title: Reproducibility and validity of oral visual inspection by trained health workers in the detection of oral precancer and cancer. Determinants of Compliance in a Cluster Randomised Controlled Trial on Screening of Breast and Cervix Cancer in Mumbai, India Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial Economic evaluation of a task-shifting intervention for common mental disorders in India. Lay health worker led intervention for depressive and anxiety disorders in India: impact on clinical and disability outcomes over 12 months Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial Cost-effectiveness of oral cancer screening: results from a cluster randomized controlled trial in India. Improved retention rates with low-cost interventions in hypertension and diabetes management in a rural African environment of nurse-led care: a cluster-randomised trial. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial Determinants of Compliance in a Cluster Randomised Controlled Trial on Screening of Breast and Cervix Cancer in Mumbai, India A cluster randomized, controlled trial of breast and cervix cancer screening in Mumbai, India: methodology and interim results after three rounds of screening. Outcome of screening by clinical examination of the breast in a trial in the Philippines Cardiovascular disease risk management in a primary health care setting of north India. Comprehensive primary health care antiepileptic drug treatment programme in rural and semi-urban Kenya
abstract: A r and omized intervention trial is in progress in Kerala , India , to evaluate the effectiveness of oral visual inspection by trained health workers ( HWs ) in the prevention of oral cancer . Fourteen health workers with college graduation as the basic qualification were trained in oral visual inspection  to identify oral cancers and precancers among the participants of the screening trial and to refer them for further confirmation and management . The aim of the present study was to evaluate the reproducibility and validity of the  screening test  provided by the health worker against the reference oral visual findings of three physicians . A total of 2069 subjects who had already been examined were re-examined by the health workers and physicians . The sensitivity and the specificity of the oral visual inspection were 94.3 % and 99.3 % respectively . There was moderate agreement between the findings of the initial and the repeat mouth examinations carried out by the health workers , which were on average 6 months apart . There was almost perfect agreement ( kappa = 0.85 ) between the findings of the health workers and the physicians in identifying the different types of oral precancerous lesions . The findings of our study indicate that it is possible to train re source persons to perform the oral cancer screening test as accurately as doctors , although experience appears to be a crucial component of health workers ' accuracy . The efficacy of such an approach to reduce the incidence of and mortality from oral cancer , however , remains to be proven Objectives : The study aims to investigate the efficacy of screening by low-cost technology in down-staging and reduction of mortality due to breast and cervix cancer . Methods : The present trial is a community-based , cluster r and omised controlled cohort study on  screening for breast and cervix cancers ( clinical breast examination and visual inspection of the cervix after application of 4 % acetic acid ) . Univariate and multivariate logistic regression analyses are conducted to identify the predictors of compliance to referral among screen-positive women and to treatment among cancer cases . Results : The compliance to diagnostic investigations is 73 % among screen-positive women referred for breast cancer and 79 % among women referred for cervix cancer . Younger women , women working in service or being self-employed , school level-educated women , mother tongue Marathi , participation in screening in all 3 rounds and women referred as screen positive for cervix cancer had higher compliance to diagnostic investigations . The compliance to treatment completion is higher in women diagnosed with breast cancer , at 95 % , compared to 86 % for cervix cancers and 81 % for cervix pre-cancers . Conclusions : Good compliance rates along with a proper system of referral , further investigations , confirmation of diagnosis and treatment as demonstrated in this trial are crucial for successful screening programmes Summary Background Robust evidence of the effectiveness of task shifting of antiretroviral therapy ( ART ) from doctors to other health workers is scarce . We aim ed to assess the effects on mortality , viral suppression , and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Exp and Treatment and Care for HIV ( STRETCH ) programme , which provides educational outreach training of nurses to initiate and represcribe ART , and to de central ise care . Methods We undertook a pragmatic , parallel , cluster-r and omised trial in South Africa between Jan 28 , 2008 , and June 30 , 2010 . We r and omly assigned 31 primary -care ART clinics to implement the STRETCH programme ( intervention group ) or to continue with st and ard care ( control group ) . The ratio of r and omisation depended on how many clinics were in each of nine strata . Two cohorts were enrolled : eligible