Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia.

BACKGROUND: Head and neck cancer squamous cell carcinoma (HNSSC) patients report substantial rates of clinically significant depression and/or anxiety, with dysphagia being a predictor of distress and poorer quality of life. Evidence-based dysphagia interventions largely focus on the remediation of physical impairment. This feasibility study evaluates an intervention which simultaneously uses a psychological therapy approach combined with swallowing impairment rehabilitation. METHODS: This prospective single cohort mixed-methods study, recruited HNSCC patients with dysphagia, from two institutions. The intervention combined Cognitive Behavioural Therapy with swallowing therapy (CB-EST), was individually tailored, for up to 10 sessions and delivered by a speech and language therapist. Primary acceptability and feasibility measures included recruitment and retention rates, data completion, intervention fidelity and the responsiveness of candidate outcome measures. Measures included a swallowing questionnaire (MDADI), EORTC-QLQH&N35, dietary restrictions scale, fatigue and function scales and the Hospital Anxiety and Depression Scale (HADS), administered pre-, post-CB-EST with three month follow-up and analysed using repeated measures ANOVA. Qualitative interviews were conducted to evaluate intervention processes. RESULTS: A total of 30/43 (70%) eligible patients agreed to participate and 25 completed the intervention. 84% were male, mean age 59 yrs. Patients were between 1 and 60 months (median 4) post-cancer treatment. All patients had advanced stage disease, treated with surgery and radiotherapy (38%) or primary chemoradiotherapy (62%). Pre to post CB-EST data showed improvements in MDADI scores (p = 0.002), EORTC-QLQH&N35 (p = 0.006), dietary scale (p < 0.0001), fatigue (p = 0.002) but no change in function scales or HADS. Barriers to recruitment were the ability to attend regular appointments and patient suitability or openness to a psychological-based intervention. CONCLUSIONS: CB-EST is a complex and novel intervention, addressing the emotional, behavioural and cognitive components of dysphagia alongside physical impairment. Preliminary results are promising. Further research is required to evaluate efficacy and effectiveness.

First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris™): a European prospective multicenter study.

PURPOSE: We evaluated a new single-use digital flexible cystoscope with an integrated grasper designed for double-J stent removal, Isiris™, addressing success rate, image quality, deflection, maneuverability and grasper functionality. METHODS: In September 2015, a prospective cohort study was conducted in six tertiary European reference centers. All consecutive patients included underwent double-J stent removal and were 18 years or older. Success rate was defined by complete stent removal. Image quality, deflection, maneuverability and grasper functionality were rated with a Likert scale. RESULTS: A total of 83 procedures were performed. 82% of procedures were performed in the endoscopy room, while the others were in the operating room since a consecutive endourological intervention was planned. The median duration of stent implantation was 28 days [14; 60]. In five patients, stent removal was not possible. Four patients had an incrusted double-J stent, and in one patient, the stent migrated into the ureter. After unsuccessful attempts of stent removal with conventional flexible cystoscope and grasper, the five patients had to be scheduled for an ureterorenoscopy procedure to remove the stent. In the other 78 patients, all double-J stents were removed successfully. Image quality, deflection, maneuverability and grasper functionality were rated as "very good" in 72.3, 78.3, 72.3 and 73.5%, respectively. CONCLUSION: This multicenter clinical evaluation of Isiris™ displayed good image quality, active deflection, maneuverability and grasper functionality. Further evaluation of stent removal outcomes, cost analysis and microbiology will help to delineate the possible place of Isiris™ in the current practice.

Swallowing outcomes for patients with oropharyngeal squamous cell carcinoma treated with primary (chemo)radiation therapy receiving either prophylactic gastrostomy or reactive nasogastric tube: A prospective cohort study.

