Non-Surgical Respiratory Management in Relation to Feeding and Growth in Patients with Robin Sequence; a Prospective Longitudinal Study.

OBJECTIVE: To reflect upon our non-surgical respiratory management by evaluating clinical outcomes regarding airway, feeding, and growth during the first year of life in patients with Robin Sequence. DESIGN: Prospective study. SETTING: Sophia Children's Hospital, Rotterdam, the Netherlands. PATIENTS/ PARTICIPANTS: 36 patients with Robin Sequence who were treated between 2011 and 2021. INTERVENTIONS: Positional therapy and respiratory support. MAIN OUTCOME MEASURE(S): Data on respiratory outcomes included polysomnography characteristics and capillary blood gas values. Feeding outcomes were based on the requirement of additional tube feeding. Outcomes on growth were expressed as standard-deviation-scores (SDS) for weight-for-age (WFA) and height-for-age (HFA). RESULTS: Twenty patients were treated with positional therapy (PT), whilst the other 16 patients required respiratory support. Twenty-two patients presented with non-isolated Robin Sequence (RS). During the first year of life, obstructive apnea hypopnea index decreased, oxygen levels enhanced, and capillary blood gas values improved. Eighty-six percent (31/36) experienced feeding difficulties, which completely resolved in 71% (22/31) during their first year of life. From start treatment, to stop treatment, to the age of 1 year, the SDS WFA worsened from -0.40 to -0.33 to -1.03, respectively. CONCLUSIONS: Non-surgical respiratory treatment resulted in an improvement of respiratory outcomes to near normal during the first year of life in patients with RS. These patients often experience feeding difficulties and endure impaired weight gain up to 1 year of age, despite near normalization of breathing. The high prevalence of feeding difficulties and impaired weight for age indicate the urgency for early recognition and adequate treatment to support optimal growth.

Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.

PURPOSE: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients. METHODS: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis). RESULTS: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant. CONCLUSION: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting. TRIAL REGISTRATION: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.

Individual factors increasing complexity of drug treatment-a narrative review.

PURPOSE: Complexity of drug treatment is known to be a risk factor for administration errors and nonadherence promoting higher healthcare costs, hospital admissions and increased mortality. Number of drugs and dose frequency are parameters often used to assess complexity related to the medication regimen. However, factors resulting from complex processes of care or arising from patient characteristics are only sporadically analyzed. Hence, the objective of this review is to give a comprehensive overview of relevant, patient-centered factors influencing complexity of drug treatment. METHODS: A purposeful literature search was performed in MEDLINE to identify potential complexity factors relating to the prescribed drug (i.e. dosage forms or other product characteristics), the specific medication regimen (i.e. dosage schemes or additional instructions), specific patient characteristics and process characteristics. Factors were included if they were associated to administration errors, nonadherence and related adverse drug events detected in community dwelling adult patients. RESULTS: Ninety-one influencing factors were identified: fourteen in "dosage forms", five in "product characteristics", twelve in "dosage schemes", nine in "additional instructions", thirty-one in "patient characteristics" and twenty in "process characteristics". CONCLUSIONS: Although the findings are limited by the non-systematic search process and the heterogeneous results, the search shows the influence of many factors on the complexity of drug treatment. However, to evaluate their relevance for individual patients, prospective studies are necessary.

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation.

BACKGROUND: The increasing complexity of current drug therapies jeopardizes patient adherence. While individual needs to simplify a medication regimen vary from patient to patient, a straightforward approach to integrate the patients' perspective into decision making for complexity reduction is still lacking. We therefore aimed to develop an electronic, algorithm-based tool that analyses complexity of drug treatment and supports the assessment and consideration of patient preferences and needs regarding the reduction of complexity of drug treatment. METHODS: Complexity factors were selected based on literature and expert rating and specified for integration in the automated assessment. Subsequently, distinct key questions were phrased and allocated to each complexity factor to guide conversation with the patient and personalize the results of the automated assessment. Furthermore, each complexity factor was complemented with a potential optimisation measure to facilitate drug treatment (e.g. a patient leaflet). Complexity factors, key questions, and optimisation strategies were technically realized as tablet computer-based application, tested, and adapted iteratively until no further technical or content-related errors occurred. RESULTS: In total, 61 complexity factors referring to the dosage form, the dosage scheme, additional instructions, the patient, the product, and the process were considered relevant for inclusion in the tool; 38 of them allowed for automated detection. In total, 52 complexity factors were complemented with at least one key question for preference assessment and at least one optimisation measure. These measures included 29 recommendations for action for the health care provider (e.g. to suggest a dosage aid), 27 training videos, 44 patient leaflets, and 5 algorithms to select and suggest alternative drugs. CONCLUSIONS: Both the set-up of an algorithm and its technical realisation as computer-based app was successful. The electronic tool covers a wide range of different factors that potentially increase the complexity of drug treatment. For the majority of factors, simple key questions could be phrased to include the patients' perspective, and, even more important, for each complexity factor, specific measures to mitigate or reduce complexity could be defined.

