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Issue 80 – January 2016
Dear subscriber
This month in Eyes on Evidence
Oxygen therapy for acute ST-segment-elevation myocardial infarction
A randomised controlled trial in Australia found that administering inhaled oxygen did not limit damage to heart muscle and could be associated with an increase in muscle damage in people with acute ST-segment-elevation myocardial infarction.
Managing chronic rhinosinusitis in adults
A systematic review found evidence supporting daily high-volume nasal irrigation with saline and topical corticosteroid treatment as a first-line maintenance treatment for adults with chronic rhinosinusitis (symptoms for 12 weeks or longer).
Thyroid function testing in primary care
A cross-sectional study at a single UK general practice found that only 2% of people who underwent thyroid function tests in primary care had thyroid disease. The study identified specific clinical characteristics, such as hair loss or constipation, that could possibly be used to target testing at people most likely to have hypothyroidism or hyperthyroidism.
Occupational therapy for older people with stroke-related disabilities who live in care homes
A UK randomised controlled trial found that brief individualised occupational therapy delivered solely by occupational therapists had no effect on the degree of functional independence among older care home residents with stroke-related disabilities who had experienced stroke several years before.
Long-term mental health effects of bullying during adolescence
A UK prospective cohort study found that young people who experienced frequent bullying at age 13 were more likely to report depression at age 18 than those who were not bullied.
Evidence summaries from NICE’s Medicines and Prescribing Programme
NICE has recently published summaries on:
- Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar)
- Type 2 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo)
- Diabetic nephropathy: blood pressure-lowering therapy
- Early breast cancer: adjuvant bisphosphonate treatment beneficial in postmenopausal women
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Overview:
- Supplemental oxygen therapy did not result in less heart damage in people with ST-segment-elevation myocardial infarction (STEMI), as measured by cardiac troponin I levels.
- Creatinine kinase results suggest that oxygen therapy could be associated with an increase in muscle damage during STEMI.
- This new evidence supports NICE guidance that oxygen should not be routinely administered to people with suspected STEMI.
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 Background: ST-segment-elevation myocardial infarction (STEMI) occurs when a coronary artery becomes blocked by a blood clot. Such a blockage can cause the heart muscle supplied by the artery to die from lack of oxygen and nutrients (ischaemia).
Some studies suggest that oxygen therapy could be beneficial as initial treatment in people with STEMI (Stavitsky et al. 1998). Other analyses, such as a recent Cochrane review (Cabello et al. 2013), do not support the use of oxygen therapy in people with STEMI and suggest that it may even be harmful.
Current advice: The NICE guideline on chest pain of recent onset (currently being updated) recommends that people with chest pain should be referred to hospital as an emergency if an acute coronary syndrome, such as STEMI, is suspected.
The guideline advises that oxygen should not be routinely administered to people with suspected acute coronary syndrome. Oxygen saturation should be monitored using pulse oximetry as soon as possible, ideally before hospital admission. Supplemental oxygen should only be offered to:
- people with oxygen saturation of less than 94% who are not at risk of hypercapnic respiratory failure, aiming for oxygen saturation of 94–98%
- people with chronic obstructive pulmonary disease who are at risk of hypercapnic respiratory failure, to achieve a target oxygen saturation of 88–92% until blood gas analysis is available.
The NICE pathway on acute coronary syndromes brings together all related NICE guidance and associated products on the conditions in a set of interactive topic-based diagrams.
New evidence: A randomised controlled trial in Australia by Stub et al. (2015) compared supplementary oxygen therapy with no oxygen therapy in people with STEMI. The Air Versus Oxygen in Myocardial Infarction (AVOID) study recruited people with chest pain who had signs of STEMI according to electrocardiogram by a paramedic.
People randomised to the oxygen therapy group received supplemental oxygen therapy at 8 litres/min by face mask in the ambulance until after transfer from the cardiac catheterisation laboratory to the cardiac unit. People randomised to the no oxygen therapy group did not receive oxygen unless oxygen saturation fell below 94%. These people received oxygen by nasal cannula (4 litres/min) or face mask (8 litres/min) until saturation reached 94%. All patients received 300 mg oral aspirin from paramedics.
