Very low‐energy and low‐energy formula diets: Effects on weight loss, obesity co‐morbidities and type 2 diabetes remission – an update on the evidence for their use in clinical practice

The role of formula very low‐energy diets (VLEDs, <800 kcal/day) and low‐energy diets (LEDs, 800–1200 kcal/day) within clinical practice has regained attention over the last few years. Formula diets can achieve clinically significant weight reduction in the short‐term (3–5 months) and new evidence demonstrates that long‐term weight loss maintenance (up to 4 years) is achievable. Weight reductions of between 10% and 15% bodyweight have been reported, which is associated with clinically meaningful health outcomes in a number of obesity‐related co‐morbidities including type 2 diabetes (T2D), obstructive sleep apnoea and osteoarthritis. Recent evidence indicates that using a formula LED with a weight loss maintenance programme can help people with overweight or obesity and T2D achieve remission. Despite this, few healthcare professionals in the UK routinely use LEDs. Concerns about adherence, risk of precipitating eating disorders, safety, cost and long‐term efficacy may, in part, contribute to their under use. To help inform healthcare professionals on the use of formula diets within clinical practice, this review examines the current evidence for the use of VLEDs and LEDs for weight loss and weight loss maintenance, and in the treatment of obesity‐related co‐morbidities, including T2D, osteoarthritis, psoriasis, obstructive sleep apnoea and secondary coronary prevention, with a particular focus on T2D remission

Reasonable adjustments to provide equitable and inclusive assessment, screening and treatment of osteoporosis for adults with intellectual disabilities: a feasibility study

Background: People with intellectual disabilities are a high risk population for developing osteoporosis and fragility fractures, yet they experience barriers to accessing dual‐energy x‐ray absorptiometry (DXA) bone mineral density (BMD) screening and fracture assessment. Reasonable adjustments are a statutory requirement in the UK, but there is a paucity of evidence‐based examples to assist their identification, implementation and evaluation. Method: Thirty adults with intellectual disabilities underwent DXA BMD screening and fracture risk assessment. Reasonable adjustments were identified and implemented. Results: The presence of osteopenia or osteoporosis was detected in 23 out of 29 (79%) participants. Osteoporosis professionals report that 17 of 18 reasonable adjustments identified and implemented are both important and easy to implement. Conclusion: Adults across all levels of intellectual disabilities can complete DXA BMD screening with reasonable adjustments. Widely implementing these reasonable adjustments would contribute to reducing inequalities in health care for adults with intellectual disabilities

Canagliflozin, dapagliflozin and empagliflozin monotherapy for treating type 2 diabetes: systematic review and economic evaluation

Background: Most people with type 2 diabetes are overweight, so initial treatment is aimed at reducing weight and increasing physical activity. Even modest weight loss can improve control of blood glucose. If drug treatment is necessary, the drug of first choice is metformin. However, some people cannot tolerate metformin, which causes diarrhoea in about 10%, and it cannot be used in people with renal impairment. This review appraises three of the newest class of drugs for monotherapy when metformin cannot be used, the sodium–glucose co-transporter 2 (SGLT2) inhibitors. Objective: To review the clinical effectiveness and cost-effectiveness of dapagliflozin (Farxiga, Bristol-Myers Squibb, Luton, UK), canagliflozin (Invokana, Janssen, High Wycombe, UK) and empagliflozin (Jardiance, Merck & Co., Darmstadt, Germany), in monotherapy in people who cannot take metformin. Sources: MEDLINE (1946 to February 2015) and EMBASE (1974 to February 2015) for randomised controlled trials lasting 24 weeks or more. For adverse events, a wider range of studies was used. Three manufacturers provided submissions. Methods: Systematic review and economic evaluation. A network meta-analysis was carried out involving the three SGLT2 inhibitors and key comparators. Critical appraisal of submissions from three manufacturers. Results: We included three trials of dapagliflozin and two each for canagliflozin and empagliflozin. The trials were of good quality. The canagliflozin and dapagliflozin trials compared them with placebo, but the two empagliflozin trials included active comparators. All three drugs were shown to be effective in improving glycaemic control, promoting weight loss and lowering blood pressure (BP). Limitations: There were no head-to-head trials of the different flozins, and no long-term data on cardiovascular outcomes in this group of patients. Most trials were against placebo. The trials were done in patient groups that were not always comparable, for example in baseline glycated haemoglobin or body mass index. Data on elderly patients were lacking. Conclusions: Dapagliflozin, canagliflozin and empagliflozin are effective in improving glycaemic control, with added benefits of some reductions in BP and weight. Adverse effects are urinary and genital tract infections in a small proportion of users. In monotherapy, the three drugs do not appear cost-effective compared with gliclazide or pioglitazone, but may be competitive against sitagliptin (Januvia, Boehringer Ingelheim, Bracknell, UK). Funding: The National Institute for Health Research Health Technology Assessment programme

