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The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy… Nathan, Hannah L; Boene, Helena; Munguambe, Khatia; Sevene, Esperança; Akeju, David; Adetoro, Olalekan O; Charanthimath, Umesh; Bellad, Mrutyunjaya B; de Greeff, Annemarie; Anthony, John; Hall, David R; Steyn, Wilhelm; Vidler, Marianne; von Dadelszen, Peter; Chappell, Lucy C; Sandall, Jane; Shennan, Andrew H Jan 5, 2018

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RESEARCH Open AccessThe CRADLE vital signs alert: qualitativeevaluation of a novel device designed foruse in pregnancy by healthcare workers inlow-resource settingsHannah L. Nathan1*, Helena Boene2, Khatia Munguambe2,3, Esperança Sevene2,3, David Akeju4,Olalekan O. Adetoro5, Umesh Charanthimath6, Mrutyunjaya B. Bellad6, Annemarie de Greeff1, John Anthony7,David R. Hall8, Wilhelm Steyn8, Marianne Vidler9, Peter von Dadelszen1, Lucy C. Chappell1, Jane Sandall1,Andrew H. Shennan1 and the CLIP Working GroupAbstractBackground: Vital signs measurement can identify pregnant and postpartum women who require urgent treatmentor referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devicessuitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring bloodpressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warningsystem alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage orsepsis. This study evaluated the usability and acceptability of the CRADLE VSA device.Methods: Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria andtertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups withhealthcare workers using the device (n = 205) and pregnant women and their family members (n = 41). Interviews andfocus groups were conducted in the local language and audio-recorded, transcribed and translated into English foranalysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach.Results: Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights earlywarning system was unanimously reported positively, giving healthcare workers confidence with decision-making anda sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly whenmeasuring vital signs in obese and hypertensive women (n = 4) and a few South African healthcare workers distrustedthe device’s accuracy (n = 7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warningsystem gave women and their families a better understanding of the importance of vital signs in pregnancy and duringthe postpartum period.Conclusion: The CRADLE device was well accepted by healthcare workers from a range of countries and levels offacility, including those with no previous vital signs measurement experience. The device motivated women toattend primary care and encouraged them to accept treatment and referral.Keywords: Pregnancy, Blood pressure, Vital signs, Early warning system, Accuracy, Pre-eclampsia, Haemorrhage,Sepsis, Qualitative methods, Low- and middle-income countries* Correspondence: hannah.nathan@kcl.ac.uk1Department of Women and Children’s Health, King’s College London,London, UKFull list of author information is available at the end of the article© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Nathan et al. Reproductive Health  (2018) 15:5 DOI 10.1186/s12978-017-0450-yPlain English summaryHigh blood pressure, bleeding and infection affect womenwho are pregnant, in labour or have recently given birth.Abnormal blood pressure and pulse measurements canindicate that a woman has one of these conditions andmay require treatment. Healthcare workers in low-incomecountries often lack the equipment and training to measureand understand blood pressure and pulse. The CRADLEVital Signs Alert is a novel device that accurately measuresblood pressure and pulse and is suitable for low-resourcesettings. Traffic lights within the device help healthcareworkers identify women who need additional treatment forthese conditions.This study evaluated whether the CRADLE device waseasy-to-use and preferred to other devices. One hundredand fifty five interviews and 6 focus groups involvingcommunity- and facility-based healthcare workers andpregnant women and their family members in India,Mozambique, Nigeria and South Africa were conducted.The healthcare workers reported the CRADLE devicewas easy-to-use. The traffic lights enabled them to makedecisions about treatments and made them feel moreprofessional. A minority of healthcare workers in SouthAfrica said the device was tiring to use and questionedits accuracy. The women and their families reported thatthe traffic lights enabled a better understanding of theirhealth. It encouraged them to attend their appointmentsand accept treatment. Overall, the CRADLE device waswell accepted by healthcare workers and pregnant womenfrom a range of countries and levels of facility.BackgroundVital signs measurement is one of the most importantscreening tools in antenatal care, identifying those whorequire urgent treatment, delivery or referral. Despite itsclinical importance, in low-resource settings healthcareworkers (HCWs) often have limited access to functioning,accurate devices appropriate for their environment [1].Even when appropriate equipment is available, the level oftraining required to accurately measure and act on vitalsign measurements (including blood pressure (BP) andpulse) is often lacking. These barriers contribute toavoidable maternal and perinatal mortality and morbidity,which are most prevalent in low-resource settings [2].The Microlife® CRADLE (Community blood pressuremonitoring in Rural Africa & Asia: Detection ofunderLying pre-Eclampsia and shock) Vital Signs Alert(VSA) is a hand-held, upper-arm, semi-automated devicemeasuring BP and pulse. The device has been accuracyvalidated in pregnancy, including pre-eclampsia andhypotensive pregnancies, according to formal validationprotocols [3, 4]. It meets the World Health Organization’scriteria for low-resource settings, being robust and portable,having low power requirements (charging through a micro-USB port), requiring minimal calibration, and beingaffordable at $25 USD per unit [5]. The CRADLE VSAhas been further modified, incorporating a traffic lightearly