The MANAS trial reported that a Lay Health Counsellor (LHC) led collaborative stepped care intervention (the "MANAS intervention") for Common Mental Disorders (CMD) was effective in public sector primary care clinics but private sector General Practitioners (GPs) did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care.
Qualitative semi-structured interviews with key members (n = 119) of the primary health care teams upon completion of the trial and additional interviews with control arm GPs upon completion of the outcome analyses which revealed non-inferiority of this arm.
Several components of the MANAS intervention were reported to have been critically important for facilitating integration, notably: screening and the categorization of the severity of CMD; provision of psychosocial treatments and adherence management; and the support of the visiting psychiatrist. Non-adherence was common, often because symptoms had been controlled or because of doubt that health care interventions could address one's 'life difficulties'. Interpersonal therapy was intended to be provided face to face by the LHC; however it could not be delivered for most eligible patients due to the cost implications related to travel to the clinic and the time lost from work. The LHCs had particular difficulty in working with patients with extreme social difficulties or alcohol related problems, and elderly patients, as the intervention seemed unable to address their specific needs. The control arm GPs adopted practices similar to the principles of the MANAS intervention; GPs routinely diagnosed CMD and provided psychoeducation, advice on life style changes and problem solving, prescribed antidepressants, and referred to specialists as appropriate.
The key factors which enhance the acceptability and integration of a LHC in primary care are training, systematic steps to build trust, the passage of time, the observable impacts on patient outcomes, and supervision by a visiting psychiatrist. Several practices by the control arm GPs approximated those of the LHC which may partly explain our findings that they were as effective as the MANAS intervention arm GPs in enabling recovery.
Background and Objective
Common mental disorders (CMD) are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India.
A cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios.
This will be the first trial of the effectiveness of a complex intervention aiming to integrate efficacious treatments for CMD into routine primary care in a developing country. If effective, its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world, but mostly in those countries where specialist mental health services are few.
The MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407
The 12 item General Health Questionnaire (GHQ-12), increasingly used to screen for common mental disorders (CMD) in primary care, has been validated in different languages and cultures. However, the validity of the Tamil version has not been established. Consecutive patients, attending a primary health care centre in Vellore, rural Tamil Nadu, India, were screened for CMD using the Tamil version of the GHQ-12. The subjects were also interviewed using the Revised Clinical Interview Schedule (CIS-R). The International Classification of Diseases-10: Primary care version (ICD-10 PHC) criteria were used to diagnose CMD. Various thresholds of the GHQ-12 were compared against the standards of the ICD-10 PHC. A receiver operator characteristic curve was drawn to obtain the best threshold value for screening. Principal Component Analysis was done to identify latent variables. The Cronbach′s alpha and the split half reliability were also calculated. One hundred and eleven (33%) subjects of the 327 patients interviewed satisfied ICD-10 PHC criteria for CMD. The optimal threshold for the GHQ-12 was 2/3. This threshold had a sensitivity 87.4% and a specificity of 79.2%. Three factors were extracted with eigen values of 5.0 (depression-anxiety), 1.7 (social performance) and 1.1 (self-esteem) which explained 42.0%, 13.9% and 9.2% of the variance. The Cronbach′s alpha was 0.86 while the split half-reliability was 0.83. The sensitivity and specificity of the Tamil version of the GHQ-12 is high. The factor structure is similar to that reported in other populations. The instrument can be employed as a screening instrument in this population.
General health questionnaire; validation; common mental disorders; screening; primary care
There is limited evidence that interventions for depression and other common mental disorders (CMD) can be integrated sustainably into primary health care in Africa. We aimed to pilot a low-cost multi-component 'Friendship Bench Intervention' for CMD, locally adapted from problem-solving therapy and delivered by trained and supervised female lay workers to learn if was feasible and possibly effective as well as how best to implement it on a larger scale.
We trained lay workers for 8 days in screening and monitoring CMD and in delivering the intervention. Ten lay workers screened consecutive adult attenders who either were referred or self-referred to the Friendship Bench between July and December 2007. Those scoring above the validated cut-point of the Shona Symptom Questionnaire (SSQ) for CMD were potentially eligible. Exclusions were suicide risk or very severe depression. All others were offered 6 sessions of problem-solving therapy (PST) enhanced with a component of activity scheduling. Weekly nurse-led group supervision and monthly supervision from a mental health specialist were provided. Data on SSQ scores at 6 weeks after entering the study were collected by an independent research nurse. Lay workers completed a brief evaluation on their experiences of delivering the intervention.
