Expert Review Committee Research Articles

The Guidelines for use and promotion of low sodium salt in China.

Both excessive intake of sodium and inadequate intake of potassium are associated with blood pressure elevation and subsequent increase in the risk of cardiovascular disease, which accounts for the largest number of deaths in China and worldwide. Low sodium salt, a mixture of mainly sodium chloride and potassium chloride, has shown its great potential as a promising population strategy for sodium intake reduction through multiple large-scale, multicenter, randomized controlled trials among populations including patients with cardiovascular disease, individuals with and without hypertension, older and younger adults, and men and women in China and other countries. This Guidelines aims to provide expert recommendations for promotion and use of low sodium salt in China, based on the current available scientific evidence regarding the effectiveness, safety, cost-effectiveness, and acceptability of low sodium salts in various population groups and different application scenarios. The suggestions to key stakeholders are also made. A working group, an expert review committee and an advisory committee were established to be responsible for formulating the guidelines' scope and key questions to be addressed, for searching, synthesizing, and evaluating research evidence, proposing and reviewing the recommendations. The consensus on the final recommendations was reached using the GRADE grid method. The working group summarized current available evidence of salt substitution regarding its effectiveness, safety, cost-effectiveness, acceptability, availability, suitability, etc. The Guidelines provided six recommendations advising different populations how to use low sodium salt, four recommendations on the application of low sodium salts in different scenarios, and five suggestions for key stakeholders to promote salt substitution. The first evidence-based guidelines on promotion and use of low sodium salts covers all key questions in relevance and would play a critical role in prevention and control of hypertension and cardiovascular disease in China and worldwide.

Management of bipolar disorder in South Africa: National Department of Health essential medicine selection and treatment algorithms

Background. Bipolar disorder (BD) is a severe mental illness associated with multimorbidity, psychosocial disability and significant public health issues. However, guideline heterogeneity clouds therapeutic decisions, particularly in relapse prevention. Polypharmacy and poor health outcomes are common. For low- and middle-income countries, deciding which medicines to procure and how to treat BD in an integrated manner remains elusive. Although South Africa (SA) is committed to universal health coverage, the estimated treatment gap for mental disorders in the public health sector is 91%. An Essential Medicines List (EML) enables equitable access to medicines, while Standard Treatment Guidelines (STGs) facilitate rational prescribing and quality care. Objectives. To describe the medicine selection process for the treatment of BD in the SA public health sector, and the treatment algorithms developed to guide integrated care. Methods. Evidence-based medicine principles, stakeholder consultation and consensus decision-making were used. The existing (2015) BD guideline and stakeholder comments were reviewed by a ministerially appointed expert review committee, following which a research question with eligibility criteria was formed, and rapid systematic evidence synthesis conducted. PubMed and Cochrane databases were searched for systematic reviews of randomised controlled trials and observational studies of acute and maintenance treatment in BD, with an additional PubMed search for primary research. Quality of the systematic reviews was appraised using the 11-item assessment of multiple systematic reviews. After costing to ensure affordability, final recommendations were made to the National EML Committee (NEMLC) using the strength of recommendation taxonomy classification. Following approval by the NEMLC, proposed medicines were incorporated into the 2019 National Department of Health Adult Hospital STGs. As the STGs are updated every 3 years, stakeholder input was sought in 2021 and 2023, with no changes to the medicine selection. Results. Seven systematic reviews and one observational study were included in the evidence synthesis. Six medicines were selected as essential for maintenance treatment: lithium, valproate, lamotrigine, olanzapine, quetiapine and clozapine. While risperidone and benzodiazepines were retained for acute mania, carbamazepine and fluoxetine were removed from acute depression. Treatment algorithms for predominantly manic and depressive courses of illness were constructed to encourage person-centred care, aiming for euthymia, individual functioning and relapse prevention. Conclusion. Evidence-based medicine principles enabled the NEMLC to select a range of essential medicines for the management of BD in a middle-income country. Local monitoring and evaluation are needed to inform future editions of the STGs and EML.

Translation and adaptation of the stroke-specific quality of life scale into Swahili.

