Search

Objectives: This cluster Randomized Controlled Trial (cRCT) aims to evaluate the effectiveness of an integrated ECD package in preventing developmental delays among children aged two years, in public health care centers, as compared to a control arm. Methods: This is a parallel, two-arm, cluster randomized controlled trial. 768 mother-child pairs (‘dyads’) attending any of the 24-public health centers in two districts of Pakistan will be recruited, with an average of 32 participants per cluster. In the intervention arm, ECD based counselling sessions will be delivered to mother–child dyads by trained staff at public health care centers. Our primary outcome is reduction in prevalence of two or more developmental delays among children, from 38% to 23% in the intervention arm. Unit of randomization will be public health care center. 24 eligible clusters recruited will be randomized into intervention and control arms, using 1:1 allocation. Discussion: The integrated model of child care into primary health care has the potential to provide a feasible and sustainable model for improving child developmental scale. Key words: Early Child Development; Prevention; Developmental Delays; Public healthcare facilities

Background Thousands of Rohingya refugee mothers at the world’s largest refugee camp located in Bangladesh are at risk of poor mental health. Accordingly, their children are also vulnerable to delayed cognitive and physical development. Objective The aim of this study is to evaluate the effectiveness of an integrated care package in reducing the prevalence of developmental delays among children aged 1 year and improving their mothers’ mental health status. Methods This is a parallel, two-arm, single-blind, cluster randomized controlled trial (cRCT). A total of 704 mother-child dyads residing at the Kutupalong refugee camp in Cox’s Bazar, Bangladesh, will be recruited from 22 clusters with 32 mother-child dyads per cluster. In the intervention arm, an integrated early childhood development and maternal mental health package will be delivered every quarter to mothers of newborns by trained community health workers until the child is 1 year old. Our primary outcome is a reduction in the prevalence of two or more childhood developmental delays of infants aged 1 year compared to the usual treatment. The secondary outcomes include reduced stunting among children and the prevalence of maternal depression. We will also assess the cost-effectiveness of the integrated intervention, and will further explore the intervention’s acceptability and feasibility. Results At the time of submission, the study was at the stage of endpoint assessment. The data analysis started in December 2020, and the results are expected to be published after the first quarter of 2021. Conclusions This study will address the burden of childhood developmental delays and poor maternal mental health in a low-resource setting. If proven effective, the delivery of the intervention through community health workers will ensure the proposed intervention’s sustainability. Trial Registration ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553 International Registered Report Identifier (IRRID) DERR1-10.2196/25047

BACKGROUND Thousands of Rohingya refugee mothers at the world’s largest refugee camp located in Bangladesh are at risk of poor mental health. Accordingly, their children are also vulnerable to delayed cognitive and physical development. OBJECTIVE The aim of this study is to evaluate the effectiveness of an integrated care package in reducing the prevalence of developmental delays among children aged 1 year and improving their mothers’ mental health status. METHODS This is a parallel, two-arm, single-blind, cluster randomized controlled trial (cRCT). A total of 704 mother-child dyads residing at the Kutupalong refugee camp in Cox’s Bazar, Bangladesh, will be recruited from 22 clusters with 32 mother-child dyads per cluster. In the intervention arm, an integrated early childhood development and maternal mental health package will be delivered every quarter to mothers of newborns by trained community health workers until the child is 1 year old. Our primary outcome is a reduction in the prevalence of two or more childhood developmental delays of infants aged 1 year compared to the usual treatment. The secondary outcomes include reduced stunting among children and the prevalence of maternal depression. We will also assess the cost-effectiveness of the integrated intervention, and will further explore the intervention’s acceptability and feasibility. RESULTS At the time of submission, the study was at the stage of endpoint assessment. The data analysis started in December 2020, and the results are expected to be published after the first quarter of 2021. CONCLUSIONS This study will address the burden of childhood developmental delays and poor maternal mental health in a low-resource setting. If proven effective, the delivery of the intervention through community health workers will ensure the proposed intervention’s sustainability. CLINICALTRIAL ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/25047

BackgroundThere were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030.AimTo assess if an integrated care package can achieve better control of diabetes.Design & settingThe pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up.MethodClinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded.ResultsThe primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11).ConclusionThe ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.

