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The Addiction Recovery Questionnaire (ARQ) is derived from the views of service users, their families and friends. Data were collected from 305 participants in the UK general population and addiction services, asked to self-identify as being in one of three groups: treatment, recovery or well-functioning, and complete the ARQ. Regression and latent class analyses were used to determine that the ARQ could distinguish the three groups. Clinically significant change values were established. Although there are some discrepancies in the way individuals define their recovery, self-identification was found to be broadly valid. The ARQ is able to assign people to different stages of recovery from addiction, and provides an instrument for monitoring change and measuring outcomes in the key components of lifestyle, involvement with substance use and self-confidence. [ABSTRACT FROM AUTHOR]

Why you should read this article: • To enhance your knowledge of the structure and main functions of the skin • To understand the aetiology, manifestations and management of skin conditions commonly seen in children • To count towards revalidation as part of your 35 hours of CPD, or you may wish to write a reflective account (UK readers) • To contribute towards your professional development and local registration renewal requirements (non-UK readers) This article, the 13th in a series on the biological basis of child health, focuses on the skin. The skin is the largest organ in the body and covers its whole outer surface, protecting it from external threats, assisting in retaining body fluids, eliminating waste products and regulating temperature. The skin also has a crucial role in wound healing and vitamin D synthesis. Skin conditions in children are often distressing for children and parents, and may significantly affect their everyday lives. This article explains how the skin develops in utero, describes the structure and functions of the skin, and explores the aetiology, manifestations and management of skin conditions commonly seen in children. [ABSTRACT FROM AUTHOR]

This qualitative study collected stakeholders' views on adapting an existing online psychotherapy programme, 'Tame Your Gut', to the needs of patients with inflammatory bowel disease (IBD) and comorbid anxiety and/or depression. Adult patients (n = 13) and health professionals (n = 12) participated in semi-structured focus groups or interviews, analysed with a thematic analysis. Patients had a generally positive attitude towards 'Tame Your Gut', while health professionals saw it as useful for selected patients only. Both groups indicated their preference for clinician-assisted online psychotherapy. 'Tame Your Gut' is acceptable to patients and health professionals but only when supported by clinicians. [ABSTRACT FROM AUTHOR]

Objective Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. Methods AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥ 14 ⁠) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. Results A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. Conclusion This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. Clinical Trial Registration Number ISRCTN11929227. [ABSTRACT FROM AUTHOR]

Background: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach.Methods: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat.Discussion: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies.Trial Registration: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018. [ABSTRACT FROM AUTHOR]

Aims The AUDIT-C is a brief and commonly used alcohol screening tool, with few data available on the relative validity of the three individual items in older adult populations. The aim of this study was to explore the validity of the AUDIT-C items in identifying unhealthy drinking among older people, with a view to developing a single-item screener. Methods A sample of 143 older adults (mean age = 71) were recruited from non-clinical settings in the UK. AUDIT-C scores were compared to an unhealthy drinking reference category of consuming more than the UK recommended weekly units of alcohol. Standard analyses were conducted for men and women, and for those prescribed medications for long term conditions. Results The AUDIT-C items performed well in identifying unhealthy drinking in this sample of older people, with generally high sensitivity, specificity and area under the ROC curve. No significant differences were found in the validity of the three items, though the combined sensitivity and specificity scores and ROC values for item 3 were consistently slightly lower than for items 1 and 2. The findings were similar for men and women, and for participants prescribed medications for long-term conditions. Conclusions AUDIT-C items 1 and 2 performed as well as item 3 in identifying unhealthy drinking among older people in this study. Both are reasonable single-item screener candidates, especially given relative ease of administration, with further validation study needed to examine psychometrics and how alcohol screening for older people can best be implemented in clinical settings. [ABSTRACT FROM AUTHOR]

Background: Neovascular age-related macular degeneration (nAMD) is a leading cause of blind registrations in the developed world. Standard therapy includes the use of anti-vascular endothelial growth factor (anti-VEGF) drugs, and whilst the clinical efficacy is well established, there is variability in the clinical effect of visual outcome. The purpose of this systematic review is to identify whether there is evidence for the influence of demographic and clinical factors on the effectiveness of anti-VEGF therapy in patients with nAMD, in settings comparable to the National Health Service (NHS). Methods: This systematic review followed the PRISMA guidelines for systematic reviews. Electronic databases Medline, EMBASE, Web of Science, CINAHL and the Cochrane Library were searched for studies dated from 2005 onwards. Studies were appraised using the Newcastle–Ottawa Score, and a narrative synthesis was used. Eligibility Criteria: Population: Patients with nAMD being treated with anti-VEGF therapy. Comparator: Presence or absence of potential predictive demographic and clinical factors. Settings: Comparable settings to NHS hospitals. Outcomes: Predicting demographic and clinical factors. Study designs: Randomised controlled trials, prospective cohort studies, retrospective cohort studies and case series dated from 2005. Results: Thirty papers were identified in this review. The evidence suggests that the number of anti-VEGF injections that patients receive, age and lesion size at baseline are factors that influence how effective anti-VEGF therapy is in the short and long term. There was also evidence that suggested that baseline visual acuity influenced the effectiveness of anti-VEGF therapy at longer time points of more than 2 years. Due to a lack of standardised statistical reporting among the included studies, it was not possible to undertake a meaningful statistical synthesis or meta-analysis. Conclusions: This review has demonstrated that there is some evidence of clinical and demographic factors that affect the effectiveness of anti-VEGF therapy and hence variation in visual acuity (VA) outcome. However, this review was unable to identify as wide a range of factors as was hoped. The findings of this review are important because some of the factors, such as VA and lesion size at diagnosis and the number of injections, are potentially modifiable through improvements in early diagnosis and service provision. Future work also needs to focus on the importance of this variation, such as the effect on patients' quality of life, and how variation can be minimised. Systematic Review Registration: This review has been registered with PROSPERO (Registration number CRD42018094191). [ABSTRACT FROM AUTHOR]

