Dilemmas of Ethics in Practice in Longitudinal Health Research: Identifying Opportunities for Widening Participation of Residents.

Background: Mechanisms for widening participation of local participants in research studies can improve governance of public health research. Research conducted in longitudinal health study areas depends on there being mutual trust and respect over time between the local residents and researchers. Ethics in practice needs consideration alongside procedural ethics. By widening participation of the experimental public-local residents and resident service providers-ethics in practice and accountability are strengthened. Methods: The study was undertaken in a longitudinal health study area in rural South Africa using multiple qualitative methods. The sample included 35 individual and five group interviews with resident local leaders and service providers, 24 individual and eight group interviews with residents of the study area, and ten researchers' reflections on two critical incidents from ethnographic field notes on dilemmas of ethics in practice. The interviews were all audio-recorded (besides one where consent to record was not given) and then transcribed verbatim and translated from Shangaan into English. Thematic analysis was conducted. Results: Residents requested the reporting back of personal screening test results from research studies, and raised informed consent issues. Researchers recognized the importance of mechanisms to increase their accountability to residents throughout the research process, and the complexity of informed consent and fieldwork procedures within research studies. Conclusion: This study elicited the views of residents and researchers in a longitudinal health study area to seek guidance on how to strengthen participation in research governance. Three strategies were identified by participants to widen participation of the experimental public. Firstly, increasing study budgets so that individual screening test results could be personally delivered back to participants. Secondly, more rigorous field staff training in informed consent and study procedures with ongoing monitoring and supervision from researchers. Thirdly, increased earlier involvement of residents in research protocol development through study advisory groups. Additional strategies include deeper involvement of Community Advisory Groups and more focused dissemination of research results to specific audiences. In general, there is a need to identify strategies for increased accountability of researchers and participatory governance through involvement of the experimental public in all aspects of longitudinal public health research as part of the ethics in practice and democratization of science.

"Research Usually Sits on Shelves, Through the Play It Was Shared." Co-producing Knowledge Through Post-show Discussions of Research-Based Theatre.

This is a critical analysis of the co-production of knowledge on health care with members of the public attending two research-based plays that were followed by post-show discussions with expert panelists. Passing On was developed from the findings of a qualitative research study of family decision making toward the end of life. Cracked explored help seeking pathways for young people experiencing psychosis in families of different ethnicities developed from a research study on this topic. The analysis provides critical reflections on the immediate, post-performance impact of research-based Theatre as a strategy to encourage the co-production of knowledge beyond delivery of the performance itself. The plays were developed through partnership working from interview transcripts and joint workshops engaging academics, users and Theatre practitioners (writers, director, actors). Post-show discussions with expert panels were held after each performance to widen participation of the public in the co-production of knowledge to enhance the impact of completed research and stimulate debate. These discussions were recorded and the audience were asked to complete post-show feedback forms. Audience members were researchers, service providers, service users, and carers. This is an analysis of the co-production of knowledge using the feedback forms and transcripts of the post-show discussions. The analysis showed evidence of impact and co-production of knowledge through dialogues that occurred between the audience members, the members of the panel, and the audience and the panel. The discussions covered policy and practice, personal experiences, and Theatre making. The post-show discussions led the public to critically discuss issues with the panel and other audience members thus widening participation in the co-production of knowledge. The feedback forms gave information on the audience demographics and the immediate impact of the performances. Research-based Theatre with post-show discussions and evaluation forms is a strategy for widening participation and engagement with health research findings, through the co-production of knowledge on complex health issues.

Do visually impaired children and their parents agree on the child's vision-related quality of life and functional vision?

AIMS: To investigate agreement between children with visual impairment (VI) and their parents on their ratings of the child's vision-related quality of life (VQoL) and functional vision (FV) using two novel self-report patient-reported outcome measures developed for this population. METHODS: 99 children aged 10-15 years (mean age=12.2, SD=1.9) with VI (best corrected acuity (logarithm of the minimum angle of resolution) 0.50 or worse in better eye) and their parents participated in a national postal survey, completing the child and proxy versions of our novel instruments assessing VQoL and FV of children with VI-the vision-related quality of life instrument for children and young people (VQoL_CYP) and the functional vision questionnaire for children and young people (FVQ_CYP), respectively. Parent-child agreement was investigated using the Bland-Altman (BA) method. Variation across key sociodemographic and clinical characteristics was examined using the Intraclass Correlation Coefficient. RESULTS: Average parental ratings of their child's VQoL and FV were significantly lower than the children's own ratings, but the range of disagreement was wide, with parents both overestimating and underestimating their child's VQoL (mean score difference=5.7, BA limits of agreement (LOA): lower -22.10 (CI 95% -24.61 to 19.59) and upper 33.50 (CI 95% 30.99 to 36.01)), but more consistently underestimating the child's FV (mean score difference=-11.8, BA LOA: lower -39.60 (CI 95% -42.12 to 37.08) and upper 16 (CI 95% 13.48 to 18.52)). There was variation in agreement by some child characteristics, including vision level, time of onset and course of VI progression. CONCLUSIONS: Visually impaired children and their parents perceive the broader impact of living with VI very differently. There is value in routine capture of information independently from children and their parents for comprehensively gauging the impact of childhood VI and tailoring appropriate interventions.

