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ObjectiveTo provide insights into women’s attitudes towards a human papillomavirus (HPV)-based cervical cancer screening strategy.Data sourcesMedline, Web of Science Core Collection, Cochrane Library, PsycINFO, CINAHL and ClinicalTrials.gov were systematically searched for published and ongoing studies (last search conducted in August 2021).Methods of study selectionThe search identified 3162 references. Qualitative and quantitative studies dealing with women’s attitudes towards, and acceptance of, an HPV-based cervical cancer screening strategy in Western healthcare systems were included. For data analysis, thematic analysis was used and synthesised findings were presented descriptively.Tabulation, integration, and resultsTwelve studies (including 9928 women) from USA, Canada, UK and Australia met the inclusion criteria. Women’s attitudes towards HPV-based screening strategies were mainly affected by the understanding of (i) the personal risk of an HPV infection, (ii) the implication of a positive finding and (iii) the overall screening purpose. Women who considered their personal risk of HPV to be low and women who feared negative implications of a positive finding were more likely to express negative attitudes, whereas positive attitudes were particularly expressed by women understanding the screening purpose. Overall acceptance of an HPV-based screening strategy ranged between 13% and 84%.ConclusionThis systematic review provides insights into the attitudes towards HPV-based cervical cancer screening and its acceptability based on studies conducted with women from USA, Canada, UK and Australia. This knowledge is essential for the development of education and information strategies to support the implementation of HPV-based cervical cancer screening.Systematic review registrationPROSPERO (CRD42020178957).

Timely publication of clinical trial results is central for evidence-based medicine. In this follow-up study we benchmark the performance of German university medical centers (UMCs) regarding timely dissemination of clinical trial results in recent years.Following the same search and tracking methods used in our previous study for the years 2009 - 2013, we identified trials led by German UMCs completed between 2014 and 2017 and tracked results dissemination for the identified trials.We identified 1,658 trials in the 2014 -2017 cohort. Of these trials, 43% published results as either journal publication or summary results within 24 months after completion date, which is an improvement of 3.8% percentage points compared to the previous study. At the UMC level, the proportion published after 24 months ranged from 14% to 71%. Five years after completion, 30% of the trials still remained unpublished.Despite minor improvements compared to the previously investigated cohort, the proportion of timely reported trials led by German UMCs remains low. German UMCs should take further steps to improve the proportion of timely reported trials.

In recent years, long-term prescribing and use of strong opioids for chronic noncancer pain (CNCP) has increased in high-income countries. Yet existing uncertainties, controversies, and differing recommendations make the rationale for prolonged opioid use in CNCP unclear. This systematic review and meta-analyses compared the efficacy, safety, and tolerability of strong opioids with placebo or nonopioid therapy in CNCP, with a special focus on chronic low back pain (CLBP). Systematic literature searches were performed in 4 electronic databases (MEDLINE, Web of Science, Cochrane Library, and CINAHL) in July 2019 and updated by regular alerts until December 2020. We included 16 placebo-controlled randomized controlled trials for CLBP and 5 studies (2 randomized controlled trials and 3 nonrandomized studies) of opioids vs nonopioids for CNCP in the quantitative and qualitative synthesis. Random effects pairwise meta-analyses were performed for efficacy, safety, and tolerability outcomes and subgroup analyses for treatment duration, study design, and opioid experience status. Very low to low certainty findings suggest that 4 to 15 weeks (short or intermediate term) opioid therapy in CLBP (compared with placebo) may cause clinically relevant reductions in pain but also more gastrointestinal and nervous system adverse events, with likely no effect on disability. By contrast, long-term opioid therapy (≥6 months) in CNCP may not be superior to nonopioids in improving pain or disability or pain-related function but seems to be associated with more adverse events, opioid abuse or dependence, and possibly an increase in all-cause mortality. Our findings also underline the importance and need for well-designed trials assessing long-term efficacy and safety of opioids for CNCP and CLBP.

Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency.In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability.Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size (500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results.RCT protocols should be made available at an early stage of the trial.

