Health systems responsiveness is a key objective of any health system, yet it is the least studied of all objectives particularly in low-income and middle-income countries. Research on health systems responsiveness highlights its multiple elements, for example, dignity and confidentiality. Little is known, however, about underlying theories of health systems responsiveness, and the mechanisms through which responsiveness works. This realist synthesis contributes to bridging these two knowledge gaps.In this realist synthesis, we will use a four-step process, comprising: mapping of theoretical bases, formulation of programme theories, theory refinement and testing of programme theories using literature and empirical data from Ghana and Vietnam. We will include theoretical and conceptual pieces, reviews, empirical studies and grey literature, alongside the primary data. We will explore responsiveness as entailing external and internal interactions within health systems. The search strategy will be purposive and iterative, with continuous screening and refinement of theories. Data extraction will be combined with quality appraisal, using appropriate tools. Each fragment of evidence will be appraised as it is being extracted, for its relevance to the emerging programme theories and methodological rigour. The extracted data pertaining to contexts, mechanisms and outcomes will be synthesised to identify patterns and contradictions. Results will be reported using narrative explanations, following established guidance on realist syntheses.Ethics approvals for the wider RESPONSE  study, of which this review is one part, were obtained from the ethics committees of the following institutions: London School of Hygiene and Tropical Medicine (ref: 22981), University of Leeds, School of Medicine (ref: MREC19-051), Ghana Health Service (ref: GHS-ERC 012/03/20) and Hanoi University of Public Health (ref: 020-149/DD-YTCC).We will disseminate results through academic papers, conference presentations and stakeholder workshops in Ghana and Vietnam.https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020200353.CRD42020200353. Full record:  The review will identify, and bridge, the knowledge gaps in the peer-reviewed and grey literature on (a) theoretical underpinnings of health systems responsiveness and (b) the mechanisms through which responsiveness works within the contexts of low-income and middle-income countries.The iterative nature of searches, screening, data extraction and quality assessments is a key strength of our approach, which allows deep engagements with the literature across multiple disciplines and settings.However, a potentially large scope of literature on various elements of health systems responsiveness would require careful management of the research team workload, through prioritisation of programme theories in the searches and the analysis.The composition of a large multicountry team will enable drawing on different context-specific understandings of health systems responsiveness.However, the large cross-country review team will require careful coordination, to ensure representation of different perspectives in the analysis and shared intellectual leadership and conclusions.when institutions… are cognisant and respond appropriately to the universally legitimate expectations of individuals… safeguarding of rights of patients to adequate… care”.3 9Health systems responsiveness is a key goal of any national health system and is “…context-sensitive vary across actors health facilities .12 20 21When considering all health systems goals ,Little is known, however, about: (a) theoretical underpinnings of the current interpretation of health systems responsiveness and (b) underlying mechanisms through which health systems responsiveness works for different actors  and under which conditions. This realist synthesis (RS) will contribute to bridging these knowledge gaps through advancing theorisation of health system responsiveness and providing an in-depth understanding of key mechanisms of how responsiveness works for different health systems actors. We hope that the results of this review will ultimately inform improvements to health systems responsiveness in Ghana, Vietnam and other LMICs.This RS is being undertaken as part of the wider RESPONSE study, which is a mixed-methods realist evaluation of health systems responsiveness in Ghana and Vietnam. RESPONSE seeks to contribute to improving health systems responsiveness in LMICs through case studies of addressing neglected health needs of vulnerable groups in Ghana and Vietnam. As described in the RESPONSE protocol available elsewhere,This RS will deepen the understanding of theoretical foundations of health systems responsiveness and the mechanisms through which health systems responsiveness works (or not) for different health systems actors in different contexts. Through developing, testing and validating programme theories, we will identify and explain which contexts trigger specific mechanisms through which health systems responsiveness can produce the intended or unintended outcomes. In the process, we will also highlight any gaps in the existing literature following our review. This RS will answer the following questions:Which substantive theories underpin the understanding of health systems responsiveness in the literature, and how do they inform these interpretations?In what way does health systems responsiveness work for different health systems actors  in the contexts of LMIC?The main result from this review will be detailed narrative explanationsThis RS uses a realist approach, which helps understand complex programmes by identifying how the multiple components interact in nonlinear ways.“…not a method or formula, but a logic of enquiry that is inherently pluralist and flexible, embracing both qualitative and quantitative, formative and summative, prospective and retrospective…”p32. Furthermore, RSs are more inclusive of the types of studies that can be included32RS, which applies realist logic to a systematic review methodology, provides in-depth understanding of complex phenomena through articulating theories shaped as CMO configurations that explain why, when and for whom the programmes or interventions work.Conceptually, RS involves broad phases that mirror the realist evaluation process: formulating questions, developing initial theories, testing and refining theories,Another key distinctive feature of the RS approach is that further to engagements with the literature, researchers also engage with key stakeholders, for example, in formulating initial theories and developing policy recommendations.33et al,In this RS, we are guided by the RAMESES publications standards for realist syntheses10.1136/bmjopen-2020-046992.supp1Supplementary dataStep 1 will involve mapping of theoretical underpinnings of health systems responsiveness in LMIC,step 2, we will formulate initial theories of how health systems responsiveness works. We will draw on theorisation of responsiveness from the previous step, team discussions and initial consultations with key health systems actorsDuring step 3, we will refine programme theories through continuing the purposeful screening of the literature alongside iterative engagements with key actorsIn step 4 will entail testing of programme theories. This will be done through using insights into empirical evaluations of implemented interventions in Ghana and Vietnam and through analysing empirical literature.et al where interview data were integrated with evidence from the literature in testing programme theories.Finally, In line with established principles on eligibility of evidence for RSs,However, we will exclude: (a) empirical  studies published before 2000, that is, the year when the WHO introduced health systems responsiveness as an explicit health systems objective, (b) studies with no full texts available for subsequent analysis and (c) studies in languages where we are unable to source translation. The review is being conducted by a team comprising speakers of English, Spanish, French, Russian and Vietnamese. While initial screening will be conducted in either of these languages, analysis will be conducted in English and we will aim to either obtain an English copy or arrange for a translation where possible.Next, we summarise eligibility following a participants–interventions–comparison/control–outcomes approach.Health system responsiveness affects a range of different populations such as communities, individuals, service providers, facility managers, regional or provincial and national-level policymakers.Our overall ‘intervention’ for improved health system responsiveness will be two types of interactions, which underpin the RESPONSE’s theoretical framework12Health system responsiveness is a complex intervention; therefore, the control is not applicable to this review. However, we will compare the CMO configurations across the different LMIC settings where it is feasible.Our overarching outcome is improved health systems responsiveness, reflected in improved interactions, which follow the socially constructed conceptualisation of responsiveness within RESPONSE.12 20–22Instead of separately considering each of seven elements of health systems responsiveness from the WHO frameworkSearching for theoretical and empirical evidence for realist reviews is highly iterative. Multiple searches will be conducted using a variety of appropriate search techniques.Conceptually, RS involves four different types of searches at different stages of the review: a background search to get a feel of the literature, progressive searches to identify programme theories, an evidence search for evaluation studies to test chosen theories and a final search once the review is almost complete to refine theories.In answering the first review question (underlying theories of responsiveness), our searches will not be limited to any geographic area, whereas in answering the second review questions (how responsiveness works) will focus on the literature from LMICs. We will search combinations of:Published literature from eight scientific databases: Applied Social Science Index Abstracts, CINAHL, Global Health, Maternity and Infant Care Database, Medline, PsycINFO, Scopus, Web of Science.Grey literature from main gateways  and relevant organisations .Health systems policy and regulatory documentation from Ghana and Vietnam.At step 1, we will search Medline (1946+) and Google Scholar for reports containing substantive theories and frameworks. MeSHs , free-text words and synonyms will be used for the following search concepts  for initial screening as appropriate. Qualitative data analysis software NVIVO (version 10) will be used for organising and managing data, cross-referencing concepts, actors and populations. Data extraction will be done with Microsoft Word or Excel.Search results will be managed using EndNote V.X9 software. Records will be uploaded into Rayyan software .Type of paper .Social science theory introduced and/or used.Elements of health systems responsiveness addressed.1 12Links to selected programme theory(ies) showing causality in CMO configurations, through