The Impact of Specialist Care on Teenage and Young Adult Patient-Reported Outcomes in England: A BRIGHTLIGHT Study.

Purpose: In England, health care policy promotes specialized age-appropriate cancer services for teenagers and young adults (TYA), for those aged 13-24 years at diagnosis. Specialist Principal Treatment Centers (PTCs) provide enhanced age-specific care for TYA, although many still receive all or some of their care in adult or children's cancer services. Our aim was to determine the patient-reported outcomes associated with TYA-PTC based care. Methods: We conducted a multicenter cohort study, recruiting 1114 TYA aged 13-24 years at diagnosis. Data collection involved a bespoke survey at 6,12,18, 24, and 36 months after diagnosis. Confounder adjusted analyses of perceived social support, illness perception, anxiety and depression, and health status, compared patients receiving NO-TYA-PTC care with those receiving ALL-TYA-PTC and SOME-TYA-PTC care. Results: Eight hundred and thirty completed the first survey. There was no difference in perceived social support, anxiety, or depression between the three categories of care. Significantly higher illness perception was observed in the ALL-TYA-PTC and SOME-TYA-PTC group compared to the NO-TYA-PTC group, (adjusted difference in mean (ADM) score on Brief Illness Perception scale 2.28 (95% confidence intervals [CI] 0.48-4.09) and 2.93 [1.27-4.59], respectively, p = 0.002). Similarly, health status was significantly better in the NO-TYA-PTC (ALL-TYA-PTC: ADM -0.011 [95%CI -0.046 to 0.024] and SOME-TYA-PTC: -0.054 [-0.086 to -0.023]; p = 0.006). Conclusion: The reason for the difference in perceived health status is unclear. TYA who accessed a TYA-PTC (all or some care) had higher perceived illness. This may reflect greater education and promotion of self-care by health care professionals in TYA units.

Salivary Electrostimulation in the Treatment of Radiation Therapy-Induced Xerostomia (LEONIDAS-2): A Multicenter, Randomized, Double-Masked, Sham-Controlled, Phase 3 Trial.

PURPOSE: Radiation therapy-induced xerostomia significantly affects quality of life in head and neck cancer survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms. METHODS AND MATERIALS: This multicenter, double-masked, randomized, sham-controlled clinical trial assessed the long-term effects of a commercially available intraoral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow, and improving quality of life in individuals with radiation therapy-induced xerostomia. Using a computer-generated randomization list, participants were assigned (1:1) to an active intraoral custom-made removable electrostimulating device or a sham device to be used for 12 months. The primary outcome was the proportion of patients reporting a 30% improvement on the xerostomia visual analog scale at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and visual analog scale) and quality-of-life questionnaires (EORTC QLQ-H&N35, OH-QoL16, and SF-36). RESULTS: As per protocol, 86 participants were recruited. Intention-to-treat analyses showed no statistical evidence of a difference between the study groups with respect to the primary outcome or for any of the secondary clinical or quality-of-life outcomes. Exploratory analyses showed a statistically significant difference in the changes over time of the dry mouth subscale score of the EORTC QLQ-H&N35 in favor of the active intervention. CONCLUSIONS: LEONIDAS-2 did not meet the primary and secondary outcomes.

Unmet Diagnostic and Therapeutic Opportunities for Chronic Obstructive Pulmonary Disease in Low- and Middle-Income Countries.

Rationale: Chronic obstructive pulmonary disease (COPD) is a prevalent and burdensome condition in low- and middle-income countries (LMICs). Challenges to better care include more effective diagnosis and access to affordable interventions. There are no previous reports describing therapeutic needs of populations with COPD in LMICs who were identified through screening. Objectives: To describe unmet therapeutic need in screening-detected COPD in LMIC settings. Methods: We compared interventions recommended by the international Global Initiative for Chronic Obstructive Lung Disease COPD strategy document, with that received in 1,000 people with COPD identified by population screening at three LMIC sites in Nepal, Peru, and Uganda. We calculated costs using data on the availability and affordability of medicines. Measurement and Main Results: The greatest unmet need for nonpharmacological interventions was for education and vaccinations (applicable to all), pulmonary rehabilitation (49%), smoking cessation (30%), and advice on biomass smoke exposure (26%). Ninety-five percent of the cases were previously undiagnosed, and few were receiving therapy (4.5% had short-acting ß-agonists). Only three of 47 people (6%) with a previous COPD diagnosis had access to drugs consistent with recommendations. None of those with more severe COPD were accessing appropriate maintenance inhalers. Even when available, maintenance treatments were unaffordable, with 30 days of treatment costing more than a low-skilled worker's daily average wage. Conclusions: We found a significant missed opportunity to reduce the burden of COPD in LMIC settings, with most cases undiagnosed. Although there is unmet need in developing novel therapies, in LMICs where the burden is greatest, better diagnosis combined with access to affordable interventions could translate to immediate benefit.

