Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety

Objective: To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low-and middle-income countries. Methods: Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. Results: We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. Conclusions: The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety

Objective: To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low-and middle-income countries. Methods: Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. Results: We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. Conclusions: The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable

A systematic review on the effectiveness of implementation strategies to postpone elective caesarean sections to ≥ 39 + (0-6) weeks of gestation

BACKGROUND Caesarean sections often have no urgent indication and are electively planned. Research showed that elective caesarean section should not be performed until 39 + (0-6) weeks of gestation to ensure best neonatal and maternal health if there are no contraindications. This was recommended by various guidelines published in the last two decades. With this systematic review, we are looking for implementation strategies trying to implement these recommendations to reduce elective caesarean section before 39 + (0-6) weeks of gestation. METHODS We performed a systematic literature search in MEDLINE, EMBASE, CENTRAL, and CINAHL on 3rd of March 2021. We included studies that assessed implementation strategies aiming to postpone elective caesarean section to ≥ 39 + (0-6) weeks of gestation. There were no restrictions regarding the type of implementation strategy or reasons for elective caesarean section. Our primary outcome was the rate of elective caesarean sections before 39 + (0-6) weeks of gestation. We used the ROBINS-I Tool for the assessment of risk of bias. We did a narrative analysis of the results. RESULTS We included 10 studies, of which were 2 interrupted time series and 8 before-after studies, covering 205,954 elective caesarean births. All studies included various types of implementation strategies. All implementation strategies showed success in decreasing the rate of elective caesarean sections performed < 39 + (0-6) weeks of gestation. Risk difference differed from - 7 (95% CI - 8; - 7) to - 45 (95% CI - 51; - 31). Three studies reported the rate of neonatal intensive care unit admission and showed little reduction. CONCLUSION This systematic review shows that all presented implementation strategies to reduce elective caesarean section before 39 + (0-6) weeks of gestation are effective. Reduction rates differ widely and it remains unclear which strategy is most successful. Strategies used locally in one hospital seem a little more effective. Included studies are either before-after studies (8) or interrupted time series (2) and the overall quality of the evidence is rather low. However, most of the studies identified specific barriers in the implementation process. For planning an implementation strategy to reduce elective caesarean section before 39 + (0-6) weeks of gestation, it is necessary to consider specific barriers and facilitators and take all obstetric personal into account. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42017078231

Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol

Mathes T, Willms G, Polus S, et al. Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol. SYSTEMATIC REVIEWS. 2018;7(1): 79.Background: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. Methods: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. Discussion: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs

Environmental Interventions to Reduce the Consumption of Sugar-Sweetened Beverages: Abridged Cochrane Systematic Review

BACKGROUND Regular consumption of sugar-sweetened beverages (SSB) can increase the risk for obesity, type 2 diabetes, cardiovascular disease, and dental caries. Interventions that alter the physical or social environment in which individuals make beverage choices have been proposed to reduce the consumption of SSB. METHODS We included randomised controlled, non-randomised controlled, and interrupted time series studies on environmental interventions, with or without behavioural co-interventions, implemented in real-world settings, lasting at least 12 weeks, and including at least 40 individuals. Studies on the taxation of SSB were not included, as these are subject of a separate Cochrane review. We used standard Cochrane methods for data extraction, risk of bias assessment, and evidence grading and synthesis. Searches were updated to January 24, 2018. RESULTS We identified 14,488 unique records and assessed 1,030 full texts for eligibility. We included 58 studies comprising a total of 1,180,096 participants and a median length of follow-up of 10 months. We found moderate-certainty evidence for consistent associations with decreases in SSB consumption or sales for the following interventions: traffic light labelling, price increases on SSB, in-store promotion of healthier beverages in supermarkets, government food benefit programs with incentives for purchasing fruits and vegetables and restrictions on SSB purchases, multi-component community campaigns focused on SSB, and interventions improving the availability of low-calorie beverages in the home environment. For the remaining interventions we found low- to very-low-certainty evidence for associations showing varying degrees of consistency. CONCLUSIONS With observed benefits outweighing observed harms, we suggest that environmental interventions to reduce the consumption of SSB be considered as part of a wider set of measures to improve population-level nutrition. Implementation should be accompanied by evaluations using appropriate methods. Future studies should examine population-level effects of interventions suitable for large-scale implementation, and interventions and settings not yet studied thoroughly

