Development and Validation of a Treatment Algorithm for Osteoarthritis Pain Management in Patients With End-Stage Kidney Disease Undergoing Hemodialysis.

Background: Although osteoarthritis is common in the hemodialysis population and leads to poor health outcomes, pain management is challenged by the absence of clinical guidance. A treatment algorithm was developed and validated to aid hemodialysis clinicians in managing osteoarthritis pain. Objective: The objective was to develop and validate a treatment algorithm for managing osteoarthritis pain in patients undergoing hemodialysis. Design: A validation study was conducted based on Lynn's method for content validation. Setting: To develop and validate a treatment algorithm, interviews were conducted virtually by the primary researcher with clinicians from various institutions across the Greater Toronto and Hamilton Area in Ontario. Patients: The treatment algorithm was developed and validated for the management of osteoarthritis pain in patients on hemodialysis. Patients were not involved in the development or validation of the tool. Measurements: The algorithm was measured for content and face validity. Content validity was measured by calculating the content validity index of each component (I-CVI) of the algorithm and the overall scale validity index (S-CVI). Face validity was assessed by calculating the percentage of positive responses to the face validity statements. Methods: A draft algorithm was developed based on literature searches and expert opinion and validated by interviewing nephrology and pain management clinicians. Through consecutive rounds of 1:1 interviews, content and face validity were assessed by asking participants to rate the relevance of each component of the algorithm and indicate their level of agreeability with a series of statements. Following each round, the I-CVI of the algorithm as well as the S-CVI was calculated and the percentage of positive responses to the statements was determined. The research team revised the algorithm in response to the findings. The final algorithm provides a stepwise approach to the non-pharmacologic and pharmacologic management of pain, including topical, oral, and opioid use. Results: A total of 18 clinicians from 7 institutions across the Greater Toronto and Hamilton Area were interviewed (10 pharmacists, 5 nurse practitioners, and 3 physicians). The average S-CVI of the algorithm across all 3 rounds was 0.93. At least 78% of participants provided positive responses to the face validity statements. Limitations: An algorithm was developed based on input from clinicians working in the province of Ontario, limiting the generalizability of the algorithm across provinces. In addition, the algorithm did not include the perspectives of primary care providers or patients/caregivers. Conclusions: An algorithm for the management of osteoarthritis pain in the hemodialysis population was developed and validated through expert review to standardize practices and encourage clinicians to use evidence-based treatments and address the psychosocial symptoms of pain. As the algorithm possesses a high degree of content and face validity, it may improve osteoarthritis pain management among patients undergoing hemodialysis. Future research will assess the implementation of the algorithm across hemodialysis settings.

Contexte: Bien que l'arthrose soit fréquente et qu'elle entraîne de mauvais résultats de santé chez les patients en hémodialyse, la gestion de la douleur liée à l'arthrose est limitée par l'absence de directives cliniques. Un algorithme de traitement a été développé et validé afin d'aider les cliniciens en hémodialyse à gérer la douleur liée à l'arthrose chez leurs patients. Objectifs: Développer et valider un algorithme de traitement pour la prise en charge de la douleur liée à l'arthrose chez les patients en hémodialyse. Conception: Étude de validation menée en utilisant la méthode de Lynn pour la validation du contenu. Cadre: Pour élaborer et valider l'algorithme, le chercheur principal a mené des entrevues en mode virtuel avec des cliniciens de divers établissements de Hamilton et de la région du Grand Toronto (Ontario). Sujets: L'algorithme de traitement a été développé et validé pour la prise en charge de la douleur liée à l'arthrose chez les patients en hémodialyse. Ces derniers n'ont pas participé au développement ou à la validation de l'outil. Mesures: La validité du contenu et la validité apparente de l'algorithme ont été évaluées. La validité du contenu a été mesurée en calculant l'indice de validité de chaque composante (I-CVI) de l'algorithme, ainsi que l'indice de validité à l'échelle globale (S-CVI). La validité apparente a été évaluée en calculant le pourcentage de réponses positives aux énoncés de validité apparente. Méthodologie: Une ébauche de l'algorithme a été développée à partir de recherches de littérature scientifique et d'avis d'experts, puis validée lors d'entretiens avec des cliniciens en néphrologie et en gestion de la douleur. Afin d'évaluer la validité du contenu et la validité apparente de l'algorithme, les cliniciens ont participé à des séries consécutives d'entretiens individuels où ils devaient évaluer la pertinence de chaque composante de l'algorithme et indiquer leur niveau d'accord avec une série d'énoncés. L'indice de validité du contenu de chaque composante (I-CVI) de l'algorithme, l'indice de validité de l'échelle globale (S-CVI) et le pourcentage de réponses positives aux énoncés ont été calculés après chaque tour. L'algorithme a ensuite été révisé par l'équipe de recherche en réponse aux résultats. L'algorithme final fournit une approche par étapes pour la gestion non pharmacologique et pharmacologique (traitement local, oral, opioïdes) de la douleur. Résultats: En tout, 18 cliniciens provenant de 7 établissements de Hamilton et de la région du Grand Toronto ont été interviewés (10 pharmaciens, 5 infirmières praticiennes et 3 médecins). L'indice S-CVI moyen de l'algorithme pour les trois séries d'entrevues était de 0,93. Au moins 78 % des participants ont fourni des réponses positives aux énoncés de validité apparente. Limites: L'algorithme a été élaboré à partir des données fournies par des cliniciens travaillant dans la province de l'Ontario, ce qui limite sa généralisabilité dans les autres provinces. Aussi, l'algorithme n'inclut pas le point de vue des prestataires de soins primaires ou des patients/soignants. Conclusion: Un algorithme de prise en charge de la douleur liée à l'arthrose chez les patients en hémodialyse a été développé et validé par des experts afin de normaliser les pratiques et d'encourager les cliniciens à utiliser des traitements fondés sur les preuves et à traiter les symptômes psychosociaux de la douleur. L'algorithme ayant montré un degré élevé de validité du contenu et de validité apparente, il a ainsi le potentiel d'améliorer la gestion de la douleur liée à l'arthrose chez les patients en hémodialyse. Les recherches à venir évalueront l'application de l'algorithme dans divers contextes d'hémodialyse.

