Measurement of the major ignored burden of multiple myeloma, pernicious anaemia and of other haematological conditions on partners and family members: A cross-sectional study.

BACKGROUND: Having a haematological condition can adversely affect the quality of life (QoL) of family members/partners of patients. It is important to measure this often ignored burden in order to implement appropriate supportive interventions. OBJECTIVE: To measure current impact of haematological conditions on the QoL of family members/partners of patients, using the Family Reported Outcome Measure-16 (FROM-16). METHODS: A cross-sectional study, recruited online through patient support groups, involved UK family members/partners of people with haematological conditions completing the FROM-16. RESULTS: 183 family members/partners (mean age = 60.5 years, SD = 13.2; females = 62.8%) of patients (mean age = 64.1, SD = 12.8; females = 46.4%) with 12 haematological conditions completed the FROM-16. The FROM-16 mean total score was 14.0 (SD = 7.2), meaning 'a moderate effect on QoL'. The mean FROM-16 scores of family members of people with multiple myeloma (mean = 15.8, SD = 6.3, n = 99) and other haematological malignancies (mean = 13.9, SD = 7.8, n = 29) were higher than of people with pernicious anaemia (mean = 10.7, SD = 7.5, n = 47) and other non-malignant conditions (mean = 11, SD = 7.4, n = 56, p < .01). Over one third (36.1%, n = 183) of family members experienced a 'very large effect' (FROM-16 score>16) on their quality of life. CONCLUSIONS: Haematological conditions, in particular those of malignant type, impact the QoL of family members/partners of patients. Healthcare professionals can now, using FROM-16, identify those most affected and should consider how to provide appropriate holistic support within routine practice.

Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16).

BACKGROUND: The FROM-16 is a generic family quality of life (QoL) instrument that measures the QoL impact of patients' disease on their family members/partners. The study aimed to assess the responsiveness of FROM-16 to change and determine Minimal Important Change (MIC). METHODS: Responsiveness and MIC for FROM-16 were assessed prospectively with patients and their family members recruited from outpatient departments of the University Hospital Wales and University Hospital Llandough, Cardiff, United Kingdom. Patients completed the EQ-5D-3L and a global severity question (GSQ) online at baseline and at 3-month follow-up. Family members completed FROM-16 at baseline and a Global Rating of Change (GRC) in addition to FROM-16 at follow-up. Responsiveness was assessed using the distribution-based (effect size-ES, standardized response mean -SRM) and anchor-based (area under the receiver operating characteristics curve ROC-AUC) approaches and by testing hypotheses on expected correlation strength between FROM-16 change score and patient assessment tools (GSQ and EQ-5D). Cohen's criteria were used for assessing ES. The AUC ≥ 0.7 was considered a good measure of responsiveness. MIC was calculated using anchor-based (ROC analysis and adjusted predictive modelling) and distribution methods based on standard deviation (SD) and standard error of the measurement (SEM). RESULTS: Eighty-three patients with 15 different health conditions and their relatives completed baseline and follow-up questionnaires and were included in the responsiveness analysis. The mean FROM-16 change over 3 months = 1.43 (SD = 4.98). The mean patient EQ-5D change over 3 months = -0.059 (SD = 0.14). The responsiveness analysis showed that the FROM-16 was responsive to change (ES = 0.2, SRM = 0.3; p < 0.01). The ES and SRM of FROM-16 change score ranged from small (ES = 0.2; SRM = 0.3) for the distribution-based method to large (ES = 0.8, SRM = 0.85) for anchor-based methods. The AUC value was above 0.7, indicating good responsiveness. There was a significant positive correlation between the FROM-16 change scores and the patient's disease severity change scores (p < 0.001). The MIC analysis was based on data from 100 family members of 100 patients. The MIC value of 4 was suggested for FROM-16. CONCLUSIONS: The results of this study confirm the longitudinal validity of FROM-16 which refers to the degree to which an instrument is able to measure change in the construct to be measured. The results yield a MIC value of 4 for FROM-16. These psychometric attributes of the FROM-16 instrument are useful in both clinical research as well as clinical practice.