Measuring the Quality of Life of Visually Impaired Children: First Stage Psychometric Evaluation of the Novel VQoL_CYP Instrument.

PURPOSE: To report piloting and initial validation of the VQoL_CYP, a novel age-appropriate vision-related quality of life (VQoL) instrument for self-reporting by children with visual impairment (VI). METHODS: Participants were a random patient sample of children with VI aged 10-15 years. 69 patients, drawn from patient databases at Great Ormond Street Hospital and Moorfields Eye Hospital, United Kingdom, participated in piloting of the draft 47-item VQoL instrument, which enabled preliminary item reduction. Subsequent administration of the instrument, alongside functional vision (FV) and generic health-related quality of life (HRQoL) self-report measures, to 101 children with VI comprising a nationally representative sample enabled further item reduction and evaluation of psychometric properties using Rasch analysis. Construct validity was assessed through Pearson correlation coefficients. RESULTS: Item reduction through piloting (8 items removed for skewness and individual item response pattern) and validation (1 item removed for skewness and 3 for misfit in Rasch) produced a 35-item scale, with fit values within acceptable limits, no notable differential item functioning, good measurement precision, ordered response categories and acceptable targeting in Rasch. The VQoL_CYP showed good construct validity, correlating strongly with HRQoL scores, moderately with FV scores but not with acuity. CONCLUSIONS: Robust child-appropriate self-report VQoL measures for children with VI are necessary for understanding the broader impacts of living with a visual disability, distinguishing these from limited functioning per se. Future planned use in larger patient samples will allow further psychometric development of the VQoL_CYP as an adjunct to objective outcomes assessment.

Importance of integrating a cultural module in the community nursing curriculum.

INTRODUCTION: The Bedouin Health module was one of the proposed interventions funded by the European Union in 2007-2008, with a focus on health services and utilisation of these services for the Bedouin people in the north of Jordan. AIM: This study aimed to evaluate the sustainability of integrating this module into the community health nursing courses at Al al-Bayt University, Jordan. METHOD: Two focus group discussions were carried out with five faculty members and five students involved in the implementation of the Bedouin Health module. Leading questions were prepared for both groups. RESULTS: Four main themes emerged across both focus groups: self-expression, sustainability, acceptance, and motivation. CONCLUSION: The findings of this study identify how crucial it is for nursing students and faculty members to be culturally competent when practising community health care in the Bedouin community.

Weak and strong publics: drawing on Nancy Fraser to explore parental participation in neonatal networks.

AIMS: We draw on the work of Nancy Fraser, and in particular her concepts of weak and strong publics, to analyze the process of parental involvement in managed neonatal network boards. BACKGROUND: Public involvement has moved beyond the individual level to include greater involvement of both patients and the public in governance. However, there is relatively little literature that explores the nature and outcomes of long-term patient involvement initiatives or has attempted to theorize, particularly at the level of corporate decision making, the process of patient and public involvement. METHODS: A repeated survey of all neonatal network managers in England was carried out in 2006-07 to capture developments and changes in parental representation over this time period. This elicited information about the current status of parent representation on neonatal network boards. Four networks were also selected as case studies. This involved interviews with key members of each network board, interviews with parent representatives, observation of meetings and access to board minutes. RESULTS: Data collected show that a wide range of approaches to involving parents has been adopted. These range from decisions not to involve parents at this level to relatively well-developed systems designed to link parent representatives on network boards to parents in neonatal units. CONCLUSION: Despite these variations, we suggest that parental participation within neonatal services remains an example of a weak public because the parent representatives had limited participation with little influence on decision making.

