University Research Ethics Committee Research Articles

Key priority areas for patient safety improvement strategy in Libya: a protocol for a modified Delphi study

IntroductionPatient safety is a global public health problem. Estimates and size of the problem of patient safety in low-income and developing countries are scarce. A systems approach is needed for...

Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy

IntroductionExercise may positively alter tumour biology through numerous modulatory and regulatory mechanisms in response to a variety of modes and dosages, evidenced in preclinical models to date. Specifically, localised and...

Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged

IntroductionAcute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4 weeks)...

The formalization of social-science research ethics

In the United States, the “common law,” that regulates ethics review is being overhauled. We ask how UK University Research Ethics Committees (U-RECs), following the American model, have been able to shape social-science research without much commotion, and whether it is time for change. Despite the misbehavior of some ethnographic researchers, most social science research is valued for and motivated by its expert engagement with moral questions regarding discrimination, unfairness, exploitation, and so on, at home and abroad: knowledge of and sensitivity to the complexities around the violation of socio-economic, political, and cultural norms and values are carried high in the social science banner. Yet, since the 1990s, social science research projects in the Anglo-American world have increasingly entrusted research ethics to the scrutiny of U-RECs. This ethical delegation gives a mandate to U-RECs, often without suitable expertise, to vet research projects in a bureaucratic and time-consuming manner. It does not just lead to misunderstandings and frustration; it also privileges research as defined by research ethics committees rather than in negotiation with the ethics we encounter “in the field.” Although formal research ethics is clearly confusing early career researchers (and others!) about the role of ethics (which?), its forms have come to shape our disciplines. How did we get there? How do we move forward?

P174 Relationship Between Mental Health of Elderly Patients with Terminal Cancer and Family Care in Japan

In Japan, which has an aging population, the number of patients with cancer and cancer-related deaths has been increasing. For a long time, it has been customary for elderly individuals to be cared by their family members living under the same roof. However, that has gradually become more difficult. We decided to clarify the relationship between the mental health of elderly patients with terminal cancer and family care. We studied patients with terminal cancer aged 65 or older that were cared by their family members. Through anonymous self-administered questionnaires, we examined the background of the study participants and their main caregivers and whether study participants were supported by their family members in terms of housekeeping, eating, excretion, cleanliness, movement, medical care, and finances. Mental health was assessed with the General Health Questionnaire-12 (GHQ-12), which uses a 4-stage Likert scale. We performed t-tests after confirming that GHQ-12 scores were normally distributed. This study was performed after approval by the Epidemiological Research Ethics Committee of University A and the ethics review committees of the participating facilities. Questionnaires were collected from 38 individuals (collection rate, 60.3%), who consisted of 14 men and 24 women. The average age was 77.8 ± 7.6 years. Regarding housekeeping, eating, excretion, cleanliness, movement and medical care, those who received care from their family members had lower GHQ-12 scores than those who did not, but there was no significant difference. In terms of finances, those who received care had significantly lower GHQ-12 scores than those who did not (p=0.035). This study demonstrates that those who receive care from their family members tend to have better mental health than those who do not, and that those who are economically supported by their families have better mental health.

Provision of positive sexual health services for young people: a realist evaluation