Stroke care requires a patient-centred, evidence-based and culturally appropriate approach for better patient clinical outcomes. Quality of life necessitates precise measuring using health-related quality measures that are self-reported and language appropriate. However, most of the self-reported measures were devised in Europe and therefore not considered contextually appropriate in other settings, more so in Africa. Our study aimed to produce a Swahili version by translating and adapting the stroke-specific quality of life (SSQOL) scale among people with stroke in Kenya. We used a questionnaire translation and cross-cultural adaptation. The pre-validation sample of 36 adult participants was drawn from 40 registered people with stroke, from the Stroke Association of Kenya (SAoK). Quantitative data were collected using both English and Swahili versions of the SSQOL scale. The mean, standard deviation (s.d.) and overall scores were calculated and are presented in tables. The back translation revealed a few inconsistencies. Minor semantic and equivalence alterations were done in the vision, mood, self-care, upper extremity function and mobility domains by the expert review committee. Respondents indicated that all questions were well-understood and captured. The stroke onset mean age was 53.69 years and the standard deviation was 14.05. The translated version of the Swahili SSQOL questionnaire is comprehensible and well-adapted to the Swahili-speaking population. The SSQOL has the potential to be a useful outcome measure for use in Swahili-speaking patients with stroke.

Mortality and Cause of Death in Children With Presumptive Disseminated Tuberculosis.

Children experience high tuberculosis (TB)-related mortality but causes of death among those with presumptive TB are poorly documented. We describe the mortality, likely causes of death, and associated risk factors among vulnerable children admitted with presumptive TB in rural Uganda. We conducted a prospective study of vulnerable children, defined as <2 years of age, HIV-positive, or severely malnourished, with a clinical suspicion of TB. Children were assessed for TB and followed for 24 weeks. TB classification and likely cause of death were assessed by an expert endpoint review committee, including insight gained from minimally invasive autopsies, when possible. Of the 219 children included, 157 (71.7%) were <2 years of age, 72 (32.9%) were HIV-positive, and 184 (84.0%) were severely malnourished. Seventy-one (32.4%) were classified as "likely tuberculosis" (15 confirmed and 56 unconfirmed), and 72 (32.9%) died. The median time to death was 12 days. The most frequent causes of death, ascertained for 59 children (81.9%), including 23 cases with autopsy results, were severe pneumonia excluding confirmed TB (23.7%), hypovolemic shock due to diarrhea (20.3%), cardiac failure (13.6%), severe sepsis (13.6%), and confirmed TB (10.2%). Mortality risk factors were confirmed TB (adjusted hazard ratio [aHR] = 2.84 [95% confidence interval (CI): 1.19-6.77]), being HIV-positive (aHR = 2.45 [95% CI: 1.37-4.38]), and severe clinical state on admission (aHR = 2.45 [95% CI: 1.29-4.66]). Vulnerable children hospitalized with presumptive TB experienced high mortality. A better understanding of the likely causes of death in this group is important to guide empirical management.

Translation and cultural adaptation of the Illness Perception Questionnaire-Revised for Dental to Brazil

This study aimed to translate and to perform the cultural adaptation of the instrument Illness Perception Questionnaire-Revised for Dental (IPQ-RD) into Brazilian Portuguese. The IPQ-RD consists of 34 items that assess the cognitive and emotional representation/perception of parents/caregivers of children with dental caries, with response options on a 5-point Likert scale, ranging from "Strongly agree" (score 1) to "Strongly disagree" (score 5). The higher the score, the lower the perception of the disease. The protocol consists of translation into Brazilian Portuguese, back-translation into English, revision by an Expert Review Committee, and pre-test (application in parents/caregivers of children in dental care). For some questions, the translated versions were identical (T1 = T2); for others, one version was preferred (T1 or T2); for still others, it was decided to modify terms to obtain greater clarity on the item (T3). In the first pre-test, three questions were misunderstood by more than 15% of the sample, after which the items were reviewed by the Expert Review Committee. In the second pre-test, the adapted version was applied to a new sample of parents/caregivers (n = 15) and the questions were understood by more than 85% of the participants. The Brazilian Portuguese version of the IPQ-RD was well understood by the evaluated population.

Treatment outcomes of multidrug-resistant TB with selective use of new drugs.