Of 395 potentially eligible, 33 (8%) were excluded due to high risk. Of the 362 left, 2% (7) declined and 10% (35) were lost to follow-up leaving an 88% response rate (n = 320). Over half (n = 166, 52%) had presented with an HIV-related problem. Mean SSQ score fell from 11.3 (sd 1.4) before treatment to 6.5 (sd 2.4) after 3-6 sessions. The drop in SSQ scores was proportional to the number of sessions attended. Nine of the ten lay workers rated themselves as very able to deliver the PST intervention.
We have found preliminary evidence of a clinically meaningful improvement in CMD associated with locally adapted problem-solving therapy delivered by lay health workers through routine primary health care in an African setting. There is a need to test the effectiveness of this task-shifting mental health intervention in an appropriately powered randomised controlled trial.
Mental distress is common in primary care and overrepresented among Human Immunodeficiency virus (HIV)-infected individuals, but access to effective treatment is limited, particularly in developing countries. Explanatory models (EM) are contextualised explanations of illnesses and treatments framed within a given society and are important in understanding an individual's perspective on the illness. Although individual variations are important in determining help-seeking and treatment behaviour patterns, the ability to cope with an illness and quality of life, the role of explanatory models in shaping treatment preferences is undervalued. The aim was to identify explanatory models employed by HIV-infected and uninfected individuals and to compare them with those employed by local health care providers. Furthermore, we aimed to build a theoretical model linking the perception of mental distress to treatment preferences and coping mechanisms.
Qualitative investigation nested in a cross-sectional validation study of 28 (male and female) attendees at four primary care clinics in Lusaka, Zambia, between December 2008 and May 2009. Consecutive clinic attendees were sampled on random days and conceptual models of mental distress were examined, using semi-structured interviews, in order to develop a taxonomic model in which each category was associated with a unique pattern of symptoms, treatment preferences and coping strategies.
Mental distress was expressed primarily as somatic complaints including headaches, perturbed sleep and autonomic symptoms. Economic difficulties and interpersonal relationship problems were the most common causal models among uninfected individuals. Newly diagnosed HIV patients presented with a high degree of hopelessness and did not value seeking help for their symptoms. Patients not receiving anti-retroviral drugs (ARV) questioned their effectiveness and were equivocal about seeking help. Individuals receiving ARV were best adjusted to their status, expressed hope and valued counseling and support groups. Health care providers reported that 40% of mental distress cases were due to HIV infection.
Patient models concerning mental distress are critical to treatment-seeking decisions and coping mechanisms. Mental health interventions should be further researched and prioritized for HIV-infected individuals.
The relationship between partner alcohol use and violence as risk factors for poor mental health in women is unclear.
To describe partner-related and other psychosocial risk factors for common mental disorders (CMDs) in women and examine inter-relationships among these factors.
Data are reported on 821 women aged 18 to 49 years from a larger population study in north Goa, India. Logistic regression models evaluated risks for women's CMDs and tested for mediation effects in the relationship between partner alcohol use and CMDs.
Excessive partner alcohol use increased the risk for CMDs 2 to 3 fold. Partner violence and alcohol-related problems each partially mediated the association between partner excessive alcohol use and CMDs. Women's own violence-related attitudes were independently associated with CMDs.
Partner alcohol use, partner violence, and women's violence-related attitudes must be addressed to prevent and treat CMDs in women.
Declaration of Interest
Common mental disorders (CMD) is a term used to describe depressive and anxiety disorders. It replaces the old term ‘neuroses’ and is widely used because of the high level of co-morbidity of depression and anxiety, which limits the validity of categorical models of classification of neurotic disorders, particularly in primary care settings. The global public health significance of CMD is highlighted by the fact that in developing countries, depression is the leading cause of years lived with disability in both men and women aged 15–44 years. This oration brings together research evidence, mostly from South Asia, to show that although the aetiology of CMD may lie in the socioeconomic circumstances faced by many patients, biological treatments such as antidepressants may be among the most cost-effective treatments in resource-poor settings. The oration demonstrates the public health implications of CMD by briefly reviewing the burden of CMD in the region and presents evidence linking the risk for CMD associated with two of the region's most important public health risk factors—poverty and gender disadvantage. The oration also presents recent evidence to establish the association of CMD with some of the region's most important public health issues: maternal and child health; and reproductive and sexual health. Next, the evidence for the efficacy of treatments for CMD in developing countries is presented, focusing on a series of recent trials that show that both psychosocial and biological treatments are effective. Finally, the implications for policy and future research are considered.
