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.
A pragmatic randomised controlled trial.
Two health centres (1° de Maio and Machava) in Maputo, Mozambique, a setting of endemic malaria and high prevalence of HIV.
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.
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).
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.
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).
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.
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.
Preventive Medicine; Public Health
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.
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.
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.
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.
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
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.
Anaemia; Chronic heart failure; Health-related quality of life; Iron deficiency
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.
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.
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.
IVIS is safe and effective in the treatment of IDA during pregnancy. Iron stores increased better with IVIS compared with OI.
Intravenous iron sucrose; iron deficiency anemia; oral iron; pregnancy anemia; serum ferritin
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.
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.
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.
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).
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.
lung neoplasms; mass screening; quality of life; spiral computed tomography
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.
A prospective cohort study (based on a cluster-randomised controlled trial, where the intervention and the usual care groups were combined).
Primary healthcare maternity clinics in 14 municipalities in south-western Finland.
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.
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).
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.
Gestational Diabetes; Iron Intake; Iron Supplementation; Pregnancy; Haemoglobin
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.
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.
Adolescents; Anaemia, Iron-deficiency; Iron; Iron supplementation; Nutrition; Slums; India
Health-related quality of life (HRQoL) was found to improve in participants of weight management interventions. However, information on moderately overweight youth as well as on maintaining HRQoL improvements following treatment is sparse. We studied the HRQoL of 74 overweight, but not obese participants (32.4% male, mean age = 11.61 ± 1.70 SD) of a comprehensive and effective six-month outpatient training at four time-points up to 12 months after end of treatment.
HRQoL was measured by self-report and proxy-report versions of the generic German KINDL-R, including six sub domains, and an obesity-specific additional module. Changes in original and z-standardized scores were analyzed by (2×4) doubly multivariate analysis of variance. This was done separately for self- and proxy-reported HRQoL, taking into account further socio-demographic background variables and social desirability. Additionally, correlations between changes in HRQoL scores and changes in zBMI were examined.
There were significant multivariate time effects for self-reported and proxy-reported HRQoL and a significant time-gender interaction in self-reports revealed (p < .05). Improvements in weight-specific HRQoL were evident during treatment (partial η2 = 0.14-0.19). Generic HRQoL further increased after end of treatment. The largest effects were found on the dimension self-esteem (partial η2 = 0.08-0.09 for proxy- and self-reported z-scores, respectively). Correlations with changes in weight were gender-specific, and weight reduction was only associated with HRQoL improvements in girls.
Positive effects of outpatient training on generic and weight-specific HRQoL of moderately overweight (not obese) children and adolescents could be demonstrated. Improvements in HRQoL were not consistently bound to weight reduction. While changes in weight-specific HRQoL were more immediate, generic HRQoL further increased after treatment ended. An extended follow-up may therefore be needed to scrutinize HRQoL improvements due to weight management.
Overweight; Health-related quality of life; Intervention; Weight reduction; Children and adolescents
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.
To determine whether the clinical effects of treatment translated into HRQoL benefits and to investigate costs of SAD treatment.
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.
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.
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.
Severe obesity is a complex condition that is associated with a wide range of serious health complications and reduced health-related quality of life (HRQoL). In addition to physiological factors, activity and participation, environmental factors, and personal factors are related to an individual’s overall quality of life HRQoL. In Norway, a course based on cognitive behavioral principles is offered to people seeking medical treatment for weight management. The aim is to assist participants to achieve a healthier lifestyle and thereby improve their HRQoL. We therefore investigated changes in HRQoL in participants after they attended this learning and mastery course, and explored how well sociodemographic variables, paid work, social support, personal factors, and surgery predicted HRQoL at 12-month follow-up.
A single-group longitudinal study was conducted. Data were collected by self-reported questionnaires. This article reports on those who had completed the questionnaire at the 12-month (n = 69) follow-up. HRQoL was assessed with the EQ-5D. Other standardized instruments measured employment, social support, self-efficacy, and surgery.
At the 12-month follow-up, participants scored higher on all dimensions of the EQ-5D and on the EQ-VAS. Generalized linear model showed that having paid work, and social support were statistically significant predictors of HRQoL at the 12-month follow-up. Sex, self-efficacy, and surgery were not statistically significant associated with HRQoL.
Participation in paid work, and receiving social support from persons with whom they had a close relationship were strongly related to HRQoL in obese people 12 months after participating in a learning and mastery course.
The study is registered in Clinical Trials: NCT01336725.
Obesity; Health-related quality of life; Social support; Patient education; Bariatric surgery
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.
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.
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.
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).
Musculo-skeletal disorders; Employee wellness; Cognitive behaviour therapy; Occupational health
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.
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.
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.
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.
Transferrin gene; HFE gene; serum transferrin; transferrin saturation; iron deficiency anaemia; SNP; menstruating women; iron intake; association study; genetic markers
Whether contraception affects health-related quality of life (HRQoL) is unclear.
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.
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).
Measures of women’s HRQoL differ with contraceptive use.
Quality of life; Contraceptive use; Tubal sterilization; Injectable contraceptive
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.
