Just telling and selling: current limitations in the use of digital media in public health: a scoping review.

OBJECTIVE: To undertake a scoping review and to map research in the area of digital media use in public health. STUDY DESIGN: Scoping review. METHODS: PubMed, PsycINFO, Google and major textbooks of public health communication and health psychology were searched for primary studies or systematic reviews examining the use of digital media in a health context. Searches focussed on studies published between the start of 2000 and the end of June 2013. Abstracts of reviews of public health interventions were examined with respect to target groups, health topic, intervention characteristics, media used, study design, issues of quality and ethics, and outcomes. To map this area of work fully, this information was supplemented by adding information from primary studies. Areas were identified where systematic review evidence was scarce or non-existent by comparing the final map with information from the reviews analysed. RESULTS: 221 systematic reviews related to digital media use in a public health context were included. Most reviews included studies with an experimental design and general 'at risk' target populations. Specific settings were not specified in the majority of reviews. A large variety of health topics were covered. About a quarter of reviews did not specify a health topic but were concerned with broader issues of health promotion, disease prevention, or health education. Over half of the reviews focussed on eHealth and telemedicine, and another third were concerned with mass media - social marketing. Reviews most frequently reported behaviour-related outcomes or conducted some form of content analysis or analysis of the use of particular media. Research gaps were identified relating to community-based research, participation and empowerment, active media use (especially with respect to visual media und use of specific visual methodologies), and the use of salutogenic or assets-based approaches. CONCLUSION: The available research relating to digital media use in public health is dominated by studies relating to eHealth, telehealth or social marketing; emphasising the passive reception of messages and a focus on individual behaviour change approaches. Issues of quality and ethics need to be taken into account more consistently. Further research is needed with respect to more participatory methods, particularly those which would seek to use digital media as a means to harness individual and community assets.

[Epidemiology of chronic non-malignant pain in Germany]. / Epidemiologie von nicht tumorbedingten chronischen Schmerzen in Deutschland.

BACKGROUND: Although chronic pain is a common health problem, epidemiological data are rare. The aim of this study is to present information on chronic, non-malignant pain in Germany. METHODS: In order to identify relevant studies on chronic pain (> 3 months) a total of 7 databases were searched in the timeframe from 1995 to 2009. Representative, recent, comprehensive and valid studies were selected. RESULTS: The prevalence of chronic pain in Germany is estimated to be 17% and varies according to the underlying cause of the disease. Neck, shoulder and back pain are the most common forms. Chronic pain has a direct impact on quality of life (QoL), days off work and costs. A variety of drugs and non-drug treatments are used. However, treatment is often inadequate with 13-51% of the patients receiving insufficient pain therapy. CONCLUSIONS: Chronic pain is a common problem which influences the QoL of patients resulting in high costs for the health system. Treatment is often inadequate. More research is needed to close knowledge gaps. The transfer of research results into clinical practice should be improved.

Routine hospital admission versus out-patient or home care in children at diagnosis of type 1 diabetes mellitus.

BACKGROUND: In many places, children newly diagnosed with type 1 diabetes mellitus are admitted to hospital for metabolic stabilisation and training, even if they are not acutely ill. Out-patient or home based management of these children could avoid the stress associated with a hospital stay, could provide a more natural learning environment for the child and its family, and might reduce costs for both the health care system and the families. OBJECTIVES: To assess the effects of routine hospital admission compared to out-patient or home-based management in children newly diagnosed with type 1 diabetes mellitus. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, EMBASE, CINAHL, and the British Nursing Index. Additionally, we searched reference lists of relevant studies identified and contacted one of the trialists about further studies. SELECTION CRITERIA: Comparative studies of initial hospitalisation compared to home-based and/or out-patient management in children with newly diagnosed type 1 diabetes. DATA COLLECTION AND ANALYSIS: Studies were independently selected by two reviewers. Data extraction and quality assessment of trials were done independently by two reviewers. Authors of included studies were contacted for missing information. Results were summarised descriptively, using tables and text. MAIN RESULTS: Seven studies were included in the review, including a total of 298 children in the out-patient/home group. The one high quality trial identified suggested that home-based management of children with newly diagnosed type 1 diabetes may lead to slightly improved long term metabolic control (at two and three years follow-up). No differences between comparison groups were found in any of the psychosocial and behavioural variables assessed or in rates of acute diabetic complications within two years. Parental costs were found to be decreased, while health system costs were increased, leaving total social costs virtually unchanged. None of the other studies assessing metabolic control found a difference between the comparison groups. There seemed to be no differences in hospitalisations or acute diabetic complications between the out-patient/home groups and the hospital groups. AUTHORS' CONCLUSIONS: Due to the generally low quality or limited applicability of the studies identified, the results of this review are inconclusive. On the whole, the data seem to suggest that where adequate out-patient/home management of type 1 diabetes in children at diagnosis can be provided, this does not lead to any disadvantages in terms of metabolic control, acute diabetic complications and hospitalisations, psychosocial variables and behaviour, or total costs.

Rosiglitazone for type 2 diabetes mellitus.