Common mental disorders; biological treatment; depression; anxiety
There is a dearth of methodological studies critically evaluating reliability, validity and feasibility of measures of common mental disorders (CMD) in low-income countries.
Test-retest and inter-rater reliability of categorisation of CMD caseness, according to locally agreed criteria using the Comprehensive Psychopathological Rating Scale (CPRS), was measured in 99 women from out-patient clinics (inter-rater) and 99 women from a primary healthcare centre (test-retest) in Ethiopia. The construct validity of CMD as measured with CPRS was assessed with exploratory factor analysis using maximum likelihood with varimax rotation.
Test-retest reliability was fair (κ = 0.29). Subsequent assessment of inter-rater reliability found excellent agreement (κ = 0.82). The construct of CMD appeared unidimensional, combining depressive, anxiety and somatic symptoms.
Detection of socioculturally meaningful cases of CMD in Ethiopia can be reliably achieved with local psychiatrist assessment using CPRS, although thorough training is essential.
Reproducibility of Results; Ethiopia; Africa South of the Sahara; Mental disorders; Factor analysis, statistical
This paper has been corrected post-publication in deviation from print and in accordance with a correction printed in the February 2012 issue of the Journal.
Depressive and anxiety disorders (common mental disorders) are the most common psychiatric condition encountered in primary healthcare.
To test the effectiveness of an intervention led by lay health counsellors in primary care settings (the MANAS intervention) to improve the outcomes of people with common mental disorders.
Twenty-four primary care facilities (12 public, 12 private) in Goa (India) were randomised to provide either collaborative stepped care or enhanced usual care to adults who screened positive for common mental disorders. Participants were assessed at 2, 6 and 12 months for presence of ICD-10 common mental disorders, the severity of symptoms of depression and anxiety, suicidal behaviour and disability levels. All analyses were intention to treat and carried out separately for private and public facilities and adjusted for the design. The trial has been registered with clinicaltrials.gov (NCT00446407).
A total of 2796 participants were recruited. In public facilities, the intervention was consistently associated with strong beneficial effects over the 12 months on all outcomes. There was a 30% decrease in the prevalence of common mental disorders among those with baseline ICD-10 diagnoses (risk ratio (RR) = 0.70, 95% CI 0.53–0.92); and a similar effect among the subgroup of participants with depression (RR = 0.76, 95% CI 0.59–0.98). Suicide attempts/plans showed a 36% reduction over 12 months (RR = 0.64, 95% CI 0.42–0.98) among baseline ICD-10 cases. Strong effects were observed on days out of work and psychological morbidity, and modest effects on overall disability. In contrast, there was little evidence of impact of the intervention on any outcome among participants attending private facilities.
Trained lay counsellors working within a collaborative-care model can reduce prevalence of common mental disorders, suicidal behaviour, psychological morbidity and disability days among those attending public primary care facilities.
There is a paucity of known correlates of common mental disorders (CMDs) among the youth age group in India. This analysis aims to determine risk factors associated with a probable diagnosis of CMD in a youth sample in India.
This is a secondary analysis of data collected via a door-to-door (community) survey of 3,662 youth (aged 16–24 years) in selected urban and rural areas in Goa. The urban and rural areas were selected based on their engagement with a Goan-based mental health charity organisation, Sangath. Point prevalence of CMD was estimated using the general health questionnaire-12 (GHQ-12). Multivariate logistic regression analyses determined factors associated with CMD and associations were stratified by gender.