Introduction: Cesarean sections are the most common major operation worldwide. One in 10 women develops a surgical-site infection after cesarean section. The PREPS pilot trial was developed to assess the feasibility of a randomized controlled trial of vaginal cleansing with chlorhexidine before cesarean section, to reduce infectious morbidity.Material and Methods: A multi-center, open-label, parallel-group pilot randomized controlled trial across 4 UK maternity units. Women aged ≥16 years, undergoing elective or emergency cesarean section, ≥34 weeks of gestation, and able to give informed consent were eligible. Women were randomized 1:1 to chlorhexidine 0.05% or no cleansing and were followed up until 6 weeks after cesarean section. The feasibility of a larger randomized controlled trial was assessed by the pilot trial's recruitment, ability to use verbal consent in an emergency, adherence, follow-up and withdrawal rates. The main clinical outcome collected was Center for Disease Control and Prevention (CDC) classification of endometritis at 30 days. Trial registration number is ISRCTN33435996.Results: A total of 320 women (128% of target) were randomized. Of these, 93% (95% CI 89%-95%) received their allocated intervention. Of the 88 women who had an emergency cesarean section, verbal consent was initially given by 32 (36%) women, with the remainder having sufficient time to give written consent. Endometritis (CDC definition) was collected from medical notes of 96% of women, 68% (95% CI 63%-73%) were followed up at both 14 and 30 days by telephone, and we were able to collect patient-reported outcomes. In the vaginal cleansing arm 2/152 (1.3%) women had endometritis compared with 1/155 (0.7%) in the no cleansing arm (RR 2.08, 95% CI 0.19-22.31).Conclusions: It is possible to perform a randomized controlled trial in women undergoing an elective or emergency cesarean section, using a verbal-followed-by-written consent process, while maintaining high adherence and retaining women in the trial. [ABSTRACT FROM AUTHOR]

Background: Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. Methods: We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen's kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. Results: Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. Conclusions: Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori. Trial registration: ISRCTN Registry ISRCTN18994246 [ABSTRACT FROM AUTHOR]

Randomised controlled trials (RCTs) can be at risk of bias. Using data from a RCT, we considered the impact of post-randomisation bias. We compared the trial primary outcome, which was administered blindly, with the secondary outcome, which was not administered blindly. From 44 schools, 522 children were randomised to receive a one-to-one maths tuition programme that was assessed using 2 outcome measures. The primary outcome measure was assessed blindly whilst the secondary outcome was delivered by the classroom teacher, and therefore this was unblinded. The effect sizes for primary and secondary outcomes were substantially different (0.33 and 1.11, respectively). Test questions that were similar between the 2 tests did not explain the difference. There was greater heterogeneity between schools for the primary outcome, compared with the secondary outcome. We conclude that, in this trial, the difference between the primary and secondary outcomes was likely to have been due to lack of blinding of testers. [ABSTRACT FROM PUBLISHER]

Purpose: Patient-reported outcome measures (PROMs) are used to understand the impact of lower limb reconstruction on patient's Health-Related Quality of Life (HRQL). Existing measures have not involved this group of patients and their experiences during development. This study aimed to develop a conceptual framework to reflect what is important to patients requiring, undergoing or after undergoing reconstructive surgery. Methods: Our population of interest was people requiring, undergoing or after undergoing reconstructive surgery due to trauma, malunion, nonunion, infection or congenital issues treated by internal or external fixation. We undertook semi-structured interviews with patients and orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) in England. Results: Thirty-two patients and 22 orthopaedic healthcare professionals (surgeons, methodologists and patient contributors) were interviewed between November 2020 and June 2021. Eight domains from a previously developed preliminary conceptual framework were used as a framework around which to code the interviews using thematic analysis. Six domains important to patients (from the perspective of patients and orthopaedic healthcare professionals) were included in the final conceptual framework: pain, perception-of-self, work and finances, daily lifestyle and functioning, emotional well-being, and support. These findings, plus meetings with our advisory panel led to the refinement of the conceptual framework. Conclusion: The first five domains relate to important outcomes for patients; they are all inter-related and their importance to patients changed throughout recovery. The final domain—support (from work, the hospital, physiotherapists and family/friends)—was vital to patients and lessened the negative impact of the other domains on their HRQL. These new data strengthen our original findings and our understanding of the domains we identified in the QES. The next step in this research is to ascertain whether current PROMs used with this group of patients adequately capture these areas of importance. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To assess the effectiveness of prenotification using a newsletter to increase questionnaire response rates within a randomized controlled trial (RCT). Study Design and Setting: An RCT set within the context of the Medical Research Council''s SCOOP trial of screening older women for fracture risk. Results: A subsample of SCOOP participants were randomized in equal numbers to receive a newsletter approximately 6 weeks before the follow-up questionnaire or no newsletter. Of the 1,342 participants in the newsletter group, 1,291 (96.2%) returned their 24-month follow-up questionnaire compared with 1,271 of the 1,344 participants who were not allocated to receive the newsletter (94.6%). The difference of 1.6% was statistically significant (P =0.05), with an odds ratio (OR) of 1.45 (95% confidence interval [CI]: 1.01, 2.10). The newsletter and no newsletter groups required a similar number of reminders (OR 0.88, 95% CI: 0.73, 1.06), had a similar number with a complete primary outcome (OR 0.95, 95% CI: 0.57, 1.58), and took a similar time to respond (log rank 1.30, P =0.25). Conclusions: This study supports previous research that suggests that prenotification increases survey response rate: albeit a small absolute increase. No previous study has shown this to be so within the context of patients enrolled within an RCT. Trials that use newsletters to keep their participants informed of the study''s progress should use the newsletter as a prenotification device as this will increase overall response rates. [Copyright &y& Elsevier]

