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1.  Intravenous iron sucrose therapy for moderate to severe anaemia in pregnancy 
Background & objectives:
Iron deficiency anaemia (IDA) is the most common nutritional deficiency in pregnancy. Prophylactic oral iron is recommended during pregnancy to meet the increased requirement. In India, women become pregnant with low baseline haemoglobin level resulting in high incidence of moderate to severe anaemia in pregnancy where oral iron therapy cannot meet the requirement. Pregnant women with moderate anaemia are to be treated with parentral iron therapy. This study was undertaken to evaluate the response and effect of intravenous iron sucrose complex (ISC) given to pregnant women with IDA.
Methods:
A prospective study was conducted (June 2009 to June 2011) in the department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi. One hundred pregnant women with haemoglobin between 5-9 g% with diagnosed iron deficiency attending antenatal clinic were given intravenous iron sucrose complex in a dose of 200 mg twice weekly schedule after calculating the dose requirement.
Results:
The mean haemoglobin raised from 7.63 ± 0.61 to 11.20 ± 0.73 g% (P<0.001) after eight wk of therapy. There was significant rise in serum ferritin levels (from 11.2 ± 4.7 to 69 ± 23.1 μg/l) (P<0.001). Reticulocyte count increased significantly after two wk of starting therapy (from 1.5 ± 0.6 to 4.6±0.8%). Other parameters including serum iron levels and red cell indices were also improved significantly. Only one woman was lost to follow up. No major side effects or anaphylactic reactions were noted during study period.
Interpretation & conclusions:
Parentral iron therapy was effective in increasing haemoglobin, serum ferritin and other haematological parameters in pregnant women with moderate anaemia. Intravenous iron sucrose can be used in hospital settings and tertiary urban hospitals where it can replace intramuscular therapy due to injection related side effects. Further, long-term comparative studies are required to recommend its use at peripheral level.
PMCID: PMC3767254  PMID: 24056559
Anaemia; iron deficiency; iron sucrose complex; parentral iron therapy; serum ferritin
2.  Anaemia, prenatal iron use, and risk of adverse pregnancy outcomes: systematic review and meta-analysis 
Objectives To summarise evidence on the associations of maternal anaemia and prenatal iron use with maternal haematological and adverse pregnancy outcomes; and to evaluate potential exposure-response relations of dose of iron, duration of use, and haemoglobin concentration in prenatal period with pregnancy outcomes.
Design Systematic review and meta-analysis
Data sources Searches of PubMed and Embase for studies published up to May 2012 and references of review articles.
Study selection criteria Randomised trials of prenatal iron use and prospective cohort studies of prenatal anaemia; cross sectional and case-control studies were excluded.
Results 48 randomised trials (17 793 women) and 44 cohort studies (1 851 682 women) were included. Iron use increased maternal mean haemoglobin concentration by 4.59 (95% confidence interval 3.72 to 5.46) g/L compared with controls and significantly reduced the risk of anaemia (relative risk 0.50, 0.42 to 0.59), iron deficiency (0.59, 0.46 to 0.79), iron deficiency anaemia (0.40, 0.26 to 0.60), and low birth weight (0.81, 0.71 to 0.93). The effect of iron on preterm birth was not significant (relative risk 0.84, 0.68 to 1.03). Analysis of cohort studies showed a significantly higher risk of low birth weight (adjusted odds ratio 1.29, 1.09 to 1.53) and preterm birth (1.21, 1.13 to 1.30) with anaemia in the first or second trimester. Exposure-response analysis indicated that for every 10 mg increase in iron dose/day, up to 66 mg/day, the relative risk of maternal anaemia was 0.88 (0.84 to 0.92) (P for linear trend<0.001). Birth weight increased by 15.1 (6.0 to 24.2) g (P for linear trend=0.005) and risk of low birth weight decreased by 3% (relative risk 0.97, 0.95 to 0.98) for every 10 mg increase in dose/day (P for linear trend<0.001). Duration of use was not significantly associated with the outcomes after adjustment for dose. Furthermore, for each 1 g/L increase in mean haemoglobin, birth weight increased by 14.0 (6.8 to 21.8) g (P for linear trend=0.002); however, mean haemoglobin was not associated with the risk of low birth weight and preterm birth. No evidence of a significant effect on duration of gestation, small for gestational age births, and birth length was noted.
Conclusions Daily prenatal use of iron substantially improved birth weight in a linear dose-response fashion, probably leading to a reduction in risk of low birth weight. An improvement in prenatal mean haemoglobin concentration linearly increased birth weight.
doi:10.1136/bmj.f3443
PMCID: PMC3689887  PMID: 23794316
3.  Intravenous versus oral iron supplementation for correction of post-transplant anaemia in renal transplant patients 
BMC Nephrology  2009;10:14.
Background
Post-transplant anaemia remains a common problem after kidney transplantation, with an incidence ranging from nearly 80% at day 0 to about 25% at 1 year. It has been associated with poor graft outcome, and recently has also been shown to be associated with increased mortality.
Our transplant unit routinely administers oral iron supplements to renal transplant recipients but this is frequently accompanied by side effects, mainly gastrointestinal intolerance. Intravenous iron is frequently administered to dialysis patients and we sought to investigate this mode of administration in transplant recipients after noticing less anaemia in several patients who had received intravenous iron just prior to being called in for transplantation.
Methods
This study is a single-centre, prospective, open-label, randomised, controlled trial of oral versus intravenous iron supplements in renal transplant recipients and aims to recruit approximately 100 patients over a 12-month period. Patients will be randomised to receive a single dose of 500 mg iron polymaltose (intravenous iron group) or 2 ferrous sulphate slow-release tablets daily (oral iron group). The primary outcome is time to normalisation of haemoglobin post-transplant. Prospective power calculations have indicated that a minimum of 48 patients in each group would have to be followed up for 3 months in order to have a 90% probability of detecting a halving of the time to correction of haemoglobin levels to ≥110 g/l in iron-treated patients, assuming an α of 0.05. All eligible adult patients undergoing renal transplantation at the Princess Alexandra Hospital will be offered participation in the trial. Exclusion criteria will include iron overload (transferrin saturation >50% or ferritin >800 μg/l), or previous intolerance of either oral or intravenous iron supplements.