In total, 3,649 (1,796 urban; 1,853 rural) youth were assessed for probable diagnosis of CMD. There was an almost equal ratio of males (49 %) to females (51 %) in the sample. During the time of the survey, 91 % of the sample was residing with parents, with 83 % being between the ages of 22 and 24 years living with parents. A small proportion of the sample never attended school (1.1 %) with the rest either educated, employed or unemployed. The point prevalence of probable CMD in the sample was 7.87 %; 95 % CI 7.01–8.80 %. Those living in urban areas had a higher prevalence of CMD (9.12 %; 95 % CI 7.90–10.52 %) compared to those living in rural areas (6.60 %; 95 % CI 5.50–7.82 %). After adjusting for a range of potential confounders, independent risk factors for CMD were being older, i.e., between 22- and 24-years old, (OR 1.60; 95 % CI 1.10–2.24; p = 0.015), residing in urban areas (OR 1.51; 95 % CI 1.12–2.04; p = 0.007), physical abuse (beaten in the last 3 months) by parents, teachers or others (OR 3.10; 95 % CI 2.11–4.51; p < 0.001), sexual harassment (OR 2.01; 95 % CI 1.30–3.20; p = 0.003) and sexual abuse (OR 2.54; 95 % CI 1.94–3.33; p < 0.001). Being able to talk about personal problems (OR 0.52; 95 % CI 0.34–0.80; p = 0.003) was a protective factor. After stratifying by gender, sexual harassment, physical and sexual abuse were associated with a likely CMD diagnosis in females and males.
Sexual and recent physical abuses were independent risk factors for CMD in both genders. In addition, being older and being able to discuss problems were associated with CMD diagnosis in females but not in males.
Youth; 16–24 years; Common mental disorders; India; Community survey
Reliance on national figures may be underestimating the extent of mental ill health in urban communities. This study demonstrates the necessity for local information on common mental disorder (CMD) and substance use by comparing data from the South East London Community Health (SELCoH) study with those from a national study, the 2007 English Adult Psychiatric Morbidity Study (APMS).
Data were used from two cross-sectional surveys, 1698 men and women residing in south London and 7403 men and women in England. The main outcome, CMD, was indicated by a score of 12 or above on the Revised Clinical Interview Schedule. Secondary outcomes included hazardous alcohol use and illicit drug use. SELCoH sample prevalence estimates of CMD were nearly twice that of the APMS England sample estimates. There was a four-fold greater proportion of depressive episode in the SELCoH sample than the APMS sample. The prevalence of hazardous alcohol use was higher in the national sample. Illicit drug use in the past year was higher in the SELCoH sample, with cannabis and cocaine the illicit drugs reported most frequently in both samples. In comparisons of the SELCoH sample with the APMS England sample and the APMS sample from the Greater London area in combined datasets, these differences remained after adjusting for socio-demographic and socioeconomic indicators for all outcomes.
Local information for estimating the prevalence of CMD and substance use is essential for surveillance and service planning. There were similarities in the demographic and socioeconomic factors related to CMD and substance use across samples.
Study objective: To test hypotheses about associations between area level exposures and the prevalence of the most common mental disorders (CMD) in Britain. A statistically significant urban-rural gradient was predicted, but not a socioeconomic gradient, in the prevalence of CMD after adjusting for characteristics of individual respondents. The study tested the hypothesis that the effects of area level exposures would be greatest among those not in paid employment.
Design: Cross sectional survey, analysed using multilevel logistic and linear regression. CMD were assessed using the General Health Questionnaire (GHQ). Electoral wards were characterised using the Carstairs index, the Office of National Statistics (ONS) Classification of Wards, and population density.
Setting: England, Wales, and Scotland.
Participants: Nearly 9000 adults aged 16–74 living in 4904 private households, nested in 642 electoral wards.
Main results: Little evidence was found of statistically significant variance in the prevalence of CMD between wards, which ranged from 18.8% to 29.5% (variance 0.035, SE 0.026) (p=0.11). Associations between CMD and characteristics of wards, such as the Carstairs index, only reached statistical significance among those who were economically inactive (adjusted odds ratio for top v bottom Carstairs score quintile 1.58, 95% CI 1.08 to 2.31) (p<0.05).
Conclusions: There may be multiple pathways linking socioeconomic inequalities and ill health. The effects of place of residence on mental health are greatest among those who are economically inactive and hence more likely to spend the time at home.
Little is known of the relationship between perinatal somatic and common mental disorder (CMD) symptoms and impaired functioning in women from settings where the burden of undernutrition and infectious disease morbidity is high.