Discriminative Accuracy of Chronic Obstructive Pulmonary Disease Screening Instruments in 3 Low- and Middle-Income Country Settings.

Importance: Most of the global morbidity and mortality in chronic obstructive pulmonary disease (COPD) occurs in low- and middle-income countries (LMICs), with significant economic effects. Objective: To assess the discriminative accuracy of 3 instruments using questionnaires and peak expiratory flow (PEF) to screen for COPD in 3 LMIC settings. Design, Setting, and Participants: A cross-sectional analysis of discriminative accuracy, conducted between January 2018 and March 2020 in semiurban Bhaktapur, Nepal; urban Lima, Peru; and rural Nakaseke, Uganda, using a random age- and sex-stratified sample of the population 40 years or older. Exposures: Three screening tools, the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE; range, 0-6; high risk indicated by a score of 5 or more or score 2-5 with low PEF [<250 L/min for females and <350 L/min for males]), the COPD in LMICs Assessment questionnaire (COLA-6; range, 0-5; high risk indicated by a score of 4 or more), and the Lung Function Questionnaire (LFQ; range, 0-25; high risk indicated by a score of 18 or less) were assessed against a reference standard diagnosis of COPD using quality-assured postbronchodilator spirometry. CAPTURE and COLA-6 include a measure of PEF. Main Outcomes and Measures: The primary outcome was discriminative accuracy of the tools in identifying COPD as measured by area under receiver operating characteristic curves (AUCs) with 95% CIs. Secondary outcomes included sensitivity, specificity, positive predictive value, and negative predictive value. Results: Among 10 709 adults who consented to participate in the study (mean age, 56.3 years (SD, 11.7); 50% female), 35% had ever smoked, and 30% were currently exposed to biomass smoke. The unweighted prevalence of COPD at the 3 sites was 18.2% (642/3534 participants) in Nepal, 2.7% (97/3550) in Peru, and 7.4% (264/3580) in Uganda. Among 1000 COPD cases, 49.3% had clinically important disease (Global Initiative for Chronic Obstructive Lung Disease classification B-D), 16.4% had severe or very severe airflow obstruction (forced expiratory volume in 1 second <50% predicted), and 95.3% of cases were previously undiagnosed. The AUC for the screening instruments ranged from 0.717 (95% CI, 0.677-0.774) for LFQ in Peru to 0.791 (95% CI, 0.770-0.809) for COLA-6 in Nepal. The sensitivity ranged from 34.8% (95% CI, 25.3%-45.2%) for COLA-6 in Nepal to 64.2% (95% CI, 60.3%-67.9%) for CAPTURE in Nepal. The mean time to administer the instruments was 7.6 minutes (SD 1.11), and data completeness was 99.5%. Conclusions and Relevance: This study demonstrated that screening instruments for COPD were feasible to administer in 3 low- and middle-income settings. Further research is needed to assess instrument performance in other low- and middle-income settings and to determine whether implementation is associated with improved clinical outcomes.

The BRIGHTLIGHT National Survey of the Impact of Specialist Teenage and Young Adult Cancer Care on Caregivers' Information and Support Needs.