Discussion
If the trial shows a reduction in the time to correction of anaemia with intravenous iron or less side effects than oral iron, then intravenous iron may become the standard of treatment in this patient group.
doi:10.1186/1471-2369-10-14
PMCID: PMC2701932  PMID: 19500381
4.  Iron Deficiency Anaemia in Pregnancy and Postpartum: Pathophysiology and Effect of Oral versus Intravenous Iron Therapy 
Journal of Pregnancy  2012;2012:630519.
Nutritional iron-deficiency anaemia (IDA) is the most common disorder in the world, affecting more than two billion people. The World Health Organization's global database on anaemia has estimated a prevalence of 14% based on a regression-based analysis. Recent data show that the prevalence of IDA in pregnant women in industrialized countries is 17.4% while the incidence of IDA in developing countries increases significantly up to 56%. Although oral iron supplementation is widely used for the treatment of IDA, not all patients respond adequately to oral iron therapy. This is due to several factors including the side effects of oral iron which lead to poor compliance and lack of efficacy. The side effects, predominantly gastrointestinal discomfort, occur in a large cohort of patients taking oral iron preparations. Previously, the use of intravenous iron had been associated with undesirable and sometimes serious side effects and therefore was underutilised. However, in recent years, new type II and III iron complexes have been developed, which offer better compliance and toleration as well as high efficacy with a good safety profile. In summary, intravenous iron can be used safely for a rapid repletion of iron stores and correction of anaemia during and after pregnancy.
doi:10.1155/2012/630519
PMCID: PMC3389687  PMID: 22792466
5.  Comparison of routine prenatal iron prophylaxis and screening and treatment for anaemia: pregnancy results and preliminary birth results from a pragmatic randomised controlled trial (PROFEG) in Maputo, Mozambique 
BMJ Open  2013;3(2):e001948.
Objective
To present the pregnancy results and interim birth results of a pragmatic randomised controlled trial comparing routine iron prophylaxis with screening and treatment for anaemia during pregnancy in a setting of endemic malaria and HIV.
Design
A pragmatic randomised controlled trial.
Setting
Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV.
Participants
Pregnant women (≥18-year-olds; non-high-risk pregnancy, n=4326) attending prenatal care consultation at the two health centres were recruited to the trial.
Interventions
The women were randomly allocated to either Routine iron (n=2184; 60 mg ferrous sulfate plus 400 μg of folic acid daily throughout pregnancy) or Selective iron (n=2142; screening and treatment for anaemia and daily intake of 1 mg of folic acid).
Outcome measures
The primary outcomes were preterm delivery (delivery <37 weeks of gestation) and low birth weight (<2500 g). The secondary outcomes were symptoms suggestive of malaria and self-reported malaria during pregnancy; birth length; caesarean section; maternal and child health status after delivery.
Results
The number of follow-up visits was similar in the two groups. Between the first and fifth visits, the two groups were similar regarding the occurrence of fever, headache, cold/chills, nausea/vomiting and body aches. There was a suggestion of increased incidence of self-reported malaria during pregnancy (OR 1.37, 95% CI 0.98 to1.92) in the Routine iron group. Birth data were available for 1109 (51%) in the Routine iron group and for 1149 (54%) in the Selective iron group. The birth outcomes were relatively similar in the two groups. However, there was a suggestion (statistically non-significant) of poorer outcomes in the Routine iron group with regard to long hospital stay after birth (relative risk (RR) 1.43, 95% CI 0.97 to 1.26; risk difference (RD) 0.02, 95% CI −0.00 to 0.03) and unavailability of delivery data (RR 1.06, 95% CI 1.00 to 1.13; RD 0.03, 95% CI −0.01 to 0.07).
Conclusions
These interim results suggest that routine iron prophylaxis during pregnancy did not confer advantage over screening and treatment for anaemia regarding maternal and child health. Complete data on birth outcomes are being collected for firmer conclusions.
Trial registration
The trial is registered at ClinicalTrials.gov, number NCT00488579 (June 2007). The first women were randomised to the trial proper April 2007–March 2008. The pilot was November 2006–March 2008. The 3-month lag was due to technical difficulties in completing trial registration.
doi:10.1136/bmjopen-2012-001948
PMCID: PMC3585968  PMID: 23396557
Preventive Medicine; Public Health
6.  Analysis of health-related quality of life and costs based on a randomised clinical trial of escitalopram for relapse prevention in patients with generalised social anxiety disorder 
Background:
Social anxiety disorder (SAD) is associated with substantial reduction in health-related quality of life (HRQoL). Escitalopram has proven efficacy in the short-term treatment of SAD and prevention of relapse.
Objectives:
To determine whether the clinical effects of treatment translated into HRQoL benefits and to investigate costs of SAD treatment.
Methods:
Data on HRQoL and resource utilisation were collected in a previously published clinical trial of escitalopram in relapse prevention. Among 517 patients, 371 responded to 12 weeks of open-label treatment with escitalopram and were randomised to escitalopram or placebo for 24 weeks. HRQoL was assessed using the short form (SF)-36 instrument and SF-6D utilities (preference-based index scores for overall HRQoL) were calculated. Costs were calculated for responders over the acute phase and for non-relapsed patients over the continuation phase, applying UK unit costs.