Mapping of Family Reported Outcome Measure (FROM-16) scores to EQ-5D: algorithm to calculate utility values.

OBJECTIVE: Although decision scientists and health economists encourage inclusion of family member/informal carer utility in health economic evaluation, there is a lack of suitable utility measures comparable to patient utility measures such those based on the EQ-5D. This study aims to predict EQ-5D-3L utility values from Family Reported Outcome Measure (FROM-16) scores, to allow the use of FROM-16 data in health economic evaluation when EQ-5D data is not available. METHODS: Data from 4228 family members/partners of patients recruited to an online cross-sectional study through 58 UK-based patient support groups, three research support platforms and Welsh social services departments were randomly divided five times into two groups, to derive and test a mapping model. Split-half cross-validation was employed, resulting in a total of ten multinomial logistic regression models. The Monte Carlo simulation procedure was used to generate predicted EQ-5D-3L responses, and utility scores were calculated and compared against observed values. Mean error and mean absolute error were calculated for all ten validation models. The final model algorithm was derived using the entire sample. RESULTS: The model was highly predictive, and its repeated fitting using multinomial logistic regression demonstrated a stable model. The mean differences between predicted and observed health utility estimates ranged from 0.005 to 0.029 across the ten modelling exercises, with an average overall difference of 0.015 (a 2.2% overestimate, not of clinical importance). CONCLUSIONS: The algorithm developed will enable researchers and decision scientists to calculate EQ-5D health utility estimates from FROM-16 scores, thus allowing the inclusion of the family impact of disease in health economic evaluation of medical interventions when EQ-5D data is not available.

Venous thromboembolic disease in adults admitted to hospital in a setting with a high burden of HIV and TB.

BACKGROUND: HIV and tuberculosis (TB) independently cause an increased risk for venous thromboembolic disease (VTE): deep vein thrombosis (DVT) and/or pulmonary embolism (PE). Data from high HIV and TB burden settings describing VTE are scarce. The Wells' DVT and PE scores are widely used but their utility in these settings has not been reported on extensively. OBJECTIVES: To evaluate new onset VTE, compare clinical characteristics by HIV status, and the presence or absence of TB disease in our setting. We also calculate the Wells' score for all patients. METHODS: A prospective cohort of adult in-patients with radiologically confirmed VTE were recruited into the study between September 2015 and May 2016. Demographics, presence of TB, HIV status, duration of treatment, CD4 count, viral load, VTE risk factors, and parameters to calculate the Wells' score were collected. RESULTS: We recruited 100 patients. Most of the patients were HIV-infected (n=59), 39 had TB disease and 32 were HIV/TB co-infected. Most of the patients had DVT only (n=83); 11 had PE, and 6 had both DVT and PE. More than a third of patients on antiretroviral treatment (ART) (43%; n=18/42) were on treatment for <6 months. Half of the patients (51%; n=20/39) were on TB treatment for <1 month. The median (interquartile range (IQR)) DVT and PE Wells' score in all sub-groups was 3.0 (1.0 - 4.0) and 3.0 (2.5 - 4.5), respectively. CONCLUSION: HIV/TB co-infection appears to confer a risk for VTE, especially early after initiation of ART and/or TB treatment, and therefore requires careful monitoring for VTE and early initiation of thrombo-prophylaxis.

Predictors of delay in the diagnosis and treatment of suspected tuberculosis in HIV co-infected patients in South Africa.

SETTING: In South Africa, the majority of tuberculosis (TB) patients are co-infected with the human immunodeficiency virus (HIV), and delays in diagnosis and treatment likely exacerbate morbidity and mortality. OBJECTIVE: To determine predictors of delays in the diagnosis and treatment of hospitalised suspected pulmonary TB patients co-infected with HIV. DESIGN: Post-analysis of data collected in a three-centre prospective cohort of in-patients clinically diagnosed with active TB in three hospitals in South Africa between 2006 and 2009 during the first 24 h of admission. Delay was assessed by asking time of first symptoms and any prior health-seeking behaviour for this episode of illness. RESULTS: Data from a total of 891 participants with a median age of 36 years and a CD4 count of 67 cells/mm(3) were analysed. Median patient, system and total delays were respectively 28, 1 and 28 days. Unemployment, treatment at Tshepong Hospital, alcohol consumption, crowding index, seeking prior treatment, cotrimoxazole treatment and WHO Stage 4 disease predicted prolonged total delay. CONCLUSION: Patient delay in seeking care for TB in this high HIV prevalence setting is substantial. Factors identified with delay could be used to develop interventions to improve care seeking and earlier diagnosis of TB.

