Babalwa Zani

World Health Organization guideline development: an evaluation.

Background Research in 2007 showed that World Health Organization (WHO) recommendations were largely based on expert opinion, rarely used systematic evidence-based methods, and did not follow the organizations own “Guidelines for Guidelines”. In response, the WHO established a “Guidelines Review Committee” (GRC) to implement and oversee internationally recognized standards. We examined the impact of these changes on WHO guideline documents and explored senior staffs perceptions of the new procedures. Methods and Findings We used the AGREE II guideline appraisal tool to appraise ten GRC-approved guidelines from nine WHO departments, and ten pre-GRC guidelines matched by department and topic. We interviewed 20 senior staff across 16 departments and analyzed the transcripts using the framework approach. Average AGREE II scores for GRC-approved guidelines were higher across all six AGREE domains compared with pre-GRC guidelines. The biggest changes were noted for “Rigour of Development” (up 37.6%, from 30.7% to 68.3%) and “Editorial Independence” (up 52.7%, from 20.9% to 73.6%). Four main themes emerged from the interviews: (1) high standards were widely recognized as essential for WHO credibility, particularly with regard to conflicts of interest; (2) views were mixed on whether WHO needed a single quality assurance mechanism, with some departments purposefully bypassing the procedures; (3) staff expressed some uncertainties in applying the GRADE approach, with departmental staff concentrating on technicalities while the GRC remained concerned the underlying principles were not fully institutionalized; (4) the capacity to implement the new standards varied widely, with many departments looking to an overstretched GRC for technical support. Conclusions Since 2007, WHO guideline development methods have become more systematic and transparent. However, some departments are bypassing the procedures, and as yet neither the GRC, nor the quality assurance standards they have set, are fully embedded within the organization.

Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register

Introduction To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs). Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. Objectives To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. Methods We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. Results Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20), Zambia (12) and Zimbabwe (9). The median sample size was 628 (range 33-9645). Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA) and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. Conclusion Prevention trials dominate the trial landscape in Africa. Of note, few principal investigators and funders are from Africa. These findings mirror our previous work and continue to indicate a need for strengthening trial research capacity in Africa.

Series: Clinical Epidemiology in South Africa. Paper 2: Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Research evidence and policy: qualitative study in selected provinces in South Africa and Cameroon

BackgroundThe translation of research into policy and practice is enhanced by policymakers who can recognise and articulate their information needs and researchers that understand the policymakers’ environment. As researchers, we sought to understand the policymaking process and how research evidence may contribute in South Africa and Cameroon.MethodsWe conducted qualitative in-depth interviews in South Africa and focus group discussions in Cameroon with purposively sampled subnational (provincial and regional) government health programme managers. Audio recorded interviews were transcribed, thematically coded and analysed.ResultsParticipants in both countries described the complex, often lengthy nature of policymaking processes, which often include back-and-forth consultations with many diverse stakeholder groups. These processes may be influenced by political structures, relationships between national and subnational levels, funding and international stakeholder agendas. Research is not a main driver of policy, but rather current contextual realities, costs, logistics and people (clinicians, NGOs, funders) influence the policy, and research plays a part. Research evidence is frequently perceived as unavailable, inaccessible, ill-timed or not applicable. The reliability of research on the internet was questioned. Evidence-informed health decision-making (EIDM) is regarded as necessary in South Africa but is less well understood in Cameroon. Insufficient time and capacity were hindrances to EIDM in both countries. Good relationships between researchers and policymakers may facilitate EIDM. Researchers should have a good understanding of the policymaking environment if they want to influence it. Greater interaction between policymakers and researchers is perceived as beneficial when formulating research and policy questions as it raises researchers’ awareness of implementation challenges and enables the design of tailored and focused strategies to respond to policymakers’ needs.ConclusionsPolicymaking is complicated, lengthy and mostly done at national level. Provinces/regions are tasked with implementation, with more room for adaptation in South Africa than in Cameroon. Research evidence plays a role in policy but does not drive it and is seen as mostly unavailable. Researchers need a thorough understanding of the policy process and environment, how the health system operates, as well as the priorities of policymakers. This can inform effective dialogue between researchers and policymakers, and contribute to enhancing use of research evidence in decision-making.

Nurse led home-based care for people with HIV/AIDS

BackgroundHome-based care is used in many countries to increase quality of life and limit hospital stay, particularly where public health services are overburdened. Home-based care objectives for HIV/AIDS can include medical care, delivery of antiretroviral treatment and psychosocial support. This review assesses the effects of home-based nursing on morbidity in people infected with HIV/AIDS.MethodsThe trials studied are in HIV positive adults and children, regardless of sex or setting and all randomised controlled. Home-based care provided by qualified nurses was compared with hospital or health-facility based treatment. The following electronic databases were searched from January 1980 to March 2015: AIDSearch, CINAHL, Cochrane Register of Controlled Trials, EMBASE, MEDLINE and PsycINFO/LIT, with an updated search in November 2016. Two authors independently screened titles and abstracts from the electronic search based on the study design, interventions and types of participant. For all selected abstracts, full text articles were obtained. The final study selection was determined with use of an eligibility form. Data extraction was performed independently from assessment of risk of bias. The results were analysed by narrative synthesis, in order to be able to obtain relevant effect measures plus 95% confidence intervals.ResultsSeven studies met the inclusion criteria. The trial size varied from 37 to 238 participants. Only one trial was conducted in children. Five studies were conducted in the USA and two in China. Four studies looked at home-based adherence support and the rest at providing home-based psychosocial support. Reported adherence to antiretroviral drugs improved with nurse-led home-based care but did not affect viral load. Psychiatric nurse support in those with existing mental health conditions improved mental health and depressive symptoms. Home-based psychological support impacted on HIV stigma, worry and physical functioning and in certain cases depressive symptoms.ConclusionsNurse-led home-based interventions could help adherence to antiretroviral therapy and improve mental health. Further larger scale studies are needed, looking in more detail at improving medical care for HIV, especially related to screening and management of opportunistic infections and co-morbidities.

Original ArticleSeries: Clinical Epidemiology in South Africa. Paper 2: Quality and reporting standards of South African primary care clinical practice guidelines

OBJECTIVES Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. STUDY DESIGN AND SETTING CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. RESULTS We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. CONCLUSIONS The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Correction: World Health Organization Guideline Development: An Evaluation

The affiliation of the third and fourth authors is incorrect. The correct affiliation is: 2 South African Cochrane Centre, South African Medical Research Council, Cape Town, South Africa.