Results:
Health-related quality of life was significantly improved after the acute phase when compared with baseline. The SF-6D utility increased by 0.047 in responders (p < 0.0001) and 0.021 in non-responders (p = 0.0005). Healthcare costs were non-significantly lower in acute phase than during prestudy phase (p = 0.0587 from NHS perspective), as were productivity costs (p = 0.1440). HRQoL at last visit was lower in relapsed than non-relapsed patients. The difference in utility was −0.026 (p = 0.0007). Healthcare and productivity costs were non-significantly lower in the escitalopram group than in the placebo group.
Conclusions:
Both effective acute treatment of SAD and prevention of relapse with escitalopram are associated with significant HRQoL benefits. Despite some limitations, the cost analysis suggests that savings in physician-visits and inpatient care may offset drug acquisition costs.
doi:10.1111/j.1742-1241.2008.01879.x
PMCID: PMC2704928  PMID: 18759783
7.  The effect of intravenous and oral iron administration on perioperative anaemia and transfusion requirements in patients undergoing elective cardiac surgery: a randomized clinical trial 
OBJECTIVES
Anaemia is a frequent complication after cardiopulmonary bypass surgery. Iron therapy has been variably employed by medical centres over the years. In our study we test o test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on blood transfusion requirements, in patients undergoing cardiopulmonary bypass surgery.
METHODS
A double-blind, randomized, placebo-controlled clinical trial with three parallel groups of patients. Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge. Group II (n = 53): oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge, and intravenous placebo while hospitalized. Group III (n = 52): oral and intravenous placebo pre- and postoperatively, following the same protocol. Data were collected preoperatively, at theatre, at intensive care unit admission, before hospital discharge and 1 month later.
RESULTS
(1) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups; (2) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period; (3) the intravenous iron group showed higher serum ferritin levels at hospital discharge (1321 ± 495 ng/ml; P < 0.001) and 1 month later (610 ± 387; P < 0.001) compared with the other groups and (4) we did not observe statistical differences in blood transfusion requirements between the three groups.
CONCLUSIONS
The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements. [Current Controlled Trials number: NCT01078818 (oral and intravenous iron in patients postoperative cardiovascular surgery under EC)].
doi:10.1093/icvts/ivs344
PMCID: PMC3501294  PMID: 22940889
Cardiac surgery; Intravenous iron supplement; Anaemia; Transfusions; Ineffective treatments
8.  Iron intake, haemoglobin and risk of gestational diabetes: a prospective cohort study 
BMJ Open  2012;2(5):e001730.
Objective
To investigate the possible association between total daily iron intake during pregnancy, haemoglobin in early pregnancy and the risk of gestational diabetes mellitus (GDM) in women at increased risk of GDM.
Design
A prospective cohort study (based on a cluster-randomised controlled trial, where the intervention and the usual care groups were combined).
Setting
Primary healthcare maternity clinics in 14 municipalities in south-western Finland.
Participants
399 Pregnant women who were at increased risk of GDM participated in a GDM prevention trial and were followed throughout pregnancy.
Main outcome measurements
The main outcome was GDM diagnosed with oral glucose tolerance test at 26–28 weeks’ gestation or based on a diagnosis recorded in the Finnish Medical Birth registry. Data on iron intake was collected using a 181-item food frequency questionnaire and separate questions for supplement use at 26–28 weeks’ gestation.
Results
GDM was diagnosed in 72 women (18.1%) in the study population. The OR for total iron intake as a continuous variable was 1.006 (95% CI 1.000 to 1.011; p=0.038) after adjustment for body mass index, age, diabetes in first-degree or second-degree relatives, GDM or macrosomia in earlier pregnancy, total energy intake, dietary fibre, saturated fatty acids and total gestational weight gain. Women in the highest fifth of total daily iron intake had an adjusted OR of 1.66 (95% CI 0.84 to 3.30; p=0.15) for GDM. After excluding participants with low haemoglobin levels (≤120 g/l) already in early pregnancy the adjusted OR was 2.35 (95% CI 1.13 to 4.92; p=0.023).
Conclusions
Our results suggest that high iron intake during pregnancy increases the risk of GDM especially in women who are not anaemic in early pregnancy and who are at increased risk of GDM. These findings suggest that routine iron supplementation should be reconsidered in this risk group of women.
doi:10.1136/bmjopen-2012-001730
PMCID: PMC3467630  PMID: 23015603
Gestational Diabetes; Iron Intake; Iron Supplementation; Pregnancy; Haemoglobin
9.  The effect of intravenous ferric carboxymaltose on health-related quality of life in patients with chronic heart failure and iron deficiency: a subanalysis of the FAIR-HF study 
European Heart Journal  2012;34(1):30-38.
Aims
Patients with chronic heart failure (CHF) show impaired health-related quality of life (HRQoL), an important target for therapeutic intervention. Impaired iron homeostasis may be one mechanism underlying the poor physical condition of CHF patients. This detailed subanalysis of the previously published FAIR-HF study evaluated baseline HRQoL in iron-deficient patients with CHF and the effect of intravenous ferric carboxymaltose (FCM) on HRQoL.
Methods and results
FAIR-HF randomized 459 patients with reduced left ventricular ejection fraction and iron deficiency, with or without anaemia, to FCM or placebo (2:1). Health-related quality of life was assessed at baseline and after 4, 12, and 24 weeks of therapy using the generic EQ-5D questionnaire and disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline mean Visual Analogue Scale (VAS) score was 54.3 ± 16.4 and KCCQ overall summary score was 52.4 ± 18.8. Ferric carboxymaltose significantly improved VAS and KCCQ (mean differences from baseline in KCCQ overall, clinical and total symptom scores, P< 0.001 vs. placebo) at all time points. At Week 24, significant improvement vs. placebo was observed in four of the five EQ-5D dimensions: mobility (P= 0.004), self-care (P< 0.001), pain/discomfort (P= 0.006), anxiety/depression (P= 0.012), and usual activity (P= 0.035). Ferric carboxymaltose improved all KCCQ domain mean scores from Week 4 onward (P≤ 0.05), except for self-efficacy and social limitation. Effects were present in both anaemic and non-anaemic patients.
