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1.  Improving women's diet quality preconceptionally and during gestation: effects on birth weight and prevalence of low birth weight—a randomized controlled efficacy trial in India (Mumbai Maternal Nutrition Project)12345 
Background: Low birth weight (LBW) is an important public health problem in undernourished populations.
Objective: We tested whether improving women's dietary micronutrient quality before conception and throughout pregnancy increases birth weight in a high-risk Indian population.
Design: The study was a nonblinded, individually randomized controlled trial. The intervention was a daily snack made from green leafy vegetables, fruit, and milk (treatment group) or low-micronutrient vegetables (potato and onion) (control group) from ≥90 d before pregnancy until delivery in addition to the usual diet. Treatment snacks contained 0.69 MJ of energy (controls: 0.37 MJ) and 10–23% of WHO Reference Nutrient Intakes of β-carotene, riboflavin, folate, vitamin B-12, calcium, and iron (controls: 0–7%). The primary outcome was birth weight.
Results: Of 6513 women randomly assigned, 2291 women became pregnant, 1962 women delivered live singleton newborns, and 1360 newborns were measured. In an intention-to-treat analysis, there was no overall increase in birth weight in the treatment group (+26 g; 95% CI: −15, 68 g; P = 0.22). There was an interaction (P < 0.001) between the allocation group and maternal prepregnant body mass index (BMI; in kg/m2) [birth-weight effect: −23, +34, and +96 g in lowest (<18.6), middle (18.6–21.8), and highest (>21.8) thirds of BMI, respectively]. In 1094 newborns whose mothers started supplementation ≥90 d before pregnancy (per-protocol analysis), birth weight was higher in the treatment group (+48 g; 95% CI: 1, 96 g; P = 0.046). Again, the effect increased with maternal BMI (−8, +79, and +113 g; P-interaction = 0.001). There were similar results for LBW (intention-to-treat OR: 0.83; 95% CI: 0.66, 1.05; P = 0.10; per-protocol OR = 0.76; 95% CI: 0.59, 0.98; P = 0.03) but no effect on gestational age in either analysis.
Conclusions: A daily snack providing additional green leafy vegetables, fruit, and milk before conception and throughout pregnancy had no overall effect on birth weight. Per-protocol and subgroup analyses indicated a possible increase in birth weight if the mother was supplemented ≥3 mo before conception and was not underweight. This trial was registered at www.controlled-trials.com/isrctn/ as ISRCTN62811278.
doi:10.3945/ajcn.114.084921
PMCID: PMC4196482  PMID: 25332324
2.  Electronic Monitoring of Oral Therapies in Ethnically Diverse and Economically Disadvantaged Patients with Rheumatoid Arthritis. Consequences of Low Adherence 
Arthritis and rheumatism  2013;65(6):1421-1429.
Background
To quantify adherence to oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis (RA) using electronic medication monitoring, and to evaluate the clinical consequences of low adherence.
Methods
107 patients with RA enrolled in a 2-year prospective cohort study agreed to have their oral RA drug therapy intake electronically monitored, with the Medication Events Monitoring System (MEMS®). Adherence to disease-modifying antirheumatic drugs (DMARDs) and prednisone were determined as the percentage of days (or weeks for methotrexate) in which the patient took the correct dose as prescribed by the physician. Patient outcomes were assessed including the Modified Health Assessment Questionnaire (MHAQ), the Disease Activity Index 28 (DAS28), quality of life and radiological damage using Sharp-van der Heijde scores.
Results
Adherence to the treatment regimen as determined by percent of correct doses was 64% for DMARDs and 70% for prednisone. Patients who had better mental health were statistically more likely to be adherent. Only 23 (21%) of the patients had an average adherence to DMARDs ≥ 80%. These patients showed significantly better disease activity scores across 2 years of follow-up than those who were less adherent (DAS28 3.3±1.3 vs. 4.1±1.2, p<0.02). Radiological scores were also worse in non-adherent patients at baseline and 12 months.
Conclusions
Only one fifth of the RA patients had an overall adherence of at least 80%. Less than two thirds of the prescribed DMARD doses were correctly taken. Adherent patients had lower disease activity and radiological damage scores across the 2 years of follow-up.
doi:10.1002/art.37917
PMCID: PMC3691007  PMID: 23728826
3.  The Symptom Burden Index: Development and Initial Findings from Use with Patients with Systemic Sclerosis 
The Journal of rheumatology  2010;37(8):10.3899/jrheum.090504.
Objective
Our study had 3 aims: (1) to evaluate the functioning of the Symptom Burden Index (SBI) in patients with systemic sclerosis (SSc); (2) to determine the amount of burden per problem experienced by patients as well as the number of patients experiencing each measured problem area, and the number of SSc problems per patient; and (3) to characterize the burden profiles of problem area-specific subgroups of patients.
