The inclusion of adults with intellectual disabilities in health research - challenges, barriers and opportunities: a mixed-method study among stakeholders in England.

BACKGROUND: The study aims to understand system barriers to research participation for people with intellectual disabilities. METHODS: A mixed-methods approach examined the inclusivity of people with intellectual disabilities (IDs) in a random sample of National Institute for Health and Care Research (NIHR) studies conducted in 2019-2020. An online questionnaire (stage 1) was sent to the selected studies lead investigators. An expert by experience panel of 25 people with intellectual disabilities (IDs, stage 2), discussed the stage 1 feedback. Descriptive statistics for quantitative data and thematic analysis for qualitative data was conducted. RESULTS: Of 180 studies reviewed, 131 studies (78%) excluded people with IDs. Of these, 45 (34.3%) study researchers provided feedback. Seven (20%) of the 34 studies which included people with IDs gave feedback. Of all respondents over half felt their study had some relevance to people with IDs. A minority (7.6%) stated their study had no relevance. For a quarter of respondents (23.5%), resource issues were a challenge. Qualitative analysis of both stages produced four overarching themes of Research design and delivery, Informed consent, Resource allocation, and Knowledge and skills. CONCLUSION: Health research continues to exclude people with IDs. Researchers and experts by experience identified non-accessible research design, lack of confidence with capacity and consent processes, limited resources such as time and a need for training as barriers. Ethics committees appear reluctant to include people with cognitive deficits to 'protect' them. People with IDs want to be included in research, not only as participants but also through coproduction.

Clinical standards for diagnosis, treatment and prevention of post-COVID-19 lung disease.

BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' care for the diagnosis, treatment and prevention of post-COVID-19 lung disease.METHODS: A panel of international experts representing scientific societies, associations and groups active in post-COVID-19 lung disease was identified; 45 completed a Delphi process. A 5-point Likert scale indicated level of agreement with the draft standards. The final version was approved by consensus (with 100% agreement).RESULTS: Four clinical standards were agreed for patients with a previous history of COVID-19: Standard 1, Patients with sequelae not explained by an alternative diagnosis should be evaluated for possible post-COVID-19 lung disease; Standard 2, Patients with lung function impairment, reduced exercise tolerance, reduced quality of life (QoL) or other relevant signs or ongoing symptoms ≥4 weeks after the onset of first symptoms should be evaluated for treatment and pulmonary rehabilitation (PR); Standard 3, The PR programme should be based on feasibility, effectiveness and cost-effectiveness criteria, organised according to local health services and tailored to an individual patient's needs; and Standard 4, Each patient undergoing and completing PR should be evaluated to determine its effectiveness and have access to a counselling/health education session.CONCLUSION: This is the first consensus-based set of clinical standards for the diagnosis, treatment and prevention of post-COVID-19 lung disease. Our aim is to improve patient care and QoL by guiding clinicians, programme managers and public health officers in planning and implementing a PR programme to manage post-COVID-19 lung disease.

What place does nurse-led research have in the COVID-19 pandemic?

AIM: Reflect upon the visibility of nursing-led research during the COVID-19 pandemic. BACKGROUND: The emerging SARS-CoV-2 infection has galvanized collaborative and multidisciplinary efforts in clinical and research practice worldwide. The scarce evidence-base to manage patients with COVID-19 has included limited nurse-led research. INTRODUCTION: Clinical research nurses have greatly contributed to the delivery of COVID-19 research, yet the number of COVID-19 nursing-led research papers appears to be limited, with even fewer nurse-led research projects funded. METHODS: Authors' views and PubMed search on 'COVID-19 and nursing'. FINDINGS: There is a dearth of nursing-led research. Most papers describe the nursing contribution to COVID-19 care, changes in nursing working arrangements and emotional burden. There are opportunities to explore the consequences to vulnerable population groups of public health measures implemented to stop the progress of the COVID-19 pandemic. DISCUSSION: Workforce gaps, limited integration in research structures and clinical redeployment may have hampered nurse-led research. COVID-19 may exacerbate staffing deficits by disrupting the education pipeline, obstructing the transition from clinical to academic practice, particularly in areas where clinical academic roles are yet to emerge. CONCLUSION: The absence of nurse-led research in COVID-19 can be explained by chronic, underlying factors and the features of the pandemic response. Emerging models of care, effective staffing and inequalities related to COVID-19 appear obvious research areas. Nursing leadership needs to strengthen its political voice and lobbying skills to secure nurse-led research funding. IMPLICATIONS FOR NURSING POLICY: Embracing international nursing research, strengthening collaborations and lobbying policymakers for investment in nurse-sensitive research would enhance the response to COVID-19.

