Experiences from the frontline: An exploration of personal advisers’ practice with claimants who have health‐related needs within UK welfare‐to‐work provision

Recent UK welfare reforms have been less successful than expected by the Government in supporting unemployed people with long‐term illness into work. Frontline workers remain a core element of the new welfare‐to‐work machinery, but operate within a changed organisational and policy landscape. These changes raise important questions regarding whether and how claimants’ health‐related barriers to work are considered. This paper examines the UK welfare‐to‐work frontline worker's role with claimants who have long‐term illness. Fieldwork observations in three not‐for‐profit employment support services and semi‐structured interviews with 29 participants (claimants, frontline workers, healthcare professionals and managers) were conducted between 2011 and 2012. Participant observation of the wider welfare‐to‐work arena was initiated in 2009 and continued until 2013. A qualitative methodology drawing on ethnographic principles was adopted. Thematic analysis of the data was carried out. The findings show that the frontline worker plays a key role in assessing and addressing claimants’ health‐related barriers to work. Two important health‐related role dimensions were identified: a health promoter role which involved giving health promotional advice to claimants about their general health; and a health monitor role which involved observing and questioning claimants about their general health. Frontline workers’ practice approaches were shaped by organisational and individual factors. Integration between the National Health Service and employment support services was limited, and the findings suggested improvements were required to ensure an adequate response to claimants’ health‐related needs to support their journey into work.     

Perceived information needs and non‐adherence: evidence from Greek patients with hypertension

Background The role of information on patients’ decision to non‐adhere is important, yet not well explored. Objective To identify differences between perceived information needs for hypertension and medication to treat it, to explore the information channels used by patients and to test what type of information is more important to adhere to medication. Design, setting and participants A questionnaire study was designed and conducted by telephone in the Centre for the Treatment of Hypertension in Athens, Greece, among 743 individuals. Main variables studied The main variables included perceived information needs, information channels, non‐adherence to medication and socio‐demographic characteristics. Main outcome measures Non‐adherence to medication was measured using the Morisky scale. Results Patients reported feeling better informed about hypertension (90%) than medication to treat it (80%). The doctor remains the dominant information source, while the Media and magazines on health issues were reported more frequently than the family and the pharmacist. Feeling well informed about medication for hypertension was a predictor of better adherence. Other determinants of adherence were the use of the Internet and the Media. Discussion The results confirm the importance of patients leaving the consultation feeling well informed about their medication as this improves adherence. They also show that the use of the Internet and the Media can be beneficial for adherence. Conclusions Given the restricted time the doctor can usually spend with the patient, it is important to know that more emphasis on the information regarding medication is important.     

‘Rule your condition,don't let it rule you’: young adults’ sense of mastery in their accounts of growing up with a chronic illness

Poor control of chronic illness is often attributed to patients’ non‐adherence to medical advice and treatment. Policy and practice has traditionally focused on improving adherence, assuming that the more patients comply, the better their control and outcomes will be. Drawing on complexity theory, we question this logic in a secondary analysis of qualitative data from studies of young adults’ experiences of growing up with a chronic illness. Examining their sense of mastery of their condition, we found they valued both being in medical control of their condition and having autonomy but had different ideas about how to achieve these goals. While some young adults mostly shared the traditional medical view that achieving good control was the key to retaining their autonomy, others saw control and autonomy as independent, non‐linear and potentially conflicting goals. The latter endeavoured to achieve both goals by striking a balance, variously adopting strategies of engagement with and resistance to their regime in the changing social contexts of their lives. We suggest that policy and practice needs to do more to promote autonomy and adaptive capacity, rather than simply maximising adherence and control, recognising the mundane complexity of living with and managing a chronic illness.     

