Observational study to estimate the proportion of surgical site infection following excision of ulcerated skin tumours (OASIS study).

BACKGROUND: Ulceration is a recognized risk factor for surgical site infection (SSI); however, the proportion of patients developing SSI after excision of an ulcerated skin cancer is unknown. AIM: To determine the proportion of participants with SSI after surgical excision of an ulcerated skin cancer. A secondary aim was to assess feasibility outcomes to inform the design of a randomized controlled trial to investigate the benefits and harms of perioperative antibiotics following excision of ulcerated tumours. METHODS: This was a multicentre, prospective, observational study of patients undergoing excision of an ulcerated skin cancer between March 2019 and March 2020. Prior to surgical excision, surface swabs of the ulcerated tumours of participants recruited from one centre were undertaken to determine organism growth. At 4 weeks after surgery, all participants were e-mailed or posted the Wound Healing Questionnaire (WHQ) to determine whether they had developed SSI. RESULTS: In total, 148 participants were recruited 105 (70.9%) males; mean ± SD age 77.1 ± 12.3 years. Primary outcome data were available for 116 (78.4%) participants, of whom 35 (30.2%) were identified as having an SSI using the WHQ with a cutoff score of 8, and 47 (40.5%) were identified with a cutoff score of 6. Using the modified WHQ in participants with wounds left to heal by secondary intention, 33 (28.4%) and 43 (37.1%) were identified to have SSI respectively. CONCLUSION: This prospective evaluation of SSI identified with the WHQ following excision of ulcerated skin cancers demonstrated a high proportion with SSI. The WHQ was acceptable to patients; however, further evaluation is required to ensure validity in assessing skin wounds.

Evaluation of the effectiveness of the Family Nurse Partnership home visiting programme in first time young mothers in Scotland: a protocol for a natural experiment.

INTRODUCTION: Individual, social and economic circumstances faced by young mothers (19 years or under) can challenge a successful start in life for their children. Intervening early might enhance life chances for both mother and child. The Family Nurse Partnership (FNP) is an intensive nurse-led home visiting programme developed in the US which aims to improve prenatal health behaviours, birth outcomes, child development and health outcomes, and maternal life course. Establishing evidence of effectiveness beyond the original US setting is important to understand where further adaptation is required within a country specific context. OBJECTIVE: This study will form one strand of the Scottish Government's plan to evaluate the effectiveness of FNP as compared to usual care for mothers and their children in Scotland and will focus only on outcomes that can be identified using routine administrative data systems. METHODS: This study is a natural experiment with a case-cohort design using linked anonymised routine health, educational and social care data. Cases will be women enrolled as FNP Clients in ten NHS Health Boards in Scotland and Controls will be women who met FNP eligibility criteria but were pregnant at a time when the programme was not recruiting. Outcomes are mapped to the Scottish FNP logic model. All comparative analyses will be pre-specified, conducted on an intention to treat basis and will use multilevel regression models to compare outcomes between groups. DISCUSSION: The study protocol is based upon the specification of FNP commissioned by the Scottish Government. This study design is novel for the evaluation of the FNP/NFP programmes which are primarily evaluated with an RCT. Outcomes included within the study have been selected on the basis that they are outcomes FNP aims to influence and where there is routine data available to assess the outcome.

Population-based Clinical Practice Research Datalink study using algorithm modelling to identify the true burden of hidradenitis suppurativa.

BACKGROUND: Epidemiology data regarding hidradenitis suppurativa (HS) are conflicting and prevalence estimates vary 80-fold, from 0·05% in a population-based study to 4%. OBJECTIVES: To assess the hypothesis that previous population-based studies underestimated true HS prevalence by missing undiagnosed cases. METHODS: We performed a population-based observational and case-control study using the U.K. Clinical Practice Research Datalink (CPRD) linked to hospital episode statistics data. Physician-diagnosed cases in the CPRD were identified from specific Read codes. Algorithms identified unrecognized 'proxy' cases, with at least five Read code records for boils in flexural skin sites. Validation of proxy cases was undertaken with general practitioner (GP) questionnaires to confirm criteria-diagnosed cases. A case-control study assessed disease associations. RESULTS: On 30 June 2013, 23 353 physician-diagnosed HS cases were documented in 4 364 308 research-standard records. In total, 68 890 proxy cases were identified, reduced to 10 146 criteria-diagnosed cases after validation, extrapolated from 107 completed questionnaires (61% return rate). Overall point prevalence was 0·77% [95% confidence interval (CI) 0·76-0·78%]. An additional 18 417 cases had a history of one to four flexural skin boils. In physician-diagnosed cases, odds ratios (ORs) for current smoker and obesity (body mass index > 30 kg m-2 ) were 3·61 (95% CI 3·44-3·79) and 3·29 (95% CI 3·14-3·45). HS was associated with type 2 diabetes, Crohn disease, hyperlipidaemia, acne and depression, and not associated with ulcerative colitis or polycystic ovary syndrome. CONCLUSIONS: Contrary to results of previous population-based studies, HS is relatively common, with a U.K. prevalence of 0·77%, one-third being unrecognized, criteria-diagnosed cases using the most stringent disease definition. If individuals with probable cases are included, HS prevalence rises to 1·19%.

