Innovative medical technologies are commonly associated with positive expectations. At the time of their introduction into care, there is often little evidence available regarding their benefits and harms. Accordingly, some innovative medical technologies with a lack of evidence are used widely until or even though findings of adverse events emerge, while others with study results supporting their safety and effectiveness remain underused. This study aims at examining the diffusion patterns of innovative medical technologies in German inpatient care between 2005 and 2017 while simultaneously considering evidence development.Based on a qualitatively derived typology and a quantitative clustering of the adoption curves, a representative sample of 21 technologies was selected for further evaluation. Published scientific evidence on efficacy/effectiveness and safety of the technologies was identified and extracted in a systematic approach. Derived from a two-dimensional classification according to the degree of utilization and availability of supportive evidence, the diffusion patterns were then assigned to the categories “Success” (widespread/positive), “Hazard” (widespread/negative), “Overadoption” (widespread/limited or none), “Underadoption” (cautious/positive), “Vigilance” (cautious/negative), and “Prudence” (cautious/limited or none).Overall, we found limited evidence on the examined technologies regarding both the quantity and quality of published randomized controlled trials. Thus, the categories “Prudence” and “Overadoption” together account for nearly three-quarters of the years evaluated, followed by “Success” with 17%. Even when evidence is available, the transfer of knowledge into practice appears to be inhibited.The successful implementation of safe and effective innovative medical technologies into practice requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of valuable health care.The online version contains supplementary material available at 10.1186/s13012-021-01159-3. Contributions to the literatureThis study presents a novel methodological approach for categorizing utilization patterns based on hospital data and selecting a balanced sample of technologies for analysis.It analyzes the relationship between utilization and scientific evidence across a comprehensive sample of 21 technologies; this has previously mostly been studied for individual technologies.Several of the 21 technologies were overadopted (utilized widely despite limited or no evidence), which entails risks for patients and health systems.Our findings reinforce the need for reconsidering how innovation systems work: how evidence is generated and disseminated, and how it is embedded in (de)implementation decisions in policy and practice.Innovative medical technologies are commonly accompanied by positive expectations. In fact, they may reduce pain and/or contribute to patients’ full recovery, improve health-related quality of life and well-being, and even create economic benefits by reducing health care expenditures in the long run . As a reThe World Health Organization (WHO) defines health technology as “any application of organized knowledge and skills in the form of medicines, medical devices, vaccines, procedures and systems, developed to solve a health problem and improve quality of life” . Many inGemeinsamer Bundesausschuss, G-BA), the highest decision-making body in the German health care system [Neue Untersuchungs- und Behandlungsmethoden, NUB); but this pathway has rarely been activated [In many countries, a positive (cost-)effectiveness evaluation is required before new medical technologies can be reimbursed in publicly funded health systems . Usuallye system . If new e system  for detactivated . The decctivated . It happctivated , 14.Research on diffusion of innovation was largely shaped by Rogers , who argTo develop a methodological approach for categorizing adoption curves of innovative medical technologies based on hospital utilization data and available scientific evidence, in order to select a varied sample for further investigation.To investigate how the diffusion patterns of the selected technologies are associated with the underlying scientific evidence on safety and efficacy/effectiveness in the German health care system, which is characterized by low entry requirements for utilization in inpatient care.Because the adoption and diffusion of innovative technologies are important drivers of value-based health care , it is iInstitut für das Entgeltsystem im Krankenhaus, InEK) [Innovative medical technologies reimbursed in German inpatient care between 2005 and 2017 were identified on the basis of the lists published annually by the German Institute for the Hospital Remuneration System  . Those ws, InEK)  and usedi)The lists of new medical diagnostic and treatment methods published annually by the InEK between 2005 and 2012 were scrutinized. These lists include all new medical diagnostic and treatment methods for which hospitals have requested permission to negotiate innovation payments with health insurers (as they are not adequately reimbursed by current DRGs). The time window was chosen to ensure that data was available for at least five years prior to the start of this research. Consequently, the observation period for this study spans the years 2005 to 2017.ii)The “DRG statistics” dataset, which includes hospital claims data reported annually to the German Federal Office of Statistics, was used to determine the number of hospitals implementing the technology and the total number of cases. DRG statistics capture anonymized information for all inpatient treatments.iii)The following criteria were applied for selection based on the information from (i) and (ii):Permission to negotiate an innovation payment for the technology was requested by more than ten hospitals and granted for at least 1 year between 2005 and 2012Case numbers and numbers of hospitals implementing the technology were available for at least 4 years100 cases or more were reimbursed for at least 1 yearTo select new technologies for the study, the following actions were taken:Overall, 59 technologies were included following these selection criteria and are listed in Table Based on the DRG case data described above, adoption curves were plotted for all 59 technologies  for the 59 technologies described above. These reports are prepared upon request to evaluate technologies for which the negotiation of innovation payments has been permitted by the InEK.The aim of this step was to gather baseline information on the availability of evidence on the safety and efficacy/effectiveness for each technology to ensure that the selected sample covers different types of adoption curves as well as different results derived from the available evidence . For this purpose, we screened reports from the Medical Review Board of the Federal Association of Sickness Funds , included studies , reported outcomes , results of included studies, and the conclusions of the MDS appraisal. Based on the latter, we classified each technology into one of the evidence groups “has potential without limitations” (1), “has potential for certain patients” (2), and “no potential” (3). It is important to note that these initial assessments were not necessarily identical to the results of the systematic identification of evidence described in step 5, below.i from all available data years j:Of the 59 technologies pre-selected in step 1, we had to select a maximum of 30 technologies for feasibility reasons, containing all curve progression types and evidence classifications. Within these groups, we chose those technologies that were most relevant to care based on high case numbers and high rates of changes in case numbers. The conjunction of these two parameters was translated into a multiplicative criterion for each technology Crit.i in descending order. To achieve a sample of 28 (as a multiple of the seven groups), the four top technologies were selected from each group . However, since curve types II, III, and V each contain fewer than four technologies, the resulting sample included only 22. To further diversify the sample and balance the selection of evidence classifications, the remaining technologies were filtered according to the following approach.Within each type of curve progression, all technologies were sorted by size based on First, technologies used in the context of an indication already strongly represented in the sample of 22 were excluded. Then, three additional technologies were selected from the evidence group “has potential without limitations” and two from the group “no potential”, as these were the least represented. This resulted in almost even distribution across the evidence groups: 55% 6 of 11) selected from group 1 , 60% (3 of 5) selected from group 2 , and 57% (4 of 7) selected from group 3 . This sample also achieved a balance between groups with clear (13 of 27) and unclear evidence (14 of 27). The selection of these five additional technologies was also based on curve progressions. Candidates were compared qualitatively and those that appeared to be particularly complementary to the technologies already in the selected sample were included. We thus aimed to obtain the broadest possible spectrum of examined technologies. The final sample of 27 is shown in the last column of Table 1 selecteClinicaltrials.org, WHO International Clinical Trials Registry Platform (ICTRP)), and selected Health Technology Assessment (HTA) databases and agencies  were searched between May and September 2019. Search strategies with high sensitivity were used, and no restriction on the study designs was included. However, only RCTs are considered for the purpose of this article; an overview of all evidence types is presented elsewhere [Subsequently, published evidence on the selected technologies was systematically identified, selected, and evaluated. For this purpose, bibliographic biomedical electronic databases , clinical trial registries . Explicit inclusion and exclusion criteria were formulated for each technology; inter alia, studies were included if they were published in the 2-year period before the first documented hospital case through the end of the observation period in 2017. Due to the number of included