Using structural‐nested models to estimate the effect of cluster‐level adherence on individual‐level outcomes with a three‐armed cluster‐randomized trial

Much attention has been paid to estimating the causal effect of adherence to a randomized protocol using instrumental variables to adjust for unmeasured confounding. Researchers tend to use the instrumental variable within one of the three main frameworks: regression with an endogenous variable, principal stratification, or structural‐nested modeling. We found in our literature review that even in simple settings, causal interpretations of analyses with endogenous regressors can be ambiguous or rely on a strong assumption that can be difficult to interpret. Principal stratification and structural‐nested modeling are alternative frameworks that render unambiguous causal interpretations based on assumptions that are, arguably, easier to interpret. Our interest stems from a wish to estimate the effect of cluster‐level adherence on individual‐level binary outcomes with a three‐armed cluster‐randomized trial and polytomous adherence. Principal stratification approaches to this problem are quite challenging because of the sheer number of principal strata involved. Therefore, we developed a structural‐nested modeling approach and, in the process, extended the methodology to accommodate cluster‐randomized trials with unequal probability of selecting individuals. Furthermore, we developed a method to implement the approach with relatively simple programming. The approach works quite well, but when the structural‐nested model does not fit the data, there is no solution to the estimating equation. We investigate the performance of the approach using simulated data, and we also use the approach to estimate the effect on pupil absence of school‐level adherence to a randomized water, sanitation, and hygiene intervention in western Kenya. Copyright © 2013 John Wiley & Sons, Ltd.     

Estimating the efficacy of an interstitial cystitis/painful bladder syndrome medication in a randomized trial with both non‐adherence and loss to follow‐up

We are motivated by a randomized clinical trial evaluating the efficacy of amitriptyline for the treatment of interstitial cystitis and painful bladder syndrome in treatment‐naïve patients. In the trial, both the non‐adherence rate and the rate of loss to follow‐up are fairly high. To estimate the effect of the treatment received on the outcome, we use the generalized structural mean model (GSMM), originally proposed to deal with non‐adherence, to adjust for both non‐adherence and loss to follow‐up. In the model, loss to follow‐up is handled by weighting the estimation equations for GSMM with one over the probability of not being lost to follow‐up, estimated using a logistic regression model. We re‐analyzed the data from the trial and found a possible benefit of amitriptyline when administered at a high‐dose level. Copyright © 2012 John Wiley & Sons, Ltd.     

Incorporation of the time aspect into the liability‐threshold model for case‐control‐family data

Familial aggregation and the role of genetic and environmental factors can be investigated through family studies analysed using the liability‐threshold model. The liability‐threshold model ignores the timing of events including the age of disease onset and right censoring, which can lead to estimates that are difficult to interpret and are potentially biased. We incorporate the time aspect into the liability‐threshold model for case‐control‐family data following the same approach that has been applied in the twin setting. Thus, the data are considered as arising from a competing risks setting and inverse probability of censoring weights are used to adjust for right censoring. In the case‐control‐family setting, recognising the existence of competing events is highly relevant to the sampling of control probands. Because of the presence of multiple family members who may be censored at different ages, the estimation of inverse probability of censoring weights is not as straightforward as in the twin setting but requires consideration. We propose to employ a composite likelihood conditioning on proband status that markedly simplifies adjustment for right censoring. We assess the proposed approach using simulation studies and apply it in the analysis of two Danish register‐based case‐control‐family studies: one on cancer diagnosed in childhood and adolescence, and one on early‐onset breast cancer. Copyright © 2017 John Wiley & Sons, Ltd.     

A community‐of‐care: the integration of a palliative approach within residential aged care facilities in Australia

In developed countries, residential aged care facilities (RACFs) are increasingly becoming the place of care and site of death for older people with complex chronic illnesses. Consequently, it is becoming ever more relevant for these facilities to provide appropriate complex, as well as end‐of‐life care for this growing group of people. Evidence‐based guidelines for providing a ‘palliative approach’ were developed and introduced in Australia in 2004, with the emphasis on improving symptom control earlier in the disease trajectory. The aim of the study reported here was to explore the extent to which a palliative approach was being used in the organisation and provision of care for older people with complex needs living in mixed‐level (a combination of low‐ and high‐level care) RACFs. This paper primarily reports on the qualitative findings. Two residential aged care organisations, one in rural New South Wales and the other in Sydney, Australia, participated. Data were collected over a 9‐month period from May until December 2008. Residents, family members and aged care staff were interviewed. Thematic analysis of participant interviews shows that while the various elements of a palliative approach are incorporated into the care of high‐level care residents, the discourse itself is not used. In this paper, we argue for a new conceptualisation of care for people in mixed‐level care facilities: a community‐of‐care, in which a palliative approach is one of several components of the care provided. The findings illuminate aged care staff experiences of providing care to high‐level care residents. They also provide valuable insights into high‐level care residents’ perceptions of their health, care provided and the way in which they foresee their care being provided in future. These findings will be important for informing clinical practice, research and policy in these settings.     