Levels of wound calprotectin and other inflammatory biomarkers aid in deciding which patients with a diabetic foot ulcer need antibiotic therapy (INDUCE study).

AIMS: Deciding if a diabetic foot ulcer is infected in a community setting is challenging without validated point-of-care tests. Four inflammatory biomarkers were investigated to develop a composite algorithm for mildly infected diabetic foot ulcers: venous white cell count, C-reactive protein (CRP) and procalcitonin, and a novel wound exudate calprotectin assay. Calprotectin is a marker of neutrophilic inflammation. METHODS: In a prospective study, people with uninfected or mildly infected diabetic foot ulcers who had not received oral antibiotics in the preceding 2 weeks were recruited from community podiatry clinics for measurement of inflammatory biomarkers. Antibiotic prescribing decisions were based on clinicians' baseline assessments and participants were reviewed 1 week later; ulcer infection was defined by clinicians' overall impression from their two assessments. RESULTS: Some 363 potential participants were screened, of whom 67 were recruited, 29 with mildly infected diabetic foot ulcers and 38 with no infection. One participant withdrew early in each group. Ulcer area was 1.32 cm2 [interquartile range (IQR) 0.32-3.61 cm2 ] in infected ulcers and 0.22 cm2 (IQR 0.09-1.46 cm2 ) in uninfected ulcers. Baseline CRP for mild infection was 9.00 mg/ml and 6.00 mg/ml for uninfected ulcers; most procalcitonin levels were undetectable. Median calprotectin level in infected diabetic foot ulcers was 1437 ng/ml and 879 ng/ml in uninfected diabetic foot ulcers. Area under the receiver operating characteristic curve for a composite algorithm incorporating calprotectin, CRP, white cell count and ulcer area was 0.68 (95% confidence intervals 0.52-0.82), sensitivity 0.64, specificity 0.81. CONCLUSIONS: A composite algorithm including CRP, calprotectin, white cell count and ulcer area may help to distinguish uninfected from mildly infected diabetic foot ulcers. Venous procalcitonin is unhelpful for mild diabetic foot ulcer infection.

Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size. METHODS: Women with PPH 1000-1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused. RESULTS: Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3-1.7), P =0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th-75th centile) of 1 (0-4.5) unit of allogeneic blood products and had an additional 300 (100-350) ml blood loss whereas those who received placebo also received 3 (0-6) units of allogeneic blood products and had 700 (200-1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group. CONCLUSIONS: Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre -1 , but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis. TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

Viscoelastometry guided fresh frozen plasma infusion for postpartum haemorrhage: OBS2, an observational study.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. Based on data from trauma studies, empirical infusions of fresh frozen plasma (FFP) are often given during severe PPH if coagulation tests are unavailable. This study observed a cohort of women with moderate/severe PPH in whom FFP infusion was guided by the use of viscoelastometric point-of-care testing (VE-POCT) and clinical assessment. METHODS: Women were enrolled into this observational study when blood loss was measured or suspected to be about 1000 mL. If Fibtem A5 determined by Rotem ® thromboelastometry remained >15 mm, or bleeding stopped, FFP was withheld. If Fibtem A5 was ≤15 mm and bleeding ongoing, women were randomized into an interventional study as previously reported. Clinical and laboratory outcomes were recorded. RESULTS: The study recruited 605 women and 98% had FFP withheld. The median (25 th -75 th centile) total blood loss was 1500 (1300-2000) mL with 300 (50-545) mL occurring after enrolment. Total blood loss was >2500 mL in 40/605 (6.6%) women. RBCs were transfused in 141/605 (23.3%) patients and 11 (1.8%) received ≥4 units. At least one invasive procedure was performed in 283/605 (46.8%) women. Level 3 care was required for 10/605 (1.7%) women. No women developed clinically significant haemostatic impairment. CONCLUSIONS: Restrictive use of FFP guided by clinical assessment of bleeding and VE-POCT is feasible and did not result in clinically significant haemostatic impairment. Studies should compare the clinical and cost effectiveness of empirical FFP infusions, according to current guidelines, with targeted use of FFP based on VE-POCT. CLINICAL TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 ) (accessed July 24, 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search?query=2011-005511-11 ) (accessed July 24, 2017).

