Description: Objectives Patients and policy makers advocate that drug treatments should be individualised. However, the term is used in a variety of ways. We set out to identify the range of related terminology and concepts in the general field of individualisation, map out the relationships between these concepts and explore how patients’ perspectives are considered. Design We consulted members of an established patient and public involvement group about their experience of medicine taking for long-term conditions and their ideas about individualisation. We then conducted a scoping review of the literature to explore how terms surrounding individualisation of drug treatment are used and defined in the literature, and to explore the extent to which patients’ perspectives are represented, with a view to informing future recommendations as to how individualisation can be operationalised. Methods We identified relevant literature using a range of search strategies. Two researchers independently extracted definitions of terms using a template. Inductive and deductive methods were used to explore the data. Results Definitions were categorised according to the following themes: medical management; pharmacogenetics, the patient's perspective; interactions between the healthcare provider and patient and management of long-term conditions. Conclusions Within the literature reviewed, the involvement of patients in the ongoing management of drug treatment was largely absent. We propose the use of a new term ‘mutually agreed tailoring’ (MAT). This describes the ongoing pharmacological management of conditions that incorporates patients’ specific needs, experiences and existing strategies for using their medications, and the professionals’ clinical judgement. This usually includes patients monitoring their symptoms and, with the support of the professional, making appropriate product, dose or timing adjustments as necessary. Our previous work suggests that many patients and doctors are successfully practising MAT, so we suggest that a formal description may facilitate wider utilisation of strategies that will improve patient outcomes.

Description: Introduction The vitamin D recommended doses during pregnancy differ between societies. The WHO guidelines do not recommend routine prenatal supplementation, but they underscore the fact that women with the lowest levels may benefit most. The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent. Our hypothesis is that in Middle Eastern pregnant women, a vitamin D dose of 3000 IU/day is required to reach a desirable maternal 25-hydroxyvitamin D [25(OH)D] level, and to positively impact infant bone mineral content (BMC). Methods and analysis This is a multicentre blinded randomised controlled trial. Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached. Eligible women will be randomised to daily equivalent doses of cholecalciferol, 600 IU or 3000 IU, from 15 to 18 weeks gestation until delivery. Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery. Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month. A sample size of 280 pregnant women is needed to demonstrate a statistically significant difference in the proportion of women reaching a 25(OH)D level ≥50 nmol/L at delivery, and a difference in infant BMC of 6 (10)g, for a 90% power and a 2.5% level of significance. The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using 2 . An independent t test will be used to compare mean infant BMC between the two arms. The primary analysis is an intention-to-treat analysis of unadjusted results. Ethics and dissemination The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22). The trial results will be published in peer-reviewed medical journals and presented at scientific conferences. Trial registration number NCT02434380.

Description: Objectives To assess whether changes in measures of fat distribution and body size during early life are associated with blood pressure at 36 months of age. Design Analysis of data collected from a prospective cohort study. Setting Community-based investigation in Southampton, UK. Participants 761 children with valid blood pressure measurements, born to women participating in the Southampton Women’s Survey. Primary and secondary outcome measures Anthropometric measurements were collected at 0, 6, 12, 24 and 36 months and conditional changes between the time points calculated. Blood pressure was measured at 36 months. Factors possibly influencing the blood pressure were assessed using linear regression. All independent variables of interest and confounding variables were included in stepwise multiple regression to identify the model that best predicted blood pressure at 36 months. Results Greater conditional gains in abdominal circumference (AC) between 0–6 and 24–36 months were associated with higher systolic and diastolic blood pressures at 36 months (p〈0.001). Subscapular skinfold and height gains were weakly associated with higher blood pressures, while greater weight gains between 0–6, 12–24 and 24–36 months were more strongly associated, but the dominant influences were AC gains, particularly from 0–6 to 24–36 months. Thus one SD score increases in AC between 0–6 and 24–36 months were associated with 1.59 mm Hg (95% CI 0.97 to 2.21) and 1.84 mm Hg (1.24 to 2.46) higher systolic blood pressures, respectively, and 1.04 mm Hg (0.57 to 1.51) and 1.02 mm Hg (0.56, 1.48) higher diastolic pressures, respectively. Conclusions Conditional gains in abdominal circumference, particularly within 6 months of birth and in the year preceding measurement, were more positively associated with blood pressure at 36 months than gains in other anthropometric measures. Above-average AC gains in early childhood may contribute to adult hypertension and increased cardiovascular disease risk.