OBJECTIVES: There is currently no consensus on the optimal feeding route for an oropharyngeal squamous cell cancer (OPSCC) patient without pre-existing dysphagia undergoing chemoradiotherapy. This study aimed to compare the swallowing outcomes for OPSCC patients fed via either prophylactic RIG (pRIG) or reactive nasogastric tube (rNGT). DESIGN: A prospective cohort study. SETTING: Four head and neck cancer centres in the North of England Cancer Network. PARTICIPANTS: Fifty-three participants with OPSCC, on a normal diet pre-(chemo) radiotherapy. MAIN OUTCOME MEASURE: Swallowing outcomes for patients with rNGT and pRIG were compared using the following outcome measures administered prospectively at pre-treatment, three and 12 months post-treatment: MD Anderson Dysphagia Inventory (MDADI), Performance Status Scales (Normalcy of Diet), timed water swallow test. RESULTS: Twenty-three patients received pRIG while 30 were planned for a rNGT. No differences in demographics were found between the groups. The rNGT group had a clinically significant higher score on MDADI at 12 months post-treatment. No significant difference was found on a timed water swallow test or diet texture scale. CONCLUSIONS: There is no statistical difference for swallowing outcomes in either group. However, patients' in the rNGT group reported a clinically meaningful difference at 1 year, with a trend for them to do better across all measures. Neither group returned to their baseline swallowing function. Further research with a larger sample size is indicated.

Head and neck cancer and dysphagia; caring for carers.

OBJECTIVES: A diagnosis of head and neck cancer (HNC) is a profound event for patients and family members who play a crucial role in their care. Eating and drinking difficulties affect patients' quality of life (QOL), but the impact on the carers' QOL has not been explored. This preliminary mixed method study reports on carer QOL over time and investigates the relationship with dysphagia. METHODS: Two hundred and eight HNC patients referred for (chemo)radiotherapy were asked to identify a carer and complete a health-related QOL and a swallowing QOL questionnaire at pre-treatment, 3 and 12 months post-treatment. Carers were given the Caregiver QOL-Cancer (CQOL-C) questionnaire at the same time points. A purposive sample of patient and carer dyads was observed over mealtimes and interviewed. RESULTS: Seventy per cent of carers returned a questionnaire at least once. There was no change in CQOL-C scores between pre-treatment and 3 months, but a significant improvement was found between 3 and 12 months post-treatment (p = 0.012). Patient-reported outcomes accounted for 52% of variance in carer QOL measurements (R(2) = 0.52, p < 0.001). Four themes emerged from the qualitative data food provision, monitoring, motivation and changes to lifestyle. CONCLUSIONS: Findings suggest a relationship between carer and patient QOL. Elsewhere, these two characteristics have been associated such that the greater the patients' physical care needs, the poorer the carers' and patients' QOL. Living with someone with dysphagia not only involves managing the physical swallowing difficulties but is also likely to impact on social activities such as participation in shared meals, leading to permanent lifestyle changes.

Dysphagia Advances in Head and Neck Cancer.

Purpose of Review: This review summarises the current literature regarding head and neck cancer-associated dysphagia. Up-to-date evidence for dysphagia outcome measurement for this population is provided, in addition to recent innovations that aim to prevent, reduce or remediate the common and debilitating side effects of treatment. Recent Findings: Both patient-reported outcomes and clinical measures are necessary to capture the multi-dimensional nature of swallowing. A minimally important difference in scores has been calculated for some of these measures, to aid interpretation and powering of clinical trials. The number of dysphagia-related trials has increased, predominantly investigating optimal treatment for oropharyngeal HPV-positive disease, and speech and language pathology interventions using an impairment-based approach. Summary: Although substantial progress has been made, further work is necessary to establish a consensus over outcome measures. Modifying treatments may improve outcomes. Several trials are underway to establish the effectiveness of speech and language pathology dysphagia interventions.

Strategies for expanding patient and public involvement into under-served head and neck cancer communities.