Conclusions
HRQoL is impaired in iron-deficient patients with CHF. Intravenous FCM significantly improved HRQoL after 4 weeks, and throughout the remaining study period. The positive effects of FCM were independent of anaemia status.
doi:10.1093/eurheartj/ehr504
PMCID: PMC3533918  PMID: 22297124
Anaemia; Chronic heart failure; Health-related quality of life; Iron deficiency
10.  Milk versus medicine for the treatment of iron deficiency anaemia in hospitalised infants 
Archives of Disease in Childhood  2005;90(10):1033-1038.
Aims: To compare iron fortified follow-on milk (iron follow-on), iron fortified partially modified cows' milk (iron milk), and iron medicine for the treatment of iron deficiency anaemia (IDA) in hospitalised infants.
Methods: In a randomised controlled trial, infants aged 9–23 months with IDA and who were hospitalised with an acute illness received iron follow-on (12 mg/l ferrous iron), iron milk (12.9 mg/l ferrous iron), or iron medicine (ferrous gluconate at 3 mg/kg of elemental iron once daily). All interventions were given for three months. Changes in measures of iron status three months after hospital discharge were determined.
Results: A total of 234 infants were randomised. Iron status was measured at follow up in 59 (70%) iron medicine, 49 (66%) iron follow-on, and 54 (70%) iron milk treated infants. There was a significant (mean, 95% CI) increase in haemoglobin (15 g/l, 13 to 16) and iron saturation (9%, 8 to 10) and decrease in ferritin (–53 µg/l, –74 to –31) in all three groups. Mean cell volume increased in iron follow-on (2 fl, 1 to 3) and iron milk (1 fl, 0.1 to 3) treated infants, but not in the iron medicine group (1 fl, –1 to 2). The proportion with IDA decreased in all three groups: iron medicine 93% to 7%, iron follow-on 83% to 8%, and iron milk 96% to 30%. Adverse effects, primarily gastrointestinal, occurred in 23% of the iron medicine, 14% of the iron follow-on, and 13% of the iron milk group.
Conclusions: Iron fortified follow-on milk, iron fortified partially modified cows' milk, and iron medicine all effectively treat IDA in infancy.
doi:10.1136/adc.2004.067876
PMCID: PMC1720139  PMID: 15956047
11.  Iron Sucrose Versus Oral Iron Therapy in Pregnancy Anemia 
Background:
Iron deficiency anemia (IDA) is the most common medical problem in pregnancy. Parenteral iron is a useful treatment, although iron dextran use decreased due to anaphylaxis. Iron sucrose is a newer agent that has overcome the shortcomings of iron dextran.
Objective:
The aim of this study was to compare the efficacy and tolerance of intravenous iron sucrose (IVIS) therapy with oral iron (OI) therapy in pregnant women with IDA and to study the factors influencing treatment.
Materials and Methods:
This prospective, randomized clinical trial included pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS or OI (ferrous fumarate). All patients were monitored for laboratory response and adverse effects. Independent sample-t test, Chi square test and ANOVA were used for statistical analysis. P < 0.05 was considered significant.
Results:
Although hemoglobin increased in both the groups, increase in the reticulocyte count and percentage increase in hemoglobin was significantly higher in the IVIS group than in the OI group (23.62% vs. 14.11%). Serum ferritin was significantly higher in the IVIS group than in the OI group (P = 0.000). The IVIS group had no major side-effects. Compliance was good with OI, although 23% had gastrointestinal side-effects. Patient weight, gestation at diagnosis, initial hemoglobin and ferritin levels did not influence the response to treatment.
Conclusion:
IVIS is safe and effective in the treatment of IDA during pregnancy. Iron stores increased better with IVIS compared with OI.
doi:10.4103/0970-0218.103467
PMCID: PMC3531012  PMID: 23293433
Intravenous iron sucrose; iron deficiency anemia; oral iron; pregnancy anemia; serum ferritin
12.  Four variants in transferrin and HFE genes as potential markers of iron deficiency anaemia risk: an association study in menstruating women 
Background
Iron deficiency anaemia is a worldwide health problem in which environmental, physiologic and genetic factors play important roles. The associations between iron status biomarkers and single nucleotide polymorphisms (SNPs) known to be related to iron metabolism were studied in menstruating women.
Methods
A group of 270 Caucasian menstruating women, a population group at risk of iron deficiency anaemia, participated in the study. Haematological and biochemical parameters were analysed and 10 selected SNPs were genotyped by minisequencing assay. The associations between genetic and biochemical data were analysed by Bayesian Model Averaging (BMA) test and decision trees. Dietary intake of a representative subgroup of these volunteers (n = 141) was assessed, and the relationship between nutrients and iron biomarkers was also determined by linear regression.
Results
Four variants, two in the transferrin gene (rs3811647, rs1799852) and two in the HFE gene (C282Y, H63D), explain 35% of the genetic variation or heritability of serum transferrin in menstruating women. The minor allele of rs3811647 was associated with higher serum transferrin levels and lower transferrin saturation, while the minor alleles of rs1799852 and the C282Y and H63D mutations of HFE were associated with lower serum transferrin levels. No association between nutrient intake and iron biomarkers was found.
Conclusions
In contrast to dietary intake, these four SNPs are strongly associated with serum transferrin. Carriers of the minor allele of rs3811647 present a reduction in iron transport to tissues, which might indicate higher iron deficiency anaemia risk, although the simultaneous presence of the minor allele of rs1799852 and HFE mutations appear to have compensatory effects. Therefore, it is suggested that these genetic variants might potentially be used as markers of iron deficiency anaemia risk.
doi:10.1186/1743-7075-8-69
PMCID: PMC3195693  PMID: 21978626
Transferrin gene; HFE gene; serum transferrin; transferrin saturation; iron deficiency anaemia; SNP; menstruating women; iron intake; association study; genetic markers
13.  Preliminary report on a study of health-related quality of life in patients with rheumatoid arthritis 
Rheumatology International  2012;33(2):429-434.