Methods
We developed the SBI to determine the effect of problems in 8 major symptomatic areas of importance to patients (skin, hand mobility, calcinosis, shortness of breath, eating, bowel, sleep, and pain).
Results
Sixty-two patients with SSc completed questionnaires on current disease-related problems, physical functioning, and health status. On average, patients were 53.4 years old and had had SSc for 8 years. Patients were mainly women (87%), English-speaking (87%), with diffuse SSc (63%), white (69%), married (61%), and lived with 1 or more additional household members (84%). Only 26% were employed full-time. The 3 most widely reported problem areas were pain, hand, and skin, experienced by 92%, 89%, and 88%, respectively. About one-third reported experiencing 0–5 problems and one-third 7–8 problems; individual patients experienced, on average, 5.7 problems.
Conclusion
Psychometric evaluation determined that (1) summarizing SBI problem area item sets to report burden scores per problem measured is justified; (2) the 8 proposed problem areas are independent and deserve separate evaluation; and (3) burden scores correlate as expected with the Health Assessment Questionnaire-Disability Index and the Medical Outcomes Study Short-Form 36 questionnaire. The number of problems experienced and the degree of problem-associated burden that patients with SSc bear are substantial. Use of the SBI's patient-focused measurements may aid physicians in resolving problems most directly affecting patients' quality of life. This approach to measuring symptomatic burden in patients with chronic disease could be extended to other conditions.
doi:10.3899/jrheum.090504
PMCID: PMC3887547  PMID: 20516027
SYSTEMIC SCLEROSIS; PATIENT CARE MANAGEMENT; SELF-ASSESSMENT; PAIN MEASUREMENT
4.  Exploring communication pathways to better health: Clinician communication of expectations for acupuncture effectiveness 
Patient education and counseling  2012;89(2):245-251.
Objective
This study tested a pathway whereby acupuncturists’ communication of optimism for treatment effectiveness would enhance patients’ satisfaction during treatment, which in turn would contribute to better pain and function outcomes for patients with osteoarthritis of the knee.
Methods
Secondary analysis from a 2 arm (real vs. sham acupuncture, high vs. neutral expectations) RCT. 311 patients with knee osteoarthritis received acupuncture over 10–12 sessions. Coders rated the degree to which acupuncturists communicated optimism for the treatment’s effectiveness. Satisfaction with acupuncture was assessed 4 weeks into treatment. Pain and function were assessed 6 weeks following treatment.
Results
Patients experiencing better outcomes were more satisfied with acupuncture during treatment, were younger, and had better baseline pain and function scores. Satisfaction during treatment was greater when patients interacted with more optimistic clinicians and had higher pretreatment expectations for acupuncture efficacy.
Conclusion
Acupuncturists’ communication of optimism about treatment effectiveness contributed to pain and function outcomes indirectly through its effect on satisfaction during treatment. Future research should model pathways through which clinician-patient communication affects mediating variables that in turn lead to improved health outcomes.
Practical Implications
While clinicians should not mislead patients, communicating hope and optimism for treatment effectiveness has therapeutic value for patients.
doi:10.1016/j.pec.2012.06.032
PMCID: PMC3489966  PMID: 22857778
5.  Evaluation of a case management service to reduce sickness absence 
Background
It is unclear whether and to what extent intensive case management is more effective than standard occupational health services in reducing sickness absence in the healthcare sector.
Aims
To evaluate a new return to work service at an English hospital trust.
Methods
The new service entailed intensive case management for staff who had been absent sick for longer than four weeks, aiming to restore function through a goal-directed and enabling approach based on a bio-psycho-social model. Assessment of the intervention was by controlled before and after comparison with a neighbouring hospital trust at which there were no major changes in the management of sickness absence. Data on outcome measures were abstracted from electronic databases held by the two trusts.
Results
At the intervention trust, the proportion of 4-week absences which continued beyond 8 weeks fell from 51.7% in 2008 to 49.1% in 2009 and 45.9% in 2010. The reduction from 2008 to 2010 contrasted with an increase at the control trust from 51.2% to 56.1% – a difference in change of 10.7% (95%CI 1.5% to 20.0%). There was also a differential improvement in mean days of absence beyond four weeks, but this was not statistically significant (1.6 days per absence, 95%CI −7.2 to 10.3 days).
Conclusion
Our findings suggest that the intervention was effective, and calculations based on an annual running cost of £57,000 suggest that it was also cost-effective. A similar intervention should now be evaluated at a larger number of hospital trusts.
doi:10.1093/occmed/kqs223
PMCID: PMC3633198  PMID: 23365116
Sickness absence; case management; intervention; evaluation; cost-effectiveness; healthcare
6.  A Randomized Controlled Trial of Acupuncture for Osteoarthritis of the Knee: Effects of Patient-Provider Communication 
Arthritis care & research  2010;62(9):1229-1236.