PURPOSE OF REVIEW: In this review, we discuss two case studies in which we summarize the process of expanding patient and public involvement (PPI) representation specific to the head and neck cancer population, highlighting the challenges and successes within each project. The first case study reports on the expansion of HaNC PPI membership, a long-established PPI forum which supports Liverpool Head and Neck Centre research. The second case study describes the establishment of a novel palliative care network in head and neck cancer in the North of England, in which PPI was central to the project's success. RECENT FINDINGS: Whilst recognizing diversity is important, it is imperative to acknowledge the contribution of existing members. Engagement with clinicians to reduce issues of gatekeeping is essential. A central theme is that the development of sustainable relationships is critical. SUMMARY: The case studies highlight the challenge of identifying and accessing such a diverse population, particularly in the context of palliative care. Successful PPI is dependent on building and maintaining relationship with PPI members, ensuring flexibility in terms of timing, platforms and venues. Relationships formation should not be restricted to the academic-PPI representative dyad but should consider both clinical-academic and community partnerships to ensure those who are part of under-served communities are afforded the opportunities to become involved in research.

Adherence to swallowing recommendations during (chemo)radiotherapy in head and neck cancer survivors: a scoping review.

PURPOSE OF REVIEW: There is a paucity of knowledge regarding patient adherence to dysphagia recommendations. It is recognized that unique barriers and facilitators contribute to poor treatment adherence in head and neck cancer (HNC) survivors. This review aims to identify the key themes and knowledge gaps regarding adherence to swallowing recommendations in HNC survivors during (chemo)radiotherapy (C)RT. RECENT FINDINGS: Seven studies were identified. Six facilitators to adherence were extracted, namely pain relief, behavioural intervention, attendance at multidisciplinary clinic, individualised swallowing therapy, absence of prophylactic percutaneous endoscopic gastronomy (PEG) and positive social control from a spouse. Barriers to adherence included pain, depression and presence of prophylactic PEG. Adherence to swallowing recommendations positively impacted swallowing outcomes in one study. SUMMARY: Little is known about adherence to swallowing recommendations during (C)RT in HNC survivors. Capturing adherence is challenging. Several knowledge gaps were identified. Further research is needed to better understand the barriers and facilitators from the survivors' perspective. This will inform development of best practice regarding how swallowing recommendations are provided to promote adherence and improve outcomes.

Late Effects of Organ Preservation Treatment on Swallowing and Voice; Presentation, Assessment, and Screening.

The prevalence of head and neck cancer (HNC) survivors is on the rise. Treatments for HNC can have a major deleterious impact on functions such as swallowing and voice. Poor functional outcomes are strongly correlated with distress, low quality of life, difficulties returning to work and socializing. Furthermore, dysphagia can have serious medical consequences such as malnutrition, dehydration, and pneumonia. A conservative estimate of the percentage of survivors living with dysphagia in the long-term is between 50 and 60%. Evidence is emerging that functions can worsen over time, sometimes several years following treatment due to radiation-associated fibrosis, neuropathy, intractable edema, and atrophy. Muscles lose their strength, pliability, stamina, and range, speed, precision, and initiation of movements necessary for swallowing and voice functions. Late treatment effects can go unrecognized, and may only be identified when there is a medical complication such as hospitalization for aspiration pneumonia. In the routine healthcare setting methods of evaluation include a detailed case history, a thorough clinical examination and instrumental assessments. Interventions for late treatment effects are limited and it is imperative that patients at risk are identified as early as possible. This paper considers the role of screening tests in monitoring swallowing and detecting aspiration in the long-term. Further work is indicated for addressing this pressing and increasingly common clinical problem.

Swallowing beyond six years post (chemo)radiotherapy for head and neck cancer; a cohort study.

