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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.
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.
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.  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.
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.
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.
PMCID: PMC3533918  PMID: 22297124
Anaemia; Chronic heart failure; Health-related quality of life; Iron deficiency
3.  The Effect of Intermittent Antenatal Iron Supplementation on Maternal and Infant Outcomes in Rural Viet Nam: A Cluster Randomised Trial 
PLoS Medicine  2013;10(6):e1001470.
Beverley-Anne Biggs and colleagues conduct a community-based cluster randomized trial in rural Viet Nam to compare the effect of antenatal iron-folic acid supplementation taken daily or twice weekly on maternal and infant outcomes.
Please see later in the article for the Editors' Summary
Anemia affects over 500 million women, and in pregnancy is associated with impaired maternal and infant outcomes. Intermittent antenatal iron supplementation is an attractive alternative to daily dosing; however, the impact of this strategy on infant outcomes remains unclear. We compared the effect of intermittent antenatal iron supplementation with daily iron supplementation on maternal and infant outcomes in rural Viet Nam.
Methods and Findings
This cluster randomised trial was conducted in Ha Nam province, Viet Nam. 1,258 pregnant women (<16 wk gestation) in 104 communes were assigned to daily iron–folic acid (IFA), twice weekly IFA, or twice weekly multiple micronutrient (MMN) supplementation. Primary outcome was birth weight. Mean birth weight was 3,148 g (standard deviation 416). There was no difference in the birth weights of infants of women receiving twice weekly IFA compared to daily IFA (mean difference [MD] 28 g; 95% CI −22 to 78), or twice weekly MMN compared to daily IFA (MD −36.8 g; 95% CI −82 to 8.2). At 32 wk gestation, maternal ferritin was lower in women receiving twice weekly IFA compared to daily IFA (geometric mean ratio 0.73; 95% CI 0.67 to 0.80), and in women receiving twice weekly MMN compared to daily IFA (geometric mean ratio 0.62; 95% CI 0.57 to 0.68), but there was no difference in hemoglobin levels. Infants of mothers who received twice weekly IFA had higher cognitive scores at 6 mo of age compared to those who received daily IFA (MD 1.89; 95% CI 0.23 to 3.56).
Twice weekly antenatal IFA or MMN did not produce a clinically important difference in birth weight, when compared to daily IFA supplementation. The significant improvement in infant cognitive outcomes at 6 mo of age following twice weekly antenatal IFA requires further exploration, and provides additional support for the use of intermittent, rather than daily, antenatal IFA in populations with low rates of iron deficiency.
Trial registration
Australia New Zealand Clinical Trials Registry 12610000944033
Please see later in the article for the Editors' Summary
Editors' Summary
Anemia is a common condition in which the blood does not supply the body with enough oxygen because of a low number of red blood cells or low levels of hemoglobin—the iron-containing pigment that enables red blood cells to carry oxygen. Iron deficiency is the most common cause of anemia worldwide and, according to the World Health Organization, affects over 2 billion people: half of all pregnant women and 40% of preschool children in low- and middle-income countries are thought to be anemic. Anemia contributes to 20% of all maternal deaths and is also linked to increased maternal morbidity, higher rates of preterm birth and low birth weight, and reduced infant survival, with potential long-term consequences for child growth and development. Identifying and treating iron deficiency anemia is therefore a global health priority.
Why Was This Study Done?
Daily iron–folic acid supplementation given from early in pregnancy is the standard recommended approach to prevent and treat anemia in pregnant women, but recently the World Health Organization recommended intermittent use because of poor compliance with daily regimes (because of side effects) and poor bowel absorption. However, the evidence from many of the studies used to support this recommendation was of poor quality, and so it remains unclear whether intermittent supplementation is as, or more, effective than daily supplementation, especially in lower income settings where antenatal testing for anemia is not readily available. So in this study, the researchers conducted a community-based cluster randomized trial (where groups of people are randomized, rather than individuals) in rural Viet Nam to compare the effect of antenatal iron–folic acid supplementation taken twice weekly (either alone, or in combination with other micronutrients) with daily iron–folic acid supplementation, on maternal and infant outcomes during the first six months of life.
What Did the Researchers Do and Find?
The researchers randomized 104 communes in Ha Nam Province, Viet Nam, and enrolled 1,258 women who were less than 16 weeks pregnant into the study between September and November 2010. Although the researchers intended to register the trial before the study started, registration was delayed by a month because the supplements arrived earlier than the researchers anticipated, and they thought it best to start recruiting at that time to avoid the Vietnamese New Year, when women might be travelling. Each woman was interviewed and had blood taken for hemoglobin and iron indices (ferritin) before receiving daily iron–folic acid supplementation (426 women), twice weekly iron–folic acid supplementation (425 women), or twice weekly iron–folic acid supplementation plus micronutrients (407 women). The women had follow-up assessments at 32 weeks gestation, delivery, and at six months postpartum: their infants were assessed at birth and at six months old.
The researchers found that at enrollment, the women's average hemoglobin concentration was 123 g/l, and 12.6% of the women were anemic. At 32 weeks gestation, 10.8% of the women were anemic, but there was no difference in hemoglobin levels between the three supplement groups. The average ferritin level was 75.6 µg/l at enrollment, with 2.2% of women iron deficient. Ferritin levels decreased from enrollment to 32 weeks gestation in all supplement groups but were lower in women who took twice weekly supplements. The researchers also found that birth weight (the primary outcome) was similar in all supplement groups, and there were also no differences in gestational age or in the risk of prematurity, stillbirth, or early neonatal death. At six months, there were also no differences in the levels of infant hemoglobin, prevalence of anemia, or growth rates. However, infants born to mothers in the twice weekly iron–folic acid group had improved cognitive development compared to infants born to mothers in the daily supplement group. Finally, the researchers found that adherence rates were significantly higher in the twice weekly iron–folic acid supplement group compared to the once daily regime.
