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Background The Target Product Profile (TPP) is a tool used in industry to guide development strategies by addressing user needs and fostering effective communication among stakeholders. However, they are not frequently used in academic research, where they may be equally useful. This systematic review aims to extract the features of accessible TPPs, to identify commonalities and facilitate their integration in academic research methodology. Methods We searched peer-reviewed papers published in English developing TPPs for different products and health conditions in four biomedical databases. Interrater agreement, computed on random abstract and paper sets (Cohen’s Kappa; percentage agreement with zero tolerance) was > 0.91. We interviewed experts from industry contexts to gain insight on the process of TPP development, and extracted general and specific features on TPP use and structure. Results 138 papers were eligible for data extraction. Of them, 92% ( n  = 128) developed a new TPP, with 41.3% ( n  = 57) focusing on therapeutics. The addressed disease categories were diverse; the largest (47.1%, n  = 65) was infectious diseases. Only one TPP was identified for several fields, including global priorities like dementia. Our analyses found that 56.5% of papers ( n  = 78) was authored by academics, and 57.8% of TPPs ( n  = 80) featured one threshold level of product performance. The number of TPP features varied widely across and within product types ( n  = 3–44). Common features included purpose/context of use, shelf life for drug stability and validation aspects. Most papers did not describe the methods used to develop the TPP. We identified aspects to be taken into account to build and report TPPs, as a starting point for more focused initiatives guiding use by academics. Discussion TPPs are used in academic research mostly for infectious diseases and have heterogeneous features. Our extraction of key features and common structures helps to understand the tool and widen its use in academia. This is of particular relevance for areas of notable unmet needs, like dementia. Collaboration between stakeholders is key for innovation. Tools to streamline communication such as TPPs would support the development of products and services in academia as well as industry.

Background Subjective cognitive decline (SCD) is present in the early stage of preclinical Alzheimer’s disease (AD) and is associated with an increased risk of further cognitive decline and AD dementia later in life. Early detection of at-risk groups with subjective complaints is critical for targeted dementia prevention at the earliest. Accurate assessment of SCD is crucial. However, current measures lack important psychometric evaluations and or reporting. Objectives To systematically evaluate measurement properties of self-reported outcome measures (PROMs) used to assess SCD in the older adult population with or at risk of AD. Methods and analysis We used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols 2015 Checklist for reporting. We conducted a literature search, screened, and included validation studies of SCD based on self-reported questionnaires from both population-based and clinical studies, conducted in older adults (≥ 55). We critically appraised the included primary studies using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. Results Sixteen studies met the inclusion criteria. The included studies reported psychometric properties of 17 SCD self-reported questionnaires. We extracted data on the structural validity, internal consistency, test-retest reliability, and cross-cultural validity and found a widespread proneness to bias across studies, and a marked heterogeneity is assessed and reported measurement properties that prevented the consolidation of results. Conclusion Our findings suggest that available SCD questionnaires lack content validity evaluation. Currently available measurements of SCD lack development and validation standards. Further work is needed to develop and validate SCD self-reported measurement with good quality measurement properties.

ObjectivesTo determine the criterion and concurrent validity of the Italian version of the short 10/66 Dementia Diagnostic Schedule and algorithm in a sample of Italian native speakers, older adults.DesignA cross-sectional, validation study.SettingThe study was conducted with older adults living in the community and in nursing homes in the Canton of Ticino, Switzerland, and the Piedmont region in Italy between March and August 2019.ParticipantsA convenience sample of 229 participants (69% females) were recruited. The eligibility criteria were being ≥60 years old and having an informant. The final sample included 74 participants (32%) with a previous clinical diagnosis of dementia and 155 (68%) cognitively healthy older adults.Primary and secondary outcome measuresThe short version of 10/66 Dementia Diagnostic Schedule consists of the Community Screening Instrument for Dementia, the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10-word list learning task with delayed recall and the depression scale, Euro-Depression (EURO-D) scale. Disability was measured using the WHO Disability Assessment Schedule (WHO-DAS II).ResultsThe Italian version of the short 10/66 Dementia Diagnostic Schedule showed fair sensitivity (87%), specificity (61%) and agreement with the clinical diagnosis of dementia (kappa=0.40, area under the receiver operating characteristics curve=0.74). Older adults with dementia living in nursing homes had higher disability scores (WHO-DAS II mean=23.14, SE=1.29) than those living in the community (WHO-DAS II mean=7.08, SE=0.66). WHO-DAS II was positively correlated with the short version of the 10/66 dementia diagnosis (β=5.23, 95% CI 2.05 to 8.41).ConclusionsIn settings where lengthy diagnostic procedures are not feasible, the short 10/66 is a practical tool to identify dementia in older adults. Our findings extend evidence on the validity of the 10/66 dementia diagnostic algorithm to high-income countries, where epidemiological evidence on dementia and its impact is outdated.