BACKGROUND: Diabetes has long been recognised as a strong, independent risk factor for cardiovascular disease, a problem which accounts for approximately 70% of all mortality in people with diabetes. Prospective studies show that compared to their non-diabetic counterparts, the relative risk of cardiovascular mortality for men with diabetes is two to three and for women with diabetes is three to four. The two biggest trials in type 2 diabetes, the United Kingdom Prospective Diabetes Study (UKPDS) and the University Group Diabetes Program (UGDP) study did not reveal a reduction of cardiovascular endpoints through improved metabolic control. Theoretical benefits of the peroxisome proliferator activated receptor gamma (PPAR-gamma) activator rosiglitazone on endothelial function and cardiovascular risk factors might result in fewer macrovascular disease events in people with type 2 diabetes mellitus. OBJECTIVES: To assess the effects of rosiglitazone in the treatment of type 2 diabetes. SEARCH STRATEGY: Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library. SELECTION CRITERIA: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 24 weeks. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. Pooling of studies by means of fixed-effects meta-analysis could be performed for adverse events only. MAIN RESULTS: Eighteen trials which randomised 3888 people to rosiglitazone treatment were identified. Longest duration of therapy was four years with a median of 26 weeks. Published studies of at least 24 weeks rosiglitazone treatment in people with type 2 diabetes mellitus did not provide evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. Metabolic control measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint did not demonstrate clinically relevant differences to other oral antidiabetic drugs. Occurrence of oedema was significantly raised (OR 2.27, 95% confidence interval (CI) 1.83 to 2.81). The single large RCT (ADOPT - A Diabetes Outcomes Progression Trial) indicated increased cardiovascular risk. New data on raised fracture rates in women reveal extensive action of rosiglitazone in various body tissues. AUTHORS' CONCLUSIONS: New studies should focus on patient-oriented outcomes to clarify the benefit-risk ratio of rosiglitazone therapy. Safety data and adverse events of all investigations (published and unpublished) should be made available to the public.

Autologous cartilage implantation for full thickness articular cartilage defects of the knee.

BACKGROUND: Treatments for managing articular cartilage defects of the knee, including drilling and abrasion arthroplasty, are not always effective. When they are, long-term benefits may not be maintained and osteoarthritis may develop, resulting in the need for a total knee replacement. An alternative is the surgical implantation of healthy cartilage cells into damaged areas (autologous cartilage implantation). OBJECTIVES: To determine the effectiveness of autologous cartilage implantation (ACI) in people with full thickness articular cartilage defects of the knee. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (15 December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2005), MEDLINE (1966 to December 2005), CINAHL (1982 to December Week 2, 2004), EMBASE (1988 to 2005 Week 50), SPORTDiscus (1830 to January 2005) and the National Research Register Issue 3, 2005. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing ACI with any other type of treatment (including no treatment or placebo) for symptomatic cartilage defects of the medial or lateral femoral condyle, femoral trochlea or patella. DATA COLLECTION AND ANALYSIS: Two review authors selected studies for inclusion independently. We assessed study quality based on adequacy of the randomisation process, adequacy of the allocation concealment process, potential for selection bias after allocation and level of masking. Data was not pooled due to clinical and methodological heterogeneity in the studies. MAIN RESULTS: We included four randomised controlled trials (266 participants). One trial of ACI versus mosaicplasty reported statistically significant results for ACI at one year, but only in a post-hoc subgroup analysis of participants with medial condylar defects; 88% had excellent or good results with ACI versus 69% with mosaicplasty. A second trial of ACI versus mosaicplasty found no statistically significant difference in clinical outcomes at two years. There was no statistically significant difference in outcomes at two years in a trial comparing ACI with microfracture. In addition, one trial of matrix-guided ACI versus microfracture did not contain enough long-term results to reach definitive conclusions. AUTHORS' CONCLUSIONS: The use of ACI and other chondral resurfacing techniques is becoming increasingly widespread. However, there is at present no evidence of significant difference between ACI and other interventions. Additional good quality randomised controlled trials with long-term functional outcomes are required.

Pioglitazone for type 2 diabetes mellitus.

BACKGROUND: Diabetes has long been recognised as a strong, independent risk factor for cardiovascular disease, a problem which accounts for approximately 70% of all mortality in people with diabetes. Prospective studies show that compared to their non-diabetic counterparts, the relative risk of cardiovascular mortality for men with diabetes is two to three and for women with diabetes is three to four. The two biggest trials in type 2 diabetes, the United Kingdom Prospective Diabetes Study (UKPDS) and the University Group Diabetes Program (UGDP) study did not reveal a reduction of cardiovascular endpoints through improved metabolic control. Theoretical benefits of the newer peroxisome proliferator activated receptor gamma (PPAR-gamma) activators like pioglitazone on endothelial function and cardiovascular risk factors might result in fewer macrovascular disease events in people with type 2 diabetes mellitus. OBJECTIVES: To assess the effects of pioglitazone in the treatment of type 2 diabetes. SEARCH STRATEGY: Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library. The last search was conducted in August 2006. SELECTION CRITERIA: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 24 weeks. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. Pooling of studies by means of random-effects meta-analysis could be performed for adverse events only. MAIN RESULTS: Twenty-two trials which randomised approximately 6200 people to pioglitazone treatment were identified. Longest duration of therapy was 34.5 months. Published studies of at least 24 weeks pioglitazone treatment in people with type 2 diabetes mellitus did not provide convincing evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. Metabolic control measured by glycosylated haemoglobin A1c (HbA1c) as a surrogate endpoint did not demonstrate clinically relevant differences to other oral antidiabetic drugs. Occurrence of oedema was significantly raised. The results of the single trial with relevant clinical endpoints (Prospective Pioglitazone Clinical Trial In Macrovascular Events--PROactive study) have to be regarded as hypothesis-generating and need confirmation. AUTHORS' CONCLUSIONS: Until new evidence becomes available, the benefit-risk ratio of pioglitazone remains unclear. Different therapeutic indications for pioglitazone of the two big U.S. and European drug agencies should be clarified to reduce uncertainties amongst patients and physicians.

Clinical and cost-effectiveness of autologous chondrocyte implantation for cartilage defects in knee joints: systematic review and economic evaluation.