Validating epilepsy diagnoses in routinely collected data

Purpose: Anonymised, routinely-collected healthcare data is increasingly being used for epilepsy research. We validated algorithms using general practitioner (GP) primary healthcare records to identify people with epilepsy from anonymised healthcare data within the Secure Anonymised Information Linkage (SAIL) databank in Wales, UK. Method: A reference population of 150 people with definite epilepsy and 150 people without epilepsy was ascertained from hospital records and linked to records contained within SAIL (containing GP records for 2.4 million people). We used three different algorithms, using combinations of GP epilepsy diagnosis and anti-epileptic drug (AED) prescription codes, to identify the reference population. Results: Combining diagnosis and AED prescription codes had a sensitivity of 84% (95% ci 77–90) and specificity of 98% (95–100) in identifying people with epilepsy; diagnosis codes alone had a sensitivity of 86% (80–91) and a specificity of 97% (92–99); and AED prescription codes alone achieved a sensitivity of 92% (70–83) and a specificity of 73% (65–80). Using AED codes only was more accurate in children achieving a sensitivity of 88% (75–95) and specificity of 98% (88–100). Conclusion: GP epilepsy diagnosis and AED prescription codes can be confidently used to identify people with epilepsy using anonymised healthcare records in Wales, U

Mobile telephone delivered contingency management for encouraging adherence to supervised methadone consumption: feasibility study for an RCT of clinical and cost-effectiveness (TIES)

Background: Prescription methadone or buprenorphine enables people with opioid use disorder to stop heroin use safely while avoiding withdrawal. To ensure methadone is taken as prescribed and to prevent diversion onto the illicit market, people starting methadone take their daily dose under a pharmacist’s supervision. Many patients miss their daily methadone dose risking withdrawal, craving for heroin and overdose due to loss of heroin tolerance. Contingency management (CM) can improve medication adherence, but remote delivery using technology may be resource-light and cost-effective. We developed an innovative way to deliver CM by mobile telephone. Software monitors patients’ attendance and supervised methadone consumption through an internet self-login at the pharmacy and sends reinforcing text messages to patients’ mobile telephones. A linked system sends medication adherence reports to prescribers and provides early warning alerts of missed doses. A pre-paid debit card system provides financial incentives. Methods: A cluster randomised controlled trial design was used to test the feasibility of conducting a future trial of mobile telephone CM to encourage adherence to supervised methadone in community pharmacies. Each cluster (drug service/3 allied pharmacies) was randomly allocated to provide patient’s presenting for a new episode of opiate agonist treatment (OAT) with either (a) mobile telephone text message CM, (b) mobile telephone text message reminders, or (c) no text messages. We assessed acceptability of the interventions, recruitment, and follow-up procedures. Results: Four drug clinics were approached and three recruited. Thirty-three pharmacists were approached and 9 recruited. Over 3 months, 173 individuals were screened and 10 enrolled. Few patients presented for OAT and high numbers were excluded due to receiving buprenorphine or not attending participating pharmacies. There was 96% consistency in recording medication adherence by self-login vs. pharmacy records. In focus groups, CM participants were positive about using self-login, the text messages, and debit card. Prescribers found weekly reporting, time saving, and allowed closer monitoring of patients. Pharmacists reported that the tablet device was easy to host. Conclusion: Mobile telephone CM worked well, but a planned future trial will use modified eligibility criteria (existing OAT patients who regularly miss their methadone/buprenorphine doses) and increase the number of participating pharmacies. Trial registration: The trial is retrospectively registered, ISRCTN 58958179

Meta-analysis of randomized and quasi-randomized clinical trials of topical antibiotics after primary closure for the prevention of surgical-site infection