The feasibility of using the EQ-5D-3L with adults with mild to moderate learning disabilities within a randomized control trial: a qualitative evaluation.

BACKGROUND: In trials incorporating a health economic evaluation component, reliable validated measures for health-related quality of life (HRQOL) are essential. The EQ-5D is the preferred measure for cost-effectiveness analysis in UK trials. This paper presents a qualitative evaluation of the use of the EQ-5D-3L in a feasibility randomised control trial with participants who had a mild- to  moderate learning disability and type 2 diabetes. METHODS: Researchers administered the EQ-5D-3L to 82 participants at baseline and 77 at follow-up. After each interview, researchers rated the ease of administering the EQ-5D-3L and made free-text entries on the administration experience. For a subset of 16 interviews, researchers audio-recorded more detailed journal entries. Ease of administration data were analysed using descriptive statistics. Free-text responses were subject to a basic content analysis. The EQ-5D-3L-related journal entries were transcribed, coded and analysed thematically. RESULTS: Over half of participants were perceived to experience difficulty answering some or all of the items in the EQ-5D-3L (60% at baseline; 54% at follow-up). Analysis of the free-text entries and audio journals identified four themes that question the use of the EQ-5D-3L in this population. The first theme is related to observations of participant intellectual ability and difficulties, for example, in understanding the wording of the measure. Theme 2 is related to the normalisation of adjustments for impairments, which rendered the measure less sensitive in this population. Theme 3 is related to researcher adaptation and non-standard administration. An overarching fourth theme was identified in that people with learning disabilities were viewed as 'unreliable witnesses' by both researchers and supporters. CONCLUSIONS: It is recommended that the EQ-5D-3L should not be used in isolation to assess health-related quality of life outcomes in trials research in adults with a learning disability. Further research is required to develop and evaluate a version of the EQ-5D appropriate for this population in trials research. It is unrealistic to expect that adjustments to the wording alone will deliver an appropriate measure: supporter or researcher involvement will almost always be required. This requirement needs to be factored into the development and administration guidelines of any new version of the EQ-5D for adults with a learning disability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41897033 [registered 21 January 2013].

Health Promotion and Wellness Initiatives Targeting Chronic Disease Prevention and Management for Adults with Intellectual and Developmental Disabilities: Recent Advancements in Type 2 Diabetes.

PURPOSE OF REVIEW: The aim of this paper was to review the recent international developments in health promotion and wellness initiatives targeting chronic disease prevention and management for adults with intellectual and developmental disabilities (IDD) targeting type 2 diabetes (T2D). RECENT FINDINGS: There has been one diabetes prevention program (STOP) and two self-management T2D education programs (DESMOND-ID; OK diabetes) adapted for this population. All three programs have been adapted from other theoretically informed and tested programs developed for the general population. Each program has employed co-design and co-production techniques with all stakeholders. The three programs all target the high-risk lifestyle factors that can lead to T2D and contribute to poor glycaemia control, and have undertaken randomized-feasibility studies, the results of which are promising. SUMMARY: This paper shows that any health promotion and wellness initiatives need to be tailored and reasonable adjustments made in order to address this population's cognitive impairments and communication difficulties.

Randomized controlled feasibility trial of supported self-management in adults with Type 2 diabetes mellitus and an intellectual disability: OK Diabetes.

