Measuring alcohol use among adolescents in Africa: A systematic scoping review of consumption, screening and assessment tools.

ISSUES: Globally, adolescent drinking is a major public health concern. Alcohol measurements are influenced by local consumption practices, patterns and perceptions of alcohol-related harm. This is the first review to examine what tools are used to measure alcohol consumption, or screen for or assess harmful use in African adolescents, and how these tools take into account the local context. APPROACH: A systematic scoping review was conducted in line with the Arksey and O'Malley framework. A search in MEDLINE, CINAHL, Global Health and the Cochrane Database covered the period of 2000-2020. KEY FINDINGS: The search identified 121 papers across 25 African countries. A range of single- and multi-item tools were identified. Very few adaptations of existing questions were specified, and this search identified no tools developed by local researchers that were fundamentally different from established tools often designed in the USA or Europe. Inconsistencies were found in the use of cut-off scores; many studies used adult cut-off scores. IMPLICATIONS AND CONCLUSION: The possible impact of African drinking practices and culture on the accuracy of alcohol screening tools is currently unknown, but is also not taken into account by most research. This, in combination with a limited geographical distribution of alcohol-related research across the continent and inconsistent use of age- and gender-specific cut-off scores, points towards probable inaccuracies in current data on adolescent alcohol use in Africa.

First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study.

BACKGROUND: Despite immunotherapy advancements for patients with advanced or metastatic non-small-cell lung cancer (NSCLC), pivotal first-line trials were limited to patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and a median age of 65 years or younger. We aimed to compare the efficacy and safety of first-line atezolizumab monotherapy with single-agent chemotherapy in patients ineligible for platinum-based chemotherapy. METHODS: This trial was a phase 3, open-label, randomised controlled study conducted at 91 sites in 23 countries across Asia, Europe, North America, and South America. Eligible patients had stage IIIB or IV NSCLC in whom platinum-doublet chemotherapy was deemed unsuitable by the investigator due to an ECOG PS 2 or 3, or alternatively, being 70 years or older with an ECOG PS 0-1 with substantial comorbidities or contraindications for platinum-doublet chemotherapy. Patients were randomised 2:1 by permuted-block randomisation (block size of six) to receive 1200 mg of atezolizumab given intravenously every 3 weeks or single-agent chemotherapy (vinorelbine [oral or intravenous] or gemcitabine [intravenous]; dosing per local label) at 3-weekly or 4-weekly cycles. The primary endpoint was overall survival assessed in the intention-to-treat population. Safety analyses were conducted in the safety-evaluable population, which included all randomised patients who received any amount of atezolizumab or chemotherapy. This trial is registered with ClinicalTrials.gov, NCT03191786. FINDINGS: Between Sept 11, 2017, and Sept 23, 2019, 453 patients were enrolled and randomised to receive atezolizumab (n=302) or chemotherapy (n=151). Atezolizumab improved overall survival compared with chemotherapy (median overall survival 10·3 months [95% CI 9·4-11·9] vs 9·2 months [5·9-11·2]; stratified hazard ratio 0·78 [0·63-0·97], p=0·028), with a 2-year survival rate of 24% (95% CI 19·3-29·4) with atezolizumab compared with 12% (6·7-18·0) with chemotherapy. Compared with chemotherapy, atezolizumab was associated with stabilisation or improvement of patient-reported health-related quality-of-life functioning scales and symptoms and fewer grade 3-4 treatment-related adverse events (49 [16%] of 300 vs 49 [33%] of 147) and treatment-related deaths (three [1%] vs four [3%]). INTERPRETATION: First-line treatment with atezolizumab monotherapy was associated with improved overall survival, a doubling of the 2-year survival rate, maintenance of quality of life, and a favourable safety profile compared with single-agent chemotherapy. These data support atezolizumab monotherapy as a potential first-line treatment option for patients with advanced NSCLC who are ineligible for platinum-based chemotherapy. FUNDING: F Hoffmann-La Roche and Genentech Inc, a member of the Roche group.

Enhancing patient and public contribution in health outcome selection during clinical guideline development: an ethnographic study.

BACKGROUND: Patient and public involvement (PPI) is a cornerstone in enhancing healthcare research and delivery, including clinical guideline development. Health outcomes concern changes in the health status of an individual or population that are attributable to an intervention. Discussion of relevant health outcomes impacts the resulting clinical guidelines for practice. This study explores how the input of PPI contributors at the National Institute of Health and Care Excellence (NICE) is integrated into guideline development, particularly in relation to health outcome selection. METHODS: The study used an ethnographic methodological approach. Data comprised: observations of committee meetings, scoping workshops and training sessions, and in-depth interviews with PPI contributors, health professionals and chairs from clinical guideline development committees. Data were analysed thematically. RESULTS: PPI contributors' input in the guideline development process was often of limited scope, particularly in selecting health outcomes. Key constraints on their input included: the technical content and language of guidelines, assumed differences in the health-related priorities between PPI contributors and health professionals, and the linear timeline of the guideline development process. However, PPI contributors can influence clinical guideline development including the selection of relevant health outcomes. This was achieved through several factors and highlights the important role of the committee chair, the importance of training and support for all committee members, the use of plain language and the opportunity for all committee members to engage. CONCLUSIONS: Lay member input during the outcome selection phase of clinical guideline development is achievable, but there are challenges to overcome. Study findings identify ways that future guideline developers can support meaningful lay involvement in guideline development and health outcome selection.