BackgroundHypertension in Pakistan affects 33% of people aged ≥45 years, and in urban areas around 70% of basic health care occurs in private facilities.AimTo assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence.Design & settingA two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015–September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up.MethodClinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged ≥25 years, systolic blood pressure [SBP] >140 mmHg, and/or diastolic blood pressure [DBP] >90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up.Staff and patients were not blinded, but outcome assessors were blinded.ResultsNine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals [CI] = -29.9 to-20.6); mean control outcome was -9.4 mmHg (95% CI = 21.2 to 2.2); and mean control–intervention difference was 15.8 (95% CI = 3.6 to 28.0; P = 0.01).ConclusionThe findings and separate process evaluation support the scaling of an integrated CVD–hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan.

Pakistan is eighth among countries with high burden of tuberculosis (TB). InPakistan free-of-charge TB diagnosis and treatment services are available. The objectiveof qualitative exploratory study was to understand how TB patients and their families copewith the lost earnings and increased expenditures (other than diagnosis and treatmentcost) related with disease and its treatment. The research methods included literaturereview, focus group discussion using vignettes and in-depth interviews with TB patients.The study was done in the rural areas of Lahore District with the support of district andlocal health facility staff. The study revealed that, Results like in many other developingcountries, TB patients rely mainly on financial and physical support of family membersand friends. Conclusion The study also highlighted the need for developing institutionalmechanisms to help patients cope with economic consequences of tuberculosis.

BackgroundIn poor urban Pakistan, private GP clinics lack adequate services to promote early child development (ECD) care. A clinic-based contextualised ECD intervention was developed for quarterly tool-assisted counselling of mothers.AimTo explore the experience and implementation of ECD intervention by the private care providers and clients, for further adaptation for scaling of quality ECD care, at primary level private healthcare facilities in Pakistan.Design & settingA mixed methods approach using quantitative records review and qualitative interviews at poor urban clinics in Rawalpindi and Lahore, Pakistan.MethodQuantitative data from study-specific records were reviewed for 1242 mother–child pairs registered in the intervention. A total of 18 semi-structured interviews with clinic staff, mothers, and research staff were conducted at four clinics. The interviews were audiorecorded and transcribed verbatim.ResultsDistrict Health Office (DHO) support allowed transparent and effective selection and training of clinic providers. Public endorsement of ECD care at private clinics and the addition of community advocates promoted ECD care uptake. Clinic settings were found feasible for clinic assistants, and acceptable to mothers, for counselling sessions. Mothers found ECD counselling methods more engaging compared to the usual care provided.ConclusionIn poor urban settings where public health care is scarce, minimal programme investment on staff training and provision of minor equipment can engage private clinics effectively in delivering ECD care.

BackgroundIn Pakistan, high prevalence of delays in early child development (ECD) is associated with poverty and lack of mothers’ caregiving skills. GP clinics, the main sources of care in poor urban localities, lack quality ECD care delivery. A contextualised intervention was developed and tested to enable GPs to deliver clinic-based, tool-assisted ECD counselling of mothers on a quarterly basis.AimTo assess the effectiveness of delivering a contextualised ECD mother-counselling intervention.Design & settingClustered randomised controlled trial, in poor urban localities of Pakistan. Locality clusters were allocated to intervention and control arm using simple randomisation.MethodA total of 2327 mother–child pairs were recruited at 32 GP clinics, one from each cluster-locality; 16 GP clinics per arm. The clinic-based counselling intervention covering child stimulation, nutrition, and maternal mental health was delivered mainly by clinic assistants to mothers at ≤6 weeks, and 3, 6, and 9 months of child age. At 12 months of child age, each mother–child pair was assessed for the primary outcome, that is, delays in the five development domains (determined by Ages and Stages Questionnaire-3 [ASQ-3] score); and secondary outcomes, namely the prevalence of stunting and maternal depression (determined by Patient Health Questionnaire-9 [PHQ-9] score). The outcome assessors were blinded to the cluster–arm allocation. Outcome analyses were calculated on cluster-level.ResultsAt 12 months, the number of children with delay in two or more development domains was significantly lower in the intervention arm (-0.17 [95% confidence interval {CI} = -0.26 to -0.09]; PPP = 0.000) respectively.ConclusionContextualised ECD care, when delivered at GP clinics in poor urban localities, can effectively reduce the developmental delays during the first 12 months of the child's life.