There are studies about health-related quality of life (HRQoL) in patients with rheumatoid arthritis (RA), but few studies prospectively assessed HRQoL. The main purpose of this study was to analyze HRQoL in patients hospitalized due to RA exacerbation and observed over a planned 2-year follow-up in an outpatient setting. The study involved 42 women and 9 men, at mean age of 62.5 years (SD ± 12.6). The mean duration of the study was 22–23 months. The HRQoL analysis was performed using the SF-36 survey. At the beginning of the study, basic data on age, sex, selected biochemical (ESR, CRP, GFR, hemoglobin, plasma albumin, plasma protein), and clinical parameters (the duration of RA, VAS, DAS28, BMI, the presence of cardiovascular disease, diabetes, osteoporosis, osteoporotic fractures, osteoarthritis, neoplasm) were collected. Questionnaires were completed at the beginning and end of the study. Statistically significant reductions in HRQoL scores were observed in social functioning (SF; 0.42 vs 0.32, P < 0.05), whereas role-emotional health (RE; 0.48 vs 0.59, P < 0.05) and mental health (MH; 0.47 vs 0.54, P < 0.05) scores were increased. A decrease in the SF was positively correlated with the lack of osteoporosis at baseline (r = 0.35, P > 0.02). An increase in the MH was inversely correlated with BMI (r = −0.31, P < 0.05), and the level of hemoglobin (r = −0.32, P < 0.028) and positively correlated with the presence of osteoarthritis at baseline (r = 0.29, P < 0.05). In RA patients, dimensions of HRQoL as SF, RE, and MH could change within 2 years and these changes could be related to comorbidities. Although preliminary findings are promising, further studies are needed.
doi:10.1007/s00296-012-2421-5
PMCID: PMC3557393  PMID: 22453529
Rheumatoid arthritis; Health-related quality of life; SF-36
14.  Short-term health-related quality of life consequences in a lung cancer CT screening trial (NELSON) 
British Journal of Cancer  2009;102(1):27-34.
Background:
In lung cancer CT screening, participants often have an indeterminate screening result at baseline requiring a follow-up CT. In subjects with either an indeterminate or a negative result after screening, we investigated whether health-related quality of life (HRQoL) changed over time and differed between groups in the short term.
Methods:
A total of 733 participants in the NELSON trial received four questionnaires: T0, before randomisation; T1, 1 week before the baseline screening; T2, 1 day after the screening; and T3, 2 months after the screening results but before the 3-month follow-up CT. HRQoL was measured as generic HRQoL (the 12-item Short Form, SF-12; the EuroQol questionnaire, EQ-5D), anxiety (the Spielberger State-Trait Anxiety Inventory, STAI-6), and lung-cancer-specific distress (the Impact of Event Scale, IES). For analyses, repeated-measures analysis of variance was used, adjusted for covariates.
Results:
Response to each questionnaire was 88% or higher. Scores on SF-12, EQ-5D, and STAI-6 showed no clinically relevant changes over time. At T3, IES scores that were clinically relevant increased after an indeterminate result, whereas these scores showed a significant decrease after a negative result. At T3, differences in IES scores between the two baseline result groups were both significant and clinically relevant (P<0.01).
Conclusion:
This longitudinal study among participants of a lung cancer screening programme showed that in the short term recipients of an indeterminate result experienced increased lung-cancer-specific distress, whereas the HRQoL changes after a negative baseline screening result may be interpreted as a relief.
doi:10.1038/sj.bjc.6605459
PMCID: PMC2813757  PMID: 19935789
lung neoplasms; mass screening; quality of life; spiral computed tomography
15.  The effect of Telehealth on disease-specific quality of life in patients with heart failure: the Whole Systems Demonstrator Telehealth Questionnaire Study 
Introduction
Primary studies and systematic reviews that have examined the effect of Telehealth (TH) on Health-Related Quality of Life (HRQoL) typically conclude that TH leads to quality of life improvements. The evidence base on which such conclusions rest is characterised by methodologically weak studies that generate equivocal findings. The effectiveness of TH, in terms of quality of life benefits, has yet to be substantiated in high-quality trials.
Aims
Using data from the WSD Telehealth Questionnaire Study we assessed the impact of TH on disease-specific HRQoL, generic HRQoL and psychological outcomes (anxiety and depression) in patients with heart failure, over a 12-month period.
Design
The WSD Telehealth Questionnaire Study is pragmatic cluster-randomised controlled trial evaluating a broad range of patient-reported outcome measures. Participants were recruited from three Sites in the UK (Cornwall, Kent and Newham). The current analyses focus on participants with heart failure.
Methods
Over 500 participants with heart failure completed measures of disease-specific HRQoL (MLHFQ), generic HRQoL (UK SF-12; EQ5D), anxiety (Brief STAI) and depression (CESD-10) at baseline. Follow-up assessments were conducted at 4 and 12 months.
Results
Primary and sensitivity analyses will be presented for the heart failure cohort and interpreted in light of existing WSD findings that examine generic HRQoL in a pooled clinical sample comprising participants with heart failure, COPD and diabetes. Specific findings from the WSD Telehealth Questionnaire Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
Conclusions
Conclusions cannot be released until the analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571121
telehealth; heart failure; quality of life; Whole System Demonstrator
16.  Iron deficiency is a key determinant of health-related quality of life in patients with chronic heart failure regardless of anaemia status 
European Journal of Heart Failure  2013;15(10):1164-1172.
Aims
To evaluate the effect of iron deficiency (ID) and/or anaemia on health-related quality of life (HRQoL) in patients with chronic heart failure (CHF).