BACKGROUND: Teenage and young adult cancer services in England are centralized in 13 principal treatment centers (TYA-PTC). These "specialist services" are designed to support caregivers as well as young people. OBJECTIVES: To evaluate whether caregivers of young people with cancer had fewer unmet information and support needs if they had all/some care in a TYA-PTC. METHODS: Participants in a cohort study of young people with cancer nominated their main carer to complete the BRIGHTLIGHT Carer Questionnaire, completed 6 months after diagnosis. Comparisons were made according to where young people's care was delivered: all, some, or no care in a TYA-PTC. Principal components analysis reduced the questionnaire to 5 dimensions, which were used as dependent variables in subsequent regression analysis. RESULTS: Four hundred seventy-six responses of 514 returned questionnaires (92%) were included in the analysis. The majority of caregivers were white, middle-aged, married/cohabiting mothers. Adjusted analysis indicated caregivers who had all/some care in a TYA-PTC had more satisfaction with support and also with services specifically provided for carers. Those who had some TYA-PTC care had greater satisfaction with information but less opportunity to be involved in decisions. CONCLUSIONS: Caregivers of young people who had no TYA-PTC care have the most unmet information and support needs. IMPLICATIONS FOR PRACTICE: Nurses outside of the TYA-PTC need to be supported by the TYA-PTC in providing information/support for caregivers. When a young person is receiving care in multiple hospitals, nurses need to optimize opportunities for caregivers to be involved in decision making.

Association of Self-reported Presenting Symptoms With Timeliness of Help-Seeking Among Adolescents and Young Adults With Cancer in the BRIGHTLIGHT Study.

Importance: Evidence regarding the presenting symptoms of cancer in adolescents and young adults can support the development of early diagnosis interventions. Objective: To examine common presenting symptoms in adolescents and young adults aged 12 to 24 years who subsequently received a diagnosis of cancer and potential variation in time to help-seeking by presenting symptom. Design, Setting, and Participants: This multicenter study is a cross-sectional analysis of the BRIGHTLIGHT cohort study, which was conducted across hospitals in England. Participants included adolescents and young adults aged 12 to 24 years with cancer. Information on 17 prespecified presenting symptoms and the interval between symptom onset and help-seeking (the patient interval) was collected through structured face-to-face interviews and was linked to national cancer registry data. Data analysis was performed from January 2018 to August 2019. Exposures: Self-reported presenting symptoms. Main Outcomes and Measures: The main outcomes were frequencies of presenting symptoms and associated symptom signatures by cancer group and the proportion of patients with each presenting symptom whose patient interval was longer than 1 month. Results: The study population consisted of 803 adolescents and young adults with valid symptom information (443 male [55%]; 509 [63%] aged 19-24 years; 705 [88%] White). The number of symptoms varied by cancer group: for example, 88 patients with leukemia (86%) presented with 2 or more symptoms, whereas only 9 patients with melanoma (31%) presented with multiple symptoms. In total, 352 unique symptom combinations were reported, with the 10 most frequent combinations accounting for 304 patients (38%). Lump or swelling was reported by more than one-half the patients (419 patients [52%; 95% CI, 49%-56%]). Other common presenting symptoms across all cancers were extreme tiredness (308 patients [38%; 95% CI, 35%-42%]), unexplained pain (281 patients [35%; 95% CI, 32%-38%]), night sweats (192 patients [24%; 95% CI, 21%-27%]), lymphadenopathy (191 patients [24%; 95% CI, 21%-27%]), and weight loss (190 patients [24%; 95% CI, 21%-27%]). The relative frequencies of presenting symptoms also varied by cancer group; some symptoms (such as lump or swelling) were highly prevalent across several cancer groups (seen in >50% of patients with lymphomas, germ cell cancers, carcinomas, bone tumors, and soft-tissue sarcomas). More than 1 in 4 patients (27%) reported a patient interval longer than 1 month; this varied from 6% (1 patient) for fits and seizures to 43% (18 patients) for recurrent infections. Conclusions and Relevance: Adolescents and young adults with cancer present with a broad spectrum of symptoms, some of which are shared across cancer types. These findings point to discordant presenting symptom prevalence estimates when information is obtained from patient report vs health records and indicate the need for further symptom epidemiology research in this population.

Primary cutaneous Mycobacterium avium complex infection following squamous cell carcinoma excision.

Primary cutaneous Mycobacterium avium complex (MAC) infection is rare, particularly among immunocompetent patients. We present the case of a purportedly healthy patient with primary cutaneous MAC infection arising within the excision margins of multiple infiltrating squamous cell carcinomas.