OBJECTIVE: To support a review of the guidance issued by the National Institute for Health and Clinical Excellence (NICE) in December 2000 by examining the current clinical and cost-effectiveness evidence on autologous cartilage transplantation. DATA SOURCES: Electronic databases. REVIEW METHODS: Evidence on clinical effectiveness was obtained from randomised trials, supplemented by data from selected observational studies for longer term results, and for the natural history of chondral lesions. Because of a lack of long-term results on outcomes such as later osteoarthritis and knee replacement, only illustrative modelling was done, using a range of assumptions that seemed reasonable, but were not evidence based. RESULTS: Four randomised controlled trials were included, as well as observational data from case series. The trials studied a total of 266 patients and the observational studies up to 101 patients. Two studies compared autologous chondrocyte implantation (ACI) with mosaicplasty, the third compared ACI with microfracture, and the fourth compared matrix-guided ACI (MACI) with microfracture. Follow-up was 1 year in one study, and up to 3 years in the remaining three studies. The first trial of ACI versus mosaicplasty found that ACI gave better results than mosaicplasty at 1 year. Overall, 88% had excellent or good results with ACI versus 69% with mosaicplasty. About half of the biopsies after ACI showed hyaline cartilage. The second trial of ACI versus mosaicplasty found little difference in clinical outcomes at 2 years. Disappointingly, biopsies from the ACI group showed fibrocartilage rather than hyaline cartilage. The trial of ACI versus microfracture also found only small differences in outcomes at 2 years. Finally, the trial of MACI versus microfracture contained insufficient long-term results at present, but the study does show the feasibility of doing ACI by the MACI technique. It also suggested that after ACI, it takes 2 years for full-thickness cartilage to be produced. Reliable costs per quality-adjusted life-year (QALY) could not be calculated owing to the absence of necessary data. Simple short-term modelling suggests that the quality of life gain from ACI versus microfracture would have to be between 70 and 100% greater over 2 years for it to be more cost-effective within the 20,000--30,000 pounds sterling per QALY cost-effectiveness thresholds. However, if the quality of life gains could be maintained for a decade, increments relative to microfracture would only have to be 10--20% greater to justify additional treatment costs within the cost-effectiveness band indicated above. Follow-up from the trials so far has only been up to 2 years, with longer term outcomes being uncertain. CONCLUSIONS: There is insufficient evidence at present to say that ACI is cost-effective compared with microfracture or mosaicplasty. Longer term outcomes are required. Economic modelling using some assumptions about long-term outcomes that seem reasonable suggests that ACI would be cost-effective because it is more likely to produce hyaline cartilage, which is more likely to be durable and to prevent osteoarthritis in the longer term (e.g. 20 years). Further research is needed into earlier methods of predicting long-term results. Basic science research is also needed into factors that influence stem cells to become chondrocytes and to produce high-quality cartilage, as it may be possible to have more patients developing hyaline cartilage after microfracture. Study is also needed into cost-effective methods of rehabilitation and the effect of early mobilisation on cartilage growth.

Ventilatory effects of 8 h of isocapnic hypoxia with and without beta-blockade in humans.

This study investigated whether changing sympathetic activity, acting via beta-receptors, might induce the progressive ventilatory changes observed in response to prolonged hypoxia. The responses of 10 human subjects to four 8-h protocols were compared: 1) isocapnic hypoxia (end-tidal PO2 = 50 Torr) plus 80-mg doses of oral propranolol; 2) isocapnic hypoxia, as in protocol 1, with oral placebo; 3) air breathing with propranolol; and 4) air breathing with placebo. Exposures were conducted in a chamber designed to maintain end-tidal gases constant by computer control. Ventilation (VE) was measured at regular intervals throughout. Additionally, the subjects' ventilatory hypoxic sensitivity and their residual VE during hyperoxia (5 min) were assessed at 0, 4, and 8 h by using a dynamic end-tidal forcing technique. beta-Blockade did not significantly alter either the rise in VE seen during 8 h of isocapnic hypoxia or the changes observed in the acute hypoxic ventilatory response and residual VE in hyperoxia over that period. The results do not provide evidence that changes in sympathetic activity acting via beta-receptors play a role in the mediation of ventilatory changes observed during 8 h of isocapnic hypoxia.

Human ventilatory response to 8 h of euoxic hypercapnia.

Ventilation (VE) rises throughout 40 min of constant elevated end-tidal PCO2 without reaching steady state (S. Khamnei and P. A. Robbins. Respir. Physiol. 81: 117-134, 1990). The present study investigates 8 h of euoxic hypercapnia to determine whether VE reaches steady state within this time. Two protocols were employed: 1) 8-h euoxic hypercapnia (end-tidal PCO2 = 6.5 Torr above prestudy value, end-tidal PO2 = 100 Torr) followed by 8-h poikilocapnic euoxia; and 2) control, where the inspired gas was air. VE was measured over a 5-min period before the experiment and then hourly over a 16-h period. In the hypercapnia protocol, VE had not reached a steady state by the first hour (P < 0.001, analysis of variance), but there were no further significant differences in VE over hours 2-8 (analysis of variance). VE fell promptly on return to eucapnic conditions. We conclude that, whereas there is a component of the VE response to hypercapnia that is slow, there is no progressive rise in VE throughout the 8-h period.

Human ventilatory response to acute hyperoxia during and after 8 h of both isocapnic and poikilocapnic hypoxia.

