Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

BACKGROUND: Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS: A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS: Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended. CONCLUSIONS: Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. TRIAL REGISTRATION: Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474

Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

Background Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. Methods A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. Results Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended. Conclusions Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474

Consumo de volumosos, produção e composição físico-química do leite de cabras F1 Boer × Saanen Roughage intake, milk yield and physicochemical composition from F1 Boer × Saanen goats

Avaliaram-se os efeitos do fornecimento de volumosos suplementares sobre o consumo, a produção e a composição físico-química do leite de cabras F1 (Boer &#215;Saanen). Utilizaram-se 18 cabras distribuídas em três baias, recebendo como suplemento, à vontade, silagem de sorgo, silagem de milho ou feno de amoreira com controle diário do consumo de matéria seca. A média diária para produção semanal foi calculada reunindo-se dados leiteiros em três períodos pós-parto: 1 (34 a 40 dias/7 dias); 2 [(64 a 70 dias/7 dias) + (91 a 97 dias)/7 dias)]/2; e 3 (125 a 131 dias/7 dias) e a média pontual diária do período pelas datas de referência dos períodos da média diária para produção semanal, que foi correlacionada à composição de gordura, proteína, lactose e extrato seco total e à contagem de células somáticas. Os dados semanais de acidez e densidade foram agrupados em 37, 81&plusmn;13, 128 e 151&plusmn;10 dias pós-parto. Com modelos mistos, o animal foi computado como aleatório e os efeitos fixos foram três suplementos e três períodos (composição, médias diárias as produções semanal e do período) ou quatro (acidez e densidade). O consumo de feno de amoreira (0,657 kg) superou o de silagem de milho (0,604 kg), que foi superior ao de silagem de sorgo (0,305 kg). No período 2, a composição em extrato etéreo foi menor, em razão do decréscimo de gordura e lactose. No período 3, a composição em proteína e a acidez aumentaram e a densidade foi maior nos períodos 1 (1,0270) e 3 (1,0277). A mamite aumentou a CCS no período 2. Para proteína, o tipo de suplemento não foi significativo, mas houve efeito da interação período pós-parto &#215;suplemento. As demais variáveis não foram influenciadas pelo tipo de suplemento, apenas pelo período pós-parto. O feno de amoreira aumenta o consumo suplementar pelas cabras em relação às silagens de milho e sorgo, mas não melhora as médias de produção e composição do leite. Cabras Boer &#215;Saanen em pastejo e sob suplementação têm bom potencial leiteiro.<br>The effects were assessed of supplying supplementary roughage on intake, milk yield and milk physical and chemical composition in F1 (Boer &#215;Saanen) goats. Eighteen females were placed in three stalls, and received as ad libitum supplement sorghum silage, corn silage and mulberry hay (MHT), with daily control of dry matter intake. The average daily production per week was calculated by gathering the milk data in three post-parturition periods: 1 (34-40 days/7 days); 2 [(64-70 days/7 days) + (91-97 days)/7 days)]/2 and 3 (125-131 days/7 days). Daily spot-average of each period (DSAP) was calculated from the reference dates of average daily production per week, that was correlated with the composition of fat, protein, lactose, total solids composition and the somatic cell count. The weekly data for acidity and density were grouped in 37, 81&plusmn;13, 128 and 151&plusmn;10 days post-parturition. Using mixed models, the animal was computed as random and the fixed effects were three supplements and three periods (composition, average daily production per week and per period) or four (acidity and density). Mulberry hay intake (0.657 kg) was greater than corn silage (0.604 kg) that was greater than sorghum silage (0.305 kg). In period 2, the ether extract composition was smaller because of the decrease in fat and lactose. In period 3, protein and acidity increased and density was great in periods 1 (1.0270) and 3 (1.0277). Mastitis increased SCC in period 2. The type of supplement was not significant for protein, but there was post partum period &#215;supplement effect. The other variables were not influenced by the type of supplement, only by the post-partum period. Mulberry hay increased the supplement intake by the goats compared to corn and sorghum silage, but it did not improve milk yield = means and composition. Grazing Boer &#215;Saanen goats with supplementation have good milk production potential