Background: Surgical-site infections (SSIs) increase patient morbidity and costs. The aim was to identify and synthesize all RCTs evaluating the effect of topical antibiotics on SSI in wounds healing by primary intention. Methods: The search included Ovid MEDLINE, Ovid Embase, the Cochrane Wounds Specialized Register, Central Register of Controlled Trials and EBSCO CINAHL from inception to May 2016. There was no restriction of language, date or setting. Two authors independently selected studies, extracted data and assessed risk of bias. When sufficient numbers of comparable trials were available, data were pooled in meta-analysis. Results: Fourteen RCTs with 6466 participants met the inclusion criteria. Pooling of eight trials (5427 participants) showed that topical antibiotics probably reduced the risk of SSI compared with no topical antibiotic (risk ratio (RR) 0·61, 95 per cent c.i. 0·42 to 0·87; moderate-quality evidence), equating to 20 fewer SSIs per 1000 patients treated. Pooling of three trials (3012 participants) for risk of allergic contact dermatitis found no clear difference between antibiotics and no antibiotic (RR 3·94, 0·46 to 34·00; very low-quality evidence). Pooling of five trials (1299 participants) indicated that topical antibiotics probably reduce the risk of SSI compared with topical antiseptics (RR 0·49, 0·30 to 0·80; moderate-quality evidence); 43 fewer SSIs per 1000 patients treated. Pooling of two trials (541 participants) showed no clear difference in the risk of allergic contact dermatitis with antibiotics or antiseptic agents (RR 0·97, 0·52 to 1·82; very low-quality evidence). Conclusion: Topical antibiotics probably prevent SSI compared with no topical antibiotic or antiseptic. No conclusion can be drawn regarding whether they cause allergic contact dermatitis

Sex and age differences in the early identification and treatment of alcohol use: a population-based study of patients with alcoholic cirrhosis

Aim To estimate sex differences in health‐care utilization among harmful/hazardous drinkers in the period before alcoholic cirrhosis diagnosis, and estimate sex differences in the extent to which alcohol use and brief alcohol interventions were documented for these individuals compared with a control cohort. Design Retrospective study using linked general practice and hospital admissions data in England. Setting Three hundred and fifty‐seven general practitioner (GP) practices in England. Participants A total of 2479 individuals with alcoholic cirrhosis (mean age at diagnosis = 56years), of whom 67% were men; and 24 790 controls without the disease. Measurements Rates of primary care visits and hospital admissions prior to the diagnosis of alcoholic cirrhosis for men and women, and the proportion of men and women with alcohol consumption and/or alcohol brief intervention documented in their medical record. Findings Compared with the general population, patients with alcoholic cirrhosis used primary and secondary health‐care services more frequently in the years leading up to their diagnosis. In the years prior to diagnosis, men used primary and secondary health‐care services more than did women (P for sex interaction P < 0.0001). Men were more likely than women to have their alcohol use recorded [odds ratio (OR) men = 1.96, 95% confidence interval (CI) = 1.7–2.3; women = 1.63, 95% CI = 1.4–1.8, P for sex interaction P < 0.0017]. By contrast, alcohol interventions were recorded more commonly among women (OR men = 4.3, 95% CI = 3.7–4.9; women = 5.8, 95% CI = 4.7–6.9, P for sex interaction = 0.07), although less common with increasing age (P for age interaction = 0.009). Conclusions In the United Kingdom, prior to alcoholic cirrhosis diagnosis, excess health‐care utilization is higher in men than women and men are more likely than women to have their alcohol use recorded. However, women appear to be more likely than men to receive alcohol brief interventions

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

Background: A variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient reported outcomes (PROMs) for English-speaking patients with venous leg ulcers (VLUs). Method: This systematic review used a two-staged approach. Electronic searches of major databases including MEDLINE were completed in October 2015 and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were undertaken using standard and adapted study-relevant criteria. Results: Ten studies with data for three generic PROMS and six condition-specific measures were identified. No generic PROM showed adequate content and criterion validity; however the EQ-5D, Nottingham Health Profile (NHP) and 12-item Health Survey Short-Form had good acceptability with scores ranging from 80% to 91%. In general, the EQ-5D showed poor responsiveness in patients with VLUs. Condition-specific PROMs demonstrated poor criterion and construct validity. Overall, good internal consistency was demonstrated for the Venous Leg Ulcer Quality of Life (VLU-QOL) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D). Test re-test reliability was also satisfactory for SPVU-5D and VeLUSET measures. Conclusions: The NHP and VLU-QOL seemed the most suitable PROMs for use by clinicians. A valid condition-specific PROM is still required