SETTING: This was a nationwide cohort study.OBJECTIVE: To assess the treatment outcomes in patients with multidrug-resistant TB (MDR-TB) who underwent treatment guided by a national TB expert review committee in South Korea.DESIGN: We enrolled all patients with MDR-TB submitted for approval for the use of new TB drugs, including bedaquiline and delamanid, from 2016 to 2019. Patients were classified into two groups: those on new TB drugs and those not on new TB drugs. We compared the final treatment outcomes between the groups and analysed the prognostic factors.RESULTS: Of a total of 785 patients, respectively 754 (96.1%) and 31 (3.9%) were classified into the "new TB drugs" group and "no new TB drugs" group. The new TB drugs group had a higher acid-fast bacilli smear positivity rate and higher resistance rate to second-line injectable drugs or fluoroquinolones. Of all the patients, 97.8% achieved culture conversion (97.7% vs. 100%), and 80.4% achieved treatment success (80.2% vs. 86.7%); there was no difference between the two groups.CONCLUSIONS: New drugs are currently recommended for use in all MDR-TB treatment regimens, and the use of new drugs, as determined by an expert committee, in mainly quinolone-susceptible MDR-TB, did not compromise the treatment success rate.

Is It Time to Commit to a Process to Re-Evaluate Oncology Drugs? A Descriptive Analysis of Systemic Therapies for Solid Tumour Indications Reviewed in Canada from 2017 to 2021.

We undertook an analysis of the Canadian Agency for Drugs and Technologies in Health (CADTH)’s health technology assessments (HTAs) of systemic therapies for solid tumour indications to determine if a mechanism to re-evaluate HTA decisions is needed based on the level of certainty supporting the original recommendation. To measure the certainty in the evidence, we analysed if: (1) overall survival (OS) was the primary endpoint in the pivotal trial, (2) median OS was available at the time of the recommendation, and (3) the expert review committee explicitly identified gaps in the evidence. There were 96 drugs approved by Health Canada that met our eligibility criteria between 1 January 2017 and 31 October 2021. Median OS was not estimable at the time of the recommendation in 57% of the positive recommendations, and the uncertainty in the magnitude of clinical benefit was identified by the expert review committee in 21% of the positive recommendations. There is uncertainty at the time of the HTA recommendation for many drugs, and thus a need to implement a process to re-evaluate drugs in Canada to allow patients timely access to promising therapies while ensuring long-term value of therapies to patients and the healthcare system.

Only two subscales of the Coping Strategies Questionnaire are culturally relevant for people with chronic low back pain in Nigerian Igbo populations: a cross-cultural adaptation and validation study

BackgroundPain coping strategies are important in the chronicity of low back pain and the associated disability. However, their exact influence is unknown in many African contexts such as rural Nigeria due to lack of outcome instruments with which to measure them. This study aimed to cross-culturally adapt and psychometrically test the Coping Strategies Questionnaire (CSQ) in Igbo populations in Nigeria.MethodsThe CSQ was forward and back translated by clinical and non-clinical translators; evaluated by an expert review committee. The translated measure was piloted amongst twelve rural Nigerian dwellers with chronic low back pain (CLBP) using the think-aloud cognitive interviewing style. Internal consistency (Cronbach’s alpha), test–retest reliability (intra-class correlation coefficient—ICC and Bland–Altman plot), and minimal detectable change were examined amongst 50 people with CLBP in rural and urban Nigerian populations. Construct validity was determined by assessing the correlations between the adapted CSQ and measures of disability, pain intensity, fear avoidance beliefs, and illness perceptions using Spearman’s correlation analyses with 200 adults with CLBP in rural Nigeria. Exploratory factor analyses using Kaiser criterion (eigenvalue) and parallel analysis as methods for determining dimensionality were conducted with the same sample.ResultsFourteen out of 42 items were routinely adopted in this population including all items of catastrophising subscale, and all but one item of praying and hoping subscale. Catastrophising and praying and hoping subscales had the highest Cronbach’s alpha. All subscales had high ICCs with Bland–Altman plots that showed good agreement. All coping strategies were positively correlated with self-reported disability and pain intensity with catastrophising subscale having the highest values. Seven-factor and three-factor structures were produced with the Kaiser criterion and parallel analysis, with different items from the original CSQ, except for catastrophising.ConclusionsCatastrophising and praying and hoping may be the relevant coping strategies in this population. More culturally relevant measures of pain coping strategies that include adaptive coping strategies may need to be developed for African contexts such as rural Nigeria.

