Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.

BACKGROUND: Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments. METHODS: This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into "satisfaction" (very satisfied or somewhat satisfied) and "non-satisfaction" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). RESULTS: We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower (£38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of £20,000 per QALY was 16%. CONCLUSION: We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46035546 registered on 11/02/10.

Social determinants of mental health among older adolescent girls living in urban informal settlements in Kenya and Nigeria during the COVID-19 pandemic.

The health burden due to mental health has historically been underestimated with focus on communicable diseases and deaths and little consideration of disability and comorbidity effects of poor mental health. Recent data show increasing trends of mental health disorders as a share of global health burdens and vulnerability of adolescents. This paper aims to explore social determinants of mental health as experienced by adolescent girls, drawing attention to gendered risks during the COVID-19 pandemic. Semi-structured interviews with twenty-two adolescent girls in urban informal settlements in Kenya and Nigeria reveal unique environmental, socio-cultural, economic and educational factors that threatened their mental wellbeing. The pandemic exacerbated these determinants. An equitable recovery will require a consideration of not only disproportional mental health outcomes, but also social determinants that contribute to these outcomes. As more than half of the urban population in sub-Saharan Africa reside in informal settlements, this study has implications for youth-focused mental health interventions in these and similar settings.

Climate Change, Extreme Weather, and Intimate Partner Violence in East African Agrarian-Based Economies.

Severe weather events can be a catalyst for intimate partner violence, particularly in agricultural settings. This research explores the association between weather and violence in parts of East Africa that rely on subsistence farming. We used IPUMS-DHS data from Uganda in 2006, Zimbabwe in 2010, and Mozambique in 2011 for intimate partner violence frequency and EM-DAT data to identify weather events by region in the year of and year prior to IPUMS-DHS data collection. This work is grounded in a conceptual framework that illustrates the mechanisms through which violence increases. We used logistic regression to estimate the odds of reporting violence in regions with severe weather events. The odds of reporting violence were 25% greater in regions with severe weather compared to regions without in Uganda (OR = 1.25, 95% CI: 1.11-1.41), 38% greater in Zimbabwe (OR = 1.38, 95% CI: 1.13-1.70), and 91% greater in Mozambique (OR = 1.91, 95% CI: 1.64-2.23). Our results add to the growing body of evidence showing that extreme weather can increase women's and girls' vulnerability to violence. Moreover, this analysis demonstrates that climate justice and intimate partner violence must be addressed together.

Policy and practices shaping the delivery of health services to pregnant adolescents in informal urban settlements in Kenya.

In Kenya, the pregnancy rate of 15% among adolescents aged 15-19 years is alarmingly high. Adolescent girls living in informal urban settlements are exposed to rapid socio-economic transitions and multiple intersecting health risks and may be particularly disadvantaged in accessing sexual reproductive health services. Understanding vulnerabilities and service-seeking behaviours from different perspectives is important in order to support the development and implementation of progressive policies and services that meet adolescents' unique needs within urban informal settlements. This study explored policy makers, community health service providers' and community members' perceptions of access to, and delivery of, sexual reproductive health services for pregnant adolescents in one informal urban settlement in Nairobi. We employed qualitative methods with respondents throughout the health system, purposively sampled by gender and diversity of roles. We conducted focus group discussions with community members (n = 2 female-only; n = 2 male-only), key informant interviews with policy makers (n = 8), traditional birth attendants (n = 12), community health volunteers (CHVs) (n = 11), a nutritionist (n = 1), social workers (n = 2) and clinical officers (n = 2). We analysed the data using thematic analysis. Government policies and strategies on sexual and reproductive health for adolescents exist in Kenya and there are examples of innovative and inclusive practice within facilities. Key factors that support the provision of services to pregnant adolescents include devolved governance, and effective collaboration and partnerships, including with CHVs. However, inadequate financing and medical supplies, human resource shortages and stigmatizing attitudes from health providers and communities, mean that pregnant adolescents from informal urban settlements often miss out on critical services. The provision of quality, youth-friendly reproductive health services for this group requires policies and practice that seek to achieve reproductive justice through centring the needs and realities of pregnant adolescents, acknowledging the complex and intersecting social inequities they face.

