Implementing health technology assessment in Kuwait: a qualitative study of perceived barriers and facilitators

Objectives: This study sought to explore main barriers and facilitators to implementing health technology assessment (HTA) in Kuwait from the perspective of key stakeholders. Methods: Semi-structured qualitative interviews were conducted with ten key stakeholders: seven healthcare providers working at various departments of the Kuwaiti Ministry of Health (MOH), and three academics with substantial experience in teaching HTA or related fields. Interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data were analyzed using an inductive thematic approach. Results: Participating stakeholders reported several factors that might act as a barrier to building HTA in Kuwait: minimal awareness of HTA, lack of institutional and human capacity, a fragmented healthcare system, poor communication between researchers and policy makers, the country's wealth, politics, as well as data quality, availability, and sharing. Institutionalizing HTA as a politically empowered body, enforcing its recommendation by law, and benefiting from neighboring countries' experiences were suggested as possible ways to move forward. Conclusion: Studies exploring the unique challenges that high-income developing countries may face in implementing HTA are still scarce. The results of this study are consistent with evidence coming from other developing countries, while also suggesting that the abundance of financial resources in the country is a double-edged sword; it has the potential to facilitate the development of HTA capacity, but also hinders recognizing the need for it

Longitudinal qualitative exploration of cancer information-seeking experiences across the disease trajectory: the INFO-SEEK protocol

Introduction Α substantial corpus of literature has sought to describe the information-seeking behaviour of patients with cancer. Yet, available evidence comes mainly from cross-sectional studies, which provide ‘snapshots’ of patients’ information needs and information-seeking styles at a single time point. Only a few longitudinal studies currently exist; however, these are quantitative in nature and, despite successfully documenting changes in patients’ information needs throughout the clinical course of cancer, they have failed to provide an evidence-based interpretation of the causes and consequences of change. The goal of this study is threefold: First, we wish to provide a holistic understanding of how cancer information-seeking behaviour may evolve across different stages of the patient journey. Second, we will seek to elucidate the contextual and intervening conditions that may affect possible changes in information seeking. Third, we will attempt to identify what the consequences of these changes are, while heightening their implications for clinical practice and policy. Methods and analysis We will carry out a longitudinal qualitative study, based on face-to-face, in-depth interviews with approximately 25 individuals diagnosed with cancer. Patients will be recruited from 2 oncology hospitals located in Ticino, Switzerland, and will be interviewed at 3 different time points: (1) within 2 weeks after receiving the cancer diagnosis; (2) within 2 weeks after their initial treatment; and (3) 6 months after their initial treatment. All interviews will be recorded and transcribed verbatim. A grounded theory approach will be used for the analysis of the data. Ethics and dissemination The study protocol has been approved by the Ethics Committee of Canton Ticino (CE 2813). Participation in the study will be voluntary, and confidentiality and anonymity ensured. Prior to study participation, patients will be asked to provide signed informed consent. Findings will be disseminated in international peer-reviewed journals and presented in relevant conferences

How methodological frameworks are being developed: evidence from a scoping review

Background: Although the benefits of using methodological frameworks are increasingly recognised, to date, there is no formal definition of what constitutes a ‘methodological framework’, nor is there any published guidance on how to develop one. For the purposes of this study we have defined a methodological framework as a structured guide to completing a process or procedure. This study’s aims are to: (a) map the existing landscape on the use of methodological frameworks; (b) identify approaches used for the development of methodological frameworks and terminology used; and (c) provide suggestions for developing future methodological frameworks. We took a broad view and did not limit our study to methodological frameworks in research and academia. Methods: A scoping review was conducted, drawing on Arksey and O’Malley’s methods and more recent guidance. We systematically searched two major electronic databases (MEDLINE and Web of Science), as well as grey literature sources and the reference lists and citations of all relevant papers. Study characteristics and approaches used for development of methodological frameworks were extracted from included studies. Descriptive analysis was conducted. Results: We included a total of 30 studies, representing a wide range of subject areas. The most commonly reported approach for developing a methodological framework was ‘Based on existing methods and guidelines’ (66.7%), followed by ‘Refined and validated’ (33.3%), ‘Experience and expertise’ (30.0%), ‘Literature review’ (26.7%), ‘Data synthesis and amalgamation’ (23.3%), ‘Data extraction’ (10.0%), ‘Iteratively developed’ (6.7%) and ‘Lab work results’ (3.3%). There was no consistent use of terminology; diverse terms for methodological framework were used across and, interchangeably, within studies. Conclusions: Although no formal guidance exists on how to develop a methodological framework, this scoping review found an overall consensus in approaches used, which can be broadly divided into three phases: (a) identifying data to inform the methodological framework; (b) developing the methodological framework; and (c) validating, testing and refining the methodological framework. Based on these phases, we provide suggestions to facilitate the development of future methodological frameworks

Reconstructing normality following the diagnosis of a childhood chronic disease: does “rare” make a difference?