warning system (EWS) [6, 7], aiming to alertHCWs and untrained users to vital sign abnormalitiessecondary to pre-eclampsia, obstetric haemorrhage andsepsis (the three leading causes of maternal mortalityworldwide) [2]. The EWS triggers for hypertension arewell-established thresholds of BP used in clinical practice.The EWS triggers for obstetric haemorrhage and sepsiswere determined through retrospective analysis of vitalsigns in women with haemorrhage; shock index (pulse/systolic BP) thresholds were found to be consistentlyreliable markers of compromise [6, 7]. The predictiveability of the hypertension and shock index EWSthresholds were prospectively validated in women fromlow- and middle-income countries with either pre-eclampsia, obstetric haemorrhage or sepsis, the resultsof which are described elsewhere (In Press). Althoughthe current model of the CRADLE VSA does not havemHealth capabilities, incorporation of mHealth technologyto future models of the CRADLE VSA is possible (i.e.transmission of vital signs data from the device to mobilephones or directly to a central facility).By enabling HCWs in low-resource settings to havebetter access to accurate vital sign measurement, theCRADLE VSA addresses the three delays model ofmaternal mortality and morbidity [8]. The model is aconceptual framework describing the three delays inreceiving care that can result in avoidable maternalmortality and morbidity: (i) delays in the recognition ofthe maternal health problem and decision to seek care;(ii) delays in reaching the health facility; (iii) delays inthe provision of adequate care. The CRADLE VSA aimsto identify those who require urgent referral (the seconddelay) and once at facility, it aims to identify those whorequire urgent intervention and monitor response tointervention (third delay). In recent years, with improvedaccess to mobile phones, even in the most remote areas ofthe world, mobile health (mHealth) technologies and otherpatient monitoring devices are becoming important toolsin maternal and perinatal health [9]. Despite improvedaccess to these technologies, formal evaluation of howdevices are integrated into routine care [10], contextualevidence on health care workers’ barriers and facilitatorsand their impact on clinical outcomes is limited [11, 12].Lessons learnt from a recent large-scale study to improvehealthcare in rural India demonstrated the importance ofcareful evaluation of how innovations might evolve duringimplementation and how users adapt to the innovationsduring scale-up [13].Prior to implementation at scale, it is important toconsider the theory of diffusion of innovation, firstdescribed by Everett Rogers in 1962 [14], and the fiveNathan et al. Reproductive Health  (2018) 15:5 Page 2 of 11categories of influence, that may be relevant to theimplementation of the CRADLE VSA: Relative advantage, which is the degree to whichan innovation is perceived as better than the idea itsupersedes (includes economic advantage,convenience and satisfaction) Compatibility with existing values and practices,which is the degree to which the innovation isperceived as being consistent with the values, pastexperiences, and needs of potential adopters Simplicity and ease-of-use Trialability, which is the degree to which theinnovation can be experimented with (a trialableinnovation represents less risk to the individual whois considering it) Observable results: the easier it is for an individualto see the results of an innovation, the more likelythey are to be adoptedThis qualitative study aimed to determine the usability,feasibility and acceptability of the CRADLE VSA amonga variety of users and in diverse socio-economic settings,considering these five clusters of influence. This willinform future device modifications and successful dissem-ination of the CRADLE VSA for routine use.MethodsStudy areaThe evaluation was conducted in two separate studies,in the community and primary health centres in multiplestudy areas in India [15], Mozambique [16] and Nigeria[17], and tertiary hospitals in South Africa. The CRADLEdevice was developed for use by all levels of HCW. Avariety of settings were included in this study to ensuretransferability of the findings and relevance for scale-up.Evaluation in India and Mozambique was embedded inthe Community Level Intervention for Pre-eclampsia(CLIP) Trial (NCT01911494) [18], a cluster randomisedcontrol trial evaluating a package of interventions includingthe CRADLE device, with evaluation in Nigeria being partof a process evaluation run alongside the trial. Details ofeach CLIP trial area are described elsewhere [15, 16, 19].Evaluation in South Africa was embedded in the CRADLE2 study, a mixed-methods observational study evaluatingthe CRADLE VSA and the predictive ability of its trafficlight EWS. This study took place in tertiary centres, wherethe rate of adverse outcomes including eclampsia andhysterectomy were high, to effectively evaluate the trafficlight thresholds in a high-risk population. These centrescared for women requiring either secondary- or tertiary-level care. In India and Mozambique, a prototype of theCRADLE VSA, with the same accuracy and featuressuitable for low-resource settings but without the trafficlight EWS, was tested; in Nigeria and South Africa, themodified CRADLE VSA, with traffic light EWS, wasassessed. For each study, HCWs were trained to use thedevice through short demonstration and practical ses-sions. The CLIP trial took place over 33 months (be-tween February 2014 and February 2017). The CRADLE2 study took place over 15 months (between January 2015and April 2016).Study designQualitative evaluation of the CRADLE VSA (and its pre-decessor: Microlife 3AS1–2) followed the FrameworkMethod [20] to determine the usability, feasibility andacceptability of the CRADLE device and the COnsolidatedcriteria for REporting Qualitative research (COREQ) Check-list was used to report the methodology and findings [21].The qualitative evaluation comprised of two phases,the first at 3 months into the studies and the second at9 months for the CRADLE 2 study in South Africa and12 months into the CLIP Trial (Table 