Development of the functional vision questionnaire for children and young people with visual impairment: the FVQ_CYP.

OBJECTIVE: To develop a novel age-appropriate measure of functional vision (FV) for self-reporting by visually impaired (VI) children and young people. DESIGN: Questionnaire development. PARTICIPANTS: A representative patient sample of VI children and young people aged 10 to 15 years, visual acuity of the logarithm of the minimum angle of resolution (logMAR) worse than 0.48, and a school-based (nonrandom) expert group sample of VI students aged 12 to 17 years. METHODS: A total of 32 qualitative semistructured interviews supplemented by narrative feedback from 15 eligible VI children and young people were used to generate draft instrument items. Seventeen VI students were consulted individually on item relevance and comprehensibility, instrument instructions, format, and administration methods. The resulting draft instrument was piloted with 101 VI children and young people comprising a nationally representative sample, drawn from 21 hospitals in the United Kingdom. Initial item reduction was informed by presence of missing data and individual item response pattern. Exploratory factor analysis (FA) and parallel analysis (PA), and Rasch analysis (RA) were applied to test the instrument's psychometric properties. MAIN OUTCOME MEASURES: Psychometric indices and validity assessment of the Functional Vision Questionnaire for Children and Young People (FVQ_CYP). RESULTS: A total of 712 qualitative statements became a 56-item draft scale, capturing the level of difficulty in performing vision-dependent activities. After piloting, items were removed iteratively as follows: 11 for high percentage of missing data, 4 for skewness, and 1 for inadequate item infit and outfit values in RA, 3 having shown differential item functioning across age groups and 1 across gender in RA. The remaining 36 items showed item fit values within acceptable limits, good measurement precision and targeting, and ordered response categories. The reduced scale has a clear unidimensional structure, with all items having a high factor loading on the single factor in FA and PA. The summary scores correlated significantly with visual acuity. CONCLUSIONS: We have developed a novel, psychometrically robust self-report questionnaire for children and young people-the FVQ_CYP-that captures the functional impact of visual disability from their perspective. The 36-item, 4-point unidimensional scale has potential as a complementary adjunct to objective clinical assessments in routine pediatric ophthalmology practice and in research.

The provision of accessible, acceptable health care in rural remote areas and the right to health: Bedouin in the North East region of Jordan.

Provision of accessible acceptable health care in remote rural areas poses a challenge to health care providers. This case study of formal and informal health care provision for Bedouin in North East Jordan is based on interviews conducted in 2007-2008 involving clinic providers, policymakers and Bedouin as part of an EC funded study from 2006 to 2010. The paper explores to what extent the right to health as set out in UN General Comment 14 (on Article 12 and 12.2 of the International Covenant on Social Economic and Cultural Rights on the right to health) can provide a framework for considering the availability, accessibility and acceptability of current provision in a rural setting in Jordan. Health care is provided in the public sector by the Ministry of Health and the Royal Medical Services to a dispersed population living in encampments and villages over a large rural area. There are issues of accessibility in terms of distance, and of acceptability in relation to the lack of local and female staff, lack of cultural competencies and poor communication. We found that these providers of health care have a developing partnership that could potentially address the challenge of provision to this rural area. The policymakers have an overview that is in line with applying the concept of health care justice for a more equitable distribution of resources and adjustment of differential access and availability. The health providers are less aware of the right to accessible acceptable health care in their day to day provision whilst the Bedouin population are quite aware of this. This case study of Bedouin in North East Jordan has particular relevance to the needs of populations - both pastoralists and non pastoralists living in remote and rural areas.

Capturing children and young people's perspectives to identify the content for a novel vision-related quality of life instrument.