Living with a childhood chronic disease can be challenging, especially if the diagnosis involves a rare condition. This study sought to elucidate how the diagnosis of a rare disease, as compared to a common, chronic condition, may influence maternal experiences of childhood illness. We conducted face-to-face, semi-structured interviews with 26 mothers of children treated in a pediatric hospital in the province of Lecco, Italy. Half of the participants had a child diagnosed with Bartter syndrome (BS), and the rest had a child suffering from celiac disease (CD). Interviews were recorded, transcribed, and analyzed using an inductive thematic approach. We identified three main themes from the analysis of our data: (1) disrupted normality and the need to know, (2) reconstructing normality, and (3) acting “normal.” Although most participants experienced the disclosure of diagnosis as a relief, processes that facilitated normality reconstruction in celiac families, notably access to appropriate information, social support, and personal contact with comparison others, were found to be important stressors for mothers living with BS. Conclusion: This comparative qualitative study provides evidence on how well-known problems associated with the rarity of childhood diseases impact on families’ efforts to cope with the illness and regain a sense of normality

First aid management of paediatric burn and scald injuries in Southern Malawi: a mixed methods study

Background: In sub-Saharan Africa, burn and scald injuries occur more commonly in children aged less than five years, than in any other age group, and carry a high lifetime morbidity. The optimal first aid at the time of injury includes the use of cool running water, which can reduce pain, scarring, and skin grafting. Data on the types of first aid used in Malawi is lacking, as is an in-depth understanding of the underlying factors which may influence this health behaviour. This study sought to: (a) document the types of first aid after paediatric burn and scald injuries in Southern Malawi; and (b) explore factors affecting the choice of first aid used. Methods and findings: We conducted a sequential explanatory mixed methods study. Quantitative analysis of a prospectively collected database of all patients aged less than 17 years admitted to the only burn unit in Southern Malawi was followed by thematic analysis of semi-structured interviews with 15 adults who had witnessed a paediatric burn or scald injury. 1326 patients aged less than 17 years were admitted to the Queen Elizabeth Central Hospital between July 2009 and December 2016. Median age was 3.0 years (IQR 1.9–5.0) and male to female ratio 1:0.9. The commonest cause of injury was hot liquid (45%), followed by open fire (31%) and porridge (12%). First aid was applied in 829 patients (69%), the commonest applications used were water (31%) and egg (21%). There was a statistically significant association between the type of first aid and secondary education of the father (p = 0.009) or mother (p = 0.036); however, the type of first aid used was more likely to be egg rather than water. Analysis of qualitative interviews identified four main themes: perceived roles and responsibilities within the community, drivers of individual behaviours, availability, and trust. Participants reported using eggs as a first aid treatment, as these were readily available and were seen to reduce the occurrence of blisters and prevent peeling of the skin. By comparison, there was a strong underlying fear of using water on burn injuries due to its association with peeling of the skin. Intergenerational learning appeared to play a strong role in influencing what is used at the time of injury, and mothers were the key source of this information. Conclusions: This study provides the largest description of first aid use in sub-Saharan Africa, strengthening the evidence that remedies aside from water are commonly used and that higher parental education levels do not translate to increased use of water, but rather use of alternative treatments. Our qualitative findings allow improved understanding of how first aid for paediatric burns is perceived in rural Malawi communities, providing insight as to why certain first aid choices are made and the possible barriers and facilitators to the adoption of water as a first aid treatment

Patient acceptability of three different central venous access devices for the delivery of systemic anticancer therapy:a qualitative study