1). Including twotime points allowed for exploration of evolving experienceusing the device over time [22]. At least 9 months into thestudy was deemed adequate time for longer-term issues tobecome apparent. Purposeful sampling was used toidentify participants with a broad range of experiencesacross sites [23]. Snowball sampling was used to ensureviews from a variety of pregnant women and familymembers [24]. CLIP and CRADLE study participantswere approached face-to-face and given information sheetsspecific to the qualitative evaluation and signed anadditional consent form to participate in the evaluation.The study comprised of semi-structured interviews[25] and focus group discussions [26] with community-and facility-level HCWs equipped with and trained touse the device and pregnant women and their familymembers who had come into contact with the device.Community HCWs included Auxiliary Nurse Midwives(ANMs) and Accredited Social Health Activists (ASHAs)in India, Agente Communitarios de Saude (APEs) inMozambique and Community Health Extension Workers(CHEWs) in Nigeria. At each site, experienced researchstaff were locally recruited and trained to conduct theinterviews and focus group discussions, with guidancefrom senior social scientists (JS, KM, HB, DA, UC). Theresearch staff were selected due to their familiarity withthe community, the CRADLE device and the researchquestion. Each interview and focus group discussion wasconducted in the participant’s workplace or home and ineither their respective country official language or thelocal language, according to the participants preference,by one interviewer and was audio-recorded. Participantswere approached to participate in either a semi-structuredinterview or a focus group discussion, with no one partici-pating in both.Nathan et al. Reproductive Health  (2018) 15:5 Page 3 of 11Data management and analysisAll data collection was led by the local team at each siteand coordinated by the CRADLE study coordinator andprincipal investigator in the UK. The field staff transcribedand translated the data to English verbatim. Accuracy wasensured by comparing the audio recording to the tran-scripts. The data was coded and thematically analysedusing NVivo version 10 [QRS, Vic, Australia] by fourresearchers, both from local sites and coordinating institu-tions. The four researchers worked independently on fourNVivo projects, each with identical coding structuresto allow for merging to a single project on completion.The researchers convened regularly (via Skype) toensure agreement in coding between researchers, dis-cussing emerging themes and to reflect on the findings.The NVivo software coding agreement function (Kappacoefficient) was used to assess agreement between coders.If coding agreement was less than 93%, coding disagree-ments were discussed during Skype meetings until theresearcher group reached a consensus. Factors that mayhave facilitated or hindered the usability, feasibility andacceptability of the device and those factors likely to influ-ence its potential translation to routine use were explored.While NVivo nodes were created to reflect the emergingthemes from participants’ discourse that could be linkedto these constructs, the participants and the specificcontexts in which such discourses were developed werecategorized and labelled by attributes that reflected theage, site, phase of the study, model of device used, yearsof experience and level of care. Through further coding,similarities and differences within, between and amongthese groups were compared and common and divergentpatterns of responses were explored.For phase 1, a deductive approach was used, with themesidentified through previous researcher experience of deviceuse. For phase 2, additional themes were iterativelydetermined through researcher consensus in responseto emerging themes from phase 1 interviews, using aninductive approach. Field notes were not taken and datasaturation was not assessed during the data collection.A large sample size was needed to understand thecountry context influence in community, primary andtertiary health centres and data saturation was achieved(sample size shown in Table 1).Ethical considerationsThe study received ethics approval from KLE University,Belgaum India (MDC/IECHSR/2011–12), the CISMInstitutional Review Board, Mozambique (CIBS_CISM/08/2013), the Olabisi Onabanjo University Teaching Hospital,Sagamu Nigeria (OOUTH/DA/326/431), University ofStellenbosch, South Africa (N14/06/068), University ofTable 1 Interviews and focus group discussions distribution across sitesSites: Mozambique(24 month CLIP trial)India (33 month CLIP trial) Nigeria (33 month CLIP trial) South Africa(12 month CRADLE study)Device Prototype CRADLE VSA Prototype CRADLE VSA CRADLE VSA CRADLE VSAFacility level Primary health centreand homePrimary health centre and home Primary health centre Tertiary hospitalNumber of study areas 2 2 2 3Participants Agente Communitariosde Saude (APEs)Auxiliary Nurse Midwives (ANMs) andAccredited Social Health Activists (ASHAs)Community Health ExtensionWorkers (CHEWs)Healthcare assistants/studentsNurses Nurses Nurses NursesDoctorsPregnant women Pregnant women andfamily membersPhase 1Timing from start oftrial/study3 months 3 months 3 months 3 monthsNumber of interviews 29 10 12 25Number of focusgroups0 0 2 0Phase 2Time from start oftrial/study12 months 12 months 12 months 9 monthsNumber of interviews 42 10 12 15Number of focusgroups0 0 2 2Nathan et al. Reproductive Health  (2018) 15:5 Page 4 of 11Cape town, South Africa (401/2014), University of FreeState, South Africa (230408–011), as well as by theUBC C&W Research Ethics Board in Canada (H12–00132).ResultsIn total, 155 interviews and six focus group discussionswere conducted in India, Mozambique, Nigeria andSouth Africa. Interviews included 114 HCW participantsand 41 pregnant women and family members (see Tables 1,2 and 3). Interviews lasted between 30 and 60 min.Of the 114 HCWs interviewed, all were either commu-nity HCWs, nurses, midwives, or clinical assistants. 