During 8 h of either isocapnic or poikilocapnic hypoxia, there may be a rise in ventilation (VE) that cannot be rapidly reversed with a return to higher PO2 (L. S. G. E. Howard and P. A. Robbins. J. Appl. Physiol. 78:1098-1107, 1995). To investigate this further, three protocols were compared: 1) 8-h isocapnic hypoxia [end-tidal PCO2 (PETCO2) held at prestudy value, end-tidal PO2 (PETO2) = 55 Torr], followed by 8-h isocapnic euoxia (PETO2 = 100 Torr); 2) 8-h poikilocapnic hypoxia followed by 8-h poikilocapnic euoxia; and 3) 16-h air-breathing control. Before and at intervals throughout each protocol, the VE response to eucapnic hyperoxia (PETCO2 held 1-2 Torr above prestudy value, PETO2 = 300 Torr) was determined. There was a significant rise in hyperoxic VE over 8 h during both forms of hypoxia (P < 0.05, analysis of variance) that persisted during the subsequent 8-h euoxic period (P < 0.05, analysis of variance). These results support the notion that an 8-h period of hypoxia increases subsequent hyperoxic VE, even if acid-base changes have been minimized through maintenance of isocapnia during the hypoxic period.

Iodine supplementation for preventing iodine deficiency disorders in children.

BACKGROUND: Iodine deficiency is the main cause of potentially preventable mental retardation in childhood, as well as causing goitre and hypothyroidism in people of all ages. It is still prevalent in large parts of the world. OBJECTIVES: To assess the effects of iodine supplementation overall, and of different forms and dosages of iodine supplementation separately, in the prevention of iodine deficiency disorders in children. SEARCH STRATEGY: The Cochrane Library, MEDLINE, EMBASE and reference lists, databases of ongoing trials and the Internet were searched. Date of latest search: October 2003. SELECTION CRITERIA: We included randomised controlled trials and prospective controlled trials not using randomisation of iodine supplementation in children living in areas of iodine deficiency. DATA COLLECTION AND ANALYSIS: Two reviewers did the initial data selection and quality assessment of trials independently. As the studies identified were not sufficiently similar and not of sufficient quality, we did not do a meta-analysis but summarised the data in a narrative format. MAIN RESULTS: Twenty-six prospective controlled trials were related to our question, assessing a total of 29613 children. Twenty of them were classified as being of low quality, six of moderate quality. Most studies used iodised oil as a supplement, but other supplements were also used. The intervention groups were compared to a non-supplemented control group, different doses or different forms of iodine supplementation. There was a clear tendency towards goitre reduction with iodine supplementation; this was significant in several studies. Significant differences in physical development were not seen, except in one study. Results for differences in cognitive and psychomotor measures were mixed, with only few studies showing a positive intervention effect. One study suggested that infant mortality was lowered after iodine supplementation. Most studies showed a significant increase in urinary iodine excretion and levels recommended by the WHO were reached in most cases after supplementation. Thyroid-stimulating hormone (TSH) levels were significantly reduced in one study. In 1.8% of the children investigated, adverse effects were found, most of them were minor and transient. REVIEWERS' CONCLUSIONS: Despite most of the included studies being of low quality, the results suggest that iodine supplementation, especially iodised oil, is an effective means of decreasing goitre rates and improving iodine status in children. Indications of positive effects on physical and mental development and mortality were seen, although results were not always significant. Adverse effects were generally minor and transient. Insufficient evidence was available on non-oil supplements. High quality controlled studies investigating relevant long term outcome measures are needed to address the question of the best form of iodine supplementation in different population groups and settings.

Routine hospital admission versus out-patient or home care in children at diagnosis of type 1 diabetes mellitus.

BACKGROUND: In many places, children newly diagnosed with type 1 diabetes mellitus are admitted to hospital for metabolic stabilisation and training, even if they are not acutely ill. Out-patient or home based management of these children could avoid the stress associated with a hospital stay, could provide a more natural learning environment for the child and its family, and might reduce costs for both the health care system and the families. OBJECTIVES: To assess the effects of routine hospital admission compared to out-patient or home-based management in children newly diagnosed with type 1 diabetes who are not acutely ill, on metabolic control, wellbeing and self-efficacy of the patient and his/her family. SEARCH STRATEGY: We searched the Cochrane Library (including the Cochrane Controlled Trials Register), Medline, Embase, Cinahl, and the British Nursing Index. Additionally, we searched reference lists of relevant studies identified and contacted one of the trialists about further studies. Date of latest search: February 2003. SELECTION CRITERIA: Comparative studies of initial hospitalisation compared to home-based and/or out-patient management in children with newly diagnosed type 1 diabetes. DATA COLLECTION AND ANALYSIS: Studies were independently selected by two reviewers. Data extraction and quality assessment of trials were done independently by two reviewers. Any differences in opinion were resolved by discussion. Authors of included studies were contacted for missing information. Results were summarised descriptively, using tables and text. MAIN RESULTS: Six studies were included in the review, including a total of 237 children in the out-patient/home group. Two studies were randomised controlled trials, three were retrospective cohort studies, and one was a prospective cohort study. Except for one randomised controlled trial that included children in the intervention group who were initially hospitalised for a brief period, studies were of low quality. The one high quality trial identified suggested that home-based management of children with newly diagnosed type 1 diabetes may lead to slightly improved long term metabolic control (at two and three years follow-up). No differences between comparison groups were found in any of the psychosocial and behavioural variables assessed or in rates of acute diabetic complications within two years. Parental costs were found to be decreased, while health system costs were increased, leaving total social costs virtually unchanged. None of the other studies assessing metabolic control found a difference between the comparison groups. There seemed to be no differences in hospitalisations or acute diabetic complications between the out-patient/home groups and the hospital groups. Results with respect to psychosocial and behavioural variables were inconclusive, with only one study finding significant results on some selected subscales of tests used. In another study, the out-patient/home group did significantly better on the assessments of treatment adherence, familial relationship and sociability, but upon further analysis this only seemed to apply to selected socioeconomic subgroups, with no clear explanations offered. REVIEWER'S CONCLUSIONS: Due to the generally low quality or limited applicability of the studies identified, the results of this review are inconclusive. On the whole, the data seem to suggest that out-patient/home management of type 1 diabetes in children at diagnosis does not lead to any disadvantages in terms of metabolic control, acute diabetic complications and hospitalisations, psychosocial variables and behaviour, or total costs. Primary research, ideally a high quality randomised controlled trial, is required.

