Protocol for a systematic review of the effects of interventions to inform or educate caregivers about childhood vaccination in low and middle-income countries.

INTRODUCTION: Despite their proven effectiveness in reducing childhood infectious diseases, the uptake of vaccines remains suboptimal in low and middle-income countries. Identifying strategies for transmitting accurate vaccine information to caregivers would boost childhood vaccination coverage in these countries. The purpose of this review is to assess the effects on childhood vaccination coverage of interventions for informing or educating caregivers about the importance of vaccines in low and middle-income countries, as defined by the World Bank. METHODS AND ANALYSIS: Eligible study designs include randomised controlled trials (RCTs) as well as non-randomised controlled trials (non-RCTs). We will conduct a comprehensive search of both peer-reviewed and grey literature available up to 31 May 2015. We will search PubMed, Scopus, Cochrane Central Register of Controlled Trials, Web of Science, Cumulative Index of Nursing and Allied Health, prospective trial registries and reference lists of relevant publications. Two authors will independently screen the search output, retrieve full texts of potentially eligible studies and assess the latter against predefined inclusion criteria. Disagreements between the two authors will be resolved through consensus and arbitration by a third author. We will pool data from studies with homogenous interventions and outcomes, using random-effects meta-analysis. We will assess statistical heterogeneity using the χ(2) test of homogeneity (with significance defined at the 10% α-level) and quantify it using Higgins' inconsistency index. We will explore the cause of any observed statistical heterogeneity using subgroup analysis, with subgroups defined by study design (RCTs vs non-RCTs) and type of intervention (information vs educational interventions). ETHICS AND DISSEMINATION: The proposed systematic review will collect and analyse secondary data that are not associated with individuals. The review will make a significant contribution to the knowledge base of interventions for improving childhood vaccination coverage in low and middle-income countries. PROTOCOL REGISTRATION NUMBER: PROSPERO, CRD42014010141.

Decentralising HIV treatment in lower- and middle-income countries

BACKGROUND: Policy makers, health staff and communities recognise that health services in lower- and middle-income countries need to improve people's access to HIV treatment and retention to treatment programmes. One strategy is to move antiretroviral delivery from hospitals to more peripheral health facilities or even beyond health facilities. This could increase the number of people with access to care, improve health outcomes, and enhance retention in treatment programmes. On the other hand, providing care at less sophisticated levels in the health service or at community-level may decrease quality of care and result in worse health outcomes. To address these uncertainties, we summarised the research studies examining the risks and benefits of decentralising antiretroviral therapy service delivery. OBJECTIVES: To assess the effects of various models that decentralised HIV treatment and care to more basic levels in the health system for initiating and maintaining antiretroviral therapy. METHODS: Search methods: We conducted a comprehensive search to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress) from 1 January 1996 to 31 March 2013, and contacted relevant organisations and researchers. The search terms included "decentralisation", "down referral", "delivery of health care", and "health services accessibility". Selection criteria: Our inclusion criteria were controlled trials (randomised and non-randomised), controlled-before and after studies, and cohorts (prospective and retrospective) in which HIV-infected people were either initiated on antiretroviral therapy or maintained on therapy in a decentralised setting in lower- and middle-income countries. We define decentralisation as providing treatment at a more basic level in the health system to the comparator. Data collection and analysis: Two authors applied the inclusion criteria and extracted ...

Task shifting from doctors to non-doctors for initiation and maintenance of antiretroviral therapy.