35%,30 and 35% of HCWs interviewed cared for women intheir homes, primary health centres and tertiary hospitals,respectively, and 87% of HCWs interviewed were female.The six focus groups comprised of six to eleven partici-pants. Of the 50 HCWs who took part, all were eithercommunity HCWs, nurses, midwives, or clinical assistants;66% worked in primary health centres and 34% worked inhospital; all HCWs included in the focus groups werefemale. For more details on participant characteristics seeTables 2 and 3.Qualitative analysis of the interviews and focus groupdiscussions revealed several major themes across countriesand some country-specific themes.Healthcare worker opinion on ease-of-useThe view held by most HCWs was that the CRADLEdevice was easy to use and, for those with prior experiencemeasuring vital signs, preferred to their prior device.Those with previous mercury sphygmomanometryexperienceFor all HCWs with previous mercury sphygmomanometryexperience (the majority), it was agreed that CRADLEdevice measurement was simpler and quicker. Sphygmo-manometry was reportedly technically difficult, oftenrequired repeating to achieve a BP reading and the HCWrisked appearing inexperienced. Some reported thatmeasurement was now less stressful. Across all sites,HCWs expressed relief not to need a stethoscope formeasurement, because it was often difficult to hear theheart sounds in busy environments and it was painful forTable 2 In-depth interview participants’ demographicinformationCharacteristics Healthcare worker (%)n = 114Other (%)an = 41CountryMozambique 35 (31%) 36 (88%)India 20 (18%) 0 (0%)Nigeria 19 (17%) 5 (12%)South Africa 40 (35%) 0 (0%)Facility levelCommunity 40 (35%) NAPrimary health centre 34 (30%) NAHospital 40 (35%) NAAge (years)15–20 1 (1%) 6 (15%)21–30 36 (32%) 16 (39%)31–40 37 (32%) 15 (37%)41–50 25 (22%) 2 (5%)51–60 13 (11%) 2 (5%)Missing 2 (2%) 0 (0)GenderFemale 99 (87%) 39 (95%)Male 14 (12%) 2 (5%)Missing 1 (1%) 0 (0%)Years of experience0–5 41 (36%) NA6–10 38 (33%) NA11+ 27 (24%) NAMissing 8 (1%) NAa33 pregnant women, 8 family membersTable 3 Focus group participants’ demographic informationCharacteristics Healthcare workers (%) n = 50CountryNigeria 33 (66%)South Africa 17 (34%)Facility levelPrimary health centre 33 (66%)Hospital 17 (34%)Age (years)15–20 0 (0)21–30 8 (16%)31–40 17 (34%)41–50 18 (36%)51–60 5 (10%)60+ 2 (4%)GenderFemale 50 (100%)Male 0 (0%)Years of experience0–5 10 (20%)6–10 10 (20%)11+ 27 (54%)Missing 3 (6%)Nathan et al. Reproductive Health  (2018) 15:5 Page 5 of 11their ears. In Nigeria, HCWs reported that previously theyhad not known when to stop inflating the cuff (which,according to the HCW, was painful for the woman), butwith the CRADLE device, the sound alerts indicated whento stop inflating. Some favoured the CRADLE devicebecause it gave exact numbers, compared to sphygmoma-nometry, which required user approximation. One HCWadmitted resorting to guessing the BP using sphygmoma-nometry because it was too challenging, illustrated in thequote below:“At times the mercury maybe moving in a scatteredmanner. So [...] we will not be able to get the accuratereading, we would rely on assumption or guessing byasking the patient if she’s sleeping very well, if she doesnot have headache, so we may we assume that thepatient does not have high blood pressure. That thingaffects our work, because at the end of the day thepatient may have hypertension.” Focus groupdiscussion, CHEW, Nigeria.Unanimously HCWs preferred the simultaneous auto-mated pulse measurement, rather than having to manuallymeasure pulse. For those measuring vital signs in women’shomes, the CRADLE device was smaller, easier to carryand more robust than their prior device. Most communityHCWs in India and Mozambique (ASHAs, ANMs, andAPEs) had no previous experience measuring vital signs,whereas community HCWs in Nigeria (CHEWS) had pre-vious experience. For those with no previous experiencemeasuring vital signs, it was noted that although they wereinitially daunted by the new equipment, after simpletraining, it became easy-to-use.Those with previous automated devices experienceHCWs in the South African hospitals often had previousexperience with sophisticated automated devices thatcould perform repeated measurements automatically andhad been used in their departments for many years. Themajority, however, reported that they liked the CRADLEdevice equally or more than the automated devices. Forseven HCWs in South Africa, there was a perception oftaking a step backwards. Of those, four HCWs describedmanual inflation as tiring and painful, particularly whenmeasuring vital signs in obese and hypertensive women(requiring more inflation). The same four HCWs alsoreported BP measurement was slower and that, unlikeautomated measurement, other tasks could not be donesimultaneously. Six of the seven HCWs with negativeviews, reported confusion about inflation, which wouldresult in errors, particularly in obese and hypertensivewomen. When probed, the descriptions indicated a lack ofunderstanding of the symbol that represented the need foradditional inflation. Of those seven HCWs with predom-inantly negative views, five were 41–50 years old and fivehad eleven or more years’ of experience.Healthcare worker opinion on the CRADLE deviceaccuracyIn women’s homes and primary health centres inMozambique, India and Nigeria the CRADLE devicewas perceived to be accurate. This perception wasstrengthened over time, demonstrated through a greaterproportion of references regarding accuracy in phase 2compared to phase 1. Accuracy was often assumed dueto its “high-tech” and “modern” appearance. One HCWattributed her perceived increase in the incidence ofhypertension she was detecting to the device’s accuracy.Another thought the device was accurate because itgave similar readings to a device she used at home.