Teaching fuzzy controllers through a V-model based methodology

Since the seminal fuzzy sets paper was published, many graduate and undergraduate academic programs have included Fuzzy logic courses, as one of the most important topics regarding Artificial Intelligence (AI). Yet, it is worth highlighting the fact that AI as a tool for education has its main roots in the way AI is taught to students, leading to the development of many educational models, seeking to accelerate the learning curve of fuzzy logic concepts and their suitability for control systems. Nevertheless, most of those methodologies are mainly focused on theoretical concepts, without improving disciplinary and transversal competences that are developed through experimental challenges; consequently, knowledge acquisition is incomplete, and the industrial requirements are not fulfilled. Henceforth, this work proposes a model inspired by the Systems Development V-Model, which allows students to understand the entire fuzzy logic controllers design process through an experimental product development process that improves lifelong learning features in students. Besides, this model supports the Challenge-Based Learning (CBL) in students, encouraging new skills development and experience gain for fuzzy logic controllers designs. Moreover, the proposed methodology in this paper, covers the adapted V-model for education to understand the designing process for fuzzy logic controllers, through a Quadcopter case study, selected due to the complexity of the system, which (as supported from the results) also leads to improve the background skills in engineering students. Therefore, results show that this model enhances student’s capacity to develop functional prototypes and promotes technological products development. Then, as validated through an expert review committee within the engineering technical field, this proposal could be easily suited into several engineering topics; such as, Electronic circuits design, Power electronics and so on.

Cross-cultural adaptation and validation of the Amharic version of Roland Morris Disability Questionnaire in people with low back pain in Ethiopia

Purpose Cross-culturally translate, adapt, and validate Roland Morris Disability Questionnaire (RMDQ) in Amharic language in Ethiopia. Methods The English version RMDQ was translated into Amharic and back-translated into English. An expert review committee reviewed the translations and created Amharic version of the RMDQ (RMDQ-Am). Pilot testing and cognitive debriefing of the RMDQ-Am were conducted with a sample of 20 individuals with LBP. The RMDQ-Am was administered to 240 individuals with LBP from three rehabilitation centers to determine its psychometric properties. Internal consistency of the tool was determined by Cronbach’s alpha. Test-retest reliability was determined by the Intraclass correlation coefficient. The Standard Error of Measurement (SEM), Minimum Detectable Change (MDC), and the Bland Altman Limit of Agreement (LOA) was also determined. The Short-Form Health Survey (SF-36) Bodily Pain and Physical Functioning subscales were used to assess convergent validity. Exploratory Factor Analysis (EFA) was used to determine the dimensionality of the tool. Results RMDQ-Am demonstrated good internal consistency (α = 0.88), excellent test-retest reliability (ICC = 0.91), SEM (1.64), MDC (3.55), and good LOA. There is a significant moderate correlation between RMDQ-Am and the Physical Functioning (Rho = −0.62, p < 0.01) and Bodily Pain (BP) (Rho = −0.41, p < 0.01) subscales of the SF-36. Exploratory Factor Analysis demonstrates that the Amharic version of RMDQ is a primary one and secondary four-factor model [The Kaiser Meyer Olkin = 0.877, X 2 (df) =1413.278/190, p < 0.001]. Conclusion RMDQ-Am is a reliable and valid tool that can be used in both clinical practice and research with the Ethiopian LBP population. IMPLICATION FOR REHABILITATION Despite LBP being a concern in Ethiopia, the magnitude of disability related to this phenomenon is not studied in the country, mainly due to the absence of validated LBP specific patient-reported outcome measures such as the Roland Morris Disability Questionnaire (RMDQ). The RMDQ was successfully translated, adapted, and validated into the Amharic language and the Ethiopian context (RMDQ-Am). The RMDQ-Am is a reliable outcome measure among the Ethiopian population with LBP, as demonstrated by the good internal consistency (α = 0.88) and excellent test-retest reliability (ICC = 0.91). There is a moderate negative correlation between the RMDQ-Am and the Physical Functioning (Rho = −0.62, p < 0.01) and Bodily Pain (Rho = −0.41, p < 0.01) subscales of the SF-36. The RMDQ-Am can be used in clinical and research settings to measure LBP-related disability and its impact among individuals living with LBP in Ethiopia.