AIMS: To undertake a feasibility randomized controlled trial of supported self-management vs treatment as usual in a population of adults with obesity, Type 2 diabetes and an intellectual disability. METHODS: We conducted an individually randomized feasibility trial. Participants were adults aged >18 years with a mild or moderate intellectual disability, living in the community with Type 2 diabetes, on any therapy other than insulin. Participants had mental capacity to consent to research and the intervention. Inclusion criteria included HbA1c > 48 mmol/mol (6.5%), BMI >25 kg/m2 , or self-reported physical activity below national guideline levels. The experimental intervention was standardized supported self-management delivered by diabetes specialist nurses plus treatment as usual, compared with treatment as usual alone. Feasibility outcomes included: recruitment and retention; intervention acceptability and feasibility; data collection and completeness for physiological state and values for candidate primary outcomes (HbA1c and BMI). RESULTS: A total of 82 participants (89% of those contacted and eligible) were randomized. All supported self-management sessions were completed by 35/41 participants (85%); only four completed no sessions. Data on the follow-up candidate primary outcomes HbA1c and BMI were obtained for 75/82 (91%) and 77/82 participants (94%), respectively. The mean baseline HbA1c was 56±16.5 mmol/mol (7.3±1.5%) and the mean BMI was 34±7.6 kg/m2 . CONCLUSIONS: Adherence to supported self-management and willingness to have blood taken for outcome measurement was good. A definitive randomized controlled trial is feasible in this population. (Trial registration: Current Controlled Trials ISRCTN41897033).

Characterizing adults with Type 2 diabetes mellitus and intellectual disability: outcomes of a case-finding study.

AIMS: To report the results of a case-finding study conducted during a feasibility trial of a supported self-management intervention for adults with mild to moderate intellectual disability and Type 2 diabetes mellitus, and to characterize the study sample in terms of diabetes control, health, and access to diabetes management services and support. METHODS: We conducted a cross-sectional case-finding study in the UK (March 2013 to June 2015), which recruited participants mainly through primary care settings. Data were obtained from medical records and during home visits. RESULTS: Of the 325 referrals, 147 eligible individuals participated. The participants' mean (sd) HbA1c concentration was 55 (15) mmol/mol [7.1 (1.4)%] and the mean (sd) BMI was 32.9 (7.9) kg/m2 , with 20% of participants having a BMI >40 kg/m2 . Self-reported frequency of physical activity was low and 79% of participants reported comorbidity, for example, cardiovascular disease, in addition to Type 2 diabetes. The majority of participants (88%) had a formal or informal supporter involved in their diabetes care, but level and consistency of support varied greatly. Post hoc exploratory analyses showed a significant association between BMI and self-reported mood, satisfaction with diet and weight. CONCLUSIONS: We found high obesity and low physical activity levels in people with intellectual disability and Type 2 diabetes. Glycaemic control was no worse than in the general Type 2 diabetes population. Increased risk of morbidity in this population is less likely to be attributable to poor glycaemic control and is probably related, at least in part, to greater prevalence of obesity and inactivity. More research, focused on weight management and increasing activity in this population, is warranted.

Neutron diffraction analysis of residual stresses near unannealed welds in anhydrous ammonia nurse tanks.

Neutron diffraction analysis was employed to measure residual stresses near welds in used anhydrous ammonia nurse tanks. Tensile residual stresses contribute to stress corrosion cracking of nurse tanks, which can cause tanks to release toxic ammonia vapor. The analysis showed that tensile residual stresses were present in the tanks measured, and the magnitudes of these stresses approached the yield strength of the steel. Implications for agricultural safety and health are discussed.

BRCA1 dysfunction in sporadic basal-like breast cancer.

Basal-like breast cancers form a distinct subtype of breast cancer characterized by the expression of markers expressed in normal basal/myoepithelial cells. Breast cancers arising in carriers of germline BRCA1 mutations are predominately of basal-like type, suggesting that BRCA1 dysfunction may play a role in the pathogenesis of sporadic basal-like cancers. We analysed 37 sporadic breast cancers expressing the basal marker cytokeratin 5/6, and age- and grade-matched controls, for downregulation of BRCA1. Although BRCA1 promoter methylation was no more common in basal-like cancers (basal 14% vs controls 11%, P=0.72), BRCA1 messenger RNA expression was twofold lower in basal-like breast cancers compared to matched controls (P=0.008). ID4, a negative regulator of BRCA1, was expressed at 9.1-fold higher levels in basal-like breast cancer (P<0.0001), suggesting a potential mechanism of BRCA1 downregulation. BRCA1 downregulation correlated with the presence of multiple basal markers, revealing heterogeneity in the basal-like phenotype. Finally, we found that 63% of metaplastic breast cancers, a rare type of basal-like cancers, had BRCA1 methylation, in comparison to 12% of controls (P<0.0001). The high prevalence of BRCA1 dysfunction identified in this study could be exploited in the development of novel approaches to targeted treatment of basal-like breast cancer.