Abstract: Background: Nursing homes have an important role in the provision of care for dependent older people. Ensuring quality of care for residents in these settings is the subject of ongoing international debates. Poor quality care has been associated with inadequate nurse staffing and poor skills mix. Objectives: To review the evidence-base for the relationship between nursing home nurse staffing (proportion of RNs and support workers) and how this affects quality of care for nursing home residents and to explore methodological lessons for future international studies. Design: A systematic mapping review of the literature. Data sources: Published reports of studies of nurse staffing and quality in care homes. Review methods: Systematic search of OVID databases. A total of 13,411 references were identified. References were screened to meet inclusion criteria. 80 papers were subjected to full scrutiny and checked for additional references (n =3). Of the 83 papers, 50 were included. Paper selection and data extraction completed by one reviewer and checked by another. Content analysis was used to synthesise the findings to provide a systematic technique for categorising data and summarising findings. Results: A growing body of literature is examining the relationships between nurse staffing levels in nursing homes and quality of care provided to residents, but predominantly focuses on US nursing facilities. The studies present a wide range and varied mass of findings that use disparate methods for defining and measuring quality (42 measures of quality identified) and nurse staffing (52 ways of measuring staffing identified). Conclusions: A focus on numbers of nurses fails to address the influence of other staffing factors (e.g. turnover, agency staff use), training and experience of staff, and care organisation and management. ‘Quality’ is a difficult concept to capture directly and the measures used focus mainly on ‘clinical’ outcomes for residents. This systematic mapping review highlights important methodological lessons for future international studies and makes an important contribution to the evidence-base of a relationship between the nursing workforce and quality of care and resident outcomes in nursing home settings. [Copyright &y& Elsevier]

Background: Research suggests that food intolerance may be a precipitating factor for migraine like headaches.Aim: To evaluate the effectiveness of the ELISA (Enzyme Linked Immuno-Sorbent Assay) Test and subsequent dietary elimination advice for the prevention of migraine like headaches.Design: Randomised controlled trial.Setting: Community based volunteers in the UK.Participants: Volunteers who met the inclusion criteria for migraine like headaches and had one or more food intolerance were included in the study. Participants received either a true diet (n = 84) or a sham diet (n = 83) sheet. Participants were advised to remove the intolerant foods from their diet for 12 weeks.Main Outcome Measures: Number of headache days over a 12 week period (item A MIDAS questionnaire). Other measures includes the total MIDAS score and total HIT-6 score.Results: The results indicated a small decrease in the number of migraine like headaches over 12 weeks, although this difference was not statistically significant (IRR 1.15 95% CI 0.94 to 1.41, p = 0.18). At the 4 week assessment, use of the ELISA test with subsequent diet elimination advice significantly reduced the number of migraine like headaches (IRR 1.23 95%CI 1.01 to 1.50, p = 0.04). The disability and impact on daily life of migraines were not significantly different between the true and sham diet groups.Conclusions: Use of the ELISA test with subsequent diet elimination advice did not reduce the disability or impact on daily life of migraine like headaches or the number of migraine like headaches at 12 weeks but it did significantly reduce the number of migraine like headaches at 4 weeks. [ABSTRACT FROM AUTHOR]

Background: Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning.Methods/design: The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort), from which we will identify those eligible to participate in a trial of collaborative care for sub-threshold depression (the CASPER trial).We aim to undertake a pragmatic randomised controlled multi-centre trial evaluating the effectiveness and cost-effectiveness of collaborative care; a low intensity psychological intervention in addition to usual general practitioner care versus usual general practitioner care alone. General practitioners from practices based in the North of England will be asked to identify potentially eligible patients over the age of 75 years. Patients will be sent a letter inviting them to participate in the study.We aim to recruit approximately 540 participants for the CASPER trial. A diagnostic interview will be carried out to ascertain trial eligibility with the major depressive episode module of the Mini International Neuropsychiatric Interview (M.I.N.I.), eligible participants randomised to either the intervention or usual care. The primary outcome will be measured with the Patient Health Questionnaire-9 (PHQ-9) and additional quality of life measures will be collected. Data will be collected at baseline, 4 and 12 months for both trial and cohort participants.Trial Registration: ISRCTN: ISRCTN02202951. [ABSTRACT FROM AUTHOR]

Abstract: Background: Diagnosis of depression in offender populations is particularly difficult for health professions because of the many vulnerable complex problems associated with this population. As offender populations represent an ‘at risk population’, one feasible approach is the use of brief standardised mood assessments that can be either self-completed or completed by a non-specialist. Aims: To review the diagnostic accuracy of brief psychometric instruments to identify depression in offender populations. Method: The authors searched five electronic databases from inception to March 2009 and examined reference lists to identify the relevant literature. The authors included studies comparing the accuracy of any brief psychometric instrument to identify depression in offender populations with a standardised diagnostic interview conducted according to internationally recognised criteria. Two reviewers independently reviewed each article to assess inclusion, extract relevant study characteristics and data. Results: In total, thirteen studies met the inclusion criteria. Instruments validated in offender populations included both general depression questionnaires as well as specific measures that had been developed for use in offender populations. The most frequently validated instruments were the General Health Questionnaire (GHQ) and the Referral Decision Scale (RDS). Conclusions: A number of different tools were identified in the review which could perhaps serve as a benchmark for the identification of depression in offender populations. [ABSTRACT FROM AUTHOR]

