle; p = 0.21, 95% CI: -60 to 293). Activity trends associated with improvement of ePRO domains, including physical functioning scores (p < 0.0001), global health scores (p = 0.02), and declining disease burden symptom scores (p = 0.042). Interpretation: Our study demonstrates that feasibility of passive wearable monitoring is challenging in a newly diagnosed MM patient population due to patient use. However, overall continuous data capture monitoring remains high among willing user participants. As therapy is initiated, we show improving activity trends, mainly in older patients, and that activity bioprofiles correlate with traditional HRQOL measurements. Funding: Grants -National Institutes of HealthP30 CA 008748, Awards - Kroll Award 2019.

Patient Perceptions of a Decision Support Tool for Men with Localized Prostate Cancer.

Purpose. To evaluate patient perceptions of a Web-based decision aid for the treatment of localized prostate cancer. Methods. We assessed patient perceptions of a multicomponent, Web-based decision aid with a preference elicitation/values clarification exercise using adaptive conjoint analysis, the generation of a summary report, and provision of information about localized prostate cancer treatment options. Using a think-aloud approach, we conducted 21 cognitive interviews with prostate cancer patients presented with the decision aid prior to seeing their urologist. Thematic content analysis was used to examine patient perceptions of the tool's components and content prior to engaging in shared decision making with their clinician. Results. Five themes were identified: 1) patients had some negative emotional reactions to the tool, pointing out what they perceived to be unnecessarily negative framing and language used; 2) patients were forced to stop and think about preferences while going through the tool and found this deliberation to be useful; 3) patients were confused by the tool; 4) patients tried to discern the intent of the conjoint analysis questions; and 5) there was a disconnect between patients' negative reactions while using the tool and a contrasting general satisfaction with the final "values profile" created by the tool. Conclusions. Studies are needed to explore the disconnect between patients' expressing negative reactions while going through some components of decision aids but satisfaction with the final output. In particular, we hypothesize that this effect might be explained by cognitive biases such as choice-supportive bias, hindsight bias, and the "IKEA effect." This is one of the first projects to elicit patient reactions while they were completing a decision aid, and we recommend further similar, qualitative postprocess evaluation studies. Highlights: We explored perceptions of a decision aid with education about localized prostate cancer treatment and preference elicitation using adaptive conjoint analysis.Patients found the tool useful but were also confused by it, tried to discern the intent of the questions, and expressed negative emotional reactions.In particular, there was a disconnect between patients' negative reactions while using the tool and general satisfaction with the final values profile generated by the tool, which is an area for future research.

Decision-Making and Health-Related Quality of Life in Patients with Melanoma Considering Adjuvant Immunotherapy.

BACKGROUND: Adjuvant anti-PD1 treatment improves relapse-free survival (RFS) but has not been shown to improve overall survival (OS) in melanoma and is associated with risks of immune-related adverse events (irAEs), some permanent. We identified factors patients consider in deciding whether to undergo adjuvant anti-PD1 treatment and assessed prospective health-related quality of life (HRQoL), treatment satisfaction, and decisional regret. PATIENTS AND METHODS: Patients with stage IIIB-IV cutaneous melanoma and free of disease, were candidates for adjuvant anti-PD1 immunotherapy, and had not yet discussed adjuvant treatment options with their oncologist were eligible. Participants viewed a 4-minute informational video tailored to their disease stage which communicated comprehensive, quantitative information about the risk of relapse both with and without adjuvant treatment, and risks of each irAE before deciding whether or not to opt for adjuvant therapy. We collected data on demographics, HRQoL, and attitudes toward adjuvant treatment over 1 year. RESULTS: 14/34 patients (41%) opted for adjuvant anti-PD1 immunotherapy, 20/34 (59%) opted for observation. Patients choosing adjuvant immunotherapy scored higher on HRQoL social well-being at pre-treatment, were more likely to endorse positive statements about adjuvant immunotherapy, and to perceive that their physician preferred adjuvant therapy. They had lower decisional regret and higher satisfaction, even if they experienced toxicity or recurrence. CONCLUSIONS: When provided with comprehensive quantitative information about risks and benefits of adjuvant anti-PD1 immunotherapy, 20/34 (59%) of patients opted for observation. Patients choosing adjuvant immunotherapy had lower decisional regret and higher satisfaction over time even if they had poorer outcomes in treatment.

Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial.