A change in the trend in dosulepin usage following the introduction of a prescribing indicator but not after two national safety warnings.

WHAT IS KNOWN AND OBJECTIVE: The tricyclic antidepressant dosulepin has been associated with an increased risk of toxicity in overdose compared with other antidepressants. In the UK, the MHRA and NICE have issued advice on the prescribing of dosulepin, and a National Prescribing Indicator (NPI) to monitor usage was introduced in Wales in 2011. The aim of this study was to assess whether trends in dosulepin usage in Wales and NE England changed following the two pieces of safety guidance and the introduction of the National Prescribing Indicator in Wales. METHODS: Primary care dosulepin usage in the 12 months prior to and following MHRA safety advice (in 2007), NICE guideline CG90 (in 2009) and the introduction of the NPI (in 2011) was obtained. Usage was measured using defined daily doses (DDDs) per 1000 prescribing units (PUs). The trends in the 12 months prior to and following the introduction of prescribing advice and the NPI were compared using an autoregressive integrated moving average (ARIMA) model. RESULTS AND DISCUSSION: In Wales, the trend in dosulepin usage did not change significantly prior to and following the MHRA advice: -0·18 and -0·43 DDDs/1000PUs per month, respectively (P = 0·07), or prior to and following NICE CG90: -0·30 and -0·49 DDDs/1000PUs per month, respectively (P = 0·35). In the 12 months prior to and following the introduction of the NPI, the trend was -0·45 and -0·98 DDDs/1000PUs per month, respectively (P = 0·001). In NE England, the trend did not alter significantly following the NICE advice or the introduction of the NPI in Wales. WHAT IS NEW AND CONCLUSION: The trend in dosulepin usage in Wales altered significantly following the introduction of the NPI, but not after the other prescribing advice. This association, coupled with the absence of a significant change in NE England over the same period, provided some evidence of the effectiveness of the NPI in prompting a change in prescribing behaviour in Wales.

Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: an updated Cochrane Review of randomized controlled trials.

AIMS: To give an updated perspective of interventions from additional data collected since our first review, conducted in 2008. BACKGROUND: This updated Cochrane Review incorporates new information from recent randomized controlled trials on culturally appropriate diabetes health education interventions. METHODS: An electronic literature search of six databases was repeated, with databases of ongoing trials checked and three journals hand-searched. Meta-analysis was carried out for sufficiently homogeneous outcomes, and common themes among trials were highlighted. RESULTS: A total of 22 new trials were added to the original 11. Meta-analysis of 28 trials containing suitable data showed significant improvements in glycaemic control (HbA1c ) and diabetes knowledge over a period of 24 months, after the delivery of culturally appropriate education to participants, compared with those receiving 'conventional' care. There were no consistent benefits over the control group in other selected outcome measures, and lack of data continued to make analysis of several outcome measures difficult. CONCLUSIONS: Research activity in this field has increased considerably over the past 6 years, with culturally appropriate diabetes education showing consistent benefits over conventional care in terms of glycaemic control and diabetes knowledge, sustained in the short- to mid-term. Further research is needed to determine the clinical significance of these improvements and their cost-effectiveness.

The evolution of worry after breast cancer risk assessment: 6-year follow-up of the TRACE study cohort.