A population-based sample of 1065 women from Butajira, Ethiopia, was recruited in pregnancy (86.4% of those eligible) and reassessed two months postnatal (954 with singleton, live infants). At both time-points, women were administered a modified version of the Patient Health Questionnaire-15 and the Self-Reporting Questionnaire (locally-validated) to assess somatic and CMD symptoms, respectively. Negative binomial regression was used to investigate associations of CMD and somatic symptoms with functional impairment (World Health Organisation Disability Assessment Scale, version-II), after adjusting for maternal anthropometric measures, physical ill-health and sociodemographic factors.
In pregnancy, somatic and CMD symptoms were independently associated with worse maternal functional impairment after adjustment for confounders (WHODAS-II score multiplied by 1.09 (95%CI 1.06, 1.13) and 1.11 (95%CI 1.08, 1.14) respectively for each additional symptom). In the postnatal period, the size of association between somatic symptoms and functional impairment was diminished, but the association with CMD symptoms was virtually unchanged (multiplier value 1.04 (95%CI 1.00, 1.09) and 1.11 (95%CI 1.07, 1.16) respectively).
Use of largely self-report measures.
Somatic and CMD symptoms were independently associated with functional impairment in both pregnancy and the postnatal period, with CMD symptoms showing a stronger and more consistent association. This emphasises the public health relevance of both CMD and somatic symptoms in the perinatal period.
Sub-Saharan Africa; Pregnancy; Postnatal; Somatic symptoms; Depression; Disability
Common mental disorders (CMDs) are an important cause of work disability. Although CMDs are known to have high recurrence rates, little is known about the recurrence of sickness absence due to CMDs. This study examines the recurrence risk of sickness absence due to CMDs.
A cohort of 9,904 employees with a sickness absence due to CMDs, working in the Dutch Post or Telecommunication company, was studied over a 7-year period. Recurrence was defined as the start of at least one new episode of sickness absence with CMDs after complete return to work for at least 28 days. The recurrence density (RD) of sickness absence with CMDs was calculated per 1,000 person-years.
Of the 9,904 employees with a first absence due to CMDs 1,925 (19%) had a recurrence, 90% of recurrences occurred within 3 years. The RD of sickness absence due to CMDs was 84.5 employees per 1,000 person-years (95% CI = 80.7–88.3). The RD of sickness absence due to CMDs was similar in women and in men. In men, depressive symptoms were related to higher recurrence of sickness absence due to CMDs than distress symptoms and adjustment disorders. In women, no difference by diagnostic category was found.
Employees with a previous episode of sickness absence with CMDs are at increased risk of recurrent sickness absence with CMDs. Relapse prevention consultations are recommended for a period of 3 years after return to work.
Recurrent sickness absence; Common mental disorders; Stress-related symptoms; Depressive symptoms; Anxiety symptoms
Chronicity and severity of early exposure to maternal common mental disorders (CMD) has been associated with poorer infant development in high-income countries. In low- and middle-income countries (LAMICs), perinatal CMD is inconsistently associated with infant development, but the impact of severity and persistence has not been examined.
A nested population-based cohort of 258 pregnant women was identified from the Perinatal Maternal Mental Disorder in Ethiopia (P-MaMiE) study, and 194 (75.2%) were successfully followed up until the infants were 12 months of age. Maternal CMD was measured in pregnancy and at two and 12 months postnatal using the WHO Self-Reporting Questionnaire, validated for use in this setting. Infant outcomes were evaluated using the Bayley Scales of Infant Development.
Antenatal maternal CMD symptoms were associated with poorer infant motor development (β^ -0.20; 95% CI: -0.37 to -0.03), but this became non-significant after adjusting for confounders. Postnatal CMD symptoms were not associated with any domain of infant development. There was evidence of a dose-response relationship between the number of time-points at which the mother had high levels of CMD symptoms (SRQ ≥ 6) and impaired infant motor development (β^ = -0.80; 95%CI -2.24, 0.65 for ante- or postnatal CMD only, β^ = -4.19; 95%CI -8.60, 0.21 for ante- and postnatal CMD, compared to no CMD; test-for-trend χ213.08(1), p < 0.001). Although this association became non-significant in the fully adjusted model, the β^ coefficients were unchanged indicating that the relationship was not confounded. In multivariable analyses, lower socio-economic status and lower infant weight-for-age were associated with significantly lower scores on both motor and cognitive developmental scales. Maternal experience of physical violence was significantly associated with impaired cognitive development.