Microarray patch for HIV prevention and as a multipurpose prevention technology to prevent HIV and unplanned pregnancy: an assessment of potential acceptability, usability, and programmatic fit in Kenya.

Background: Microarray patches (MAPs), a novel drug delivery system, are being developed for HIV pre-exposure prophylaxis (PrEP) delivery and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy. Prevention technologies must meet the needs of target audiences, be acceptable, easy to use, and fit health system requirements. Methodology: We explored perceptions about MAP technology and assessed usability, hypothetical acceptability, and potential programmatic fit of MAP prototypes using focus group discussions (FGD), usability exercises, and key informant interviews (KII) among key populations in Kiambu County, Kenya. Adolescent girls and young women (AGYW), female sex workers (FSW), and men who have sex with men (MSM) assessed the usability and acceptability of a MAP prototype. Male partners of AGYW/FSW assessed MAP acceptability as partners of likely users. We analyzed data using NVivo, applying an inductive approach. Health service providers and policymakers assessed programmatic fit. Usability exercise participants applied a no-drug, no-microneedle MAP prototype and assessed MAP features. Results: We implemented 10 FGD (4 AGYW; 2 FSW; 2 MSM; 2 male partners); 47 mock use exercises (19 AGYW; 9 FSW; 8 MSM; 11 HSP); and 6 policymaker KII. Participants reported high interest in MAPs due to discreet and easy use, long-term protection, and potential for self-administration. MAP size and duration of protection were key characteristics influencing acceptability. Most AGYW preferred the MPT MAP over an HIV PrEP-only MAP. FSW saw value in both MAP indications and voiced need for MPTs that protect from other infections. Preferred duration of protection was 1-3 months. Some participants would accept a larger MAP if it provided longer protection. Participants suggested revisions to the feedback indicator to improve confidence. Policymakers described the MPT MAP as "killing two birds with one stone," in addressing AGYW needs for both HIV protection and contraception. An MPT MAP is aligned with Kenya's policy of integrating health care programs. Conclusions: MAPs for HIV PrEP and as an MPT both were acceptable across participant groups. Some groups valued an MPT MAP over an HIV PrEP MAP. Prototype refinements will improve usability and confidence.

Utilizing User Preferences in Designing the AGILE (Accelerating Access to Gender-Based Violence Information and Services Leveraging on Technology Enhanced) Chatbot.

INTRODUCTION: Technology advancements have enhanced artificial intelligence, leading to a user shift towards virtual assistants, but a human-centered approach is needed to assess for acceptability and effectiveness. The AGILE chatbot is designed in Kenya with features to redefine the response towards gender-based violence (GBV) among vulnerable populations, including adolescents, young women and men, and sexual and gender minorities, to offer accurate and reliable information among users. METHODS: We conducted an exploratory qualitative study through focus group discussions (FGDs) targeting 150 participants sampled from vulnerable categories; adolescent girls and boys, young women, young men, and sexual and gender minorities. The FGDs included multiple inquiries to assess knowledge and prior interaction with intelligent conversational assistants to inform the user-centric development of a decision-supportive chatbot and a pilot of the chatbot prototype. Each focus group comprised 9-10 members, and the discussions lasted about two hours to gain qualitative user insights and experiences. We used thematic analysis and drew on grounded theory to analyze the data. RESULTS: The analysis resulted in 14 salient themes composed of sexual violence, physical violence, emotional violence, intimate partner violence, female genital mutilation, sexual reproductive health, mental health, help-seeking behaviors/where to seek support, who to talk to, and what information they would like, features of the chatbot, access of chatbot, abuse and HIV, family and community conflicts, and information for self-care. CONCLUSION: Adopting a human-centered approach in designing an effective chatbot with as many human features as possible is crucial in increasing utilization, addressing the gaps presented by marginalized/vulnerable populations, and reducing the current GBV epidemic by moving prevention and response services closer to people in need.

