Development of the item pool for the ‘WHO-ageism scale’:Conceptualisation, item generation, and content validity assessment

OBJECTIVES: ageism harms individuals' health and wellbeing and can be costly to societies. Reliable and valid measures that can quantify ageism are critical for achieving accurate data on its global prevalence, determinants and impacts, and to evaluate the effectiveness of interventions to reduce it. Ageism scales exist; however, none have been demonstrated to validly measure ageism in a manner consistent with consensus definitions of the concept (i.e. as manifested in all of stereotypes, prejudices and discrimination), whilst also quantifying ageism against all groups, from a target and perpetrator perspective, and across diverse country settings. Our objective was to develop an item pool to meet this need.METHODS: we completed the conceptualisation, item generation and content validity assessment phases of a new World Health Organisation (WHO) WHO-ageism item pool that aims to measure the multi-dimensional nature of ageism. These phases drew on a review of available evidence, an experts' workshop and structured content validity reviews conducted by experts in scale development and ageism drawn from every world region defined by WHO.RESULTS: our resulting item pool is designed to provide a multi-dimensional measure of ageism against all ages measured from both a perpetration and experienced perspective and that can produce valid and reliable scores within diverse country contexts and comparable scores across these contexts.CONCLUSIONS: our item pool is the first major step in providing a global and comprehensive measure of ageism. Future phases of research will refine the item pool and establish the statistical psychometric properties of the final tool

A systematic review of existing ageism scales

Ageism has been shown to have a negative impact on older people’s health and wellbeing. Though multiple scales are currently being used to measure this increasingly important issue, syntheses of the psychometric properties of these scales are unavailable. This means that existing estimates of ageism prevalence may not be accurate. We conducted a systematic review aimed at identifying available ageism scales and evaluating their scope and psychometric properties. A comprehensive search strategy was used across fourteen different databases, including PubMed and CINAHL. Independent reviewers extracted data and appraised risk of bias following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Of the 29,664 records identified, 106 studies, assessing 11 explicit scales of ageism, were eligible for inclusion. Only one scale, the ‘Expectations Regarding Aging’ met minimum requirements for psychometric validation (i.e., adequate content validity, structural validity and internal consistency). Still, this scale only assesses the ‘stereotype’ dimension of ageism, thus failing to evaluate the other two ageism dimensions (prejudice and discrimination). This paper highlights the need to develop and validate a scale that accounts for the multidimensional nature of ageism. Having a scale that can accurately measure ageism prevalence is key in a time of increasing and rapid population ageing, where the magnitude of this phenomenon may be increasing

Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials

Abstract Background For 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89–93% maternal and 100% fetal/neonatal mortality. Early in the 2013–2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interventions in favor of pregnant women (and children). Despite these recommendations and multiple ethics committee requests for their inclusion on grounds of justice, equity, and medical need, pregnant women were excluded from all drug and vaccine trials in the affected countries, either without justification or on grounds of potential fetal harm. An opportunity to offer pregnant women the same access to potentially life-saving interventions as others, and to obtain data to inform their future use, was lost. Once again, pregnant women were denied autonomy and their right to decide. Conclusion We recommend that, without clear justification for exclusion, pregnant women are included in clinical trials for EBOV and other life-threatening conditions, with lay language on risks and benefits in information documents, so that pregnant women can make their own decision to participate. Their automatic exclusion from trials for other conditions should be questioned

Erratum to: Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic

Abstract Background Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC reviews WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. Conclusions To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care

Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic

Abstract Background Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC reviews WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. Conclusions To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to strengthen reviews through the different perspectives provided without the ‘opportunity costs’ for time to final approval of multiple, independent reviews, (6) direct information exchange between the chairs of advisory, safety review and ethics committees, (7) more Ethics Committee support for investigators than is standard and (8) a global consultation on criteria for inclusion of pregnant women and children in interventional studies for conditions which put them at particularly high risk of mortality or other irreversible adverse outcomes under standard-of-care