Objectives
There is conflicting evidence on the efficacy of Traditional Chinese Acupuncture (TCA), and the role of placebo effects elicited by acupuncturists’ behavior has not been elucidated. We conducted a 3-month randomized clinical trial in patients with knee osteoarthritis to compare the efficacy of TCA to sham acupuncture, and examine the effects of acupuncturists’ communication style.
Methods
Acupuncturists were trained to interact in one of two communication styles: ‘high’ or ‘neutral’ expectations. Patients were randomized to one of 3 groups: waiting list, ‘high’ or ‘neutral’, and nested within style, TCA or sham acupuncture over 6 weeks. Sham acupuncture was performed in non-meridian points, with shallow needles and minimal stimulation. Primary outcome measures were: Joint-specific Multidimensional Assessment of Pain (J-MAP), Western Ontario McMaster Osteoarthritis Index (WOMAC), and satisfaction.
Results
455 patients who received treatment (TCA or sham) and 72 controls were included. No statistically significant differences were observed between TCA or sham acupuncture, but both groups had significant reductions in J-MAP and WOMAC pain compared to the waiting group (-1.1, -1.0, and -0.1, p<0.001; -13.7, -14, -1.7, p<0.001). Statistically significant differences were observed in J-MAP pain reduction and satisfaction, favoring the ‘high’ expectations group. Fifty-two percent and 43% in the TCA and sham groups thought they had received TCA (kappa=0.05), suggesting successful blinding.
Conclusion
TCA was not superior to sham acupuncture. However, acupuncturists’ style had significant effects on pain reduction and satisfaction, suggesting that the analgesic benefits of acupuncture can be partially mediated through placebo effects related to the acupuncturist's behavior.
doi:10.1002/acr.20225
PMCID: PMC3651275  PMID: 20506122
7.  Impact of Educational and Patient Decision Aids on Decisional Conflict Associated with Total Knee Arthroplasty 
Arthritis care & research  2012;64(2):229-237.
Our objective was to examine the impact of a videobooklet patient decision aid supplemented by an interactive values clarification exercise on decisional conflict in patients with knee osteoarthritis (OA) considering total knee arthroplasy. 208 patients participated in the study (mean age 63 years; 68% female; 66% White). Participants were randomized to 1 of 3 groups: (1) Educational booklet on OA management (control); (2) Patient decision aid (videobooklet) on OA management; and (3) Patient decision aid (videobooklet) + adaptive conjoint analysis ACA tool. The ACA tool enables patients to consider competing attributes (i.e. specific risks/benefits) by asking them to rate a series of paired-comparisons. The primary outcome was the decisional conflict scale ranging from 0 to 100. Differences between groups were analyzed using analysis of variance (ANOVA) and Tukey's honestly significant difference tests. Overall, decisional conflict decreased significantly in all groups (p<0.05). The largest reduction in decisional conflict was observed for participants in the videobooklet decision aid group (21 points). Statistically significant differences in pre vs. post-intervention total scores favored the videobooklet group compared to the control group (21 vs. 10) and to the videobooklet plus ACA group (21 vs. 14; p<0.001). Changes in the decisional conflict score for the control compared to the videobooklet decision aid + ACA group were not significantly different. In our study, an audiovisual patient decision aid decreased decisional conflict more than printed material alone, or than the addition of a more complex computer-based ACA tool requiring more intense cognitive involvement and explicit value choices.
doi:10.1002/acr.20646
PMCID: PMC3634330  PMID: 21954198
8.  Coding Geriatric syndromes: How good are we? 
High quality coding of hospital activity is important because the data is used for resource allocation and measuring performance. There is little information on the quality of coding of admissions of frail older people who have multiple diagnoses, co-morbidities and functional impairment. Presence or absence of four geriatric syndromes and eight medical conditions was noted on case note review (CNR). Discharge summaries (DS) and hospital coding (HC) were reviewed and compared with the CNR. Forty patients had at least one geriatric syndrome noted in the DS; 16 (40.0%) were captured by the HC. Of 57 patients with at least one medical condition noted in the DS, 52 (91.2%) were captured by the HC (p<0.0001 for difference in HC capture rates). We have demonstrated poor capture of information on geriatric syndromes compared to medical conditions in discharge summaries and hospital coding and propose a problem list bookmark approach to improve this.
PMCID: PMC3191527  PMID: 22003315
Coding; routine data; geriatric syndromes; frailty

Results 1-8 (8)