BackgroundEnglish and international policy calls for positive, comprehensive youth sexual health services (PCYSHS) that support young people to achieve sexual wellbeing. In practice, youth sexual health services are often oriented solely towards reducing unwanted conceptions and preventing sexually transmitted infections. This study aimed to develop theory and recommendations for practitioners to support delivery of PCYSHS. MethodsA realist evaluation was undertaken to uncover what works, for whom, and under what conditions, to deliver PCYSHS. We developed concepts and initial theories, in which we combined existing substantive theory with a logic model based on stakeholder's tacit knowledge, observational visits, and data that were relevant to underlying causal processes, extracted from academic and policy literature (27 sources). Academic sources were identified via a systematic search of four electronic databases. Search terms were “sexual health”, combined with “sex positive”, “young people”, “service”, and synonyms (“reproductive health”, “sexual subjectivity”, “sexual rights”, “holistic”, “integrated”, “reproductive rights”, “preventative”, “comprehensive”, “young”, “youth” “teen*”, “adolescen*”, “intervention*”, “framework*”, “paradigm*”, “programme*”, “model*”, “trial*”, “pilot*”) with no date restrictions. We selected papers relating to whole system transformation to PCYSHS in developed countries, written in English. Papers that considered only education settings, one-off interventions, or information resources were excluded. Papers were appraised by rigour and relevance in accordance with realist methodology guidelines. Evidence was then gathered from case studies of three services in England that had attempted implementation of PCYSHS. Data were derived via stakeholder interviews (n=24), social and print media (15), service specifications (5), and evaluation and consultation documentation (5). Analysis of these data (Nvivo, version 10) was directed at substantiating, refining, or refuting the initial theories. Ethics approval was given by Sheffield Hallam University Research Ethics Committee. Findings76 sources contributed to the development and testing of programme theories. The theories articulated how local buy-in to PCYSHS could be led by the following factors: clarity of both the concept and individual role; conviction in the approach to bring about positive change for young people; and coherence with local and national priorities. The theories suggested the mechanisms by which these factors work and showed the ways in which outcomes are contextually dependent. InterpretationThis study explains some of the challenges of translating the policy ambition of PCYSHS into practice. The realist inquiry found theoretical mechanisms that might affect delivery of PCYSHS and the contextual conditions that could hinder or enable them. These theories can help inform the development and evaluation of PCYSHS initiatives. FundingSheffield Hallam University Faculty PhD scholarship.

Effects of a peer-assisted tai-chi-qigong programme on social isolation and psychological wellbeing in Chinese hidden elders: a pilot randomised controlled trial

BackgroundThe term hidden elder is used in Chinese society to describe older adults who are socially isolated and refuse social participation. Substantial evidence has indicated the important role of social isolation in increasing psychiatric morbidity and mortality risks in later life. Innovative service is promptly needed to address the social and psychological health needs of hidden elders. We aimed to test the feasibility and the preliminary effectiveness of a peer-assisted tai-chi-qigong programme in strengthening social networks and enhancing psychosocial wellbeing of Chinese hidden elders. MethodsThis randomised controlled trial recruited 46 people aged 60 years or older who did not engage in any social activities, through the social network of two community centres in Hong Kong. Participants were randomised to receive either peer-assisted tai-chi-qigong (n=24) or usual care (n=22) with computer-generated random codes. In the 3-month tai-chi-qigong programme, participants practiced two 60-min sessions each week, during which they were paired up with socially active older adults. Both groups received usual care, which included regular home visits by social workers. The primary outcome was social network using the Lubben social network scale-6 (LSNS-6). Secondary outcomes were De Jong Gieveld loneliness scale score, SF-12 quality of life score, and mental health inventory score. Data were collected at baseline and 3 months thereafter. We used a generalised estimating equations model for intention-to-treat analysis. Ethics approval was obtained from the Joint Clinical Research Ethics Committee of the Chinese University of Hong Kong and New Territory East Cluster. Written informed consent was obtained from every eligible person. Trial registration number CUHK_CCRB00489. FindingsThe improvement in the primary outcome, LSNS-6, did not differ significantly between the groups (regression coefficient of group by time interaction B=0·76, 95% CI −1·39 to 2·92, p=0·487; Cohen's d effect size 0·304). Participants who received the peer-assisted tai-chi-qigong programme generally showed better improvement in outcomes than the control group. With support from peer elders, the compliance rate of elders participating in tai-chi-qigong was 71% (ranged from 66–100%). InterpretationThis pilot study showed that peer-assisted tai-chi-qigong is a feasible social intervention for hidden elders. A full-scale trial is needed to assess the possible benefits for social and physical health. FundingThis study was funded by the School Seeding Fund, the Nethersole School of Nursing, the Chinese University of Hong Kong.

