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Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Background: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care.Methods: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months.Results: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results.Conclusions: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated.Trial Registration: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010. [ABSTRACT FROM AUTHOR]

Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 ≥ 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.Trial Registration: Pakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014) India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014). [ABSTRACT FROM AUTHOR]

Background: Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments.Methods: The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.Results: Six hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01).Conclusions: Without face-to-face explanation and at the end of a long questionnaire, the MGI was feasible to use, and acceptable to RCT participants. It allowed individual participants to include issues that were important to them, but which are not well captured by existing tools. The MGI unites the explanatory power of qualitative research with the comparative power of quantitative designs, is inexpensive to administer, and requires minimal linguistic and conceptual translation.Trial Registration: ISRCTN27575146 (date assigned 23 March 2011). [ABSTRACT FROM AUTHOR]

Schizophrenia is a complex illness with unknown aetiology and pathogenesis. Currently, a considerable number of patients with schizophrenia do not receive standardised and systematic treatment in China. In the past years, many controlled trials have been conducted in chronic schizophrenia. In contrast, research on first-episode schizophrenia is lacking. This paper describes the background and design of the Chinese First-Episode Schizophrenia Trial project — a multicentre, randomised, open-label clinical trial. A total of 600 first-episode schizophrenia patients were randomly divided into 3 groups and treated with risperidone, aripiprazole, and olanzapine for 1 year. During the study period, only 1 medication change of the 3 antipsychotic medications was allowed. [ABSTRACT FROM AUTHOR]

Purpose: This paper describes the impact of a care recommendation (CR) letter intervention on patients with multisomatoform disorder (MSD) and analysis of patient factors that affect the response to the intervention.Methods: One hundred eighty-eight patients from 3 family practices, identified through screening of 2,902 consecutive patients, were classified using somatization diagnoses based on the number of unexplained physical symptoms from a standardized mental health interview. In a controlled, single-crossover trial, patients were randomized to have their primary care physician receive the CR letter either immediately following enrollment or 12 months after enrollment. The CR letter notified the physician of the patient's somatization status and provided recommendations for the patient's care. Patients were followed for 24 months with assessments of functional status at baseline, 12, and 24 months.Results: Longitudinal analysis revealed a 12-month intervention effect for patients with multisomatoform disorder (MSD) of 5.5 points (P < .001) on the physical functioning (PCS) scale of the SF-36. Analysis of scores on the MCS scale of the SF-36 found no significant effect on mental functioning. The intervention was more effective for patients with 1 or more comorbid chronic physical diseases (P = .01).Conclusions: The CR letter has a favorable impact on physical impairment of primary care patients with MSD, especially for patients with comorbid chronic physical disease. Multisomatoform disorder appears to be a useful diagnostic classification for managing and studying somatization in primary care patients. [ABSTRACT FROM AUTHOR]