identifying evidence on which key contexts trigger specific mechanisms to produce intended or unintended outcomes.In step 1 of our RS, we will specifically focus on understanding theorisation of responsiveness and will use and potentially expand headings a–c. In steps 2–4, we will add headings d–e as applicable to stages of theory development, refinement and testing.The primary data collection in step 4 will involve tailored topic guides for interviews and focus groups, which will be structured around the selected programme theories. Transcripts from the interviews and focus groups will be coded by the CMO configurations (or their fragments) to help refine, discard or consolidate the causality within selected programme theories during the analysis.Quality assessment, data extraction and collation of stakeholder opinions are typically combined in RS,relevance to programme theories of health systems responsiveness, specifically ability to provide insights into contexts, mechanisms and outcomes and rigour, commensurate to respective study types.23 32All studies will be considered for their Quality appraisal in RS is usually done on case-by-case basis and we will adapt and use appropriate tools  or CASP  quality appraisal toolsWe will undertake a retroductive approach to analysis meaning, combining both inductive and deductive reasoning logics together.37Analysis of subgroups in RS normally emerges as part of the theory elicitation process.23Analysis of theorisation of health systems responsiveness in step 1 will not be restricted to any geographical, health condition or population subsets. As the review develops, from step two onwards we will add focus on empirical literature from the LMICs. We are particularly interested in maternal mental health as a possible condition subset, and key health systems actors  as a population subset. However, the subgroup analysis will be fully driven by the theory elicitation.We will relate the results of our analyses within these subsets to the health systems responsiveness as a whole, reflected in internal and external interactions within health systems. Extracted data pertaining to contexts, mechanisms and outcomes will be synthesised to identify patterns and contradictions in the relationships between contexts, mechanisms and outcomes. These relationships will be documented and will inform initial theories from step 2, to be subsequently refined and tested during steps 3 and 4, respectively. Data synthesis will also lead us to identify social science theories that may further explain our programme theories. At this stage, middle-range theories will be identified and extracted.Our synthesis will be specifically concerned with understanding the conditions under which health systems responsiveness works (or not) for different health systems actors. Data synthesis in RS takes several forms, essentially entailing a form of ‘triangulation’, bringing together information from different studies to explain why a pattern of outcomes may occur.We will specifically synthesise data along our conceptualisations of health systems responsiveness . However, patients and members of the public will be involved in steps 2–4 as part of the wider stakeholder engagement. In step 2, their involvement would be as sources of local knowledge in identifying priority areas for responsiveness during initial consultations. In step 3, their involvement would comprise more active participation in the iterative engagements during intervention coproduction. In step 4, patient and public involvement would be evaluative of the effects of interventions.Ethics approvals for the wider RESPONSE study, which also cover the primary data collection for the RS, were obtained from the London School of Hygiene and Tropical Medicine (ref: 22981), the University of Leeds School of Medicine (ref: MREC19-051), Ghana Health Service (ref GHS-ERC 012/03/20) and Hanoi University of Public Health (ref 020-149/DD-YTCC).We will disseminate results through academic papers and stakeholder workshops in Ghana and Vietnam. The findings will also be presented at national and international scientific conferences, such as the biannual Global Symposia on Health Systems Research.


Premenstrual syndrome (PMS) is a cyclically occurring combination of various symptoms, leading to decreased life quality among approximately 30% of women of childbearing age. PMS etiology remains unknown; however, there are some suggestions that inappropriate inflammatory response and oxidative stress are involved. This study aimed to systematically review case–control and cross-sectional studies investigating inflammation markers, oxidative stress, and antioxidant status among women with PMS and controls. The study protocol was registered with PROSPERO (no. CRD42020178545), and the authors followed the guidelines for performing a systemic review recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). By searching PubMed and Scopus databases (up to 8 January 2021), six case–control studies and five cross-sectional studies of medium or high quality were classified to the review. The systematic review included 652 women with PMS and 678 controls, for whom 36 eligible markers were determined. Limited evidence indicates increased levels of inflammatory parameters and suggests decreased antioxidant status in PMS women. Insufficient data with inconsistent results made it impossible to formulate a firm conclusion on the contribution of oxidative stress in PMS occurrence. To acknowledge the role of inflammation, oxidative stress, and antioxidant status in the pathophysiology of PMS, further research with case–control design and large study groups is needed. Premenstrual syndrome (PMS) is a combination of emotional and physical symptoms that occur cyclically in the luteal phase of the menstrual cycle and significantly influence the quality of life . It is aThere are speculations that women with PMS are more sensitive to fluctuations in sex hormone levels during the menstrual cycle ; howeverAnother potential mechanism currently under investigation is an inappropriate inflammatory response to various stimulants  and the occurrence of oxidative stress defined as an imbalance between the production of reactive oxygen species (ROS) and their inactivation by antioxidant protection mechanisms . Both inThe protocol for this review has been registered in the International Prospective Register of Systematic Reviews (CRD42020178545).An initial systematic review of the literature was conducted in May 2020 with PubMed and Scopus, with an update in January 2021. Databases were searched separately by two authors  to identify studies on inflammation, oxidative stress markers, and antioxidants levels in women with PMS and control groups. The systematic review had included studies published up to 8 January 2021. For searching the following key terms and the conjunctive normal form were used:  OR (PMS)) AND ((inflammation) OR (DNA damage) OR (oxidative stress) OR (antioxidant capacity) OR (antioxidant status) OR (lipid peroxidation) OR  OR (glutathione peroxidase) OR (glutathione reductase) OR (8-isoprostane) OR (nitric oxide) OR (8-hydroxyguanosine) OR (superoxide dismutase) OR  OR (hs-CRP) OR (nitrotyrosine) OR (protein carbonyls) OR (deoxyguanosine) OR (interleukin-6) OR  OR (protein carbonyl content) OR (advanced glycation end products) OR (advanced oxidation protein products)). We also performed a manual search of the retrieved articles’ references to identify other potentially eligible studies.Inclusion criteria were as follows: (1) studies where women with PMS and healthy controls were compared for markers of inflammation or/and oxidative stress or/and antioxidants; (2) studies with the use of a well-described scale or specific criteria to diagnose PMS; (3) studies involving nonpregnant, currently menstruating women in a general good health condition; (4) studies of case–control or cross-sectional design; (5) studies in English. Studies were excluded if: (1) there was no control group; (2) there was no description of the scale or criteria used to diagnose PMS; (3) no inflammation or oxidative stress or antioxidant markers were examined; (4) the language of the study was other than English. Two authors  applied these criteria, and any disagreements were discussed and resolved by a consensus or consultation with the senior author (J.K.). We decided not to include as one of the inclusion criteria a strict PMS diagnosis established by the Daily Symptom Rating due to the International Society for Premenstrual Disorders position, according to which it is necessary only for clinical trials and intervention studies . Insteadp-value between cases and controls.All identified studies were reviewed independently by two authors , and results were entered into data tables designed before data extraction. The following data were extracted from the studies: authors’ names, study design, year of the publication, study location, number of cases and controls, diagnostic criteria for PMS, mean ± standard deviation (SD) or range of age for cases and controls, participants characteristics , biomarkers of interests, and information whether the results were adjusted for potential confounders. Moreover, we extracted data concerning the main results of the studies included in the review: mean ± SD or median and range of biological parameters for cases and controls, units, type of biological sample, The quality of the studies was assessed independently by two authors  according to a modification of the Newcastle–Ottawa Quality Assessment Scale (NOS) separately for case–control  and for We used a modified version of NOS in order to include the specificity of the subject of the review; for example, for case–control studies we decided to award points not only for the validated tool  to assess PMS, but also for a well-described one, due to the reasons mentioned previously. Due to the fact that the potentially important factors contributing to PMS are not definitely defined, we assigned a point for including any of them (such as body mass index or age of menarche) in the adjustment of the study results. The NOS is recommended by the Cochrane Collaboration for use in nonrandomized studies, as a validated, quick and adaptable tool for quality assessment. However, it should be underlined that it is not validated for cross-sectional studies and some researchers indicate problems with its poor agreement in point awarding. The NOS evaluates three parameters  divided across eight (for case–control studies) or seven  specific items ,17. DetaSix hundred and eighty-four papers were identified in the initial databases search (509 for PubMed and 175 for Scopus) and two additional records were identified through the manual search of the reference lists of the eligible articles. The selection of papers for this review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart—Based on inclusion and exclusion criteria, 11 studies were selected and included in the systematic review: six with case–control and five with cross-sectional design. The characteristics of the studies included in this review are summarized in The methodological