Neighbouring green space and all-cause mortality in elderly people in Hong Kong: a retrospective cohort study

BackgroundThe worldwide trend in population ageing has been met by a concomitant research interest in the effect of environmental factors on the health of elderly people. Green space is an important constituent of the living environment, with regard to modifying local air quality and microclimate, and has been qualitatively shown to benefit both physical and psychological aspects of health through several pathways. We aimed to quantitatively and comprehensively evaluate the effect of green space on all-cause mortality in elderly people in Hong Kong. MethodsIn this retrospective cohort study, we studied the effect of green space on all-cause mortality in participants identified from a community-sourced cohort of Chinese elderly people (aged ≥65 years) who resided in all regions of Hong Kong between 2001 and 2014. The Normalized Difference Vegetation Index was assigned to a 300 m radius buffer around each residential address to identify the qualitative coverage of green space. The proportion of green space was calculated according to counts of pixels with green compared with the total counts of pixels (15 × 15 m). Mortality data were ascertained from the Government Death Registry over a 14-year follow-up. Cox proportional hazard models were used to estimate hazard ratio (HRs) and their corresponding 95% CIs for all-cause mortality, adjusted for demographic and socioeconomic characteristics, lifestyle, housing type, and years of living in Hong Kong. Additional covariates were added to the model to examine underlying mechanisms. The study was approved by the Clinical Research Ethics Committee of the Chinese University of Hong Kong, and all participants gave written informed consent. FindingsOf 3556 elderly participants, 795 (22%) died over the 14-year follow-up. A 10% increase in coverage of green space within a 300 m buffer of participants' addresses was associated with a reduction in all-cause mortality during a 1-month period (HR 0·96, 95% CI 0·94–0·98; p=0·03), after adjusting for sex, age, marital and socioeconomic status, current smoking status, housing type, and years of living in Hong Kong. 10·3% of the variation for the effect size of green space on all-cause mortality could be explained by particulate matter 2·5 concentration, physical activity, and cognitive mental status. InterpretationChinese elderly people living in greener neighbourhoods might have a lower mortality risk than those living in areas with less green space, independent of other confounding factors, although further studies with larger sample sizes recruiting participants from more diverse environments are needed. Our findings suggest that increasing the coverage of green space could be effective at constructing an age-friendly city and could promoting ageing by enhancing physical activity and cognitive mental function in elderly people, lessening the risk of all-cause mortality. FundingNone.

Decisional support for young people who self-harm: protocol for a feasibility trial.

IntroductionSelf-harm is common in adolescents, and it is the strongest predictor of suicide. Young people who self-harm are often unsure of how and where to get help. Decision aids (DAs) have been shown to help with decisional conflict where there is uncertainty around different options. We have developed an online DA to support young people in help-seeking for self-harm. A feasibility trial will examine the acceptability of the online intervention and the ability to recruit and follow-up participants within a school setting.Methods and analysisIn this parallel arm, single-blind feasibility trial, 60 participants aged 12–18 years who have self-harmed in the past 12 months, will be randomised to either (1) a group receiving the online DA or (2) a control group receiving general information about feelings and emotions. Both groups will complete measures assessing decision-making and help-seeking behaviour. The school counsellor will be notified of any participants who have been randomised to ensure safeguarding for the young person. Participants in both groups will be followed up at 4 weeks, and the measures will be repeated. Qualitative interviews will be conducted with a subset of participants to explore their views and experiences of the DA and of participation in the study.Ethics and disseminationEthical approval was granted by King's College London (KCL) College Research Ethics Committee. Results of this study will help to clarify if we can recruit and administer an online decisional support intervention within a school setting for young people who self-harm. The study will inform the design and implementation of a larger randomised controlled trial to test the effectiveness of the DA. Dissemination of the study findings will target publication in peer-reviewed journals of general and special interest. The funder will be sent a report outlining the major findings of the study.Trial registration numberISRCTN11230559.