STEMI was assessed by a doctor on arrival at the hospital and confirmed using angiography. Additional antiplatelet therapy and choice of anticoagulation and intervention strategy were at the discretion of the treating cardiologist.
Blood samples were taken from participants at baseline and then every 6 hours for the first 24 hours and every 12 hours up to 72 hours. The primary outcome was extent of heart muscle damage (size of myocardial infarct), assessed using peak concentration of cardiac troponin I and creatinine kinase (cardiac biomarkers released as a result of heart damage).
A total of 638 people were randomised by paramedics to oxygen therapy (n=318) or no oxygen therapy (n=320). The primary outcome was assessed in 441 patients in whom STEMI was confirmed (n=218 in the oxygen group and n=223 in the no oxygen group).
Peak concentration of cardiac troponin I was similar in the oxygen group (57.4 microgram/litre) and the no oxygen group (48.0 microgram/litre; ratio of means=1.20, 95% confidence interval [CI] 0.92 to 1.55, p=0.18). Peak creatinine kinase concentration was higher in the oxygen group (1948 U/litre) than in the no oxygen group (1543 U/litre; ratio of means=1.26, 95% CI 1.05 to 1.52, p=0.01).
At hospital discharge, the mortality rate was not statistically different in the oxygen group (1.8%) and the no oxygen group (4.5%; p=0.11). However, people in the oxygen group had a higher rate of in-hospital recurrent myocardial infarctions (5.5% versus 0.9% in the no oxygen group; p=0.006) and cardiac arrhythmias (40.4% versus 31.4%; p=0.05).
Limitations of this study include that it did not have enough statistical power to produce robust results for the clinical outcomes of mortality, recurrent myocardial infarction and cardiac arrhythmia. In addition, paramedics, patients and hospital cardiology teams were not blinded to treatment allocation.
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Commentary by Professor Tom Quinn, Professor of Nursing, Faculty of Health, Social Care and Education, Kingston University London and St George’s, University of London:
“Giving supplementary oxygen to people who have myocardial infarction has been commonplace for decades, despite a randomised trial by Rawles et al. in 1976 suggesting harm. A Cochrane review published in 2010 (Cabello et al.) also suggested harm and led to changes in professional society guidelines in the USA, Europe and Australasia to reflect existing guidance by the British Thoracic Society.
“This new trial from Australia adds to the suspicion that oxygen may do more harm than good in patients with STEMI. The study found that supplemental oxygen therapy did not result in less heart damage according to cardiac troponin I levels. Instead, the creatinine kinase results suggest oxygen therapy could be associated with an increase in muscle damage during STEMI. No significant difference in major adverse cardiac events (a composite of all-cause mortality, recurrent ischaemia, repeat revascularisation and stroke) was observed between those randomised to oxygen or air.
“There are several limitations to this study, including lack of reporting of mortality in 14 patients who declined consent following enrolment by paramedics, missing data on peak cardiac troponin I levels in 18, and loss to follow up of 22. In addition, this study was not powered for mortality and focused instead on the surrogate end point of infarct size.
“Undertaking randomised trials in the prehospital ambulance setting is challenging, and very different from recruiting in the ward or clinic. A pragmatic approach, as taken for this study, is appropriate. Exposure of an individual paramedic to a patient with STEMI, the condition of interest in this trial, is infrequent – perhaps once or twice a year. Misdiagnosis is not uncommon – around a quarter of patients enrolled in this trial did not have STEMI confirmed at subsequent cardiological review. And of course blinding is nigh on impossible with this intervention in this clinical setting (although blind assessment of the primary end point was achieved).
“Practice probably should not change on the basis of this study. Current guidance seems appropriate until the results of the much larger DETO2X-AMI study are published. This study currently recruiting in Sweden and is powered for mortality. The findings will hopefully answer the important question of supplemental oxygen therapy for myocardial infarction for patients and clinicians alike.”
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Study sponsorship: Alfred Foundation, FALCK Foundation and Paramedics Australia.
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Overview:
- Daily high-volume saline irrigation and topical corticosteroid therapy should be, according to the available evidence, the first-line therapy for chronic rhinosinusitis (symptoms for 12 weeks or longer).