Methods and results
We undertook a post-hoc analysis of a cohort of CHF patients in a single-centre study evaluating cognitive function. At recruitment, patients provided baseline information and completed the Minnesota Living with Heart Failure questionnaire (MLHFQ) for HRQoL (higher scores reflect worse HRQoL). At the same time, blood samples were taken for serological evaluation. ID was defined as serum ferritin levels <100 ng/mL or serum ferritin <800 ng/mL with transferrin saturation <20%. Anaemia was defined as haemoglobin ≤12 g/dL. A total of 552 CHF patients were eligible for inclusion, with an average age of 72 years and 40% in NYHA class III or IV. The MLHFQ overall summary scores were 41.0 ± 24.7 among those with ID, vs. 34.4 ± 26.4 for non-ID patients (P = 0.003), indicating worse HRQoL. When adjusted for other factors associated with HRQoL, ID was significantly associated with worse MLHFQ overall summary (P = 0.008) and physical dimension scores (P = 0.002), whereas anaemia was not (both P > 0.05). Increased levels of soluble transferrin receptor were also associated with impaired HRQoL (P ≤ 0.001). Adjusting for haemoglobin and C-reactive protein, ID was more pronounced in patients with anaemia compared with those without (P < 0.001).
Conclusion
In patients with CHF, ID but not anaemia was associated with reduced HRQoL, mostly due to physical factors.
doi:10.1093/eurjhf/hft083
PMCID: PMC3782146  PMID: 23703106
Iron deficiency; Anaemia; Health-related quality of life
17.  Psychometric validation of the visual function questionnaire-25 in patients with diabetic macular edema 
Background
Diabetic Macular Edema (DME) is a common cause of impaired vision and blindness amongst diabetics. If not detected and treated early, the resulting vision loss can lead to considerable health costs and decreased health-related quality of life (HRQoL). The aim of this study was to provide evidence of the psychometric properties of the National Eye Institute - Visual Functioning Questionnaire (VFQ-25) for use in a cohort of DME patients who participated in a clinical efficacy and safety trial of pegaptinib sodium (Macugen).
Methods
A phase 2/3 randomised, double masked trial evaluated pegaptanib injection versus sham injection in patients with DME. The analysis was conducted using baseline HRQoL data of the VFQ-25 and the EQ-5D, on a modified intent-to-treat sample of 235 patients. These measures were administered by a trained interviewer by telephone in all but one of the study countries, where face-to-face interviews were conducted in the clinic. The measures were completed in the week prior to baseline, and after 54 weeks of treatment. Distance visual acuity, measured according to the Early Treatment Diabetic Retinopathy Study (ETDRS), was assessed at all time points. Psychometric properties of the VFQ-25 assessed included domain structure, reliability, concurrent and construct validity, responsiveness.
Results
The VFQ-25 was found to consist of 11 domains slightly different than those proposed. Nevertheless, none of the eight established multi-item scales met the criterion for further splitting and the VFQ-25 was scored as in the developers’ instructions. Internal consistency reliability was demonstrated for six out of the eight original multi-item scales, with Cronbach's alpha ranging from 0.58 (Distance Activities) to 0.85 (Vision Specific: Dependency). The VFQ-25 domains generally showed a low to moderate correlation with EQ-5D visual analogue scale (range 0.16-0.43) and with the visual acuity score (range 0.10-0.41). Construct validity was upheld with higher VFQ-25 scores for patients who saw more letters according to the ETDRS. Almost all scales were shown to be responsive with Guyatt's statistic ranging from 0.10 to 0.56 at 54 weeks.
Conclusions
The VFQ-25 has evidence to support its validity and reliability for measuring HRQoL in DME. However, some operating characteristics of the instrument need further consideration and discussion in the case of DME patients. Further research is therefore warranted in this indication.
doi:10.1186/1477-7525-11-10
PMCID: PMC3599421  PMID: 23347793
Diabetic macular edema; Visual functioning questionnaire; Psychometric analyses
18.  The impact of an employee wellness programme in clothing/textile manufacturing companies: a randomised controlled trial 
BMC Public Health  2013;13:25.
Background
The prevalence of health risk behaviours is growing amongst South African employees. Health risk behaviours have been identified as a major contributor to reduced health related quality of life (HRQoL) and the increased prevalence of non-communicable diseases. Worksite wellness programmes promise to promote behaviour changes amongst employees and to improve their HRQoL. The aim of this study was to evaluate the short-term effects of an employee wellness programme on HRQoL, health behaviour change, body mass index (BMI) and absenteeism amongst clothing and textile manufacturing employees.
Methods
The study used a randomised control trial design. The sample consisted of 80 subjects from three clothing manufacturing companies in Cape Town, South Africa. The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT) as well as weekly supervised exercise classes over six weeks. The control group received a once-off health promotion talk and various educational pamphlets, with no further intervention. Measurements were recorded at baseline and at six weeks post-intervention. Outcome measures included the EQ-5D, Stanford Exercise Behaviours Scale, body mass index and absenteeism.
Data was analysed with the Statistica-8 software program. Non-parametric tests were used to evaluate the differences in the medians between the two groups and to determine the level of significance. The Sign test was used to determine the within group changes. The Mann–Whitney U test was used to determine the difference between the two groups.
Results
At six weeks post intervention the experimental group (39 subjects) demonstrated improvement in almost every parameter. In contrast, apart from an overall decrease in time off work and a reduction in BMI for all study participants, there was no significant change noted in the behaviour of the control group (41 subjects). Seventy percent of the experimental group had improved HRQoL EQ-5D VAS scores post intervention, indicating improved perceived HRQoL. In comparison, only 58% of the control group had improved HRQoL EQ-5D VAS scores post intervention. There was no significant difference between the two groups at baseline or at six weeks post intervention.