Exclusion of an extracolonic disease modifier locus on chromosome 1p33-36 in a large Swiss familial adenomatous polyposis kindred.

Familial adenomatous polyposis (FAP), an autosomal dominantly inherited colorectal cancer predisposition syndrome, displays considerable inter- and intrafamilial phenotypic heterogeneity, which represents a major problem in genetic counselling of APC mutation carriers. The Min mouse model indicated a putative disease modifier locus on chromosome 4, which is syntenic to human chromosome 1p35-36. This finding was subsequently supported by parametric and nonparametric linkage analyses in FAP families, however, without identifying functional variants in candidate genes. Recently, germline mutations in the base-excision repair gene MYH (1p33-34) have been described in patients with multiple adenomas, pointing to a possible role as disease modifier in FAP. Here, we present critical reassessment of one of the largest FAP kindreds published, which was previously used in linkage mapping of 1p35-36. In this family, all affected members harbour the same APC germline mutation (5945delA), but display marked phenotypic variability, in particular regarding the occurrence of extracolonic disease that segregates in several branches of the family tree. Using updated clinical information, additional mutation carriers and polymorphic markers, fine mapping of the critical region as well as mutation analysis of the MYH gene were performed. These investigations allowed us to significantly exclude (i) the 1p33-36 region as a modifier locus and (ii) MYH as a modifier gene for extracolonic disease in this FAP kindred. Our results do not eliminate 1p33-36 from suspicion in other families, but clearly indicate that in our family linkage analysis of further putative candidate regions is necessary to identify a disease modifier locus in FAP.

A blind caries and fluorosis prevalence study of school-children in naturally fluoridated and nonfluoridated townships of Morayshire, Scotland.

OBJECTIVES: To undertake a blind caries and fluorosis prevalence study of Grade 1 (aged 5/6 yr) and Grade 4-7 (aged 8-12 yr) children from naturally water-fluoridated (1 ppm, since 1985) Burghead, Findhorn & Kinloss (F), and nearby nonfluoridated Buckie & Portessie (N-F), in rural Morayshire, Scotland. METHODS: A blind clinical (+ 10% repeats) caries study of the above townships' 5/6-yr-old lifetime (15 F; 43 N-F), and 8-12-yr-old lifetime (55 F; 136 N-F)/school-lifetime (31 F; 37 N-F) residents was undertaken following bussing of these children to a common examination site in close-by Elgin Town Hall. Initially, each child was asked about their own perception of the aesthetics of their maxillary front teeth. Fluorosis was assessed clinically using the TF Index, as well as photographically - for later blind scoring (+ 10% repeats for lifetime 8-12-yr-olds) of slides by four dental and two lay 'jurors', alongside a now-established UK 'bench-mark' mildly mottled (TFI = 2), fluorosis comparator slide, judged in previous studies to be aesthetically lay-acceptable. In addition, by parental questionnaire, information was sought concerning their child's fluoride supplement and dentifrice usage histories. RESULTS: For 5/6-yr-olds, mean primary caries scores were 96.0% less in fluoridated than nonfluoridated subjects (P < 0.01). In 8-12-yr-olds, DMFT values favoured water-fluoridated subjects; their caries-free trend was significant (P < 0.001 overall). Clinically, 33% of all lifetime F subjects and 18% of all N-F pupils had fluorosed maxillary anterior teeth (P = 0.045), but no statistically significant difference was found between the 7% F and 3% N-F subjects with TFI scores > 2 (P = 0.25). Photographically, 'jury' mottling assessment (+ 10% repeats) of projected slides resulted in at least 1 : 6 positive scores in 43.6% of F and 30.9% of N-F pupils, albeit they unanimously scored only nine F and five N-F children as having fluorosed teeth (P < 0.01). In no case did all members score TFI > 2. Dental and lay scorers rated TFI = (1/2) in only a further 9.1% and 5.5% of F subjects, respectively, compared to 0.7% and 1.5% respectively of N-F pupils. Again, TFI > 2 was scored unanimously in no child. No differences were found regarding the children's own degree of anterior tooth aesthetic nonacceptability between F (11%) and N-F (12%) prevalence (P = 0.75). Finally, only one F child had taken F supplements and, while 26 N-F had used F drops, no significant relationship was found between their usage and TFI values in the latter group (P = 0.49). Additionally, no relationship was noted between clinical TFI scores and the age at which parents stated fluoridated dentifrice toothbrushing commenced, between 0 and 24 + months of age. CONCLUSIONS: Considerable caries benefit has accrued to those Morayshire rural children who have received naturally fluoridated water (at 1 ppm) throughout their lives, as compared to their socioeconomically similar, nonfluoridated rural counterparts. Furthermore, in spite of all but two subjects claiming to have brushed regularly with fluoridated dentifrice (and no evidence of the availability of nonfluoridated toothpaste being purchasable in the five townships), only borderline mild fluorosis disadvantages have been noted clinically, and none by the subjects' own aesthetic perceptions. Finally, no evidence was found to suggest any delay in permanent tooth eruption patterns of the F subjects. It would seem appropriate therefore, that adjustment of Scots' drinking waters' natural fluoride levels to 1 ppm should be pursued to extend similar dental advantages to the vast majority of that population (both young and old) which, it is well documented, has the worst dental health of mainland UK.