ObjectiveTimely publication of clinical trial results is central for evidence-based medicine. The performance of university medical centers (UMCs) regarding timely results publication informs the local and national decision makers, patients, and the public about the need to improve trial results dissemination.Study Design and SettingFollowing the same search and tracking methods used in our previous study for the years 2009 - 2013, we identified trials led by German UMCs completed between 2014 and 2017 and tracked results dissemination for the identified trials.ResultsWe identified 1,658 trials in the 2014-2017 cohort. Of these trials, 43% published results as either journal publication or summary results within 24 months after completion date, which is an improvement of 3.8% percentage points compared to the previous study. At the UMC level, the 24-month publication rates varied from 14% to 71%. Five years after completion, still 30% of the trials remained unpublished.ConclusionDespite minor improvements compared to the previously investigated cohort, the rate of timely reporting of trials led by German UMCs remains low. German UMCs should take further steps to improve timely reporting rates.

Unpredictable disease trajectories make early clarification of end-of-life (EoL) care preferences in older patients with multimorbidity advisable. This mixed methods systematic review synthesizes studies and assesses such preferences. Two independent reviewers screened title/abstracts/full texts in seven databases, extracted data and used the Mixed Methods Appraisal Tool to assess risk of bias (RoB). We synthesized findings from 22 studies (3243 patients) narratively and, where possible, quantitatively. Nineteen studies assessed willingness to receive life-sustaining treatments (LSTs), six, the preferred place of care, and eight, preferences regarding shared decision-making processes. When unspecified, 21% of patients in four studies preferred any LST option. In three studies, fewer patients chose LST when faced with death and deteriorating health, and more when treatment promised life extension. In 13 studies, 67% and 48% of patients respectively were willing to receive cardiopulmonary resuscitation and mechanical ventilation, but willingness decreased with deteriorating health. Further, 52% of patients from three studies wished to die at home. Seven studies showed that unless incapacitated, most patients prefer to decide on their EoL care themselves. High non-response rates meant RoB was high in most studies. Knowledge of EoL care preferences of older patients with multimorbidity increases the chance such care will be provided. ispartof: JOURNAL OF CLINICAL MEDICINE vol:10 issue:1 ispartof: location:Switzerland status: published

BackgroundDecisions in healthcare are ideally made on basis of the results of clinical trials, published in study registries, as primary journal articles or summarized in secondary research articles. It is still unclear, whether and to what extent public and commercial expenses invested in clinical trials pays out in a way that their findings have an impact on publication output and medical practice.MethodsThe aim of this project was to examine the lifecycle of clinical trials from their registration to their publication and citation in secondary research articles by determining the proportion of trials that were published and were included in systematic review and clinical guidelines. We set-up a cohort of randomized controlled trials (n=691). We created and compared four sub-cohorts of investigator initiated trials (IITs) and industry sponsor trials (ISTs) with and without German contribution. For each trial, we searched for corresponding publications and citing systematic reviews and clinical guidelines.Additionally, we investigated what study characteristics are associated with publication and impact by using multivariable logistic regressions. ResultsOf the 691 trials, 576 (83%) were published as method article or result article in a medical journal and/or the trial results were made available in study registries; results were available for 555 (80%) of the trials. More than half (52%) of the trials were cited by a systematic review and about a quarter (26%) reached impact in a clinical guideline. Drug trials and larger trials are associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as journal article, results of ISTs more often in study registries. International ISTs gain less often impact by inclusion in systematic reviews or guidelines than publicly sponsored trials.ConclusionA considerable proportion of clinical trials investigated was published and had an impact on clinical practice, whereas the proportions depend on specific study characteristic. Study registries are an important alternative or complement to journal articles for publishing study results. There is still a need to improve the transfer of knowledge generated in clinical research into practice.

IntroductionThe US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety suggest that people’s risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description. Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA) is the first-ever conducted trial that aims at investigating the effects of these two modes of learning on individuals’ risk perception and behaviour in the long-term administration of WHO-III opioids in chronic non-cancer pain.Methods and analysisERONA—an exploratory, randomised controlled online survey intervention trial with two parallel arms—will examine the opioid-associated risk perception and behaviour of four groups involved in the long-term administration of WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances. Participants will be randomly assigned to one of two online risk education interventions, description based or experiencebased. Both interventions will present the best medical evidence available. Participants will be queried at baseline and after intervention on their risk perception of opioids’ benefit–harm ratio, their medical risk literacy and their current/intended risk behaviour (in terms of prescribing, taking or counselling, depending on study group). A follow-up will occur after 9 months, when participants will be queried on their actual risk behaviour. The study was developed by the authors and will be conducted by the market research institution IPSOS Health.Ethics and disseminationThe study was approved by the Institutional Review Board of the Max Planck Institute for Human Development. Results will be disseminated through peer-reviewed journals, conference presentations and social media.Trial registration numberDRKS00020358.