The study supports the hypothesis that it is the accumulation of risk exposures across time rather than early exposure to maternal CMD per se that is more likely to affect child development. Further investigation of the impact of chronicity of maternal CMD upon child development in LAMICs is indicated. In the Ethiopian setting, poverty, interpersonal violence and infant undernutrition should be targets for interventions to reduce the loss of child developmental potential.
Migration and ethnic minority status have been associated with higher occurrence of common mental disorders (CMD), while mental health care utilisation by non-Western migrants has been reported to be low compared to the general population in Western host countries. Still, the evidence-base for this is poor. This study evaluates uptake of mental health services for CMD and psychological distress among first-generation non-Western migrants in Amsterdam, the Netherlands.
A population-based survey. First generation non-Western migrants and ethnic Dutch respondents (N = 580) participated in structured interviews in their own languages. The interview included the Composite International Diagnostic Interview (CIDI) and the Kessler psychological distress scale (K10). Uptake of services was measured by self-report. Data were analysed using weighting techniques and multivariate logistic regression.
Of subjects with a CMD during six months preceding the interview, 50.9% reported care for mental problems in that period; 35.0% contacted specialised services. In relation to CMD, ethnic groups were equally likely to access specialised mental health services. In relation to psychological distress, however, Moroccan migrants reported less uptake of primary care services (OR = 0.37; 95% CI = 0.15 to 0.88).
About half of the ethnic Dutch, Turkish and Moroccan population in Amsterdam with CMD contact mental health services. Since the primary purpose of specialised mental health services is to treat "cases", this study provides strong indications for equal access to specialised care for these ethnic groups. The purpose of primary care services is however to treat psychological distress, so that access appears to be lower among Moroccan migrants.
To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study.
Data Source and Setting
Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics.
Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence.
Data Collection and Abstraction Methods
Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data.
Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed:
Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site.
Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.
Ethics committees; research; health services research; qualitative research; multicenter studies
Women of Indian origin are said to have a lower rate of recognized common mental disorders and a higher frequency of consultation in primary care than white British. The aim of this study was to evaluate factors, including explanatory models (patient perspectives) of illness, associated with common mental disorders and with frequency of consultation among women of Indian origin in primary care. The investigation was conducted in a general practice in West London with a large Indian population. Consecutive woman attenders of Indian descent were screened with the General Health Questionnaire-12 to identify probable cases of psychiatric morbidity. 100 patients were interviewed with the Revised Clinical Interview Schedule (CIS-R), a specific tool for the diagnosis of common mental disorders, and the Short Explanatory Model Interview, which elicits the individual's conceptualization of his or her illness. Those patients who satisfied CIS-R criteria were classified as 'cases', the others as 'controls'. Common mental disorders were documented in 30% of patients. The general practitioner's diagnosis of common mental disorders had a sensitivity of 17% and a specificity of 91%. Individuals with common mental disorders had a higher frequency of consultation (P = 0.017), were less likely to see depression as an indication for medical intervention and were more likely to withhold some of their concerns from the general practitioner. Incorrect diagnosis by the GP was most likely to occur when patients did not disclose all their complaints. These associations were all statistically significant after adjustment for possible confounders by multiple linear and logistic regression. Women of Indian origin in this sample had rates of common mental disorders similar to those in other UK populations. Differing conceptualizations of common mental disorders may contribute to their underrecognition in women of Indian origin.
Common mental disorders (CMD) negatively affect work functioning. In the health service sector not only the prevalence of CMDs is high, but work functioning problems are associated with a risk of serious consequences for patients and healthcare providers. If work functioning problems due to CMDs are detected early, timely help can be provided. Therefore, the aim of this study is to develop a detection questionnaire for impaired work functioning due to CMDs in nurses and allied health professionals working in hospitals.
First, an item pool was developed by a systematic literature study and five focus group interviews with employees and experts. To evaluate the content validity, additional interviews were held. Second, a cross-sectional assessment of the item pool in 314 nurses and allied health professionals was used for item selection and for identification and corroboration of subscales by explorative and confirmatory factor analysis.
The study results in the Nurses Work Functioning Questionnaire (NWFQ), a 50-item self-report questionnaire consisting of seven subscales: cognitive aspects of task execution, impaired decision making, causing incidents at work, avoidance behavior, conflicts and irritations with colleagues, impaired contact with patients and their family, and lack of energy and motivation. The questionnaire has a proven high content validity. All subscales have good or acceptable internal consistency.