OBJECTIVE: To describe a child-centered approach to identifying content for a novel self-report questionnaire for assessing vision-related quality of life (QoL) of visually impaired (VI) or blind (BL) children and young people. DESIGN: Questionnaire development. PARTICIPANTS: A stratified random patient sample of children and young people who are VI/BL (visual acuity in the better eye Snellen <6/18; logarithm of the minimum angle of resolution <0.51) as the result of any visual disorder, but in the absence of any other significant impairment, aged 10 to 15 years (N=49); and a convenience school-based sample of children and young people who are VI/BL and aged 10 to 17 years (N=29). METHODS: Individual interviews were conducted with a stratified random sample of 32 children and young people, aged 10 to 15 years, who were VI/BL. The interviews followed a topic guide based on vision-related issues identified from a focus group of affected children and young people, combined with a literature review and consultations with professionals. Collaborative qualitative thematic analysis was undertaken and used to derive draft items of the instrument, using the children's own language wherever possible. Items were reduced, rephrased, and refined through individual consultation, as well as an expert reference group of children and young people who were VI/BL, and supplemented by the research team's consensus. MAIN OUTCOME MEASURES: A draft 47-item instrument. RESULTS: A total of 874 potential questionnaire items were initially generated spanning the following domains: social relations, acceptance, and participation; independence and autonomy; psychological and emotional well-being; future-aspirations and fears; functioning-home, school, and leisure; and treatment of eye condition. This was eventually reduced to a 47-item instrument with each item presented as a vignette describing a QoL issue from an "illustrative" child's perspective. Thus, the responding child reports on how much he/she is presently like and how much he/she wishes to be like that child, using a 4-point Likert-type scale. CONCLUSIONS: We demonstrate that a child-centered approach to identifying the content for a self-report vision-related QoL questionnaire is feasible. We suggest this approach is critical to accurately capturing children and young peoples' subjective perspectives on the impact of living with impaired vision.

'Silent voices' in health services research: ethnicity and socioeconomic variation in participation in studies of quality of life in childhood visual disability.

Purpose. To investigate patterns of participation of visually impaired (VI) children and their families in health services research. Methods. The authors compared clinical and sociodemographic characteristics of children and their families who participated with those who did not participate in two studies of quality of life (QoL) of VI children. In Study 1, the authors interviewed VI children and adolescents, aged 10 to 15 years, about their vision-related quality of life (VRQoL) as the first phase of a program to develop a VRQoL instrument for this population. One hundred seven children with visual impairment (visual acuity in the better eye LogMar worse than 0.51) were invited to participate in the interviews. Study 2 investigated health-related quality of life (HRQoL) of VI children using an existing generic instrument, administered in a postal survey. 151 VI children and adolescents, aged 2 to 16 years, with hereditary retinal disorders were invited to participate in the survey. Results. The overall participation level was below 50%. In both studies, participants from white ethnic and more affluent socioeconomic backgrounds were overrepresented. Participation did not vary by age, sex, or clinical characteristics. Conclusions. The authors suggest that there are barriers to participation in child- and family-centered research on childhood visual disability for children from socioeconomically deprived or ethnic minority groups. They urge assessment and reporting of participation patterns in further health services research on childhood visual disability. Failure to recognize that there are "silent voices" is likely to have important implications for equitable and appropriate service planning and provision for VI children.

A cross-sectional study of vascular risk factors in a rural South African population: data from the Southern African Stroke Prevention Initiative (SASPI).

BACKGROUND: Rural sub-Saharan Africa is at an early stage of economic and health transition. It is predicted that the 21st century will see a serious added economic burden from non-communicable disease including vascular disease in low-income countries as they progress through the transition. The stage of vascular disease in a population is thought to result from the prevalence of vascular risk factors. Already hypertension and stroke are common in adults in sub-Saharan Africa. Using a multidisciplinary approach we aimed to assess the prevalence of several vascular risk factors in Agincourt, a rural demographic surveillance site in South Africa. METHODS: We performed a cross sectional random sample survey of adults aged over 35 in Agincourt (population approximately 70 000). Participants were visited at home by a trained nurse who administered a questionnaire, carried out clinical measurements and took a blood sample. From this we assessed participants' history of vascular risk, blood pressure using an OMRON 705 CP monitor, waist circumference, body mass index (BMI), ankle brachial index (ABI), and total and HDL cholesterol. RESULTS: 402 people (24% men) participated. There was a high prevalence of smoking in men, but the number of cigarettes smoked was small. There was a striking difference in mean BMI between men and women (22.8 kg/m2 versus 27.2 kg/m2), but levels of blood pressure were very similar. 43% of participants had a blood pressure greater than 140/90 or were on anti-hypertensive treatment and 37% of participants identified with measured high blood pressure were on pharmacological treatment. 12% of participants had an ABI of < 0.9, sugesting the presence of sub-clinical atheroma. 25.6% of participants had a total cholesterol level > 5 mmol/l. CONCLUSION: We found a high prevalence of hypertension, obesity in women, and a suggestion of subclinical atheroma despite relatively favourable cholesterol levels in a rural South African population. South Africa is facing the challenge of an emerging epidemic of vascular disease. Research to establish the social determinates of these risk factors and interventions to reduce both individual and population risk are required.