quality assessment of the studies included in the review indicated that nearly 64% of the articles were of high quality ,25,26,27Among 11 studies included in the systematic review, four , Among studies included in the systematic review, total oxidative stress indicators, lipid peroxidation, protein oxidation products, and other oxidative stress parameters related to PMS were examined . Total oFrom the other oxidative stress markers, only four parameters were determined in the studies included in this review ,19,22. AFour studies included in the review examined total antioxidant capacity (TAC) in blood in PMS cases and controls ,20,22,23Five studies comparing specific blood levels of vitamins and minerals in PMS cases and healthy controls were analyzed ,25,26,28We did not identify studies that included a variety of antioxidant enzyme markers, which met the review eligible criteria. Only in one paper superoxide dismutase (SOD) activity was measured and results for both groups were similar .To the best of our knowledge, this is the first systematic review to clarify potential associations of inflammation, oxidative stress, and antioxidants status with PMS. Limited evidence suggests that women with PMS may have higher levels of some inflammatory parameters and lower antioxidants status. Evidence regarding oxidative stress is insufficient to formulate a clear statement at this time.In the studies included in this systematic review, levels of some mediators considered typical for chronic inflammation such as hsCRP ,27, TNF-Only a few studies regarding oxidative stress in PMS are available; wherein in this review, four studies were included with inconsistent results ,19,22,23Regarding vitamins involved in anti-inflammatory and antioxidant actions, vitamin D was assessed in two independent studies, where lower levels in PMS cases were found ,28. VitaZinc status was determined in three studies ,26,28 inIn summary, it can be suggested that a reduced antioxidant capacity in PMS cases may be probable; however, the role of increased oxidative stress remains uncertain. Due to the cross-sectional or case–control design of the included studies, it cannot be judged whether the potential imbalance of oxidant–antioxidant status is the reason for occurring symptoms or a consequence. With a limited number of studies and small sample sizes, it is impossible to verify the hypothesis that oxidant–antioxidant balance plays a significant role in PMS occurrence.Despite extensive research, PMS’s etiology remains unknown ,8. It isProgestins and estrogens have anti-inflammatory actions as well as they may act as potential antioxidants . HoweverTo the best of our knowledge, this is the first systematic review to clarify potential associations of inflammation, oxidative stress, and antioxidants status with PMS. This review’s strength is primarily strict compliance with instruction for performing a systemic review recommended by PRISMA . Two indThis paper also has several limitations. Although the quality assessment of the studies included in the review showed that nearly 64% of them were of high quality and none were considered low quality, the sample sizes in particular studies were relatively small, leading to difficulties in reaching statistically significant differences. There was also a high heterogeneity in the study designs, and the diagnosis of PMS was not always made with a validated method. Moreover, adjustment for potential confounders was made only in one study , althougDue to the fact that PMS is a common problem of unspecified etiology that can significantly lower the quality of women’s lives, it is important to point out and research possible mechanisms that may lead to symptoms. Therefore, it is necessary to establish the role of inflammation, oxidative stress and antioxidants in the pathogenesis of PMS. There is a need to conduct more homogeneous research with a strict diagnosis of PMS made using a validated method, strict inclusion and exclusion criteria, including supplement intake, and adjust results for possible confounders. Moreover, it is relevant to arrange a psychiatrist consultation for the potential study participants to rule out undiagnosed illnesses, which may have symptoms similar to those typical in PMS. It is crucial to investigate the meaning of inflammation, oxidative stress, and antioxidant status in PMS development because of the potential clinical implications for treatment and prevention by raising awareness among women about factors that may potentially reduce PMS. To these factors, among others we include a healthy diet, reducing overweight and obesity when occurring, avoiding a sedentary lifestyle, and quitting smoking.Limited evidence indicates that women with PMS may have higher levels of some inflammatory parameters and suggests lower antioxidants status. Data on the contribution of oxidative stress in women with PMS are insufficient to formulate conclusions. Obtained results are of great importance for public health due to the common prevalence of premenstrual syndrome and its negative impact on life quality. Based on the present findings, and with all the limitations described above, well-designed research should be considered in the future to develop firm conclusions on the associations between inflammation, oxidative stress, and antioxidant status versus PMS.


Population-based cohort studies can be a resource for tumor specimens, annotated with demographic, lifestyle, and health history data, that support innovative studies of cancer. Our aim was to establish and test a process for accessing tumor samples, held at pathology laboratories around British Columbia (BC), for participants of the BC Generations Project (BCGP). Through the BC Cancer Registry, we identified pathology reports for 1100 (93%) of the 1180 incident solid cancer cases diagnosed in BCGP as of 2019. Using manually abstracted data from the reports, we successfully retrieved 183 (92%) of the 200 formalin-fixed, paraffin-embedded (FFPE) blocks  that we requested from pathology laboratories. No important differences in retrieval rates by cancer site, sample location (Greater Vancouver vs. Outside Greater Vancouver), sample type (biopsy vs. excision) or year of diagnosis were identified. A text mining solution recently implemented by the Registry will allow us to automate the process for data abstraction and should capture pathology reports for 100% of all newly diagnosed BCGP cancer cases moving forward. This will further enhance the utility of BCGP as a high-quality tumor tissue research resource. Cancers of the same anatomical site can be heterogeneous diseases with distinct molecular characteristics that predict prognosis and response to treatment. There is growing recognition that such cancers may also have distinct risk factors . For exaResearchers are increasingly interested in accessing tumor samples to identify distinct molecular subtypes and evaluate subtype-specific disease etiology. To support epidemiologic studies, these samples will need to come from well-characterized, prospectively followed study populations with detailed data on a variety of demographic, lifestyle, and environmental factors. These data are also increasingly important for clinical studies as they can be useful predictors of prognosis and treatment response ,5.Various large-scale cohort studies from around the world have established tumor tissue repositories to support innovative research ,7,8,9. CThe BCGP, one of CanPath’s contributing regional cohorts , includeThe BC Cancer Registry is a population-based registry that receives pathology reports from hospital and regional pathology services to ascertain primary cancer diagnoses. Annually, BCGP participants are linked to the BC Cancer Registry to identify incident cancers. The Registry does not record the data needed for the identification and retrieval of tumor specimens from the pathology reports. Instead, working with analysts in the BC Cancer Surveillance & Outcomes, Data and Analytics Group and the Provincial Health Services Authority (PHSA) Information Management/Information Technology Services (IMITS), we linked the first name, last name, date of birth, sex, and personal health number (PHN) of each incident BCGP solid cancer case to all pathology reports stored for that case within the Cancer Agency Information System (CAIS). Through this linkage, we obtained ~5000 documents, each one representing a pathology report or an addendum to a previous pathology report.Pathology reports linked with each BCGP cancer case were manually reviewed to identify those reports relevant to the cancer of interest by comparing cancer site and date of pathology review in the report to the cancer site and date of diagnosis provided through linkage with the Registry. We restricted review to solid cancers. Microsoft Access was used to create a database to house information abstracted from each of the pathology reports. For each case-specific report, the following information was entered into the database: (1) name and address of the pathology laboratory; (2) accession number; (3) report date; (4) sample type ; (5) total number of FFPE blocks created; and (6) block IDs containing the tumor specimen.From among the successfully abstracted pathology reports with an identifiable sample location (within the Province of British Columbia) and sample type information, we randomly selected a total of 200 breast, lung, bladder, and pancreatic cancer cases for which to attempt the retrieval of samples from pathology laboratories. We selected these cancer sites as they capture a representative range of cancer characteristics  with which to evaluate the effectiveness of our access process. Among those cases for whom both biopsy and resection samples were identified, the sample source was randomly selected.Access to tumor samples was granted at the health authority level, including those within Greater Vancouver  and those outside Greater Vancouver . Though specific cost structures and procedures for accessing tumor samples did vary across the health authorities, in general, the access process required submission of a study protocol, Research Ethics Board certificate, list of accession numbers with block IDs and application forms specific to each health authority to a research coordinator. If the pathology report specified the FFPE blocks containing tumor tissue, we requested those blocks. If blocks containing the tumor were not specified, we requested all available blocks. Applications were typically reviewed by pathology laboratory personnel. Once the applications were approved, blocks were shipped directly to Dr. Eric Belanger, pathologist and study co-investigator, at Vancouver General Hospital for visual inspection. All samples were returned to the pathology laboratories within six months.Any solid cancer sites with less than 20 cases diagnosed in BCGP were grouped together as “Other”. This included cancers of the brain, liver, stomach, esophagus, cervix, larynx, and testes. We evaluated, by cancer site, the number and proportion of cases for which a pathology report was successfully identified. Because knowledge of the location is critical