When is a REC not a REC? When it is a gatekeeper

This essay responds to an article, ‘Variation in university research ethics review’, published in this issue. It argues that the authors of that paper do not fully distinguish the usual function of university research ethics committees (RECs) from that of a gatekeeper. The latter term more accurately describes the task they happen to have asked them to fulfil in the course of conducting some empirical research. Whilst they are not alone in making it, the result of this conflation is that the reflections they offer are misguided. In this short comment I briefly discuss the distinction between a REC and a gatekeeper, and indicate how it impacts on the proposals sketched by Vadeboncoeur et al.

Prevalence of anaemia and associated risk factors among pregnant women attending antenatal care in Gulu and Hoima Regional Hospitals in Uganda: A cross sectional study.

BackgroundAnaemia is a public health problem affecting over 1.62 billion people globally. It affects all age groups of people and is particularly more prevalent in pregnant women. Africa carries a high burden of anaemia; in Uganda 24 % of women of child bearing age have anaemia. Pregnant women living in poverty are at greater risk of developing iron deficiency anaemia. The objective of this study was to determine the prevalence of anaemia and the associated risk factors in pregnant women attending antenatal care at Gulu and Hoima Regional Hospitals in Northern and Western Uganda respectively.MethodsWe conducted a cross sectional study in Gulu and Hoima Regional Hospitals from July to October 2012. Our study participants were pregnant women attending antenatal care. Socio-demographic data were collected using structured questionnaires and blood samples were collected for haemoglobin estimation. Haemoglobin concentration was determined using an automated analyzer closed mode of blood sampling. Data were analysed using Stata version 12. Odds ratio was used as a measure of association, with 95 % confidence interval; and independent risk factors for anaemia were investigated using logistic regression analyses. Ethical approval was obtained from Gulu University Research Ethics Committee and written informed consent was obtained from each study participant.ResultsThe overall prevalence of anaemia was 22.1 %; higher in Gulu (32.9 %) than in Hoima (12.1 %), p < 0.001. In Gulu, the prevalence of mild anaemia was 23 %, moderate anaemia was 9 %, and severe anaemia was 0.8 %, while in Hoima, the prevalence of mild anaemia was 9 %, moderate anaemia was 2.5 %, and severe anaemia was 0.5 %. Independent risk factors for anaemia were: being a housewife [Adjusted Odds Ratio (AOR) = 1.7, 95 % CI: 1.05–2.68]; and being a resident in Gulu (AOR = 3.6, 95 % CI: 2.41–5.58).ConclusionThe prevalence of anaemia in pregnant women in Gulu is higher than in Hoima. Amongst pregnancy women, being a housewife is an independent risk factor for anaemia. Greater efforts are required to encourage early antenatal attendance from women in these at risk groups. This would allow iron and folic acid supplementation during pregnancy, which would potentially reduce the prevalence of anaemia.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-016-0865-4) contains supplementary material, which is available to authorized users.

Understanding academic attitudes towards the ethical challenges posed by social media research

In this paper, we outline an online survey-based study seeking to understand academic attitudes towards social media research ethics (SMRE). As the exploratory phase of a wider research project, findings are discussed in relation to the responses of 30 participants, spanning multiple faculties and locations at one international university. The paper presents an empirical measure of attitudes towards social media research ethics, reflecting core issues outlined throughout the nascent Internet-mediated research (IMR) literature, in addition to survey questions relating to familiarity with SMRE guidance, and experience of reviewing SMRE proposals from students and/or as part of the university's research ethics committees (RECs). Findings indicate notable variance in academic attitudes towards the ethical challenges of social media research, reflecting the complexity of decision-making within this context and further emphasising the need to understand influencing factors. Future directions are discussed in relation to the tentative findings presented by the current study.