- This systematic review supports current European recommendations to treat people who have chronic rhinosinusitis with topical steroids and nasal irrigation, and review treatment after 4 weeks.
- The evidence on the efficacy of oral antibiotics to treat chronic rhinosinusitis was conflicting.
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 Background: Rhinosinusitis is inflammation of the mucosal lining of the nose and paranasal sinuses (European Position Paper on Rhinosinusitis and Nasal Polyps 2012). Rhinosinusitis is defined by nasal blockage, runny nose (rhinorrhoea) or both, and at least one of reduced sense of smell (hyposmia) or facial pressure, confirmed by endoscopic or radiological findings. Rhinosinusitis is considered chronic if these symptoms have persisted for 12 weeks or longer.
Potential causes of chronic rhinosinusitis include allergy and bacterial toxins, but the aetiology of the condition is still uncertain. The condition usually follows a gradual course. Some people with chronic rhinosinusitis may also develop nasal polyps, but the reason for this is unknown.
Current advice: The European Position Paper on Rhinosinusitis and Nasal Polyps (2012) recommends first-line treatment of chronic rhinosinusitis with topical steroids and nasal saline irrigation. The person with rhinosinusitis should then be re-evaluated after 4 weeks. Those people who show improvement should continue with this treatment. People who do not show improvement should be referred to an ear, nose and throat specialist.
People who are referred should undergo endoscopy to establish the level of mucosal disease. People with mild symptoms and no serious mucosal disease should continue with topical steroids and nasal irrigation. People with moderate or severe symptoms and signs of mucosal disease, and people with mild disease who do not improve after 3 months, should be considered for long-term antibiotics or surgery.
Doxycyline or short-course oral steroids may be considered for people with moderate or severe disease and nasal polyps.
The NICE pathway on ear, nose and throat conditions brings together all related NICE guidance and associated products on these conditions in a set of interactive topic-based diagrams. The NICE Clinical Knowledge Summary on sinusitis provides a readily accessible summary of the current evidence base and best practice on this topic.
New evidence: A systematic review of 29 studies (12 meta-analyses that assessed more than 60 randomised controlled trials [RCTs], 13 systematic reviews and 4 RCTs) by Rudmik et al. (2015) considered the evidence on medical treatments for adults with chronic rhinosinusitis.
When maintenance treatment was considered, topical corticosteroids had the strongest evidence (6 meta-analyses of more than 40 RCTs). For people with nasal polyps (4 meta-analyses), intranasal corticosteroid spray was associated with improvement in symptoms compared with placebo (3 meta-analyses). Intranasal corticosteroid spray also improved overall symptom scores, polyp size and polyp recurrence after surgery (2 meta-analyses).
For people without nasal polyps (2 meta-analyses), intranasal corticosteroid spray improved symptoms and the proportion of responders compared with placebo (1 meta-analysis). However, corticosteroids failed to improve symptoms and treatment response in the other meta-analysis. The authors suggested that there was a need for higher quality trials for people without polyps.
Saline irrigation for maintenance treatment was considered in 1 meta-analysis and 2 systematic reviews. Sinonasal saline irrigations improved symptoms in people with and without nasal polyps compared with no treatment (1 meta-analysis). However, when saline irrigation was compared directly with topical corticosteroids, it was associated with less improvement (1 meta-analysis). Similar symptom improvements were reported with isotonic and hypertonic saline irrigations (1 meta-analysis), but volumes over 100 ml were superior to low-volume nasal spray techniques (1 systematic review).
The authors considered both leukotriene antagonists and allergy immunotherapy as maintenance treatment for chronic rhinosinusitis. However, the evidence on these was relatively weak. For intermittent or rescue treatments, conflicting evidence was found for oral antibiotics used short term (1 systematic review) or long term (2 systematic reviews and 1 meta-analysis).
The authors concluded that the available evidence supported daily high-volume saline irrigation with topical corticosteroid therapy as first-line therapy for chronic rhinosinusitis. Limitations of this systematic review include the differences between the studies assessed, such as in the diagnostic criteria used, and the use of mixed populations of people with and without polyps. The quality of the studies included in the systematic review was generally poor or moderate and the clinical significance of effect sizes was unclear.