to sample retrieval, any pathology reports from which sample location could not be identified were considered missing. Among those cases for which pathology reports with sample location information was identified, we evaluated, stratified by cancer site, the number and proportion of cases by sample location , sample type , and year of cancer diagnosis (2009–2014 or 2015–2019). For sample location, “Both” captured those cases with multiple biopsy samples, multiple excision samples or both biopsy and excision samples, with at least one sample located in Greater Vancouver and at least one sample located outside of Greater Vancouver.For the 200 cases that we requested samples, we examined, stratified by cancer site, the number and proportion of samples returned by sample location, sample type and diagnosis year. We also calculated an overall success rate for tumor sample acquisition by multiplying the proportion of pathology reports identified for breast, lung, bladder, and pancreas cancers by the proportion of samples for all these tumors that were successfully received.n = 384) and prostate (n = 210). A pathology report with sample location information was successfully identified for 1100 (93%) of these solid cancers. Pathology reports could not be identified for 75 cases, and an additional five cases had pathology reports with missing sample location information. The proportion of reports successfully identified did vary by cancer site. At least 85% of reports were identified across each of the individual cancer sites except for pancreatic cancer, for which only 65% of reports were identified , the blocks containing the tumor specimen were not specified, so all available blocks (up to 87) were requested. Requests to the seven different health authorities were all submitted by January 2021. Approvals were successfully obtained from all sites by February, and, by March 2021, samples had been received from all but one of the health authorities. Due to staffing shortages, samples from the remaining health authority were not received until September 2021.We received 183 (92%) of the requested samples. The remaining 17 samples were out for other studies or could not be located by the pathology laboratory. There was some variation in retrieval rates by cancer site; only 82% of requested pancreas tumor samples were retrieved, whereas 96% of lung tumor samples were retrieved. This exercise demonstrates the tremendous potential for BCGP to serve as a population-based resource for highly annotated tumor tissue samples. Of the 1180 incident solid cancers diagnosed within BCGP, we were only unable to identify pathology reports for 75 cases. This was attributed to a system malfunction that resulted in a loss of data within CAIS. However, it remains unclear as to why such an occurrence had a greater impact on pancreatic cancer pathology reports than the other cancer sites.Regional differences in the numbers of identified reports were observed and likely reflected a combination of the population distribution of the BCGP, with most participants residing in the Greater Vancouver area , and regNinety-two percent of requested samples were successfully retrieved. Twenty-six percent of the reports associated with these samples did not indicate which block specifically contained tumor tissue. For tumor samples associated with such reports to be useful for future research, an extra step will be required, where slides associated with the tumor blocks are first reviewed by a pathologist to identify the most relevant blocks. The 17 samples that we did not receive were primarily excision samples, and this is reflected in the lower retrieval rates seen for excision versus biopsy samples across the four cancer sites. The regional difference in the success of retrieval for bladder cancer is because the missing bladder tumor excision samples were mostly from the Greater Vancouver area.Our overall tumor sample acquisition rate 87%) is higher than that reported by previous studies. For example, the Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial only reported a sample retrieval success rate of 47% [% is highThe Province of BC has moved away from paper-based pathology reports to an electronic health record format called CareConnect. The BC Cancer Registry recently deployed the Electronic Mapping, Reporting, and Coding (eMaRC) system  to captuOur evaluation of pathology report availability captured a comprehensive range of cancer sites, and our evaluation of tumor retrieval rates included four cancer sites that are broadly representative of incidence rates and tumor sizes of other solid cancers. Given the small number of cases for many of the cancer sites, we could not conduct detailed, site-specific evaluations of variation in report availability and tumor retrieval rates by sample location, sample type and diagnosis year.Pending further development of the eMaRC automated data extraction platform, we believe that BCGP can serve as a high-quality resource for well-annotated tumor samples across a broad range of cancer sites. Cohort studies in other jurisdictions across Canada should explore the potential to establish similar resources.


P ≤ 0.05). The sampled wood tree species had the highest energy potential were Celtis durandii , Parkinsonia aculeata , Delonix regia , and Bligihia unijugata . Access to wood fuel by the households was mainly constrained by limited household income levels, long distances trekked, and inadequate awareness about wood fuel sources and availability. To conserve wood fuel, the refugees deploy several measures including the use of mobile solar gadgets for cooking and lighting, taking up agroforestry, use of briquettes, adoption of energy-saving cooking stoves, and establishment of new woodlots. Therefore, to reverse this trend, the Ugandan government and development partners should prioritise energy investments by supporting cheaper energy alternatives such as mobile solar gadgets and energy-saving cooking technologies, and establishment of woodlots.For the last three decades, Uganda has lost considerable natural vegetation cover in the refugee settlements and buffer zones due to the high demand for wood fuel and timber. It is worthy to note that the supplies of wood fuel are more likely to dwindle in the near future. This study explored the determinants of harvested wood-fuel choices and their energy potential. It also examined the implemented energy conservation measures and constraints faced by the refugees both in Palorinya and Imvepi refugee settlements in Northern Uganda. The data were collected by conducting household interviews and collection of wood species samples for energy potential laboratory analysis. Findings indicate that the major sources of wood fuel were firewood, charcoal, briquettes, and biomass fuels. The major refugee choices that determined wood-fuel collection included the family size of the house hold, culture, method of cooking, type of food cooked, high poverty levels, and availability of family labour ( Uganda is one of the countries in Africa, which hosts the highest number of refugees mainly from South Sudan, Democratic Republic of Congo, Rwanda, Burundi, Sudan, and Ethiopia among others who are settled in gazetted refugee settlements . Over 1.There are currently eleven refugee settlements in Uganda, spread across the country to accommodate refugees coming from different directions. These are managed by camp commanders and staff from the United Nations High Commissioner of Refugees. However, in this study, only two refugee settlements of Imvepi and Palorinya were selected and investigated because of their degazettement status, nationality of refugees from South Sudan, and proximity to forest reserves and wetlands. The establishment of these refugee settlements has come at a cost to the Ugandan government leading to increased outbreak of human diseases from appalling sanitation and nutritional challenges , 9 and vThe continued influx of refugees in Uganda has made it difficult to reduce overharvesting of firewood and charcoal because most of the solutions to wood fuel crisis are implemented at a local or pilot scale but not at settlement or regional levels. This study also recognises that many studies that have investigated refugees and wood fuel have paid more attention to the technologies involved in the use of wood fuel , 15, accThe study is conceptualised  around tThe study refugee settlements were Palorinya (37.58 sqkm) and Imvepi (52.937 sqkm) located in Northern Uganda . PalorinThe climate of the study area is tropical. Rainfall in the region follows a bimodal distribution pattern with lighter rains received between April and June and the second rains in August and October. The mean annual precipitation is 1,250 mm, whereas the average temperature ranges on the other hand between 20°C and 30°C . The maiThis study was field based, conducted using both qualitative and quantitative methods in 2019. The sampled population involved refugees and key informants from two refugee settlements . This study sampled 398 refugee households with a representation of 199 households from each. The sample size was determined following  samplingIn each refugee settlement, a stratified random sampling method was used following the zonal camp refugee registration lists. Selection of refugee households was based on the daily use of wood fuel for cooking and residence time in the refugee settlement of at least a year. Data from the interviews were categorised according to household family size, i.e., very small (1–3), small (3–5), medium (6–8), large (9–12), and very large (12–15), to examine if these influenced the determinants of wood fuel collection and use. In addition, two focus group discussions consisting of 15 members  were conducted in each settlement. Also, the key informants included settlement leaders, Officials of the office of the Prime Minister, United Nations High Commissioner for Refugees officials, District Natural Resources Officials (DNROs) from Obongi and Arua Districts, and members of the refugee-working group.The significant determinants of wood fuel choices among the different household family size categories were tested using the binomial statistical test (BST), a nonparametric statistical test that compares responses to a variable with binary outcomes. The BST procedure compares the observed frequencies of the two categories of a dichotomous variable to the frequencies that are expected under a binomial distribution with a specified probability parameter .Tree wood species samples were collected from each interviewed household. The woody biomass samples from the harvested tree species were collected, stored in cool and aerated containers, and transported to the laboratory for energy potential analysis. The species were classified according to weight, burning quality, moisture content, and size. Wood species weights were determined using mobile weighing scales, while burning quality and moisture content were determined in the laboratory. Samples were analyzed for dry matter using a vacuum oven at temperatures of 103°C, overnight until a constant weight was attained, while the energy