Fish oil in people with type 2 diabetes mellitus.

BACKGROUND: People with type 2 diabetes mellitus are at increased risk from cardiovascular disease. Dietary fish oils are known to reduce triglyceride levels, but their impact on cholesterol levels, glycemic control and vascular outcomes are not well known. OBJECTIVES: To determine the effects of fish oil supplementation on cardiovascular outcomes, cholesterol levels and glycemic control in people with type 2 diabetes mellitus. SEARCH STRATEGY: We carried out a comprehensive search of the Cochrane Controlled Trials Register, Medline, Embase, Lilacs, bibliographies of relevant papers and contacted experts for identifying additional trials. Date of last search: September 2000. SELECTION CRITERIA: All randomized placebo-controlled trials in which fish oil supplementation was the only intervention in people with type 2 diabetes were included. Authors were contacted for missing information. DATA COLLECTION AND ANALYSIS: Three investigators performed data extraction and quality scoring independently with discrepancies resolved by consensus. MAIN RESULTS: Eighteen trials including 823 participants followed for a mean of 12 weeks were included. Doses of fish oil used ranged from 3 to 18 g/day. No trials with vascular event or mortality endpoints were identified. The outcomes studied were glycemic control and lipid levels. Meta-analysis of pooled data demonstrated a statistically significant effect of fish oil in lowering triglycerides by 0.56 mmol/l (95% CI -0.71 to -0.40 mmol/l) and raising LDL cholesterol by 0.21 mmol/l (95% CI 0.02 to 0.41 mmol/l). No statistically significant effect was observed for fasting glucose, HbA1c, total or HDL cholesterol. The triglyceride lowering effect and the elevation in LDL cholesterol were most marked in those trials that recruited people with hypertriglyceridemia and used higher doses of fish oil. No adverse effects of the intervention were reported. REVIEWER'S CONCLUSIONS: Fish oil supplementation in type 2 diabetes lowers triglycerides, may raise LDL cholesterol (especially in hypertriglyceridemic patients on higher doses of fish oil) and has no statistically significant effect on glycemic control. Trials with vascular event or mortality defined endpoints are needed.

Iodised salt for preventing iodine deficiency disorders.

BACKGROUND: Iodine deficiency is the main cause for potentially preventable mental retardation in childhood, as well as causing goitre and hypothyroidism in people of all ages. It is still prevalent in large parts of the world. OBJECTIVES: To assess the effects of iodised salt in comparison with other forms of iodine supplementation or placebo in the prevention of iodine deficiency disorders. SEARCH STRATEGY: We searched the Cochrane Library, Medline, the Register of Chinese trials developed by the Chinese Cochrane Centre, and the Chinese Med Database. We performed handsearching of a number of journals (Chinese Journal of Control of Endemic Diseases, Chinese Journal of Epidemiology, Chinese Journal of Preventive Medicine, and Studies of Trace Elements and Health up to February 2001), and searched reference lists, databases of ongoing trials and the Internet. Date of latest search: November 2001. SELECTION CRITERIA: We included prospective controlled studies of iodised salt versus other forms of iodine supplementation or placebo in people living in areas of iodine deficiency. Studies reported mainly goitre rates and urinary iodine excretion as outcome measures. DATA COLLECTION AND ANALYSIS: The initial data selection and quality assessment of trials was done independently by two reviewers. Subsequently, after the scope of the review was slightly widened from including only randomised controlled trials to including non-randomised prospective comparative studies, a third reviewer repeated the trials selection and quality assessment. As the studies identified were not sufficiently similar and not of sufficient quality, we did not do a meta-analysis but summarised the data in a narrative format. MAIN RESULTS: We found six prospective controlled trials relating to our question. Four of these were described as randomised controlled trials, one was a prospective controlled trial that did not specify allocation to comparison groups, and one was a repeated cross-sectional study comparing different interventions. Comparison interventions included non-iodised salt, iodised water, iodised oil, and salt iodisation with potassium iodide versus potassium iodate. Numbers of participants in the trials ranged from 35 to 334; over 20,000 people were included in the cross-sectional study. Three studies were in children only, two investigated both groups of children and adults and one investigated pregnant women. There was a tendency towards goitre reduction with iodised salt, although this was not significant in all studies. There was also an improved iodine status in most studies (except in small children in one of the studies), although urinary iodine excretion did not always reach the levels recommended by the WHO. None of the studies observed any adverse effects of iodised salt. REVIEWER'S CONCLUSIONS: The results suggest that iodised salt is an effective means of improving iodine status. No conclusions can be made about improvements in other, more patient-oriented outcomes, such as physical and mental development in children and mortality. None of the studies specifically investigated development of iodine-induced hyperthyroidism, which can be easily overlooked if just assessed on the basis of symptoms. High quality controlled studies investigating relevant long term outcome measures are needed to address questions of dosage and best means of iodine supplementation in different population groups and settings.