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Commentary by Carl Philpott, Clinical Senior Lecturer, Norwich Medical School and Honorary Consultant Ear, Nose and Throat Surgeon and Rhinologist, James Paget University Hospital:
“The evidence presented by Rudmik et al. (2015) confirms the conclusions in the European Position Paper on Rhinosinusitis and Nasal Polyps (2012), but doesn’t add any new evidence or recommendations. This is not surprising because there have been no new RCTs in that time for chronic rhinosinusitis. Although open label and non-randomised series have been reported, any publications since 2012 have been themselves meta-analyses. As such, this systematic review supports the current recommendations to treat people who have chronic rhinosinusitis with topical steroids and nasal irrigation, and review treatment after 4 weeks.
“Practice variation in the UK is high. Longitudinal data from the Clinical Practice Research Datalink (CPRD) show that 1% of UK adults receive treatment for chronic rhinosinusitis from their GP each year, averaging 4 GP visits (Gulliford et al. 2014). These people receive multiple medications, with 91% receiving an antibiotic prescription. The recent ENT-UK commissioning guideline (Royal College of Surgeons of England 2013) does not recommend routine antibiotic use for chronic rhinosinusitis in primary care, but GPs often prescribe repeated courses (Akkerman et al. 2005), which may cause resistance.
“There is growing interest in the immune-modulating effects of macrolide antibiotics in chronic airway inflammatory disease. Low-dose, long-term macrolides are being prescribed in chronic rhinosinusitis for their effect on immune response and not primarily as antibacterial agents (Cervin and Wallwork 2007). Some evidence exists for longer term antibiotic use in secondary care, but this evidence is from 2 small conflicting RCTs (Wallwork et al. 2006 and Videler et al. 2011), resulting in a call for further larger trials (Piromchai et al. 2011). Recently some Clinical Commissioning Groups (CCGs) have insisted on a 3 month trial of macrolide antibiotics before people with chronic rhinosinusitis can be referred to secondary care (Soni-Jaiswal et al. 2015), despite the fact that no high-level evidence is available to support this approach.
“Hospital Episode Statistics show that 1 in 3 people with chronic rhinosinusitis attending ear, nose and throat clinics in England are considered not to have responded adequately to current medical treatment and are considered for surgery. However, insufficient evidence is available to define the role of surgery, which has contributed to a 5-fold variation in UK intervention rates (Royal College of Surgeons of England 2013). Symptom duration before surgery varies from under 1 to over 10 years (Hopkins et al. 2015a, Hopkins et al. 2015b). If surgery is less effective than continued medical therapy, patients may be exposed to unnecessary risks and morbidity. If surgery is better, current variation reflects suboptimal patient care.”
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Study sponsorship: None stated.
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Overview:
- A study at a single UK general practice found that only 2% of people who underwent thyroid function tests had results suggestive of thyroid disease.
- Further analyses suggested that thyroid function tests could possibly be targeted at people with constipation, hair loss, palpitations and diarrhoea, particularly if pregnant.
- However, a normal test result may reassure the patient and the doctor in a person with any clinical symptoms associated with possible thyroid disease.
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 Background: Thyroid disease can occur when the thyroid gland produces too little or too much of the hormone thyroxine. Both underactive thyroid (hypothyroidism) and overactive thyroid (hyperthyroidism) have non-specific symptoms, which can make the disorders hard to diagnose.
Thyroid disease is diagnosed with a thyroid function test, which measures levels of circulating thyroid stimulating hormone (TSH) and free thyroxine (FT4). Approximately 10 million thyroid function tests are ordered each year in the UK, at an estimated cost of £30 million (Beckett and Toft 2003).
Current advice: The British Thyroid Association, the British Thyroid Foundation and the Association for Clinical Biochemistry have jointly produced UK guidelines for the use of thyroid function tests.
The guidance states that people with type 1 diabetes should undergo thyroid function testing every 12 months, whereas thyroid function testing is required only at diagnosis in people with type 2 diabetes. The NICE guideline on type 1 diabetes in adults recommends that blood TSH levels should be measured at annual review in people with type 1 diabetes.