values of woody species were determined using an oxygen bomb calorimeter.This study covered refugees from South Sudan hosted in Palorinya (Obongi District) and Imvepi (Arua District) refugee settlements located in Northern Uganda. The refugees revealed that they used relatively more firewood (84%) and charcoal (13%) followed by the use of briquettes (2%) and other biomass fuels (1%) such as agricultural residues, husks, and grasses for cooking. In the focus group discussions, the refugees reported having at least 2 meals per day and the wood fuel collection and production were largely carried out by children  and women. The main sources of firewood included natural and artificial forests, bushes, and thickets. The respondents explained during the focus group discussions that this, however, does not come free as they must give part of their food ratios that include maize, beans, or cooking oil in exchange for firewood from the host community.Firewood was mainly collected from the bushes, while charcoal was largely purchased from the host communities because the refugees are prohibited from burning charcoal within the settlements. However, the key informants reported that the nationals in the host communities have allowed the refugees to cut down trees in their land, from which charcoal is made but later share it in agreed proportions. The collections were largely made in the morning and evening times from either within the refugee settlements (30%) or the host community (70%). The majority of the refugees made at least 1–3 trips per week, while the rest made 5–7 trips, and the harvested firewood was largely transported on the heads and stored in kitchens, house verandas, and courtyards, while charcoal was kept indoors. The most frequently utilised technologies to cook are the three-stone fire (68%), clay charcoal stoves (27%), and rocket Lorena stoves (5%).The refugee families were composed of household heads, children, and relatives. Of the 389 participants, the majority of those interviewed were female household heads (71%). The interviewed respondents were largely married (75%), single (13%), widowed (6%), divorced (4%), and separated (2%) . The aveP < 0.05) (P < 0.05). This was followed by the methods used for cooking, high poverty rates, and the type of food cooked. Surprisingly, the household size categories that did not impact on the collection and use of firewood were the small (3–5) and very large (12–15) (P < 0.05). In the use of charcoal, the household categories of very small (1–3) and medium (6–8) opted more for charcoal followed by the small (3–5) category. In these categories, the determinants that did not significantly influence the uptake of charcoal were the availability of labour, type of food cooked, and culture (P > 0.05). However, the large (9–12) and very large (12–15) household size categories did not have any significant contribution on the use of charcoal by the refugees. One of the key informants revealed that intensive firewood collection, charcoal burning, and uncontrolled brick-laying activities were the leading causes of tree depletions.The refuge household sizes had a significant contribution on the demand for wood fuel. Depending on the membership of each household, families were categorised as very small (1–3), small (3–5), medium (6–8), large (9–12), and very large (12–15) because these influenced the amount of food cooked and frequency. The household size categories that had a significant contribution to the collection and use of firewood were the large (9–12), medium (6–8), and very small (1–3) ( < 0.05) . Other sAlangium chinense, Acanthus arborea, Funtumia africana, and Cola gigantea. In terms of calorific potential, this study shows that the higher the percentage of firewood dry matter, the lower the calorific values, and vice versa. As per the wood density of collected firewood, the wood species with the highest calorific values were Celtis durandii , Parkinsonia aculeata , Delonix regia , and Bligihia unijugata . These wood species were common among the household size categories of large (9–12), medium (6–8), and very small (1–3) members.Despite the categories of refugee household sizes, the collected head weights of firewood were made of various wood species with differing calorific potential . From thIn the collection and use of firewood, the studied household size categories were mostly affected by low household income and long distances travelled in search of the wood . This waThis result presents the wood fuel  conservation measures implemented by the stakeholders in the refugee settlements . The meaFirewood is the main energy source for cooking and heating among the South Sudanese refugees settling in Northern Uganda . For sucCeltis durandii, Parkinsonia aculeata, Delonix regia, and Bligihia unijugata. High calorific values are an indication of more lignin properties compared with cellulose because the former has a lower degree of oxidation that raises the heating value and thus higher calorific values [The wood species with the highest calorific values were c values . Overallc values . A similc values . The trec values . Some trc values , which mHousehold income and distances travelled in search for wood affected wood fuel use, among the household size categories studied. These findings are related to observations from studies elsewhere , 38–41. The main energy conservation measures adopted included agroforestry, use of mobile solar gadgets, use of energy-saving cook stoves, use of briquettes, and establishment of new woodlots. These are employed by individuals, refuge community, government, and NGOs. The study findings reveal low adoption of modern energy conservation measures, owing to the high poverty levels in refugee situations vis-à-vis high-cost requirements for modern energy conservation technologies, which resonance with findings by previous studies , 21, 29.The study also notes that NGOs are the main stakeholders promoting energy conservation, followed by the government, while the community and individuals are meagrely involved. This is because refugees are mainly concerned with their immediate/short-term needs since they have lost hope to plan for the future . Noted iFurther revelation relates to the view that different stakeholders have prioritised different energy conservation strategies. The results reveal the absence of an integrated plan of implementation to increase the uptake of the various energy conservation measures. Community involvement is noted to be low, yet according to , any typP ≤ 0.05). In terms of calorific potential, this study reveals that the higher the percentage of firewood dry matter, the lower the calorific values, and vice versa. In firewood collection and use, the studied household size categories were mostly constrained by low household income and long distances travelled in search of wood fuel. To reduce pressure on the wood fuel, the stakeholders undertook conservation measures such as the use of mobile solar gadgets for cooking and lighting, conducting environmental awareness and sensitisation programmes, and taking up agroforestry-related activities. Our study reveals that the provision of alternative sources of energy has the potential to reduce overdependence on wood fuel by the South Sudan refugees in Uganda. Therefore, the government ought to support other cheaper energy alternatives like mobile solar gadgets and energy-saving cooking technologies, while the local administrators should integrate the refugee needs in the district development plans for equal distribution of resources at large. More sensitisation programmes of wood fuel conservation should be promoted by all stakeholders in the refugee settlements.The study area remains highly populated with refugee settlements from South Sudan, meaning that pressure on wood fuel is still far from ending unless this situation is overturned in the near future. This study reports forth that the refugees used more firewood followed by charcoal, briquettes, and other biomass fuels such as agricultural residues, husks, and grasses as cooking fuel. The household size categories that had a significant contribution to the collection and use of firewood were the large families. The most significant determinants were the size of the house, refugee culture, weak enforcement of environmental laws and regulations, and availability of family labour (


Improving access to end-of-life symptom control interventions among cancer patients is a public health priority in Tanzania, and innovative community-based solutions are needed. Mobile health technology holds promise; however, existing resources are limited, and outpatient access to palliative care specialists is poor. A mobile platform that extends palliative care specialist access via shared care with community-based local health workers (LHWs) and provides remote support for pain and other symptom management can address this care gap.The aim of this study is to design and develop mobile-Palliative Care Link (mPCL), a web and mobile app to support outpatient symptom assessment and care coordination and control, with a focus on pain.A human-centered iterative design framework was used to develop the mPCL prototype for use by Tanzanian palliative care specialists , poor-prognosis cancer patients and their lay caregivers (patients and caregivers), and LHWs. Central to mPCL is the validated African Palliative Care Outcome Scale (POS), which was adapted for automated, twice-weekly collection of quality of life–focused patient and caregiver responses and timely review, reaction, and tracking by specialists and LHWs. Prototype usability testing sessions were conducted in person with 21 key informants representing target end users. Sessions consisted of direct observations and qualitative and quantitative feedback on app ease of use and recommendations for improvement. Results were applied to optimize the prototype for subsequent real-world testing. Early pilot testing was conducted by deploying the app among 10 patients and caregivers, randomized to mPCL use versus phone-contact POS collection, and then gathering specialist and study team feedback to further optimize the prototype for a broader randomized field study to examine the app’s effectiveness in symptom control among cancer patients.mPCL functionalities include the ability to create and update a synoptic clinical record, regular real-time symptom assessment, patient or caregiver and care team communication and care coordination, symptom-focused educational resources, and ready access to emergency phone contact with a care team member. Results from the usability and pilot testing demonstrated that all users were able to successfully navigate the app, and feedback suggests that mPCL has clinical utility. User-informed recommendations included further improvement in app navigation, simplification of patient and caregiver components and language, and delineation of user roles.We designed, built, and tested a usable, functional mobile app prototype that supports outpatient palliative care for Tanzanian patients with cancer. mPCL is expressly designed to facilitate coordinated care via customized