What Do These Findings Mean?
These findings suggest that in an area of Southeast Asia with low anemia prevalence, once daily antenatal supplementation with iron–folic acid did not provide any benefits in birth weight or improved infant growth over twice weekly supplementation. Furthermore, twice weekly supplementation with iron–folic acid was associated with improved maternal adherence rates and also improved cognitive development in infants aged six months—a finding that requires further study and provides added support for the use of intermittent iron–folic acid supplementation over daily supplementation.
Additional Information
Please access these websites via the online version of this summary at
The World Health Organization website has comprehensive information on anemia, including a report of global estimates and the guideline Intermittent Iron and Folic Acid Supplementation in Non-Anaemic Pregnant Women
Wikipedia provides information on iron supplementation (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
PMCID: PMC3708703  PMID: 23853552
4.  The impact of biologics on health-related quality of life in patients with inflammatory bowel disease 
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.
PMCID: PMC3108643  PMID: 21694833
inflammatory bowel disease; health-related quality of life; health care costs; biologics
5.  Mothers of Very Low Birth Weight Children at School Age: Quality of Life Outcomes from the Newborn Lung Project Statewide Cohort Study 
This study aimed to: (1) determine the health-related quality of life (HRQoL) in mothers of five year old very low birth weight (VLBW) and normal birth weight (NBW) children; (2) determine what extent stress mediates the relationship between case status and maternal HRQoL; and (3) examine the pre-pregnancy, pregnancy, birth, and child health-related factors in predicting maternal HRQoL among mothers of five year old VLBW children.
A telephone interview was administered to 297 mothers of VLBW children and 290 mothers of NBW children who were enrolled in the Newborn Lung Project Statewide Cohort Study.
Mothers of VLBW children experienced worse physical and mental HRQoL than mothers of NBW children (52.8 versus 55.3 points, p<0.0001, and 48.9 versus 50.5 points, p=0.02, respectively). Adjusted analyses showed that maternal mental HRQoL was similar between cases and controls while physical HRQoL when children were age five was significantly different between cases and controls (Beta:−2.02, p=0.0006); this relationship was mediated by maternal stress. Among mothers of VLBW children, stress significantly contributed to adverse HRQoL outcomes when children were age five. Child behavior problems at age two were also associated with worse subsequent maternal mental HRQoL (Beta: −1.8 per SD, p=0.004), while each week of neonatal intensive care unit stay was associated with worse physical HRQoL (Beta: −0.26, p=0.02).
While caring for a VLBW child negatively impacts the HRQoL of mothers, this relationship was partially explained by maternal stress. Addressing maternal stress may be an important way to improve long-term HRQoL.
PMCID: PMC3390448  PMID: 22161725
Very low birth weight; maternal stress; maternal health-related quality of life; life course
6.  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.
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).
In patients with CHF, ID but not anaemia was associated with reduced HRQoL, mostly due to physical factors.
PMCID: PMC3782146  PMID: 23703106
Iron deficiency; Anaemia; Health-related quality of life
7.  Daily oral iron supplementation during pregnancy 
Iron and folic acid supplementation has been the preferred intervention to improve iron stores and prevent anaemia among pregnant women, and it may also improve other maternal and birth outcomes.
To assess the effects of daily oral iron supplements for pregnant women, either alone or in conjunction with folic acid, or with other vitamins and minerals as a public health intervention.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (2 July 2012). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) (2 July 2012) and contacted relevant organisations for the identification of ongoing and unpublished studies.
Selection criteria
Randomised or quasi-randomised trials evaluating the effects of oral preventive supplementation with daily iron, iron + folic acid or iron + other vitamins and minerals during pregnancy.
Data collection and analysis
We assessed the methodological quality of trials using standard Cochrane criteria. Two review authors independently assessed trial eligibility, extracted data and conducted checks for accuracy.
Main results
We included 60 trials. Forty-three trials, involving more than 27,402 women, contributed data and compared the effects of daily oral supplements containing iron versus no iron or placebo.
Overall, women taking iron supplements were less likely to have low birthweight newborns (below 2500 g) compared with controls (8.4% versus 10.2%, average risk ratio (RR) 0.81; 95% confidence interval (CI) 0.68 to 0.97, 11 trials, 8480 women) and mean birthweight was 30.81 g greater for those infants whose mothers received iron during pregnancy (average mean difference (MD) 30.81; 95% CI 5.94 to 55.68, 14 trials, 9385 women). Preventive iron supplementation reduced the risk of maternal anaemia at term by 70% (RR 0.30; 95% CI 0.19 to 0.46, 14 trials, 2199 women) and iron deficiency at term by 57% (RR 0.43; 95% CI 0.27 to 0.66, seven trials, 1256 women). Although the difference between groups did not reach statistical significance, women who received iron supplements were more likely than controls to report side effects (25.3% versus 9.91%) (RR 2.36; 95% CI 0.96 to 5.82, 11 trials, 4418 women), particularly at doses 60 mg of elemental iron or higher. Women receiving iron were on average more likely to have higher haemoglobin (Hb) concentrations at term and in the postpartum period, but were at increased risk of Hb concentrations greater than 130g/L during pregnancy and at term. Twenty-three studies were conducted in countries that in 2011 had some malaria risk in parts of the country. In some of these countries/territories, malaria is present only in certain areas or up to a particular altitude. Only two of these reported malaria outcomes. There is no evidence that iron supplementation increases placental malaria. For some outcomes heterogeneity was higher than 50%.