The UK guidelines for the use of thyroid function tests add that thyroid function should be tested in people with suspected goitre, atrial fibrillation, dyslipidaemia or osteoporosis. People with Down’s syndrome and Turner’s syndrome, and those receiving amiodarone or lithium, should also undergo regular thyroid function tests.
The NICE guideline on fertility problems advises that women with possible fertility problems are no more likely than the general population to have thyroid disease and the routine measurement of thyroid function should not be offered. Estimation of thyroid function should be confined to women with symptoms of thyroid disease.
New evidence: Werhun and Hamilton (2015) did a cross-sectional study followed by a cohort study to assess the frequency of thyroid testing in primary care and whether testing could be better targeted.
The authors retrospectively identified people who had been tested for TSH levels over a 12-month period at a general practice in Devon. People who had a TSH concentration of more than 4.5 mU/l were categorised as having hypothyroidism, and those who had TSH levels of less than 0.01 mU/l were classified as having hyperthyroidism.
A total of 16,487 people were registered at the practice, and 2035 (12.3%) people underwent a thyroid function test during the study period and were included in this analysis. Of the people who had a test, 42 (2.1%) had thyroid disease: 35 (1.7%) had hypothyroidism and 7 (0.3%) had hyperthyroidism.
Four clinical features were present more frequently in people who tested positive for thyroid disease than in those who tested negative. These features were pregnancy (odds ratio [OR]=36, 95% confidence interval [CI] 8.3 to 159, p<0.001), constipation (OR=8.7, 95% CI 1.9 to 40, p=0.005), hair loss (OR=4.9, 95% CI 1.1 to 21, p=0.037) and palpitations (OR=3.5, 95% CI 1.2 to 10, p=0.021). Two further symptoms were associated with hyperthyroidism only: weight gain (OR=18, 95% CI 1.6 to 190, p=0.018) and diarrhoea (OR=13, 95% CI 1.2 to 130, p=0.033).
The authors then did a cohort study to evaluate the extent to which each of these 6 clinical features predicted whether a person was offered a thyroid test and diagnosed with thyroid disease. The authors retrospectively identified from the practice’s records a random group of 100 people for each of 5 of the 6 features associated with thyroid disease (not enough data was available to assess weight gain). Five years’ worth of follow-up data was then analysed for these people.
More than three-quarters of people with palpitations (n=91), constipation (n=82), diarrhoea (n=79) or hair loss (n=80) underwent a TSH test, but only about a third of pregnant women (n=32) had a test. Each of these 5 factors had a small positive predictive value for identifying thyroid disease in people who had been tested (range 3.9 to 21%).
This study is limited by the fact that it was conducted at a single general practice in an area with a small proportion of ethnic minorities, so the results may not be generalisable to elsewhere in the UK. In addition, both elements of this research were retrospective and relied on existing clinical records.
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Commentary by Dr Brian Shine, Consultant Chemical Pathologist, John Radcliffe Hospital, Oxford:
“This study found that 12.3% of people without previously identified thyroid disease in a single general practice had thyroid function tests over a 12-month period. Overall, 2.1% of people tested had an abnormal TSH level.
“Females were more likely to have abnormal results, particularly in pregnancy, as were people with constipation, hair loss, palpitations, weight gain and diarrhoea. Other features traditionally thought to be signs of thyroid dysfunction, such as fatigue and dizziness, did not seem to be associated with abnormal TSH levels.
“Of 100 people each with pregnancy, constipation, hair loss, palpitations and diarrhoea, 32–91% had a thyroid function test over 5 years. The test results were abnormal in 5.1% (for diarrhoea) to 17.5% (for hair loss, most with possible hypothyroidism). The authors suggest that the higher levels of abnormal results in these groups indicate that thyroid testing could be targeted in people with these clinical features.
“This study helps us understand why GPs request thyroid function tests. About a quarter of participants underwent a thyroid function test as ‘screening’ because of existing conditions, including type 2 diabetes and hypertension. The remainder were tested because of clinical symptoms associated with possible thyroid disease.
“The quarter of tests apparently requested because of existing conditions had a low yield (2.0% were abnormal), which is comparable to the yield in the overall population in this study. However, some authors have suggested routine thyroid screening of all people with type 2 diabetes (Perros et al. 1995).
