Using qualitative research to develop an elaboration of the TIDieR checklist for interventions to enhance vaccination communication: short report

BACKGROUND: The COVID-19 pandemic has led to an increased interest in communication with the public regarding vaccination. Our recent Cochrane qualitative evidence synthesis points to several factors that could influence the implementation and success of healthcare worker communication with older adults about vaccination. However, it is often difficult to assess whether factors identified as potentially important in qualitative studies have been considered in randomized trials because of poor trial reporting. We therefore decided to use our qualitative evidence synthesis findings to encourage better reporting of vaccination communication interventions in trials by developing an elaboration of the TIDieR (Template for Intervention Description and Replication) checklist for intervention reporting. METHODS: We examined the findings from our Cochrane qualitative evidence synthesis on healthcare workers’ perceptions of and experiences with communicating about vaccination with adults over the age of 50 years. We identified factors that could influence the implementation and uptake, and thereby the effectiveness, of vaccination communication interventions. We then drafted a list of the information elements we would need from trial reports to assess whether these factors had been considered in the development of the interventions evaluated in these trials. Finally, we compared our list of information elements to the TIDieR checklist items. We were able to align all of our information elements with the TIDieR items. However, for several of the TIDieR items, we developed a more detailed description to ensure that relevant information would be captured sufficiently in trial reports. RESULTS: We developed elaborations for the following TIDieR items: “Why” (item 2), “What—materials” (item 3), “Who provided” (item 5), “How” (item 6), “Where” (item 7) and “Tailoring” (item 9). CONCLUSIONS: Both qualitative research and trials of intervention effectiveness are critical to furthering our understanding of what works, where, for whom and through which mechanisms. However, a key ingredient for developing this understanding is adequate reporting of intervention design, content and implementation in randomized trials. We hope that this elaboration of the TIDier checklist will improve reporting of interventions in trials focused on vaccine communication with older adults, and thereby enhance the usability of this research for developing future communication strategies

Screening for tuberculosis infection among newly arrived asylum seekers: Comparison of QuantiFERON®TB Gold with tuberculin skin test

Background: QuantiFERON®TB Gold (QFT) is a promising blood test for tuberculosis infection but with few data so far from immigrant screening. The aim of this study was to compare results of QFT and tuberculin skin test (TST) among newly arrived asylum seekers in Norway and to assess the role of QFT in routine diagnostic screening for latent tuberculosis infection. Methods: The 1000 asylum seekers (age ≥ 18 years) enrolled in the study were voluntarily recruited from 2813 consecutive asylum seekers arriving at the national reception centre from September 2005 to June 2006. Participation included a QFT test and a questionnaire in addition to the mandatory TST and chest X-ray. Results: Among 912 asylum seekers with valid test results, 29% (264) had a positive QFT test whereas 50% (460) tested positive with TST (indurations ≥ 6 mm), indicating a high proportion of latent infection within this group. Among the TST positive participants 50% were QFT negative, whereas 7% of the TST negative participants were QFT positive. There was a significant association between increase in size of TST result and the likelihood of being QFT positive. Agreement between the tests was 71–79% depending on the chosen TST cut-off and it was higher for nonvaccinated individuals. Conclusion: By using QFT in routine screening, further follow-up could be avoided in 43% of the asylum seekers who would have been referred if based only on a positive TST (≥ 6 mm). The proportion of individuals referred will be the same whether QFT replaces TST or is used as a supplement to confirm a positive TST, but the number tested will vary greatly. All three screening approaches would identify the same proportion (88–89%) of asylum seekers with a positive QFT and/or a TST ≥ 15 mm, but different groups will be missed

How many of persistent coughers have pulmonary tuberculosis? Populationbased cohort study in Ethiopia

Objective Many individuals with persistent cough and smear microscopy-negative sputum test for tuberculosis (TB) remain at risk of developing the disease. This study estimates the incidence of pulmonary TB (PTB) among initially smear-negative persistent coughers and its risk factors. Design A prospective population-based follow-up study. Setting Health extension workers visited all households in Dale woreda three times at 4-month intervals in 2016–2017 to identify individuals with symptoms compatible with TB (presumptive TB) using pretested and semistructured questionnaires. Participants We followed 3484 presumptive TB cases (≥15 years) with an initial smear-negative TB (PTB) test. Outcome measures Bacteriologically confirmed PTB (PTB b+) and clinically diagnosed PTB (PTB c+). Results 3484 persons with initially smear-negative presumptive PTB were followed for 2155 person-years (median 0.8 years); 90 individuals had PTB b+ and 90 had PTB c+. The incidence rates for PTB b+ and PTB c+ were both 4176 (95% CI 3378 to 5109) per 100 000 person-years. We used penalised (lasso) and non-penalised proportional hazards Cox regression models containing all exposures and outcomes to explore associations between exposures and outcomes. In lasso regression, the risk of development of PTB b+ was 63% (HR 0.37) lower for people aged 35–64 years and 77% (HR 0.23) lower for those aged ≥65 years compared with 15–34 year-olds. Men had a 62% (HR 1.62) greater risk of PTB b+ development than women. The risk of PTB c+ was 39% (HR 0.61) lower for people aged 35–54 years than for those aged 15–34 years. Men had a 56% (HR 1.56) greater risk of PTB c+ development than women. Conclusions PTB incidence rate among persistent coughers was high, especially among men and young adults, the latter signifying sustained transmission. Awareness about this among healthcare workers may improve identification of more new TB cases.publishedVersio