BackgroundIn Pakistan about 18% of all adults are affected by hypertension, and only one in eight of the prevalent cases have their hypertension controlled. As in many other low-middle income countries, a public–private partnership approach is being considered for delivering non-communicable disease care in urban areas.AimThis process evaluation was undertaken to understand how an integrated care intervention was experienced by the care providers and patients, and to inform modifications before possible scaling.Design & settingThe mixed-methods study was conducted as part of a cluster randomised trial on integrated hypertension care at 26 private clinics.MethodThe care practices were assessed by analysing the clinical records of 1138 registered patients with hypertension. Then semi-structured interviews with service providers and patients were used to understand their respective care experiences. A framework approach was applied to analyse and interpret the qualitative data.ResultsDistrict-led objective selection and context-sensitive staff training helped to get the clinics engaged in partnership working. About one-third of patients with hypertension had associated diabetes or renal compromise. The prescription of drugs is influenced by multiple non-clinical considerations of providers and patients. Many doctors allowed the use of home-based remedies as supplements to the prescribed allopathic drugs. Female patients faced more challenges in managing lifestyle changes. The intervention improved adherence to follow-up visits, but patient attrition remained a challenge.ConclusionThe integrated hypertension care intervention at private clinics is feasible, and leads to improved diagnosis and treatment in low-income country urban setting. The authors recommend continued implementation research and informed scaling of hypertension care at private clinics.

Summary Objectives To develop and validate clinical guidelines for diagnosis of smear-negative pulmonary tuberculosis (TB) in developing countries with low-HIV prevalence. Methods We developed diagnostic guidelines for smear-negative TB. Clinical diagnoses based on these guidelines were compared with sputum culture, chest X-rays and reports of an expert panel. Results The guidelines achieved a sensitivity of 0.59 [confidence interval (CI) 0.46–0.66] and a specificity of 0.86 (CI 0.84–0.88) in diagnosing smear-negative TB. A total of 6.8% of patients who initially improved after a course of antibiotics were later confirmed to have TB. Clinicians detected an abnormal chest X-ray in 92% (CI 88–96%) and radiological signs of pulmonary TB in 98% (CI 94–100%) of cases. Conclusions Our experience highlights a number of dilemmas faced in developing, testing and implementing diagnostic guidelines in poorly resourced conditions. Using radiological criteria for TB and appropriate training can help in improving the diagnostic skills of primary care clinicians working in low-HIV settings with access to X-ray facilities. But a significant number of apparently smear-negative TB cases may in fact be smear positive and TB programmes should focus on improving the quality of direct acid-fast bacilli microscopy. The value of an antibiotic trial is questionable due to the relatively large number of false negatives generated by this approach. Objectifs Developper et valider des directives cliniques pour le diagnostic de la tuberculose pulmonaire a frottis negatif dans des pays en developpement avec une faible prevalence VIH. Methodes Nous avons developpe des directives de diagnostic pour la tuberculose a frottis negatif. Les diagnostics cliniques bases sur ces directives ont ete compares a la culture du crachat, a la radiographie aux rayons X des poumons et aux rapports d'un comite d'experts. Resultats Les directives ont atteint une sensibilite de 0.59 (IC: 0.46–0.66) et une specificite de 0.86 (IC: 0.84–0.88) pour le diagnostic de la tuberculose a frottis negatif. 6.8% des patients qui avaient initialement presente une amelioration suite au traitement par antibiotiques ont plus tard ete confirmes comme cas de tuberculose. Les cliniciens ont detecte une radiographie anormale des poumons chez 92% (IC: 88–96%) et des signes radiologiques de tuberculose pulmonaire chez 98% (IC: 94–100%) des cas. Conclusion Notre experience de tester et developper des directives de diagnostic dans des conditions a ressources pauvres a revele un nombre de dilemmes rencontres dans les pays en developpement. L'utilisation de critere radiologique pour la tuberculose et une formation appropriee peut aider a ameliorer les competences de diagnostic des cliniciens dans les centres de soins primaires dans les regions a faible prevalence de VIH ayant acces a la radiographie aux rayons X. En effet, un nombre important de cas de tuberculose a frottis apparemment negatifs peuvent en fait etre des cas a frottis positif et les programmes de tuberculose devraient se concentrer sur l'amelioration de la qualite de la microscopie directe basee sur la detection de bacilles acido-alcolo-resistants. La question de la validite d'un essai d'antibiotique se pose a cause du nombre relativement eleve de faux negatifs generes par cette approche. Objetivos Desarrollar y validar guias clinicas para el diagnostico de la tuberculosis pulmonar con lamina negativa en paises en vias de desarrollo con una prevalencia baja de VIH. Metodos Se desarrollaron guias diagnosticas para tuberculosis con lamina negativa. El diagnostico clinico basado en estas guias se comparo con el cultivo de esputo, placa de rayos-X y reportes de un panel de expertos. Resultados Las guias alcanzaron una sensibilidad del 0.59 (IC 0.46–0.66) y una especificidad de 0.86 (IC 0.84–0.88) en el diagnostico de la tuberculosis con lamina negativa. En un 6.8% de los pacientes que mejoraron inicialmente tras el tratamiento con antibioticos, se confirmo posteriormente que tenian TB. Los clinicos detectaron una placa de rayos-X anormal en el 92% (IC 88–96%) de los casos, y signos radiologicos de tuberculosis en un 98% (IC 94–100%) de ellos. Conclusiones Nuestra experiencia resalta una serie de retos a los cuales hay que enfrentarse al desarrollar, testar e implementar guias diagnosticas en condiciones de pocos recursos. El uso de criterios radiologicos para TB y un entrenamiento apropiado, pueden ayudar a mejorar las habilidades diagnosticas de los clinicos de atencion primaria trabajando en lugares con una baja prevalencia de VIH y con acceso a rayos-X. Un numero significativo de casos de TB con una lamina aparentemente negativa, pueden de hecho tener lamina positiva, de modo que los programas de TB deberian centrarse en mejorar la calidad de la microscopia directa para la deteccion de bacilos acido-resistentes. El valor de un ensayo clinico con antibioticos es cuestionable debido al gran numero de falsos negativos generados.