technologies and the high number of hits resulting from the sensitive searches, a rapid review approach  was adopPositive: The authors’ conclusions are consistently positive regarding efficacy/effectiveness and safety, and across patient groups. When a neutral  and a positive  statement were combined, the publication was considered positive.Negative: The authors’ conclusions are consistently negative regarding efficacy/effectiveness and safety, and across patient groups. When a neutral  and a negative  statement were combined, the publication was classified as negative.Neutral: The authors conclude no difference between intervention and comparative intervention.Inconclusive: The authors conclude that no definitive statement can be made.Based on the aggregated assessment of all outcomes by the authors in the “Conclusions” section, each publication was labeled based on its key message:In a final step, the diffusion of innovative medical technologies into the German health care system was examined against the background of available scientific evidence in order to identify successful and failed diffusion patterns and possible changes therein. For this purpose, we adapted the grid design for classification of health care innovations from Denis et al. . The exp"Evidence" for each technology was categorized using a modified version of the World Health Organization/Health Evidence Network criteria [The identified body of criteria , 28 . No definitive comparator or clear coding was available for 6 out of 27 technologies , so these were excluded from further analysis. For the remaining 21 technologies, we cumulated the case numbers to transform the adoption curves ; two in the treatment of atrial fibrillation ; one is used in surgery when extracorporeal circulation is required (EABO). Four technologies are applied to the urinary system, with a focus on surgical continence therapy (ACT), fluorescence-assisted transurethral resection (F-TUR), and dialysis . One technology (LVRC) concerns the respiratory system for the treatment of emphysema which may occur in a number of chronic lung diseases . Lastly, we examined drug-eluting beads for transarterial chemoembolization (DEB-TACE) and molecular monitoring of residual tumor burden (MRD).Figure For the majority of technologies 16 of 21), no relevant study of acceptable scientific quality as defined for this work was available at the time of introduction. For more than half, no (6 of 21) or only limited 5 of 21) evidence was identified over the entire observation period. The evidence on four further technologies  was considered “limited” at the end of the period because of conflicting study results. In contrast to the sparse evidence base, 13 out of 21 technologies were utilized widely over time. In relation to the years evaluated across all technologies, the proportion of no available (127 of 246 data years) or limited evidence (63 of 246 data years) predominates ,” moderate positive evidence was already available at the time of its introduction into German inpatient care. Therefore, the process can initially be considered as “Success.” However, this changed over time to “Overadoption” due to inconsistent findings in several studies. Moderate positive evidence was also available for the procedure “fluorescence-assisted transurethral resection (F-TUR)” even 1 year before its introduction. However, throughout the entire observation period, the procedure was utilized cautiously in only a fraction of the target population.Figure All technologies together were applied to a total of 775,410, a mean of 36,924 and a median of 11,468 cases during the observation period. The group of technologies for which no credible or even negative evidence was available in 2017 was applied to an average of 46,565 cases , while those with positive study results were only applied to an average of 12,822 cases . The three technologies most relevant to care overall as determined by cumulative cases , all resulted in “Overadoption.”This study aimed to explore the diffusion of new technologies in German inpatient care, focusing on the relationship between utilization and available scientific evidence. Previous research found a gap between existing rigorous evidence and lack of application of new technologies , 30, 31.In addition, study results must be disseminated from the moment of publication onward to reach potential adopters ; in our Concerning the change in diffusion patterns over time, we predominantly captured cases of users becoming more courageous in their use of technologies the benefits of which remain unclear. For example, the diffusion of “drug-coated balloon catheter in intracranial, abdominal, upper leg and lower leg vessels ” was categorized as “Overadoption” in the end of the observation period. Regarding DCB-AV, the technology spreads rapidly from three cases in 2008 to a total of 18,318 cases in 2017, although no RCT at all could be identified. The evidence base for DCB-IV is similarly weak, with exceeding the threshold of widespread utilization like DCV-AV already in 2009, the year after introduction to the German health care system. Interestingly, the application of DCB in both ULV and LLV was intermediately considered as “Success.” The utilization rates increased above the threshold before findings of supportive evidence emerged, and adoption was therefore classified as “Overadoption” starting in 2009. However, in 2012, one RCT considering both application areas concluded that the technologies showed superior outcomes compared to standard balloon angioplasty ; this waWe also observed an increase in technologies changing to successful diffusion in the end of the observation period. For example, the rapidly rising utilization rates of “implantation of a drug-eluting stent in lower leg vessels (DES-LLV)” were accompanied by supportive evidence. The first identified RCT was published in 2009 by Falkowsky et al. . The autA successful diffusion should maximize patient benefit and minimize potential risks. Ideally, the transfer of innovative medical technologies into practice should be guided and accompanied by the existing scientific evidence and induce the systematic generation of new data . As onlyIn addition to clinical studies, observational or “real-world” evidence can also be generated through medical device registries. Making the use of registries mandatory for innovative technologies could further enhance the evaluation of effectiveness and risks under routine practice conditions and provide insight into mid- and long-term outcomes. Thus, registries would offer valuable information for improving quality of care when incorporated into decision-making for (de)adopting new technologies . What isAs mentioned, the level of reimbursement substantially influences the utilization of new technologies in German health care , 33. ThuLast but not least, successful diffusion also requires the de-implementation of low-value technologies that do not provide any benefit for patients, may have harmful consequences, and/or lead to a waste of health care resources –52. AlthIn brief, understanding technology diffusion requires an in-depth exploration of factors related to the technology itself, its potential adopters, and the context , 57. TheIt is plausible that the following limitations may have influenced the results of this study. Despite our best efforts, it is possible that the systematic review missed relevant studies. Furthermore, the two-dimensional evaluation scheme does not take into consideration factors relevant to the diffusion of innovative medical technologies other than scientific evidence. The analysis is based on a sample obtained through defined criteria and an empirical selection process. Even though this was designed to yield a sample that was both varied and feasible, it is possible that a different sample would have resulted in different findings. Results for the 21 technologies investigated are not generalizable for all innovative medical technologies in an overarching way for several reasons. The final sample consists predominantly of cardiovascular interventions. Additionally, the initial sample of 59 technologies was based on the official list of technologies, for which hospitals applied for innovation payments. By definition, these lists do not include interventions that are less expensive than existing alternatives, but may still be invasive and potentially harmful. The selection criterion of overall relevance to care does not imply that non-selected technologies are irrelevant and should not be investigated or addressed. The sole focus on RCTs may have resulted in the loss of important results from other study designs. Systematic reviews and outcomes from observational studies can play an important role in clinical decision-making and may have influenced the implementation process . DissemiThis study makes a substantial contribution to research on the diffusion of innovative medical technologies in German inpatient care. We analyzed diffusion patterns and evidence development for 21 technologies using quantitative and qualitative methods. We observed that the diffusion rate of new technologies is often not in line with available scientific evidence. At the end of the observation period, the share of overadopted technologies predominated, which indicates considerable potential for harm to patients and inefficiencies for the health care system. Overall, there is a lack of evidence regarding the efficacy/effectiveness and benefit of innovative medical technologies utilized in German inpatient care. Even in cases of available evidence, the transfer of knowledge into practice seems inhibited. The successful diffusion of innovation requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Responsive policies must facilitate the diffusion of valuable technologies in health care and curb the spread of potentially dangerous and ineffective technologies. On the one hand, creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of “true” innovations in the health care sector. On the other hand, supporting the development of de-implementation strategies is crucial, not least for the German health care system.Additional file 1: Adoption curves for all 59 technologies.Additional file 2: Additional description of the methodology.