“As we are getting more experience we are liking thisapparatus more. Now we know that to detect one caseof hypertension we have to check everyone’s BPfrequently. As days are passing our faith on machineand accuracy of recording BP has increasedtremendously.” Interview, ANM, India.In South Africa, views on accuracy varied, with a fewSouth African HCWs distrusting the CRADLE device’saccuracy (n = 7). Reasons for doubting the accuracyincluded variations in BP minute-to-minute and seeingmore women with hypertension since using the CRADLEdevice (a reason for assuming accuracy for others). Sevenpercent of South African HCWs (2% of all HCWs, n = 4),some of whom also questioned BP accuracy, reported thatthe CRADLE device overestimated pulse in comparison tomanual palpation.The chief nurse at one South African hospitalsuggested that the accuracy concerns were only in verybusy areas of the hospital where staff were dealing withhigh volumes of patients and struggling with theworkload.“Now my assumption is that this [CRADLE device]isn't suitable for the high number of patients we have.You know, it's 24/7, a lot of people per day. It seemslike the places where people distrust the device themost are the busiest place.” Focus group discussion,Chief nurse, South Africa.Another nurse at the same hospital affirmed this view:“And it could be a perception, because if you have topump […] 200 patients, and you don't get accuratereadings, […] that makes it hard to believe in thesemachines, because you don't like it, because you haveNathan et al. Reproductive Health  (2018) 15:5 Page 6 of 11to work so hard. So, then, the variability is so big. So itmight be true, but if you have to pump 3, 4 times forone patient, you get negative from the start.” Focusgroup discussion, Nurse, South Africa.The majority in South Africa trusted the accuracy of theCRADLE device. Some acknowledged that the perceivedincrease in hypertension may be because their previousdevices were underestimating BP. Others acknowledgedthat occasional unexpected BP readings may have beenlinked to incorrect technique rather than the device itself.Healthcare worker opinion on the CRADLE traffic light EWSIn Nigeria and South Africa, the sites with the CRADLEdevice with traffic lights, the traffic lights EWS wereunanimously perceived positively. Many of those trainedto interpret the numbers reported that, although theyrelied on the numbers, the traffic lights were a usefuladdition. The traffic lights reassured the HCW on theirdecision to escalate care, giving them confidence to actquickly. For some, the traffic lights would alert to aproblem that would have otherwise been missed. Forthose with more limited training i.e. community HCWs,the traffic lights were even more useful. These views areillustrated in the quote below:“[The traffic lights are] very useful. It’s just like thetraffic light we see on the road, because it will tell youwhen you are supposed to go, when you are supposedto stop, when there is danger sign. So the one seen on[CRADLE device], it will tell okay, this patient is okay,or that you have to refer this patient as fast aspossible. So it is very useful.” Interview, Nurse, Nigeria.Some reported the traffic lights made counselling ofwomen easier, with the lights being used to illustrate theproblem and encourage acceptance of referral or treatment.These views were particularly strong in comparison tosphygmomanometry, a process that restricted involvementof the women in the management of their health.“The [traffic lights] have always been of significanthelp to the midwives. You can easily educate themusing the traffic lights on the device and tell them ifthey need some care. You can even go as far as usinganother patient with a normal BP as an example.”Interview, Senior nurse, Nigeria.Healthcare worker opinion on impact on work-lifeA consistent theme from Mozambique, India and NigeriaHCWs was the sense of professionalism and job satisfac-tion that the CRADLE device had given them. Manydescribed feeling proud and confident when using thedevice and become more respected in the community.The device aided communication with senior HCWsand gave them a sense of empowerment to makeclinical decisions. These feeling were expressed in thefollowing two quotes:“Before we used to get confused about BP so we used toask our senior doctors to check the BP again as we aregetting high BP. Now we are confident in telling ourseniors that ‘I have detected one HDP case so pleasedo the needful’.” Interview, ANM, India.HCWs reported that the device made it easier to per-suade women to be referred when there was a problem.Although the CRADLE device may have encouragedmore women to attend primary health centres, they donot associate the device with a heavier workload becausethe device identified problems earlier, thereby reducingtheir subsequent workload arising from complications.“For me, it has a positive impact […], truly speaking itreduces my workload […]. For example, if someonesuffers from high blood pressure and it gives herconvulsions. I think it is two times better to work for20 women rather than only one who gives you a hardtime because it is necessary to have medicine to treatthe convulsions, we might lose her.” Interview, Nurse,Mozambique.In South Africa, although the majority agreed that vitalsigns measurement was now quicker, 8 HCWs reportedthat due to perceived errors, difficulties measuring BP inhypertensive women, and inability to do other taskswhilst measuring vital signs, workload had increased.“It is actually more time consuming when you need topump it up because when you are pumping up youcould have done something else for your patient, likethe temperature reading, or make your patientcomfortable or something. And now I have to standand normally while the blood pressure is reading Ispeak to the patient to find out how the patient isdoing and then we do our notes and we do ourrecordings.” Interview, Nurse, South Africa.HCW-reported technical issues and errorsIn Mozambique and India the CRADLE device waspowered by replaceable batteries. Unanimously, HCWsreported that battery life was adequate, lasting 2–3 monthsdepending on intensity of use.In Nigeria and South Africa, the CRADLE devicecharged via a micro-USB port. In Nigeria, one chargelasted 2–4 weeks, depending on intensity of use. Chargingwas dependent on electricity availability, which oftenresulted in the device being charged when electricityNathan et al. Reproductive Health  (2018) 15:5 Page 7 of 11became available, regardless of the battery life. At theSouth