Authors’ conclusions
Prenatal supplementation with daily iron are effective to reduce the risk of low birthweight, and to prevent maternal anaemia and iron deficiency in pregnancy. Associated maternal side effects and particularly high Hb concentrations during pregnancy at currently used doses suggest the need to update recommendations on doses and regimens for routine iron supplementation.
PMCID: PMC4233117  PMID: 23235616
*Dietary Supplements [adverse effects]; Anemia, Iron-Deficiency [*prevention & control]; Folic Acid [*administration & dosage]; Infant, Low Birth Weight; Infant, Newborn; Iron [*administration & dosage]; Iron, Dietary [administration & dosage]; Pregnancy Complications, Hematologic [*prevention & control]; Pregnancy Outcome; Prenatal Care [methods]; Randomized Controlled Trials as Topic; Female; Humans; Pregnancy
8.  Predictors of health-related quality of life in stroke patients after neurological inpatient rehabilitation: a prospective study 
The goal of the study was to investigate the long-term course of health-related quality of life (HRQoL) in stroke survivors during and up to 2.5 years after inpatient neurological rehabilitation and to identify predictors of HRQoL.
HRQoL was determined in 152 stroke survivors in a single-centre prospective cohort study at four time points: upon admission to inpatient rehabilitation, at discharge, and one and 2.5 years after discharge. Their HRQoL was determined by administering the EQ-5D at all four measurement points. During inpatient rehabilitation, the SF-36 was administered in addition to the EQ-5D. Predictors were identified through multiple regression analysis.
During inpatient rehabilitation, the “European Index” of the EQ-5D rose significantly (p < 0.001) from 45.4 to 66.7. The change in HRQoL on the SF-36 was convergent. The HRQoL of the stroke patients living at home remained at the same level for 2.5 years following discharge. In the multiple regression analysis, the EQ-5D Index at discharge (p = 0.049), the risk of falls as defined by Runge and Rehfeld (p = 0.001), and the change in emotional quality of life on the SF-36 during inpatient rehabilitation (p = 0.048) predicted HRQoL 2.5 years following discharge.
On the basis of our results, we conclude that the long-term health-related quality of life of stroke survivors can be positively influenced by reducing the risk of falls and improving emotional well-being during neurological inpatient rehabilitation.
Electronic supplementary material
The online version of this article (doi:10.1186/s12955-015-0258-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4448207  PMID: 25971254
Health-related quality of life; EQ-5D; Stroke; Rehabilitation; Predictors; Prospective study
9.  Health-related quality of life and long-term care needs among elderly individuals living alone: a cross-sectional study in rural areas of Shaanxi Province, China 
BMC Public Health  2013;13:313.
The number of elderly individuals living alone is rising, especially in rural areas of China, and their health-related quality of life (HRQoL) is an increasing public health concern. However, little is known about factors that influence HRQoL and the need for long-term care services. The aim of the study was to identify these factors and the long-term care requirements of persons aged 60 and older living alone in rural areas of Shaanxi Province, China.
The study included 424 older subjects, selected by stratified random sampling. Logistic regression adjusted for age was conducted to analyze factors influencing HRQoL and the need for long-term care services. Pearson correlative analysis was conducted to assess the correlation between HRQoL score and long-term care needs.
HRQoL among elderly subjects living alone declined with age in both males and females. The main diseases influencing HRQoL among the elderly were hypertension, cardiac disease, chronic bronchitis, neurological disease and cancer. Cataract disease was the most important factor related to HRQoL. This was followed by long-term care needs, living conditions, economic status, Cardiovascular disease, osteoporosis and age. Factors affecting long-term care needs were economic status, education level, alcohol intake, living conditions, general health and age. HRQoL and long-term care needs among this elderly population were significantly correlated (r=−0.204, p<0.01).
For elderly persons living alone, factors such as chronic disease, lower income level and living in a rural area may limit their ability to form social relationships. Reducing the level of loneliness, with better care and support, may be helpful in improving their HRQoL. There is a need for an overall improvement in the planning, provision and financing of long-term care and psychogeriatric services for elderly individuals living alone in China.
PMCID: PMC3642010  PMID: 23566211
Health-related quality of life; SF-36; Long-term care; Elderly subjects living alone
10.  Intravenous versus oral iron supplementation for correction of post-transplant anaemia in renal transplant patients 
BMC Nephrology  2009;10:14.
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.
PMCID: PMC2701932  PMID: 19500381
11.  Health-related quality of life in patients with surgically treated lumbar disc herniation 
Acta Orthopaedica  2011;82(2):198-203.
Background and purpose
Health-related quality of life (HRQoL) instruments have been of increasing interest for evaluation of medical treatments over the past 10–15 years. In this prospective, long-term follow-up study we investigated the influence of preoperative factors and the change in HRQoL over time after lumbar disc herniation surgery.
117 patients surgically treated for lumbar disc herniation (L4-L5 or L5-S1) were evaluated with a self-completion HRQoL instrument (EQ-5D) preoperatively, after 2 years (96 patients) and after 7 years (89 patients). Baseline data (age, sex, duration of leg pain, surgical level) and degree of leg and back pain (VAS) were obtained preoperatively. The mean age was 39 (18–66) years, 54% were men, and the surgical level was L5-S1 in 58% of the patients. The change in EQ-5D score at the 2-year follow-up was analyzed by testing for correlation and by using a multiple regression model including all baseline factors (age, sex, duration of pain, degree of leg and back pain, and baseline EQ-5D score) as potential predictors.
