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There is a need for clinical tools to identify cultural issues in diagnostic assessment.To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice.Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored.Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time.The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool.

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The multidisciplinary “New Millennium Indian Technology Leadership Initiative” Arthritis Project was undertaken to validate Ayurvedic medicines. Herbal formulations in popular use were selected by expert consensus and standardized using modern tools. Our clinical strategy evolved from simple exploratory evaluations to better powered statistically designed drug trials. The results of the first drug trial are presented here. Five oral formulations (coded A, B, C, D and E), with a common base of Zingiber officinale and Tinospora cordifolia with a maximum of four plant extracts, were evaluated; with placebo and glucosamine as controls. 245 patients suffering from symptomatic OA knees were randomized into seven arms (35 patients per arm) of a double blind, parallel efficacy, multicentric trial of sixteen weeks duration. The groups matched well at baseline. There were no differences for patient withdrawals (17.5%) or adverse events (AE) of mild nature. Intention-to-treat efficacy analysis, demonstrated no significant differences (P < .05) for pain (weight bearing) and WOMAC questionnaire (knee function); placebo response was high. Based on better pain relief, significant (P < .05) least analgesic consumption and improved knee status, “C” formulation was selected for further development. Controlled exploratory drug trials with multiple treatment arms may be used to economically evaluate several candidate standardized formulations.

Context:Development of the cultural formulation interview (CFI) in DSM-5 required validation for cross-cultural and global use.Aims:To assess the overall value (OV) of CFI in the domains of feasibility, acceptability, and utility from the vantage points of clinician-interviewers, patients and accompanying relatives.Settings and Design:We conducted cross-sectional semi-structured debriefing interviews in a psychiatric outpatient clinic of a general hospital.Materials and Methods:We debriefed 36 patients, 12 relatives and eight interviewing clinicians following the audio-recorded CFI. We transformed their Likert scale responses into ordinal values – positive for agreement and negative for disagreement (range +2 to −2).Statistical Analysis:We compared mean ratings of patients, relatives and clinician-interviewers using nonparametric tests. Clinician-wise grouping of patients enabled assessment of clinician effects, inasmuch as patients were randomly interviewed by eight clinicians. We assessed the influence of the presence of relatives, clinical diagnosis and interview characteristics by comparing means. Patient and clinician background characteristics were also compared.Results:Patients, relatives and clinicians rated the CFI positively with few differences among them. Patients with serious mental disorders gave lower ratings. Rating of OV was lower for patients and clinicians when relatives were present. Clinician effects were minimal. Clinicians experienced with culturally diverse patients rated the CFI more positively. Narratives clarified the rationale for ratings.Conclusions:Though developed for the American DSM-5, the CFI was valued by clinicians, patients and relatives in out-patient psychiatric assessment in urban Pune, India. Though relatives may add information and other value, their presence in the interview may impose additional demands on clinicians. Our findings contribute to cross-cultural evaluation of the CFI.

Hydroxychloroquine sulfate (HCQS) is a popular disease-modifying antirheumatic drug (DMARD) despite modest efficacy and toxicity. Ayurveda (ancient India medicinal system) physicians treat rheumatoid arthritis (RA) with allegedly safer herbal formulations. We report a head-to-head comparison in an exploratory drug trial. The objective is to compare standardized Ayurvedic formulations and HCQS in the treatment of RA. One hundred twenty-one patients with active moderately severe RA (ACR 1988 classified) were randomized into a 24-week investigator-blind, parallel efficacy, three-arm (two Ayurvedic and HCQS) multicenter drug trial study; polyherb (Tinospora cordifolia and Zingiber officinale based) and monoherb (Semecarpus anacardium). Study measures included joint counts (pain/tenderness and swelling), pain visual analogue scale, global disease assessments, and health assessment questionnaire. Oral meloxicam (fixed-dosage schedule) was prescribed to all patients during the initial 16 weeks. Patients on prednisolone could continue a fixed stable dose (<7.5 mg daily). Rescue oral use of paracetamol was permitted and monitored. All groups matched well at baseline. An intent-to-treat analysis (ANOVA, significance P < 0.05) did not show significant differences by treatment groups. In the polyherb, monoherb, and HCQS arms, 44%, 36%, and 51%, respectively, showed ACR 20 index improvement. Several efficacy measures improved significantly in the HCQS and polyherb groups with no difference between the groups (corrected P). However, the latter was individually superior to monoherb. Only mild adverse events (gut and skin, and none withdrew) were reported with no differences between the groups. Forty-two patients dropped out. This preliminary drug trial controlled for HCQS demonstrated a standardized Ayurvedic polyherb drug to be effective and safe in controlling active RA. A better-designed study with a longer evaluation period is recommended.

OBJECTIVES:Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA).METHODS:Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group.RESULTS:The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits.CONCLUSIONS:Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Depression, though generally episodic, results in lasting disability, distress, and burden. Rising prevalence of depression and suicide in the context of epidemiological transition demands more attention to social dimensions like gender related stresses, dysfunction, and their role in outcome of depression. Cross-sectional and follow-up assessment of men and women with depression at a psychiatric tertiary centre was undertaken to compare their illness characteristics including suicidal ideation, stresses, and functioning on GAF, SOFAS, and GARF scales (N = 107). We reassessed the patients on HDRS-17 after 6 weeks of treatment. Paired t-test and chi-square test of significance were used to compare the two groups, both before and after treatment. Interpersonal and marital stresses were reported more commonly by women (P < 0.001) and financial stresses by men (P < 0.001) though relational functioning was equally impaired in both. Women had suffered stresses for significantly longer duration (P = 0.0038). Men had more impairment in social and occupational functioning compared to females (P = 0.0062). History of suicide attempts was significantly associated with more severe depression and lower levels of functioning in case of females with untreated depression. Significant cross-gender differences in stresses, their duration, and types of dysfunction mandate focusing on these aspects over and above the criterion-based diagnosis.