Postnatal depression (PND) impacts on the mother and her partner, the family, mother-baby interaction and on the baby. This review synthesises the evidence from qualitative and quantitative research to determine whether screening for PND is acceptable to women and healthcare professionals. The research literature was systematically searched to retrieve articles available until February 2007. No language or geographical restrictions were applied. Studies were included if the acceptability of PND screening was assessed during the prenatal and postnatal period. Data were synthesised using the textual narrative approach. Fifteen of the 16 eligible studies focused on the acceptability of the Edinburgh Postnatal Depression Scale (EPDS). Screening for PND was generally found to be acceptable to women and healthcare professionals, although aspects of its administration were identified as being important. Specifically, a woman needs to feel comfortable about the screening process if she is to answer the questions honestly. This may be facilitated through forewarning and administration by a trusted person in her own home. Healthcare professionals need to be aware of differing cultural attitudes towards answering the questions, and the ambiguity of the question about self-harm. Further research into the acceptability of strategies other than EPDS is needed. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: A survey of randomized controlled trials found that almost a quarter of trials had more than 10% of responses missing for the primary outcome. There are a number of ways in which data could be missing: the subject is unable to provide it, or they withdraw, or become lost to follow-up. Such attrition means that balance in baseline characteristics for those randomized may not be maintained in the subsample who has outcome data. For individual trials, if the attrition is systematic and linked to outcome, then this will result in biased estimates of the overall effect. It then follows that if such trials are combined in a meta-analysis, it will result in a biased estimate of the overall effect and be misleading. The aim of this study was to investigate the impact of attrition on baseline imbalance within individual trials and across multiple trials. Study Design and Setting: In this article, we used individual patient data from a convenience sample of 10 trials evaluating interventions for the treatment of musculoskeletal disorders. Meta-analyses using the mean difference at baseline between the trial arms were carried out using individual patient data from these trials. The analyses were first carried out using all randomized participants and secondly only including participants with outcome data on the quality-of-life score. Meta-regression was carried out to evaluate whether the level of baseline imbalance was associated with the level of attrition. Results: The overall attrition rates for the quality-of-life score ranged between 4% and 28% of the total randomized patients. All trials showed some level of differential attrition between the treatment arms, ranging from 1% to 14%. Attrition within the control group ranged from 3% to 25% and within the intervention group, it ranged from 0% to 31%. For individual trials, there was no indication that attrition altered the results in favor of either the treatment or the control. Forest plots highlighted that the attrition had some impact on the baseline imbalance for the primary outcome score as more heterogeneity was introduced (I-squared value of 0.4% for the initial data set vs. I-squared value of 16.9% for the analyzed data set). However, the standardized mean difference increased only slightly (from 0.01 to 0.03 with 95% confidence interval [CI]: −0.05, 0.10). Meta-regression showed little or no evidence of a significant dose–response relationship between the level of attrition and the baseline imbalance (coefficient 0.73, 95% CI: −0.81, 2.28). Conclusion: Although, in theory, attrition can introduce selection bias in randomized trials, we did not find sufficient evidence to support this claim in our convenience sample of trials. However, the number of trials included was relatively small, which may have led to small but important differences in outcomes being missed. In addition, only 2 of 10 trials included had attrition levels greater than 15% suggesting a low level of potential bias. Meta-analyses and systematic reviews should always consider the impact of attrition on baseline imbalances and where possible any baseline imbalances in the analyzed data set and their impact on the outcomes reported. [Copyright &y& Elsevier]

Objectives. To investigate which methods to identify post-natal depression are the most extensively validated, in what setting and in what language. Methods. A systematic search of the literature was undertaken to retrieve English and non-English language articles available until February 2007. This included searching 16 electronic databases, forward citation searching, personal communication with authors and inspection of reference lists. Results. A total of 60 studies (published in 64 articles) met the inclusion criteria. Four PND specific measures and nine generic depression (and sometimes anxiety) measures were found to have been validated against a diagnostic reference standard in pregnant or post-natal populations. The Edinburgh Post-natal Depression Scale (EPDS) was the most frequently validated method to identify women with PND. The EPDS has been translated and validated in 20 different languages. The majority of studies were undertaken at ante-natal clinics ( n=15), after the birth in post-natal wards ( n=12) or during post-natal visits or follow-up clinics ( n=16). Conclusions. The EPDS is the most frequently researched method to identify PND and has been translated and validated in multiple different languages. [ABSTRACT FROM AUTHOR]

There has been an increase in the number of systematic reviews of diagnostic tests, which has resulted in the introduction of two checklists: statement for reporting of diagnostic accuracy (STARD) and quality assessment of diagnostic accuracy studies (QUADAS). To examine the validity and usefulness of QUADAS when applied to diagnostic accuracy studies using psychometric instruments and to examine the quality in reporting of these studies during practical application of the checklist. Two reviewers independently rated the quality of 54 studies using QUADAS. The proportion of agreement was used to assess overall agreement and individual agreement of QUADAS items between reviewers. The overall agreement between the two reviewers for all QUADAS items combined was 85.7%. The proportion of agreement between reviewers for each item ranged from just over 57–100% and was over 80% for 8 of the items. The poorest agreement was associated with the items for selection criteria, indeterminate results and withdrawals. None of the studies adequately reported all relevant information to enable all QUADAS item to be scored as ‘yes’. Overall QUADAS was relatively easy to use and appears to be an acceptable tool for appraising the quality of diagnostic accuracy studies using psychometric instruments. The application of QUADAS was hampered by the poor quality of reporting encountered. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To elicit researchers'' experiences and knowledge of how the randomization process can be undermined. Study Design and Setting: Web-based survey conducted in February 2006 using a convenience sample of individuals who are, or have been, involved in some aspect of randomized controlled trials. Results: Thirty responses were received that described incidences of manipulation. Seven reasons were identified for manipulation: interest of participants, demonstrating treatment efficacy, treatment preference, lack of knowledge, pressure from participants, pressure from trial workers, and practical or technical concerns. In many cases when manipulation was discovered, it was rarely mentioned in the trial publication. Twenty-three responses that described technical errors were received. Technical errors were reported for both the generation and implementation stages of the randomization process. Conclusions: This study provides further evidence on trial subversion and highlighted that the potential for technical errors can be reduced, and in most cases eliminated, if certain guidelines are followed. Recommendations are as follows: use simple randomization where possible, use third party allocation, test computer randomization programs prior to participant recruitment and ensure that individuals are aware of the procedures needed to be performed if the treatment allocations cannot be accessed using the intended methods. [Copyright &y& Elsevier]