patients in cohort 1 were adults ( aged ≥16 years ) with CD4 counts of 350 cells per μL or less who were not receiving ART ; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment . The primary outcome in cohort 1 was time to death ( superiority analysis ) . The primary outcome in cohort 2 was the proportion with undetectable viral loads ( < 400 copies per mL ) 12 months after enrolment ( equivalence analysis , prespecified difference < 6 % ) . Patients and clinicians could not be masked to group assignment . The interim analysis was blind , but data analysts were not masked after the data base was locked for final analysis . Analyses were done by intention to treat . This trial is registered , number IS RCT N46836853 . Findings 5390 patients in cohort 1 and 3029 in cohort 2 were in the intervention group , and 3862 in cohort 1 and 3202 in cohort 2 were in the control group . Median follow-up was 16·3 months ( IQR 12·2–18·0 ) in cohort 1 and 18·0 months ( 18·0–18·0 ) in cohort 2 . In cohort 1 , 997 ( 20 % ) of 4943 patients analysed in the intervention group and 747 ( 19 % ) of 3862 in the control group with known vital status at the end of the trial had died . Time to death did not differ ( hazard ratio [ HR ] 0·94 , 95 % CI 0·76–1·15 ) . In a preplanned subgroup analysis of patients with baseline  CD4 counts of 201–350 cells per μL , mortality was slightly lower in the intervention group than in the control group ( 0·73 , 0·54–1.00 ; p=0·052 ) , but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less ( 0·94 , 0·76–1·15 ; p=0·577 ) . In cohort 2 , viral load suppression 12 months after enrolment was equivalent in intervention ( 2156 [ 71 % ] of 3029 patients ) and control groups ( 2230 [ 70 % ] of 3202 ; risk difference 1·1 % , 95 % CI −2·4 to 4·6 ) . Interpretation Expansion of primary -care nurses ' roles to include ART initiation and represcription can be done safely , and improve health outcomes and quality of care , but might not reduce time to ART or mortality . Funding UK Medical Research Council , Development Cooperation Irel and , and Canadian International Development Agency OBJECTIVE To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary -care setting s in Goa , India . METHODS Cost-utility and cost-effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary -care facilities . Subjects were r and omly assigned to an intervention or a control arm . Eligible subjects in the intervention arm were given psycho-education , case management , interpersonal psychotherapy and /or antidepressants by lay health workers . Subjects in the control arm were treated by physicians . The use of health-care re sources , the disability of each subject and degree of psychiatric morbidity , as measured by the Revised Clinical Interview Schedule , were determined at 2 , 6 and 12 months . FINDINGS Complete data , from all three follow-ups , were collected from 1243 ( 75.4 % ) and 938 ( 81.7 % ) of the subjects enrolled in the study facilities from the public and private sectors , respectively . Within the public facilities , subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm . Time costs were also significantly lower in the intervention arm than in the control arm , whereas health system costs in the two arms were similar . Within the private facilities , however , the effectiveness and costs recorded in the two arms were similar . CONCLUSION Within public primary -care facilities in Goa , the use of lay health workers in the care of subjects with common mental disorders was not only cost-effective but also cost-saving 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 . Background Depressive and anxiety disorders ( common mental disorders ) are the most common psychiatric condition encountered in primary healthcare . Aims To test the effectiveness of an intervention led by lay health counsellors in primary care setting s ( the MANAS intervention ) to improve the outcomes of people with common mental disorders . Method Twenty-four primary care facilities ( 12 public , 12 private ) in Goa ( India ) were r and omised 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 clinical trials.gov ( NCT00446407 ) . Results 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 . Conclusions 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 Summary Background The treatment of perinatal depression is a public-health priority because of its high prevalence and association with disability and poor infant development . We integrated a cognitive behaviour therapy-based intervention into the routine work of community-based primary health workers in rural Pakistan and assessed the effect of this intervention on  maternal depression and infant outcomes . Methods We r and omly assigned 40 Union Council clusters in rural Rawalpindi , Pakistan , in equal numbers to intervention or control . Married women ( aged 16–45 years ) in their third trimester of pregnancy with perinatal depression were eligible to participate . In the intervention group , primary health workers were trained to deliver the psychological intervention , whereas in the control group untrained health workers made an equal number of visits to the depressed mothers . The primary outcomes were infant weight and height at 6 months and 12 months , and secondary outcome was maternal depression . The interviewers were unaware of what group the participants were