Development and Validation of a Uremic Pruritus Treatment Algorithm and Patient Information Toolkit in Patients With Chronic Kidney Disease and End Stage Kidney Disease.

CONTEXT: Uremic pruritus (UP) affects up to half of all patients with kidney disease and has been independently associated with poor patient outcomes. UP is a challenging symptom for clinicians to manage as there are no validated guidelines for its treatment. OBJECTIVES: The study aimed to develop and validate an algorithm and patient information toolkit for the treatment of UP in patients with kidney disease. METHODS: The study involved a literature search and development of an initial draft algorithm, followed by content and face validation of this algorithm. Validation entailed three rounds of interviews with six nephrology clinicians per round. Participants assessed the relevance of each component of the algorithm and then rated a series of statements on a scale of 1-5 to assess face validity of the algorithm. After each round, the content validity index (CVI) of each algorithm component was calculated, and the algorithm was revised by the study team in response to findings. This process was followed by a second study that developed and validated a patient information pamphlet and video. RESULTS: Algorithm validation participants were affiliated with three institutions and included seven physicians, four registered nurses, three nurse practitioners, three pharmacists, and a dietician. The average CVI of the algorithm components across all three rounds was 0.89, with 0.80 commonly cited as the lower acceptable limit for content validation. More than 78% of participants rated each face validity statement as "Agree" or "Strongly Agree". For the patient information tools, five clinicians and 15 patients were included in validation. The average CVI was 1.00 for both tools, and the average face validity was 92%. CONCLUSION: A treatment algorithm and patient information toolkit for managing UP in patients with kidney disease were developed and validated through expert review. Further research will be conducted on implementation of the treatment algorithm and evaluating patient-reported outcomes.

The Association of Functional Status with Mortality and Dialysis Modality Change: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

BACKGROUND: Little is known about the prevalence of functional impairment in peritoneal dialysis (PD) patients, its variation by country, and its association with mortality or transfer to hemodialysis. METHODS: A prospective cohort study was conducted in PD patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) (2014 - 2017). Functional status (FS) was assessed by combining self-reports of 8 instrumental and 5 basic activities of daily living, using the Lawton-Brody and the Katz questionnaires. Summary FS scores, ranging from 1.25 (most dependent) to 13 (independent), were based on the patient's ability to perform each activity with or without assistance. Logistic regression was used to estimate the odds ratio (OR; 95% confidence interval [CI]) of a FS score < 11 comparing each country with the United States (US). Cox regression was used to estimate the hazard ratio (HR; 95% CI) for the effect of a low FS score on mortality and transfer to hemodialysis, adjusting for case mix. RESULTS: Of 2,593 patients with complete data on FS, 48% were fully independent (FS = 13), 32% had a FS score 11 to < 13, 14% had a FS score 8 to < 11, and 6% had a FS score < 8. Relative to the US, low FS scores (< 11; more dependent) were more frequent in Thailand (OR = 10.48, 5.90 - 18.60) and the United Kingdom (UK) (OR = 3.29, 1.77 - 6.08), but similar in other PDOPPS countries. The FS score was inversely and monotonically associated with mortality but not with transfer to hemodialysis; the HR, comparing a FS score < 8 vs 13, was 4.01 (2.44 - 6.61) for mortality and 0.91 (0.58 - 1.43) for transfer to hemodialysis. CONCLUSION: Regional differences in FS scores observed across PDOPPS countries may have been partly due to differences in regional patient selection for PD. Functional impairment was associated with mortality but not with permanent transfer to hemodialysis.

The Enigmatic Fallopian Tube: A More Common Cause of Catheter Malfunction than Previously Recognized.