85% of the patients reported improvement in EQ-5D two years after surgery and this result remained at the long-term follow-up. The mean difference (change) between the preoperative EQ-5D score and the 2-year and 7-year scores was 0.59 (p < 0.001) and 0.62 (p < 0.001), respectively. However, the HRQoL for this patient group did not reach the mean level of previously reported values for a normal population of the same age range at any of the follow-ups. The changes in EQ-5D score between the 2- and 7-year follow-ups were not statistically significant (mean change 0.03, p = 0.2). There was a correlation between baseline leg pain and the change in EQ-5D at the 2-year (r = 0.33, p = 0.002) and 7-year follow-up (r = 0.23, p = 0.04). However, when using regression analysis the only statistically significant predictor for change in EQ-5D was baseline EQ-5D score.
Our findings suggest that HRQoL (as measured by EQ-5D) improved 2 years after lumbar disc herniation surgery, but there was no further improvement after 5 more years. Low quality of life and severe leg pain at baseline are important predictors of improvement in quality of life after lumbar disc herniation surgery.
PMCID: PMC3235291  PMID: 21434763
12.  Influence of Mckenzie protocol and two modes of endurance exercises on health-related quality of life of patients with long-term mechanical low-back pain 
The Pan African Medical Journal  2014;17(Suppl 1):5.
Long-term Mechanical Low-Back Pain (LMLBP) negatively impacts on patients’ physical capacity and quality of life. This study investigated the relationship between Health-Related Quality of Life (HRQoL) and pain intensity, and the influence of static and dynamic back extensors’ endurance exercises on HRQoL in Nigerian patients with LMLBP treated with the McKenzie Protocol (MP).
A single-blind controlled trial involving 84 patients who received treatment thrice weekly for eight weeks was conducted. Participants were assigned to the MP Group (MPG), MP plus Static Back Endurance Exercise Group (MPSBEEG) or MP plus Dynamic Endurance Exercise Group (MPDBEEG) using permuted randomization. HRQoL and pain was assessed using the Short-Form (SF-36) questionnaire and Quadruple Visual Analogue Scale respectively.
Sixty seven participants aged 51.8 ± 7.35 years completed the study. A total drop-out rate of 20.2% was observed in the study. Within-group comparison across weeks 0-4, 4-8 and 0-8 of the study revealed significant differences in HRQoL scores (p < 0.05). Treatment Effect Scores (TES) across the groups were significantly different (p = 0.001). MPSBEEG and MPDBEEG were comparable in TES on General Health Perception (GHP) at week 4; and GHP and Physical Functioning at week 8 respectively (p > 0.05). However, MPDEEG had significantly higher TES in the other domains of the SF-36 (p = 0.001).
HRQoL in patients with LMLBP decreases with pain severity. Each of MP, static and dynamic back extensors endurance exercises significantly improved HRQoL in LMLBP. However, the addition of dynamic back extensors endurance exercise to MP led to greater improvement in HRQoL.
PMCID: PMC3946222  PMID: 24624241
Mckenzie protocol; endurance exercises; quality of life; back pain
13.  Health-related quality-of-life of coal-based sponge iron plant workers in Barjora, India: a cross-sectional study 
BMJ Open  2014;4(9):e006047.
During the last decade, coal-based sponge iron plants, a highly polluted industry, have grown rapidly in Barjora, India. Understanding their workers’ perception of health is essential in people-centered healthcare. The aim of the study was to assess their health-related quality-of-life (HRQoL), and to determine factors that independently predict their HRQoL.
Cross-sectional study.
Coal-based sponge iron plants in Barjora, India.
258 coal-based sponge iron plant workers.
Primary outcome measure
HRQoL was measured using the EuroQol-5D-5L.
The response rate was 100%. Participants with problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 23.3%, 5.1%, 10.9%, 39.5% and 45.5%, respectively. 36.8% of participants reported health state 11111 (no problem in any EQ-5D dimension). The mean visual analogue scale (EQ-VAS) was 69.8 (18.5 SD). The odds of mobility problems decreased with age (OR 0.95, 95% CI 0.91 to 0.99, p=0.016), were lower in participants with presence/history of any respiratory disease (0.27, 0.13 to 0.55, p<0.001), scheduled caste/scheduled tribe/other backward class workers (0.44, 0.22 to 0.89, p=0.021), manual workers (0.40, 0.16 to 0.99, p=0.047) and non-smokers (2.63, 1.27 to 5.46, p=0.009). The odds of pain/discomfort and anxiety/depression were lower in participants with any respiratory disease (0.44, 0.24 to 0.79, p=0.006; and 0.52, 0.29 to 0.92, p=0.026, respectively). The EQ-VAS was worse in manual participants (coefficient −6.91, 95% CI −12.40 to −1.41, p=0.014), with any respiratory disease (−8.13, −13.12 to −3.13, p=0.002), alcohol drinkers (−4.81, −9.47 to −0.15, p=0.043), literates (7.70, 0.97 to 14.43, p=0.025) and Hindus (13.41, 2.62 to 24.20, p=0.015).
Many coal-based sponge iron plant workers in Barjora have problems in their HRQoL, and the predictors of different aspects of HRQoL were identified. The study findings could be taken into consideration in future interventional studies aimed at improving the HRQoL of these workers.
PMCID: PMC4158191  PMID: 25190619
14.  Health-related quality of life and the predictive role of sense of coherence, spirituality and religious coping in a sample of Iranian women with breast cancer: a prospective study with comparative design 
There is disagreement among studies of health-related quality of life (HRQoL) changes in breast cancer patients over time. Reportedly, assessment of HRQoL prior to diagnosis may be crucial to provide a clear point of comparison for later measurements. The aims of this study were (1) to investigate changes in HRQoL, sense of coherence (SOC), spirituality and religious coping in a group of women with breast cancer from the pre-diagnosis phase to 6 months later in comparison with a control group, and (2) to explore the predictor role of SOC, spirituality, and religious coping within the breast cancer group at the 6-month follow-up.