assigned to . Analysis was by intention to treat . The study is registered as IS RCT N65316374 . Findings The number of clusters per group was 20 , with 463 mothers in the intervention group and 440 in the control group . At 6 months , 97 ( 23 % ) of 418 and 211 ( 53 % ) of 400 mothers in the intervention and control groups , respectively , met the criteria for major depression ( adjusted odds ratio ( OR ) 0·22 , 95 % CI 0·14 to 0·36 , p<0·0001 ) . These effects were sustained at 12 months ( 111/412 [ 27 % ] vs 226/386 [ 59 % ] , adjusted OR 0·23 , 95 % CI 0·15 to 0·36 , p<0·0001 ) . The differences in weight-for-age and height-for-age Z scores for infants in the two groups were not significant at 6 months ( −0·83 vs −0·86 , p=0·7 and −2·03 vs −2·16 , p=0·3 , respectively ) or 12 months ( −0·64 vs −0·8 , p=0·3 and −1·10 vs −1·36 , p=0·07 , respectively ) . Interpretation This psychological intervention delivered by community-based primary health workers has the potential to be integrated into health systems in re source -poor setting s. Funding Wellcome Trust OBJECTIVE To evaluate  oral cancer screening by visual inspection . METHODS A cluster r and omized controlled trial was initiated in Triv and rum district , Kerala , India . Of 13 population clusters , seven were r and omly allocated to three rounds of screening between 1996 and 2004 , while st and ard care  was provided in six ( control arm ) . An activity-based approach was employed to calculate costs associated with various components of the screening trial . Information on the re sources used and on clinical events in each trial arm was derived from trial data bases . Total costs for each cluster were estimated in 2004 United States dollars ( US$ ) . The incremental cost per life-year saved was calculated for all eligible individuals and for high-risk individuals ( i.e. tobacco or alcohol users ) . FINDINGS The proportion of oral cancers detected at an early stage ( i.e. stage I or II ) was higher in the intervention arm than the control arm ( 42 % versus 24 % , respectively ) . The incremental cost per life-year saved was US$ 835 for all individuals eligible for screening and US$ 156 for high-risk individuals . Oral cancer screening  by  visual inspection  was performed for under US$ 6 per person . CONCLUSION The most cost-effective approach to oral cancer screening by visual inspection is to offer it to the high-risk population . Targeted screening of this group will ensure that screening can be offered at a reasonable cost in a limited-re source setting OBJECTIVE To compare the effects of low-level facility-based interventions on patient retention rates for cardiovascular ( CV ) disease in an environment of task shifting and nurse-led care in rural health districts in Central Cameroon . METHODS This study is an open-label , three-arm , cluster-r and omised trial in nurse-led facilities . All three groups implemented a treatment contract . The control group ( group 1 ) had no additional intervention , group 2 received the incentive of 1 month of free treatment every forth month of regularly respected visits , and group 3 received reminder letters in case of a missed follow-up visit . The primary outcome was patient retention at 1 year . Secondary outcomes were adherence to follow-up visit schemes and changes in blood pressure ( BP ) and blood glucose levels . Patients ' monthly spending for drugs and transport was calculated retrospectively . RESULTS A total of 33 centres and 221 patients were included . After 1 year , 109 patients ( 49.3 % ) remained in the programme . Retention rates in groups 2 and 3 were 60 % and 65 % , respectively , against 29 % in the control group . The differences between the intervention groups and the control group were significant ( P < 0.001 ) , but differences between the two intervention groups were not ( P = 0.719 ) . There were no significant differences in BP or fasting plasma glucose trends between retained patients in the study groups . Average monthly cost to patients for antihypertensive medication was € 1.1 ± 0.9 and for diabetics € 1.2 ± 1.1 . Transport costs to the centres were on average € 1.1 ± 1.0 for hypertensive patients and € 1.1 ± 1.6 for patients with diabetes . CONCLUSIONS Low-cost interventions suited to an environment of task shifting and nurse-led care and needing minimal additional re sources can significantly improve retention rates in CV disease management in rural Africa . The combination of a treatment contract and reminder letters in case of missed appointments was an effective measure to retain patients in care BACKGROUND Oral cancer is common in men from developing countries , and is increased by tobacco and alcohol use . We aim ed to assess the effect of visual screening on oral cancer mortality in a cluster-r and omised controlled trial in India . METHODS Of the 13 clusters chosen for the study , seven were r and omised to three rounds of oral visual inspection by trained health workers  at 3-year intervals and six to a control group during 1996 - 2004 , in Triv and rum district , Kerala , India . Healthy participants aged 35 years and older were eligible for the study . Screen-positive people were referred for clinical examination by doctors , biopsy , and treatment . Outcome measures were survival , case fatality , and oral cancer mortality . Oral cancer mortality in the study groups was analysed and compared by use of cluster analysis . Analysis was by intention to treat . FINDINGS Of the 96,517 eligible participants in the intervention group , 87,655 ( 91 % ) were screened at least once , 53,312 ( 55 % ) twice , and 29,102 ( 30 % ) three times . Of the 5145 individuals who screened positive , 3218 ( 63 % ) complied with referral . 