Abstract: Objective: To investigate the trade off between performing an individual randomized trial with a Complier Average Causal Effect analysis and accepting the fact that there will be some contamination, with a cluster randomized trial and the subsequent effect on the sample size and power of the trial. Study Design and Setting: Monte Carlo simulations were undertaken to generate trial data where there was some contamination of control participants. The trials were simulated so the null hypothesis was false. Assessments were made of whether a type II error had been committed (i.e., whether the false null had not been rejected). Results: As contamination increases, the power of the study to detect a true difference between the two groups declines. Using a Complier Average Causal Effect approach, unless anticipated contamination exceeds 30%, retains a sample size advantage over the cluster randomized design despite a relatively small cluster (i.e., 10) and reasonably small ICC (i.e., 0.04). Conclusion: If contamination can be measured precisely or estimated then in some circumstances individual allocation has an advantage over cluster randomization in statistical efficiency. [Copyright &y& Elsevier]

Background: Bisphosphonate-related osteonecrosis of the jaws (BRONJ) presents the clinician with significant management dilemmas. The purpose of this study was to distil information related to this disorder by comprehensively reviewing the literature. Methods: The structure and function of bisphosphonates, and their role in the development of BRONJ will be discussed, as will the possible mechanisms through which this pathology develops. A review of cases presented in the literature will be undertaken, and suggestions offered as to the management of this pathology in terms of surgical and conservative approaches. Results: Presentation of BRONJ is currently more common in patients taking intravenous forms of bisphosphonates, but there is a fear that the long-term cumulative effects of oral bisphosphonates may see BRONJ increasingly occurring in this patient group. Conclusions: Prevention is superior to treatment, and the establishment of meticulous oral hygiene and pre-emptive surgical treatment prior to commencement of bisphosphonate therapy is recommended. [ABSTRACT FROM AUTHOR]

When randomised controlled trials show a difference that is not statistically significant there is a risk of interpretive bias.1 Interpretive bias occurs when authors and readers overemphasise or underemphasise results. For example, authors may claim that the non-significant result is due to lack of power rather than lack of effect, using terms such as borderline significance or stating that no firm conclusions can be drawn because of the modest sample size. In contrast, if the study shows a non-significant effect that opposes the study hypothesis, it may be downplayed by emphasising the results are not statistically significant. We investigated the problem of interpretive bias in a sample of recently published trials with findings that did not support the study hypothesis. [ABSTRACT FROM AUTHOR]

This article discusses restrictions during randomization, which makes it easier to predict the next allocation. Problems with simple randomization are discussed in the article although some researchers believe that it is a safer method with less chance for technical errors as with restricted randomization. The article reviews sample randomized trials, published by major medical journals, to find that fewer than 10% of the journals use simple randomization.

BACKGROUND Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited. METHODS We performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEI\4 range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points. RESULTS A total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at lyear was 17.8 among the 284 patients with available data the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95°/o confidence interval ICI], 3.l to 8.8; one-sided P=0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7. 2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1° of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively. CONCLUSIONS Collagenase injection was not noninferior to limited fasciectomy with respect the score on the PEM at 1 year after treatment. [ABSTRACT FROM AUTHOR]

In this randomized, double-blind, placebo-controlled trial, 207 participants with knee osteoarthritis with inadequate response to current medications were randomly assigned to receive methotrexate or placebo. Average knee pain at 6 months measured using a numerical rating scale decreased from 6.4 to 5.1 in the methotrexate group versus 6.8 to 6.2 in the placebo group. Findings suggest that oral methotrexate added to usual medications can reduce knee pain in patients with osteoarthritis. Visual Abstract. Pain Reduction With Oral Methotrexate in Knee Osteoarthritis: In this randomized, double-blind, placebo-controlled trial, 207 participants with knee osteoarthritis with inadequate response to current medications were randomly assigned to receive methotrexate or placebo. Average knee pain at 6 months measured using a numerical rating scale decreased from 6.4 to 5.1 in the methotrexate group versus 6.8 to 6.2 in the placebo group. Findings suggest that oral methotrexate added to usual medications can reduce knee pain in patients with osteoarthritis. Background: Treatments for osteoarthritis (OA) are limited. Previous small studies suggest that the antirheumatic drug methotrexate may be a potential treatment for OA pain. Objective: To assess symptomatic benefits of methotrexate in knee OA (KOA). Design: A multicenter, randomized, double-blind, placebo-controlled trial done between 13 June 2014 and 13 October 2017. (ISRCTN77854383; EudraCT: 2013-001689-41) Setting: 15 secondary care musculoskeletal clinics in the United Kingdom. Participants: A total of 207 participants with symptomatic, radiographic KOA and knee pain (severity ≥4 out of 10) on most days in the past 3 months with inadequate response to current medication were approached for inclusion. Intervention: Participants were randomly assigned 1:1 to oral methotrexate once weekly (6-week escalation 10 to 25 mg) or matched placebo over 12 months and continued usual analgesia. Measurements: The primary end point was average knee pain (numerical rating scale [NRS] 0 to 10) at 6 months, with 12-month follow-up to assess longer-term response. Secondary end points included knee stiffness and function outcomes and adverse events (AEs). Results: A total of 155 participants (64% women; mean age, 60.9 years; 50% Kellgren–Lawrence grade 3 to 4) were randomly assigned to methotrexate (n  = 77) or placebo (n  = 78). Follow-up was 86% (n  = 134; methotrexate: 66, placebo: 68) at 6 months. Mean knee pain decreased from 6.4 (SD, 1.80) at baseline to 5.1 (SD, 2.32) at 6 months in the methotrexate group and from 6.8 (SD, 1.62) to 6.2 (SD, 2.30) in the placebo group. The primary intention-to-treat analysis showed a statistically significant pain reduction of 0.79 NRS points in favor of methotrexate (95% CI, 0.08 to 1.51; P  = 0.030). There were also statistically significant treatment group differences in favor of methotrexate at 6 months for Western Ontario and McMaster Universities Osteoarthritis Index stiffness (0.60 points [CI, 0.01 to 1.18]; P  = 0.045) and function (5.01 points [CI, 1.29 to 8.74]; P  = 0.008). Treatment adherence analysis supported a dose-response effect. Four unrelated serious AEs were reported (methotrexate: 2, placebo: 2). Limitation: Not permitting oral methotrexate to be changed to subcutaneous delivery for intolerance. Conclusion: Oral methotrexate added to usual medications demonstrated statistically significant reduction in KOA pain, stiffness, and function at 6 months. Primary Funding Source: Versus Arthritis. [ABSTRACT FROM AUTHOR]