OBJECTIVE: The objective of this prospective study is to report on long-term swallowing outcomes in a group of head and neck cancer patients following (chemo) radiotherapy treatment, assess for changes over time and identify any predictor variables of outcome. MATERIALS AND METHODS: 42 survivors were assessed on four swallowing measures and followed up from pre-treatment to six years post 3D (chemo) radiotherapy. Measures included a swallowing specific QOL questionnaire, penetration-aspiration scale, dietary restrictions and a timed water swallow test. RESULTS: At six years, 71% reported swallowing difficulties on the questionnaire. One fifth of patients had aspiration, with a raised risk of chest infection. Seven percent required a laryngectomy for a dysfunctional larynx. Despite this, half the group reported having a normal diet. There was variation in the pattern of change between one and six years. A significant deterioration was only observed in the timed water swallow test (p < 0.0001). Larger radiotherapy volume predicted this outcome. None of the variables tested predicted outcome for the other three swallow measures. CONCLUSION: Patients continue to report swallowing difficulties at six years, with a proportion having persistent aspiration. Further work on identifying the risk factors associated with aspiration tolerance, aspiration pneumonia, prevention and management is warranted. Long-term dysphagia remains a significant and serious concern following (chemo) radiotherapy for HNC and swallowing outcomes should continue to be monitored over time.

The emerging role of intravesical botulinum toxin therapy in idiopathic detrusor overactivity.

Recently there has been considerable original research into the use of the botulinum neurotoxins in idiopathic detrusor overactivity (DO). This common condition underlies the overactive bladder syndrome in a significant proportion of cases and was previously known as idiopathic detrusor instability. Failure of initial pharmacotherapy in this condition leaves few effective conservative/medical treatment options. Early reports of botulinum toxin (BoNT) therapy have been extremely promising, and the therapy appears to bridge the gap in such patients, before resorting to invasive surgical procedures. Approximately 30 studies have been reported often with widely differing techniques and some clinicians are beginning to administer BoNT for this unlicensed indication. This has led to the urgent need to critically review all available evidence to assess efficacy, safety and technique. In addition to performing a systematic Medline review, all abstracts presented to urological, urogynaecological and incontinence meetings that reported BoNT usage in idiopathic DO were analysed. Remarkable efficacy has been demonstrated in the vast majority of reported series and the treatment has also been used safely in paediatric and elderly populations. Side effects in all populations appear to be minimal and short lived. However, all the series are small and there remains a considerable number of fundamental questions to be answered. Hopefully large-scale robust randomised controlled trials will provide the necessary answers to facilitate the widespread adoption of this technique. Until then caution must be exercised in this unlicensed indication.

Conditions for binding bovine IgG1 to protein A-Sepharose.

Conditions were established so that both subclasses of bovine IgG were bound to Protein A-Sepharose. Increasing the pH of the starting buffer to pH 8.0 from pH 7.0 and increasing the starting phosphate concentration of the buffer to 0.5 M from 0.2 M enhanced the separation. Using these modifications in the buffer system, IgG1 was eluted from pH 7.0 to 7.8 and IgG2 at pH 5.0. Two major peaks were associated with IgG1 activity indicating heterogeneity of binding to protein A-Sepharose. One peak was found for IgG2. The molecular weights of the fractions were determined to be that of IgG by sodium dodecyl sulfate polyacrylamide gel electrophoresis.

Differential expression of proteins in muscle and electric organ, a muscle derivative.

The electric organ of electric fish develops from a myogenic lineage. We have used immunohistochemistry and immunoblotting to determine which features of the muscle phenotype are retained and whether any new ones are expressed in mature electrocytes of the electric fish Sternopygus. The muscle-specific intermediate filament desmin was found throughout the electrocytes, and different desmin antibodies detected molecules with different subcellular distributions. Western blots confirm that these antibodies recognize a protein of MW = 53 kD, the molecular weight of desmin. Other muscle proteins were also present within electrocytes: Actin and sarcomeric alpha-actinin were found within the subsynaptic membrane beneath the plasmalemma of the electrocytes, and talin and acetylcholine receptors were detected both at the innervated posterior face and at the non-innervated anterior face. This was confirmed using rhodamine-conjugated alpha-bungarotoxin. Neither myosin heavy chain nor tropomyosin was present in electrocytes. Finally, we detected within electrocytes a type I acidic keratin that forms a filamentous meshwork within each cell. Immunoblots corroborate this result: A keratin-positive doublet of MW = 50 kD and 57 kD was found in both electrocytes and skin. Myosin, actin, talin, tropomyosin, desmin, alpha-actinin, and acetylcholine receptor, but not keratin, were all expressed in fish skeletal muscle fibers. Thus, electrocytes retain some muscle-specific proteins, do not express others, and in addition, express a non-muscle protein.