Conclusion
An employee wellness programme based on the principles of CBT combined with weekly aerobic exercise class was beneficial in improving the perceived HRQoL and changing health-related behaviours of clothing manufacturing employees. However, it cannot be concluded that the EWP was more effective than the once off health promotion talk as no significant changes were noted between the two groups at 6-weeks post intervention.This trial has been registered with ClinicalTrials.gov (trial registration number NCT01625039).
doi:10.1186/1471-2458-13-25
PMCID: PMC3574831  PMID: 23311458
Musculo-skeletal disorders; Employee wellness; Cognitive behaviour therapy; Occupational health
19.  Review of health-related quality of life data in multiple myeloma patients treated with novel agents 
Leukemia  2013;27(10):1959-1969.
In multiple myeloma (MM), health-related quality of life (HRQoL) data is becoming increasingly important, owing to improved survival outcomes and the impact of treatment-related toxicity on HRQoL. Researchers are more frequently including HRQoL assessments in clinical trials, but analysis and reporting of this data has not been consistent. A systematic literature review assessed the effect of novel agents (thalidomide, bortezomib and lenalidomide) on HRQoL in MM patients, and evaluated the subsequent reporting of these HRQoL results. A relatively small body of literature addresses HRQoL data in MM patients treated with novel MM therapeutic agents: 9 manuscripts and 15 conference proceedings. The literature demonstrates the complementary value of HRQoL when assessing clinical response, progression, overall survival and toxicity. However, weaknesses and inconsistencies in analysis and presentation of HRQoL data were observed, often complicating interpretation of the impact of treatment on HRQoL in MM. Further evaluation of HRQoL in MM patients treated with novel agents is required in larger cohorts, and ideally in head-to-head comparative studies. Additionally, the development of standardised MM-specific best practice guidelines in HRQoL data collection and analysis is recommended. These would ensure that future data are more useful in guiding predictive models and clinical decisions.
doi:10.1038/leu.2013.185
PMCID: PMC3806249  PMID: 23783393
multiple myeloma; quality of life; thalidomide; bortezomib; lenalidomide
20.  Ferrous versus Ferric Oral Iron Formulations for the Treatment of Iron Deficiency: A Clinical Overview 
The Scientific World Journal  2012;2012:846824.
Iron deficiency anaemia represents a major public health problem, particularly in infants, young children, pregnant women, and females with heavy menses. Oral iron supplementation is a cheap, safe, and effective means of increasing haemoglobin levels and restoring iron stores to prevent and correct iron deficiency. Many preparations are available, varying widely in dosage, formulation (quick or prolonged release), and chemical state (ferrous or ferric form). The debate over the advantages of ferrous versus ferric formulations is ongoing. In this literature review, the tolerability and efficacy of ferrous versus ferric iron formulations are evaluated. We focused on studies comparing ferrous sulphate preparations with ferric iron polymaltose complex preparations, the two predominant forms of iron used. Current data show that slow-release ferrous sulphate preparations remain the established and standard treatment of iron deficiency, irrespective of the indication, given their good bioavailability, efficacy, and acceptable tolerability demonstrated in several large clinical studies.
doi:10.1100/2012/846824
PMCID: PMC3354642  PMID: 22654638
21.  Effectiveness of Weekly Supplementation of Iron to Control Anaemia Among Adolescent Girls of Nashik, Maharashtra, India 
A national nutritional anaemia-control programme in India, focusing on supplementation of iron to pregnant women after the first trimester of pregnancy, failed to make an impact. It is prudent to recommend the correction of iron stores before the woman becomes pregnant. ‘Efficacy’ of weekly supplementation of iron has been proved to improve iron stores in adolescence in many studies abroad and in India. The objective was to study the ‘effectiveness’ of a weekly iron-supplementation regimen among urban-slum, rural, and tribal girls of Nashik district, Maharashtra, India. A baseline and the mid-term assessments were done using the cluster-sampling techniques. In each stratum, 30 clusters were identified. Twelve and 10 adolescent girls from each cluster were identified in the baseline and mid-term surveys respectively. The haemoglobin estimation was done using the HemoCue system. Data were analyzed using the Epi Info software (version 6.04). The overall prevalence of anaemia came down significantly to 54.3% from 65.3%. The decline was statistically significant (p<0.001) in tribal girls (48.6% from 68.9%) and among rural girls (51.6% from 62.8%). But the decline was not statistically significant among urban slum girls. Similarly, a significant rise in the mean haemoglobin levels was seen among tribal and rural girls. However, it did not increase significantly among urban slum girls. The programme had performed poorly in urban-slum areas, as the mean number of tablets consumed in urban-slum areas was only 5.6±3.3, as against 6.7±2.6 tablets in tribal girls and 7.2±2.2 tablets in rural girls. Considering the biological and operational feasibility and the effectiveness of the intervention, weekly supplementation of iron to adolescent girls should be universally started to correct the iron stores of a woman before she becomes pregnant.
PMCID: PMC2740684  PMID: 18637530
Adolescents; Anaemia, Iron-deficiency; Iron; Iron supplementation; Nutrition; Slums; India
22.  Associations between recent contraceptive use and quality of life among women 
Contraception  2011;85(3):282-287.
Background
Whether contraception affects health-related quality of life (HRQoL) is unclear.
Study Design
Cross-sectional analysis of routine intake data collected from women aged 18–50 years, including the RAND-36 measure of HRQoL, pregnancy intentions, and recent contraceptive use. We used multivariable logistic regression to test the relationship between HRQoL and use of any and specific contraceptives. Physical and mental HRQoL were dichotomized based on U.S. population averages. Models were adjusted for age, race, marital status, education and pregnancy intentions.
Results
Among the 726 women, those using any form of contraception were more likely to have average or better mental HRQoL than women using no contraception (adjusted odds ratio (aOR)=1.60, 95% confidence interval (CI) 1.01, 2.53). Women using injectable contraception were less likely than those using combined hormonal methods to have average or better physical HRQoL (aOR=0.26, 95% CI 0.09, 0.80) and mental-HRQoL (aOR=0.24, 95% CI 0.06, 0.86).