Objectives: This multicentre, assessor‐blinded, two‐arm cluster randomized trial evaluated the clinical and cost‐effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools. Methods: Pupils aged 11–13 years with their own mobile telephone attending secondary schools with above average free school meals eligibility were randomized (at year‐group level) to receive a lesson and twice‐daily text messages or to usual care. Year‐groups (n = 84) from 42 schools including 4680 pupils (intervention, n = 2262; control, n = 2418) were randomized. Results: In 2383 participants with valid data at baseline and 2.5 years, the primary outcome of presence of at least one treated or untreated carious lesion (D4‐6 MFT [Decayed, Missing and Filled Teeth] in permanent teeth using International Caries Detection and Assessment System) was 44.6% in the intervention group and 43.0% in control (odds ratio [OR] 1.04, 95% CI 0.85–1.26, p =.72). There were no statistically significant differences in secondary outcomes of presence of at least one treated or untreated carious lesion (D1‐6 MFT), number of D4‐6 MFT and D1‐6 MFT, plaque and bleeding scores or health‐related‐ (Child Health Utility 9D) or oral health‐related‐ quality of life (CARIES‐QC). However, twice‐daily toothbrushing, reported by 77.6% of pupils at baseline, increased at 6 months (intervention, 86.9%; control, 83.0%; OR 1.30, 95% CI 1.03–1.63, p =.03), but returned to no difference at 2.5 years (intervention, 81.0%; control, 79.9%; OR 1.05, 95% CI 0.84–1.30, p =.69). Estimated incremental costs and quality‐adjusted life‐years (QALYs) of the intervention, relative to control, were £1.02 (95% CI −1.29 to 3.23) and −0.003 (95% CI −0.009 to 0.002), respectively, with a 7% chance of being cost‐effective (£20 000/QALY gained threshold). Conclusion: There was no evidence of statistically significant difference for caries prevalence at 2.5‐years. The intervention's positive 6‐month toothbrushing behaviour change did not translate into caries reduction. (ISRCTN 12139369). COVID‐19 pandemic adversly affected follow‐up. [ABSTRACT FROM AUTHOR]

Background: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior.Methods: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials.Discussion: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates.Trial Registration: ISRCTN 15373349 . Registered before recruitment on 03 December 2014 prior to first recruit. [ABSTRACT FROM AUTHOR]

Aim: To assess the risks, benefits, and resource implications of home‐blended food for children with gastrostomy tubes compared with a formula diet. Method: This prospective cohort study of children (aged 0–18 years) collected baseline data on gastrointestinal symptoms, nutritional intake, anthropometric outcomes, parent and child quality of life, and resource use. A propensity score‐weighted generalized linear mixed model was used to compare children receiving a home‐blended versus formula diet. Results: Baseline data were obtained for 180 children (2019–2021; 107 males, 73 females; mean age 9 years 7 months [SD 4 years 5 months]). Children receiving a home‐blended diet (n = 104) had similar diagnoses and age but more lived in areas of lower deprivation and parental education was higher compared to the parents of children receiving a formula diet (n = 76). Children receiving home‐blended diets had significantly better gastrointestinal scores than those receiving formula diets (B = 13.8, p < 0.001). The number of gut infections and tube blockages were similar between the two groups but with fewer stoma site infections in the group receiving home‐blended food. Children receiving a home‐blended diet had more fibre in their diet compared to children receiving a formula diet. Interpretation: Home‐blended diets should be seen as a safe option for children who are gastrostomy‐fed unless clinically contraindicated. Equality of access to home‐blended diets for children with gastrostomy should be assessed by local clinical teams. What this paper adds: Children with gastrostomy receiving a home‐blended diet had fewer gastrointestinal symptoms compared to children receiving a formula diet.Children with gastrostomy receiving a home‐blended diet had no more complications than children receiving a formula diet. What this paper adds: Children with gastrostomy receiving a home‐blended diet had fewer gastrointestinal symptoms compared to children receiving a formula diet.Children with gastrostomy receiving a home‐blended diet had no more complications than children receiving a formula diet. [ABSTRACT FROM AUTHOR]