Radiographic features and poor prognostic factors of interstitial lung disease with nivolumab for non-small cell lung cancer.

Nivolumab can cause interstitial lung disease (ILD), which may be fatal; however, mortality risk factors have not been identified. This postmarketing study evaluated the poor prognostic factors of ILD in nivolumab‐treated patients with non–small cell lung cancer (NSCLC) in Japan. Clinical and chest imaging findings for each ILD case were assessed by an expert central review committee, and prognosis was evaluated by radiographic findings, including the presence/absence of peritumoral ground‐glass opacity (peritumoral‐GGO). Poor prognostic factors were identified by univariate and multivariate Cox regression analysis. Of the 238 patients with nivolumab‐induced ILD, 37 died. The main radiographic patterns of ILD were cryptogenic organizing pneumonia/chronic eosinophilic pneumonia–like (53.4%), faint infiltration pattern/acute hypersensitivity pneumonia–like (20.2%), diffuse alveolar damage (DAD)‐like (10.9%), and nonspecific interstitial pneumonia–like (6.3%). The main poor prognostic factors identified were DAD‐like pattern (highest hazard ratio: 10.72), ≤60 days from the start of nivolumab treatment to the onset of ILD, pleural effusion before treatment, lesion distribution contralateral or bilateral to the tumor, and abnormal change in C‐reactive protein (CRP) levels. Of the 37 deaths due to ILD, 17 had DAD‐like radiographic pattern, three had peritumoral‐GGO, and five had a change in radiographic pattern from non‐DAD at the onset to DAD‐like. Patients with NSCLC who develop ILD during nivolumab treatment should be managed carefully if they have poor prognostic factors such as DAD‐like radiographic pattern, onset of ILD ≤60 days from nivolumab initiation, pleural effusion before nivolumab treatment, lesion distribution contralateral or bilateral to the tumor, and abnormal changes in CRP levels.

Treatment and relapse of interstitial lung disease in nivolumab-treated patients with non-small cell lung cancer.

Nivolumab, a human monoclonal antibody against programmed death‐1, is approved for the treatment of non–small cell lung cancer (NSCLC). Although nivolumab is generally well tolerated, it can cause interstitial lung disease (ILD), a rare but potentially fatal immune‐related adverse event. Currently, there are limited data available on the treatment of nivolumab‐induced ILD and its outcome. This retrospective cohort study based on a post–marketing study described the treatment of nivolumab‐induced ILD and its outcome in NSCLC patients in Japan through the assessment of clinical and chest imaging findings by an expert central review committee. Treatment details for patients who experienced a relapse of ILD were also analyzed. Of the 238 patients identified as having nivolumab‐induced ILD, 37 patients died of ILD. Corticosteroids were used in 207 (87.0%) patients. Of those, 172 (83.1%) patients responded well and survived and 35 (16.9%) died (most died during corticosteroid treatment). A total of nine patients experienced a relapse; at the time of relapse, four patients were taking nivolumab. Of those who were receiving corticosteroids at the time of relapse, three of four patients were taking low doses or had nearly completed dose tapering. All patients (except one, whose treatment was unknown) received corticosteroids for the treatment of relapse, but one patient died. Patients with NSCLC who experience nivolumab‐induced ILD are treated effectively with corticosteroids, and providing extra care when ceasing or reducing the corticosteroid dose may prevent relapse of ILD.

Cross-cultural translation, adaptation, and validation of the Amharic version pain self-efficacy questionnaire in people with low back pain in Ethiopia

BackgroundThe Pain Self-Efficacy Questionnaire (PSEQ) is a valid and reliable instrument that evaluates pain self-efficacy beliefs in people with pain conditions. However, it has not been validated and used in Ethiopia. We conducted this study to translate, adapt, and test the psychometric properties of the PSEQ in the Amharic language and Ethiopian context for its use with people experiencing low back pain (LBP).MethodsThe PSEQ was translated into Amharic and then back-translated into English. An expert review committee created a final Amharic version of the tool (PSEQ-Am), followed by pilot testing and cognitive debriefing with a sample of 20 people with LBP. The psychometric properties of the final version of PSEQ-Am were assessed in a sample of 240 people with LBP recruited from three rehabilitation centers in Ethiopia. Cronbach’s alpha and Intra-class correlation coefficient were calculated to describe the reliability and internal consistency of the tool. The SF-36-Am bodily pain subscale was used to assess convergent validity. Confirmatory Factor Analysis (CFA) and Exploratory Factor Analysis (EFA) were performed to determine the dimensionality of the instrument.ResultsPSEQ-Am demonstrated excellent test-retest reliability (ICC = 0.93) and internal consistency (Cronbach’s alpha = 0.91). As hypothesized, the tool demonstrated a significant moderate correlation with the Bodily Pain subscale of the SF-36-Am (Rho = 0.51, p < 0.01). EFA analysis shows that the Amharic version of PSEQ is a dominant one factor and secondary two factor structure.ConclusionThis study shows that PSEQ-Am is a reliable and valid tool that can be used in both clinical practice and research in the Ethiopian low back pain population.