BACKGROUND: The high levels of healthcare worker shortage is recognised as a severe impediment to increasing patients' access to antiretroviral therapy. This is particularly of concern where the burden of disease is greatest and the access to trained doctors is limited.This review aims to better inform HIV care programmes that are currently underway, and those planned, by assessing if task-shifting care from doctors to non-doctors provides both high quality and safe care for all patients requiring antiretroviral treatment. OBJECTIVES: To evaluate the quality of initiation and maintenance of HIV/AIDS care in models that task shift care from doctors to non-doctors. SEARCH METHODS: We conducted a comprehensive search to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress) from 1 January 1996 to 28 March 2014, with major HIV/AIDS conferences searched 23 May 2014. We had also contacted relevant organizations and researchers. Key words included MeSH terms and free-text terms relevant to 'task shifting', 'skill mix', 'integration of tasks', 'service delivery' and 'health services accessibility'. SELECTION CRITERIA: We included controlled trials (randomised or non-randomised), controlled-before and after studies, and cohort studies (prospective or retrospective) comparing doctor-led antiretroviral therapy delivery to delivery that included another cadre of health worker other than a doctor, for initiating treatment, continuing treatment, or both, in HIV infected patients. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles, abstracts and descriptor terms of the results of the electronic search and applied our eligibility criteria using a standardized eligibility form to full texts of potentially eligible or uncertain abstracts. Two reviewers independently extracted data on standardized data extraction forms. Where possible, data were pooled using random effects meta-analysis. We assessed evidence quality with GRADE methodology. MAIN RESULTS: Ten studies met our inclusion criteria, all of which were conducted in Africa. Of these four were randomised controlled trials while the remaining six were cohort studies.From the trial data, when nurses initiated and provided follow-up HIV therapy, there was high quality evidence of no difference in death at one year, unadjusted risk ratio was 0.96 (95% CI 0.82 to 1.12), one trial, cluster adjusted n = 2770. There was moderate quality evidence of lower rates of losses to follow-up at one year, relative risk of 0.73 (95% CI 0.55 to 0.97). From the cohort data, there was low quality evidence that there may be an increased risk of death in the task shifting group, relative risk 1.23 (95% CI 1.14 to 1.33, two cohorts, n = 39 160) and very low quality data reporting no difference in patients lost to follow-up between groups, relative risk 0.30 (95% CI 0.05 to 1.94).From the trial data, when doctors initiated therapy and nurses provided follow-up, there was moderate quality evidence that there is probably no difference in death compared with doctor-led care at one year, relative risk of 0.89 (95% CI 0.59 to 1.32), two trials, cluster adjusted n = 4332. There was moderate quality evidence that there is probably no difference in the numbers of patients lost to follow-up at one year, relative risk 1.27 (95% CI 0.92 to 1.77), P = 0.15. From the cohort data, there is very low quality data that death at one year may be lower in the task shifting group, relative risk 0.19 (95% CI 0.05 to 0.78), one cohort, n = 2772, and very low quality evidence that loss to follow-up was reduced, relative risk 0.34 (95% CI 0.18 to 0.66).From the trial data, for maintenance therapy delivered in the community there was moderate quality evidence that there is probably no difference in mortality when doctors deliver care in the hospital or specially trained field workers provide home-based maintenance care and antiretroviral therapy at one year, relative risk 1.0 (95% CI 0.62 to 1.62), 1 trial, cluster adjusted n = 559. There is moderate quality evidence from this trial that losses to follow-up are probably no different at one year, relative risk 0.52 (0.12 to 2.3), P = 0.39. The cohort studies did not report on one year follow-up for these outcomes.Across the studies that reported on virological and immunological outcomes, there was no clear evidence of difference whether a doctor or nurse or clinical officer delivered therapy. Three studies report on costs to patients, indicating a reduction in travel costs to treatment facilities where task shifting was occurring closer to patients homes. There is conflicting evidence regarding the relative cost to the health system, as implementation of the strategy may increase costs. The two studies reporting the patient and staff perceptions of the quality of care, report good acceptability of the service by patients, and general acceptance by doctors of the shifting of roles. One trial reported on the time to initiation of antiretroviral therapy, finding no clear evidence of a difference between groups. The same trial reports on new diagnosis of tuberculosis which favours nurse initiation of HIV care for increasing the numbers of diagnoses of tuberculosis made. AUTHORS' CONCLUSIONS: Our review found moderate quality evidence that shifting responsibility from doctors to adequately trained and supported nurses or community health workers for managing HIV patients probably does not decrease the quality of care and, in the case of nurse initiated care, may decrease the numbers of patients lost to follow-up.

Decentralising HIV treatment in lower- and middle-income countries.

BACKGROUND: Policy makers, health staff and communities recognise that health services in lower- and middle-income countries need to improve people's access to HIV treatment and retention to treatment programmes. One strategy is to move antiretroviral delivery from hospitals to more peripheral health facilities or even beyond health facilities. This could increase the number of people with access to care, improve health outcomes, and enhance retention in treatment programmes. On the other hand, providing care at less sophisticated levels in the health service or at community-level may decrease quality of care and result in worse health outcomes. To address these uncertainties, we summarised the research studies examining the risks and benefits of decentralising antiretroviral therapy service delivery. OBJECTIVES: To assess the effects of various models that decentralised HIV treatment and care to more basic levels in the health system for initiating and maintaining antiretroviral therapy. SEARCH METHODS: We conducted a comprehensive search to identify all relevant studies regardless of language or publication status (published, unpublished, in press, and in progress) from 1 January 1996 to 31 March 2013, and contacted relevant organisations and researchers. The search terms included 'decentralisation', 'down referral', 'delivery of health care', and 'health services accessibility'. SELECTION CRITERIA: Our inclusion criteria were controlled trials (randomised and non-randomised), controlled-before and after studies, and cohorts (prospective and retrospective) in which HIV-infected people were either initiated on antiretroviral therapy or maintained on therapy in a decentralised setting in lower- and middle-income countries. We define decentralisation as providing treatment at a more basic level in the health system to the comparator. DATA COLLECTION AND ANALYSIS: Two authors applied the inclusion criteria and extracted data independently. We designed a framework to describe different decentralisation strategies, and then grouped studies against these strategies. Data were pooled using random-effects meta-analysis. Because loss to follow up in HIV programmes is known to include some deaths, we used attrition as our primary outcome, defined as death plus loss to follow-up. We assessed evidence quality with GRADE methodology. MAIN RESULTS: Sixteen studies met the inclusion criteria, all but one were from Africa, comprising two cluster randomised trials and 14 cohort studies. Antiretroviral therapy started at a hospital and maintained at a health centre (partial decentralisation) probably reduces attrition (RR 0.46, 95% CI 0.29 to 0.71, 4 studies, 39 090 patients, moderate quality evidence). There may be fewer patients lost to care with this model (RR 0.55, 95% CI 0.45 to 0.69, low quality evidence).We are uncertain whether there is a difference in attrition for antiretroviral therapy started and maintained at a health centre (full decentralisation) compared to a hospital at 12 months (RR 0.70, 95% CI 0.47 to 1.02; four studies, 56 360 patients, very low quality evidence), but there are probably fewer patients lost to care with this model (RR 0.3, 95% CI 0.17 to 0.54, moderate quality evidence).When antiretroviral maintenance therapy is delivered at home by trained volunteers, there is probably no difference in attrition at 12 months (RR 0.95, 95% CI 0.62 to 1.46, two trials, 1453 patients, moderate quality evidence). AUTHORS' CONCLUSIONS: Decentralisation of HIV care aims to improve patient access and retention in care. Most data were from good quality cohort studies but confounding between site of treatment and outcomes cannot be excluded. Nevertheless, this review found that attrition appears to be lower in partial decentralisation models of treatment, where antiretrovirals were started at hospital and continued in the health centre; with antiretroviral drugs started and continued at health centres, no difference in attrition was detected, but there were fewer patients lost to care. For antiretroviral therapy provided at home by trained volunteers, no difference in outcomes were detected when compared to facility-based care.