However, there was a large overlap in the data ranges with no universal limit apparent. Rather, many factors were found to combine to affect the overall outcome including loading time, the type of implant and the material being used. The tables provided in this review summarise these factors and will aid investigators in identifying the most relevant micromotion values for their biomaterial and implant development research.Much research effort is being invested into the development of porous biomaterials that enhance implant osseointegration. Large micromotions at the bone-implant interface impair this osseointegration process, resulting in fibrous capsule formation and implant loosening. This systematic review compiled all the in vivo evidence available to establish if there is a universal limit of tolerable micromotion for implant osseointegration. The protocol was registered with the International Prospective Register for Systematic Reviews (ID: CRD42020196686). Pubmed, Scopus and Web of Knowledge databases were searched for studies containing terms relating to micromotion and osseointegration. The mean value of micromotion for implants that osseointegrated was 32% of the mean value for those that did not (112 ± 176 µm versus 349 ± 231 µm,  This has resulted in a continued drive from research centres of excellence and industry to develop new technology that improves outcomes, reduces revision rates, and enables treatment for more patients’ groups, such as those that are younger and more active.Metallic protheses implanted directly into bone have revolutionised the treatment of dental, orthopaedic and spinal disease, pain and trauma, with millions of procedures performed annually worldwide4. Micromotion is the temporary localised relative movement that occurs between an implant surface and adjacent bone when functional loading is applied6; with any permanent displacement known as subsidence/migration. These sub-millimetre (hence micro) motions are too small to be seen by the naked eye. Micromotion is the result of primary implant instability and differing bone/implant material moduli, and consequently depends on the implant material, bone density, implant/bone geometry, surgical technique, and the level of interference fit, as well as the magnitude and direction of the applied loading9.In silico and in vitro modelling are at the heart of the pre-clinical development process for new implant technologies. In the field of implant fixation, a common parameter investigated is the amount of oscillatory micromotion at the bone-implant interface11. Failed osseointegration leads to aseptic implant loosening, implant failure and the need for expensive revision surgery, both financially and in terms of quality of life12. Thus, much research time and resource has been invested to ensure new implant designs and surgical techniques result in acceptable/improved micromotion at the bone-implant interface22. There even exists an ASTM standard (F2537–06) to ensure micromotion is measured accurately and repeatably.Micromotion is investigated as in vivo data suggest that too much of it leads to failed implant osseointegration: a fibrous capsule forms around the implant rather than a direct structural and functional connection between the host bone and implant28. However, the evidence in the 1990s for the 150 µm limit was inconclusive and much time has subsequently elapsed meaning that there is likely much more data available with which to draw conclusions about the relationship between micromotion and osseointegration31.Micromotion data are often compared to a limit, below which the implant is considered to pass/be suitable for clinical use, and above which it is considered to be at risk of failed osseointegration. Early in vivo research suggested an upper limit of 150 µm of micromotion and over time this value has become an oft-cited gold standardThis systematic review aimed to compile all the quantitative in vivo evidence relating micromotion to osseointegration to answer the following research questions: (1) Is there value of micromotion that can be universally used as a limit for in vitro or in silico modelling? (2) To what extent is micromotion correlated with bone-implant contact? (3) Which factors influence the relationship between micromotion and osseointegration?284 unique records were identified from the databases Fig. . After ip < 0.001, Fig. One human and twenty-four animal studies were identified Table . For thep value = 0.001). Similarly, when micromotion was measured at the end of the study duration, implants that osseointegrated had lower micromotion than implants that did not . Comparing values of micromotion between the methods (measured vs applied), no differences were observed for the osseointegrated group, and similarly there was no difference between the methods for the non-osseointegrated group. . Micromotion and BIC were not correlated for the non-osseointegrated group , nor the full dataset .Out of the 24 animal studies, 13 studies examined osseointegration as the percentage of BIC, 2 studies reported on bone ingrowth and 1 study reported on both BIC and bone ingrowth. For implants that were defined as osseointegrated, a positive correlation was observed between micromotion and % BIC .There was a positive correlation between observation time and percentage BIC, with longer study duration time resulting in better percentage BIC 44  and study duration , combined with different localised implant/bone geometry lead to different stress–strain states, with too much strain leading to fibrous tissue formation61. Indeed, by considering the interfacial stress–strain state, it is possible to relate implant bony ingrowth theory59 to fracture healing theory65, which intuitively one would expect given the involvement of the same cell types66. Conversely, when the implant/environmental conditions that affect the interfacial stress–strain state are ignored, counter-intuitive trends can be observed. For example, when neglecting these factors, it was found that increased micromotion was positively correlated with increased percentage BIC  bone relative to the total implant length34.Another explanation for the contradictory in vivo data is that micromotion is a simplified, clinically convenient measure, which overlooks the fundamental mechanobiological mechanisms that drive implant osseointegration. In vivo data coupled with finite element analyses suggest that it is the interfacial stress–strain state resulting from implant micromotion that stimulates osseointegration8. Both measurement techniques were able to identify differences in micromotion between implants that osseointegrated and those that did not. Interestingly, when comparing the results between the two different methods, no differences were found.Historically, the causal effect of implant micromotion on osseointegration was investigated by applying known displacement and subsequently measuring osseointegration. However, more recently, research method has shifted to applying known loads and quantifying micromotion at the end of the experimentet al67. For the same reason, it was not possible to perform a cumulative meta-analysis to quantify the risk of bias between studies. Rather, to provide some quantitative analysis we applied Mann Whitney tests to the data extracted from each study. Further we isolated the effects of studies that applied micromotion, and those that measured it, and found that this did not affect the principal finding our systematic review , following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklistStudies which fulfilled the following criteria were included: (1) in vivo animal research or post-mortem human data where the implant was inserted pre-mortem. (2) testing of osseointegration when micromotion was either applied or measured with micromotion values reported in the form of displacement (3) the study was an original research article; and (4) the studies were published in English.Articles were excluded if: (1) micromotion was measured indirectly and/or reported