A sample of women with breast cancer (n = 162) and a matched control group (n = 210) responded to the following instruments on both occasions: the European Organization for Research and Treatment of Cancer QLQ-C30, the SOC Scale, the Spiritual Perspective Scale and the Brief Religious Coping Scale. A series of General Linear Model (GLM) Repeated Measures was used to determine changes between the groups over time. Also, Multiple Linear Regression analyses were applied to each of the HRQoL dimensions, as dependent variable at the 6 months follow-up.
Physical and role function, fatigue, and financial difficulties were rated worse by the women with breast cancer during the first 6 months in comparison to the controls, which was both a statistically (p < 0.001) and clinically significant difference. Women had better scores for global quality of life (p < 0.001), and emotional functioning (p < 0.01) during the same period of time. The degree of SOC (p < 0.01) and baseline ratings of several dimensions of HRQoL (p < 0.05) were the most important predictors of HRQoL changes.
Collecting HRQoL data before a final diagnosis of breast cancer is important to identify women at risk of deterioration in HRQoL during and after treatment. Special attention should be paid to physical and role functioning impairment, fatigue, and financial difficulties experienced by these women. These results underscore that the degree of SOC may be more important as a predictor for HRQoL changes in this sample than spirituality and religious coping.
PMCID: PMC4392858  PMID: 25889384
Health-related quality of life; Breast cancer; Sense of coherence; Spirituality; Religious coping
15.  Cardiac rehabilitation may not provide a quality of life benefit in coronary artery disease patients 
Improvements in patient-reported health-related quality of life (HRQoL) are important goals of cardiac rehabilitation (CR). In patients undergoing coronary angiography for angina and with documented coronary artery disease (CAD), the present study compared HRQoL over 6 months in CR participants and non-participants. Clinical predictors of CR participants were also assessed.
A total of 221 consecutive patients undergoing angiography for angina with documented CAD and who were eligible for a CR program were recruited. CR participants were enrolled in a six-week Phase II outpatient CR course (31%, n = 68) within 2 months following angiography and the non-participants were included as a control. At baseline (angiography), one and six months post angiography, clinical and HRQoL data were obtained including the Short Form-36 (SF-36) and the Seattle Angina Questionnaire (SAQ). The response rate for the HRQoL assessment was 68% (n = 150). Cross sectional comparisons were age-adjusted and performed using logistic or linear regression as appropriate. Longitudinal changes in HRQoL were assessed using least squares regression. Finally, a multiple logistic regression was fitted with CR participant as the final outcome.
At angiography, the CR non-participants were older, and age-adjusted analyses revealed poorer physical (angina limitation: 54 ± 25 versus 64 ± 22, p <0.05) and mental HRQoL (significant psycho-social distress: 62%, n = 95 versus 47%, n = 32, p <0.05) compared to the CR participants. In addition, the CR participants were more likely to have undergone angiography for myocardial infarction (OR = 2.8, 95% CI 1.5-5.3, p = 0.001). By six months, all patients showed an improvement in HRQoL indices, however the rate of improvement did not differ between the controls and CR participants.
Following angiography, CAD patients reported improvements in both generic and disease-specific HRQoL, however CR participation did not influence this outcome. This may be explained by biases in CR enrollment, whereby acute patients, who may be less limited in HRQoL compared to stable, chronic patients, are targeted for CR participation. Further investigation is required so CR programs maximize the quality of life benefits to all potential CR patients.
PMCID: PMC3558459  PMID: 23164456
Coronary artery disease; Cardiac rehabilitation; Health-related quality of life
16.  Quality of life in rectal cancer patients after radical surgery: a survey of Chinese patients 
We aimed to investigate the impact of sociodemographic and clinical characteristics on health-related quality of life (HRQoL) in disease-free survivors after radical surgery for rectal cancer in a Chinese mainland population.
We performed a cross-sectional survey from August 2002 to February 2011 by use of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38 questionnaires of 438 patients who underwent curative surgery for rectal cancer. Patients who were followed up for a minimum of 6 months, had no relevant major comorbidities and whose disease had not recurred were asked to complete both questionnaires. The impact of sociodemographic and clinical characteristics on HRQoL were compared by univariate and multivariate regression analyses.
In total, 285 patients responded to the survey (response rate, 65.1%). Psychological-related HRQoL variables such as emotional function (P = 0.021) and future perspectives (P = 0.044) were poorer for younger patients than for older patients; and physiological-related HRQoL was reflected by physical function (P = 0.039), which was poorer for older patients than for younger patients. In terms of physiologic function and symptoms concerning HRQoL, such as pain (P = 0.002) and insomnia (P = 0.018), females had lower values than males. Low education and unemployment were associated with a worse HRQoL. HRQoL was worse for patients with stomas compared to those without, especially in psychosocial areas such as role function (P = 0.025), social function (P <0.001) and body image (P = 0.004). Financial HRQoL was worse for younger patients and patients with stoma.
HRQoL aspects and degrees to which they were impaired after curative surgery for rectal cancer were different when compared by many sociodemographic and clinical factors in Chinese mainland patients.
PMCID: PMC4059026  PMID: 24886668
Health-related quality of life; Rectal cancer; Surgery; Chinese
17.  Health-related quality of life in Greek chronic hepatitis C patients during pegylated interferon and ribavirin treatment 
Hippokratia  2010;14(2):122-125.
Background - Aims: Chronic hepatitis C (CHC) can cause a series of neuropsychiatric symptoms, whereas the currently approved treatment for this disease often induces similar symptoms as well. The aim of the present study was to compare Greek CHC patients' health-related quality of life (HRQoL) with that of healthy controls, to identify any possible relationships between HRQoL and demographic and laboratory parameters and to study the fluctuation of HRQoL during therapy and follow-up.