Adolescent alcohol consumption: protocol for a scoping review of screening and assessment tools used in Africa.

BACKGROUND: Alcohol consumption is a key public health challenge in sub-Saharan Africa, which has the highest burden of alcohol attributable injury and disease of any region. Excess alcohol use is particularly harmful for adolescents and has been associated with neurocognitive defects and social and emotional problems. Effective screening and assessment tools are necessary to implement, evaluate and monitor interventions to prevent and decrease adolescent alcohol use. Most of these tools have been used among adolescent groups in high income settings; data on their effectiveness in Africa, where much alcohol use is unregulated, is limited. This scoping review will examine and map the range of tools in use and create an evidence base for future research in adolescent alcohol prevention and control in Africa. METHODS: The review will include all relevant study designs and grey literature. Inclusion and exclusion criteria have been designed using the Population - Concept - Context framework, and two reviewers will independently screen titles, abstracts and then full text to determine eligibility of articles. The Cochrane Library, MEDLINE, CINAHL and Global Health data bases will be searched for peer reviewed publications. The search strategy for grey literature will include Google searches and searches in websites of pertinent professional bodies and charities. The methodological framework proposed by Arksey and O'Malley and adaptations by the Joanna Briggs Institute and Levac et al. will be used. An iterative approach to charting, collating, summarising and reporting the data will be taken, with the development of charting forms and the final presentation of results led by the extracted data. RESULTS: This scoping review protocol describes a secondary analysis of data already collected to explore and map alcohol consumption measurement tools in adolescents in Africa. CONCLUSIONS: It is anticipated that our findings will provide an evidence base surrounding tools used to measure adolescent alcohol consumption in Africa. These findings are likely to be useful in informing future research, policy and public health strategies. Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia. SYSTEMATIC REVIEW REGISTRATION: Scoping Review Registration: Open Science Framework ( https://osf.io/bjhgw/ ).

Interventions for adolescent alcohol consumption in Africa: protocol for a scoping review including an overview of reviews.

BACKGROUND: Harmful alcohol use is a leading risk to the health of populations worldwide. Within Africa, where most consumers are adolescents, alcohol use represents a key public health challenge. Interventions to prevent or substantially delay alcohol uptake and decrease alcohol consumption in adolescence could significantly decrease morbidity and mortality, through both immediate effects and future improved adult outcomes. In Africa, these interventions are urgently needed; however, key data necessary to develop them are lacking as most evidence to date relates to high-income countries. The purpose of this review is to examine and map the range of interventions in use and create an evidence base for future research in this area. METHODS: In the first instance, we will conduct a review of systematic reviews relevant to global adolescent alcohol interventions. We will search the Cochrane Database of Systematic Reviews, MEDLINE (Ovid), CINAHL, Web of Science, Global Health and PubMed using a broad search. In the second instance we will conduct a scoping review by drawing on the methodological framework proposed by Arksey and O'Malley. We will search for all study designs and grey literature using the Cochrane Database of Systematic Reviews, MEDLINE (Ovid), CINAHL, Web of Science and Global Health, Google searches and searches in websites of relevant professional bodies and charities. An iterative approach to charting, collating, summarising and reporting the data will be taken, with the development of charting forms and the final presentation of results led by the extracted data. In both instances, the inclusion and exclusion criteria have been pre-defined, and two reviewers will independently screen abstracts and full text to determine eligibility of articles. DISCUSSION: It is anticipated that our findings will map intervention strategies aiming to reduce adolescent alcohol consumption in Africa. These findings are likely to be useful in informing future research, policy and public health strategies. Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia. PROTOCOL REGISTRATION: This protocol was submitted to the Open Science Framework on May 03, 2021. www.osf.io/qnvba.

PPI in research: a reflection from early stage researchers.