as implant stability quotient (ISQ) or resonance frequency analysis (RFA); (2) Study duration less than 3 weeks; (3) Finite element analysis (FEA) or computational studies; (4) cemented implants; (5) cadaveric bone in vitro experiments where prostheses were inserted post-mortem; and (6) synthetic bone in vitro experiments.th November 2020, in the following databases: PubMed, Scopus and Web of Science. The search strategy identified papers which included the following terms: (micromotion OR "micro-motion" OR "micro motion") AND ("osseointegration" OR "osteointegration").An electronic search was performed for articles published up to 16Two independent reviewers  assessed the titles and abstracts of all the studies and discarded studies that met any of the exclusion criteria. The full text of all remaining studies was then assessed against the inclusion and exclusion criteria. Any disagreement regarding eligibility of articles were resolved by a third reviewer (R.v.A.).Data relating to osseointegrated and non-osseointegrated values of micromotion were extracted. The country, animal species, number of study groups, duration of the experiment, implant material and loading conditions were recorded. The outcome of osseointegration measured as bony ingrowth or percentage bone-implant-contact (BIC) were also recorded.The micromotion methodology (applied or measured) was also recorded. In the applied group, known values of micromotion in the form of cyclic loading were directly applied as a controlled experimental condition and then osseointegration was assessed. In measured group, micromotion was not a controlled experimental condition, rather micromotion at the bone-implant interface was measured once the implant had osseointegrated/not.All micromotion values were grouped into osseointegrated/not, according to the definition used by the original study authors. Data were first tested for normality, and then non-parametric Mann Whitney tests were used to compare differences between groups.Micromotion values were further discretised according to the study method (applied vs measured micromotion). Then analysis 1) was repeated for both of these subgroups.Spearman correlation tests were used to examine correlation between percentage BIC and micromotion values for three groups: all data, osseointegrated, non-osseointegrated.Spearman correlation tests were used to examine the correlation between percentage BIC and study duration.Data were analysed and plotted using Graph Pad Prism 8 software and have been reported as mean ± standard deviation (SD). Four analyses were performed:α = 0.05.The significance level was set to


To identify and map evidence about the consequences of unpaid caring for all carers of older people, and effective interventions to support this carer population.A rapid review of systematic reviews, focused on the consequences for carers of unpaid caring for older people, and interventions to support this heterogeneous group of carers. Reviews of carers of all ages were eligible, with any outcome measures relating to carers’ health, and social and financial well-being. Searches were conducted in MEDLINE, PsycInfo and Epistemonikos (January 2000 to January 2020). Records were screened, and included systematic reviews were quality appraised. Summary data were extracted and a narrative synthesis produced.Twelve systematic reviews reporting evidence about the consequences of caring for carers (n=6) and assessing the effectiveness of carer interventions (n=6) were included. The review evidence typically focused on mental health outcomes, with little information identified about carers’ physical, social and financial well-being. Clear estimates of the prevalence and severity of carer outcomes, and how these differ between carers and non-carers, were absent. A range of interventions were identified, but there was no strong evidence of effectiveness. In some studies, the choice of outcome measure may underestimate the full impact of an intervention.Current evidence fails to fully quantify the impacts that caring for older people has on carers’ health and well-being. Information on social patterning of the consequences of caring is absent. Systematic measurement of a broad range of outcomes, with comparison to the general population, is needed to better understand the true consequences of caring. Classification of unpaid caring as a social determinant of health could be an effective lever to bring greater focus and support to this population. Further work is needed to develop and identify suitable interventions in order to support evidence-based policymaking and practice. A rapid review of published systematic reviews offers a useful and efficient approach to summarising evidence about caring for older people, without duplicating existing work.This approach allowed us to identify key gaps in this evidence base and make clear recommendations for future research.A limitation of this method is the exclusion of primary research studies that have not yet been subject to a systematic review.Most of the included systematic reviews were published within the last 3 years, signalling a contemporary evidence base.Populations are ageing worldwide. Life expectancy is increasing in many high-income countries, while the proportion of those aged 65 and over is projected to increase 16% by 2050.8Carers make a critical contribution to health and social care.and the most effective forms of carer support. This will enhance our understanding of how best to support carers of older people.Recognition of the role and contribution of carers has grown since the 1960s.We undertook a review of systematic reviews to map current evidence about caring for an older person, addressing two key questions:What are the consequences of caring for older people for the health, and social and financial well-being of carers, and what do we know about how these consequences vary by age, sex, socioeconomic status and geographical location?Which interventions are effective (including consideration of costs) to promote health and well-being and access to services among these carers?The aim of this work was to provide an overview of what is known, as well as identifying key gaps, to support evidence-informed practice for those caring for older people.The approach to this evidence synthesis was a rapid review of published systematic reviews (from hereon referred to as ‘rapid review’). Preliminary scoping of the literature identified multiple systematic reviews on both the consequences of caring and associated interventions to support those caring for older people. Thus, the review of reviews (‘umbrella review’) approach was most appropriate as an efficient approach to assessing the evidence, without duplicating existing research. Rapid review methodology was employed, which uses a streamlined approach to study selection and synthesis in order to produce a timely overview of evidence.24 25The following methods are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.https://www.epistemonikos.org/) in January 2020, and were limited to English language publications published after 2000.A search strategy was developed, piloted and refined, combining terms for ‘carers’ with validated systematic review filters see .26 Searc10.1136/bmjopen-2020-046187.supp1Supplementary datadid not specify an age threshold  for older care recipients. Therefore, no age criteria for care recipients were specified in this rapid review. Instead, reviews were included if the care recipient population was described as older people, or where the recipient population was likely to include older populations. In consultation with a study steering group, reviews that focused solely on carers of people with dementia were excluded, as evidence about dementia caregivers has been summarised in three recently published reviews.carers’ health, well-being and access to services, reviews of joint carer and recipient interventions were excluded. Eligible outcomes were any that related to carers’ health, social and financial well-being and