Conclusions
Measures of women’s HRQoL differ with contraceptive use.
doi:10.1016/j.contraception.2011.08.004
PMCID: PMC3273651  PMID: 22067760
Quality of life; Contraceptive use; Tubal sterilization; Injectable contraceptive
23.  Quality of life is associated with physical activity and fitness in cystic fibrosis 
Background
Health-related and disease-specific quality of life (HRQoL) has been increasingly valued as relevant clinical parameter in cystic fibrosis (CF) clinical care and clinical trials. HRQoL measures should assess – among other domains – daily functioning from a patient’s perspective. However, validation studies for the most frequently used HRQoL questionnaire in CF, the Cystic Fibrosis Questionnaire (CFQ), have not included measures of physical activity or fitness. The objective of this study was, therefore, to determine the cross-sectional and longitudinal relationships between HRQoL, physical activity and fitness in patients with CF.
Methods
Baseline (n = 76) and 6-month follow-up data (n = 70) from patients with CF (age ≥12 years, FEV1 ≥35%) were analysed. Patients participated in two multi-centre exercise intervention studies with identical assessment methodology. Outcome variables included HRQoL (German revised multi-dimensional disease-specific CFQ (CFQ-R)), body composition, pulmonary function, physical activity, short-term muscle power, and aerobic fitness by peak oxygen uptake and aerobic power.
Results
Peak oxygen uptake was positively related to 7 of 13 HRQoL scales cross-sectionally (r = 0.30-0.46). Muscle power (r = 0.25-0.32) and peak aerobic power (r = 0.24-0.35) were positively related to 4 scales each, and reported physical activity to 1 scale (r = 0.29). Changes in HRQoL-scores were directly and significantly related to changes in reported activity (r = 0.35-0.39), peak aerobic power (r = 0.31-0.34), and peak oxygen uptake (r = 0.26-0.37) in 3 scales each. Established associates of HRQoL such as FEV1 or body mass index correlated positively with fewer scales (all 0.24 < r < 0.55).
Conclusions
HRQoL was associated with physical fitness, especially aerobic fitness, and to a lesser extent with reported physical activity. These findings underline the importance of physical fitness for HRQoL in CF and provide an additional rationale for exercise testing in this population.
Trial registration
ClinicalTrials.gov, NCT00231686
doi:10.1186/1471-2466-14-26
PMCID: PMC3942299  PMID: 24571729
Exercise testing; Oxygen uptake; Longitudinal analysis; Accelerometry; Questionnaire
24.  Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials 
Objectives To evaluate the efficacy and safety of intravenous iron, focusing primarily on its effects on haemoglobin, requirement for transfusion, and risk of infection.
Design Systematic review and meta-analysis of randomised controlled trials investigating the safety and efficacy of intravenous iron therapy.
Data sources Randomised controlled trials from Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1966 to June 2013, with no language restrictions.
Eligibility criteria for selecting studies Eligible trials were randomised controlled trials of intravenous iron compared with either no iron or oral iron. Crossover and observational studies were excluded.
Main outcome measures Change in haemoglobin concentration and risk of allogeneic red blood cell transfusion (efficacy) and risk of infection (safety).
Results Of the 75 trials meeting the inclusion criteria, 72 studies including 10 605 patients provided quantitative outcome data for meta-analysis. Intravenous iron was associated with an increase in haemoglobin concentration (standardised mean difference 6.5 g/L, 95% confidence interval 5.1 g/L to 7.9 g/L) and a reduced risk of requirement for red blood cell transfusion (risk ratio 0.74, 95% confidence interval 0.62 to 0.88), especially when intravenous iron was used with erythroid stimulating agents (ESAs) or in patients with a lower baseline plasma ferritin concentration. There were no significant interactions between the efficacy of intravenous iron and type or dose administered. Intravenous iron was, however, associated with a significant increase in risk of infection (relative risk 1.33, 95% confidence interval 1.10 to 1.64) compared with oral or no iron supplementation. The results remained similar when only high quality trials were analysed.
Conclusions Intravenous iron therapy is effective in increasing haemoglobin concentration and reducing the risk of allogeneic red blood cell transfusion and could have broad applicability to a range of acute care settings. This potential benefit is counterbalanced by a potential increased risk of infection.
doi:10.1136/bmj.f4822
PMCID: PMC3805480  PMID: 23950195
25.  Treatment of Anemia in Heart Failure: Potential Risks and Benefits of Intravenous Iron Therapy in Cardiovascular Disease 
Cardiology in review  2010;18(5):240-250.
Iron-deficiency anemia is common is patients with heart failure (HF), but the optimum diagnostic tests to detect iron deficiency and the treatment options to replete iron have not been fully characterized. Recent studies in patients with HF indicate that intravenous iron can rapidly replenish iron stores in patients having iron-deficiency anemia, with resultant increased hemoglobin levels and improved functional capacity. Preliminary data from a sub-group analysis also suggests that supplemental intravenous iron therapy can improve functional capacity even in those subjects without anemia. The mechanisms responsible for this observation are not fully characterized, but may be related to beneficial effects of iron supplementation on mitochondrial respiration in skeletal muscle. The long-term safety of using intravenous iron supplementation in HF populations is not known. Iron is a known pro-oxidant factor that can inhibit nitric oxide signaling and irreversibly injury cells. Increased iron stores are associated with vascular endothelial dysfunction and increased risk of coronary heart disease events. Additional clinical trials are needed to more fully characterize the therapeutic potential and safety of intravenous iron in HF patients.
doi:10.1097/CRD.0b013e3181e71150
PMCID: PMC2921175  PMID: 20699672
heart failure; anemia; iron metabolism; reactive oxygen species; exercise; clinical trials

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