Caring Behaviors Inventory-24: translation, cross-cultural adaptation and psychometric testing for use in a Swedish context

BackgroundPatients’ health and wellbeing are promoted when nurses successfully conceptualize caring in clinical practice. Measuring caring behaviors can advance knowledge about caring and has potential to improve caring practices and the outcomes of care. The Caring Behaviors Inventory-24 (CBI-24) is an empirical instrument for measuring caring, developed to determine perceptions of caring among patients and nurses. Since the instrument was not available in Swedish, the aim of this study was therefore to translate into Swedish and cross-culturally adapt CBI-24 for a Swedish healthcare context, and to psychometrically analyze the Swedish version of CBI-24.MethodsThe study used a traditional forward and back translation process in six stages: (1) two simultaneous translations by bilingual experts; (2) expert review committee synthesis; (3) blind back translation; (4) expert review committee deliberations; (5) pre-testing with cognitive interviews, and (6) psychometric evaluations.ResultsThe translation process was systematically conducted and entailed discussions regarding semantic, idiomatic, experiential and conceptual equivalence. The cognitive interviews generated thoughts and reflections, which resulted in adjusting three items of the CBI-24 SWE. For psychometric analyses, 234 persons answered the questionnaire. Results indicated acceptable overall model fit in the χ2-value for the confirmatory factor analysis, while for the heuristic goodness-of-fit indices, the comparative fit index (CFI) and the standardized mean square residual (SMSR) indicated good model fits, and the root mean square error approximation (RMSEA) indicated an acceptable fit.ConclusionsCBI-24 SWE has been shown to be a psychometrically acceptable instrument for use in Swedish research contexts. Further studies regarding the clinical usefulness of the instrument may be in order. In particular, CBI-24 SWE should be evaluated among nurses in rural areas.

The Igbo Brief Illness Perceptions Questionnaire: A cross-cultural adaptation and validation study in Nigerian populations with chronic low back pain.

Illness perceptions predict chronic low back pain (CLBP) disability. This study cross-culturally adapted and validated the Igbo Brief Illness Perceptions Questionnaire (Igbo-BIPQ) in people with CLBP in rural/urban Nigeria. A cross-cultural adaptation and validation of the Igbo-BIPQ was undertaken. The BIPQ was forward/back-translated by clinical/non-clinical translators. An expert review committee appraised the translations. The questionnaire was pre-tested on twelve rural Nigerian dwellers with CLBP. Internal consistency using Cronbach's alpha; test-retest reliability using intra-class correlation coefficient and Bland-Altman plot; and minimal detectable change were investigated amongst 50 people with CLBP in rural and urban Nigeria. Construct validity was determined by correlating the Igbo-BIPQ score with those of eleven-point box scale and Igbo Roland Morris Disability Questionnaire (Igbo-RMDQ) using Pearson's correlation analyses in 200 adults with CLBP in rural Nigeria. Ceiling and floor effects were investigated in both samples. Good face/content validity, internal consistency (α= 0.76) and intraclass correlation coefficient (ICC = 0.78); standard error of measurement and minimal detectable change of 5.44 and 15.08 respectively; moderate correlations with pain intensity and self-reported disability (r⩾ 0.4); no ceiling/floor effects were observed for Igbo-BIPQ. This study provides evidence of some aspects of validity and reliability of the Igbo-BIPQ.

Translation, Cross-Cultural Adaptation, and Psychometric Analysis of the Attitudes Towards Homelessness Inventory for Use in Sweden.