Protecting the integrity of clinical laboratory test results.

The authors' inspection reports demonstrate that the improper alteration of patient data is not a rare aberration in private commercial clinical laboratories. Although laboratory surveyors could be trained to recognize this problem, the availability of unprotected test systems makes even trained inspectors ineffectual. Both regulatory agencies and professional accrediting agencies should be concerned that their surveyors may be placing a seal of approval on what are, in reality, compromised or even fabricated data. In proposing the regulations discussed in this paper, the FDA sought to "preserve the integrity of the agency's enforcement process." This goal will remain unattainable, however, until a mechanism has been devised to secure the original raw data produced by all of the analytical systems being used not only in clinical laboratories but also in environmental laboratories, pharmaceutical laboratories, etc. Laboratories, as well as regulatory agencies and accrediting bodies, need to be concerned on behalf of the patient, but laboratories may also need to be concerned on their own behalf. In the coming era of unprecedented cost constraints and competitive bidding, unscrupulous testing facilities or groups of such facilities could have a significant edge over their conscientious competitors if the issues raised here continue to be ignored. Although the analytical data management systems provide tremendous benefits, some have serious problems in ensuring the security of their data. However, if regulatory agencies, accrediting bodies, professional organizations, and the analyzer vendors make a united commitment, the problem of securing the integrity of analytical data could eventually be resolved. It is hoped that such a commitment will be made in the near future.

The association between lameness and fertility in dairy cows.

One thousand, four hundred and ninety-one lactations in 770 Friesian, Holstein and Ayrshire crossbred cows have been used to study the associations between lameness and fertility. Lameness was associated with a longer interval between calving and first service and a longer interval between calving and conception. The largest increases in these intervals, of 17 and 30 days, respectively, occurred in cows with either sole or white line lesions occurring between 36 and 70 days after calving. The conception rate during the 63 days before a diagnosis of lameness was made was lower (31 per cent) than at other times (40 per cent).

Effect of wet weather on lameness in dairy cattle.

The incidence of lameness in cows recorded by five veterinary practices over one year and one practice over four years was plotted with rainfall and potential soil moisture deficit. Correlation coefficients calculated between lameness, rainfall and potential soil moisture deficit over two-week periods showed the incidence of lameness in summer to be significantly related to the potential soil moisture deficit in the same two-week period and rainfall in the previous two-week period. Differences in patterns of lameness incidence among practices and years were also partly explained by differences in rainfall and potential soil moisture deficit; however, these effects were small compared with those of other factors that affect lameness incidence such as herd size, age and stage of lactation.