Power and poverty: A participatory study on the complexities of HIV and intimate partner violence in an informal urban settlement in Nairobi, Kenya.

People in informal urban settlements in Kenya face multiple inequalities, yet researchers investigate issues such as HIV or intimate partner violence (IPV) in isolation, targeting single populations and focusing on individual behaviour, without involving informal settlement dwellers. We formed a study team of researchers (n = 4) and lay investigators (n = 11) from an informal settlement in Nairobi, Kenya to understand the power dynamics in the informal urban settlement that influence vulnerability to IPV and HIV among women and men from key populations in this context. We facilitated participatory workshops with 56 women and 32 men from different marginalised groups and interviewed 10 key informants. We used a participatory data analysis approach. Our findings suggest the IPV and HIV nexus is rooted in the daily struggle for cash and survival in the informal urban settlement where lucrative livelihoods are scarce and a few gatekeepers regulate access to opportunities. Power is gendered and used to exercise control over people and resources. Common coping strategies applied to mitigate against the effects of poverty and powerlessness amplify vulnerabilities to HIV and IPV. These complex power relations create and sustain an environment conducive to IPV and HIV. Prevention interventions thus need to address underlying structural drivers, uphold human rights, create safe environments, and promote participation to maximise and sustain the positive effects of biomedical, behavioural, and empowerment strategies.

Food insecurity and COVID-19 risk in low- and middle-income countries.

The COVID-19 pandemic prompted social distancing, workplace closures, and restrictions on mobility and trade that had cascading effects on economic activity, food prices, and employment in low- and middle-income countries. Using longitudinal data from Bangladesh, Kenya, and Nigeria covering a period from October 2020 to April 2021, the paper assesses whether knowledge of a person infected with COVID-19 is associated with food insecurity, job loss and business closures, and coping strategies to smooth consumption. The likelihood of households to experience food insecurity at the extensive and intensive margins increased among those who knew an infected person in Bangladesh and Kenya.

Changes in prevalence of violence and risk factors for violence and HIV among children and young people in Kenya: a comparison of the 2010 and 2019 Kenya Violence Against Children and Youth Surveys.

BACKGROUND: Previous research has shown a high prevalence of violence among young people in Kenya. Violence is a known risk factor for HIV acquisition and these two public health issues could be viewed as a syndemic. In 2010, Kenya became the third country to implement the Violence Against Children and Youth Survey (VACS). The study found a high prevalence of violence in the country. Led by the Government of Kenya, stakeholders implemented several prevention and response strategies to reduce violence. In 2019, Kenya implemented a second VACS. This study examines the changes in violence and risk factors for violence and HIV between 2010 and 2019. METHODS: The 2010 and 2019 VACS used a similar sampling approach and measures. Both VACS were cross-sectional national household surveys of young people aged 13-24 years, designed to produce national estimates of physical, sexual, and emotional violence. Prevalence and changes in lifetime experiences of violence and risk factors for violence and HIV were estimated. The VACS uses a three-stage cluster sampling approach with random selection of enumeration areas as the first stage, households as the second stage, and an eligible participant from the selected household as the third stage. The VACS questionnaire contains sections on demographics, risk and protective factors, violence victimisation, violence perpetration, sexual behaviour, HIV testing and services, violence service knowledge and uptake, and health outcomes. For this study, the main outcome variables were violence victimisation, context of violence, and risk factors for violence. All analyses were done with the entire sample of 13-24-year-olds stratified by sex and survey year. FINDINGS: The prevalence of lifetime sexual, physical, and emotional violence significantly declined in 2019 compared with 2010, including unwanted sexual touching, for both females and males. Experience of pressured and forced sex among females also decreased between the surveys. Additionally, significantly more females sought and received services for sexual violence and significantly more males knew of a place to seek help in 2019 than in 2010. The prevalence of several risk factors for violence and HIV also declined, including infrequent condom use, endorsement of inequitable gender norms, endorsement of norms justifying wife beating, and never testing for HIV. INTERPRETATION: Kenya observed significant declines in the prevalence of lifetime violence and some risk factors for violence and HIV, and improvements in some service seeking indicators between 2010 and 2019. Continued prioritisation of preventing and responding to violence in Kenya could contribute to further reductions in violence and its negative outcomes. Other countries in the region that have made substantial investments and implemented similar violence prevention programmes could use repeat VACS data to monitor violence and related outcomes over time. FUNDING: None.