interfaces supporting core users—patients or caregivers, LHWs, and members of the palliative care team—and their respective roles. Future work is needed to demonstrate the effectiveness and sustainability of mPCL to remotely support the symptom control needs of Tanzanian cancer patients, particularly in harder-to-reach areas. Cancer is a growing public health concern in sub-Saharan Africa, with at least 500,000 annual deaths in recent years; a doubling of cancer incidence and mortality is projected by 2030 -4. AlthoDue to the limited pool of palliative care specialists and low public and private investment in cancer control, there is an urgent need for novel, sustainable, and community-based solutions to address inadequate specialty palliative care services throughout Africa -8, with With the increasing adoption of mobile technology, there is great potential to improve outpatient cancer symptom management through remote access to palliative care. In Tanzania, cell phone ownership increased from 10% in 2002 to 73% in 2015, and smartphone ownership increased from 8% to 13% between 2013 and 2017  promisesA systematic review of existing mobile and web apps focused on pain control in a range of medical conditions, including cancer, reported that although the number of such apps is growing, none of the apps described in scientific databases were available commercially. Furthermore, among the 283 pain control–focused apps identified in the 5 app stores (including Google Play and Apple App Store), scientific evidence of efficacy was nonexistent .A more recent systematic review examined available full-text publications on mobile apps with the following characteristics: focused on cancer pain, downloaded and registered on either a mobile phone or computer, using a numeric scale to assess pain, reporting patient follow-up for more than a week, and available in English. Of the 13 studies reviewed, 5 were randomized controlled trials. The results of this review revealed that app-supported pain control is generally effective in the high-resource setting. Specifically, among the randomized controlled studies reviewed, patients who used the tested apps had less pain than patients without access to the apps. Other outcomes, such as quality of life, pain catastrophizing, and pain self-efficacy, were also improved in app users versus in those from control groups . ExistinFew studies have examined mobile palliative care solutions in low-resource countries among those with noncommunicable diseases (NCDs), despite increasing awareness of the symptom control needs of patients with chronic diseases, including patients with cancer, and knowledge that by 2030, NCDs will be more prevalent than communicable diseases ,18-30. LThis study was approved by the Institutional Review Board of the Muhimbili University of Health and Allied Sciences . Signed informed consent was obtained from all participants before enrollment into the study.Using WHO palliative care pillars  as a framework  and respThe app design and development process consisted of six stages.The multidisciplinary study team established to design and test mPCL included Tanzanian- and US-based partner institutions and organizations—MUHAS, ORCI, Maine Medical Center—and a social software enterprise Dimagi. Team members included Tanzanian and US palliative care specialists, health services researchers, software engineers and designers, and a user experience (UX) specialist (author RM). The team met remotely via videoconference on a monthly basis and communicated via email throughout the app design, development, and testing periods .The study team defined 3 mPCL design requirements based on a proposed workflow that was endorsed by clinical study team members. Design requirements were as follows:Requirement 1: Streamlined and timely collection of patient self-reported symptoms. Central to mPCL’s utility is its ability to regularly and in real time assess the patient’s quality of life (with a focus on pain control) through scheduled, twice-weekly POS delivery and response collection, including 7 patient-focused items and 3 caregiver-completed items  and palliative care nurses (hereafter referred to as nurses). The specialist physician’s primary tasks are to generate a shared synoptic clinical record and palliative care plan, review POS results, and oversee the patient’s care. Nurses support the development of the synoptic clinical record, conduct visits with the patient or caregiver in coordination with the LHW, and serve as a liaison between all care team members as well as an emergency contact for patients or caregivers. As such, both specialist physicians and nurses play a role in creating synoptic clinical records in mPCL. The clinical record and care plan can be viewed by other members of the care team and can be updated at any time by the specialist based on POS responses and input from the nurse, LHW, and patient or caregiver. Specialist physicians have the exclusive ability to prescribe, supply, and make adjustments to morphine and other medications critical to pain and other symptom management.The community-based LHW, located in close proximity to the patient’s or caregiver’s home, assists with regular remote assessment, monitoring, and management of the patient’s symptoms via in-person visits recorded in the form of mPCL follow-up interactions and through mPCL communication or care coordination in partnership with other team members, thereby providing frontline care based on direct ongoing specialist guidance and the needs of the patient.The cancer patient receiving outpatient, home-based palliative care as well as their caregiver, responsible for providing in-home patient support, can access and use the app to complete the 10-item POS and submit results to mPCL’s cloud-based server for subsequent review by the LHW and review or action by a specialist. Additional patient-centric design specifications include a set of low-literacy educational resources developed in Kiswahili (Tanzania’s primary language) with a focus on the causes and management of common late-stage cancer symptoms.Requirement 3: Symptom response–focused communication between the care team and patient or caregiver. Shared access to POS results, an evolving synoptic clinical record and palliative care plan, and follow-up notes by care team members on interactions with the patient or caregiver allow for: (1) timely communication to support patient-centered care plan decision making in response to an LHW’s in-person assessment of the patient experiencing escalating symptoms or other needs, (2) coordination of care to implement changes to the care plan, and (3) important updates regarding changes in patient status . mPCL also provides patients with ready access emergency phone contact with a specialist or LHW in the event of rapidly escalating symptoms or acute changes in clinical status.In accordance with HCD methodology, user characteristics and needs were gathered and analyzed to create a set of user requirements before app development . The firThe app prototype, mPCL v.0, was designed and built to directly support the core requirements defined in Stage 2, summarized above. The process of designing and creating the prototype involved (1) drafting the data architecture, (2) creating display pages and input forms to populate with content, and (3) defining custom user interfaces and permissions for types of users based on their specific roles and tasks. Periodic technical reviews and audits were conducted internally by Dimagi to ensure app design optimization and to verify technical requirements for data collection and analysis, for example, configuring unique user names and updating a change in medication. The back and front ends of the functional prototype were built and prepared by Dimagi staff with feedback from clinical team members and the team’s UX specialist. mPCL was developed on CommCare; Dimagi’s open-source, secure, cloud-based case management platform that allows end users to collect data and deliver interventions via custom-built mobile and web apps. This enabled the team to rapidly iterate the design and prepare a functional prototype for testing and use .Once the prototype was complete, an expert review was conducted by the UX specialist. The goal of this review was to identify and fix areas where the app was not in compliance with established UX best practices. The UX specialist ascertained areas of improvement and suggested changes. These changes were reviewed by team members and implemented into an updated version of the app. Key improvements included reorganizing the workflow in the app to make it easier for specialists and LHWs to access patient information, changes to the set of data shown for each user group to ensure availability of all essential information, and updates to labels and terminology to improve clarity and ease of use.Usability and pilot testing were conducted with target end users, whereby the mPCL prototype was iterated and further developed after each phase of testing.mPCL v.0 usability was assessed in individualized in-person usability testing sessions conducted by the UX specialist with participants representing target end users. Two site visits in Tanzania were led by US study team members, in collaboration with MUHAS and ORCI partners, to conduct in-person prototype usability testing and then train end users on the system just before the pilot test. The goals of usability testing were to (1) validate the design of mPCL and identify any remaining design issues, (2) uncover opportunities for system improvement, and (3) learn about the target user’s behaviors and prototype app interactions . mPCL v.Usability testing sessions occurred in person in a private space at ORCI. Testing for patients and LHWs was conducted in Kiswahili, with a translator. Testing for specialists was conducted in English. Patients were first briefly trained by a study team member on the basic use of mPCL. They were then asked to use an mPCL-equipped study smartphone to perform the following tasks to assess usability: (1) access educational resources, (2) complete and submit POS responses, and (3) contact a care team member. Specialist physicians were asked to use an mPCL-equipped tablet to (1) set up a mock patient’s synoptic clinical record, including a discharge palliative care plan; (2) review POS results; (3) enter follow-up patient notes, including changes in care plan; and (4) exchange notes with an LHW. These notes were intended to document requests for in-person assessment, collect additional clinical information, convey treatment recommendations and care plan changes. The nurse was asked to (1) register a mock patient into mPCL and enter relevant sociodemographic and clinical information into the synoptic clinical record, (2) complete the POS, (3) record a note documenting an interaction with the patient, (4) review the patient’s POS results and medications, and (5) update the individual’s contact information. LHWs were asked to use a study mPCL-equipped smartphone to (1) review a mock patient record, including POS results and (2) exchange notes with a mock specialist and patient regarding the patient’s assessment