Patients and Methods: Ninty nine patients with CHC and 91 healthy controls were enrolled in the study. ALT, viral load, HCV genotype, fibrosis stage by liver biopsy and BMI, were determined at baseline. All patients completed the SF-36 quality of life questionnaire, which was self-administered, before treatment. They were treated with pegylated interferon α2-a or α-2b and ribavirin for 24 or 48 weeks and evaluated in the middle of therapy, at the end and six months after treatment cessation. SF-36 questionnaire was also completed in each evaluation.
Results: Patients' HRQoL was found to be below that of healthy controls in all SF-36 scales before treatment. There was a significant negative association between history of drug abuse and general health and a positive association between age and mental health. Multivariate analysis revealed that history of drug abuse seemed to play a significant role in bodily pain and general health of patients, as well as age did in vitality and mental health. The course of patients' HRQoL showed that in the middle of treatment values in all SF-36 scales were below those of baseline and they returned to pretreatment levels at the end of therapy. However, at the end of the six month follow-up period, an improvement in almost all scales compared to baseline was noted.
Conclusion: Our results showed that a) Greek CHC patients' HRQoL was worse than that of healthy individuals and fluctuated significantly during treatment b) A history of drug abuse and age can independently affect HRQoL c) During treatment values of HRQoL are worsened possibly due to interferon-a treatment and d) In the long-term treatment results in improvement of HRQoL.
PMCID: PMC2895284  PMID: 20596269
Health-related quality of life; chronic hepatitis C; pegylated interferon; sustained virological response
18.  Impact of Lifestyle Intervention and Metformin on Health-Related Quality of Life: the Diabetes Prevention Program Randomized Trial 
Journal of General Internal Medicine  2012;27(12):1594-1601.
Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL).
To assess changes in HRQoL after interventions aimed at diabetes risk reduction.
A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m²; 68 % women, and 45 % members of minority groups.
Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB).
HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %.
After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p = 0.04) and PCS (+1.57, p < 0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p = 0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p < 0.001), physical function (+3.6, p < 0.001), bodily pain (+1.9, p = 0.01), and vitality (+2.1, p = 0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score.
Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-012-2122-5) contains supplementary material, which is available to authorized users.
PMCID: PMC3509296  PMID: 22692637
quality of life; lifestyle; metformin; diabetes risk; weight loss
19.  Cardiovascular Complications Secondary to Graves’ Disease: A Prospective Study from Ukraine 
PLoS ONE  2015;10(3):e0122388.
Graves’ disease (GD) is a common cause of hyperthyroidism resulting in development of thyrotoxic heart disease (THD).
to assess cardiovascular disorders and health related quality of life (HRQoL) in patients with THD secondary to GD.
Patients and Methods
All patients diagnosed with THD secondary to GD between January 2011 and December 2013 were eligible for this study. Clinical assessment was performed at baseline and at the follow-up visit after the restoring of euthyroid state. HRQoL was studied with a questionnaire EQ-5D-5L.
Follow-up data were available for 61 patients, but only 30 patients with THD secondary to GD were consented to participate in investigation of their HRQoL. The frequency of cardiovascular complications was significantly reduced as compared before and after the antithyroid therapy as follows: resting heart rate (122 vs. 74 bpm), blood pressure: systolic (155 vs. 123 mm Hg), diastolic (83 vs. 66 mm Hg), supraventricular premature contractions (71% vs. 7%), atrial fibrillation (72% vs. 25%), congestive heart failure (69% vs. 20%), thyrotoxic cardiomyopathy (77% vs. 26%), all p<0.01. Anti-TSH receptor antibodies were determined as independent predictor of left ventricular geometry changes, (b-coefficient = 0.04, 95%CI 0.01–0.07, p = 0.02). HRQoL was improved in all domains and self-rated health increased from 43 to 75 units by visual analogue score (p<0.001).
Restoring of euthyroid state in patients with GD is associated with significant elimination of cardiovascular disorders and improvement of HRQoL. To our knowledge this is the first study evaluating Ukrainian patients with THD secondary to GD with focus on HRQoL.
PMCID: PMC4372210  PMID: 25803030
20.  Intravenous ferric carboxymaltose for anaemia in pregnancy 
Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. Current options for treatment are limited: these include oral iron supplementation, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric carboxymaltose is a new treatment option that may be better tolerated.
The study was designed to assess the safety and efficacy of iron deficiency anaemia (IDA) correction with intravenous ferric carboxymaltose in pregnant women with mild, moderate and severe anaemia in the second and third trimester.
Prospective observational study; 65 anaemic pregnant women received ferric carboxymaltose up to 15 mg/kg between 24 and 40 weeks of pregnancy (median 35 weeks gestational age, SD 3.6). Treatment effectiveness was assessed by repeat haemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion.
Intravenous ferric carboxymaltose infusion significantly increased Hb values (p < 0.01) above baseline levels in all women. Increased Hb values were observed at 3 and 6 weeks post infusion and up to 8 weeks post-infusion. Ferritin values increased significantly after the infusion. Only 4 women had repeat ferritin values post-partum which remained above baseline levels. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. Of the 29 (44.6%) women interviewed, 19 (65.5%) women reported an improvement in their well-being and 9 (31%) felt no different after the infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 13 (20%) patients.
Our prospective data is consistent with existing observational reports of the safe and effective use of ferric carboxymaltose in the treatment of iron deficiency anaemia in pregnancy.
PMCID: PMC3986933  PMID: 24667031
Pregnancy; Iron deficiency; Peri-partum anaemia; Intravenous ferric carboxymaltose; Red blood cell transfusion
21.  Intermittent oral iron supplementation during pregnancy (Review) 
Anaemia is a frequent condition during pregnancy, particularly among women from developing countries who have insufficient iron intake to meet increased iron needs of both the mother and the fetus. Traditionally, gestational anaemia has been prevented with the provision of daily iron supplements throughout pregnancy, but adherence to this regimen due to side effects, interrupted supply of the supplements, and concerns about safety among women with an adequate iron intake, have limited the use of this intervention. Intermittent (i.e. one, two or three times a week on non-consecutive days) supplementation with iron alone or in combination with folic acid or other vitamins and minerals has recently been proposed as an alternative to daily supplementation.