African hospitals, reliable electricity was not aconcern. HCWs would charge the device whenever it wasnot in use and would take it off charge before it was fullycharged. For this reason, it was not possible for HCWs tojudge how long one charge lasted as it was rarely allowedto run flat. Some reflected this was done out of habit,because it is how they charged their previous automatedBP devices and other ward equipment.On switching on the device, the ‘low battery’ symbol isdisplayed, as are all other symbols. In Nigeria and SouthAfrica, there was some confusion regarding the ‘lowbattery’ symbol. When probed, responses suggestedconfusion between the display shown immediately uponswitching on the device and a true ‘low battery’ symbolwhich flashes throughout vital signs measurement.These findings demonstrate that the display can misleadthe user into thinking the device needs charging morefrequently than is required and will be fed back to themanufacturers.Three percent of all HCWs (n = 5) reported mechanicalissues requiring replacement. Problems included a brokenhand pump, broken tubing and three broken chargingports. In South Africa, charging cables (generic micro-USB chargers, also used for most mobile phones) neededto be replaced frequently. Even so, HCWs preferred mi-cro-USB charging to replaceable batteries, as electricity ismore readily available than new batteries.There were very few reports of errors. Someacknowledged that errors were associated with com-promised technique e.g. movement. 6% of all HCWs(n = 10) thought errors were more frequent when thebattery was low rather than considering well-establishedcauses of errors. Many expressed that they appreciatedthe error alerts on the CRADLE device, explaining thatwith mercury sphygmomanometry errors occurredwithout their knowledge. This was illustrated in thequote below:“And if we have made any mistake, [the CRADLEdevice] will show error. If we have made a mistake, wecan see the suggestions and repeat it again. In that oneyou cannot. We don’t realise. We might think that weare not able to hear and so we keep inflatingrepeatedly.” Interview, ANM, India.Opinions of the women and their familiesUnanimously, pregnant women liked the CRADLE device.The device gave them and their families a better under-standing of the importance of the measurement of vitalsigns in pregnant and postpartum women because, unlikesphygmomanometry, they could see the numbers (and thetraffic lights, depending on the site). This was reiteratedby the HCWs.“If they are educated, they see and ask how much [theBP] is. We hold it in front of them and show them.[HCW]: ‘See this is your BP.’ [Patient]: ‘It is good thatyou come, check and show us. If we go to [thehospital], they don’t tell us anything. They only write itdown and give it. Only when we ask them ourselves,they tell us. If we cannot read, we cannot make out.But you explain it to us, come all the way here, checkand tell us how much it is.’” Interview, ASHA, India.Community HCWs could measure vital signs in thewoman’s home using the CRADLE device (previouslydifficult because mercury sphygmomanometry was lessportable). Women and their families saw this as a positivechange because they no longer needed to travel to healthcentres.Like many HCWs, the pregnant women assumed accur-acy due to its digital function and modern look. It wasperceived as an improvement in the antenatal serviceprovided at primary health centres and was resulting inmore women attending centres. Family members also feltpositively about the device, even asking if their vital signscould be measured.“My husband liked it, because he felt that the level ofcare I now receive has improved compared to the onesI received during the previous pregnancies. He washappy and prayed for those who introduced the[CRADLE] device.” Interview Pregnant woman,Nigeria.DiscussionThese findings demonstrate that the CRADLE devicewas easy-to-use by all levels of HCW and well acceptedby the vast majority, despite some having never measuredvital signs previously. Technical modifications, includingthe traffic light early warning system and micro-USBcharging, to ensure suitability for community HCWs inlow-resource settings were of benefit to users. The trafficlight EWS was appreciated by all, even those with priortraining to respond to vital sign thresholds.The findings also highlighted minor technical issuesthat need to be addressed prior to scale-up, either byrequesting manufacturing adaptations or by improvingdevice training.Strengths of this study include the range of countries,levels of facility, HCWs experience and training and thedifferent studies hosting the evaluation. A sufficientnumber of interviews and focus groups ensured theoreticalsaturation and having two phases of data collection (at3 months and 9 or 12 months) allowed for temporalvariations to be explored. The study gives an extensiveand diverse range of views increasing the likelihood oftransferability. In addition, all data was collected byNathan et al. Reproductive Health  (2018) 15:5 Page 8 of 11local researchers with familiarity of the region and socio-cultural context, some of whom also participated in theanalysis.A limitation of the study is the potential impact ofsocial desirability bias. Participants were aware of theirrole in the study and the objective to explore theirviews related to the CRADLE device. Participants mayhave perceived the researcher as a person of power,aiming to portray the CRADLE device as a success, whichmay have influenced participant responses. To minimisethis, specific instructions regarding the purpose and confi-dentiality of the interviews were explained.The influence of researcher reflexivity was considered[27, 28]. Some of the researchers worked on other aspectsof the study and had extensive understanding of theCRADLE device. Throughout the research process, theresearchers considered their own opinions of the device,their relationship with the participants and the influenceon the data generated. Although they may have taken adifferent emphasis from that of independent observers,detailed exploration of the facilitators and barriers waspossible