Stakeholder involvement throughout health technology assessment: an example from palliative care

Objectives: Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA. Methods: A 5-step “INTEGRATE-HTA Model” developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face–face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England. Results: Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use. Conclusion: Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed

Guidance on the integrated assessment of complex health technologies: the INTEGRATE-HTA model

Challenges in assessments of health technologies In recent years there have been major advances in the development of health technology assessment (HTA). However, HTA still has certain limitations when assessing technologies which are complex, i.e. consist of several interacting components, target different groups or organizational levels, have multiple and variable outcomes, and/or permit a certain degree of flexibility or tailoring (Craig et al., 2008), fi are context-dependent - current HTA usually focusses on the technology, not on the system within which it is used, fi perform differently depending on the way they are implemented, fi have different effects on different individuals. Furthermore, HTA usually assesses and appraises aspects side-by-side, while decision-making needs an integrated perspective on the value of a technology. In the EU-funded INTEGRATE-HTA project, we developed concepts and methods to deal with these challenges, which are described in six guidances. Because of the interactions, an integrated assessment needs to start from the beginning of the assessment. This guidance provides a systematic five-step-process for an integrated assessment of complex technologies (the INTEGRATE-HTA Model). Purpose and scope of the guidance The aim of the INTEGRATE-HTA project is to provide concepts and methods that enable a patient-centred, comprehensive, and integrated assessment of complex health technologies. The purpose of this guidance is to structure the overall HTA-process. The INTEGRATE-HTA Model outlines an integrated scoping process, a coordinated application of assessment methods for different aspects and an integrated and structured decision-making process. It is intended for HTA agencies, HTA researchers and those engaged in the evaluation of complex health technologies. As it links the assessment to the decision-making process, it also addresses HTA commissioners and other stakeholders using or planning HTAs. While all technologies are arguably complex, some are more complex than others. Applying this guidance might lead to a more thorough and therefore more time-consuming process. Depending on the degree of complexity, one might choose to follow the whole process as described in this guidance, or only focus on certain steps. The guidance provides an operational definition to assess the complexity of technologies which can be used to identify specific aspects that will need more attention than others. What the guidance does not provide is a post-hoc solution for assessments that have already been completed. | 6 Development of the guidance The INTEGRATE-HTA Model presented in this guidance was developed based on a systematic literature search on approaches for integration, on the experiences of traditional HTAs, as well as on the other methodological guidances developed in the INTEGRATE-HTA project. It was tested in a case study on palliative care and iteratively revised during the practical application. The guidance was again revised after internal and external peer-review. Application of this guidance For a comprehensive integrated assessment of a complex technology, we developed a five-step process, the INTEGRATE-HTA model. In Step 1, the HTA objective and the technology are defined with the support from a panel of stakeholders. An initial logic model is developed in Step 2. The initial logic model provides a structured overview of the technology, the context, implementation issues, and relevant patient groups. It then frames the assessment of the effectiveness, as well as economic, ethical, legal, and socio-cultural aspects in Step 3. In Step 4, a graphical overview of the assessment results, structured by the logic model, is provided. Step 5 is a structured decision-making process informed by the HTA (and is thus not formally part of the HTA, but follows it). fi Step 1: In step 1, the technology under assessment and the objective of the HTA are defined. Especially for complex technologies, such as palliative care, the definition of the technology alone is a challenge that must not be underestimated. It is recommended to do this based on a tentative literature review and with the support of stakeholder advisory panels (SAPs) which should comprise clinical experts, academics, patients, possibly their relatives and/or other caretakers, and the public. The setting of an objective considering all relevant aspects of complexity and structured by assessment criteria is important. The assessment criteria will usually reflect values of the stakeholders as well as the input from the theoretical, methodological and empirical literature. fi Step 2: In step 2, an initial logic model is developed (see Guidance on the use of logic models in health technology assessments of complex interventions). The model provides a structured overview on participants, interventions, comparators, and outcomes. Parallel to this, groups of patients that are distinguished by different preferences and treatment moderators (see Guidance for the assessment of treatment moderation and patients’ preferences) are identified. Specific context and implementation issues are also identified as part of the initial logic model (see Guidance for the Assessment of Context and Implementation in Health Technology Assessments (HTA) and Systematic Reviews of Complex Interventions). The product of this step is the logic model as a graphical representation of all aspects and their interactions that are relevant for the assessment of the complex technology. fi Step 3: In step 3, the logic model serves as a conceptual framework that guides the evidence assessment. Depending on the specific aspect (e.g. effectiveness, economic, ethical, socio-cultural, or legal aspects) different methods are available for the assessment (see Guidance for assessing effectiveness, economic aspects, ethical aspects, socio-cultural aspects and legal aspects in complex technologies). The outputs of step 3 are evidence reports and standardized evidence summaries for each assessment aspect (e.g. report on economics, report on ethical aspects, etc.). fi Step 4: In step 4, the assessment results of step 3 are structured using the logic model developed in step 2. Whereas the initial logic model in step 2 specifies what evidence is relevant, the extended logic model to assist decision-making in step 4 visualizes the assessment results as well as the interaction with respect to the HTA objectives. It also allows for the consideration of different scenarios depending on the variation in context, implementation and patient characteristics. 7 | fi Step 5: Step 5 involves a structured decision-making process and is not an integral part of the HTA in the narrow sense. Decision-making can be supported by applying quantitative e.g. MCDA- (Multi-criteria decision analysis) or qualitative decision support tools. Flexibility in the application of these tools by the decision committee is crucial, taking different decision settings and evidence needs into consideration. Conclusions In current HTA, different aspects are usually assessed and presented independent of each other. Context, implementation issues and patient characteristics are rarely considered. The INTEGRATE-HTA Model enables a coordinated assessment of all these aspects and addresses their interdependencies. The perspective of stakeholders such as patients and professionals with their values and preferences is integrated in the INTEGRATE-HTA Model to obtain HTA results that are meaningful for all relevant stakeholders. Finally, health policy makers obtain an integrated perspective of the assessment results to achieve fair and legitimate conclusions at the end of the HTA process. The application of the model will usually require more time and resources than traditional HTA. An initial assessment of the degree and the character of complexity of a technology might be helpful to decide whether or not the whole process or only specific elements will be applied