BACKGROUND: The importance of patient and public involvement (PPI) in the design and conduct of health research projects is gaining widespread recognition; however, it is still a developing area. Furthermore, PPI in methodological health research can help increase research value Thus, it is of great importance that researchers, especially early stage researchers continue to discuss and learn about the future challenges and opportunities of PPI. OBJECTIVE: With this commentary, we aim to disseminate i) key messages from a recent PPI training event and ii) discuss what early stage researchers (ESRs) in the "Methods in Research on Research" (MiRoR) project can do to improve our current and future work by considering and incorporating PPI. MAIN BODY: The latest MiRoR network meeting held at the University of Split in Croatia (2nd-3rd October), included a PPI training session with presentations from Mr. Stephens a patient, about "Waste in research" and Dr. Westmore a funder on "Research integrity", followed by smaller round-table discussions. This provided early stage researchers (ESRs) with an opportunity to discuss and explore the benefits and challenges of PPI in research, and the appropriate questions and research that is required for improving the implementation of PPI in clinical research. CONCLUSION: As with intervention research, PPI is also important for methodological research since this will help to increase both the value, integrity and quality of research.By providing early stage researchers with appropriate educational, interactive and real-world training, this will introduce the various merits and challenges associated with PPI in early-stage research.

Participating in core outcome set development via Delphi surveys: qualitative interviews provide pointers to inform guidance.

OBJECTIVES: To explore participants' views of Delphi surveys in core outcome set (COS) development. STUDY DESIGN AND SETTING: Patients and health professionals (n=24) from seven recently concluded COS studies that had involved a Delphi survey took part in semistructured qualitative interviews (telephone and email exchange). Interviews explored participants' understanding of COS and their experiences of the Delphi survey. Analysis was thematic. RESULTS: Several interviewees had previously participated in two or more COS or Delphi surveys. Those with multiple experiences of participation generally understood the purpose of COS and were satisfied with the Delphi survey. However, some interviewees who were first-time participants struggled to understand the purpose of COS and aspects of the Delphi survey, which limited their contribution and satisfaction with the study. Interviewees also differed in how they interpreted and subsequently used the written documentation provided to COS participants. Some interviewees wanted guidance regarding whose perspective to take into account when scoring outcomes and on how to use the scoring system. Interviewees reported being motivated to take part by the international and expert consensus aspects of the Delphi survey. A few interviewees reported experiencing either positive or negative emotional impacts arising from when they reviewed outcomes and stakeholder feedback. CONCLUSION: This study identifies important information that should be communicated to COS Delphi study participants. It also indicates the importance of communicating about COS Delphi studies in ways that are accessible and salient to participants, to enhance their experience of participation and make the process more meaningful for all.

Correction to: Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.

In the original publication [1] the abbreviation for Core outcome sets (COS) was pluralized unnecessarily throughout the next.

Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.

BACKGROUND: There are numerous challenges in including patients in a core outcome set (COS) study, these can vary depending on the patient group. This study describes current efforts to include patients in the development of COS, with the aim of identifying areas for further improvement and study. METHODS: Using the COMET database, corresponding authors of COS projects registered or published from 1 January 2013 to 2 February 2017 were invited via a personalised email to participate in a short online survey. The survey and emails were constructed to maximise the response rate by following the academic literature on enhancing survey responses. Personalised reminder emails were sent to non-responders. This survey explored the frequency of patient input in COS studies, who was involved, what methods were used and whether or not the COS development was international. RESULTS: One hundred and ninety-two COS developers were sent the survey. Responses were collected from 21 February 2017 until 7 May 2017. One hundred and forty-six unique developers responded, yielding a 76% response rate and data in relation to 195 unique COSs (as some developers had worked on multiple COSs). Of focus here are their responses regarding 162 COSs at the published, completed or ongoing stages of development. Inclusion of patient participants was indicated in 87% (141/162) of COSs in the published completed or ongoing stages and over 94% (65/69) of ongoing COS projects. Nearly half (65/135) of COSs included patient participants from two or more countries and 22% (30/135) included patient participants from five or more countries. The Delphi survey was reported as being used singularly or in combination with other methods in 85% (119/140) of projects. Almost a quarter (16/65) of ongoing studies reported using a combination of qualitative interviews, Delphi survey and consensus meeting. CONCLUSIONS: These findings indicated that the Delphi survey is the most popular method of facilitating patient participation, while the combination of qualitative interviews, Delphi survey and consensus meetings is the most popular combination of methods. The increased inclusion of patient participants in the development of COSs is encouraging, as is the international approach to COS development that some developers are adopting.

Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers?

BACKGROUND: Compulsory submission of a checklist from the relevant reporting guideline is one of the most widespread journal requirements aiming to improve completeness of reporting. However, the current suboptimal levels of adherence to reporting guidelines observed in the literature may indicate that this journal policy is not having a significant effect. FINDINGS: We explored whether authors provided the appropriate CONSORT checklist extension for their study and whether there were inconsistencies between what authors claimed on the submitted checklist and what was actually reported in the published paper. We randomly selected 12 randomized trials from three journals that provide the originally submitted checklist and analyzed six core CONSORT items. Only one paper used the appropriate checklist extension and had no inconsistencies between what was claimed in the submitted checklist and what was reported in the published paper. CONCLUSION: Journals should take further actions to take full advantage of the requirement for the submission of fulfilled CONSORT checklists, thus ensuring that these checklists reflect what is reported in the manuscript.