Elective neck treatment during salvage (pharyngo) laryngectomy.

PURPOSE: This study aimed at determining the importance of an elective neck dissection (END) in case of a cN0 laryngeal or hypopharyngeal carcinoma after (chemo) radiation. METHODS: Retrospective review was made of patients treated in a single tertiary center between 2002 and 2014. Influence of an END in case of a cN0 salvage laryngectomy on complications, recurrence-free survival and disease-specific survival was assessed. INCLUSION CRITERIA: squamous cell carcinoma and cN0 neck. EXCLUSION CRITERIA: second primary tumor in the head and neck, a total laryngectomy because of a dysfunctional larynx, or a previously performed neck dissection. RESULTS: Of the 86 included patients, 27 (31%) underwent an END, of which 1 had occult metastasis (4%). Of the remaining 59 patients (69%) without an END, 3 developed a regional recurrence (5%). The overall survival was significantly higher for patients who had an END (p = 0.037). The incidence of complications was not significantly different between the two groups. CONCLUSIONS: In light of the limited complications of an END and the poor prognosis of regional recurrence after previous (chemo)radiotherapy and a (pharyngo)laryngectomy, we advise consideration of an END at the time of a salvage laryngectomy.

Predictive factors for pharyngocutaneous fistulization after total laryngectomy: a Dutch Head and Neck Society audit.

BACKGROUND: Incidences of pharyngocutaneous fistulization (PCF) after total laryngectomy (TL) reported in the literature vary widely, ranging from 2.6 to 65.5%. Comparison between different centers might identify risk factors, but also might enable improvements in quality of care. To enable this on a national level, an audit in the 8 principle Dutch Head and Neck Centers (DHNC) was initiated. METHODS: A retrospective chart review of all 324 patients undergoing laryngectomy in a 2-year (2012 and 2013) period was performed. Overall PCF%, PCF% per center and factors predictive for PCF were identified. Furthermore, a prognostic model predicting the PCF% per center was developed. To provide additional data, a survey among the head and neck surgeons of the participating centers was carried out. RESULTS: Overall PCF% was 25.9. The multivariable prediction model revealed that previous treatment with (chemo)radiotherapy in combination with a long interval between primary treatment and TL, previous tracheotomy, near total pharyngectomy, neck dissection, and BMI < 18 were the best predictors for PCF. Early oral intake did not influence PCF rate. PCF% varied quite widely between centers, but for a large extend this could be explained with the prediction model. PCF performance rate (difference between the PCF% and the predicted PCF%) per DHNC, though, shows that not all differences are explained by factors established in the prediction model. However, these factors explain enough of the differences that, compensating for these factors, hospital is no longer independently predictive for PCF. CONCLUSIONS: This nationwide audit has provided valid comparative PCF data confirming the known risk factors from the literature which are important for counseling on PCF risks. Data show that variations in PCF% in the DHNCs (in part) are explainable by the variations in these predictive factors. Since elective neck dissection is a major risk factor for PCF, it only should be performed on well funded indication.

[Simplifying complex drug therapies : Challenges and solutions]. / Komplexe Arzneimitteltherapien vereinfachen : Herausforderungen und Lösungsansätze.

The difficulties of managing a complex medication regimen are often underestimated in outpatient care. A large number of drugs (polypharmacy) and complicated dosage schemes or dosage forms may overstrain patients. Indeed, wrong drug administration can impair treatment success or cause adverse drug events.Patients are often unaware of the medication administration errors. Furthermore they do not voice administration problems, often because they are not aware of the potential to optimize their drug therapy. Medication regimen complexity can often be reduced by simple measures. However, feasible concepts for reducing medication regimen complexity in a structured way have been lacking in routine care so far.Electronic decision support facilitates systematic and efficient identification of factors that increase the complexity of a medication regimen. Furthermore, electronic decision aids may enable physicians and pharmacists to take appropriate measures in order to reduce medication regimen complexity. Personalizing the analysis and resulting measures to reduce medication regimen complexity might increase readiness of patients to implement changes in treatment and, thus, probably increase adherence. The first results of a prospective trial that is supported by the Federal Joint Committee (G-BA) Innovationsfonds (HIOPP-6, Komplexitätsreduktion in der Polypharmazie unter Beachtung von Patientenpräferenzen) will be available in autumn 2018 and answer these questions.

Individualized Dynamic Prediction Model for Patient-Reported Voice Quality in Early-Stage Glottic Cancer.