Isolation and purification of bovine IgM by dissociating immunoglobulin-brucella complexes.

Methods for the dissociation of immunoglobulin-Brucella complexes (IgM-rich) were evaluated. The antigen-antibody complex was separated from serum by centrifugation and dissociated with either H2O, 2.0 M pH 2.0 glycine buffer, or various concentrations of KSCN. Optimal antibody recoveries for KSCN were obtained using 1.0--2.0 M KSCN. Dissociation of the complex with water resulted in the highest recovery of antibody and the glycine buffer was lowest. Immunoelectrophoretic analysis of the eluted antibody revealed the presence of IgG and IgM. At concentrations of KSCN greater than 2.5 M, albumin-like protein was also eluted from the antibody-antigen complex. The IgM could readily be separated from IgG and albumin by gel filtration. Purified IgM was Brucella specific, monodisperse, and had a sedimentation coefficient of 20.0.

Fractionation of cocksfoot (Dactylis glomerata) pollen by preparative isoelectric focussing.

The technique of isoelectric focussing in polyacrylamide gel has been developed to a preparative mode. Using the improved technique cocksfoot (Dactylis glomerata) pollen has been split into many components, and the allergenic reactions of the preparations have been studied by passive transfer in animal skin and by RAST.

Family correlates of a 10-year pulmonary health trend in cystic fibrosis.

In this study, 33% of the variance in the 10-year trend of forced expiratory volume in 1 second (FEV1), used as an index of pulmonary health, was explained by differences in family characteristics at the start of the study. Balanced family coping, a family emphasis on personal growth, and compliance with treatment for 91 children with cystic fibrosis were assessed at the start of the study and the FEV1 was observed at every clinic visit over the next 10 years. When both parents' coping emphasized family integration, support for self, and medical consultation, the FEV1 trend was better. Compliance with daily chest physical therapy and with quarterly clinic visits was associated with a better FEV1 trend. Poorer FEV1 trend was associated with active social involvement of family members. Older patients and patients whose parents worked more hours outside the home had lower compliance. These findings support the importance of encouraging families to balance their resources between the child's health needs and family needs.

Social influences on conditioned cortisol secretion in the squirrel monkey.

'Social buffering'--the apparent capacity of group membership to reduce the adrenocortical response to stress, was investigated in squirrel monkeys by means of a between-within experimental design. Adult males were assigned to two groups. Group paired (n = 6) received pairings of a conditional stimulus (CS) with footshock. Group control (n = 6) received CS presentations without shock. All animals were then tested with 10 presentations of the CS without shock under three social-housing conditions, in four successive phases of the experiment: individual, dyad, group, and individual housing. Neither group showed a cortisol response to the CS prior to training. Following training, CS-evoked elevations of cortisol were found only in group paired, and only in the individual housing conditions. These results replicate and extend our previous finding that the presence of conspecifics can ameliorate a neuroendocrine response to psychological stressors in squirrel monkeys.

Parents' perceptions of helpful vs unhelpful types of support in managing the care of preadolescents with chronic conditions.