and symptom control. All usability testing participants were observed performing the predefined tasks and all issues that arose in performing the tasks  were documented. Recorded usability issues and participants’ recommendations for changes to the prototype design were reviewed and considered by the study team. At the end of the usability testing, all participants completed a verbally administered survey that assessed users’ perceived mPCL ease or difficulty of use. A set of recommendations was derived from usability testing feedback to inform the iteration of a more robust and user-validated mPCL prototype. App modifications ultimately accepted and employed were based on feasible design decisions with the goal of maximizing usability. The final mPCL v.1.0 prototype was then used in the subsequent pilot test.As part of a larger prospective field study of the system, cancer patients were enrolled and consented upon planned discharge to home from ORCI and randomized to either the mPCL intervention or twice-weekly phone collection of POS responses by an ORCI-based clinician team member.Here, we describe the pilot testing used to inform the final version of mPCL (v.1.1), deployed and tested in the field study. A full description of the field study and its outcomes will be reported elsewhere (manuscript in preparation). In brief, patient eligibility for both the pilot test and field study included (1) an adult ORCI inpatient with known untreatable cancer, being discharged to home, (2) a 4-month life expectancy or greater per specialist physician assessment, (3) residence within 50 km of ORCI for medication access, (4) caregiver available to support outpatient care for the illness duration, (5) an LHW consented to support the patient’s outpatient care for the test’s duration (up to 4 months post discharge), and (6) completed primary school education. Intervention patients lacking personal smartphones were loaned an Android device with the mPCL app preinstalled and available for use during the 4-month study period, and those with reliable access to their own personal smartphone were provided the option to install and use the mPCL app on their own device. An ORCI information technology specialist working directly with the study team assisted patients with the preparation and maintenance of devices for study purposes  and served as the first point of contact to respond to any emergent technical issues over the course of the study. For specialists, mPCL was accessible from their office-based computers as a web app as well as their smartphones as a web or native mobile app. LHWs had the option to either use their own mPCL-enabled smartphones or an Android device provided for use during the study with the mPCL mobile app preinstalled.Real-time feedback and input regarding mPCL use as well as study process or procedure problems were requested via email and during regular team meetings from specialists (physicians and nurse), and ORCI-based study personnel during the 2-month pilot test period. Within this time, a total of 10 patients were enrolled and randomized to mPCL versus phone contact. At the end of the 2-month pilot test period, patient recruitment was held for close to a month during which mPCL use feedback and pilot test process recommendations were compiled, analyzed and used to iterate on and finalize the app prototype, mPCL v 1.1, for further field study.A total of 21 potential target end users participated in mPCL v.0 usability testing: 7 patients and caregivers, 8 specialists, and 6 LHWs. Of the 7 patients who participated, 6 were women (1 man), and none of them reported any secondary school education or spoke English. Patients’ ages ranged from 34 to 64 years, and 2 patients or their caregivers owned an Android smartphone, 4 owned a mobile phone, and 1 did not own a phone. Among specialists, 7 physicians and 1 nurse participated, and 6 of them were women (2 men). Specialists had 4-14 years of clinical experience, were English speaking, and owned Android smartphones. The LHW participants included 4 women and 2 men with 4-14 years of clinical experience; all owned Android smartphones. All LHWs were fluent in Kiswahili, with a few also conversant in tribal languages, and reported limited English language proficiency.Open-ended user feedback and usability issues identified during usability tests were itemized and reviewed by the mPCL study team for optimization of mPCL v.0 to mPCL v.1.0. This included review of direct feedback from users on role-specific tasks and navigation of custom interfaces, designed for each user role. Design component improvement recommendations were subsequently reviewed, validated and acted upon. Examples of user task performance improvement recommendations prompting app optimization included (1) reformatting the POS assessment for patients and caregivers to display individual items one at a time instead of all on one page, making it easier for those not accustomed to navigating a touchscreen; (2) adding more comprehensive clinical data for collection by specialists, specifically providing more detail on the patient’s current and historical medications; (3) adding more information on the patient’s social history to the clinical record ; (4) translating all information displayed to LHWs into Kiswahili to make the app easier to use for those with limited English language proficiency; and (5) adding the individual patient’s cancer type and stage to the patient list display for easier identification. Other emergent themes in user feedback that were acted upon included the need for clearer delineation of user roles and tasks and related user permissions  and clarification of POS data collection and monitoring . As summarized in During the 2-month mPCL pilot test period, 4 specialist physicians, 1 nurse, 5 LHWs, and 10 patients who were randomized to mPCL use versus phone-contact POS collection were enrolled. Specialists, including a subset of mPCL users who were also study team members  were asked to provide real-time feedback on issues or questions related to either mPCL v.1.0 use or study processes and procedures, in preparation for the subsequent field study. The mPCL v1.1 prototype functionalities summarized below were focused on real-time symptom assessment and care coordination, with the primary aim of effective symptom management and maintenance of quality of life. For the purpose of the mPCL field study, we defined and validated 4 individual mPCL user groups with interfaces, access, and permissions to functionalities specific to each group’s roles and tasks in managing study patients: specialist physician, nurse, LHW, and patient or caregiver. Specifically, a nurse was determined to be the only user group with the ability to register a new study patient in mPCL via the Enroll New Patient module. Additional tasks assigned to the nurse to support field study-specific activities  were built and validated via the pilot test, in preparation for the subsequent field study. Field study-specific surveys for each user group were directly included and disseminated to users through the app  assessment, as this would strengthen future mHealth studies and allow investigators to synthesize and compare results of individual studies in a range of settings and populations . Here, wCancer-related pain is a global issue, with the greatest concern among those in underresourced settings where access to specialists and other resources, including medications, is limited or nonexistent. mPCL is focused on pain and other acute and chronic late-stage symptoms, directly linked to quality of life, among patients with cancer from a low-resource sub-Saharan African country. The design of an interface and functionalities specific to the role of and usability tested among each member of the palliative care team promises to address some of the limitations cited in previous work in this area. Critical to the utility and usability of mPCL was attention to the unique cultural, sociodemographic, and educational experiences (including language proficiencies) and backgrounds of patients and their caregivers. We adopted a rigorous HCD approach with active engagement and participation of patients and caregivers throughout the app design process—a technique that is viewed as essential to the adoption and ultimate effectiveness  of new technologies in low-resource settings -40.Core to mPCL functionality is the scheduled delivery and collection of patient symptoms and quality of life indicators made available real time to all care team members. This functionality promises to deliver a prompt response to escalating symptoms. The clinician end users viewed immediate access to the synoptic clinical record and follow-up notes, as well as functions focused on user group communication and care coordination, as critical. The generation and tracking of the synoptic clinical record were not found to be cumbersome among the specialists who participated in both initial usability testing and early pilot testing and users perceived the clinical information to be up to date. In line with previous literature revealing that real-time communication improves outcome relative to adequate pain control, access to emergency phone contact with a care team member was seen as an essential component of mPCL .Notably, both patients and LHWs reported the importance of the educational module in improving awareness of anticipated late-stage, cancer-associated symptoms as well as an understanding of the basic means to control these symptoms. Although these resources were directed at the patient and caregiver, LHWs reported that this information was informative for them personally and they believed that it supported them in their care of patients with cancer.Here, we describe the design and development of a mobile app aimed at extending the reach of a limited pool of specialists, dedicated to symptom control and improved quality of life among late-stage cancer patients in low-resource settings.We followed an HCD framework with direct engagement of all target end user groups—specialists (physicians and nurses), LHWs, and patients and caregivers—to design the prototype. The central focus of the app was real-time symptom monitoring  and communication. Usability testing revealed general app acceptance, and early pilot testing showed the app to be usable and feasible in the setting of a single urban cancer institute. Our broader, randomized field study will provide further evidence regarding the clinical utility of mPCL. Additional questions related to this work include the generalizability of mPCL to other geographic settings and in settings with less access to symptom control medications and other support resources. As mobile technologies continue to grow and evolve in low-resource settings such as Tanzania, the field of cancer medicine can greatly benefit from an understanding of how to build patient-centric tools optimized for remote symptom monitoring and tracking as well as effective and efficient care coordination. Furthermore, rigorous studies of the use of tools such as mPCL in practice will be critical to understanding how they can be widely adopted and scaled.