OBJECTIVE: Early-stage glottic cancer (ESGC) is a malignancy of the head and neck. Besides disease control, preservation and improvement of voice quality are essential. To enable expectation management and well-informed decision-making, patients should be sufficiently counseled with individualized information on expected voice quality. This study aims to develop an individualized dynamic prediction model for patient-reported voice quality. This model should be able to provide individualized predictions at every time point from intake to the end of follow-up. STUDY DESIGN: Longitudinal cohort study. SETTING: Tertiary cancer center. METHODS: Patients treated for ESGC were included in this study (N = 294). The Voice Handicap Index was obtained prospectively. The framework of mixed and joint models was used. The prognostic factors used are treatment, age, gender, comorbidity, performance score, smoking, T-stage, and involvement of the anterior commissure. The overall performance of these models was assessed during an internal cross-validation procedure and presentation of absolute errors using box plots. RESULTS: The mean age in this cohort was 67 years and 81.3% are male. Patients were treated with transoral CO2 laser microsurgery (57.8%), single vocal cord irradiation up to (24.5), or local radiotherapy (17.5%). The mean follow-up was 43.4 months (SD 21.5). Including more measurements during prediction improves predictive performance. Including more clinical and demographic variables did not provide better predictions. Little differences in predictive performance between models were found. CONCLUSION: We developed a dynamic individualized prediction model for patient-reported voice quality. This model has the potential to empower patients and professionals in making well-informed decisions and enables tailor-made counseling.

Clinical Relevance of Resection Margins in Patients with Total Laryngectomy or Laryngopharyngectomy.

BACKGROUND: Laryngeal and hypopharyngeal cancer is complex and resection margins are therefore constrained. The aim of this study was to investigate the clinical relevance of resection margins in laryngeal and hypopharyngeal surgery. METHODS: A retrospective cohort study was performed for patients treated with a total laryngectomy (TL) or laryngopharyngectomy (TLP) for laryngeal or hypopharyngeal squamous cell carcinoma (LSCC and HSCC, respectively). Within the groups primary LSCC, recurrent LSCC, primary HSCC, and recurrent HSCC the relationship between the status of the resection margin according to the Royal Collage of Pathology and the recurrence and survival rates were investigated. RESULTS: Positive resection margins were found in 54% for primary LSCC, 29% for recurrent LSCC, 62% for primary HSCC, and 44% for recurrent HSCC. For primary and recurrent LSCC, there was a linear association between total recurrence and narrowing margins (p = 0.007 resp. p = 0.008). Multivariate survival analysis for primary and recurrent LSCC showed a significantly worse disease free and disease-specific survival in case of positive margins compared to clear margins. CONCLUSION: Similar survival rates were recorded for close and clear margins for primary and recurrent LSCC. This may suggest that a margin > 5 mm is not clinically relevant in terms of survival. Therefore, a margin of 1-5 mm should be accepted in certain subsites. Margins < 1 mm are related to significantly worse outcomes and should be avoided.

A New Proposal for Adequate Resection Margins in Larynx and Hypopharynx Tumor Surgery-Are the RCP Guidelines Feasible?

BACKGROUND: Resection margins are an important prognostic factor for patients with head and neck cancer. In general, for head and neck surgery, a margin >5 mm is advised by the Royal College of Pathologists. However, this cannot always be achieved during laryngeal and hypopharyngeal surgery. The aim of this study is to identify the resection surfaces and measure the maximum feasible margins per subsite. The clinical relevance of these maximum feasible resection margins were analyzed in this descriptive anatomical study. METHODS: head and neck surgeons and a pathologist from the Erasmus MC performed a total laryngectomy and laryngopharyngectomy on a head and neck specimen specifically available for research. RESULTS: For a total laryngectomy, resection margins >5 mm were not feasible for the ventral and dorsal resection surface. For a total laryngopharyngectomy, resection margins >5 mm were not feasible for the ventral, dorsal and lateral resection surface. CONCLUSION: Clear resection margins, defined as a margin >5 mm, are not always feasible in laryngeal and hypopharyngeal surgery, due to the anatomy of the larynx and tumor location. However, striving for a maximum feasible margin is still the main goal. We propose a new guideline for maximum feasible but adequate resection margins in larynx and hypopharynx tumor surgery.

Longitudinal Patient-Reported Voice Quality in Early-Stage Glottic Cancer.