Study protocol: improving patient choice in treating low back pain (IMPACT-LBP): a randomised controlled trial of a decision support package for use in physical therapy.

BACKGROUND: Low back pain is a common and costly condition. There are several treatment options for people suffering from back pain, but there are few data on how to improve patients' treatment choices. This study will test the effects of a decision support package (DSP), designed to help patients seeking care for back pain to make better, more informed choices about their treatment within a physiotherapy department. The package will be designed to assist both therapist and patient. METHODS/DESIGN: Firstly, in collaboration with physiotherapists, patients and experts in the field of decision support and decision aids, we will develop the DSP. The work will include: a literature and evidence review; secondary analysis of existing qualitative data; exploration of patients' perspectives through focus groups and exploration of experts' perspectives using a nominal group technique and a Delphi study.Secondly, we will carry out a pilot single centre randomised controlled trial within NHS Coventry Community Physiotherapy. We will randomise physiotherapists to receive either training for the DSP or not. We will randomly allocate patients seeking treatment for non specific low back pain to either a physiotherapist trained in decision support or to receive usual care. Our primary outcome measure will be patient satisfaction with treatment at three month follow-up. We will also estimate the cost-effectiveness of the intervention, and assess the value of conducting further research. DISCUSSION: Informed shared decision-making should be an important part of any clinical consultation, particularly when there are several treatments, which potentially have moderate effects. The results of this pilot will help us determine the benefits of improving the decision-making process in clinical practice on patient satisfaction. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46035546.

Design and development of a decision support package for low back pain.

OBJECTIVE: To develop a decision support package for people with low back pain (LBP) referred for physiotherapy. METHODS: We used a program of exploratory work, including literature reviews, a Delphi study, a nominal group with physiotherapists, focus groups with patients, and secondary analysis of existing interview data. RESULTS: We developed an information booklet describing the evidence-based treatment modalities available in a physiotherapy department. This includes data on likely benefits and risks and how the intervention is delivered. The booklet specifically addresses questions identified as important in our exploratory work. Space is provided for patients to note down the pros and cons of each treatment and what matters to them when choosing treatments. The patient is subsequently directed to a section that explores any gaps in knowledge, values, support, and choice before finally clarifying if a treatment decision is possible. At this stage they are encouraged to note down any questions or concerns they have to be discussed at the first physiotherapy consultation. This overall package includes patient material in the form of a booklet posted prior to their consultation, plus the enhanced consultation with the specially trained physiotherapist. Patients then receive their chosen treatment. In addition we developed a training package for physiotherapists that explains the content of the booklet and supports them in using informed, shared decision making in their consultation. CONCLUSION: This package has the potential to improve effectiveness of treatments and patient satisfaction for LBP by facilitating patient choice and therefore matching patients more effectively to different treatments.

Automated proteomics of E. coli via top-down electron-transfer dissociation mass spectrometry.

Electron-transfer dissociation (ETD) has recently been introduced as a fragmentation method for peptide and protein analysis. Unlike collisionally induced dissociation (CID), fragmentation by ETD occurs randomly along the peptide backbone. With the use of the sequences determined from the protein termini and the parent protein mass, intact proteins can be unambiguously identified. Because of the fast kinetics of these reactions, top-down proteomics can be performed using ETD in a linear ion trap mass spectrometer on a chromatographic time scale. Here we demonstrate the utility of ETD in high-throughput top-down proteomics using soluble extracts of E. coli. Development of a multidimensional fractionation platform, as well as a custom algorithm and scoring scheme specifically designed for this type of data, is described. The analysis resulted in the robust identification of 322 different protein forms representing 174 proteins, comprising one of the most comprehensive data sets assembled on intact proteins to date.