Sociodemographic Characteristics Related to Resistance to Breast Cancer Screening

Objective: To describe the sociodemographic characteristics of women related to resistance to breast cancer. Methods: Cross-sectional study, with a quantitative approach, whose research took place in the Basic Family Health Units of the municipality of Mossoró. The study included 362 women aged between 40 and 69 years. One used a validated questionnaire with questions divided into five blocks. The data were entered in a spreadsheet, transferred to the SPSS software, and subsequently coded to perform the analysis. The Research Ethics Committee of the State University of Rio Grande do Norte, in Opinion No. 356958, approved the project. Results: Black women were two times more likely to be resistant when compared to white women (OR = 2.01, 95% CI = 1.12 - 3.69; p = 0.018). Women who have studied up to primary school 122 (58.1%) were two times more likely to be resistant when compared to those 14 (6.7%) who studied up to higher education (OR = 2.69; 95% CI = 1.31 - 5.48; p = 0.012). Women who had first-degree relatives with breast cancer 153 (72.9%) were three times more likely to be resistant. Conclusions: The findings show the need for investments in educational practices with a view to public awareness and professionals’ training to disseminate information regarding tests used in practice directed to women’s health.

Palliation of Malignant Esophageal Obstruction and Fistulas with Metallic Stents: A Tertiary Center Experience

Background: To determine the usefulness of metallic stent in advanced oesophageal malignancies. Methods: In a retrospective study conducted at the Endoscopy Unit of King Abdulaziz University Hospital, patients underwent stent placement, with or without palliative radiotherapy for inoperable esophageal cancer, during the period spanning January 2010 through December 2014. Ethical approval for this study was granted by the King Abdulaziz University Research Ethics Committee. Data were collected from the electronic database of the hospital. All patients underwent OGD before stenting to know site of tumor, length of tumor and degree of stricture. Barium meal and CT scan was also done in some cases to know exact characteristics of tumor. Stent was selected more than 2 cm longer than the length of tumor. Self expanding metallic stents were used in all cases. Confirmation of proper placement of stent was done using fluoroscopy. Complications post stenting were analysed. Results: A total of 15 cases were studied. Males were 53.3% while females were 46.7%. Youngest patient was 39 yr old and eldest was 79 years with mean 64.93 years. Mean height was 159.73 cm and mean weight 54.98 kilogram. Co-morbidities like DM was 20%, DM with HTN was 6.7%, bronchial asthma 13.3% and DM with HTN with IHD and Renal implant in 6.7%. Diagnosis at admission was esophageal squamous cell carcinoma in 33.3%, esophageal adeno-carcinoma in 53.3%, gastric cancer in 6.7%, tracho-esophageal fistula in 6.7%. Stage 3 was 13.3%, and stage 4 was 86.7%. Surgical resection and palliation was done in14.2%, and only palliation was done in 92.9% of cases. SEMS were used in all patients and majority had Niti-S stent placed in 73.3% and Wallflex in 13.3% and Ultraflex in 6.7% and Boston in 6.7% cases. Dysphagia was Indication of stenting in 100% of cases and stricture in 57.1% and stricture and recurrent aspiration in 42.9%. Post stenting complications were early in 20% and late in 40%. Tumor ingrowth was in 20%, GERD in 20%, Mild chest pain and discomfort in 10%, stent migration in 10%, fistula formation in 10%, chest pain and GERD in 10%, and aspiration and pneumonia in 20%. Conclusions: Self expanding metallic stents are invaluable in advanced oesophageal cancer for palliation and alleviation of symptoms and better quality of life. Patients prior to chemoradiotherapy may get benefit of stenting making oesophageal passage patent which may otherwise get occluded by edema caused by radiotherapy.