“The authors believe that their study shows that thyroid function testing for screening and for some symptoms (such as fatigue) is not effective because of the low yield of abnormal test results. However, a normal test result may reassure the patient and the doctor. An abnormal test result is more likely for some specific symptoms, such as hair loss. More testing may lead to earlier diagnosis, and this may be cost effective.”
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Study sponsorship: National Institute for Health Research.
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Overview:
- A UK randomised controlled trial found that brief individualised occupational therapy delivered solely by occupational therapists had no effect on the degree of functional independence among older care home residents with stroke-related disabilities who had experienced stroke several years before. Many had severe or very severe dependency levels at baseline.
- Community-based rehabilitation teams should focus on using interventions with proven efficacy on people with stroke who are most likely to benefit.
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 Background: In the UK, around 1 in 10 people who survive a stroke are unable to return home and instead are discharged to a care home (Sentinel Stroke National Audit Programme 2015). Many people who enter a care home become inactive and experience a deterioration in their ability to carry out personal activities of daily living, such as getting dressed and washed.
Occupational therapy delivered at home has been shown to improve people’s ability to complete personal activities of daily living after stroke (Legg et al. 2007). However, little evidence is available to support occupational therapy for people with stroke-related disabilities who live in care homes (Fletcher-Smith et al. 2013).
Current advice: The NICE guideline on stroke rehabilitation recommends that occupational therapy should be provided after stroke for people who are likely to benefit. Occupational therapy should address difficulties with personal activities of daily living. Therapy may consist of restorative strategies, such as encouraging people with arm weakness to incorporate both arms, or compensatory strategies, such as teaching people to dress one-handed.
The guideline adds that people who have difficulties with activities of daily living after stroke should have regular monitoring and treatment by occupational therapists with core skills and training in the analysis and management of activities of daily living. Treatment should continue until the person is stable or able to progress independently.
Relevant stroke rehabilitation therapy should be offered to people who have the ability to participate, and where functional goals can be achieved. Therapy should initially be offered for at least 45 minutes for a minimum of 5 days per week. If more rehabilitation is needed at a later stage, the intensity of the therapy should be tailored to the person’s needs at that time.
The NICE pathway on stroke brings together all related NICE guidance and associated products on the condition in a set of interactive topic-based diagrams.
New evidence: A randomised controlled trial by Sackley et al. (2015) investigated individualised occupational therapy for older people who had stroke-related disabilities and lived in care homes. A random selection of care homes across the UK with more than 10 beds were invited to participate in the study. Those care homes that agreed and had eligible consenting residents were then randomly allocated to either an occupational therapy intervention or a control group. Eligible care home residents were those with a history of ischaemic or haemorrhagic stroke or of transient ischaemic attack.
The intervention comprised a 3-month programme of individualised occupational therapy designed to improve or maintain participants’ functional capacity. Occupational therapists trained participants in techniques to assist with personal activities of daily living and mobility. Therapists also made changes to participants’ environments where necessary, such as offering walking aids and raised toilet seats, and provided education to care home staff. The primary outcome was score on the Barthel index, a measure of dependence in self-care activities such as feeding, at 3 months after randomisation.
A total of 228 care homes were recruited and randomly assigned to the intervention (114 homes, n=568 residents) or the control (114 homes, n=474 residents). Participants were aged 82.9 years on average and most (64%) lived in a home with nursing care. The majority (over 70%) of participants were classified as having severe or very severe dependency at baseline (Barthel index score 0 to 9). The 498 (88%) people in the intervention arm who received occupational therapy had a mean of 5.1 sessions, with a median session duration of 30 minutes.
At 3-month follow-up, dependence did not differ between the occupational therapy group and the control group (difference in adjusted mean Barthel index=0.19, 95% confidence interval –0.33 to 0.70, p=0.48). The 2 study groups also did not differ significantly at 6 months (p=0.99) or 12 months (p=0.58).
Strengths of this study include its size, the geographical diversity of participating care homes, and the inclusion of people who had cognitive or communication impairments after stroke. However, many participants had severe or very severe dependency levels at baseline, which may have limited their ability to participate in the intervention. In addition, participants had experienced stroke several years before taking part in the study.