To assess the benefits and harms of intermittent supplementation with iron alone or in combination with folic acid or other vitamins and minerals to pregnant women on neonatal and pregnancy outcomes.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (23 March 2012). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) for ongoing studies and contacted relevant organisations for the identification of ongoing and unpublished studies (23 March 2012).
Selection criteria
Randomised or quasi-randomised trials.
Data collection and analysis
We assessed the methodological quality of trials using standard Cochrane criteria. Two review authors independently assessed trial eligibility, extracted data and conducted checks for accuracy.
Main results
This review includes 21 trials from 13 different countries, but only 18 trials (with 4072 women) reported on our outcomes of interest and contributed data to the review. All of these studies compared daily versus intermittent iron supplementation.
Three studies provided iron alone, 12 iron+folic acid and three more iron plus multiple vitamins and minerals. Their methodological quality was mixed and most had high levels of attrition. Overall, there was no clear evidence of differences between groups for infant primary outcomes: low birthweight (average risk ratio (RR) 0.96; 95% confidence interval (CI) 0.61 to 1.52, seven studies), infant birthweight (mean difference MD −8.62 g; 95% CI −52.76 g to 35.52 g, eight studies), premature birth (average RR 1.82; 95% CI 0.75 to 4.40, four studies). None of the studies reported neonatal deaths or congenital anomalies.
For maternal outcomes, there was no clear evidence of differences between groups for anaemia at term (average RR 1.22; 95% CI 0.84 to 1.80, four studies) and women receiving intermittent supplementation had less side effects (average RR 0.56; 95% CI 0.37 to 0.84, 11 studies) than those receiving daily supplements. Women receiving intermittent supplements were also at lower risk of having high haemoglobin (Hb) concentrations (greater than 130 g/L) during the second or third trimester of pregnancy (average RR 0.48; 95% CI 0.35 to 0.67, 13 studies). There were no significant differences in iron-deficiency anaemia between women receiving intermittent or daily iron+folic acid supplementation (average RR 0.71; 95% CI 0.08 to 6.63, 1 study). There were no maternal deaths (six studies) or women with severe anaemia in pregnancy (six studies). None of the studies reported on iron deficiency at term or infections during pregnancy.
Where sufficient data were available for primary outcomes, we set up subgroups to look for possible differences between studies in terms of earlier or later supplementation; women’s anaemia status at the start of supplementation; higher and lower weekly doses of iron; and the malarial status of the region in which the trials were conducted. There was no clear effect of these variables on the results of the review.
Authors’ conclusions
The present systematic review is the most comprehensive summary of the evidence assessing the benefits and harms of intermittent iron supplementation regimens in pregnant women on haematological and pregnancy outcomes. The findings suggest that intermittent iron+folic acid regimens produce similar maternal and infant outcomes at birth as daily supplementation but are associated with fewer side effects. Women receiving daily supplements had increased risk of developing high levels of Hb in mid and late pregnancy but were less likely to present mild anaemia near term. Although the evidence is limited and the quality of the trials was low or very low, intermittent may be a feasible alternative to daily iron supplementation among those pregnant women who are not anaemic and have adequate antenatal care.
PMCID: PMC4053594  PMID: 22786531
*Dietary Supplements [adverse effects]; Administration, Oral; Anemia, Iron-Deficiency [blood; *prevention & control]; Developing Countries; Drug Administration Schedule; Drug Combinations; Folic Acid [administration & dosage]; Hemoglobin A [metabolism]; Infant, Low Birth Weight; Infant, Newborn; Iron [*administration & dosage; adverse effects]; Iron, Dietary [*administration & dosage]; Pregnancy Complications, Hematologic [blood; prevention & control]; Premature Birth; Randomized Controlled Trials as Topic; Vitamins [administration & dosage]; Female; Humans; Pregnancy
22.  The Bidirectional Relationship between Quality of Life and Eating Disorder Symptoms: A 9-Year Community-Based Study of Australian Women 
PLoS ONE  2015;10(3):e0120591.
Studies that have investigated quality of life (QoL) in eating disorders (EDs) have been focussed on the impact of the ED on QoL and little is known regarding the possible reciprocal impact of QoL on EDs. The aim of this study was to provide a first-time investigation of possible bidirectional relationships between EDs and both health-related QoL (HRQoL) and psychological distress (PD).
Structural equation modeling was applied to longitudinal data collected from a community sample of Australian women (N = 828) surveyed at baseline, five annual follow-ups, and again after nine years. Participants reported height and weight (from which body mass index, BMI, was calculated) and completed measures of ED symptoms (Eating Disorder Examination Questionnaire), HRQoL (12-item Medical Outcomes Study Short Form), and PD (Kessler Psychological Distress Scale).
Overall, evidence was found for a bidirectional relationship, whereby ED symptoms predicted reduced HRQoL and greater PD over time, while lower levels of HRQoL and greater PD in turn predicted increased levels of ED symptoms. These relationships were stable, observable within 12 months, and remained observable over a time period of at least four years. However, also observed were some inconsistent findings where ED symptoms predicted a short term (one year) improvement in mental HRQoL. This short term boost was not sustained at longer follow-ups.