An economic study was conducted alongside a clinical trial at three sites in Pakistan to establish the costs and effectiveness of different strategies for implementing directly observed treatment (DOT) for tuberculosis. Patients were randomly allocated to one of three arms: DOTS with direct observation by health workers (at health centres or by community health workers); DOTS with direct observation by family members; and DOTS without direct observation. The clinical trial found no statistically significant difference in cure rate for the different arms. The economic study collected data on the full range of health service costs and patient costs of the different treatment arms. Data were also disaggregated by gender, rural and urban patients, by treatment site and by economic categories, to investigate the costs of the different strategies, their cost-effectiveness and the impact that they might have on patient compliance with treatment. The study found that direct observation by health centre-based health workers was the least cost-effective of the strategies tested (US dollars 310 per case cured). This is an interesting result, as this is the model recommended by the World Health Organization and International Union against Tuberculosis and Lung Disease. Attending health centres daily during the first 2 months generated high patient costs (direct and in terms of time lost), yet cure rates for this group fell below those of the non-observed group (58%, compared with 62%). One factor suggested by this study is that the high costs of attending may be deterring patients, and in particular, economically active patients who have most to lose from the time taken by direct observation. Without stronger evidence of benefits, it is hard to justify the costs to health services and patients that this type of direct observation imposes. The self-administered group came out as most cost-effective (164 dollars per case cured). The community health worker sub-group achieved the highest cure rates (67%), with a cost per case only slightly higher than the self-administered group (172 dollars per case cured). This approach should be investigated further, along with other approaches to improving patient compliance.

A randomized controlled trial was carried out in Pakistan in 1999 to establish the effectiveness of the direct observation component of DOTS programmes. It found no significant differences in cure rates for patients directly observed by health facility workers, community health workers or by family members, as compared with the control group who had self-administered treatment. This paper reports on the social studies which were carried out during and after this trial, to explain these results. They consisted of a survey of all patients (64% response rate); in-depth interviews with a smaller sample of different types of patients; and focus group discussions with patients and providers. One finding was that of the 32 in-depth interview patients, 13 (mainly from the health facility observation group) failed to comply with their allocated DOT approach during the trial, citing the inconvenience of the method of observation. Another finding was that while patients found the overall TB care approach efficient and economical in general, they faced numerous barriers to regular attendance for the direct observation of drug-taking (most especially, time, travel costs, ill health and need to pursue their occupation). This may be one of the reasons why there was no overall benefit from direct observation in the trial. Provider attitudes were also poor: health facility workers expressed cynical and uncaring views; community health workers were more positive, but still arranged direct observation to suit their, rather than patients', schedules. The article concludes that direct observation, if used, should be flexible and convenient, whether at a health facility close to the patient's home or in the community. The emphasis should shift in practice from tablet watching towards treatment support, together with education and other adherence measures.