Introduction: In line with national guidance, mental health Trusts in England are implementing complete smoke-free policies. We investigated inpatients' changes in smoking behavior, tobacco dependence, vaping, and motivation to stop smoking between pre-admission and post-discharge.Methods: We surveyed acute adult mental health inpatients from 14 wards in three mental health Trusts in England in 2019. Structured face-to-face and telephone interviews with patients who smoked on or during admission were conducted during the admission period and at one week and one month after discharge. Data on smoking status; daily cigarette consumption; Heaviness of Smoking Index (HSI); Strength of Urges to Smoke (SUTS); Motivation to Stop Smoking (MTSS) and vaping were collected and analyzed using regression and probit models.Results: Inpatient smoking prevalence was 51.9%, and a total of 152 of all 555 eligible smokers (27%) were recruited. Attrition was high: 49.3% at the first and 50.7% at the second follow-up interview. Changes in self-reported smoking status, motivation to quit, and vaping did not change significantly over the study period. Cigarette consumption (p < 0.001) and Heaviness of Smoking Index (p < 0.001) modestly reduced. The frequency and strength of urges to smoke (p = 0.011 and 0.012, respectively) decreased modestly after discharge but were scored as high by 57% and 60% of participants during admission respectively. Just over half (56%) reported being offered smoking cessation support on admission.Conclusions: This study identified very modest changes in smoking-related outcomes during and after admission and indicates major challenges to smoke-free policy implementation, including limited support for patients who smoke.Implications: Despite mental health Trusts in England had developed and implemented smoke-free policies to meet national guidelines, adherence to these policies and provision of effective smoking cessation and temporary abstinence support for inpatients admitted to acute adult mental health wards appear to be limited. Patients who smoke on admission are likely to continue to do so during admission and after discharge, and only a very modest change in smoking behaviors appears to take place. Important opportunities to promote smoking cessation in this population are missed. Barriers to effective support need to be identified and addressed. [ABSTRACT FROM AUTHOR]

Background: Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.Methods: We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.Findings: Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.Interpretation: This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.Funding: National Institute for Health Research. [ABSTRACT FROM AUTHOR]

Objectives: Evidence suggests that maternal psychological distress is an under-diagnosed condition that can have lasting impacts on child outcomes. Models based solely on maternal outcomes have not found screening to be cost-effective. This research explores the effects of self-reported maternal psychological distress on children's language and behavioural development up to the age of 7. Methods: Using longitudinal survey data from 10,893 families in the UK Millennium Cohort Study, multilevel models are used to explore the differential effects of maternal diagnosed and treated depression versus untreated maternal psychological distress during the postnatal year on longer-term child outcomes. Results: Both diagnosed and treated depression and self-reported maternal psychological distress have detrimental effects on child behavioural development. Behavioural outcomes up to age 5 were better for children of women who received treatment for depression, compared with children those whose mothers' psychological distress was untreated, but this was not maintained to age 7. Little or no evidence of a difference was found between maternal psychological distress and child language development. Conclusions for Practice: This research highlights the lack of effectiveness of existing treatment for maternal psychological distress both to benefit child development and to provide long-term symptom remediation for women. Future research could aim to identify more effective treatments for both women and children. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Using Dietetic Assistants to Improve the Outcome of Hip Fracture: A Randomised Controlled Trial of Nutritional Support in an Acute Trauma Ward," by D. Duncan et al in a 2006 issue.

The article discusses non-compliance in the design and conduct of randomized controlled trials (RCTs). Noncompliance can cause problems at the analysis stage. The ideas behind choosing complier average causal effect (CACE) to analyze trials involving noncompliance is presented. The only disadvantage of CACE approach is that it can produce wider confidence intervals than the ITT and per-protocol analyzes. The ITT is suggested as primary and the CACE as a secondary approach to analysis.

Presents a review of the prevalence of adequate allocation concealment and its association with the statistical significance of trial results. Way that the effect of adequacy of allocation concealment in randomised controlled trials may influence the degree of effect; Assertion that almost a fifth of trials recently published in major medical journals used inadequate concealment and a quarter failed to describe how the allocation was concealed.

Background: About a third of women receiving pethidine for labour pain subsequently require an epidural, which provides effective pain relief but increases the risk of instrumental vaginal delivery. Remifentanil patient-controlled analgesia (PCA) in labour is an alternative to pethidine, but is not widely used. We aimed to evaluate epidural analgesia progression among women using remifentanil PCA compared with pethidine.Methods: We did an open-label, multicentre, randomised controlled trial in 14 UK maternity units. We included women aged 16 years or older, beyond 37 weeks' gestation, in labour with a singleton cephalic presentation, and who requested opioid pain relief. We randomly assigned eligible participants (1:1) to either the intravenous remifentanil PCA group (40 μg bolus on demand with a 2 min lockout) or the intramuscular pethidine group (100 mg every 4 h, up to 400 mg in 24 h), using a web-based or telephone randomisation service with a minimisation algorithm for parity, maternal age, ethnicity, and mode of labour onset. Because of the differences in routes of drug administration, study participants and health-care providers were not masked to the group allocation. The primary outcome was the proportion of women who received epidural analgesia after enrolment for pain relief in labour. Primary analyses were unadjusted and analysed by the intention-to-treat principle. This study is registered with the ISRCTN registry, number ISRCTN29654603.Findings: Between May 13, 2014, and Sept 2, 2016, 201 women were randomly assigned to the remifentanil PCA group and 200 to the pethidine group. One participant in the pethidine group withdrew consent, leaving 199 for analyses. The proportions of epidural conversion were 19% (39 of 201) in the remifentanil PCA group and 41% (81 of 199) in the pethidine group (risk ratio 0·48, 95% CI 0·34-0·66; p<0·0001). There were no serious adverse events or drug reactions directly attributable to either analgesic during the study.Interpretation: Intravenous remifentanil PCA halved the proportion of epidural conversions compared with intramuscular pethidine. This finding challenges routine pethidine use as standard of care in labour.Funding: National Institute for Health Research Clinician Scientist Award. [ABSTRACT FROM AUTHOR]