Rheumatoid arthritis; Health-related quality of life; SF-36
To test whether women with hyperemesis gravidarum (HG) demonstrated lower health-related quality of life (HRQoL) scores compared with those with nausea and vomiting of pregnancy (NVP).
Women with HG or NVP were examined during the first trimester. Multivariate models identified characteristics of women at risk for low HRQoL, as measured by an NVP-specific HRQoL test and a generic HRQoL test, the Short Form (SF)-36.
Although the SF-36 assessment did not discriminate between the two groups, the NVP-specific test showed that women with HG (N¼29) were 3–6 times more likely than women with NVP (N¼48) to have low HRQoL. Both tests demonstrated that perceived physical symptoms and multiple psychosocial factors, such as depression and marital status, seemed to be equally or more important than having HG.
Although a low HRQoL was associated with an HG diagnosis, multiple physical symptoms and psychosocial factors placed both groups of women at risk. Journal of Perinatology (2011) 31, 10–20; doi:10.1038/jp.2010.54; published online 22 April 2010
hyperemesis gravidarum; nausea; vomiting; pregnancy; quality of life
Chronic neck pain is a common condition associated not only with a decrease in neck muscle strength, but also with decrease in health-related quality of life (HRQoL). While neck strength training has been shown to be effective in improving neck muscle strength and reducing neck pain, HRQoL among patients with neck pain has been reported as an outcome in only two short-term exercise intervention studies. Thus, reports on the influence of a long-term neck strength training intervention on HRQoL among patients with chronic neck pain have been lacking. This study reports the effect of one-year neck strength training on HRQoL in females with chronic neck pain.
One hundred eighty female office workers, 25 to 53 years of age, with chronic neck pain were randomized to a strength training group (STG, n = 60), endurance training group (ETG, n = 60) or control group (CG, n = 60). The STG performed high-intensity isometric neck strengthening exercises with an elastic band while the ETG performed lighter dynamic neck muscle training. The CG received a single session of guidance on stretching exercises. HRQoL was assessed using the generic 15D questionnaire at baseline and after 12 months. Statistical comparisons among the groups were performed using bootstrap-type analysis of covariance (ANCOVA) with baseline values as covariates. Effect sizes were calculated using the Cohen method for paired samples.
Training led to statistically significant improvement in the 15D total scores for both training groups, whereas no changes occurred for the control group (P = 0.012, between groups). The STG improved significantly in five of 15 dimensions, while the ETG improved significantly in two dimensions. Effect size (and 95% confidence intervals) for the 15D total score was 0.39 (0.13 to 0.72) for the STG, 0.37 (0.08 to 0.67) for the ETG, and -0.06 (-0.25 to 0.15) for the CG.
One year of either strength or endurance training seemed to moderately enhance the HRQoL. Neck and upper body training can be recommended to improve HRQoL of females with neck pain if they are motivated for long-term regular exercise.
The study objectives were to identify types of complementary therapy that are most predictive of health outcomes, including functional status, physical health–related quality of life (HRQoL), and mental HRQoL among older adults.
This was a prospective study.
The study comprised computer-assisted interviews conducted in participants' homes.
Subjects included 1683 adults aged 55 and older who participated in the 2002 National Health Interview Survey and the 2003 Medical Expenditure Panel Survey.
Functional status, physical HRQoL, and mental HRQoL at 1-year follow-up.
The use of biologically based therapies predicted better functional status, such that users reported less functional impairment than nonusers (p < 0.01), adjusting for age, gender, race/ethnicity, education, health insurance, household income, and comorbid conditions. Users of manipulative and body-based methods reported less functional impairment (p < 0.05). They also reported better physical and mental health–related quality of life, though these relationships were marginally significant. Other groups of therapies, alternative medical systems, mind–body therapies, and prayer were not predictive of either functional status or HRQoL.
Favorable effects were observed among users of biologically based therapies and users of manipulative and body-based methods. Other types of complementary therapy had no effects on health status over a 1-year follow-up period.
Inflammatory bowel disease (IBD) is characterized by a chronic relapsing inflammation of the gastrointestinal tract. Adult IBD patients suffer from a disabling disease which greatly affects health-related quality of life (HRQoL). A worse HRQoL in these patients may result in a defensive and ineffective use of medical attention and thus higher medical costs. Because of its chronic nature, IBD may also cause psychological problems in many patients which may also influence HRQoL and care-seeking behavior. An important factor reducing HRQoL is disease activity. Induction of remission and long-term remission are important goals for improving HRQoL. Furthermore, remission is associated with a decreased need for hospitalization and surgery and increased employment, which in turn improve HRQoL. Treatment strategies available for many years are corticosteroids, 5-aminosalicylates and immunnosuppressants, but these treatments did not show significant long-term improvement on HRQoL. The biologics, which induce rapid and sustained remission, may improve HRQoL.
To review and evaluate the current literature on the effect of biologics on HRQoL of IBD patients.