OBJECTIVE: To identify parents' perceptions of helpful vs unhelpful types of social support received in managing the care of preadolescents with chronic conditions. DESIGN: Multimethod cohort study with 1-year follow-up. SETTING: General community. PARTICIPANTS: Volunteer, consecutive sample of parents of 124 preadolescents with a variety of chronic conditions. METHODS: In-depth, in-home interviews conducted with parents. Quantitative data from the Social Support Assessment questionnaire was used to assess and compare sources and types of helpful support at baseline and 1 year later. Content analytic methods were used to categorize unsupportive behaviors described by parents during the first interview. RESULTS: Both mothers and fathers reported that other family members were the primary source of helpful emotional and tangible support, while health care providers were the primary source of helpful informational support. The amount of perceived support from family members, community members, and service providers stayed relatively stable over time, except that fathers reported a significant increase in helpful emotional and informational support from extended family members from baseline to 1 year later. Also, 388 incidents of unsupportive behaviors were identified; the majority of these behaviors were attributed to health professionals and extended family members. CONCLUSION: While patterns of perceived support remained relatively stable over a 1-year period, reports of unsupportive behaviors suggest gaps in service and problems that must be addressed to improve the care that children with chronic conditions and their families receive.

An evaluation of human papillomavirus testing as part of referral to colposcopy clinics.

OBJECTIVE: To determine the usefulness of human papillomavirus (HPV) testing as a triage method for predicting which women referred to a colposcopy clinic were most likely to have histologically confirmed cervical intraepithelial neoplasia (CIN). METHODS: Papanicolaou tests, ViraPap tests for HPV infection, and colposcopically directed biopsies were performed concurrently on 482 women referred to a student health colposcopy clinic. RESULTS: The results demonstrated that HPV positivity was associated with a greatly increased likelihood of histologic confirmation of CIN, especially among women with concurrent cytologic findings that were negative or showed only atypical squamous cells of undetermined significance. CONCLUSIONS: Testing for HPV appears to have a role in the triage of students now being referred to our colposcopy clinic. A combination of HPV testing and repeated cytologic screening would provide reasonably sensitive screening for cervical neoplasia while limiting the use of colposcopic services, which are currently overburdened. The eventual usefulness of HPV testing will depend on the cost and availability of colposcopy services, the cost of Papanicolaou tests, the cost and accuracy of HPV tests, and the predictive value of HPV detection in the population being screened.

The impact of family functioning on health changes in children with cystic fibrosis.

Family stress, family and personal resources, and parental coping were operationalized from self-report questionnaires completed by mothers and fathers in 72 two-parent families who had a child with cystic fibrosis (CF). Three-month and 15-month changes in clinically recorded measures of the CF child's height and weight data and pulmonary functioning were correlated with the family functioning variables. Each of the four criterion indices of CF child health changes were regressed separately on the significant family functioning variables. Twenty-two percent of the variance in 15-month height and weight changes were explained by family stress, family resources, and parental coping. Family functioning variables also explained 17% of the variance in 3-month pulmonary functioning changes and 15% of the variance in 3-month height and weight changes. These findings suggest that the way in which the family functions has indirect effects on critical indices of a CF child's health. These data lend support to an increased focus by physicians and other medical professionals on the health of the total family system as a way to enhance outcomes for children with CF.

Immunogenicity of Brucella abortus salt-extractable proteins.

The immunogenic properties of salt-extractable proteins and chromatographic fractions thereof from Brucella abortus were evaluated in lemmings (Dicrostonyx rubricatus). The efficacy of the Brucella proteins as immunogens was determined after challenge with virulent B. abortus strain 2308 and was based on protection against clinical signs and gross lesions of brucellosis, as well as on numbers of viable Brucella in the spleen. Vaccination of lemmings with as little as 0.1 microgram of salt-extractable proteins (CSP) suppressed splenic infection, resulting in reduced numbers of viable organisms per spleen of 5-6 logs compared to non-vaccinated controls. Protein fractions separated by column chromatography were generally effective in reducing splenic infection, and contained proteins with molecular weights of 30,000, 20,000 and 12,000. Vaccines containing chemically modified dodecanoyl-CSP offered no additional advantage over unmodified CSP vaccines.