due to a good understanding of the intricacies ofthe device.The majority of studies evaluating BP devices focus onaccuracy, describing quantitative validations. Very fewstudies have evaluated the usability and acceptability of de-vices, or assessed the problem from the user’s perspectiverather than the developer’s perspective, these being criticalfor successful implementation. The only published studiesto qualitatively evaluate BP devices in the hands of users arestudies of home BP monitoring and telehealth in high-income countries, exploring the use of BP devices in thehands of patients rather than HCWs [29–32]. This study isunique in that it explores the opinions of a variety of HCWsfrom a number of low- and middle-income countries.The study findings can be explained following thediffusion of innovation model and the impact of the fivecategories of influence the model describes [14].Relative advantage, simplicity and ease-of-useIn Mozambique, India and Nigeria, the CRADLE devicewas perceived as a welcomed resource improvementcompatible with existing routines, despite differences inlevel of experience, training, and working-environmentacross sites. Their previous BP device experience wasmore varied, with some having used automated devicesbut most having only used mercury sphygmomanometry.The CRADLE device was perceived as more techno-logically advanced and easier-to-use than their previousequipment and accuracy was presumed.Observable resultsIn Mozambique, India and Nigeria, the device improvedconfidence and job satisfaction for many HCWs. Thedevice empowered lower cadres of HCW to undertaketheir work with confidence and the traffic lights werereported to improve escalation of care for all cadres ofHCW. The traffic lights also gave women a betterunderstanding of their health and the need for vitalsigns monitoring. This led to the perception that morewomen chose to attend primary health centres and easiercounselling of women who needed urgent treatment orreferral.Compatibility with existing values and practicesAcross the sites, HCWs reported that although morewomen attended health centres because of the device,this did not negatively impact on their workload as thedevice enabled complications to be identified and treatedpromptly. Rather than perceiving the immediate burdenof having more women to attend to, these HCWs werevaluing the longer-term gains of the device. This is animportant finding, which can be utilised when transmit-ting the value of the CRADLE device to other HCWs atscale-up.In South Africa, although the majority thought posi-tively, a small proportion of HCWs disliked the CRADLEdevice and questioned its accuracy. These HCWs workedin very busy units, measuring vital signs many times a day,having previously relied on sophisticated (but necessarilyvalidated or accurate) automated machines. Manualinflation with the CRADLE replacement was perceivedas a step backwards and resulted in resentment of theCRADLE device. Although the CRADLE device is moreaccurate than their existing devices, the HCWs associatedtheir sophisticated machines with better accuracy. Theirexisting workload and previous device experience influ-enced their opinions. This lack of awareness of deviceaccuracy can be described as a barrier to successful uptake[33]. Of note, they questioned CRADLE device accuracyspecifically in those requiring more manual inflation(obese and hypertensive women). BP measurement can bemore challenging in these women. These isolated negativeexperiences can impact on successful implementation andcan be difficult to overcome [33, 34].In South Africa, older age emerged as a barrier toadoption in this study, perhaps due to resistance tochange rather than fear of technological complexity. Theyounger respondents were more adaptable to the noveltechnology, whereas the older respondents were comfort-able with their existing devices and resistant to change intheir routines. Age has also been identified as a barrierto the uptake of technology in other studies [33, 35].Older users may need additional training and supportto improve adoption.Across the Mozambique, India and Nigeria sites andat two of the three South African sites, there was astrong researcher presence and support system. At theseNathan et al. Reproductive Health  (2018) 15:5 Page 9 of 11sites, research staff could assist and reassure HCWs usingthe new technology and educate on the importance ofaccurate devices. Successful implementation at the otherSouth African site may have been hindered by the limitedtechnical support. Similar barriers have been demon-strated in other studies evaluating the implementationof newly adopted health technologies [33].Implications for clinicians and policy-makersThis study has demonstrated the importance of trainingand support when implementing a new technology. Ithas also highlighted aspects of the CRADLE device thatrequire more focused education (accuracy, inflation,charging). Considering these findings, a simple trainingpackage that is transferable across settings and comple-ments the simplicity of the device is designed for scale-up.The perception of the user plays a crucial role in theinnovation process [34]. This study has shown that existingworkload and previous experience should be considered ascontext-dependent barriers and facilitators to implementa-tion at scale. The study suggests that in relatively busy andwell-resourced areas, such as South African tertiary cen-tres, fully-automated vital signs devices, that automaticallyand regularly repeat readings, may be more appropriate, ifaccuracy has been confirmed. The traffic light EWS, how-ever, remains a useful component even amongst trainedstaff. An automated version of the CRADLE device may bebetter suited in these settings.The CRADLE VSA was designed for use by communityHCWs to identify pregnant and postpartum women whorequire urgent intervention and referral. When consideringthe CRADLE device in the context of the three delaysmodel of emergency obstetric care, it was designed toaddress the second and third delays (identifying and reach-ing health facility and receiving adequate and appropriatetreatment) [8]. Reflecting