[Aetiological diagnosis of cerebral infarction in a county hospital]. / Diagnóstico etiológico del infarto cerebral en el hospital comarcal.

INTRODUCTION: Cerebral infarction (CI) can be classified aetiologically in several different ways using explicit diagnostic criteria. However, the extent to which these diagnostic criteria are actually implemented in clinical practice is unknown. Aims. The aim of this study was to analyse the management and use of diagnostic tests in the aetiological diagnosis of CI in two county hospitals and to compare this with the most common recommendations. We also sought to analyse the clinical and demographic variables that may help to explain why these guidelines are not followed. PATIENTS AND METHODS: We reviewed the discharge abstracts of 307 cases of CI attended in two county hospitals between 1999 and 2000 and we analysed the clinical data, diagnostic tests and the final diagnosis. The diagnoses were reorganised using the TOAST, Laussane, NINDS and SEN 98 classifications and we analysed the frequency with which the diagnostic tests were employed in each aetiological subtype. RESULTS: Average age: 71.3 years; 59.3% were males. CAT scans were performed in 97.1% of cases, neurosonology was used in 40.1% and echocardiography was performed in 8.5%. The aetiological diagnosis was: atherothrombotic 22.4%, cardioembolic 10.7%, lacunar 26%, unusual causes 0.3% and unknown causes 1.6%. In 37.4% of cases the diagnosis was given as unspecified CI. On reclassifying the diagnoses according to SEN 98 criteria, we obtained the following: atherothrombotic 19.5%, cardioembolic 2.8%, lacunar 13.7% and of unknown origin 63.5%. 0.6% of the cases were unclassifiable. Factors that exerted an influence on the fact that diagnostic tests were less frequently carried out included age, level of awareness and mortality. The most frequent cause of incomplete studies was the absence of carotid Doppler. CONCLUSIONS: The guidelines for aetiological diagnosis of CI are not often followed. Systematic performance of a neurosonological study would improve aetiological diagnosis of CI.

Faecal calprotectin testing for differentiating amongst inflammatory and non-inflammatory bowel diseases: systematic review and economic evaluation.

BACKGROUND: Irritable bowel syndrome (IBS) is common, and causes pain, bloating and diarrhoea and/or constipation. It is a troublesome condition that reduces the quality of life but causes no permanent damage. Inflammatory bowel disease (IBD) comprises mainly ulcerative colitis (UC) and Crohn's disease (CD). Both cause serious complications and may lead to sections of the bowel having to be removed, although this is more common with CD. The presenting symptoms of IBS and IBD can be similar. Distinguishing them on clinical signs and symptoms can be difficult. Until recently, colonoscopy was often required to rule out IBD. In younger people, > 60% of colonoscopies showed no abnormality. Faecal calprotectin (FC) is a protein released by the white blood cells, neutrophils, found in inflamed areas of the bowel in IBD. Determining the level of FC in stool samples may help distinguish IBS from IBD. OBJECTIVE: To review the value of FC for distinguishing between IBD and non-IBD. DATA SOURCES: Sources included MEDLINE, EMBASE, The Cochrane Library, Web of Science, websites of journals and the European Crohn's and Colitis Organisation (conference abstracts 2012 and 2013), and contact with experts. REVIEW METHODS: Systematic review and economic modelling. Review Manager (RevMan) version 5.2 (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for most analysis, with statistical analyses done in Stata version 12 (StataCorp LP, College Station, TX, USA). Forest plots and receiver operating characteristic curves were produced. Quality Assessment of Diagnostic Accuracy Studies was used for quality assessment. Economic modelling was done in Microsoft Excel 2010 (Microsoft Corporation, Redmond, WA, USA). LIMITATIONS: Studies were often small, most used only one calprotectin cut-off level, and nearly all came from secondary care populations. RESULTS: Twenty-eight studies provided data for 2 × 2 tables and were included in meta-analyses, with seven in the most important comparison in adults (IBS vs. IBD) and eight in the key comparison in paediatrics (IBD vs. non-IBD). Most studies used laboratory enzyme-linked immunosorbent assay (ELISA) tests. For distinguishing between IBD and IBS in adults, these gave pooled sensitivity of 93% and specificity of 94% at FC cut-off level of 50 µg/g. Sensitivities at that cut-off ranged from 83% to 100%, and specificities from 60% to 100%. For distinguishing between IBD and non-IBD in paediatric populations with ELISA tests, sensitivities ranged from 95% to 100% at cut-off of 50 µg/g and specificities of 44-93%. Few studies used point-of-care testing but that seemed as reliable as ELISA, though perhaps less specific. The evidence did not provide any grounds for preferring one test over others on clinical effectiveness grounds. FC testing in primary care could reduce the need for referral and colonoscopies. Any quality-adjusted life-year gains are likely to be small because of the low prevalence of IBD and the high sensitivities of all of the tests, resulting in few false negatives with IBD. However, considerable savings could accrue. Areas of uncertainty include the optimum management of people with borderline results (50-150 µg/g), most of whom do not have IBD. Repeat testing may be appropriate before referral. CONCLUSIONS: Faecal calprotectin can be a highly sensitive way of detecting IBD, although there are inevitably trade-offs between sensitivity and specificity, with some false positives (IBS with positive calprotectin) if a low calprotectin cut-off is used. In most cases, a negative calprotectin rules out IBD, thereby sparing most people with IBS from having to have invasive investigations, such as colonoscopy. STUDY REGISTRATION: PROSPERO CRD 42012003287. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Insulin sensitisers in the treatment of non-alcoholic fatty liver disease: a systematic review.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is closely linked with obesity and the prevalence of NAFLD is about 17% to 33% in the Western world. There is a strong association of NAFLD with insulin resistance and, hence, insulin sensitisers have been tried. This systematic review examined the clinical effectiveness of insulin sensitisers in patients with NAFLD, to help decide whether or not a trial or trials of the insulin sensitisers was necessary and also to explore whether or not non-invasive alternatives to liver biopsy were available that could be used in a large trial of the insulin sensitisers. OBJECTIVE: To review the use of insulin sensitisers in the treatment of NAFLD. REVIEW METHODS: A systematic review of the clinical effectiveness of metformin, rosiglitazone and pioglitazone was carried out, including reviews and randomised controlled trials (RCTs). Databases searched were MEDLINE, 1950 to June 2010; EMBASE, 1980 to June 2010; Science Citation Index Expanded, June 2010; Conference Proceedings Citation Index - Science June 2010; The Cochrane Library 2005-10. Abstracts were screened independently by two researchers. A narrative review of diagnostic methods was conducted. RESULTS: Clinical effectiveness. We identified 15 RCTs (one available as abstract). Four papers explored efficacy of pioglitazone, one rosiglitazone, eight metformin; two compared metformin and rosiglitazone, although one used both metformin and rosiglitazone. The duration of most trials was between 6 and 12 months. Many trials had a small number of participants and the quality of the studies was mixed. Pioglitazone improved all parameters of liver histology. Metformin showed mixed results, with ultrasound changes in two studies showing some improvement in steatosis, whereas there were no changes in the other two. Metformin, however, showed no improvement in non-alcoholic steatohepatitis (NASH) stages. Metformin showed greater reduction in glycosylated haemoglobin (-0.23% to -1.2% vs -0.2% to -0.7%) and fasting plasma glucose (+0.05 to -3.19 mmol/l vs -0.17 to -1.11 mmol/l) compared with pioglitazone. Metformin led to weight reduction (-4.3 to -6.7 kg), whereas participants on pioglitazone gained weight (+2.5 to +4.7 kg). Alanine aminotransferase levels were reduced with both metformin and pioglitazone; however, the reduction in levels with pioglitazone was not different to that caused by vitamin E. Most studies suggested that metformin led to a significant reduction in insulin resistance. Diagnosis. Non-invasive methods of diagnosing NAFLD without liver biopsy, using combinations of clinical history, laboratory tests and ultrasound, have been explored, but so far liver biopsy is the only proven method of distinguishing simple steatosis from NASH. Transient elastography appears useful, but less so in obese individuals. Magnetic resonance spectroscopy shows promise, but is expensive and not readily available. LIMITATIONS: Mixed quality of trials, with lack of detail as to how some trials were conducted. Many trials had small numbers of patients. CONCLUSIONS: The main need for drug trials is at the NASH stage. However, at present, any trial in the more advanced forms of NAFLD would have to use liver biopsy. The highest priority for research may, therefore, be in the diagnosis of NAFLD, and the differentiation between steatosis and NASH. The newer agents, the glucagon-like peptide-1 analogues such as liraglutide, may be more worthy of a trial. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Self-monitoring of blood glucose in type 2 diabetes: systematic review.