OBJECTIVES: There is little evidence regarding the long-term psychological implications of breast cancer risk assessment for women at moderate genetic risk. A follow-up study of a trial cohort was conducted to evaluate psychological outcomes and their predictors at 6-year follow-up. A further aim was to examine threshold scores for high cancer worry. METHODS: Questionnaires were sent to 384 women assessed as moderate risk during a UK trial of genetic assessment (TRACE). Measures included cancer worry, perceived risk, health behaviours, general anxiety, psychological morbidity, optimism, and background variables assessed during TRACE and at 6-year follow-up. RESULTS: Reductions from baseline cancer worry and breast self-examination (BrSE) frequency were maintained 6 years after risk assessment, with relatively consistent levels over short- and long-term follow-up. Provision of risk information led to short-term reductions in perceived risk. During the 6-year period, 43% of women reported having made lifestyle changes and 27% had requested a mammogram. Baseline and post-risk cancer worry were the only significant predictors of long-term cancer worry. Greater worry at baseline predicted more frequent BrSE and higher perceived risk, but not lifestyle change or mammogram requests, at 6 years. Eighteen percent of women reported cancer worry above a threshold of 12.5 at long-term follow-up, compared with 30% at baseline. CONCLUSIONS: Overall reductions in cancer worry following moderate risk assessment were maintained in the long term. However, women at risk of sustained high cancer worry should be identified at an early stage in the risk assessment process for more intensive psycho-educational intervention. Copyright © 2010 John Wiley & Sons, Ltd.

Culturally appropriate health education for Type 2 diabetes in ethnic minority groups: a systematic and narrative review of randomized controlled trials.

To determine if culturally appropriate health education is more effective than 'usual' health education for people with diabetes from ethnic minority groups living in high- and upper-middle-income countries. A systematic review with meta-analysis, following the methodology of the Cochrane Collaboration. Electronic literature searches of nine databases were made, with hand searching of three journals and 16 author contacts. The criteria for inclusion into the analysis were randomized controlled trials of a specified diabetes health education intervention, and a named ethnic minority group with Type 2 diabetes. Data were collected on HbA(1c), blood pressure, and quality-of-life measures. A narrative review was also performed. Few studies fitted the selection criteria, and were heterogeneous in methodologies and outcome measures, making meta-analysis difficult. HbA(1c) showed an improvement at 3 months [weighted mean difference (WMD) -0.32%, 95% confidence interval (CI) -0.63, -0.01] and 6 months post intervention (WMD -0.60%, 95% CI -0.85, -0.35). Knowledge scores also improved in the intervention groups at 6 months (standardized mean difference 0.46, 95% CI 0.27, 0.65). There was only one longer-term follow-up study, and one formal cost-effectiveness analysis. Culturally appropriate health education was more effective than 'usual' health education in improving HbA(1c) and knowledge in the short to medium term. Due to poor standardization between studies, the data did not allow determination of the key elements of interventions across countries, ethnic groups and health systems, or a broad view of their cost-effectiveness. The narrative review identifies learning points to direct future research.

Systematic review of respite care in the frail elderly.

OBJECTIVES: To assess the effectiveness and cost-effectiveness of breaks in care in improving the well-being of informal carers of frail and disabled older people living in the community and to identify carer needs and barriers to uptake of respite services. DATA SOURCES: Major electronic databases were searched from the earliest possible date to April 2008. REVIEW METHODS: Selected studies were assessed and subjected to extraction of numerical data for meta-analysis of quantitative studies and extraction of text for thematic analysis of qualitative studies. Quality of the studies was assessed using checklists specifically designed for the current review. RESULTS: In total, 104 papers were identified for inclusion in the quantitative synthesis, 16 of which were appropriate for meta-analysis. Carer burden was reduced at 2-6 months' follow-up in single-sample studies but not in randomised controlled trials (RCTs) and quasi-experimental studies. Depression was reduced in RCTs in the short term and for home care but not for day care. These effects, however, were not significant in random-effects models. There was a trend for longer interventions to have more positive effects than shorter interventions. There was no effect of respite on anxiety, but it had positive effects on morale and anger and hostility. Single-group studies suggested that quality of life was worse after respite use. There were increased rates of institutionalisation after respite use; however, this does not establish a causal relationship as it may be a result of respite being provided late in the caregiving career. A total of 70 papers were identified for inclusion in the qualitative synthesis. Uptake of respite care was influenced by: carer attitudes to caring and respite provision; the caregiving relationship; knowledge of, and availability of, services; the acceptability to, and impact of respite care on, care recipients; hassles resulting from the use of respite care; quality of respite care; and the appropriateness and flexibility of service provision. Carers expressed needs for active information provision about services, support offered early in the caregiving career, access to a variety of services with flexible provision, reliable transport services, continuity of care, good-quality care, appropriate environments, care that provides benefits for care recipients (socialisation and stimulation), and appropriate activities for care recipients' levels of abilities and interests. CONCLUSIONS: There was some evidence to support respite having a positive effect on carers but the evidence was limited and weak. It is difficult, therefore, to make recommendations as to the most appropriate form of delivery of respite, apart from the suggestion that a range of services is probably most appropriate, to provide flexibility of respite provision and responsiveness to carer and care recipient characteristics and needs and also changes in those needs over time. There is a need for further high-quality larger trials that include economic evaluations.