95,356 eligible participants in the control group received st and ard care . 205 oral cancer cases and 77 oral cancer deaths were recorded in the intervention group compared with 158 cases and 87 deaths in the control group ( mortality rate ratio 0.79 [ 95 % CI 0.51 - 1.22 ] ) . 70 oral cancer deaths took place in users of tobacco or alcohol , or both , in the intervention group , compared with 85 in controls ( 0.66 [ 0.45 - 0.95 ] ) . The mortality rate ratio was 0.57 ( 0.35 - 0.93 ) in male tobacco or alcohol users and 0.78 ( 0.43 - 1.42 ) in female users . INTERPRETATION : Oral visual screening can reduce mortality in high-risk individuals and has the potential of preventing at least 37,000 oral cancer deaths worldwide Objectives : This study aims to investigate the efficacy of screening by low-cost technology in down-staging and reducing mortality due to breast and cervix cancer . Methods : The present trial is a community-based , cluster r and omised controlled cohort study on  screening for breast and cervix cancers ( clinical breast examination and visual inspection of the cervix after application of 4 % acetic acid ) . Univariate and multivariate logistic regression analyses are conducted to identify the predictors of participation in screening . Results : The average compliance is 71.43 and 64.93 % for breast and cervix cancer screening , respectively , with the highest compliance in round 1 . At the end of 3 screening rounds , 94 and 84 % of the eligible women were screened at least once for breast and cervix cancer , respectively . Younger women , women from other than Hindu and Muslim communities , school level-educated women , women belonging to lower-income families , Marathi-speaking women , married women and women who had previously consulted for any breast or gynaecological complaints had higher compliance to participation in screening . Conclusions : Good compliance rates to screening have been demonstrated in the trial , reflecting acceptance of the study by the society , which has implication s while translating the trial into a programme Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries . In May 1998 , supported by a grant from the NCI ( US ) , the Tata Memorial Hospital , Mumbai , India , started a cluster-r and omized , controlled , screening-trial for cervix and breast cancer using trained primary health workers to provide health-education , visual-inspection of cervix ( with 4 % acetic acid-VIA ) and clinical breast examination ( CBE ) in the screening arm , and only health education in the control arm . Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers . The methodology and interim results after three rounds of screening are presented here . Good r and omization was achieved between the screening ( n = 75360 ) and control arms ( n = 76178 ) . In the screening arm we see : High screening participation rates ; Low attrition ; Good compliance to diagnostic confirmation ; Significant downstaging ; Excellent treatment completion rate ; Improving case fatality ratios . The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion , language , age , education , occupation , income and health-seeking behavior for gynecological and breast-related complaints . During the same period , in the control arm we see excellent participation rate for health education ; Low attrition and a good number of symptomatic referrals for both cervix and breast The value of screening by Clinical Examination of the Breast ( CBE ) as a means of reducing mortality from breast cancer ( BC ) is not established . The issue is relevant , as CBE may be a suitable option for countries in economic transition , where incidence rates are on the increase but limited re sources do not permit screening by mammography . Our aims were to assess whether mass screening by CBE carried out by trained para‐medical personnel is feasible in an urban population of a low‐income country , and its efficacy in reducing BC mortality . Our study was design ed as a r and omised controlled trial of the effect on BC mortality of 5 annual CBE carried out by trained nurses . The target population was women aged 35–64 years , resident in 12 municipalities of the National Capital Region of Manila , Philippines . The units of r and omization were the 202 health centres ( HC ) within the selected municipalities . During 1995 nurses and midwives were recruited and trained in performing CBE . The first round of screening took place in 1996–1997 . The intervention however showed a refractory attitude of the population with respect to clinical follow‐up and was discontinued after the completion of the first screening round . Cases of breast cancer occurring in the study population during 1996–1999 were identified by the 2 local population ‐based registries . In the single screening round 151,168 women were interviewed and offered CBE  , 92 % accepted ( 138,392 ) , 3,479 were detected positive for a lump and referred for diagnosis . Of these only 1220 women ( 35 % ) completed diagnostic follow‐up , whereas 42.4 % actively refused further investigation even with home visits , and 22.5 % were not traced . Of 53 cases that occurred among screen‐positive women in the 2 years after CBE only 34 were diagnosed through the intervention . Eighty cases occurred among screen‐negative women . The test sensitivity  for CBE repeated annually was 53.2 % . The actual sensitivity of the programme was 25.6 % and positive predictive value 1 % . Screen‐detected cases were non‐significantly less advanced than the others . Previous studies have shown that most breast cancer cases in the Philippines present at advanced stages and have an unfavourable outcome . Although CBE undertaken by health workers seems to offer a cost‐effective approach to reducing mortality , the sensitivity of the screening programme in the real context was low . Moreover , in this relatively well‐educated population , cultural and logistic barriers to seeking diagnosis and treatment persist and need to be addressed before any screening programme is introduced . © 2005 Wiley‐Liss , OBJECTIVE This study was primarily carried out to assess the feasibility of an adapted WHO CVD risk management package in a primary care setting . METHODS A community intervention trial was conducted in eight health posts located in rural , urban , and slum areas of northern India . After a 4 day training , eight health workers implemented the package among 1010 adults > or = 30 years of age from a r and omly chosen cluster of households . Locally adapted scenario 1 WHO protocol was used for the assessment of CVD risks . The health workers inquired about smoking , alcohol , diet , physical activity , symptoms of angina , and transient ischaemic attacks ; and measured systolic blood pressure ( SBP7 ) , height , and weight . Those with a risk were counseled and referred to a physician . Hypertensives were followed at 1 , 3 , and 5-month interval to reinforce risk prevention and adherence to treatment . In a 20 % r and om sub sample , in the study and control area before and after the intervention , WHO STEPS instrument was used to evaluate effectiveness of the package . FINDINGS After training , the knowledge of health workers regarding risk factors and symptoms of CVDs increased from 47 % to 92.5 % , and their performance in detection of risks was comparable to the investigator . All health workers could pay scheduled home visits regularly . They referred 279 ( 27.6 % ) individuals having raised systolic blood pressure ( SBP )  , and 74.5 % contacted the doctor . Significant decrease in mean SBP ( 8.8 mm Hg ) was observed during follow-up . Significantly higher reports of intention to quit tobacco ( 60.3 % vs 25.5 % ) and regular intake of anti-hypertensive medication ( 58.3 % vs 34.8 % ) were observed in the intervention area compared to the control area . CONCLUSION Adapted WHO CVD risk management package can be implemented through primary care system A programme of antiepileptic treatment in a rural and semi-urban region in Kenya was assessed . Patients with generalised tonic-clonic seizures were treated according to one of two simple drug protocol s. Health workers screened cases reported by key informants in the community . From the 529 patients identified by health workers as having active seizures 302 patients aged 6 - 65 years were recruited by a psychiatrist for therapy with carbamazepine or phenobarbitone . Treatment was supervised largely by primary health workers , and the programme was monitored by a research team , which assessed the effectiveness of treatment . Of the 249 patients who completed the study , 53 % became seizure-free in the second 6 months of therapy , and another 26 % had substantially ( 50 % or more reduction ) fewer seizures than in the 6 months before therapy . The similarity of these findings to those obtained in newly diagnosed patients in the developed world , the low drop-out rate , the low rate of withdrawal due to adverse effects , and the acceptable compliance with therapy indicate that health workers can monitor therapy adequately . Most patients had had several years of delay before starting therapy for their epilepsy , yet they responded well -- a finding that does not support the suggestion that the disorder becomes intractable if not treated early
target: The majority of studies showed improved health outcomes when compared with usual healthcare , including reductions in blood pressure , increased uptake of medications and lower depression scores .
  Factors such as training of NPHWs , provision of algorithms and protocol s for screening , treatment and drug titration were the main enablers of the task-shifting intervention .
  The main barriers identified were restrictions on prescribing medications and availability of medicines .
  CONCLUSIONS Task-shifting from physicians to NPHWs , if accompanied by health system re-structuring is a potentially effective and affordable strategy for improving access to healthcare for NCDs .
background: BACKGROUND One potential solution to limited healthcare access in low and middle income countries ( LMIC ) is task-shifting- the training of  non-physician healthcare workers ( NPHWs ) to perform tasks traditionally undertaken by physicians .
  The aim of this paper is to conduct a systematic review of studies involving task-shifting for the management of non-communicable disease ( NCD ) in LMIC .