Not only do ED symptoms impact on HRQoL and PD, but perceived poor HRQoL and PD also contribute to ED symptom development or exacerbation. This supports a movement away from symptom-centric approaches whereby HRQoL is conceptualized as a passive outcome expected to be rectified by addressing ED symptoms. Improvement in QoL and PD might rather be viewed as targets to be pursued in their own right under broader approaches in the treatment of EDs.
PMCID: PMC4374670  PMID: 25812047
23.  Health-Related Quality of Life Among Cancer Survivors Attending Support Groups 
There is limited research on the relationship between Health-related quality of life (HRQoL) and socioeconomic status (SES) among long-term cancer survivors. The goal of this study was to assess Global HRQoL among 102 adult cancer survivors attending support groups in San Diego County and to examine differences by SES and acculturation. Community-based participatory research methods were followed to recruit a purposive sample of English and Spanish-speaking adult cancer survivors attending cancer support groups. Self-report questionnaires assessing age, acculturation (i.e., language), SES (i.e., income and education), cancer history, and Global HRQoL measured by the FACT-G were administered. Multivariate regression examined the relationship between SES and acculturation with HRQoL, adjusting for covariates. Participants were 58.8 years on average (SD=10.06) and varied in terms of SES. Most participants (91.5 %) were women, 51.7 % were non-Hispanic white, and 48.3 % were Hispanic/Latino. Global HRQoL scores in the study sample were lower compared to previously reported studies. After adjusting for covariates, SES and acculturation were not significantly related to HRQoL. Stage at diagnosis was significantly related to HRQoL measures in adjusted analyses. HRQoL did not vary by SES or acculturation. There is a need to increase access to linguistically and culturally appropriate cancer care and supportive care services. Future studies may find existing support group settings useful for targeting psychosocial issues for more advanced stage cancer survivors.
PMCID: PMC4310803  PMID: 25066251
Health-related quality of life; Survivorship; Cancer; Socioeconomic status; Acculturation; Support groups
24.  Health related quality of life in Middle Eastern children with beta-thalassemia 
BMC Blood Disorders  2012;12:6.
Thalassemia is a common disorder worldwide with a predominant incidence in Mediterranean countries, North Africa, the Middle East, India, Central Asia, and Southeast Asia. Whilst substantial progress has been made towards the improvement of Health related quality of life (HRQoL) in western countries, scarce evidence-based data exists on HRQol of thalassemia children and adolescents living in developing countries.
We studied 60 thalassemia children from Middle Eastern countries with a median age of 10 years (range 5 to 17 years). HRQoL was assessed with the Pediatric Quality of Life Inventory (PedsQL) 4.0. The Questionnaire was completed at baseline by all patients and their parents. The agreement between child-self and parent-proxy HRQoL reports and the relationship between HRQoL profiles and socio-demographic and clinical factors were investigated.
The scores of parents were generally lower than those of their children for Emotional Functioning (mean 75 vs 85; p = 0.002), Psychosocial Health Summary (mean 70.3 vs 79.1; p = 0.015) and the Total Summary Score (mean 74.3 vs 77.7 p = 0.047). HRQoL was not associated with ferritin levels, hepatomegaly or frequency of transfusions or iron chelation therapy. Multivariate analysis showed that a delayed start of iron chelation had a negative impact on total PedsQL scores of both children (p = 0.046) and their parents (p = 0.007).
The PedsQL 4.0 is a useful tool for the measurement of HRQoL in pediatric thalassemia patients. This study shows that delayed start of iron chelation has a negative impact on children’s HRQoL.
PMCID: PMC3496588  PMID: 22726530
Quality of life; Thalassemia; PEDsQL 4.0
25.  Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient’s perspective 
The availability of the tyrosine-kinase inhibitor (TKI), imatinib, and later introduction of second generation TKIs, dasatinib and nilotinib, have not only improved clinical outcomes of patients with chronic myeloid leukemia (CML), but also provide multiple therapeutic options for CML patients. Despite the widespread use of these oral therapies, little is known about the impact of different treatment regimens on patient-reported outcomes (PROs) among CML patients. The objective of this study was to assess the impact of patient-reported treatment restrictions and negative medication experiences (NMEs) on satisfaction and other health outcomes among patients with CML treated with oral TKIs.
Participants recruited from survey panels and patient networks in the United States (US) and Europe completed an online questionnaire. Respondents included adults (≥18 years) with chronic-phase CML currently on TKI treatment. Study variables included treatment difficulty (i.e., difficulty in following treatment regimens), CML dietary/dosing requirements, NMEs, and validated PROs assessing treatment satisfaction, health-related quality of life (HRQoL), activity impairment, and non-adherence. Structural equation models assessed associations among variables, controlling for covariates.
303 patients with CML (US n=152; Europe n=151; mean age 51.5 years; 46.2% male) completed the questionnaire. Approximately 30% of patients reported treatment difficulties; treatment difficulty was higher among nilotinib (63.3%) than among dasatinib (2.6%) or imatinib (19.2%) treated patients (p<0.0001). Non-adherence was generally low; however, patients on nilotinib vs. imatinib reported missing doses more often (p<0.05). Treatment satisfaction was associated with significantly increased HRQoL (p<0.05) and lower activity impairment (p<0.01). NMEs were associated with decreased treatment satisfaction (p<0.01) and HRQoL (p<0.05), and greater activity impairment (p<0.01). Higher overall treatment restrictions were associated with greater treatment difficulty (p<0.001), which correlated with non-adherence (p<0.01).
Treatment satisfaction and NMEs are important factors associated with HRQoL among patients with CML. Increased treatment restrictions and associated difficulty may affect adherence with TKIs. Choosing a CML treatment regimen that is simple and conveniently adaptable in patients’ normal routine can be an important determinant of HRQoL and adherence.
PMCID: PMC3851879  PMID: 24099272
CML; Adherence; Quality of life; Treatment satisfaction; Treatment restrictions

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