Clinical decision‐making in the context of chronic illness

This paper develops a framework to compare clinical decision making in relation to chronic and acute medical conditions. Much of the literature on patient‐physician decision making has focused on acute and often life‐threatening medical situations in which the patient is highly dependent upon the expertise of the physician in providing the therapeutic options. Decision making is often constrained and driven by the overwhelming impact of the acute medical problem on all aspects of the individual’s life. With chronic conditions, patients are increasingly knowledgeable, not only about their medical conditions, but also about traditional, complementary, and alternative therapeutic options. They must make multiple and repetitive decisions, with variable outcomes, about how they will live with their chronic condition. Consequently, they often know more than attending treatment personnel about their own situations, including symptoms, responses to previous treatment, and lifestyle preferences. This paper compares the nature of the illness, the characteristics of the decisions themselves, the role of the patient, the decision‐making relationship, and the decision‐making environment in acute and chronic illnesses. The author argues for a different understanding of the decision‐making relationships and processes characteristic in chronic conditions that take into account the role of trade‐offs between medical regimens and lifestyle choices in shaping both the process and outcomes of clinical decision‐making. The paper addresses the concerns of a range of professional providers and consumers.     

The medical visit context of treatment decision‐making and the therapeutic relationship

The ascendance of the autonomy paradigm in treatment decision‐making has evolved over the past several decades to the point where few bioethicists would question that it is the guiding value driving health‐care provider behaviour. In achieving quasi‐legal status, decision‐making has come to be regarded as a formality largely removed from the broader context of medical communication and the therapeutic relationship within which care is delivered. Moreover, disregard for individual patient preference, resistance, reluctance, or incompetence has at times produced pro forma and useless autonomy rituals. Failures of this kind, have been largely attributed to the psychological dynamics of the patients, physicians, illnesses, and contexts that characterize the medical decision. There has been little attempt to provide a framework for accommodating or understanding the larger social context and social influences that contribute to this variation. Applying Paulo Freire’s participatory social orientation model to the context of the medical visit suggests a framework for viewing the impact of physicians’ communication behaviours on patients’ capacity for treatment decision‐making. Physicians’ use of communication strategies can act to reinforce an experience of patient dependence or self‐reliance in regard to the patient‐physician relationship generally and treatment decision‐making, in particular. Certain communications enhance patient participation in the medical visit’s dialogue, contribute to patient engagement in problem posing and problem‐solving, and finally, facilitate patient confidence and competence to undertake autonomous action. The purpose of this essay is to place treatment decision‐making within the broader context of the therapeutic relationship, and to describe ways in which routine medical visit communication can accommodate individual patient preferences and help develop and further patient capacity for autonomous decision‐making.     

Flexible Rigidity

Summary

This paper examines adherence to AIDS treatment, focusing on the challenges posed by rapidly changing treatment protocols. We examine the evolving views of treatment adherence, and endorse the “concordance” approach. This emphasizes collaboration and negotiation between provider and patient to formulate and maintain a manageable treatment regimen tailored to what the patient is ready, willing, and able to tolerate. Given the extreme rapidity with which treatment guidelines are revised or even reversed, the persistent uncertainty surrounding treatment risks and benefits, and the great variability in individuals' ability to tolerate a given regimen, we propose the term “flexible rigidity” to describe the type of adherence best suited to AIDS treatment. We present an organizational approach to supporting the type of provider-patient relationships needed to improve treatment adherence that features treatment-readiness assessment and custom-tailoring of treatment for those at all stages of the treatment-readiness continuum. We note that this model could be applied as well to prevention and management of other chronic diseases.     