Description: Introduction UK doctors are now required to participate in revalidation to maintain their licence to practise. Appraisal is a fundamental component of revalidation. However, objective evidence of appraisal changing doctors’ behaviour and directly resulting in improved patient care is limited. In particular, it is not clear how the process of appraisal is supposed to change doctors’ behaviour and improve clinical performance. The aim of this research is to understand how and why appraisal of doctors is supposed to produce its effect. Methods and analysis Realist review is a theory-driven interpretive approach to evidence synthesis. It applies realist logic of inquiry to produce an explanatory analysis of an intervention that is, what works, for whom, in what circumstances, in what respects. Using a realist review approach, an initial programme theory of appraisal will be developed by consulting with key stakeholders in doctors’ appraisal in expert panels (ethical approval is not required), and by searching the literature to identify relevant existing theories. The search strategy will have a number of phases including a combination of: (1) electronic database searching, for example, EMBASE, MEDLINE, the Cochrane Library, ASSIA, (2) ‘cited by’ articles search, (3) citation searching, (4) contacting authors and (5) grey literature searching. The search for evidence will be iteratively extended and refocused as the review progresses. Studies will be included based on their ability to provide data that enable testing of the programme theory. Data extraction will be conducted, for example, by note taking and annotation at different review stages as is consistent with the realist approach. The evidence will be synthesised using realist logic to interrogate the final programme theory of the impact of appraisal on doctors’ performance. The synthesis results will be written up according to RAMESES guidelines and disseminated through peer-reviewed publication and presentations. Trial registration number The protocol is registered with PROSPERO 2014:CRD42014007092.

Description: Objective The main objective of this work was to translate the English version of ASSET (A Shortened Stress Evaluation Tool) into the Portuguese version and to validate its psychometric properties. Additionally, this work tested the convergent validity of the instrument. Methods The translation and retroversion were conducted by experts and submitted to the authors for approval. Within an observational, cross-sectional study, regarding mental health at the workplace, ASSET together with other scales was applied to a sample of 405 participants. The psychometric validity of the subscales was studied using confirmatory factorial analysis. Results The factorial structure of ASSET is globally supported by the results, with the Perceptions of Your Job and Attitudes Towards your Organisation subscales requiring slight adjustments in the item structure and the Your Health subscales replicating the original structure. The convergent validity also supports the ASSET, showing that all subscales are significantly correlated with variables used to test convergence. Conclusions Globally, the results constitute an important contribution to ASSET and open the possibility of its usage among Portuguese-speaking countries. The results provide an evidence on the validity of the instrument and, in particular, of the mental and physical health subscales.

Description: Objectives To measure changes in length of stay following total knee and hip replacement (TKR and THR) between 1997 and 2014 and estimate the impact on hospital reimbursement, all else being equal. Further, to assess the degree to which observed trends can be explained by improved efficiency or changes in patient profiles. Design Cross-sectional study using routinely collected data. Setting National Health Service primary care records from 1995 to 2014 in the Clinical Practice Research Datalink were linked to hospital inpatient data from 1997 to 2014 in Hospital Episode Statistics Admitted Patient Care. Participants Study participants had a diagnosis of osteoarthritis or rheumatoid arthritis. Interventions Primary TKR, primary THR, revision TKR and revision THR. Primary outcome measures Length of stay and hospital reimbursement. Results 10 260 primary TKR, 10 961 primary THR, 505 revision TKR and 633 revision THR were included. Expected length of stay fell from 16.0 days (95% CI 14.9 to 17.2) in 1997 to 5.4 (5.2 to 5.6) in 2014 for primary TKR and from 14.4 (13.7 to 15.0) to 5.6 (5.4 to 5.8) for primary THR, leading to savings of £1537 and £1412, respectively. Length of stay fell from 29.8 (17.5 to 50.5) to 11.0 (8.3 to 14.6) for revision TKR and from 18.3 (11.6 to 28.9) to 12.5 (9.3 to 16.8) for revision THR, but no significant reduction in reimbursement was estimated. The estimated effect of year of surgery remained similar when patient characteristics were included. Conclusions Length of stay for joint replacement fell substantially from 1997 to 2014. These reductions have translated into substantial savings. While patient characteristics affect length of stay and reimbursement, patient profiles have remained broadly stable over time. The observed reductions appear to be mostly explained by improved efficiency.

Description: Objectives We conducted an individual participant meta-analysis to test the hypothesis that cortisol patterns indicative of dysregulated hypothalamic–pituitary–adrenal axis functioning would be prospectively associated with poorer well-being at follow-up. Setting Four large UK-based cohort studies. Participants Those providing valid salivary or serum cortisol samples (n=7515 for morning cortisol; n=1612 for cortisol awakening response) at baseline (age 44–82) and well-being data on the Warwick Edinburgh Mental Wellbeing Scale at follow-up (0–8 years) were included. Results Well-being was not associated with morning cortisol, diurnal slope or awakening response though a borderline association with evening cortisol was found. Adjusting for sex and follow-up time, each 1 SD increase in evening cortisol was associated with a –0.47 (95% CI –1.00 to 0.05) point lower well-being. This was attenuated by adjustment for body mass index, smoking and socioeconomic position. Between-study heterogeneity was low. Conclusions This study does not support the hypothesis that diurnal cortisol is prospectively associated with well-being up to 8 years later. However, replication in prospective studies with cortisol samples over multiple days is required.