Background: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures.Objective: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial.Methods: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517).Primary Outcome: incidence of falls per participant in the 12 months following randomisation.Secondary Outcomes: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation.Results: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73-1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP -69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses.Conclusion: The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK. [ABSTRACT FROM AUTHOR]

Background: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. Methods: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. Discussion: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. Trial registration: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020. [ABSTRACT FROM AUTHOR]

Introduction: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. Methods: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation. Results: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries. Conclusions: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums. Trial registration: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/. [ABSTRACT FROM AUTHOR]

Approximately 1.5 million referrals are made to Improving Access to Psychological Therapy (IAPT) services annually. However, treatment is received in less than half of cases due to ineligibility or non-attendance. The aim was to explore risk factors for non-attendance at the initial two IAPT appointments following referral. An exploratory, retrospective analysis of referral and attendance data from five IAPT services in the North of England. Participants were 97,020 referrals received 2010–2014. Main outcome was attendance at the first two offered appointments (assessment and initial treatment). Based on data from two services, 66% of referrals resulted in assessment attendance. Across all five services 57% of patients who attended for assessment subsequently attended the first treatment appointment. The odds of attending an assessment appointment were more than 3 times higher for self-referrals than for GP referrals (OR 3.46, 95% CI 3.27–3.66, p < 0.001). Factors important to treatment appointment attendance following assessment were the service, referral source, presenting problem, and anxiety severity. Initial appointment non-attendance is a consistent problem for IAPT services. Specific factors that may support IAPT services to improve non-attendance rates are identified. IAPT indicators of success should take account of non-attendance at initial appointments. [ABSTRACT FROM AUTHOR]

Objective: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. Methods: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18–80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. Results: Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. Conclusion: Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. Trial registration: ISRCTN80441309 (prospectively registered on 24/01/2019). [ABSTRACT FROM AUTHOR]

Background: Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF. Methods: Adults over 65 years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24 months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms. Discussion: The PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-reviewed journal. Trial registration: ISRCTN76296703. Prospectively registered on 5th April 2018 [ABSTRACT FROM AUTHOR]

During the coronavirus 2019 (COVID-19) pandemic, the implementation of non-contact infrared thermometry (NCIT) became an increasingly popular method of screening body temperature. However, data on the accuracy of these devices and the standardisation of their use are limited. In the current study, the body temperature of non-febrile volunteers was measured using infrared (IR) thermography, IR tympanic ther- mometry and IR gun thermometry at different facial feature locations and distances and compared with SpotOn core-body temperature. Poor agreement was found between all IR devices and SpotOn measurements (intra-class correlation coefficient <0.8). Bland--Alman analysis showed the narrowest limits of agreement with the IR gun at 3 cm from the forehead (bias = 0.19°C, limits of agreement (LOA): --0.58°C to 0.97°C) and widest with the IR gun at the nose (bias = 1.40°C, LOA: --1.15°C to 3.94°C). Thus, our findings challenge the established use of IR thermometry devices within hospital settings without adequate standard operating procedures to reduce operator error. [ABSTRACT FROM AUTHOR]

Background: Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients' ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods: A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. Discussion: The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. Trial registration: International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019 [ABSTRACT FROM AUTHOR]

People with severe mental illness (SMI) have reduced life expectancy compared with the general population, which can be explained partly by their increased risk of diabetes. We conducted a meta-analysis to determine the clinical effectiveness of pharmacological and non-pharmacological interventions for improving glycaemic control in people with SMI (PROSPERO registration: CRD42015015558). A systematic literature search was performed on 30/10/2015 to identify randomised controlled trials (RCTs) in adults with SMI, with or without a diagnosis of diabetes that measured fasting blood glucose or glycated haemoglobin (HbA1c). Screening and data extraction were carried out independently by two reviewers. We used random effects meta-analysis to estimate effectiveness, and subgroup analysis and univariate meta-regression to explore heterogeneity. The Cochrane Collaboration’s tool was used to assess risk of bias. We found 54 eligible RCTs in 4,392 adults (40 pharmacological, 13 behavioural, one mixed intervention). Data for meta-analysis were available from 48 RCTs (n = 4052). Both pharmacological (mean difference (MD), -0.11mmol/L; 95% confidence interval (CI), [-0.19, -0.02], p = 0.02, n = 2536) and behavioural interventions (MD, -0.28mmol//L; 95% CI, [-0.43, -0.12], p<0.001, n = 956) were effective in lowering fasting glucose, but not HbA1c (pharmacological MD, -0.03%; 95% CI, [-0.12, 0.06], p = 0.52, n = 1515; behavioural MD, 0.18%; 95% CI, [-0.07, 0.42], p = 0.16, n = 140) compared with usual care or placebo. In subgroup analysis of pharmacological interventions, metformin and antipsychotic switching strategies improved HbA1c. Behavioural interventions of longer duration and those including repeated physical activity had greater effects on fasting glucose than those without these characteristics. Baseline levels of fasting glucose explained some of the heterogeneity in behavioural interventions but not in pharmacological interventions. Although the strength of the evidence is limited by inadequate trial design and reporting and significant heterogeneity, there is some evidence that behavioural interventions, antipsychotic switching, and metformin can lead to clinically important improvements in glycaemic measurements in adults with SMI. [ABSTRACT FROM AUTHOR]