BackgroundHomelessness is an increasing problem worldwide, and the origins of homelessness in high‐income countries are multifaceted. Due to stigma and discrimination, persons in homelessness delay seeking health care, resulting in avoidable illness and death. The Attitudes Towards Homelessness Inventory (ATHI) was developed to cover multiple dimensions of attitudes toward persons in homelessness and to detect changes in multiple segments of populations. It has, however, not previously been translated to Swedish.AimsThe aim of the present study was to translate, cross‐culturally adapt, and psychometrically test the ATHI for use in a Swedish healthcare context.MethodsThe project used a traditional forward‐ and back‐translation process in six stages: (1) two simultaneous translations by bilingual experts; (2) expert review committee synthesis; (3) blind back‐translation; (4) expert review committee deliberations; (5) pre‐testing with cognitive interviews including registered nurses (n = 5), nursing students (n = 5), and women in homelessness (n = 5); and (6) psychometric evaluations. The final ATHI questionnaire was answered by 228 registered nurses and nursing students in the year 2019.ResultsThe translation process was systematically conducted and entailed discussions regarding semantic, idiomatic, experiential, and conceptual equivalence. Confirmatory factor analysis was used to examine if the collected data fitted the hypothesized four‐factor structure of the ATHI. Overall, it was found that the model had an acceptable fit and that the Swedish version of ATHI may be used in a Swedish healthcare context.Linking Evidence to ActionThe ATHI has been shown to be a psychometrically acceptable research instrument for use in a Swedish healthcare context. The systematic and rigorous process applied in this study, including experts with diverse competencies in translation proceedings and testing, improved the reliability and validity of the final Swedish version of the ATHI. The instrument may be used to investigate attitudes toward women in homelessness among nursing students and RNs in Sweden.

World Health Organisation Disability Assessment Schedule (WHODAS 2.0): development and validation of the Nigerian Igbo version in patients with chronic low back pain

BackgroundGlobally, the leading cause of years lived with disability is low back pain (LBP). Chronic low back pain (CLBP) is responsible for most of the cost and disability associated with LBP. This is more devastating in low income countries, particularly in rural Nigeria with one of the greatest global burdens of LBP. No Igbo back pain specific measure captures remunerative or non-remunerative work outcomes. Disability measurement using these tools may not fully explain work-related disability and community participation, a limitation not evident in the World Health Organisation Disability Assessment Schedule (WHODAS 2.0). This study aimed to cross-culturally adapt the WHODAS 2.0 and validate it in rural and urban Nigerian populations with CLBP.MethodsTranslation, cultural adaptation, test–retest, and cross-sectional psychometric testing was performed. WHODAS 2.0 was forward and back translated by clinical/non-clinical translators. Expert review committee evaluated the translations. Twelve people with CLBP in a rural Nigerian community piloted/pre-tested the questionnaire. Cronbach’s alpha assessing internal consistency; intraclass correlation coefficient and Bland–Altman plots assessing test–retest reliability; and minimal detectable change were investigated in a convenience sample of 50 adults with CLBP in rural and urban Nigeria. Construct validity was examined using Spearman’s correlation analyses with the back-performance scale, Igbo Roland Morris Disability Questionnaire and eleven-point box scale; and exploratory factor analysis in a random sample of 200 adults with CLBP in rural Nigeria. Ceiling and floor effects were investigated in both samples.ResultsPatient instructions were also translated. ‘Waist pain/lower back pain’ was added to ‘illness(es)’ to make the measure relevant for this study whilst allowing for future studies involving other conditions. The Igbo phrase for ‘family and friends’ was used to better represent ‘people close to you’ in item D4.3. The Igbo-WHODAS had good internal consistency (α = 0.75–0.97); intra class correlation coefficients (ICC = 0.81–0.93); standard error of measurements (5.05–11.10) and minimal detectable change (13.99–30.77). Igbo-WHODAS correlated moderately with performance-based disability, self-reported back pain-specific disability and pain intensity, with a seven-factor structure and no floor and ceiling effects.ConclusionsIgbo-WHODAS appears psychometrically sound. Its research and clinical utility require further testing.

Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada.