Treatment completion for latent tuberculosis infection in Norway: a prospective cohort study

Background: Successful treatment of latent tuberculosis infection (LTBI) is essential to reduce tuberculosis (TB) incidence rates in low-burden countries. This study measures treatment completion and determinants of non-completion of LTBI treatment in Norway in 2016. Methods: This prospective cohort study included all individuals notified with LTBI treatment to the Norwegian Surveillance System for Infectious Diseases (MSIS) in 2016. We obtained data from MSIS and from a standardized form that was sent to health care providers at the time of patient notification to MSIS. We determined completion rates. Pearson’s chi squared test was used to study associations between pairs of categorical variables and separate crude and multivariable logistic regression models were used to identify factors associated with treatment completion and adverse drug effects. Results: We obtained information on treatment completion from 719 of the 726 individuals notified for LTBI treatment in 2016. Overall, 91% completed treatment. Treatment completion was highest in the foreign-born group [foreign-born, n = 562 (92%) vs Norwegian-born, n = 115 (85%), p = 0.007]. Treatment completion did not differ significantly between prescribed regimens (p = 0.124). Adverse events were the most common reason for incomplete treatment. We found no significant differences in adverse events when comparing weekly rifapentine (3RPH) with three months daily isoniazid and rifampicin (3RH). However, there were significantly fewer adverse events with 3RPH compared to other regimens (p = 0.037). Age over 35 years was significantly associated with adverse events irrespective of regimen (p = 0.024), whereas immunosuppression was not significantly associated with adverse events after adjusting for other variables (p = 0.306). Treatment under direct observation had a significant effect on treatment completion for foreign-born (multivariate Wald p-value = 0.017), but not for Norwegian-born (multivariate Wald p-value = 0.408) individuals. Conclusions: We report a very high treatment completion rate, especially among individuals from countries with high TB incidence. The follow-up from tuberculosis-coordinators and the frequent use of directly observed treatment probably contributes to this. Few severe adverse events were reported, even with increased age and in individuals that are more susceptible. While these results are promising, issues of cost-effectiveness and targeting treatment to individuals at highest risk of TB are important components of public health impact.publishedVersio

School based screening for tuberculosis infection in Norway: comparison of positive tuberculin skin test with interferon-gamma release assay

<p>Abstract</p> <p>Background</p> <p>In Norway, screening for tuberculosis infection by tuberculin skin test (TST) has been offered for several decades to all children in 9th grade of school, prior to BCG-vaccination. The incidence of tuberculosis in Norway is low and infection with <it>M. tuberculosis </it>is considered rare. QuantiFERON^®TB Gold (QFT) is a new and specific blood test for tuberculosis infection. So far, there have been few reports of QFT used in screening of predominantly unexposed, healthy, TST-positive children, including first and second generation immigrants. In order to evaluate the current TST screening and BCG-vaccination programme we aimed to (1) measure the prevalence of QFT positivity among TST positive children identified in the school based screening, and (2) measure the association between demographic and clinical risk factors for tuberculosis infection and QFT positivity.</p> <p>Methods</p> <p>This cross-sectional multi-centre study was conducted during the school year 2005–6 and the TST positive children were recruited from seven public hospitals covering rural and urban areas in Norway. Participation included a QFT test and a questionnaire regarding demographic and clinical risk factors for latent infection. All positive QFT results were confirmed by re-analysis of the same plasma sample. If the confirmatory test was negative the result was reported as non-conclusive and the participant was offered a new test.</p> <p>Results</p> <p>Among 511 TST positive children only 9% (44) had a confirmed positive QFT result. QFT positivity was associated with larger TST induration, origin outside Western countries and known exposure to tuberculosis. Most children (79%) had TST reactions in the range of 6–14 mm; 5% of these were QFT positive. Discrepant results between the tests were common even for TST reactions above 15 mm, as only 22 % had a positive QFT.</p> <p>Conclusion</p> <p>The results support the assumption that factors other than tuberculosis infection are widely contributing to positive TST results in this group and indicate the improved specificity of QFT for latent tuberculosis. Our study suggests a very low prevalence of latent tuberculosis infection among 9th grade school children in Norway. The result will inform the discussion in Norway of the usefulness of the current TST screening and BCG-policy.</p

Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania

Introduction: As many as 250 million children under the age of 5 may not be reaching their full developmental potential partly due to poor nutrition during pregnancy and the first 2 years of life. Micronutrients, including vitamin B12, are important for the development of brain structure and function; however, the timing, duration and severity of deficiencies may alter the impact on functional development outcomes. Consequently, to fully explore the effect of vitamin B12 on cognitive function, it is crucial to measure neurodevelopment at different ages, in different populations and with vitamin B12 supplementation at different times during the critical periods of neurodevelopment. Methods and analysis In this project, we follow up children from four recently completed randomised placebo-controlled trials of oral vitamin B12 supplementation, two in India and two in Tanzania, to explore the long-term effects on neurodevelopmental outcomes and growth. All the included trials provided at least two recommended dietary allowances of oral vitamin B12 daily for at least 6 months. Vitamin B12 was supplemented either during pregnancy, early infancy or early childhood. Primary outcomes are neurodevelopmental status, cognitive function and growth later in childhood. We apply validated and culturally appropriate instruments to identify relevant developmental outcomes. All statistical analyses will be done according to intention-to-treat principles. The project provides an excellent opportunity to examine the effect of vitamin B12 supplementation in different periods during early life and measure the outcomes later in childhood. Ethics and dissemination The study has received ethical approvals from all relevant authorities in Norway, USA, Tanzania and India and complies fully with ethical principles for medical research. Results will be presented at national and international research and policy meetings and published in peer-reviewed scientific journals, preferably open access. Trial registration number NCT00641862 (Bangalore); NCT00717730, updated CTRI/2016/11/007494 (Delhi); NCT00197548 and NCT00421668 (Dar es Salaam)

The Risk of Invasive Pneumococcal Disease Differs between Risk Groups in Norway Following Widespread Use of the 13-Valent Pneumococcal Vaccine in Children

The elderly and adults with medical risk conditions remain at high risk of invasive pneumococcal disease (IPD), highlighting the importance of adequate preventive efforts. In an observational population-based study in Norway (pop ≥ 5 years, 2009–2017) covering six years post-PCV13 implementation, we explored the incidence and risk of IPD associated with age and comorbidities. We obtained the data on 5535 IPD cases from the Norwegian Surveillance System for Communicable Diseases and the population data from Statistics Norway. To define comorbidities, we obtained ICD-10 codes from the Norwegian Patient Registry for the cases and the Norwegian population. The average annual decrease in PCV13 IPD incidence was significant in all risk groups and decreased post-PCV13 introduction by 16–20% per risk group, implying a nondifferential indirect protection from the childhood vaccination. The IPD incidence remained high in the medical risk groups. The relative importance of medical risk conditions was 2.8 to 6 times higher in those aged 5–64 versus ≥65 years for all types of IPD, since age itself is a risk factor for IPD. In groups without medical risk, the risk of IPD was eight times higher in those aged ≥65 compared to those 5–64 years (RR 8.3 (95% CI 7.3–9.5)). Our results underscore the need for age- and risk-group-based prevention strategies

Sammenligning av QuantiFERON®TB Gold med tuberkulin hudtest for å forbedre diagnostikk og rutinemessig screening for tuberkulosesmitte blant nyankomne asylsøkere til Norge