OBJECTIVES: To examine whether or not self-monitoring of blood glucose (SMBG) is worthwhile, in terms of glycaemic control, hypoglycaemia, quality of life (QoL) and cost per quality-adjusted life-year (QALY), in people with type 2 diabetes (T2DM) who were not treated with insulin or who were on basal insulin in combination with oral agents. DATA SOURCES: Literature searched included systematic reviews published since 1996, and a systematic review and meta-analyses of randomised controlled trials (RCTs) identified from the reviews, and from searches for more recent trials, along with review of qualitative and economic studies. Search strategies were limited to the English language and to articles published since 1996, and included: databases searched from 1996 to April 2009 - The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science - limited to meeting abstracts; and websites. REVIEW METHODS: The intervention was self-testing of blood glucose with a meter and test strips. Studies included adult patients with T2DM on any oral treatment or combination of regimens, including lifestyle, oral agents or once-daily basal insulin. Existing systematic reviews of SMBG were summarised and results compared. Evidence synthesis of all of the studies meeting the inclusion criteria was carried out using a narrative review. Data were analysed by outcome and subgroups. HbA1c data from RCTs were summarised using a meta-analysis. Heterogeneity was calculated using the chi-squared and I2 methods. The following analyses were carried out: SMBG compared to self-monitoring of urine glucose, SMBG versus no SMBG, more intensive SMBG versus less intensive SMBG, and more intensive SMBG versus no SMBG. Available qualitative data gained from in-depth interview studies, repeated interviews, and questionnaire and survey data were summarised. RESULTS: The review identified 30 RCTs, although few were of high quality. Ten trials comparing SMBG with no SMBG showed statistically significant reduction in HbA1C of 0.21%, which may not be considered clinically significant. A similar, though not statistically significant difference, was shown where SMBG with education was compared to SMBG without education or feedback. RCTs showed no consistent effect on hypoglycaemic episodes and no impact on medication changes. Review of cost-effectiveness studies showed that costs of SMBG per annum vary considerably (10-259 pounds). Although some studies assert that SMBG may lead to savings in health-care costs which may offset the costs of testing, the best analysis to date (DiGEM - Diabetes Glycaemic Education and Monitoring) concluded that SMBG was not cost-effective. Qualitative studies revealed that there was a lack of education in how to interpret and use the data from SMBG, and that failure to act on the results was common. CONCLUSIONS: The evidence suggested that SMBG is of limited clinical effectiveness in improving glycaemic control in people with T2DM on oral agents, or diet alone, and is therefore unlikely to be cost-effective. SMBG may lead to improved glycaemic control only in the context of appropriate education - both for patients and health-care professionals - on how to respond to the data, in terms of lifestyle and treatment adjustment. Also, SMBG may be more effective if patients are able to self-adjust drug treatment. Further research is required on the type of education and feedback that are most helpful, characteristics of patients benefiting most from SMBG, optimal timing and frequency of SMBG, and the circumstances under which SMBG causes anxiety and/or depression.

Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation.

BACKGROUND: In May 2008, the National Institute for Health and Clinical Excellence (NICE) issued an updated guideline [clinical guideline (CG) 66] for the management of all aspects of type 2 diabetes. This report aims to provide information on new drug developments to support a 'new drugs update' to the 2008 guideline. OBJECTIVE: To review the newer agents available for blood glucose control in type 2 diabetes from four classes: the glucagon-like peptide-1 (GLP-1) analogue exenatide; dipeptidyl peptidase-4 (DPP-4) inhibitors sitagliptin and vildagliptin; the long-acting insulin analogues, glargine and detemir; and to review concerns about the safety of the thiazolidinediones. DATA SOURCES: The following databases were searched: MEDLINE (1990-April 2008), EMBASE (1990-April 2008), the Cochrane Library (all sections) Issue 2, 2008, and the Science Citation Index and ISI Proceedings (2000-April 2008). The websites of the American Diabetes Association, the European Association for the Study of Diabetes, the US Food and Drug Administration, the European Medicines Evaluation Agency and the Medicines and Healthcare Products Regulatory Agency were searched, as were manufacturers' websites. REVIEW METHODS: Data extraction was carried out by one person, and checked by a second. Studies were assessed for quality using standard methods for reviews of trials. Meta-analyses were carried out using the Cochrane Review Manager (RevMan) software. Inclusion and exclusion criteria were based on current standard clinical practice in the UK, as outlined in NICE CG 66. The outcomes for the GLP-1 analogues, DPP-4 inhibitors and the long-acting insulin analogues were: glycaemic control, reflected by glycated haemoglobin (HbA1c) level, hypoglycaemic episodes, changes in weight, adverse events, quality of life and costs. Modelling of the cost-effectiveness of the various regimes used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model. RESULTS: Exenatide improved glycaemic control by around 1%, and had the added benefit of weight loss. The gliptins were effective in improving glycaemic control, reducing HbA1c level by about 0.8%. Glargine and detemir were equivalent to Neutral Protamine Hagedorn (NPH) (and to each other) in terms of glycaemic control but had modest advantages in terms of hypoglycaemia, especially nocturnal. Detemir, used only once daily, appeared to cause slightly less weight gain than glargine. The glitazones appeared to have similar effectiveness in controlling hyperglycaemia. Both can cause heart failure and fractures, but rosiglitazone appears to slightly increase the risk of cardiovascular events whereas pioglitazone reduces it. Eight trials examined the benefits of adding pioglitazone to an insulin regimen; in our meta-analysis, the mean reduction in HbA1c level was 0.54% [95% confidence interval (CI) -0.70 to -0.38] and hypoglycaemia was marginally more frequent in the pioglitazone arms [relative risk (RR) 1.27, 95% CI 0.99 to 1.63]. In most studies, those on pioglitazone gained more weight than those who were not. In terms of annual drug acquisition costs among the non-insulin regimes for a representative patient with a body mass index of around 30 kg/m2, the gliptins were the cheapest of the new drugs, with costs of between 386 pounds and 460 pounds. The glitazone costs were similar, with total annual costs for pioglitazone and for rosiglitazone of around 437 pounds and 482 pounds, respectively. Exenatide was more expensive, with an annual cost of around 830 pounds. Regimens containing insulin fell between the gliptins and exenatide in terms of their direct costs, with a NPH-based regimen having an annual cost of around 468 pounds for the representative patient, whereas the glargine and detemir regimens were more expensive, at around 634 pounds and 716 pounds, respectively. Comparisons of sitagliptin and rosiglitazone, and of vidagliptin and pioglitazone slowed clinical equivalence in terms of quality-adjusted life-years (QALYs), but the gliptins were marginally less costly. Exenatide, when compared with glargine, appeared to be cost-effective. Comparing glargine with NPH showed an additional anticipated cost of around 1800 pounds. Within the comparison of detemir and NPH, the overall treatment costs for detemir were slightly higher, at between 2700 pounds and 2600 pounds. LIMITATIONS: The UKPDS Outcomes Model does not directly address aspects of the treatments under consideration, for example the direct utility effects from weight loss or weight gain, severe hypoglycaemic events and the fear of severe hypoglycaemic events. Also, small differences in QALYs among the drugs lead to fluctuations in incremental cost-effectiveness ratios. CONCLUSIONS: Exenatide, the gliptins and detemir were all clinically effective. The long-acting insulin analogues glargine and detemir appeared to have only slight clinical advantages over NPH, but had much higher costs and did not appear to be cost-effective as first-line insulins for type 2 diabetes. Neither did exenatide appear to be cost-effective compared with NPH but, when used as third drug after failure of dual oral combination therapy, exenatide appeared cost-effective relative to glargine in this analysis. The gliptins are similar to the glitazones in glycaemic control and costs, and appeared to have fewer long-term side effects. Therefore, it appears, as supported by recent NICE guidelines, that NPH should be the preferred first-line insulin for the treatment of type 2 diabetes. More economic analysis is required to establish when it becomes cost-effective to switch from NPH to a long-acting analogue. Also, long-term follow-up studies of exenatide and the gliptins, and data on combined insulin and exenatide treatment, would be useful.