Challenges experienced by service providers in the delivery of medico-legal services to survivors of sexual violence in Kenya.

While much discussion has been devoted to defining the standards of care required when offering services to survivors of sexual violence, much less attention has been given to procedures for evidence collection to allow the successful prosecution of perpetrators. In Kenya there are no comprehensive guidelines that outline the roles of the survivor, the community, health care workers, and the police with regard to the handling of forensic evidence, a deficit that contributes to delays in prosecuting, or even a failure to prosecute sex offenders. This study examines some of the obstacles in Kenya to the adequate handling of forensic evidence in sexual violence cases. It was based on in-depth interviews with respondents drawn from health facilities, police stations, civil society organizations and with the Government Chemist in three Kenyan provinces. The study's objective was to examine the existing policy requirements regarding the maintenance of an evidence chain by the health and criminal justice systems, and how effectively they are being implemented. The findings indicate that the quality of the evidence obtained by the health care workers was often deficient, depending on the time elapsed before the rape survivor reports to the health facility; the equipment available at the health facility; the age of the survivor; and the level of knowledge of the service provider regarding the types of evidence to be collected from survivors of sexual violence.

Using VCT statistics from Kenya in understanding the association between gender and HIV.

This paper demonstrates the importance of utilising official statistics from the voluntary counselling and testing centres (VCT) to determine the association between gender and HIV infection rates in Kenya.The study design adopted was a record based survey of data collected from VCT sites in Kenya between the second quarter of 2001 and the second quarter of 2004. Of those who were tested, significantly more females tested positive (P<0.0001) and had twice as high a chance of being infected by HIV (Odds ratio 2.27 with CI 2.23 to 2.31) than males.We conclude that VCT statistics may lead to better planning of services and gender sensitive interventions if utilised well.

Using VCT Statistics from Kenya in Understanding the Association between Gender and HIV

This paper demonstrates the importance of utilising official statistics from the voluntary counselling and testing centres (VCT) to determine the association between gender and HIV infection rates in Kenya.The study design adopted was a record based survey of data collected from VCT sites in Kenya between the second quarter of 2001 and the second quarter of 2004. Of those who were tested; significantly more females tested positive (P0.0001) and had twice as high a chance of being infected by HIV (Odds ratio 2.27 with CI 2.23 to 2.31) than males.We conclude that VCT statistics may lead to better planning of services and gender sensitive interventions if utilised well

Intention-to-treat analysis in the chronic suppurative otitis media trials.

OBJECTIVE: To determine the extent of application of the intention to treat principle in the chronic suppurative otitis media (CSOM) randomised controlled trials. DESIGN: Data were extracted from 28 CSOM randomised controlled trials. MAIN OUTCOME MEASURES: Conceptual and methodological approaches of dealing with protocol deviations with respect to withdrawal, missing response and non-compliance. RESULTS: Of the 28 CSOM trials included in this study, only one (4%) trial mentioned intention-to-treat (ITT) analysis. However, 10(36%) other trials which did not mention ITT, had no protocol deviations and thus carried out an ITT analysis by default. It is highly likely that a biased treatment effect existed in the trial that mentioned ITT since the authors undertook a complete case analysis disregarding the 22% protocol deviators. There were no attempts in any of the trials to impute for missing responses and carrying out a sensitivity analysis. For trials with a big percentage of protocol deviations, the validity of their results are brought to question. CONCLUSIONS: In practice, not all those entered into a randomised-controlled trial will complete the trial. Thus intention-to-treat analysis is an important aspect of randomised controlled trials of health care interventions which tries to bridge this gap. It is important for authors to explicitly state the protocol deviations, the methods used to handle them and the potential effect with reference to bias and study outcome.