Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis.

OBJECTIVE: To search for and critically appraise the psychometric quality of patient-reported outcome measures (PROMs) developed or validated in optic neuritis, in order to support high-quality research and care. METHODS: We systematically searched MEDLINE(Ovid), Embase(Ovid), PsycINFO(Ovid) and CINAHLPlus(EBSCO), and additional grey literature to November 2021, to identify PROM development or validation studies applicable to optic neuritis associated with any systemic or neurologic disease in adults. We included instruments developed using classic test theory or Rasch analysis approaches. We used established quality criteria to assess content development, validity, reliability, and responsiveness, grading multiple domains from A (high quality) to C (low quality). RESULTS: From 3142 screened abstracts we identified five PROM instruments potentially applicable to optic neuritis: three differing versions of the National Eye Institute (NEI)-Visual Function Questionnaire (VFQ): the 51-item VFQ; the 25-item VFQ and a 10-item neuro-ophthalmology supplement; and the Impact of Visual Impairment Scale (IVIS), a constituent of the Multiple Sclerosis Quality of Life Inventory (MSQLI) handbook, derived from the Functional Assessment of Multiple Sclerosis (FAMS). Psychometric appraisal revealed the NEI-VFQ-51 and 10-item neuro module had some relevant content development but weak psychometric development, and the FAMS had stronger psychometric development using Rasch Analysis, but was only somewhat relevant to optic neuritis. We identified no content or psychometric development for IVIS. CONCLUSION: There is unmet need for a PROM with strong content and psychometric development applicable to optic neuritis for use in virtual care pathways and clinical trials to support drug marketing authorisation.

Retinal Vein Occlusion with COVID-19: A Case Report and Review of Literature.

OBJECTIVES: To provide a case report of Retinal Vein Occlusion (RVO) with COVID-19 infection. CASE: A 15-year-old healthy male presented with blurring of vision, 2+ vitreous cells, retinal haemorrhages and dilated and tortuous retinal vessels in the left eye within 28 days of a positive COVID-19 reverse transcriptase polymerase chain reaction (RT-PCR) assay. He was diagnosed with left non-ischaemic CRVO, with a suspected aetiology of COVID-19. DISCUSSION: A literature review found 12 reported cases of RVO associated with COVID-19. All but one patient was younger than 60, with a mean age of 42 years. Management varied, but in the majority (8/12), visual acuity (VA) improved with follow-up, and five (42%) had a final VA of 20/20. CONCLUSION: In the absence of other known aetiological factors, ophthalmologists should consider COVID-19 as a cause of RVO. The outcome can vary, but the majority can expect improvement in VA with time.

Evaluating patient-reported outcome measures (PROMs) for clinical trials and clinical practice in adult patients with uveitis or scleritis: a systematic review.

Patient reported outcome measures (PROMs) capture impact of disease and treatment on quality of life, and have an emerging role in clinical trial outcome measurement. This study included a systematic review and quality appraisal of PROMs developed or validated for use in adults with uveitis or scleritis. We searched MEDLINE, EMBASE, PsycINFO, CINAHL and grey literature sources, to 5 November 2021. We used established quality criteria to grade each PROM instrument in multiple domains from A (high quality) to C (low quality), and assessed content development, validity, reliability and responsiveness. For instruments developed using classic test theory-based psychometric approaches, we assessed acceptability, item targeting and internal consistency. For instruments developed using Item Response Theory (IRT) (e.g. Rasch analysis), we assessed response categories, dimensionality, measurement precision, item fit statistics, differential item functioning and targeting. We identified and appraised four instruments applicable to certain uveitis types, but none for scleritis. Specifically, the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ), a 3-part PROM for Birdshot retinochoroiditis (Birdshot Disease & Medication Symptoms Questionnaire [BD&MSQ], the quality of life (QoL) impact of Birdshot Chorioretinopathy [QoL BCR], and the QoL impact of BCR medication [QoL Meds], the Kings Sarcoidosis Questionnaire (KSQ), and a PROM for cytomegalovirus retinitis. These instruments had limited coverage for these heterogeneous conditions, with a focus on very rare subtypes. Psychometric appraisal revealed considerable variability between instruments, limited content development, and only one developed using Item Response Theory. In conclusion, there are few validated PROMs for patients with uveitis and none for scleritis, and existing instruments have suboptimal psychometric performance. We articulate why we do not recommend their inclusion as clinical trial outcome measures for drug licensing purposes, and highlight an unmet need for PROMs applicable to uveitis and scleritis.

The role of community health workers in cervical cancer screening in low-income and middle-income countries: a systematic scoping review of the literature.

INTRODUCTION: Community-based screening for cervical cancer and task sharing to community health workers (CHWs) have been suggested as a potential way to increase screening coverage in low- and middle-income countries (LMICs). The aims of the scoping review were to understand the following: (i) where and how CHWs are currently deployed in screening in LMIC settings; (ii) the methods used to train and support CHWs in screening, and (iii) The evidence on the cost-effectiveness of using CHWs to assist in screening. METHODS: A scoping literature search of 11 major databases and the grey literature was performed between 1978 and 2018. We included comprehensive search terms for 'CHWs' and 'Cervical Cancer', and used the World Bank criteria to define LMICs. RESULTS: Of the 420 articles screened, 15 met the inclusion criteria for review. Studies were located in Africa (n=5), Asia (n=5), and South and Central America (n=5). CHWs played a role in community education and raising awareness (n=14), conducting or assisting in cervical screening (n=5), or follow-up (n=1). 11 studies described CHW training activities. Only one study provided a formal cost analysis. CONCLUSION: The roles of CHWs in cervical cancer screening in LMICs have largely to date focused on education, outreach, and awareness programmes. Community-based approaches to cervical cancer screening are feasible, although the sociocultural context plays an important role in the acceptability of these interventions. Further in-depth contextually grounded studies exploring the acceptability of such interventions are required, as well as studies exploring the cost-effectiveness of involving CHWs in cervical cancer screening activities.