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Commentary by Rory J O’Connor, Associate Clinical Professor of Rehabilitation Medicine, Academic Department of Rehabilitation Medicine, University of Leeds and Lead Clinician, National Demonstration Centre in Rehabilitation, Leeds Teaching Hospitals NHS Trust:
“Occupational therapy has an important role to play in the rehabilitation and management of stroke survivors living with complex disabilities. Sackley et al. found that occupational therapy had no effect on older people with stroke-related disabilities who lived in care homes, but a number of factors may have contributed to this null finding.
“Occupational therapy, like any other rehabilitation intervention, needs to be delivered in sufficient dose to effect change. Sackley et al. used 5 sessions of 30 minutes each over 3 months, which falls well below the input specified in the NICE guideline on stroke rehabilitation. Furthermore, rehabilitation is a multidisciplinary intervention and is best delivered by a team of healthcare professionals who, between them, are able to assess, negotiate person-centred goals, and deliver evidenced-based treatment.
“The intervention for the residents was provided, on average, 3 years after the onset of stroke. Most improvements would have already occurred by this time. The intervention might have been more effective if targeted towards people with less severe physical and cognitive impairments, as indicated by the authors’ pilot study. It is also uncertain to what extent depression may have contributed to residents’ lack of improvement. Sackley et al. do not state whether participants who were found to be depressed using the geriatric depression scale-15 received treatment for these symptoms.
“There is a possibility that the choice of the Barthel index as the primary outcome measure may have resulted in a type II error in this study (O’Connor et al. 2004). It is a lost opportunity not to use outcome measures with psychometric properties that complement the sophistication of the other aspects of this trial’s design.
“In summary, stroke survivors with substantial physical and cognitive impairments, depression and comorbidities who live in care homes do not benefit from brief, unidisciplinary interventions. With the limited resources available to community-based rehabilitation teams, interventions should be focused on stroke survivors who are most likely to benefit.”
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Study sponsorship: National Institute for Health Research.
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Overview:
- People who experienced frequent bullying as a 13 year old were more likely to report depression at age 18 than those who were not bullied.
- NICE guidance for depression recommends exploring bullying as a possible factor that could contribute to depression.
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 Background: Bullying can be described as behaviour that is repeated and intended to hurt someone either physically or emotionally. An estimated 40% of young people in England experience bullying at least once a year, with 8% bullied daily (Department for Education 2014).
Young people who have experienced bullying at some point are at increased risk of anxiety or depression (Bond et al. 2001). This effect can persist into adulthood: people who experienced bullying as a young person are at increased risk of mental health problems as an adult (Copeland et al. 2013).
Current advice: The NICE guideline on social and emotional wellbeing in secondary education recommends that young people should be provided with a safe environment that reduces the threat of bullying and violence. The curriculum in secondary education should promote positive behaviours and successful relationships and help to reduce disruptive behaviour and bullying.
The guideline on depression in adults recommends that interpersonal and social difficulties should be taken into account, along with mental state and associated functional difficulties, when assessing a person who may have depression.
The guideline on depression in children and young people adds that the assessment of a child or young person with depression should always involve asking the patient and their parent(s) or carer(s) directly about whether the child or young person has any experience of being bullied or abused.
The NICE pathway on social and emotional wellbeing for children and young people brings together all related NICE guidance and associated products on the area in a set of interactive topic-based diagrams.
New evidence: Bowes et al. (2015) analysed longitudinal cohort data to investigate whether a link existed between bullying during adolescence and depression in adulthood.
The authors used a sample from the Avon Longitudinal Study of Parents and Children (ALSPAC). This study enrolled pregnant women in the south west of England in 1991–2 and has followed up their 13,988 children.
This analysis comprised all children who completed a self-reported measure of bullying at age 13 years and had also completed a self-administered test on depression at age 18 years. Data on bullying at age 13 was available for 6719 people, of whom 2430 (36.2%) were bullied occasionally (less than 4 times in the past 6 months) and 1199 (17.8%) were bullied frequently (4 or more times in the past 6 months). A total of 2668 of these participants had data on depression at 18 years and were included in the sample.