Short-term associations between disease and milk yield of dairy cows.

Short-term associations between disease and milk yield were studied in 1594 lactations occurring between 1977 and 1982 in 732 Friesian, Ayrshire and Holstein crossbred cows. Statistically significant differences in milk yield between one week before and one week after clinical diagnosis were observed for ketosis (5.1 kg/d), hypomagnesaemia (4.1 kg/d), mastitis occurring after peak yield (2.1 kg/d) and lameness (1.1 kg/d). Milk yield declined for as much as 2-4 weeks before diagnosis of disease, and total losses in milk yield associated with ketosis or hypomagnesaemia were estimated to be 60-70 kg. No significant differences were found for endometritis or for mastitis when it occurred before peak yield. Milk yield was suppressed for about 4 weeks after calvings with retained placenta, but there were no corresponding effects of dystocia or hypocalcaemia on milk yield. It is suggested that if automatic daily milk recording is available it may be possible to detect deviations from normal, and hence detect subclinical disease 2 or more weeks before its clinical appearance.

Effects of stage of lactation, month, age, origin and heart girth on lameness in dairy cattle.

Lameness in herds during one year was commonest in the first month of lactation (15 per cent of all cases). Leg lesions were particularly common at this time (24 per cent of all cases of leg lesions) but white line abscess and sole ulcer were more common a month later. Foul-in-the-foot was one of the two most common lesions at all stages of pregnancy and lactation, and white line abscess the most common (20 per cent of all lesions) in late lactation. Both sole ulcer and underrun heel had lower incidence in the second half of the year than the first. White line abscess was particularly common in March and November although there were significant interactions between month and veterinary practice; foul-in-the-foot was most common in October. Susceptibility to lameness increased with age; 10-year-old cows were over four times more likely to develop lameness than three-year-old cows. This was due particularly to increased incidence with age of white line abscess and sole ulcer and, to a lesser extent, underrun heel. In contrast, foul-in-the-foot and leg lesions showed little change with age. Whereas these lesions accounted for 68 per cent of the total in cows up to two years old, they accounted for only 15 per cent of all lesions in cows over 10 years old. White line abscess was slightly commoner in cows with large heart girths.

Effects of season, herd size, management system and veterinary practice on the lameness incidence in dairy cattle.

The incidence of lameness in herds visited by veterinary practitioners in winter (0.87 cases per 100 cows per month) was greater than in summer (0.71 cases per 100 cows per month). The relative proportions of leg lesions and underrun heel were higher, and those of foul-in-the-foot, interdigital hyperplasia and foreign body in the sole were lower in winter than in summer. In winter, leg lesions and aseptic laminitis were most common in cows housed in cowsheds, white line abscess in cows in strawyards and sole ulcer in cows in either cowsheds or cubicles with concrete yards. The overall incidence of lesions was lower in strawyard accommodation (0.71 cases per 100 cows per month) than in cubicles with yards (0.93 cases per 100 cows per month). Veterinary practitioners saw proportionally fewer cases of foul-in-the-foot but proportionally more cases of sole ulcer in larger than in smaller herds. The animal incidence of lameness ranged from 1.7 to 11.4 per cent among practices; in 20 practices which recorded a total of at least 100 lesions in both summer and winter there was a large variation in the proportions observed of each lesion. A principal component analysis contrasted those practices which tended to see mainly cases of white line abscess, white line separation, foul-in-the-foot and leg lesions with those which saw mainly cases of underrun heel, interdigital hyperplasia, punctured sole with pus and sole ulcer. Twenty-nine per cent of cases of underrun heel and 22 per cent of cases of both deep sepsis and interdigital hyperplasia occurred in conjunction with another lesion.

Use of COSREEL clinical codes in large animal veterinary practice.

COSREEL, a computerised animal health recording system with a versatile coding system for recording diagnoses, symptoms and medical and surgical treatments, has been tested by veterinary surgeons in practice. The codes were found to be logical and generally easy to use. The application of these codes, with particular reference to their use in infertility investigations, is illustrated.