What community measurements can be used to predict bone disease in patients with COPD?

BACKGROUND: Osteoporosis is common in patients with COPD. Previously we have reported that loss of fat-free mass (FFM), measured by dual X-ray absorptiometry (DXA) is associated with loss of bone mineral density (BMD). In addition, in patients with a low body mass index (BMI) and a low FFM, all had evidence of bone thinning, 50% having osteopenia and 50% osteoporosis. We explored the utility of different anthropometric measures in detecting osteoporosis in a community-based COPD population. METHODS: Patients with confirmed COPD and not on long-term oral corticosteroids (n=58) performed spirometry. They underwent nutritional assessment by skinfold anthropometry, midarm circumference, calculation of both % ideal body weight (IBW) and BMI. All had DXA assessment of BMD. RESULTS: A total of 58 COPD patients had anthropometric measurements taken, with a mean age of 66.8 (SD 8.7) years, 31 (58%) were male, with a forced expiratory volume in 1s (FEV(1)) of 54.17 (20.18)% predicted. Osteoporosis was present at either the hip or lumbar region in 14 patients (24%). The useful anthropometric measurements identifying those with osteoporosis were both % IBW and BMI. The adjusted odds ratio for %IBW was 0.93 (95% confidence interval (CI) 0.87, 0.99), p=0.016 and for BMI: 0.79 (0.64-0.98), p=0.03. The receiver operating characteristics (ROC) score for both was 0.88, indicating a good fit. CONCLUSION: Osteoporosis is common, even in patients with mild airways obstruction. Nutritional assessment, incorporating a calculation of their BMI or %IBW may confer an additional benefit in detecting those at risk of osteoporosis and guide referral for BMD measurement.

Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency.

BACKGROUND: Vitamin B12 deficiency is common and rises with age. Most people with vitamin B12 deficiency are treated in primary care with intramuscular vitamin B12 which is a considerable source of work for health care professionals. Several case control and case series studies have reported equal efficacy of oral administration of vitamin B12 but it is rarely prescribed in this form, other than in Sweden and Canada. Doctors may not be prescribing oral formulations because they are unaware of this option or have concerns regarding effectiveness. OBJECTIVES: To assess the effectiveness of oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency. SEARCH STRATEGY: Searches were undertaken of The Cochrane Library, MEDLINE, EMBASE and Lilacs in early 2005. The bibliographies of all relevant papers identified using this strategy were searched. In addition we contacted authors of relevant identified studies and Vitamin B12 research and pharmaceutical companies to enquire about other published or unpublished studies and ongoing trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) examining the use of oral or intramuscular vitamin B12 to treat vitamin B12 deficiency. DATA COLLECTION AND ANALYSIS: All abstracts or titles identified by the electronic searches were independently scrutinised by two reviewers. When a difference between reviewers arose, we obtained and reviewed a hard copy of the papers and made decisions by consensus. We obtained a copy of all pre-selected papers and two researchers independently extracted the data from these studies using piloted data extraction forms. The whole group checked whether inclusion and exclusion criteria were met, and disagreement was decided by consensus. The methodological quality of the included studies was independently assessed by two researchers and disagreements were brought back to the whole group and resolved by consensus. MAIN RESULTS: Two RCT's comparing oral with intramuscular administration of vitamin B12 met our inclusion criteria. The trials recruited a total of 108 participants and followed up 93 of these from 90 days to four months. High oral doses of B12 (1000 mcg and 2000 mcg) were as effective as intramuscular administration in achieving haematological and neurological responses. AUTHORS' CONCLUSIONS: The evidence derived from these limited studies suggests that 2000 mcg doses of oral vitamin B12 daily and 1000 mcg doses initially daily and thereafter weekly and then monthly may be as effective as intramuscular administration in obtaining short term haematological and neurological responses in vitamin B12 deficient patients.