In Virginia, 56% of colorectal cancers (CRC) are diagnosed late, making it one of three enduring CRC mortality hotspots in the US. Cervical cancer (CCa) exhibits a similar pattern, with 48% late-stage diagnosis. Mortality for these cancers is worse for non-Latinx/e(nL)-Black people relative to nL-White people in Virginia, but preventable with equitable screening access and timely diagnostic follow-up. However, structural barriers, such as fractured referral systems and extended time between medical visits, remain. Because Federally Qualified Health Centers (FQHCs) care for a large proportion of racial and ethnic minorities, and underserved communities, regardless of ability to pay, they are ideal partners to tackle structural barriers to cancer screenings. We piloted a quality improvement initiative at five FQHCs in southcentral Virginia to identify and address structural, race-related barriers to CRC, as well as CCa screening and diagnostic follow-up using evidence-based approaches. Uniquely, FQHCs were paired with local community organizations in a didactic partnership, to elevate the community’s voice while together, increase support, acceptance, uptake, and intervention sustainability. We report on project development, and share preliminary data within the context of project goals, namely, to increase cancer screenings by 5–10%, improve knowledge and diagnostic follow-up processes, and build longitudinal partnerships. With 56% of colorectal cancers (CRC) diagnosed at later stages, it is no surprise that Virginia (VA) remains one of three enduring CRC mortality hotspots in the United States . Black VMuch attention has been given toward addressing individual and interpersonal level barriers to cancer screening, such as increasing opportunities for provider recommendation, and improving patient knowledge to address awareness, receptivity, and fear ,5. HowevThe principles of community engagement are based on a core belief that academics work alongside communities to ensure a shared agenda and a respectful understanding of the community context, while cultivating strong relationships with key partners, and leveraging available resources . Public COALESCE—Clinics and Communities Tackling Racial Disparities Structural in Cancer Screening. The purpose of COALESCE was to facilitate the development and execution of a quality improvement initiative (QI) within Federally Qualified Health Centers (FQHCs), to identify and address structural, race-related barriers to CRC and CCa screening and diagnostic follow-up. Uniquely, Project COALESCE would facilitate a partnership between FQHCs and local community organizations to work together  to identify the targets, design a plan of action, and disseminate the QI initiative. FQHCs are community-based clinics that receive funds from the Health Resources and Services Administration (HRSA) to provide primary care regardless of a patient’s ability to pay. The goals of COALESCE were to: (1) increase CRC and CCa screenings by 5–10% at each FQHC; (2) improve diagnostic follow-up processes; (3) increase provider and community cancer screening knowledge; (4) build longitudinal partnerships that support cancer health equity initiatives beyond the term of the project. The following is a description of our experiences developing and facilitating this adapted model of academic–community partnerships. In this manuscript, we describe the process of development for Project Project COALESCE was designed as a small, feasibility pilot to stimulate a mutually beneficial partnership between an FQHC and a non-clinical community partner organization to identity a structural barrier and an evidence-based intervention (EBI) to implement towards improving CRC and CCa screening compliance. Uniquely, in this design, the role of the academic partner was strictly facilitation of the partnership, that is, convening regular meetings, the provision of training, and implementation support. Equalizing QI knowledge, and allowing the choice of EBI by each dyad were critical design elements, as clinics and community organizations best understand how and what would be best adapted and implemented within their communities. Working jointly (as a dyad), the FQHC and their community partner assessed their own practices, processes, resources, and perceived barriers pertaining to these cancer screenings, and selected an EBI to jointly implement towards increasing screening rates. The intention was that the dyadic approach would leverage exploration of critical barriers from the clinic and community perspectives, and begin to build robust partnerships directed by patient and community need rather than the priorities of the FQHC or the academic organization. As this was a feasibility pilot, we used 2018 HRSA  data to The partner non-clinical community organizations were either identified by the FQHC based on their existing relationship (for two of the FQHCs), or recommended by the project PI based on existing relationships with the Virginia Commonwealth University Massey Cancer Center (MCC), Office of Community Outreach and Engagement (for three FQHCs). Selected community organizations had aligned interests to improve the health of their communities, including access to cancer screenings and follow-up cancer care. They also served in the same patient service area and communities served by the partner FQHC. They were to join as equal accountability and didactic partners to the FQHC, assisting in an honest assessment of needs, development of plans, and implementation of adapted EBIs based on their collective findings. The FQHCs and community organizations were acknowledged as equal partners not only during their recruitment, contractual process, and training, but importantly, their equal partnership was also acknowledged by allocating an equal amount of grant dollars to compensate for their participation. The joint responsibility was also acknowledged by adjoining their deliverables such that the success of the QI initiative was dependent on their equal participation, measured by templated reports (co-developed during the recruitment process) that included joint evaluations. The submission of this  report would trigger grant disbursements to participating entities.The primary target for the program was to increase screening rates by 5–10% in 24 months, which was agreed upon by each FQHC as a reasonable goal. To estimate the approximate number of women eligible for CCa screening (denominator), the reported total patient population was multiplied by the proportion of adults aged 18–64, assuming a 50/50 split of the population by gender. We then used the HRSA-reported CCa screening average for the five participating FQHC, estimated at 49.6%. Based on this, we estimated having to screen 3000 age-eligible women to increase this average CCa screening rate across the five clinics from 49.6% to 60% over a 24-month period, consistent with the length of the project. Using the same estimation and the proportion of adults 65+ reported in HRSA, we estimate having to screen around 1300 individuals to increase the average CRC screening rate across the five clinics from 38.2% to 50% over the project period. All participating FQHCs agreed to provide up to date (CY2020) baseline data that would allow us to estimate their latest, actual CCa and CRC screening rates overall, and by race/ethnicity. They also provided data on the number of clinical and non-clinical staff, and information on the availability of various services relevant to cancer screening access  as part of the initial needs assessment. Finally, they also agreed to submit the same data at 12 and 24 months, inclusive of the number of abnormal screenings found during the project, to estimate potential cancers averted. The community organizations provided a total number of members, overall, and by race and ethnicity, as well as broad information regarding their focus and services.We scheduled monthly didactic-style one-hour meetings to train the FQHCs and partner community organizations (referred to as dyads) on various quality improvement (QI) tools, and to exchange information on processes and progress towards stated common goals. Upon receiving training, dyads used the QI tools to jointly identify and address barriers to CRC and CCa screening as follows: first, dyads conducted an environmental scan (ES) using an adaptation of the CDC-recommended University of Kentucky’s seven-step process  to broadWe additionally conducted semi-structured qualitative interviews with members of the leadership, clinical and non-clinical staff of the FQHC, and members of the community organization to describe how each dyad developed and worked as a team. We also deployed two surveys: the first survey was for providers only, and consisted of a subset of questions from the National Survey of Primary Care Physicians’ Cancer Screening Recommendations and Practices . The purEach monthly meeting featured a QI subject matter expert (SME) to discuss each of the above-mentioned tools. Additionally, we brought SMEs to discuss available CRC and CCa screening EBIs, and explain their science, successes, and opportunities across various communities. We proposed using the Interactive Systems Framework for dissemination and implementation to identify the “how to” gaps that influence what works in the field for the benefit of the public . AttendaWe developed a minimally burdensome, maximally informative report template, with the participant’s input. This template was informed by validated tools, such as the TeamSTEPPS patient safety approach used in healthcare to improve communication and teamwork skills among healthcare professionals , and a h13 . Qualitative data  will be analyzed using a grounded theory approach to identify common, emerging themes. As data collection is ongoing, herein we provide the initial, univariate analysis of baseline data for year one of the project. Quantitative data will be summarized and analyzed descriptively using t-tests for continuous variables, chi-squared tests for proportional and categorical variables, all at alpha 0.05 as the statistical significance threshold, and using StataIC 13 Stata Statistical Software: Release n = 21), the five participating FQHCs served a higher proportion of patients that were younger than 65 , uninsured , and had double the proportion of nL-Black patients than non-participating FQHCs . Though the HRSA-reported CRC and CCa screening rates for the five participating FQHCs (38% and 50%) did not significantly differ from the same screening rates for non-participating FQHCs (40% and 47%), rates for all FQHCs were well below the state (70% and 91%), and the Healthy People 2030 screening goals (74% and 84%) for these cancers, respectively  priorities and they began to understand our [community organization’s] value at the table.”—Community PartnerThough academic–community partnerships have become quite common, clinical–academic–community partnerships are less common, and when done, their primary focus remains in research capacity building  versus iThis unique convening of community-based clinical, non-clinical, and academic partners represents an adaptation and extension of traditional community-engaged framework. This may be a model for partnership-building among entities who share common goals, serve the same communities, have different expertise and community knowledge about existing strengths and barriers, but who have no history of partnership. The fact that participation and engagement have remained high suggests commitment to the project and its goals. The work conducted to date by the dyads has been significant, and retention has been key. Qualitative interviews will help to understand how dyads have been working as a team, the quality of the partnership developing, and which aspects have helped or hindered their progress and experience. Continued evaluation of the partnership development process will be critical for identifying best practices for building and maintaining a working relationship in the future.CRC and CCa are screenable, preventable, and can be treated successfully if caught early, making it imperative that all Americans have equitable access. To identify and address the most salient structural barriers in each community, Project COALESCE has brought together clinical and non-clinical community partners. The success of bringing dyads together to complete critical QI self-analyses is encouraging. Although dyads have primarily identified EBIs that continue to address individual-level barriers, it is hoped that continued engagement in rounds of PDSA, the deepening of dyad partnerships, and facilitation support from VCU/MCC partners will provide the tools needed to step outside of their comfort zone to address structural issues that are not routinely discussed.