Integrated assessment of home based palliative care with and without reinforced caregiver support: ‘A demonstration of INTEGRATE-HTA methodological guidances’

About this Executive Summary This comprehensive executive summary reports on a case study designed to demonstrate the application of a number of the key concepts and methods developed in the INTEGRATE-HTA project to the assessment of complex technologies. The case study focuses on models of home based palliative care with and without an additional element of caregiver support, known as reinforced and non-reinforced home based palliative care respectively. What is already known about the topic With changing disease patterns in Europe, increasingly complex health care technologies, such as palliative care, have gained importance. Current HTA methods rarely take account of wider legal, ethical and socio-cultural issues or context and implementation and are not adequately equipped to assess highly complex technologies, despite considerable progress in recent years. As a result, HTA is rarely applied to highly complex health technologies. What this case study report adds The INTEGRATE-HTA project developed concepts and methods for the assessment of complex technologies, taking into account legal, ethical and socio-cultural issues as well as context and implementation. This case study is designed to demonstrate the application of a number of the key concepts and methods developed in the INTEGRATE-HTA project to home based palliative care, with and without an additional element of caregiver support, as an example of a complex technology; known as “reinforced” and “non-reinforced” home based palliative care respectively. The INTEGRATE-HTA model, developed to enable integration of relevant assessment aspects, is used to structure this report. The case study reports on the application of some of the concepts and methods developed within the INTEGRATE-HTA project to the assessment of effectiveness as well as economic, sociocultural, ethical, and legal aspects; patient preferences and patient-specific moderators of treatment and context and implementation issues related to reinforced and non-reinforced home based palliative care. The highly complex nature of reinforced and non-reinforced home based palliative care is illustrated through an assessment of complexity characteristics. | 4 The case study also involved extensive lay and professional stakeholder involvement, using a variety of methods, to inform the HTA process at key stages throughout the project. Key messages are highlighted for both HTA research and for palliative care. The implications for research and practice The concepts and methods developed in the INTEGRATE-HTA project have been shown to be feasible and to have the potential to offer added value, but require further development and application in the assessment of other complex technologies. Reinforced and non-reinforced models palliative care are highly complex. The case study findings offer some insights into their effectiveness as well as economic, sociocultural, ethical, and legal issues; patient preferences and patient-specific moderators of treatment as well as context and implementation issues