Measurement of the association between perceived exercise capability and childhood obesity: a feasibility study

BackgroundAccording to the COM-B model of behaviour, three factors are essential for behaviour to occur: capability, opportunity, and motivation. Some evidence suggests that obese children tend to feel less capable of exercising. An instrument aiming to measure perceived exercise capability, opportunity, and motivation was created and subsequently used to investigate the association between perceived exercise capability and childhood obesity, and how perceived exercise capability could be improved through intervention. MethodsA 19 item questionnaire about exercise capability, opportunity, and motivation was created systematically with the COM-B model. On arrival at a 6 week weight-management camp in northern England, children completed the questionnaire; Spanish schoolchildren attending after-school exercise sessions in Spain also completed the questionnaire to test generalisability of findings. Motion-sensor computer games were implemented at weekly sessions at the English weight-management camp to encourage exercise and improve attendees’ perceived exercise capability. No participants withdrew from the study. Linear regression was used to investigate associations between body-mass index SD scores (BMI SDS) and perceived exercise capability, opportunity, and motivation; confirmatory factor analysis was conducted to investigate scale construct validity; Cronbach's α tests were conducted to measure internal consistency. Informed consent was obtained from all children, and from their parents or guardians. Ethics approval was granted by the Imperial College Research Ethics Committee and the Ethics Committee for Clinical Research, University of La Rioja. FindingsOn arrival at the camp, questionnaires were completed by 71 English children (34 girls, 48%) aged 9–17 years (mean 12·2, SD 2·0) with BMI SDS 2·80 (SD 0·66) and by 45 Spanish schoolchildren (22 girls, 49%) aged 9–13 years (mean 10·5, SD 1·2) with mean BMI SDS 0·80 (SD 0·99). 22 attendees of the English camp (12 girls, 55%) aged 9–16 years (mean 12·1, SD 2·2) reported how much they enjoyed the games; and they completed the COM-B questionnaire on both arrival at, and departure from, the camp. Questionnaire composite capability, opportunity, and motivation scores tested adequately for internal consistency (Cronbach's α=0·712–0·796) and construct validity (χ2/df=1·55, root mean square error of approximation 0·072, comparative fit index 0·92). Linear regression revealed an inverse association between perceived exercise capability and BMI SDS for both English (β=–0·289, p=0·010) and Spanish (β=–0·446, p=0·047) children; no association between BMI SDS and perceived exercise opportunity or motivation was found. A positive correlation was found between extent of motion-sensor game enjoyment and improvement in perceived exercise capability (r(22)=0·538, p=0·010), but not opportunity or motivation improvement, during stays at the camp. InterpretationPerceived exercise capability can be measured with the instrument described here. This small-sample study provides preliminary evidence for an association between low perceived exercise capability and childhood obesity and for the possibility that perceived exercise capability can be improved through intervention. FundingThis research was supported by the Engineering and Physical Sciences Research Council (grant EP/K012673/1).

Patients' experiences in community health centres under the health-care reform: research findings from a cross-sectional study using the Primary Care Assessment Tool in China