The Nurses Work Functioning Questionnaire gives insight into precise and concrete aspects of impaired work functioning of nurses and allied health professionals. The scores can be used as a starting point for purposeful interventions.
Electronic supplementary material
The online version of this article (doi:10.1007/s00420-011-0649-0) contains supplementary material, which is available to authorized users.
Occupational health; Work functioning; Questionnaire; Common mental disorders; Nurses
Chronically ill patients often experience psychosocial problems in everyday life. A biopsychosocial approach is considered to be essential in chronic care. In Dutch primary health care the current biomedically oriented clinical practice may conflict with the biopsychosocial approach. This study is aimed to explore the views of Dutch stakeholders on achieving a biopsychosocial approach to the care of patients with chronic diseases.
In a qualitative explorative study design, we held semi-structured interviews with stakeholders, face-to-face or by telephone. Data were analysed using content analysis. Thirty representatives of Dutch patients with chronic illnesses, primary care professionals, policy makers, health inspectorate, health insurers, educational institutes and researchers were interviewed.
Stakeholders were aware that a systematic biopsychosocial care approach is lacking in current practice. Opportunities for effective change are multidimensional. Achieving a biopsychosocial approach to care relates to active patient participation, the training of professionals, high-quality guidelines, protocols and tools, integrated primary care, research and financial issues.
Although the principles and importance of the biopsychosocial model have been recognized, the provision of care that starts from the medical, emotional or social needs of individual patients does not fit in easily with the current Dutch health care system. All parties involved need to make a commitment to realize the ideal of biopsychosocial chronic care. Together they need to equip health professionals with skills to understand patients' multifaceted needs and to reward integrated biopsychosocial care. Patients need to be empowered to be active partners in their own care.
Objective The article assesses variables associated with general practitioners (GPs) taking on patients suffering from common mental disorders (CMD).
Method The study is based on a sample of 398 GPs, representative of the 7199 equivalent full-time GPs practising in Quebec, the second-largest province of Canada. GPs were asked to answer a 143-item questionnaire related to their socio-demographic profile, clinical practice, patient characteristics, perceived interprofessional relationships, quality of care, and support strategies for improving continuity of care. Descriptive, bivariate, and multivariate analyses were performed.
Results This study demonstrates that the following dimensions are associated with GPs taking on patients with CMD: (1) their interest and knowledge in dealing with such patients; (2) the relative simplicity of treating CMD cases; (3) the quality of, and interest in, mental healthcare collaboration; and (4) the availability of diversified services. The main enabling variable in GPs taking on CMD patients is their interest in mental disorders. Conversely, the principal impeding variable is their positive perception of relationships with psychiatric teams.
Conclusions In accordance with current healthcare reforms, this study reinforces the need to promote GP interest and training in mental health care. Increasing GP co-ordination with psycho-social services, along with developing integrated care models including specialised care, is strongly recommended.
depression and anxiety; primary care; patients with mental disorders
The present study has been carried out to examine the concepts of Common Mental Disorders held by primary health care providers in Goa. Ethnographic interviews and focus group discussions with primary health care (PHC) staff (n=33) and traditional healers (n=12) were done. Responses relating to the recognition and nature of case vignettes of depression, panic and agoraphobic disorder and multiple unexplained somatic symptoms and open-ended questions about mental illness were elicited. PHC staff recognised the somatic vignette frequently while the phobic vignette was rarely recognised. Both the somatic and the depression vignettes were related to non-somatic aetiologies frequently; Hindu spiritual healers used supernatural explanations while Catholic priests used psychological and cognitive models. Treatment was either religious/spiritual or psychological respectively. Implications for training and service included closer links between psychiatry and community medicine and avoiding the use of complex classification systems in primary care.
Common mental disorders; primary care; traditional healers; cross-cultural psychiatry
Common mental disorders (CMDs) are an important cause of sickness absence and long-term work disability. Although CMDs are known to have high recurrence rates, little is known about the recurrence of sickness absence due to CMDs. The aim of this study was to investigate the recurrence of sickness absence due to CMDs, including distress, adjustment disorders, depressive disorders and anxiety disorders, according to age, in male and female employees in the Netherlands.
Data on sickness absence episodes due to CMDs were obtained for 137,172 employees working in the Dutch Post and Telecommunication companies between 2001 and 2007. The incidence density (ID) and recurrence density (RD) of sickness absence due to CMDs was calculated per 1000 person-years in men and women in the age-groups of < 35 years, 35-44 years, 45-54 years, and ≥ 55 years.