OBJECTIVE: Patient-reported voice quality is an important outcome during counseling in early-stage glottic cancer. However, there is a paucity of adequate longitudinal studies concerning voice outcomes. This study aimed to investigate longitudinal trajectories for patient-reported voice quality and associated risk factors for treatment modalities such as transoral CO2 laser microsurgery, single vocal cord irradiation, and local radiotherapy. STUDY DESIGN: A longitudinal observational cohort study. SETTING: Tertiary cancer center. METHODS: Patients treated for Tcis-T1b, N0M0 glottic cancer were included in this study (N = 294). The Voice Handicap Index was obtained at baseline and during follow-up (N = 1944). Mixed-effects models were used for investigating the different trajectories for patient-reported voice quality. RESULTS: The mean follow-up duration was 43.4 (SD 21.5) months. Patients received transoral CO2 laser microsurgery (57.8%), single vocal cord irradiation (24.5%), or local radiotherapy (17.5%). A steeper improvement during the first year after treatment for single vocal cord irradiation (-15.7) and local radiotherapy (-12.4) was seen, compared with a more stable trajectory for laser surgery (-6.1). All treatment modalities showed equivalent outcomes during long-term follow-up. Associated risk factors for different longitudinal trajectories were age, tumor stage, and comorbidity. CONCLUSION: Longitudinal patient-reported voice quality after treatment for early-stage glottic cancer is heterogeneous and nonlinear. Most improvement is seen during the first year of follow-up and differs between treatment modalities. No clinically significant differences in long-term trajectories were found. Insight into longitudinal trajectories can enhance individual patient counseling and provide the foundation for an individualized dynamic prediction model.

HIOPP-6 - a pilot study on the evaluation of an electronic tool to assess and reduce the complexity of drug treatment considering patients' views.

BACKGROUND: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed. METHODS: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (GI_with) and a version without (GI_without) integrated key questions for the personalization of the analysis, while the control group (GC) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective. RESULTS: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in GI_with, 83 in GI_without, and 2 in GC. Patients in GI_with were more likely to rate an optimization measure as helpful than patients in GI_without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167). CONCLUSIONS: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies. TRIAL REGISTRATION: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021).

Development and Pilot-Testing of Key Questions to Identify Patients' Difficulties in Medication Administration.

PURPOSE: The development and testing of key questions suitable to identify patients' difficulties with medication administration. MATERIALS AND METHODS: We used a consecutive five-step process to draft key questions regarding 43 aspects of medication administration that can be difficult for patients who manage a complex drug treatment: Step 1) Identification of potentially error-prone characteristics of drug treatment (such as certain dosage forms) and initial draft of key questions. Step 2) Assessment of how comprehensible the questions are for patients. Step 3) Pre-testing of exemplary key questions with patients and monitoring of patient's actual medication administration behavior. Step 4) Evaluation by general practitioners of how well the questions may be integrated into actual patient visits. Step 5) Final approval of the questions in an expert panel. Thereafter, we pilot-tested exemplary questions with 36 patients (43 tests). In the course of this pilot-testing, the patients' answers to the key questions were tested against both their actual behavior during medication administration and against their answers to more general questions regarding potential difficulties with medication administration. RESULTS: More than half of the key questions (N = 24/43) were revised at least once during the development process. During the pilot-testing, 55.8% of the pilot-tests (N = 24/43) revealed medication administration difficulties. It was observed that the key questions identified significantly more difficulties (N = 17) than the general questions (N = 8; P = 0.021, positive predictive value = 94.4% vs 88.9%). In one case, both a key question and a general question identified difficulties, which, however, was not confirmed during the drug administration demonstration, indicating a false positive rate of 5.3% in both cases. CONCLUSION: We developed key questions aimed at detecting administration errors with a high specificity and a significantly higher sensitivity than general questions, suggesting that the resource-intensive demonstration of medication administration can be reserved for the detection of rarer and uncommon administration errors.

The desirability of education in didactic skills according to medical interns.

Since all doctors at some point in their career will be faced with their role as a teacher, it appears desirable that future doctors are educated in didactic skills. At present, however, there are no formal opportunities for developing didactic skills at the majority of Dutch medical faculties. The main question of this study is: How do medical interns perceive the quality and quantity of their education in didactic skills? The Dutch Association for Medical Interns (LOCA) ran a national survey among 1,008 medical interns that measured the interns' self-assessed needs for training in didactic skills during medical school. Almost 80 % of the respondents argue that the mastery of didactic skills composes an essential competency for doctors, with the skill of providing adequate feedback considered to be the most important didactic quality for doctors. Of the respondents, 41 % wish to be educated in didactic skills, both during their medical undergraduate degree and during their subsequent training to become a resident. Teaching while being observed and receiving feedback in this setting is regarded as a particularly valuable didactic method by 74 % of the medical interns. Of the respondents, 82 % would invest time to follow training for the development of didactic skills if it was offered. Medical interns stress the importance of doctors' didactic skills during their clinical internships. Compared with current levels, most interns desire increased attention to the formal development of didactic skills during medical school. Considering the importance of didactic skills and the need for more extensive training, the LOCA advises medical faculties to include more formal didactic training in the medical curriculum.