BackgroundChina is reshaping its health-care system to orient towards primary care. We developed a short instrument on the basis of the Primary Care Assessment Tool-Adult Edition (PCAT-AE) to assess patients' experiences of primary-care delivery in community health centres, the major primary-care provider in urban areas. MethodsA multistage cluster sampling method was used to select seven geographical regions in southern China where the population's ageing and gender structure is similar to that of China's overall population. A validated PCAT-AE (Mandarin Chinese short version) with 33 PCAT items on a four-point Likert-type scale was used, with higher scores representing better primary-care experiences. This study was approved by the Ethics Committee of Guangzhou Medical University, Guangzhou, China, and the Survey and Behaviour Research Ethics Committee of The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China (TB106179/MD10606). All study participants provided written consent. FindingsThe overall response rate of adult subjects interviewed at community health centres was 85·8% (3360 of 3916). Both frequent (2237) and less-frequent service users (1123) were surveyed, among which 1122 (33%) patients had an optimum PCAT score (higher than the third quantile of the score range—ie, above 99 of 132). The proportion of subjects with optimum scores in individual primary-care domains ranged from 62·1% (95%CI 59·8–64·3) in the comprehensiveness of service attribute to only 16·6% (14·7–18·7) in the community orientation attribute. Among all subjects, those with social medical insurance were more likely to report optimum primary care experience (adjusted odds ratio 2·30, 95% CI 1·92–2·75) than those uninsured. In the stratified analysis among subjects who were uninsured, those attending community health centres owned and managed by the government as their usual source of primary care had the highest PCAT scores compared with other models of community health centres owned and managed by secondary or tertiary hospitals (95·16 vs 90·18; p=0·0001) or by private investors (95·16 vs 87·80; p<0·0001), as a result of better first-contact care and coordination of care. InterpretationThe study suggests an urgent need to understand and address how social medical insurance coverage could affect patients' experiences. The community health centre model with a government-dominant top-down approach seems to be most effective in solving conundrums for China's health-care reform. FundingThis study was funded by the Bauhinia Foundation Research Centre; Department of Health, Guangdong province (C2009006/2009–2013); Department of Education, Guangdong province (BKZZ2011047/2010–2013); Medical Research Fund, Chinese Medical Association (2010-08-05); and Community Health Research Fund, Community Health Association of China (2012-2-91). HHXW was supported by a postdoctoral research fellowship in the Hong Kong–Scotland Partners in Post Doctoral Research programme, Research Grants Council of Hong Kong and the Scottish Government (S-CUHK402/12). JJW is supported by Guangdong Exemplary Centres for Exploratory Teaching in Higher Education Institutions—General Practice Exploratory Teaching Centre (GDJG-2010-N38-35, Guangdong Department of Education) and The Ninth Round of Guangdong Key Disciplines—General Practice (GDJY-2012-N13-85, Guangdong Department of Education), both of which he leads.

Controlled Clinical Trials with Doping Substances in Sports Law

The research ethics committee of a German medical university recently faced a totally new problem. The department for sports medicine had asked the committee to approve a protocol for a controlled clinical trial about the efficacy and safety of doping substances in cycling. This article considers the difficulties of the German law on this matter.

Media contribution to violence against health workers in China: a content analysis study of 124 online media reports

BackgroundViolence against health workers has been widely reported by the Chinese media. We aimed to identify the characteristics of the violent events as reported by the media and explore the possible role of media in such violence. MethodsWe used content analysis to study all available online newspaper reports of violence against health workers in China from Jan 1, 2013, to March 31, 2015. Duplicates of the same event were analysed in combination. Two researchers independently coded the data. Ethical approval was obtained from Zhejiang University Research Ethics Committee. Informed consent was not necessary because no patients were involved. FindingsWe found 124 incidents from 26 provinces. 73 occurred in tertiary-care facilities, 35 in secondary care, three in community facilities, and 13 in facilities such as private hospitals. 41 (33%) were reported from the emergency department, 22 (18%) in general medicine, 17 (14%) in general surgery, nine (7%) in obstetrics and gynaecology, eight (6%) in paediatrics, two (2%) in psychiatry, and 25 (20%) in other departments (eg, intensive-care unit, operating rooms, and radiology). 77 victims were doctors and 39 were nurses. In 116 (93·5%) cases the perpetrator was male, and 21 (17%) were reported to be drunk. In 31 (25%) cases the episode followed the death of a patient. The incidents included six (5%) murders and 12 (10%) serious injuries, mostly stabbing, including a doctor who had his throat cut. Two doctors were forced to kneel down before the body. 92 (74%) incidents involved relatives or friends of the patient, and 14 (11%) involved “Yi Nao gangs” who threatened and assaulted hospital personnel and damaged facilities to extort compensation. Two perpetrators were imprisoned, two sentenced to death, and one committed suicide, but the overwhelming majority were unpunished. Most reports attributed the violence to spontaneous justified anger resulting from poor care, unmet demands, or high costs. InterpretationThese reports represent extreme examples and are the tip of the iceberg. But the way in which they are reported and widely disseminated has bred fear in health professionals. Concerns that such reports of compensation, obtained with impunity, might contribute to copycat behaviours have also been expressed on social media. FundingNone.