access to services.As the focus of the (second) review question was about interventions to promote Reviews published after 2000 in English were included, and reviews of studies with any study design were eligible. Reviews must have met at least three of the five Database of Abstracts of Reviews of Effects (DARE) criteria to be considered a systematic review, with criterion 3 being mandatory.https://rayyan.qcri.org), an online platform to manage and assist screening for systematic reviews.Records were managed in Rayyan software  and those reporting effectiveness of carer interventions (question 2). Summary tables were produced to describe review characteristics, the type of evidence identified and indicative risk of bias. Findings were synthesised: first by the judged risk of bias  to prioritise the most robust evidence; and then by the type of consequence (question 1) and type of intervention (question 2). For review question 2, all identified interventions from included reviews were mapped against the outcomes reported to identify key gaps in evidence.A steering group representing diverse perspectives and organisations provided advice on the content of the review and dissemination in regular meetings. In particular, we excluded carers of people with dementia from this study after discussion with them.Twelve systematic reviews met the review criteria . Six revOf the six systematic reviews reporting evidence about the consequences of caring for older people: none were judged to have a low risk of bias; two a moderate risk of biasTwo reviews reported that carers of older people experience ‘burden’and severe depression, although it was not clear how ‘mild’, ‘moderate’ and ‘severe’ were defined.33Four reviews reported that carers of older people experience ‘burden’, anxiety and stress, but prevalence and severity were either not quantified or highly variable.There was limited and mixed evidence about the consequences of caring for physical health in one review, with a positive impact on self-rated health but also evidence of increased pain and medication usage.33Of the six reviews reporting evidence about interventions to support those caring for older people, two were judged to have a low risk of biasTwo reviews reported evidence on respite interventions for carers of older people.Limited evidence was presented in one review for the ability of a mindfulness stress reduction intervention to improve carer depression and anxiety. However, this intervention had no impact on stress, health service use, quality of life or self-compassion. In the same review, a combined yoga and meditation intervention appeared to improve carer self-compassion and quality of life.40Reviews judged to have a high risk of bias reported evidence about cognitive, psychosocial and education-based interventions.A review judged to be at high risk of bias reported limited and inconsistent evidence that a cognitive-based intervention was beneficial to carers.Evidence for the impact of self-help and supported therapy on carer depression, anxiety and ‘burden’ was inconsistent.38Finally, one review reported evidence about web-based educational interventions. Components of these educational interventions reported in the review included nurse and peer-led support to answer questions by email, provision of information on websites and training in relaxation and exercise skills. There was no consistent evidence that these interventions were more beneficial than usual care.37Older people’s need for unpaid care is predicted to rise with population ageing.The challenges and demands of unpaid caring for older people are well documented.The evidence reviewed here highlights gaps in our understanding and suggests that a wider consideration of relevant outcomes is needed. Research into the impact of caring and effectiveness of carer interventions must consider outcomes beyond mental health. In particular, physical health was largely neglected in these reviews about caring for older populations. A bias towards mental and psychological, rather than physical, health outcomes has also been noted by others in evidence about the consequences of caring.Another limitation of the current evidence base is the oft-used outcome ‘carer burden’. This is an ambiguous and contentious term,A final limitation of the evidence relates to whether chosen outcomes are adequate to capture the likely impact of interventions. Poor choice of outcomes may underestimate or overlook the ways in which an intervention can effectively support and benefit carers of older people. This was most apparent in the reviews of respite interventions. Despite respite being valued by carers, there was no evidence that it improved carers’ mental health or ‘carer burden’. Yet respite alone cannot be expected to improve mental health, with other therapeutic support necessary to address these sorts of needs. There may also be outcomes where appropriate respite, even in the short term, may show beneficial effects . Evaluations could offer a more meaningful understanding of how an intervention can support carers by giving greater consideration to the outcomes measured and the potential pathways to impact.Overall, our review of reviews indicates that a more robust and comprehensive evidence base is needed to inform policy and practice for supporting carers of older people. One mechanism to achieve this is by conceptualising unpaid caring as a social determinant of health. Social determinants are factors relating to life conditions and circumstances, such as age, income and working conditions, that impact on health. To locate unpaid caring as a social determinant recognises that this responsibility is likely to place carers at greater risk of poor health. Conceptualising unpaid caring as a social determinant of health is possible with an adaption of Dahlgren and Whitehead’s model .54 WorkiMoving forward, we propose the following future research priorities:A high-quality comprehensive systematic review about the impact of caring for older people on outcomes overlooked in current systematic reviews: physical health, and social and financial well-being. A systematic review of these outcomes should draw on evidence from non-peer-reviewed sources  and qualitative research to capture the full breadth of available evidence.Clear quantification of the prevalence and severity of mental health outcomes and other illnesses experienced by carers of older people, with comparisons to the general population to highlight the extent of any impact on health and well-being, and potential inequalities between carers and non-carers.Robust development and evaluation of promising interventions for carers of older people, with consideration of pathways to impact and a broader range of relevant outcomes.The priorities outlined above have potential to address gaps in the current evidence base identified in our review, and to improve the overall quality and scope of evidence about caring for older people.Our chosen method was a review of published systematic reviews to avoid duplicating existing work. This is a valuable approach that has highlighted key gaps in the evidence base about caring for older people. A limitation of this method is that primary studies, which have not yet been subjected to a systematic review, are inevitably excluded. However, nine of the 12 included systematic reviews were published within the last 3 years (2017–2019) and the remainder published between 2007 and 2012. The number of primary studies potentially excluded by using this method is therefore likely to be low.Current evidence about caring for older people lacks the necessary detail to fully quantify the impact of unpaid caring on carers, and to identify how this population of carers should be supported. Classification of unpaid caring as a social determinant of health could be an effective lever to bring greater focus to this population in an area of growing unmet need. Further research is needed to identify suitable interventions in order to support evidence-based policymaking and practice.