Introduksjon: QuantiFERON®TB Gold (QFT) er en ny blodtest for påvisning av tuberkulosesmitte, men med få data så langt fra undersøkelse av immigranter. Målet med studien var å sammenligne resultat av QFT og tuberkulin hudtest blant nyankomne asylsøkere i Norge og å vurdere hvilken rolle QFT bør ha i screening for latent tuberkulose. Metode: Alle asylsøkere, 18 år eller eldre, som ankom Tanum asylmottak fra september 2005 ble invitert til å delta og ble inkludert etter informert samtykke. Inkludering pågikk inntil et forhåndsbestemt antall på 1000 inkluderte ble nådd. Siste deltager ble inkludert i juni 2006. Deltagelse innebar en QFT test og standardiserte spørsmål, i tillegg til den lovpålagte tuberkulintesten og lungerøntgen. Resultat: Totalt 2813 asylsøkere ankom Tanum asylmottak i inkluderingsperioden (sept 05-juni 06).  Blant de 1000 deltagerne hadde 912 gyldige testresultater og ble inkludert i analysen, 29 % (264) hadde positiv QFT, mens 50 % (460) hadde positiv tuberkulintest (indurasjon &gt; 6mm). Det indikerer en høy andel smittede personer i denne gruppen. Blant deltagere med positiv tuberkulintest hadde 50 % negativ QFT, mens 7 % av dem med negativ tuberkulintest hadde positiv QFT. Det var en signifikant sammenheng mellom økning i tuberkulinutslag og sannsynligheten for å ha positiv QFT. Samsvar mellom testene var 71-79%, avhengig av grenseverdi for tuberkulin. Det var bedre samsvar mellom testene for ikke-vaksinerte personer. Konklusjon: Ved å implementere QFT som rutine kan videre oppfølging avsluttes for 42% av dem som ville ha blitt henvist basert kun på tuberkulinresultat (&gt; 6mm). Andelen som henvises vil være den samme enten QFT implementeres som erstatning for eller som supplement for å bekrefte en positiv tuberkulinreaksjon, men antallet som testes vil variere mye. Ulike tilnærminger vil identifisere samme andel (88-89%) av asylsøkere med positiv QFT og/eller sterkt positiv tuberkulinutslag (&gt;15mm), men ulike grupper vil mistes.Introduction: QuantiFERON®TB Gold (QFT), a new blood test that detects tuberculosis infection, currently provides few data from immigrant screening. This study aimed to compare results of QFT and tuberculin skin tests (TST) among newly arrived asylum seekers in Norway and also assess the role of QFT in screening for latent tuberculosis. Methods: All asylum seekers, 18 years or older, who arrived at Tanum reception center from September 2005 were invited to participate and included after informed consent. Enrollment was continued until a fixed sample size of 1000 participants was reached. The last participant was included in June 2006. In addition to mandatory TST and chest X-ray, study participants underwent a QFT test and answered standardized questions. Results: A total of 2813 asylum seekers arrived at Tanum reception center during the inclusion period. Among the 1000 study participants, 912 showed valid test results and were included in analysis; 29% (264) had a positive QFT test and 50% (460) tested positive with TST (indurations &gt;6 mm), indicating a high proportion of latent infection within this population. Among the TST-positive participants, 50% were QFT-negative, whereas 7% of the TST-negative participants were QFT-positive. A significant association occurred between increase in size of TST induration and positive QFT result. Test agreement (71%–79%) depended on the chosen TST cut-off and was higher for nonvaccinated individuals. Conclusions: By implementing QFT as a routine screening test further follow up can be avoided for 42% of asylum seekers who would have been referred based only on a positive TST (&gt;6 mm). The proportion of individuals referred remained the same whether QFT replaced TST or confirmed a positive TST; however, the number of individuals tested varied greatly. Different approaches would identify the same proportion (88%-89%) of asylum seekers with either a positive QFT or a strongly positive TST (&gt;15 mm), but different groups will be missed.ISBN 978-91-85721-53-5</p

Temporal patterns in <it>count-to-ten</it> fetal movement charts and their associations with pregnancy characteristics: a prospective cohort study

Abstract Background Fetal movement counting has long been suggested as a screening tool to identify impaired placental function. However, quantitative limits for decreased fetal movement perform poorly for screening purposes, indicating the need for methodological refinement. We aimed to identify the main individual temporal patterns in fetal movement counting charts, and explore their associations with pregnancy characteristics. Methods In a population-based prospective cohort in Norway, 2009–2011, women with singleton pregnancies counted fetal movements daily from pregnancy week 24 until delivery using a modified "count-to-ten” procedure. To account for intra-woman correlation of observations, we used functional data analysis and corresponding functional principal component analysis to identify the main individual temporal patterns in fetal movement count data. The temporal patterns are described by continuous functional principal component (FPC) curves, with an individual score on each FPC for each woman. These scores were later used as outcome variables in multivariable linear regression analyses, with pregnancy characteristics as explanatory variables. Results Fetal movement charts from 1086 pregnancies were included. Three FPC curves explained almost 99% of the variation in the temporal data, with the first FPC, representing the individual overall counting time, accounting for 91% alone. There were several statistically significant associations between the FPCs and various pregnancy characteristics. However, the effects were small and of limited clinical value. Conclusions This statistical approach for analyzing fetal movement counting data successfully captured clinically meaningful individual temporal patterns and how these patterns vary between women. Maternal body mass index, gestational age and placental site explained little of the variation in the temporal fetal movement counting patterns. Thus, a perceived decrease in fetal movement should not be attributed to a woman’s basic pregnancy characteristics, but assessed as a potential marker of risk.</p