Behavioural and emotional problems in children affected by parental migration in rural China: a cross-sectional survey

BackgroundConcerns for the welfare and human capital development of children of migrant workers in China are growing. An estimated 60 million children were left behind in rural areas, and a further 15 million accompanied their parents to urban areas. The aim of this study was to investigate the effects of migration on psychosocial and developmental outcomes of left-behind children (LBC) and urban migrant children (UMC). MethodsSelf-completion and well-validated questionnaires were administered to primary-school and middle-school children, who were identified by random stratified sampling of schools and within schools in two rural counties and two cities, which are the major feeder and receiving areas for migrants in Zhejiang province, respectively. The questionnaire included migration status and history, and the Strengths and Difficulties Questionnaire (SDQ), which measures emotional disorders, conduct disorders, hyperactivity, peer problems, and prosocial behaviours. Logistic regression was used to define the effect of migration on SDQ outcomes. Informed consent was obtained from children and their parents, and ethical approval from Zhejiang University Research Ethics Committee. FindingsFull data were available for 1876 UMC and 671 LBC aged 9–17 years (1287 boys and 1124 girls [136 were excluded in the analysis because of missing data]; mean age 13·5 years [SD 1·5] for boys and 13·3 years [1·6] for girls). 192 (8%; 120 [6%] UMC and 72 [11%] LBC) had emotional disorders, 298 (12%; 221 [12%] UMC and 77 [12%] LBC) had conduct disorders, 300 (12%; 214 [11%] UMC and 86 [13%] LBC) showed hyperactivity, 357 (14%; 96 [5%] UMC and 261 [39%] LBC) reported peer problems, and 2327 (91%; 1726 [92%] UMC and 601 [90%] LBC) had prosocial tendency. Compared with UMC, LBC manifested more emotional disorders (adjusted odds ratio 1·77 [95% CI 1·26–2·48]; p=0·001) and peer problems (11·21 [8·46–14·85]; p=0·000), but were less likely to be prosocial (0·71 [0·51–0·99]; p=0·04). Large differences were reported between the two groups in emotional disorders, peer problems, total difficulty score, and prosocial tendency, some of the key items of the SDQ. InterpretationMigration with parents, rather than separation from parents, led to more favourable emotional and behavioural outcomes. Follow-up studies are needed to explore the long-term effects of parental rural–urban migration on children. FundingUBS Optimus Foundation.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

A quantifiable measure of muscle activity related to the cervical spine may provide further understanding and evidence based support for chiropractic techniques. Surface electromyography (sEMG) is a noninvasive method of measuring muscle activity of the splenius muscle when the horse is at rest. To determine if there is a relationship between objective measurable muscle parameters and misalignments and muscle tension in the equine cervical spine. Controlled paired randomised study. Privately owned horses (n = 14), of mixed sex, age and mean height 157.8 cm were selected and assigned a group by matching work, management regime, age, sex and breed. The treatment group (n = 7) underwent manual chiropractic treatment following palpation. The control group underwent palpation only. A Delsys 4 sensor system was used for data collection. Probes were positioned on the muscle halfway between C1/C2 joint and the crest on the left and right sides, between the tendon insertion and the motor point to maximise signals. sEMG readings were taken at immediately before (0) and after palpation (PP) and 30 min later (30). Data were tested for normality and variance by one-way ANOVA and paired t test. Post treatment, there was a significant decrease (P<0.01) in sEMG activity for treatment group at 0 to 30 and PP to 30. There was a significant decrease (P<0.05) in sEMG for right side for treatment group at 0 to 30 and PP to 30. There were no such significant effects for the control group. The majority (83%) of horses had atlas rotation and tilt to the right. This preliminary study supports use of sEMG as a means of assessing muscle activity of equines and suggests a statistically significant reduction in splenius muscle activity is observed following manual chiropractic treatment although the benefit to the horse is unknown. Ethical animal research: The study protocol was reviewed by the College Research Ethics Committee before commencement of the study. Owners gave informed consent for their horses' inclusion in the study. McTimoney College of Chiropractic assisted with the hiring of the equipment. Competing interests: None declared.