Estimands in clinical trials – broadening the perspective

Defining the scientific questions of interest in a clinical trial is crucial to align its planning, design, conduct, analysis, and interpretation. However, practical experience shows that oftentimes specific choices in the statistical analysis blur the scientific question either in part or even completely, resulting in misalignment between trial objectives, conduct, analysis, and confusion in interpretation. The need for more clarity was highlighted by the Steering Committee of the International Council for Harmonization (ICH) in 2014, which endorsed a Concept Paper with the goal of developing a new regulatory guidance, suggested to be an addendum to ICH guideline E9. Triggered by these developments, we elaborate in this paper what the relevant questions in drug development are and how they fit with the current practice of intention‐to‐treat analyses. To this end, we consider the perspectives of patients, physicians, regulators, and payers. We argue that despite the different backgrounds and motivations of the various stakeholders, they all have similar interests in what the clinical trial estimands should be. Broadly, these can be classified into estimands addressing (a) lack of adherence to treatment due to different reasons and (b) efficacy and safety profiles when patients, in fact, are able to adhere to the treatment for its intended duration. We conclude that disentangling adherence to treatment and the efficacy and safety of treatment in patients that adhere leads to a transparent and clinical meaningful assessment of treatment risks and benefits. We touch upon statistical considerations and offer a discussion of additional implications. Copyright © 2016 John Wiley & Sons, Ltd.     

‘They’re doing surgery on two people’: a meta‐ethnography of the influences on couples’ treatment decision making for prostate cancer

Background Current orthodoxy suggests that patients need to be provided with full information about their care and that treatment options should be discussed with patients and family members. This imperative is especially challenging when there is a lack of consensus about treatment effectiveness and equivocacy over different types of interventions. In the case of prostate cancer, evidence is contested as to the efficacy of different treatments. Thus, involving patients and their family members in treatment choices is complex and little is known about how patients and their partners process these decisions when there is uncertainty about different outcomes. This paper has reviewed the literature on the way couples approach such decision making in relation to treatment for prostate cancer. Objective A meta‐ethnographic synthesis of published qualitative papers that focused on the influences on patients’, and their partners’ treatment decision making for prostate cancer, was conducted in order to identify and understand barriers and facilitators which impact on this process. Results Our synthesis indicates that the couples’ relationship ‘dynamic’ provides a contextual background against which treatment decisions are negotiated and made. Discussion and conclusions We propose that the findings from this synthesis can enhance the potential for shared decision making for patients, and their partners, when facing a treatment decision for prostate cancer. By understanding the couples’ relationship dynamic pre‐diagnosis, clinicians may be able to tailor the communication and information provision to both patients and their partners, providing a personalized approach to treatment decision making.     

A comparison of the results of intent‐to‐treat,per‐protocol,and g‐estimation in the presence of non‐random treatment changes in a time‐to‐event non‐inferiority trial

While intent‐to‐treat (ITT) analysis is widely accepted for superiority trials, there remains debate about its role in non‐inferiority trials. It has often been said that ITT analysis tends to be anti‐conservative in demonstrating non‐inferiority, suggesting that per‐protocol (PP) analysis may be preferable for non‐inferiority trials, despite the inherent bias of such analyses. We propose using randomization‐based g‐estimation analyses that more effectively preserve the integrity of randomization than do the more widely used PP analyses. Simulation studies were conducted to investigate the impacts of different types of treatment changes on the conservatism or anti‐conservatism of analyses using the ITT, PP, and g‐estimation methods in a time‐to‐event outcome. The ITT results were anti‐conservative for all simulations. Anti‐conservativeness increased with the percentage of treatment change and was more pronounced for outcome‐dependent treatment changes. PP analysis, in which treatment‐switching cases were censored at the time of treatment change, maintained type I error near the nominal level for independent treatment changes, whereas for outcome‐dependent cases, PP analysis was either conservative or anti‐conservative depending on the mechanism underlying the percentage of treatment changes. G‐estimation analysis maintained type I error near the nominal level even for outcome‐dependent treatment changes, although information on unmeasured covariates is not used in the analysis. Thus, randomization‐based g‐estimation analyses should be used to supplement the more conventional ITT and PP analyses, especially for non‐inferiority trials. Copyright © 2010 John Wiley & Sons, Ltd.     