Objective: Three types of central venous access devices (CVADs) are routinely used in the delivery of intravenous systemic anticancer therapy (SACT): peripherally inserted central catheters (PICCs), subcutaneously tunnelled central catheters (Hickman-type devices) and totally implantable chest wall ports (Ports). This qualitative study, nested within a multicentre, randomised controlled trial, sought to explore patient acceptability and experiences of the three devices. Design: Eight focus groups were audio-recorded, transcribed and thematically analysed. Setting: Six outpatient cancer treatment centres in the UK. Participants: Forty-two patients (20 female, mean age 61.7 years) who had taken part or were taking part in the broader trial. Intervention: As part of the larger, randomised controlled trial, participants had been randomly assigned one of three CVADs for the administration of SACT. Results: Attitudes towards all three devices were positive, with patients viewing their CVAD as part of their treatment and recovery. Participants with PICCs and Hickmans tended to compare their device favourably with peripheral cannulation. By comparison, participants with Ports consistently compared their device with PICCs and Hickmans, emphasising the perceived superiority of Ports. Ports were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships. Conclusions: Patient experiences and preferences have not been systematically used to inform policy and practice regarding CVAD availability and selection. Our research identified patterns of patient device preferences that favoured Ports, although this was not universal. Results of this study could improve support for patients and offer greater scope for incorporating patient perspectives into decision-making processes. Trial registration number: ISRCTN44504648

Can a meta-ethnography be updated by different reviewers? Reflections from a recent update

Over the last decade, there has been a proliferation of published meta-ethnographies. Yet, strategies and techniques for updating have not received the same attention, rendering answers to important methodological questions still elusive. One such question has to do with who can perform an update. Although it is not uncommon for quantitative systematic reviews and statistical meta-analyses to be updated by different reviewers, qualitative synthesists might find themselves caught between a rock and a hard place. On the one hand, as meta-ethnography constitutes an interpretation three times removed from the lived experience of the participants in the original studies, it could be argued that an update by different reviewers might add an extra layer of interpretation. By comparison, updating by the same reviewers could give rise to concerns about the robustness of updated findings, as an implicit drive for making new data fit the original work might be difficult to control for. We recently reported the findings of our attempt to update an earlier meta-ethnography of primary care antibiotic prescribing, conducted by a different team of reviewers. In this article, we wish to contribute to the emerging debate on the necessity of promoting a culture of updating in qualitative evidence synthesis, by discussing some of the practical and methodological issues we considered at each stage of the process and offering lessons learnt from our experience

HTA community perspectives on the use of patient preference information: lessons learned from a survey with members of HTA bodies

This research sought to assess whether and how patient preference (PP) data are currently used within health technology assessment (HTA) bodies and affiliated organizations involved in technology/drug appraisals and assessments. An exploratory survey was developed by the PP Project Subcommittee of the HTA International Patient and Citizen Involvement Interest Group to gain insight into the use, impact, and role of PP data in HTA, as well as the perceived barriers to its incorporation. Forty members of HTA bodies and affiliated organizations from twelve countries completed the online survey. PP data were reported to be formally considered as part of the HTA evidence review process by 82.5 percent of the respondents, while 39.4 percent reported that most of the appraisals and assessments within their organization in the past year had submitted PP data. The leading reason for why PP data were not submitted in most assessments was time/resource constraints followed by lack of clarity on PP data impact. Participants reported that PP data had a moderate level of influence on the deliberative process and outcome of the decision, but a higher level of influence on the decision’s quality. Most (81.8 percent) felt patient advocacy groups should be primarily responsible for generating and submitting this type of evidence. Insights from the survey confirm the use of PP data in HTA but reveal barriers to its broader and more meaningful integration. Encouragingly, participants believe obstacles can be overcome, paving the way for a second phase of research involving in-depth collaborative workshops with HTA representatives

Mapping the Insomnia Severity Index instrument to EQ-5D health state utilities: a United Kingdom perspective