this, HCWs reported that thedevice enabled identification of women needing interven-tion, who might have otherwise been missed and that thetraffic light EWS encouraged the decision for escalation ofcare. This device has the potential to strengthen task-sharing approaches and may improve the quality and safetyof care women receive. An unanticipated finding from ourstudy was that the CRADLE VSA could also address thefirst delay (deciding to seek care). Women were motivatedto attend because of the new technology. The visual trafficlight triggers gave the women a better understanding ofthe importance of screening and assisted in explaining themeaning of abnormalities and encouraged acceptance oflife-saving treatments and referral to higher-level facilities.A major influencer of poor antenatal care attendance isexperience of poor-quality care [30, 36]. The introductionof the CRADLE VSA to facilities may enhance perceptionsof high quality care and encourage better antenatal attend-ance, which would be of interest to policy-makers.ConclusionsThis study enabled better understanding of the facilitatorsand barriers to use of the CRADLE VSA. The CRADLEdevice was well accepted by healthcare workers from arange of countries and levels of facility, including thosewith no previous vital signs measurement experience. Thedevice motivated women to attend primary care andencouraged them to accept treatment and referral. Thesefindings could be used to guide scale-up.The device was designed to identify women who are atrisk of avoidable maternal morbidity and mortality andprompt escalation of care. Although this study demon-strated that the device is acceptable and of benefit toHCWs, it is not known whether this will be translated toreductions in maternal mortality and morbidity. TheCRADLE 3 Trial is underway across ten low-incomecountry sites to determine the impact that the CRADLEVSA and a simple training package implemented atcommunity, clinic and hospital level, has on maternalmortality and severe morbidity.AbbreviationsANMs: Auxiliary Nurse Midwives; APEs: Agente Communitarios de Saude;ASHAs: Accredited Social Health Activists; BP: Blood pressure;CHEWs: Community Health Extension Workers; CLIP: Community LevelIntervention for Pre-eclampsia; CRADLE: Community blood pressuremonitoring in Rural Africa & Asia: Detection of underLying pre-Eclampsia andshock); EWS: Early warning system; HCWs: Healthcare workers; VSA: VitalSigns AlertAcknowledgementsThe authors would like to thank all participants in the study. We alsoacknowledge the support of CISM, Mozambique; KLE University, JN MedicalCollege, SN Medical College, India; the Centre for Research in ReproductiveHealth, Sagamu, Nigeria; University of British Columbia (UBC). We thank theresearch office staff for assisting in data translation and transcription. Finally,a special thanks to all the focus group and interview participants.This work is part of the King’s College London CRADLE 2 study and theUniversity of British Columbia PRE-EMPT (Pre-eclampsia/Eclampsia, Monitoring,Prevention and Treatment) Initiative, both supported by the Bill & Melinda GatesFoundation.FundingThe study was funded by the Bill and & Melinda Gates Foundation (Grant ID:OPP1086183).Availability of data and materialsThe datasets used and/or analysed during the current study are availablefrom the corresponding author on reasonable request.Authors’ contributionsHLN drafted the manuscript and led data collection and analysis. HBsupported the analysis and interpretations of the quantitative data, providedoversight throughout project implementation and manuscript writing. DA,UC and ADG contributed to the conception and design of the study andcontributed to data collection. KM, MV and JS supervised HLN and HB,contributed to analysis, interpretation of the qualitative data and revised themanuscript. OA, MB, JA, DRH, WS, PvD, LCC, AHS provided critical manuscriptrevision and provided insight for interpretation. JS and AHS providedintellectual input to manuscript development. All authors read and approvedthe final manuscript.Ethics approval and consent to participateThe study received ethics approval from KLE University, Belgaum India(MDC/IECHSR/2011–12), the CISM Institutional Review Board, MozambiqueNathan et al. Reproductive Health  (2018) 15:5 Page 10 of 11(CIBS_CISM/08/2013), the Olabisi Onabanjo University Teaching Hospital,Sagamu Nigeria (OOUTH/DA/326/431), University of Stellenbosch, SouthAfrica (N14/06/068), University of Cape town, South Africa (401/2014),University of Free State, South Africa (230408–011), as well as by the UBCC&W Research Ethics Board in Canada (H12–00132). Written informedconsent was obtained from all participants prior to data collection.Consent for publicationNot applicable.Competing interestsThe authors declare they have no competing interests.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1Department of Women and Children’s Health, King’s College London,London, UK. 2Centro de Investigação em Saúde da Manhiça (CISM), Vila daManhiça, Moçambique. 3Universidade Eduardo Mondlane, Faculdade deMedicina, Av. Salvador Allende, 702 R/C, Maputo, Moçambique. 4Departmentof Sociology, University of Lagos, Lagos, Nigeria. 5Centre for ReproductiveHealth, Sagamu, Ogun State, Nigeria. 6KLE University’s Jawaharlal NehruMedical College, Belgaum, Karnataka, India. 7Maternity Centre, Groote SchuurHospital, University of Cape Town, Cape Town, South Africa. 8Department ofObstetrics and Gynaecology, Tygerberg Hospital, Stellenbosch University,Cape Town, South Africa. 9Department of Obstetrics and Gynaecology, andthe Child and Family Research Institute, University of British Columbia,Vancouver, Canada.Received: 29 August 2017 Accepted: 27 December 2017References1. Parati G, Mendis S, Abegunde D, Asmar R, Mieke S, Murray A, et al.Recommendations for blood pressure measuring devices for office/clinicuse in low resource settings. Blood Press. Monit. 2005;10(1):3–10.2. Say L, Chou D, Gemmill A, Tunçalp Ö, Moller A-B, Daniels J, et al. Globalcauses of maternal death: a WHO systematic analysis. 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