PURPOSE: We compare health-related quality of life using a broad range of validated measures in patients randomized to robotic-assisted radical cystectomy vs open radical cystectomy. METHODS: We retrospectively analyzed patients that had enrolled in both a randomized controlled trial comparing robotic-assisted laparoscopic radical cystectomy vs open radical cystectomy and a separate prospective study of health-related quality of life. The prospective health-related quality of life study collected 14 patient-reported outcomes measures preoperatively and at 3, 6, 12, 18, and 24 months postoperatively. Linear mixed-effects models with an interaction term (study arm×time) were used to test for differences in mean domain scores and differing effects of approach over time, adjusting for baseline scores. RESULTS: A total of 72 patients were analyzed (n=32 robotic-assisted radical cystectomy, n=40 open radical cystectomy). From 3-24 months post-radical cystectomy, no significant differences in mean scores were detected. Mean differences were small in the following European Organization for Research and Treatment of Cancer QLQ-C30 (Core Quality of Life Questionnaire) domains: Global Quality of Life (-1.1; 95% CI -8.4, 6.2), Physical Functioning (-0.4; 95% CI -5.8, 5.0), Role Functioning (0.7; 95% CI -8.6, 10.0). Mean differences were also small in bladder cancer-specific domains (European Organization for Research and Treatment of Cancer QLQ-BLM30 [Muscle Invasive Bladder Cancer Quality of Life Questionnaire]): Body Image (2.9; 95% CI -7.2, 13.1), Urinary Symptoms (8.0; 95% CI -3.0, 19.0). In Urostomy Symptoms, there was a significant interaction term (P < .001) due to lower open radical cystectomy scores at 3 and 24 months. Other domains evaluating urinary, bowel, sexual, and psychosocial health-related quality of life were similar. CONCLUSIONS: Over a broad range of health-related quality of life domains comparing robotic-assisted radical cystectomy and open radical cystectomy, there are unlikely to be clinically relevant differences in the medium to long term, and therefore health-related quality of life over this time period should not be a consideration in choosing between approaches.

Association of smoking history on health-related quality of life in patients undergoing radical cystecomy.

PURPOSE: Radical cystectomy (RC) has the potential to impact health-related quality of life (HRQOL). Many patients who undergo RC are current or former smokers. To better inform preoperative patient counseling, we examined the association between smoking status and HRQOL after RC. MATERIALS AND METHODS: A secondary analysis was performed on a prospective, longitudinal study (2008-2014) examining HRQOL in patients undergoing RC for bladder cancer. We analyzed 12 validated patient-reported outcome measures that focused on functional, symptomatic, psychosocial, and global HRQOL domains. Measures were collected pre-operatively and 3-, 6-, 12-, 18-, and 24-months postoperatively. For each HRQOL domain, we estimated the mean domain scores using a generalized estimation equation linear regression model. Each model included survey time, smoking status, and time-smoking interaction as covariates. Pairwise comparisons of current, former, and never smokers were estimated from the models. RESULTS: Of the 411 patients available for analysis, 29% (n = 119) never smoked, 59% (n = 244) were former smokers, and 12% (n = 48) were current smokers. Over the follow-up period, never smokers compared to current smokers had better global QOL scores (mean difference = +8.9; 95% CI 1.3-16; p = 0.023) and lower pain levels (mean difference = -10; 95% CI -19 to -0.54; p = 0.036). Compared to current smokers, former smokers had marginal improvements in global QOL (+6.9 points) and pain (-7.5 points) during the follow-up period. CONCLUSIONS: Current smokers reported worse HRQOL recovery in the 24-months after RC. These findings can be used to counsel patients who smoke on recovery expectations.

Palliative and end-of-life care needs, experiences, and preferences of LGBTQ+ individuals with serious illness: A systematic mixed-methods review.