HENRY: development,pilot and long‐term evaluation of a programme to help practitioners work more effectively with parents of babies and pre‐school children to prevent childhood obesity

Background Despite epidemic numbers of obese and overweight pre‐school children, professionals report a lack of confidence and self‐efficacy in working with parents around lifestyle change. HENRY – Health Exercise Nutrition for the Really Young – trains health and community practitioners to work more sensitively and effectively with parents of babies and pre‐school children around obesity and lifestyle concerns. Underpinned by the Family Partnership Model, reflective practice and solution‐focused techniques, it offers face‐to‐face training and e‐learning. This paper describes the development, pilot and evaluation of HENRY Sure Start Children's Centres. Methods Twelve Children's Centres in Oxfordshire took part in the pilot involving 137 staff. Questionnaires were administered at the end of training courses. Self‐reported confidence ratings were obtained before and after training. Postal questionnaires were sent to Centre managers 2–6 months later to ascertain long‐term effects. Nine managers participated in in‐depth interviews. A further 535 learners completed the e‐learning course and online feedback. Results One hundred and thirty‐one staff (96%) completed the training course and valued it as a way of enhancing skills and knowledge. Mean (±SD) self‐reported confidence ratings increased (4.1 ± 0.7 to 7.2 ± 0.7; P < 0.00001). An influence on personal as well as professional lives was apparent. Long‐term follow‐up indicated ongoing impact attributed to HENRY on both Centres and staff. All 535 e‐learners successfully completed: 98% would recommend HENRY; 94% thought it enhanced their skills as well as knowledge. Conclusions HENRY is an innovative approach that offers some promise in tackling obesity through training community and health practitioners to work more effectively with parents of very young children. It appears to have an effect on participants' personal lives as well as professional work. A large‐scale long‐term study would be required to ascertain if there is the desired impact on young children's lifestyles and risk of obesity.     

The k‐in‐a‐row up‐and‐down design,revisited

The percentile‐finding experimental design known variously as ‘forced‐choice fixed‐staircase’, ‘geometric up‐and‐down’ or ‘k‐in‐a‐row’ (KR) was introduced by Wetherill four decades ago. To date, KR has been by far the most widely used up‐and‐down (U&D) design for estimating non‐median percentiles; it is implemented most commonly in sensory studies. However, its statistical properties have not been fully documented, and the existence of a unique mode in its asymptotic treatment distribution has been recently disputed. Here we revisit the KR design and its basic properties. We find that KR does generate a unique stationary mode near its target percentile, and also displays better operational characteristics than two other U&D designs that have been studied more extensively. Supporting proofs and numerical calculations are presented. A recent experimental example from anesthesiology serves to highlight some of the ‘up‐and‐down’ design family's properties and advantages. Copyright © 2009 John Wiley & Sons, Ltd.     

Fathers’ contributions to the management of their child’s long‐term medical condition: a narrative review of the literature

Context Fathers’ contributions to the management of long‐term childhood medical conditions are under‐represented in the literature; therefore, the full extent of their involvement is poorly understood by practitioners and researchers, so strategies for promoting their involvement have not yet been fully considered. Objective To review studies of fathers’ actual contributions in a wide range of conditions, the potential to optimize their contribution through additional interventions by health professionals and a direction for future research. Design Narrative review of the literature. Methods CINAHL, Medline, PsychInfo and ERIC databases were searched electronically between the years 1995–2008. The terms adherence, adjustment, child, chronic, compliance, concordance, condition, coping, disease, father, illness, information, long‐term, management/intervention, mother, role, self‐care and treatment were searched for separately and in combination. English language papers reporting primary research were selected and supplemented by hand‐searching reference lists. Thirty‐five papers (arising from 29 studies) met criteria and were selected for narrative review. Results Five themes were identified: (i) the impact of long‐term conditions on fathers’ ability to promote their child’s well‐being, (ii) factors influencing fathers’ involvement in health care, (iii) personal growth/beneficial effects for fathers, (iv) the impact of father’s involvement on family functioning and (v) strategies that increase fathers’ participation in their child’s health care and in research investigating fathers’ participation. Conclusions The review suggests that fathers’ involvement in children’s health care can positively impact on fathers’, mothers’ and children’s well‐being and family functioning. A range of strategies are identified to inform the promotion of fathers’ contributions and future research investigating their input.