Ongoing training of community health workers in low-income andmiddle-income countries: a systematic scoping review of the literature.

OBJECTIVES: Understanding the current landscape of ongoing training for community health workers (CHWs) in low-income and middle-income countries (LMICs) is important both for organisations responsible for their training, as well as researchers and policy makers. This scoping review explores this under-researched area by mapping the current delivery implementation and evaluation of ongoing training provision for CHWs in LMICs. DESIGN: Systematic scoping review. DATA SOURCES: MEDLINE, Embase, AMED, Global Health, Web of Science, Scopus, ASSIA, LILACS, BEI and ERIC. STUDY SELECTION: Original studies focusing on the provision of ongoing training for CHWs working in a country defined as low income and middle income according to World Bank Group 2012 classification of economies. RESULTS: The scoping review found 35 original studies that met the inclusion criteria. Ongoing training activities for CHWs were described as supervision (n=19), inservice or refresher training (n=13) or a mixture of both (n=3). Although the majority of studies emphasised the importance of providing ongoing training, several studies reported no impact of ongoing training on performance indicators. The majority of ongoing training was delivered inperson; however, four studies reported the use of mobile technologies to support training delivery. The outcomes from ongoing training activities were measured and reported in different ways, including changes in behaviour, attitudes and practice measured in a quantitative manner (n=16), knowledge and skills (n=6), qualitative assessments (n=5) or a mixed methods approach combining one of the aforementioned modalities (n=8). CONCLUSIONS: This scoping review highlights the diverse range of ongoing training for CHWs in LMICs. Given the expansion of CHW programmes globally, more attention should be given to the design, delivery, monitoring and sustainability of ongoing training from a health systems strengthening perspective.

Why do women request an elective cesarean delivery for non-medical reasons? A systematic review of the qualitative literature.

BACKGROUND: Cesarean rates have increased significantly over the past decade. The reasons for this are both complex and context specific, and have significant consequences for health resources. The aim of this systematic review was to assess published, peer-reviewed, and gray qualitative literature on the reasons behind cesarean delivery on maternal request (CDMR). METHODS: A systematic search of MEDLINE, EMBASE, CINAHL, LILACS, and PsycINFO databases was performed for all relevant articles published between January 2006 and June 2016. Reference lists of all included studies were also searched in addition to select web-based sources. Studies were included if they qualitatively evaluated women's preferences for CDMR, with no geographic restriction. Findings from the studies were narratively and thematically synthesized. RESULTS: Sixteen studies were included in this review. Three themes were identified as to why women choose CDMR, which were: social norms, emotional experiences, and personal experiences. A woman's decision was often shaped by various influences including family, friends, and the media. In addition, previous experience of childbirth and interactions with health care professionals contributed to a strong preference for CDMR. CDMR provided women with a sense of control over the birth and diminished feelings of fear. CONCLUSIONS: The reasons behind CDMR are multifactorial and complex. Situation-specific cultural factors, fear of pain during childbirth, previous experience, and interactions with health care professionals are likely to have led to the increase in CDMR. Multifaceted, context-specific approaches are required if there is to be a reduction in CDMR rates.

25-Hydroxyvitamin D2 /D3 levels and factors associated with systemic inflammation and melanoma survival in the Leeds Melanoma Cohort.

Lower 25-hydroxyvitamin D2 /D3 levels at melanoma diagnosis are associated with thicker primaries and poorer survival. We postulated that this might relate to the deleterious effect of systemic inflammation as 25-hydroxyvitamin D2 /D3 levels are inversely associated with levels of C-reactive protein. 2,182 participants in the Leeds Melanoma Cohort (median follow-up 7.98 years) provided data on drug exposure, comorbidities and a serum 25-hydroxyvitamin D2 /D3 level at recruitment. Factors reported to modify systemic inflammation (low vitamin D levels, high body mass index, use of aspirin or nonsteroidal anti-inflammatory drugs or smoking were tested as predictors of microscopic ulceration (in which primary tumors are inflamed) and melanoma-specific survival (MSS). Ulceration was independently associated with lower 25-hydroxyvitamin D2 /D3 levels (odds ratio (OR) = 0.94 per 10 nmol/L, 95% CI 0.88-1.00, p = 0.05) and smoking at diagnosis (OR = 1.47, 95% CI 1.00-2.15, p = 0.04). In analyses adjusted for age and sex, a protective effect was seen of 25-hydroxyvitamin D2 /D3 levels at diagnosis on melanoma death (OR = 0.89 per 10 nmol/L, 95% CI 0.83-0.95, p < 0.001) and smoking increased the risk of death (OR = 1.13 per 10 years, 95% CI 1.05-1.22, p = 0.001). In multivariable analyses (adjusted for tumor thickness) the associations with death from melanoma were low 25-hydroxyvitamin D2 /D3 level at recruitment (<20 nmol/L vs. 20-60 nmol/L, hazard ratio (HR) = 1.52, 95% CI 0.97-2.40, p = 0.07) and smoking duration at diagnosis (HR = 1.11, 95% CI 1.03-1.20, p = 0.009). The study shows evidence that lower vitamin D levels and smoking are associated with ulceration of primary melanomas and poorer MSS. Further analyses are necessary to understand any biological mechanisms that underlie these findings.