BACKGROUND: Lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ+) individuals experience discrimination throughout the care continuum, including during serious illness and at end of life. High-quality palliative care requires that health professionals deliver individualized services that reflect the needs, experiences, and preferences of LGBTQ+ persons. AIM: To identify and appraise existing evidence related to the needs, experiences, and preferences for palliative and end of life care among LGBTQ+ individuals with serious illness. DESIGN: Data-based convergent synthesis design reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SOURCES: PubMed, Embase, Cochrane CENTRAL, PsycINFO, CINAHL, and Scopus from January 1, 2010 to November 6, 2020. RESULTS: Of 4875 results captured, 69 articles underwent full-text review and 13 were retained for analysis. Most studies were from North America with trans individuals represented in 10 of 13 studies. Needs (n = 6) included increased social support, institutional safety, economic and legal supports, and advocacy to mitigate health barriers.Experiences (n = 12) were driven by fear and worry associated with discrimination/stigma,providers' hetero-/cisnormative assumptions, homophobia and transphobia, social isolation, and an undignified death. Preferences (n = 6) pertained to inclusion of chosen families in decision-making, disclosure of LGBTQ+ identity based on safety of the clinical environment, and a desire to maintain autonomy. CONCLUSIONS: The robustness of the science has improved regarding the needs, experiences, and preferences of trans individuals. Actionable, inclusive policies coupled with sustained and integrated cultural sensitivity training for health workers are mandatory. Interventional research is critical to enhance tailored palliative care for LGBTQ+ people and their chosen families.

Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04.

OBJECTIVES: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI. METHODS: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable. RESULTS: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). CONCLUSION: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

Challenges and positive impact of rare cancer caregiving: A mixed-methods study of caregivers of patients with Erdheim-Chester disease and other histiocytic neoplasms.

Background: The importance of deriving benefit and meaning has been identified among cancer caregivers, but this has yet to be examined in the context of rare cancers. We sought to characterize unmet needs and experiences of caregivers of patients with Erdheim-Chester disease (ECD) and other histiocytic neoplasms (HN) and to identify factors associated with finding benefit and meaning-making in providing care for patients with rare cancers. Methods: Caregivers of patients with ECD and other HN completed quantitative surveys. Linear univariable regression modeling examined associations between unmet needs, social and family support, and intolerance of uncertainty with benefit finding and meaning-making. A subset participated in qualitative interviews assessing experiences of rare cancer caregiving that were analyzed with applied thematic analysis (NCT039900428). Findings: Of caregivers (N = 92, M = 54 years old, 68% female) of patients with ECD (75%) and other HN (25%), 78% reported moderately or severely unmet support needs, most frequently informational (58%) and psychological/emotional (66%) needs. Caregivers with unmet informational, psychological/emotional, and social support needs, difficulty tolerating uncertainty, a longer duration of the patient's illness, lower social support, more family conflict, and higher anxiety and depression symptoms demonstrated less benefit finding and meaning-making (ps <.05). Qualitative interviews (N = 19) underscored information and support needs and the capacity to derive meaning from caregiving. Interpretation: Rare cancer caregivers report numerous unmet information and support needs, needs that arise from disease rarity itself and which are associated with diminished capacity for deriving benefit and meaning from caregiving. Findings highlight targets for interventions to improve support for caregivers with HN and other rare cancers. Funding: NIH P30 CA008748 (PI: Craig Thompson, MD), NIH T32 CA009461 (H.M.; PI: Jamie Ostroff, PhD), Frame Family Fund (E.L.D.), Applebaum Foundation (E.L.D.).

Development and psychometric evaluation of the Spanish version of the lung cancer screening health belief scale.

OBJECTIVE: The aim of this study was to describe the translation and psychometric testing of the Lung Cancer Screening Health Belief Scale (LCSHBS) into Spanish. METHODS: The English version of the LCSHBS was professionally translated in accordance with best practices in the translation of patient-reported outcome tools. The independent certified professional translator completed a forward translation of the LCSHBS from English to Spanish, followed by a review of the translated questionnaire by a certified Memorial Sloan Kettering Cancer Center Spanish-English bicultural expert, who reviewed the scale for accuracy. RESULTS: Initial testing of the scales is valid and reliable, and supports the Spanish version of the LCSHBS (LCSHBS-S). Internal consistency reliability of the scales was supported with Cronbach's ranging from 0.81 to 0.96. Construct validity was established with confirmatory factor analysis and testing for differences between individuals who have and have not screened in theoretically proposed directions. These newly translated scales can help investigators expand this research into the large Spanish-speaking lung screening-eligible population as they develop and test critical behavioural interventions to increase lung cancer screening in the at-risk population. CONCLUSIONS: Development of effective interventions to enhance shared decision-making about lung cancer screening between patients and providers must first identify factors influencing the individual's screening participation. Future efforts facilitating patient-provider conversations are better informed by understanding the perspective of the individual making the decision.

Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.

BACKGROUND: The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking. METHODS: We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer. RESULTS: Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test). CONCLUSIONS: Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.).