The ID of one episode of CMDs sickness absence was 25.0 per 1000 person-years, and the RD was 76.7 per 1000 person-years. Sickness absence due to psychiatric disorders (anxiety and depression) does not have a higher recurrence density of sickness absence due to any CMDs as compared to stress-related disorders (distress and adjustment disorders): 81.6 versus 76.0 per 1000 person-years. The ID of sickness absence due to CMDs was higher in women than in men, but the RD was similar. Recurrences were more frequent in women < 35 years and in women between 35 and 44 years of age. We observed no differences between age groups in men. Recurrences among employees with recurrent episodes occurred within 3 years in 90% of cases and the median time-to-onset of recurrence was 11 (10-13) months in men and 10 (9-12) months in women.
Employees who have been absent from work due to CMDs are at increased risk of recurrent sickness absence due to CMDs and should be monitored after they return to work. The RD was similar in men and in women. In women < 45 years the RD was higher than in women ≥ 45 years. In men no age differences were observed.
To reduce the duration of sick leave and loss of productivity due to common mental disorders (CMDs), we developed a return-to-work programme to be provided by occupational physicians (OPs) based on the principles of exposure in vivo (RTW-E programme). This study evaluates this programme's effectiveness and cost-effectiveness by comparing it with care as usual (CAU). The three research questions we have are: 1) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders, compared with care as usual? 2) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders? 3) From a societal perspective, is an RTW-E programme cost-effective compared with care as usual?
This study was designed as a pragmatic cluster-randomized controlled trial with a one-year follow-up and randomization on the level of OPs. We aimed for 60 OPs in order to include 200 patients. Patients in the intervention group received the RTW-E programme. Patients in the control group received care as usual. Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks. As primary outcome measures, we calculated the time until full return to work and the duration of sick leave. Secondary outcome measures were time until partial return to work, prevalence rate of sick leave at 3, 6, 9, and 12 months' follow-up, and scores of symptoms of distress, anxiety, depression, somatization, and fatigue; work capacity; perceived working conditions; self-efficacy for return to work; coping behaviour; avoidance behaviour; patient satisfaction; and work adaptations. As process measures, we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups. Economic costs were calculated from a societal perspective. The total costs consisted of the costs of consuming health care, costs of production loss due to sick leave and reduced productivity, and out-of-pocket costs of patients for travelling to their OP.
The results will be published in 2009. The strengths and weaknesses of the study protocol are discussed.
Implementing change in primary care is difficult, and little practical guidance is available to assist small primary care practices. Methods to structure care and develop new roles are often needed to implement an evidence-based practice that improves care. This study explored the process of change used to implement clinical guidelines for primary and secondary prevention of cardiovascular disease in primary care practices that used a common electronic medical record (EMR).
Multiple conceptual frameworks informed the design of this study designed to explain the complex phenomena of implementing change in primary care practice. Qualitative methods were used to examine the processes of change that practice members used to implement the guidelines. Purposive sampling in eight primary care practices within the Practice Partner Research Network-Translating Researching into Practice (PPRNet-TRIP II) clinical trial yielded 28 staff members and clinicians who were interviewed regarding how change in practice occurred while implementing clinical guidelines for primary and secondary prevention of cardiovascular disease and strokes.
A conceptual framework for implementing clinical guidelines into primary care practice was developed through this research. Seven concepts and their relationships were modelled within this framework: leaders setting a vision with clear goals for staff to embrace; involving the team to enable the goals and vision for the practice to be achieved; enhancing communication systems to reinforce goals for patient care; developing the team to enable the staff to contribute toward practice improvement; taking small steps, encouraging practices' tests of small changes in practice; assimilating the electronic medical record to maximize clinical effectiveness, enhancing practices' use of the electronic tool they have invested in for patient care improvement; and providing feedback within a culture of improvement, leading to an iterative cycle of goal setting by leaders.
This conceptual framework provides a mental model which can serve as a guide for practice leaders implementing clinical guidelines in primary care practice using electronic medical records. Using the concepts as implementation and evaluation criteria, program developers and teams can stimulate improvements in their practice settings. Investing in collaborative team development of clinicians and staff may enable the practice environment to be more adaptive to change and improvement.