This longitudinal study aimed at evaluating the relationships between socio-economic status (SES) and early literacy and numeracy skills, testing home literacy and home numeracy as mediators. It also investigated the interaction of home literacy and numeracy on early literacy and numeracy skills. The study involved 310 preschool children attending the second and the third year. Parents completed questionnaires on SES and home literacy and numeracy. In the first session, children were administered language measures and non-symbolic numeracy skills and, in the second wave, tasks of early literacy and symbolic numeracy skills. Structural equation models (SEMs) showed that SES was predictive of early language and literacy skills and non-symbolic numeracy skills. In addition, home literacy and home numeracy significantly mediated the relationships between SES and children’s skills. Finally, home literacy and home numeracy showed a significant negative interaction on symbolic numeracy skills. Implications for research and educational settings are discussed. However, the debate on how to operationalize SES is still ongoing. The choice of SES measure usually includes education, occupation, and income  are trained at school, but during preschool years children already spontaneously develop basic calculation skills  and showEarly numeracy abilities involve the understanding of magnitudes and the development of numerical processing skills and are manifested during the first few months of life in humans from various cultural backgrounds . The appAs far as literacy is concerned, previous reviews have outlined how letter knowledge and phonemic awareness represent strong predictors of later decoding skills .Many studies have addressed the role of home literacy activities in literacy development  and thatPrevious research found that home literacy, that is, exposure to books and reading in the familiar context, is positively related to early language skills such as expressive and receptive language  and earlHowever, some contrasting results are reported in the literature on the relationship between home literacy and early literacy skills. A study by Indeed, many pieces of evidence now indicate that parents also matter in the development of children’s numeracy skills and recognize the influential role of home numeracy activities , definedA relatively minor number of studies have directly investigated the cross-domain effects of home literacy on numeracy and those of home numeracy on literacy. These studies tried to understand whether home-learning experiences might have specific effects only on their direct domains (home literacy for literacy and home numeracy for numeracy) or, instead if there are cross-domains effects, that is home literacy affecting early numeracy skills and home numeracy affecting early literacy skills . Baker . SimilarWithin a longitudinal design involving 4- and 5-years old children attending preschool, the present study was aimed at evaluating the relationships of SES with early language and literacy skills and that of SES with early non-symbolic and symbolic numeracy skills, considering the role of home literacy and numeracy as potential mediators. Further, we evaluated the interaction of home literacy and numeracy on early language/literacy and symbolic/non-symbolic numeracy skills, including SES as a potential mediator. Home literacy and home numeracy were evaluated as single constructs and included both direct  and indirect  activities. To fulfill the project’s aim, we administered children two different sets of measures in the first and second waves of assessment. In the first wave, we evaluated measures that were thought to be adequate for the age range, and that first emerge in the developmental trajectory of literacy and numeracy skills. Therefore, we included vocabulary and morpho-syntactic comprehension as a proxy of language skills and non-symbolic quantity comparison and seriation as precursors of numeracy skills. Then, in the second wave, we choose measures of letter knowledge, early writing, and phonological awareness as indexes of early literacy skills and symbolic number recognition and biunivocal correspondence as indexes of early numeracy skills.The main objectives and expected results of the study were the following:1.Considering SES, we aimed to evaluate if it predicts both home literacy and numeracy activities and children skills. Based on previous studies, strong evidence suggests that SES predicts early language skills  and, in turn, early literacy skills. However, for the latter, an intervening role of school activities might damper the influence of SES. Concerning early numeracy, minor evidence is available and reported high variability between countries and different school systems . Some au2.Regarding home literacy and home numeracy activities, we expect direct relationships between home literacy and language and literacy skills and between home numeracy and non-symbolic and symbolic numeracy skills. Further, we aim to evaluate if they mediate the role of SES on children’s skills.3.Finally, we aim to evaluate the interaction’s effect between home literacy and numeracy on children’s literacy and numeracy skills, including SES as a mediator. Since relatively more studies reported an effect of home literacy on numeracy compared to that of home numeracy on literacy, we expect the interaction to be associated with numeracy skills rather than with language and literacy skills.Previous results on the Italian context did not find a direct relationship between home literacy and early literacy skills, nor evidence of an interaction between language and numeracy skills. Therefore, variations due to different socio-educational contexts might be expected with respect to previous literature.A total of 310 Italian monolingual children  were involved in the study in two times points: in the spring of the second year of preschool (mean age = 56.95 months ± 3.66), and 1 year later, in the spring of the third year of preschool (mean age = 68.55 months ± 3.47). Parents of children received the questionnaires about SES and home literacy and numeracy. All children attended a public all-day preschool program in Italy where the Laboratory for the Assessment of Learning Disabilities (LADA) of Bologna University’s Department of Psychology was running the LOGOS project, funded by the Municipality of Bologna, which is aimed at the early identification of literacy and numeracy skills. None of the children had been referred to neuropsychiatric units for any range of developmental disorders or sensory or neurological impairments. Thus, the sample was relatively homogeneous for educational exposure, considering that all the teachers received training on early literacy and numeracy skills within the project. The Italian preschool program is a 3-year program that involves children from 3 to 6 years. During these preschool years, formal instruction regarding literacy and numeracy skills is not provided. However, children are engaged in activities that are aimed at improving socialization and numeracy and linguistic development.The parents of all children involved in the study gave their informed consent, and the Bioethical Committee of the University of Bologna approved the LOGOS project .Information regarding the parents’ socio-EL and occupation was collected and scored, according to the Four Factor Index of Social Status (SES) , to achiA questionnaire assessing home literacy and home numeracy activities was administered to parents. Parents could complete it together or by who spends more time with the child, usually the mother. In line with other studies that adopted a similar approach, we opted for a short questionnaire that is easy to fill out by parents to encourage greater adherence to the study . The queThe following tasks taken from the Learning Difficulties Indexes IDA;  were use1.Vocabulary. Children were asked to name 36 images disposed on three grids with 12 images each selected for decreasing frequency in spoken language . The acc2.Morpho-syntactic comprehension. Children were presented with three pictures representing three different scenarios. For each picture, they were asked to identify or manipulate elements of the scene by comprehending different types of sentences pronounced by the examiner . The morpho-syntactic structures investigated were: singular/plurals, locatives, active/passive, and relative clauses. A total of 18 sentences were presented, and for each of them, a score of 2 (correct answer at first attempt), 1 (correct answer at the second attempt), or 0 (wrong answer) was given. The total score, ranging from 0 to 36, was considered. The scale’s Cronbach’s alpha was 0.70, according to the test manual.The tasks used were taken from the battery Number Sense: Prerequisites , which a1.Quantity comparison. Children were shown two illustrated baskets and were asked to quickly choose the one with a greater number of fruits in it, without counting, therefore relying on estimation processes. The number of fruits varied from 3 to 20, and the difference in quantity between sets ranged from 1 to 6 units. A total of 12 items was presented. A score of 1 (correct answer) or 0 (wrong answer) was given for each item, for a maximum total score of 12. There was a Cronbach’s alpha of 0.64, according to the test manual.2.Seriation. This subtest included two tasks: (a) First, children were