Phase ii data are increasingly being used as primary evidence for public reimbursement for oncologic drugs. We compared the frequency of reimbursement recommendations for phase ii and phase iii submissions and assessed for variables associated with a positive or conditional recommendation. We identified submissions made to the pan-Canadian Oncology Drug Review's Expert Review Committee (perc), of the Canadian Agency for Drugs and Technologies in Health, July 2011 to July 2019, that were supported only by phase ii data. We identified variables within the perc's deliberative framework, including clinical and economic factors, associated with the final reimbursement recommendation. We conducted a multivariable analysis with logistic regression for these variables: feasibility of phase iii study, hematologic indication, and unmet need. We identified 139 submissions with a perc final recommendation. In 27 instances (19%), the submission had only phase ii evidence, and a positive recommendation was issued for 63% of them (the positive recommendation rate was 82% for submissions with phase iii evidence). Clinical benefit (p < 0.001), unmet need (p = 0.047), and patient alignment (p = 0.015) were associated with a positive recommendation. If a future phase iii study was deemed feasible for submissions with only phase ii evidence, then in univariable (p = 0.040) and multivariable analysis (p = 0.024), the perc was less likely to recommend reimbursement (odds ratio: 0.132). Although more than half the oncologic submissions with phase ii data were recommended for public reimbursement, compared with submissions having phase iii data, they were less likely to be recommended. A positive or conditional recommendation was more likely if clinical benefit and alignment with patient values was demonstrated. The perc was less likely to recommend reimbursement for submissions with phase ii evidence if a phase iii trial was deemed possible.

Reliability and Validity of an Adapted Questionnaire Assessing Occupational Exposures to Hazardous Chemicals among Health Care Workers in Bhutan.

Background: Collection of reliable and valid occupational history data is of utmost importance to assess work-related exposures and their health effects. Few standardized questionnaires are available for the collection of occupational history data in low-and-middle income countries. Objective: To adapt and test a validated questionnaire developed in the United States by the National Institute of Safety and Health, in order to assess occupational chemical exposures among health care workers in Bhutan. Methods: The questionnaire was first adapted to suit the Bhutanese context with the advice of an expert review committee. 30 health care workers then completed the questionnaire at baseline and 10–14 days later. Test-retest reliability was assessed by calculating Cohen's κ and percentage agreement. Results: The questionnaire had high test-retest reliability. Cohen's κ ranged from 0.61 to 1.00, and percentage agreement ranged from 86.7% to 100%. Further adaptations included omitting questions on chemicals not available in Bhutan. Conclusion: The adapted questionnaire is appropriate for assessing occupational chemical exposures among health care workers in Bhutan.

Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada.

e14133 Background: Historically, pharmaceutical companies submitted phase III evidence for consideration of public reimbursement; however, phase II data is being more commonly used as primary evidence. Whether submissions with phase II data lead to similar rates of positive reimbursement recommendations as phase III data has not been comprehensively investigated. We compared frequency of reimbursement recommendations between phase II and phase III submissions for oncologic drugs and assessed for factors associated with a positive or conditional recommendation. Methods: We identified all submissions with phase II data from the CADTH pCODR’s expert review committee (pERC) recommendations from July 2011 to July 2019. We identified fourteen binary variables relating to clinical benefit, patient-based values, economic impact, and adoption feasibility. We used Fisher’s exact test to characterize associations between all variables and the final recommendation. We conducted multivariable analysis with logistic regression for three variables: feasibility of phase III study, hematologic indication, and unmet need. Results: We identified 139 submissions with a pERC final recommendation. Twenty-seven (19%) submissions were supported by phase II evidence, with 63% having a positive recommendation in comparison to 82% among submissions with phase III evidence. Clinical benefit (p &lt; 0.001), gap in current treatment standards (p = 0.047), and patient alignment (p = 0.015) were associated with a positive recommendation, whereas the future feasibility of conducting a phase III study was associated with a negative recommendation (p = 0.040). No significant association was found between the recommendation and factors related to cost effectiveness or adoption feasibility. In multivariable analysis, only feasibility of a phase III study was significantly associated with a negative recommendation (p = 0.024, OR = 0.132). Conclusions: Oncologic submissions with phase II data were less likely to be recommended for public reimbursement than phase III studies. Positive or conditional recommendation was more likely if they demonstrated clinical benefit and aligned with patient values. pERC was less likely to recommend a submission with phase II if a phase III trial was either possible or already initiated.