People who had experienced bullying frequently as a young person were significantly more likely to be depressed as an adult than people who had not been bullied (odds ratio [OR]=3.33, 95% confidence interval [CI] 2.32 to 4.78). This association persisted after the analysis was adjusted for confounding factors such as previous depression and parental education and socioeconomic status (adjusted OR=2.32, 95% CI 1.49 to 3.63).
A multivariable logistic model suggested that 29.2% (95% CI 10.9% to 43.7%) of the total risk of depression at age 18 could be explained by bullying in adolescence.
Strengths of this study include the large sample size, long follow-up and detailed information on exposure, outcomes and confounders. However, a relatively small proportion of the original ALSPAC cohort were eligible for inclusion in this analysis, and these participants came from families of higher education and social class than the complete cohort. In addition, the measures of bullying and depression were self-reported, and residual confounding cannot be ruled out.
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Commentary by Dr Margaret DeJong, Consultant Child and Adolescent Psychiatrist, Great Ormond Street Hospital for Children:
“This study is important because it is the clearest evidence to date of a strong association between bullying in early adolescence and clinical depression in late adolescence. The longitudinal design, large sample size and good clinical measure of depression at age 18 add to the robustness of this finding.
“The researchers also examined and took account of earlier depression and of emotional and behavioural difficulties, which may predispose vulnerable individuals to both bullying and later depression. The presence of a history of early maltreatment was established, because this may link to later peer victimisation. Even after eliminating these potential ‘confounders’, the association was still statistically significant.
“It is important to emphasise that a strong association does not prove that bullying causes depression, although there are good reasons to think that it contributes in a major way. Existing clinical practice guidance for depression recommends an exploration of bullying, as well as maltreatment, as possible factors that could cause depression. This study reinforces the importance of effective anti-bullying policies in school as a preventative measure for depression.
“Future studies should ensure a sample with more diverse ethnic and social class representation, to eliminate the possible bias of this study. Risk and protective factors such as gender, sexual orientation, ethnicity, age and disability should be looked at. The impact of cyber bullying, an important new area of peer victimisation that has emerged since this study was carried out, also needs to be explored.”
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Study sponsorship: ALSPAC is funded by the UK Medical Research Council, the Wellcome Trust and the University of Bristol. This analysis was funded by the Wellcome Trust.
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Evidence summaries: new medicines form part of NICE’s service to provide high quality medicines and prescribing information to the NHS and patients in England. The summaries are aimed at commissioners, budget holders and groups such as Area Prescribing Committees to help them make informed decisions and aid local planning on the introduction of key new medicines. Evidence summaries: new medicines do not constitute formal NICE guidance but are designed to support the managed introduction of selected new medicines or new indications for existing medicines not covered by NICE’s Technology Appraisal programme.
NICE has recently published the following Evidence summaries: new medicines:
- Diabetes mellitus type 1 and type 2: insulin glargine biosimilar (Abasaglar)
Insulin glargine biosimilar (Abasaglar) is licensed for the treatment of diabetes mellitus in adults, young people and children over 2 years. Two phase III randomised controlled trials compared insulin glargine biosimilar (Abasaglar) with insulin glargine (Lantus) in people with type 1 and type 2 diabetes.
- Type 2 diabetes mellitus in adults: high-strength insulin glargine 300 units/ml (Toujeo)
Toujeo is a high-strength insulin glargine product containing 300 units/ml solution for injection in a pre-filled pen. Three phase III studies tested whether insulin glargine 300 units/ml (Toujeo) was non-inferior to insulin glargine 100 units/ml (Lantus) in terms of reduction of glycated haemoglobin and hypoglycaemia risk in adults with type 2 diabetes.
Medicines evidence commentaries form part of NICE’s Medicines Awareness Service and help contextualise important new evidence, highlighting areas that could signal a change in clinical practice. They do not constitute formal NICE guidance. These commentaries are published in NICE’s Medicines Awareness Weekly service and are available online in NICE Evidence Search.
NICE has recently published the following Medicines evidence commentaries:
Subscribe to the Medicines Awareness Service on the NICE website.
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