asked to put in ascending order a set of four pictures of the same object drawn in different dimensions ; (b) second, a fifth picture was given to the child, who was asked to put it in the correct place in the ordered composition (insertion). For each object placed in the correct position, a score of 1 was assigned. The total score, ranging from 0 to 20, was considered. The size seriation subtest’s KR-20 is 0.89, according to the test manual.1.cane (dog), and casa (house)]. Each item received a score of 1 for correct responses and a score of 0 for incorrect answers, for a maximum total score of 4. The reliability score (KR-20) was 0.78, according to the test manual.Phonological awareness. This task was taken from the IDA battery . It was 2.Letter knowledge. This task was adapted from the IDA battery . Childre3.ape (bee), serpente (snake), coccinella (ladybug), and treno (train). A score from 0 (absence of signs) to 9  was given for each word according to how the writing approximates the correct writing of the word. Scores ranged from 0 to 45, and Cronbach alpha calculated on the study’s sample was 0.87.Early writing. This task was developed for the purpose of the present study. Children were asked to pretend to be writers, and they were asked to write five words: their first name, For being administered collectively, these tasks were adapted from the battery Number Sense: Prerequisites .1.Number recognition: Children receive a card with the digits 1 to 9 randomly distributed on a grid among blank squares. It is similar to a bingo card. Children are required to sign the number read aloud by the experimenter with a different colored pencil for each number. The examiner named five different numbers, and the score ranged from 0 to 5. Cronbach alpha was 0.89, according to the test manual.2.Biunivocal correspondence. Children were provided with a card similar to the previous task, but boxes represented sets of elements (little stars ranging from 1 to 9). The examiner named five different numbers, requesting the child choose the set with the corresponding number of stars. For each digit correctly associated with a quantity, a score of 1 was given (score range: 0–5). Cronbach alpha was 0.77, according to the test manual.Questionnaires on SES and home literacy/numeracy were given to parents during the first wave of assessment. Tasks in the first wave of assessment were administered individually by trained psychologists in a quiet room at the children’s school, in a single session lasting about 30 min. In the second wave, tasks were administered collectively in small groups of around 10–12 children in a single session lasting about 30 min. Breaks were allowed if the child showed signs of fatigue. Special attention was given to ascertaining that children had correctly understood the instructions; verbal instructions were minimized, and examples for each task were provided.Preliminary analysis on outliers evidenced that few participants scored over the absolute value of 3 SDs on some tasks. These were less than 5% of the data, and we were allowed to proceed with the Winsorizing method , which sWe did not find any issues of non-linear relationships between dependent and independent variables using the scatter plot graphic builder in SPSS v26. We also checked the plot of the standardized residuals errors by the regression standardized predicted values and found that all the residuals were distributed randomly around zero, meeting the homoscedasticity in our data.Therefore, we concluded that parametric tests were suitable for these data, also considering the increased chance of Type II error when applying non-parametric analysis to (close to) normally distributed data e.g., .Pearson correlations between the main variables included in the study were performed.A structural equation model ; Root Mean Square Error of Approximation (RMSEA), Comparative Fit Index (CFI), Tucker-Lewis Index (TLI). A non-significant Chi-square test of model fit, TLI and CFI values equal to or higher than 0.90 indicate an acceptable model fit; RMSEA close to 0.08 or lower, indicate an acceptable fit  = 0.568, p < 0.01], although not overlapping. Home literacy was further related to all language and literacy measures except vocabulary and, although to a lesser degree, with numeracy task of biunivocal correspondence. Home numeracy was related to all measures in the numeracy domain and with all language measures except vocabulary. Then, there were significant intra-domain relationships for all language measures. For numeracy measures, there were significant relationships between seriation and number recognition and between quantity comparison and biunivocal correspondence but not between quantity comparison and number recognition and between seriation and biunivocal correspondence. Considering inter-domain relationships, the highest correlations index was found between phonological awareness and number recognition .Descriptive statistics and correlations among the observed variables are reported in To better understand the predictive power of SES on children’s early literacy and numeracy skills and on home literacy and numeracy, a SEM was performed , which ip < 0.01), but the path from SES to Symbolic number was not (p > 0.05). All the other paths in the model were significant; see The hypothesized path from the observed variable (SES) to the latent variables Language, Literacy, and Non-symbolic number was significant (p < 0.01), and non-symbolic numeracy predicted symbolic numeracy from age four to age five (p < 0.05). All the other paths were significant, and the model’s fit was acceptable  and, therefore, the others interaction’s paths were deleted from the model. The interaction effect of home literacy and home numeracy on symbolic numeracy is shown in p > 0.05). All the other paths were significant; see the summary in Results showed that the interaction effect is significant only on Symbolic-Numeracy  year of preschool. SES, home literacy, and home numeracy were collected during the first wave of assessment.We first explored correlations between the measures included in the study, and it emerged that SES was significantly related to all measures excluded biunivocal correspondence and quantity comparison. Then, there were domain-specific relationships between home literacy and language and literacy measures (except for a non-significant correlation between home literacy and vocabulary) and between home numeracy and all numeracy skills. Cross-domain relationships were found between home numeracy and all measures of language skills, but home literacy was related only with the numeracy task of biunivocal correspondence. Intra-domain relationships were found for all language measures but for the numeracy domain, there were only significant relationships between seriation and number recognition and between quantity comparison and biunivocal correspondence. There were also multiple cross-domain relationships amongst children’s skills, with the highest value for the correlation between phonological awareness and number knowledge.Taken together, these results suggest a complex pattern of relationships that reinforce the evidence reported in the literature about reciprocal interactions between SES, home literacy and numeracy, and children’s early skills as well as cross-domain relationships between literacy and numeracy , 2021.However, to better understand longitudinal causal pathways and cross-domain interactions, we developed two different SEM models.In the first model, we considered SES to be a potential predictor of early language skills and early literacy skills, and symbolic and non-symbolic numeracy skills, including home literacy and numeracy as potential mediators. Results showed that SES had significant direct effects on early language and literacy skills. Home literacy significantly mediated the role of SES for language skills in the second year of preschool and early literacy skills at the end of preschool. Language skills were predictive of early literacy skills 1 year later. Concerning numeracy, it emerged that SES was predictive of non-symbolic skills but not of later symbolic skills. Home numeracy significantly mediated the role of SES on both waves of assessment. Also, early non-symbolic skills were significantly related to later numeracy skills. Considering the amount of variance explained in the model, this was higher for the second wave of assessment compared to the first and for early literacy (0.27) compared to symbolic numeracy (0.19).This pattern of results reinforces some aspects of previous evidence and offers partially divergent results and new insights.First of all, given the observed direct path from home literacy and numeracy to children’s skills, this study reinforces the body of evidence that highlights the importance of home literacy on children’s early language and literacy skills e.g.,  and thatConsidering the relationship between SES and the numeracy domain, our results found that SES was significantly related to non-symbolic but not symbolic skills. These results contrast with some previous studies , which fSignificantly, this study adds important new insights with respect to previous literature showing that, although SES predicted both home literacy and numeracy skills, home literacy partially mediates the effect of SES on language and literacy measures in addition to non-symbolic numeracy and fully mediates