Distribution of a subclinical marker of cardiovascular risk, the ankle brachial index, in a rural African population: SASPI study.

BACKGROUND: In sub-Saharan Africa, hypertension and stroke are emerging as an important cause of death and disability, whereas coronary heart disease appears still to be uncommon. The aim of our study was to measure for the first time in an African population the ankle brachial index (ABI), which is known to be a good marker of subclinical atheroma and of the risk of future cardiovascular events. METHODS: The study was part of the Southern African Stroke Prevention Initiative (SASPI). It comprised a cross-sectional survey conducted in rural north-east South Africa in the sub-district of Agincourt, in which the demography of the population has been closely monitored. A stratified sample of 10 villages were selected and within these a random sample was chosen of 526 men and women aged 35 years and older. Subjects were visited on up to three occasions to be interviewed and have a clinical examination by specially trained nurses. This included an assessment of cardiovascular risk factors and measurement of the ABI (ratio of ankle : brachial systolic pressure) using a Doppler ultrasound machine. RESULTS: The sample comprised 322 subjects in whom the mean ABI (lower of either leg) was 1.05 in both men and women. The distribution of ABI was negatively skewed and a low ABI of 0.9 or less, indicative of significant atheroma and higher cardiovascular risk, increased with age from 3.9% in 40-49 year olds to 39.7% in those aged 70 years and older. Lower ABI was related to current cigarette smoking (P=0.02) and higher systolic and diastolic blood pressure (P<0.01, P=0.02, respectively) but not total cholesterol levels, which were relatively low in this population (mean 4.47 mmol/l). CONCLUSION: The distribution of the ABI in this rural African population was very similar to that reported in western populations, and suggests that this population has subclinical peripheral atheroma and is at an increased risk of future cardiovascular events, thus providing further evidence of an epidemiological transition towards cardiovascular disease.

Women as moral pioneers? Experiences of first trimester antenatal screening.

The implementation of innovative medical technologies can raise unprecedented ethical, legal and social dilemmas. This is particularly so in the area of antenatal screening, which is dominated by the language of risk and probabilities. Second trimester serum screening for Down's syndrome and neural tube defects has a well-established place in antenatal care. Increasingly, first trimester screening with biochemical and ultrasound markers is being proposed as advance on this, yielding higher detection rates of Down's syndrome at an earlier gestational age. This article explores the experiences of 14 women offered innovative first trimester screening, which takes place within the context of a detailed ultrasound scan. The study is set within the UK, where recent policy changes mean that the offer of screening for fetal anomalies, particularly Down's syndrome, will become a routine part of antenatal care and offered to all pregnant women. This paper focuses on the significance of the scan in first trimester screening, and some of the potential dilemmas for women that can result from this. It then discusses the ways in which women made their decisions about screening, in particular, their work as 'moral pioneers'. We found that the part played by the ultrasound scan in first trimester screening, particularly in relation to the higher-quality images now being obtained, has the potential to introduce new and novel ethical dilemmas for pregnant women. Although concerns have been raised about pregnant women viewing ultrasound scans as benign, many of the women reported having thought carefully through their own moral beliefs and values prior to screening. It seems that whatever other implications they may have, first trimester screening technologies will continue the tradition of pregnant women acting as 'moral pioneers' in increasingly complex settings.

Participating in medical education: views of patients and carers living in deprived communities.

OBJECTIVES: Active patient involvement in community-based education is still relatively novel; in particular, the involvement of patients living in socially and economically deprived areas is still unusual. This study explores the views of patients and carers living in deprived areas on their participation in medical education. DESIGN: A total of 36 patients and 18 parents were interviewed at home by Year 1 students undertaking an accelerated 4-year degree programme. Subsequently, taped interviews using a topic guide were carried out with 18 patients/carers. Their views on their active involvement with medical students are presented here. RESULTS: Most of the patients in this study did not view themselves as teaching the students but considered their role to be more one of partnership, explanation and sharing. They considered that they were the 'best judges' of certain aspects of their illness. These aspects related to psychological, social and behavioural issues, which impacted on both themselves and their families. Patients considered these issues to be as important as the medical condition they were diagnosed with. Patients also raised issues concerning the importance of doctors listening to patients. CONCLUSION: This study showed that patients living in areas of deprivation were positive about being involved in medical education. They considered their personal experience and knowledge of illness to be an important aspect of student learning. They were happy to share this knowledge and they were very keen that doctors should listen to them. The challenge for medical educators is to ensure that this is achieved.