Weight loss interventions for chronic asthma.

BACKGROUND: Asthma and obesity are both public health problems with increasing prevalence globally. Several epidemiological studies have shown an association between asthma and obesity, however there is no good quality evidence on the effect of weight loss on asthma control. OBJECTIVES: To assess the effect of various interventions for weight loss on measures of asthma control and weight loss amongst overweight or obese patients with chronic asthma. SEARCH METHODS: We searched the Cochrane Airways Group's Specialized Register of Trials (CAGR) (derived from systematic searches of bibliographic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL, AMED and PsycINFO, and handsearching of respiratory journals and meeting abstracts). We also searched ongoing trials web sites and dissertation databases up to March 2012. We contacted experts in the field and searched reference lists for additional studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of weight loss interventions for overweight or obese participants with asthma compared to either no intervention for weight loss or an alternative weight loss intervention. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study eligibility and risk of bias, and extracted data using a data extraction form. We did not undertake any meta-analysis as there were no suitable data to combine. MAIN RESULTS: We included four completed studies conducted amongst adults (n = 197). Two were published as abstracts, and two as full articles. Interventions included supervised physical activity, low calorie diet and anti-obesity drugs (singly or in combination), and were compared to usual care (two studies), low calorie diet (one study), while one study had three intervention arms (physical activity versus low calorie diet versus a combination of the two). Two studies were conducted in high-income countries, while two were conducted in upper, middle-income countries.All studies had an unclear risk of selection and a high risk of detection bias. One of the studies found a statistically significant reduction in symptoms scores in treatment compared to control groups: the difference between groups in total St. George's Respiratory Questionnaire (SGRQ) score was -10 units (95% CI -18 to-1; P = 0.02). One study showed reduction in doses of rescue medication in treatment compared with control groups in the short term. Weight loss was associated with some improvement in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) in one study, which was statistically significant, but clinically unimportant; there was no improvement in peak expiratory flow rate (PEFR). No data were reported on health care utilization and adverse effects. One study reported statistically significant weight loss in the treatment group compared to controls with no intervention, which was still significant at one year follow-up. AUTHORS' CONCLUSIONS: Implications for practice This review found one randomized trial that showed that weight loss may be beneficial for improving asthma control in overweight and obese patients, in conjunction with weight loss in intervention groups in the short term. Applying the GRADE system to the results of this review however, shows that the quality of evidence is low, because although all four studies are RCTs there were serious methodological limitations in the studies (unclear risk of selection bias and high risk of detection bias) and imprecision (small sample size). There is inadequate evidence to comment on the effect of weight loss interventions on quality of life and health care utilization. In addition, there was inadequate reporting of data on adverse effects to permit proper balancing of harms and benefits of the interventions. On account of this low quality of evidence, the benefit of weight loss as an intervention for asthma control remains uncertain, and as such, clinicians should be prepared to help patients to make a decision that is consistent with their own values.Implications for research The finding that most of the included studies were of low methodological quality highlights the need for further well designed RCTs, with emphasis on adequate methods of allocation sequence generation as well as allocation concealment and longer follow-up periods. These studies need to report more fully on relevant outcomes (both statistically significant and otherwise) such as: asthma symptoms/control, use of rescue medication, change in lung function parameters (actual mean/median values), hospital utilization, quality of life, and adverse effects. There is also a need for longer intervention as well as follow-up durations to evaluate the effect of sustained measures to achieve weight loss, and to determine if these effects are still significantly present after a considerable period of time.There is also a need for these well designed studies in children and adolescents, as well as in low-income countries such as Africa, where the prepackaged, low energy diets, as well as structured physical activity-based interventions utilized in these included studies, may not be feasible or applicable.