the relationship between SES and symbolic numeracy skills. Previous studies already suggested an influence of SES on home literacy  and homeAs a second aim of the study, we also wanted to understand the cross-domain effects of home literacy and numeracy and children’s skills. To this purpose, we developed a model of the interaction between home literacy and numeracy on the two different domains, including SES as a mediator. It emerged that the interaction of home literacy and home numeracy was not significant in language and literacy skills and non-symbolic numeracy measures. Instead, it was negatively significant for children’s symbolic numeracy skills. The analysis revealed that if home literacy is high when home numeracy is low, this enhances numeracy skills (mainly symbolic ones). These results are partially in line with previous studies that found a relationship between home literacy and numeracy skills  and reinThere are some limitations of the present study that need to be considered. First, we did not test specific relationships of SES and home literacy and numeracy with single literacy and numeracy factors, although this was partially considered in correlation analyses. In other words, it might be that SES might differently affect subdomains of literacy and numeracy, and this should be considered in forthcoming studies. In addition, measures of home literacy and numeracy did not distinguish between formal and informal activities. We opted for a short questionnaire to encourage greater adherence to the study, proposing a questionnaire that is easy to fill out by parents and in line with other studies that adopted a similar approach . HoweverDespite these limitations, the present study adds a significant contribution to the previous evidence regarding three main points. First, the study evidenced that home literacy and home numeracy partially or fully mediated the relationships between SES and children’s skills, suggesting that home activities might dampen the detrimental effects of SES on children’s skills. Secondly, the study highlighted a significant interaction of home literacy and home numeracy on symbolic numeracy skills, suggesting that home literacy might represent a protective factor when home numeracy is low. Finally, the present study was conducted on monolingual Italian children and their parents; Italian is a highly transparent language, and, since most studies were conducted on opaque language such as English, the study adds insights about the generalizability of results of previous studies to different linguistic and cultural contexts.These results have potential implications for educational settings. Given the potential role of home literacy and home numeracy in mediating children’s literacy and numeracy skills, the present study indirectly reinforces the importance of implementing parents’ intervention programs to foster home literacy and numeracy practices. These interventions might reduce the negative impact of SES on children’s early literacy and numeracy skills and possibly on future academic achievements. Particular attention should be given to low-SES populations for whom intervention programs might be of specific relevance and impact. This study also suggests that parents’ intervention programs should focus on both literacy and numeracy activities.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by the Bioethics Committee of the University of Bologna. Written informed consent to participate in this study was provided by the participants’ legal guardian/next of kin.BP and PB conceived the presented idea, developed the assessment protocol, and wrote a preliminary version of the manuscript. BP carried out the experiment and collected and analyzed the data. DC and PB performed the statistical analyses. AF and BP contributed to the interpretation of the results. AF, BP, and PB revised and significantly contributed to the final version of the manuscript. All authors discussed the results and contributed to the final manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Global Health: Science and Practice (GHSP), responding to what we saw as an important gap in access to robust program-related evidence in global health. It was our conviction that a new kind of journalIn 2013, the U.S. Agency for International Development (USAID) and the Johns Hopkins Center for Communication Programs launched practice-based evidence—lessons that can be drawn from actual programs, especially those implemented at scale.The “practice” in GHSP’s name has remained a central focus. As with other peer-reviewed journals, we certainly have been striving to contribute to evidence-based practice. What is not so typical of journals in this field, but that has been a central preoccupation for us is For programs to be more effective and achieve greater impact, the various actors of the system that create and use practice-based evidence need to be better connected.utility of study findings.“Science” is also centrally important to us, in several ways. Robust evidence on the effectiveness of interventions is certainly of interest to us, so methodologic rigor is an important criterion in our review process. In that respect, GHSP is similar to many other journals. But at least equally important for us is the real-world there’s a science to practice; good, critical, reflective practice requires that we bring rigor and objectivity to our program inquiry. We need to take program performance measurement seriously, be open to disconfirming evidence, and be ready to move in new directions if evidence points us there. We believe that those engaged in program work are continuously drawing useful lessons from their work and that rigorously assessing and documenting and then sharing these lessons can benefit others. We’re interested in drawing lessons from exemplary programs, but we’re equally interested in those that have struggled. We’re concerned with what works (and doesn’t work), under what conditions, to achieve impact at scale on a sustained basis.Furthermore, we believe There is rich learning to be had from things that don't work as well as we planned. We understand that the success of a program is almost invariably attributable not only to the intervention itself but to a complex and dynamic interaction between the intervention and the specific context in which it is delivered. At GHSP, we expect authors to provide sufficient detail on the setting or context to allow readers to understand the interplay between intervention and context so they can make better-informed judgments of transferability to their own work settings. An important part of what we do at GHSP is to provide a platform for sharing such insights.Certainly, experimental designs provide stronger evidence for causal inference, but we don’t believe in an evidence hierarchy that automatically places randomized controlled trials and meta-analytic systematic reviews at the pinnacle. There are other kinds of evidence and other ways of understanding rigor or robustness that may be equally relevant when we’re trying to understand what works in the real world.We are not saying that rigor, as conventionally understood, is not important. What we may think of as research principles certainly apply to program-based evidence. Authors need to be thinking about measurement validity, representativeness, counterfactuals and comparators, confounding, appropriate analytic methods, and sound causal reasoning. Even in opinion pieces, such as viewpoints and commentaries, authors need to offer well-supported arguments.Although work is often done in low- and middle-income countries by researchers based in high-income countries, it’s problematic for us when we receive articles on which the authors are overwhelmingly from high-income countries. This is not only a matter of fairness and equity but also of validity. Articles reflecting only an external perspective neglect valuable insights into the realities and nuances of the local system that authors and actors in LMICs can provide.Similarly, though we welcome papers from donor-funded, in-country projects, we are especially interested in articles that reflect the input and perspective of those working in ministries of health and other in-country institutions.Over the past year, we have intentionally refocused efforts to ensure that the articles we publish adequately reflect in-country voice and perspective. Last year, we updated our editorial policies to reflect our efforts to ensure that articles reporting findings from specific countries have meaningful participation from in-country authors.Similarly, last year,We are continuing to identify new editorial board members who can bring valuable research and program experience to help inform GHSP’s vision in the future.In the field of open-access peer-reviewed journals, GHSP has the luxury of publishing articles with no submission fees to authors because of our special funding arrangements with USAID. This allows us to eliminate financial barriers disproportionately affecting early-career professionals and individuals in low- and middle-income countries, as they seek to share learning.We recognize that we still have much to do in realizing our mission to contribute to more effective health programs and greater population health impact. We invite readers, authors, and reviewers to work with us toward this end and invite your suggestions on how we can do a better job.