A core element of the Strengthening Responses to Dementia in Developing Countries (STRiDE) programme was to generate novel data on the prevalence, cost and impact of dementia in low- and middle-income countries, to build better health policy. Indonesia and South Africa are two middle-income countries in need of such data. To present the STRiDE methodology and generate estimates of dementia prevalence in Indonesia and South Africa. We conducted community-based, single-phase, cross-sectional studies in Indonesia and South Africa, randomly sampling participants aged 65 years or older in each country. Dementia prevalence rates for each country were generated by using the 10/66 short schedule and applying its diagnostic algorithm. Weighted estimates were calculated with national sociodemographic data. Data were collected between September and December 2021 in 2110 people in Indonesia and 408 people in South Africa. The adjusted weighted dementia prevalence was 27.9% (95% CI 25.2-28.9) in Indonesia and 12.5% (95% CI 9.5-16.0) in South Africa. Our results indicate that there could be >4.2 million people in Indonesia and >450 000 people in South Africa who have dementia. Only five participants (0.2%) in Indonesia and two (0.5%) in South Africa had been previously diagnosed with dementia. Despite prevalence estimates being high, formal diagnosis rates of dementia were very low across both countries (<1%). Further STRiDE investigations will provide indications of the impact and costs of dementia in these countries, but our results provide evidence that dementia needs to be prioritised within national health and social care policy agendas.

Background: Alzheimer’s disease (AD) pathology is present many years before the onset of clinical symptoms. AD dementia cannot be treated. Timely and early detection of people at risk of developing AD is key for primary and secondary prevention. Moreover, understanding the underlying pathology that is present in the earliest stages of AD, and the genetic predisposition to that might contribute to the development of targeted disease-modifying treatments. Objectives: In this study, we aimed to explore whether genetic disposition to AD in asymptomatic individuals is associated with altered intrinsic functional connectivity as well as cognitive performance on neuropsychological tests. Methods: We examined 136 cognitively healthy adults (old group: mean age = 69.32, SD = 4.23; young group: mean age = 31.34, SD = 13.12). All participants had undergone resting-state functional magnetic resonance imagining (fMRI), DNA genotyping to ascertain polygenic risk scores (PRS), and neuropsychological testing for global cognition, working memory, verbal fluency, and executive functions. Results: Two-step hierarchical regression analysis revealed that higher PRS was significantly associated with lower scores in working memory tasks (Letter Number Span: ΔR2 = 0.077 (p 60 years). PRS did not show significant modulations of the intrinsic functional connectivity of the posterior cingulate cortex (PCC) with other regions of interest in the brain that are affected in AD. Conclusion: Allele polymorphisms may modify the effect of other AD risk factors. This potential modulation warrants further investigations, particularly in cognitively healthy adults.

Cross‐cultural adaptation is an important part of using validated questionnaires across countries and settings. Here we describe the cross‐cultural process adopted in the STRiDE (STrengthening Responses to dementia in DEveloping countries) program. We adopted a cross‐cultural adaptation process including forward translation, back translations, and cognitive interviews of the STRiDE toolkit. In total, 50 older adults and 41 carers across sites in Indonesia and South Africa participated in cognitive interviews; field notes and verbatim quotes are reported. We describe the cross‐cultural adaptation process of the STRiDE toolkit. During the process, issues were identified with the translated toolkit, including aspects related to cultural appropriateness, terminology equivalence, and timings. The data demonstrate that a rigorous, yet pragmatic, cross‐cultural adaptation process can be achieved even with limited resources. Our process should help the design and conduct of future dementia research in various contexts.