Objective: This study aimed to map the Insomnia Severity Index (ISI) to the EQ-5D-3L utility values from a UK perspective. Methods: Source data were derived from the 2020 National Health and Wellness Survey (NHWS) for France, Germany, Italy, Spain, the UK and the US. Ordinary least squares regression, generalised linear model (GLM), censored least absolute deviation, and adjusted limited dependent variable mixture model (ALDVMM) were employed to explore the relationship between ISI total summary score and EQ-5D utility while accounting for adjustment covariates derived from the NHWS. Fitting performance was assessed using standard metrics, including mean-squared error (MSE) and coefficient of determination (R2). Results: A total of 17,955 respondent observations were included, with a mean ISI score of 12.12 ± 5.32 and a mean EQ-5D-3L utility (UK tariff) of 0.71 ± 0.23. GLM gamma-log and ALDVMM were the two best performing models. The ALDVMM had better fitting performance (R2 = 0.320, MSE 0.0347) than the GLM gamma-log (R2 = 0.303, MSE 0.0353); in train-test split-sample validation, ALDVMM also slightly outperformed the GLM gamma-log model, with an MSE of 0.0351 versus 0.0355. Based on fitting performance, ALDVMM and GLM gamma-log were the preferred models. Conclusions: In the absence of preference-based measures, this study provides an updated mapping algorithm for estimating EQ-5D-3L utilities from the ISI summary total score. This new mapping not only draws its strengths from the use of a large international dataset but also the incorporation of adjustment variables (including sociodemographic and general health characteristics) to reduce the effects of confounders

Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT

Background: Venous access devices are used for patients receiving long-term chemotherapy. These include centrally inserted tunnelled catheters or Hickman-type devices (Hickman), peripherally inserted central catheters (PICCs) and centrally inserted totally implantable venous access devices (PORTs). Objectives: To evaluate the clinical effectiveness, safety, cost-effectiveness and acceptability of these devices for the central delivery of chemotherapy. Design: An open, multicentre, randomised controlled trial to inform three comparisons: (1) peripherally inserted central catheters versus Hickman, (2) PORTs versus Hickman and (3) PORTs versus peripherally inserted central catheters. Pre-trial and post-trial qualitative research and economic evaluation were also conducted. Setting: This took place in 18 UK oncology centres. Participants: Adult patients (aged ≥ 18 years) receiving chemotherapy (≥ 12 weeks) for either a solid or a haematological malignancy were randomised via minimisation. Interventions: Hickman, peripherally inserted central catheters and PORTs. Primary outcome: A composite of infection (laboratory confirmed, suspected catheter related and exit site infection), mechanical failure, venous thrombosis, pulmonary embolism, inability to aspirate blood and other complications in the intention-to-treat population. Results: Overall, 1061 participants were recruited to inform three comparisons. First, for the comparison of peripherally inserted central catheters (n = 212) with Hickman (n = 212), it could not be concluded that peripherally inserted central catheters were significantly non-inferior to Hickman in terms of complication rate (odds ratio 1.15, 95% confidence interval 0.78 to 1.71). The use of peripherally inserted central catheters compared with Hickman was associated with a substantially lower cost (–£1553) and a small decrement in quality-adjusted life-years gained (–0.009). Second, for the comparison of PORTs (n = 253) with Hickman (n = 303), PORTs were found to be statistically significantly superior to Hickman in terms of complication rate (odds ratio 0.54, 95% confidence interval 0.37 to 0.77). PORTs were found to dominate Hickman with lower costs (–£45) and greater quality-adjusted life-years gained (0.004). This was alongside a lower complications rate (difference of 14%); the incremental cost per complication averted was £1.36. Third, for the comparison of PORTs (n = 147) with peripherally inserted central catheters (n = 199), PORTs were found to be statistically significantly superior to peripherally inserted central catheters in terms of complication rate (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). PORTs were associated with an incremental cost of £2706 when compared with peripherally inserted central catheters and a decrement in quality-adjusted life-years gained (–0.018) PORTs are dominated by peripherally inserted central catheters: alongside a lower complications rate (difference of 15%), the incremental cost per complication averted was £104. The qualitative work showed that attitudes towards all three devices were positive, with patients viewing their central venous access device as part of their treatment and recovery. PORTs were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships. The main limitation was the lack of adequate power (54%) in the non-inferiority comparison between peripherally inserted central catheters and Hickman. Conclusions: In the delivery of long-term chemotherapy, peripherally inserted central catheters should be considered a cost-effective option when compared with Hickman. There were significant clinical benefits when comparing PORTs with Hickman and with peripherally inserted central catheters. The health economic benefits were less clear from the perspective of incremental cost per quality-adjusted life-years gained. However, dependent on the willingness to pay, PORTs may be considered to be cost-effective from the perspective of complications averted. Future work: The deliverability of a PORTs service merits further study to understand the barriers to and methods of improving the service. Trial registration: This trial is registered as ISRCTN44504648. Funding: This project was funded by the National Institute for Health Research (NHIR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 47. See the NIHR Journals Library website for further project information