Description: Objectives To analyse the experience of individual family carers of people with dementia who received a manual-based coping strategy programme (STrAtegies for RelaTives, START), demonstrated in a randomised-controlled trial to reduce affective symptoms. Design A qualitative study using self-completed questionnaires exploring the experience of the START intervention. Two researchers transcribed, coded and analysed completed questionnaires thematically. Setting Three mental health and one neurology dementia clinic in South East England. Participants Participants were primary family carers of a patient diagnosed with dementia who provided support at least weekly to their relative. We invited those in the treatment group remaining in the START study at 2 years postrandomisation (n=132) to participate. 75 people, comprising a maximum variation sample, responded. Primary and secondary outcome measures (1) Important aspects of the therapy. (2) Continued use of the intervention after the end of the therapy. (3) Unhelpful aspects of the therapy and suggestions for improvement. (4) Appropriate time for intervention delivery. Results Carers identified several different components as important: relaxation techniques, education about dementia, strategies to help manage the behaviour of the person with dementia, contact with the therapist and changing unhelpful thoughts. Two-thirds of the participants reported that they continue to use the intervention's techniques at 2-year follow up. Few participants suggested changes to the intervention content, but some wanted more sessions and others wanted the involvement of more family members. Most were happy with receiving the intervention shortly after diagnosis, although some relatives of people with moderate dementia thought it should have been delivered at an earlier stage. Conclusions Participants’ varied responses about which aspects of START were helpful suggest that a multicomponent intervention is suited to the differing circumstances of dementia carers, providing a range of potentially helpful strategies. The continued use of the strategies 2 years after receiving the intervention could be a mechanism for the intervention remaining effective.

Description: Objectives The UK government's response to the obesity epidemic calls for action in communities to improve people's health behaviour. This study evaluated the effects of a community intervention on dietary quality and levels of physical activity of women from disadvantaged backgrounds. Design Non-randomised controlled evaluation of a complex public health intervention. Participants 527 women attending Sure Start Children's Centres (SSCC) in Southampton (intervention) and 495 women attending SSCCs in Gosport and Havant (control). Intervention Training SSCC staff in behaviour change skills that would empower women to change their health behaviours. Outcomes Main outcomes dietary quality and physical activity. Intermediate outcomes self-efficacy and sense of control. Results 1-year post-training, intervention staff used skills to support behaviour change significantly more than control staff. There were statistically significant reductions of 0.1 SD in the dietary quality of all women between baseline and follow-up and reductions in self-efficacy and sense of control. The decline in self-efficacy and control was significantly smaller in women in the intervention group than in women in the control group (adjusted differences in self-efficacy and control, respectively, 0.26 (95% CI 0.001 to 0.50) and 0.35 (0.05 to 0.65)). A lower decline in control was associated with higher levels of exposure in women in the intervention group. There was a statistically significant improvement in physical activity in the intervention group, with 22.9% of women reporting the highest level of physical activity compared with 12.4% at baseline, and a smaller improvement in the control group. The difference in change in physical activity level between the groups was not statistically significant (adjusted difference 1.02 (0.74 to 1.41)). Conclusions While the intervention did not improve women's diets and physical activity levels, it had a protective effect on intermediate factors—control and self-efficacy—suggesting that a more prolonged exposure to the intervention might improve health behaviour. Further evaluation in a more controlled setting is justified.

Description: Objectives People from Minority Ethnic groups tend to present late to dementia services, often in crisis. Culture-specific barriers to help-seeking seem to underlie this. We sought to determine these barriers to timely help-seeking for dementia among people from South Asian backgrounds and what the features of an intervention to overcome them would be. Study design Qualitative study to delineate barriers to and facilitators of help-seeking for South Asian adults with dementia through focus groups and individual interviews. Setting Community settings in and around Greater London. Participants To achieve a maximum variation sample, we purposively recruited 53 English or Bengali speaking South Asian adults without a known diagnosis of dementia through community centres and snowballing. Results Participants ranged in age from 18 to 83 years, were mostly female and were 60% Bangladeshi. We recruited people from different religions and occupational backgrounds and included those with experience of caring for someone with dementia as well as those without this experience. Participants identified four main barriers to timely diagnosis: barriers to help-seeking for memory problems; the threshold for seeking help for memory problems; ways to overcome barriers to help-seeking; what features an educational resource should have. Conclusions We have identified the features of an intervention with the potential to improve timely dementia diagnosis in South Asians. The next steps are to devise and test such an intervention.