We performed a MEDLINE search and reviewed the effect of different biologics on HRQoL. The following subjects and synonyms of these terms were used: inflammatory bowel disease, Crohn’s disease, ulcerative colitis, quality of life, health-related quality of life, fatigue, different anti-TNF medication, and biologicals/biologics (MESH). Studies included were limited to English-language, adult population, full-text, randomized, double-blind, placebo-controlled in which HRQoL was measured.
Out of 202 identified articles, 8 randomized controlled trials (RCT) met the inclusion criteria. Two RCTs on infliximab showed significant improvement of HRQoL compared to placebo which was sustained over the long term. One RCT on adalimumab showed a significant and sustained improvement of HRQoL compared to placebo. This study showed also significant decrease of fatigue in the adalimumab-treated patients. Three RCTs on certolizumab showed a significant improvement of HRQoL in the intervention group compared to placebo. Two RCTs of natalizumab treatment were found. One study showed significant and sustained improvement compared to placebo, and also scores of HRQoL comparable to that in the general population, but in the other no significant results were found.
The biologics infliximab, adalimumab, certolizumab, and natalizumab demonstrated significant improvement of HRQoL of IBD patients compared with placebo. However, we found differences in improvement of HRQoL between the different biologics.
inflammatory bowel disease; health-related quality of life; health care costs; biologics
This study was planned to determine whether iron deficiency in pregnancy predisposed to the development of folate deficiency and also the smallest daily iron supplement that maintained haemoglobin levels in pregnancy.
Three groups of women were given oral ferrous fumarate supplying 30, 60, and 120 mg of iron; a fourth group was given 1 g of parenteral iron in early pregnancy followed by oral iron (60 mg); a fifth group received a placebo. Tablets were taken once daily.
Oral iron 30 mg once daily maintained haemoglobin levels throughout pregnancy. Women whose marrows lacked demonstrable iron at the 37th week had a significantly higher incidence of megaloblastic haemopoiesis (28·7%) than those with demonstrable iron stores (15·3%); women taking oral iron did not have a lower frequency of megaloblastosis than those given a placebo. We concluded that iron does not have a direct effect on folate status in pregnancy, that the association of iron deficiency and megaloblastic anaemia in pregnancy is the result of poor nutrition, and that there is no cause-and-effect relation between them.
Background & objectives:
Despite routine iron supplementation and promotion of diet modification, iron deficiency anaemia (IDA) remains widely prevalent in our antenatal population. Recent studies in pediatric population have highlighted the role of Helicobacter pylori infection in IDA. This study was undertaken to study the effect of eradication therapy in H. pylori infected pregnant women with IDA.
Randomized placebo-controlled double blind clinical trial was done on 40 antenatal women between 14-30 wk gestation, with mild to moderate IDA and having H. pylori infection, as detected by stool antigen test. These women were randomly divided into group I (n=20): H. pylori treatment group (amoxicillin, clarithromycin, omeprazole for 2 wk) and group II (n=20): placebo group. Both groups received therapeutic doses of iron and folic acid. Outcome measures were improvement in haematological parameters and serum iron profile after 6 wk of oral iron therapy.
The prevalence of iron deficiency in pregnant women with mild to moderate anaemia was 39.8 per cent (95% CI 35.7, 44.3); and 62.5 per cent (95% CI 52, 73) of these pregnant women with IDA were infected with H. pylori. After 6 wk of therapeutic oral iron and folic acid supplementation, the rise in haemoglobin, packed cell volume, serum iron and percentage transferrin saturation was significantly (P<0.05) higher in the group given H. pylori eradication therapy as compared to the placebo group.
Interpretation & conclusions:
Our results showed a high occurrence of H. pylori infection in pregnant women with IDA. Eradication therapy resulted in significantly better response to oral iron supplementation among H. pylori infected pregnant women with IDA.
Eradication therapy; Helicobacter pylori; iron deficiency anaemia; pregnancy
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).
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.
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.
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.
Diabetic macular edema; Visual functioning questionnaire; Psychometric analyses
Oral iron supplementation is usually the first choice for the treatment of iron deficiency anemia (IDA) because of its effectiveness and low cost. But unfortunately in many iron deficient conditions, oral iron is a less than the ideal treatment mainly because of adverse events related to the gastrointestinal tract as well as the long course required to treat anemia and replenish body iron stores. The first iron product for intravenous use was high-molecular-weight iron dextran. However, dextran-containing intravenous iron preparations are associated with an elevated risk of anaphylactic reactions, which made physicians reluctant to prescribe intravenous iron in the treatment of iron deficiency anemia for many years. In 1999 and 2001, two new intravenous iron preparations (ferric gluconate and iron sucrose) were introduced into the market as safer alternatives to iron dextran. Over the last five years, three new intravenous iron dextran-free preparations have been developed and have better safety profiles than the more traditional intravenous compounds, as none require test doses and all these products are promising in respect to a more rapid replacement of body iron stores (15-60 minutes/infusion) as they can be given at higher doses (from 500 mg to more than 1000 mg/infusion). The purpose of this review is to discuss some pertinent issues in relation to the history, pharmacology, administration, efficacy, safety profile and toxicity of intravenous iron for the treatment of iron deficiency anemia.
Iron deficiency; Anemia, iron-deficiency; Iron compounds; Infusions, intravenous