Background: The German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial’s impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort. Methods: The research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov. Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication’s target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.Results: We included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).Conclusions: The results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

Background Hypertension is a major public health challenge affecting more than one billion people worldwide; it disproportionately affects populations in low- and middle-income countries (LMICs), where health systems are generally weak. The increasing prevalence of hypertension is associated with population growth, ageing, genetic factors, and behavioural risk factors, such as excessive salt and fat consumption, physical inactivity, being overweight and obese, harmful alcohol consumption, and poor management of stress. Over the long term, hypertension leads to risk for cardiovascular events, such as heart disease, stroke, kidney failure, disability, and premature mortality. Cardiovascular events can be preventable when high-risk populations are targeted, for example, through population-wide screening strategies. When available resources are limited, taking a total risk approach whereby several risk factors of hypertension are taken into consideration (e.g. age, gender, lifestyle factors, diabetes, blood cholesterol) can enable more accurate targeting of high-risk groups. Targeting of high-risk groups can help reduce costs in that resources are not spent on the entire population. Early detection in the form of screening for hypertension (and associated risk factors) can help identify high-risk groups, which can result in timely treatment and management of risk factors. Ultimately, early detection can help reduce morbidity and mortality linked to it and can help contain health-related costs, for example, those associated with hospitalisation due to severe illness and poorly managed risk factors and comorbidities. Objectives To assess the effectiveness of different screening strategies for hypertension (mass, targeted, or opportunistic) to reduce morbidity and mortality associated with hypertension. Search methods An Information Specialist searched the Cochrane Register of Studies (CRS-Web), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Latin American Caribbean Health Sciences Literature (LILACS) Bireme, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) without language, publication year, or publication status restrictions. The searches were conducted from inception until 9 April 2020. Selection criteria Randomised controlled trials (RCTs) and non-RCTs (NRCTs), that is, controlled before and after (CBA), interrupted time series (ITS), and prospective analytic cohort studies of healthy adolescents, adults, and elderly people participating in mass, targeted, or opportunistic screening of hypertension. Data collection and analysis Screening of all retrieved studies was done in Covidence. A team of reviewers, in pairs, independently assessed titles and abstracts of identified studies and acquired full texts for studies that were potentially eligible. Studies were deemed to be eligible for full-text screening if two review authors agreed, or if consensus was reached through discussion with a third review author. It was planned that at least two review authors would independently extract data from included studies, assess risk of bias using pre-specified Cochrane criteria, and conduct a meta-analysis of sufficiently similar studies or present a narrative synthesis of the results. Main results We screened 9335 titles and abstracts. We identified 54 potentially eligible studies for full-text screening. However, no studies met the eligibility criteria. Authors' conclusions There is an implicit assumption that early detection of hypertension through screening can reduce the burden of morbidity and mortality, but this assumption has not been tested in rigorous research studies. High-quality evidence from RCTs or programmatic evidence from NRCTs on the effectiveness and costs or harms of different screening strategies for hypertension (mass, targeted, or opportunistic) to reduce hypertension-related morbidity and mortality is lacking.

School gardening programmes are among the most promising interventions to improve children's vegetable intake. Yet, low vegetable intake among children remains a persistent public health challenge. This study aimed to explore children's perspectives, experiences, and motivations concerning school gardening in order to better understand and increase its potential for health promotion. Using participant observation and semi-structured interviews, we provided 45 primary schoolchildren (9-10 years) from Amsterdam, who participated in a comprehensive year-round school gardening programme, the opportunity to share their experiences and ideas on school gardening. Children particularly expressed enjoyment of the outdoor gardening portion of the programme as it enabled them to be physically active and independently nurture their gardens. Harvesting was the children's favourite activity, followed by planting and sowing. In contrast, insufficient gardening time and long explanations or instructions were especially disliked. Experiencing fun and enjoyment appeared to play a vital role in children's motivation to actively participate. Children's suggestions for programme improvements included more autonomy and opportunities for experimentation, and competition elements to increase fun and variety. Our results indicate that gaining insight into children's perspectives allows matching school gardening programmes more to children's wishes and expectations, thereby potentially enhancing their intrinsic motivation for gardening and vegetable consumption.