Successful performance of peritoneal dialysis (PD) depends on a properly functioning PD catheter. Catheter malfunction remains a significant cause of technique failure, especially early in the course of therapy. Common causes of catheter malfunction include catheter displacement, omental or bowel wrapping, and fibrin clots. Less commonly, various intraperitoneal structures have been reported to lead to obstruction, including appendices epiploicae of sigmoid colon and the fallopian tube. Peritoneal dialysis catheter blockage due to fimbriae of the fallopian tube is being recognized as an important cause of catheter malfunction in females due to the increasing availability of diagnostic laparoscopy. We report 5 episodes of catheter malfunction in 4 patients on PD from a single center as a result of obstruction by the fallopian tube.

Functional Dependence and Mortality in the International Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: Patients receiving long-term dialysis have among the highest mortality and hospitalization rates. In the nonrenal literature, functional dependence is recognized as a contributor to subsequent disability, recurrent hospitalization, and increased mortality. A higher burden of functional dependence with progressive worsening of kidney function has been observed in several studies, suggesting that functional dependence may contribute to both morbidity and mortality in dialysis patients. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 7,226 hemodialysis patients from 12 countries in the DOPPS (Dialysis Outcomes and Practice Patterns Study) phase 4 (2009-2011) with self-reported data for functional status. PREDICTOR: Patients' ability to perform 13 basic and instrumental activities of daily living was summarized to create an overall functional status score (range, 1.25 [most dependent] to 13 [functionally independent]). OUTCOME: Cox regression was used to estimate the association between functional status and all-cause mortality, adjusting for several demographic and clinical risk factors for mortality. Median follow-up was 17.2 months. RESULTS: The proportion of patients who could perform each activity of daily living task without assistance ranged from 97% (eating) to 47% (doing housework). 36% of patients could perform all 13 tasks without assistance (functional status = 13), and 14% of patients had high functional dependence (functional status < 8). Functionally independent patients were younger and had many indicators of better health status, including higher quality of life. Compared with functionally independent patients, the adjusted HR for mortality was 2.37 (95% CI, 1.92-2.94) for patients with functional status < 8. LIMITATIONS: Possible nonresponse bias and residual confounding. CONCLUSIONS: We found a high burden of functional dependence across all age groups and across all DOPPS countries. When adjusting for several known mortality risk factors, including age, access type, cachexia, and multimorbidity, functional dependence was a strong consistent predictor of mortality.

The impact of transfer from hemodialysis on peritoneal dialysis technique survival.

BACKGROUND: A significant proportion of peritoneal dialysis (PD) patients receive an initial period of hemodialysis (HD) before transitioning to PD ("PD-switch"). We sought to better understand the risks of PD technique failure (TF) and mortality for those patients compared with patients starting with PD as their first dialysis modality ("PD-first"). METHODS: Using Canadian Organ Replacement Register data, we compared the risk of PD TF between PD-first and PD-switch patients within the first year after HD initiation. In a secondary analysis, the PD-switch patients were stratified into three groups based on timing of the switch from initial HD to PD as follows: 0 - 90 days, 91 - 180 days, and 181 - 365 days. Each group was compared with PD-first patients for risk of PD TF and death. RESULTS: Between 2001 and 2010, 9404 patients initiated PD as their first renal replacement therapy, and 3757 switched from HD to PD. After multivariable adjustment, the risk of PD TF was higher among PD-switch patients than among PD-first patients [adjusted hazard ratio (AHR): 1.37; 95% confidence interval (CI): 1.26 to 1.49], particularly within the first year after the switch from HD to PD (AHR: 1.51; 95% CI: 1.36 to 1.68). There was no association between time on HD within the first year and subsequent risk of PD TF. For all the stratified PD-switch groups, death rates were higher than those for PD-first patients. CONCLUSIONS: Compared with patients who start renal replacement therapy with PD, those who transfer from HD to PD within the first year on dialysis experience higher rates of PD TF and death, with the highest risk being observed in the initial year after the switch to PD.

A palliative approach to dialysis care: a patient-centered transition to the end of life.

As the importance of providing patient-centered palliative care for patients with advanced illnesses gains attention, standard dialysis delivery may be inconsistent with the goals of care for many patients with ESRD. Many dialysis patients with life expectancy of <1 year may desire a palliative approach to dialysis care, which focuses on aligning patient treatment with patients' informed preferences. This commentary elucidates what comprises a palliative approach to dialysis care and describes its potential and appropriate use. It also reviews the barriers to integrating such an approach into the current clinical paradigm of care and existing infrastructure and outlines system-level changes needed to accommodate such an approach.

Early dialysis initiation and rates and timing of withdrawal from dialysis in Canada.

BACKGROUND AND OBJECTIVES: The number of elderly patients and those with higher estimated GFR (eGFR) initiating dialysis have recently increased. This study sought to determine rates of withdrawal from dialysis and variables associated with withdrawal. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Canadian Organ Replacement Registry data were used to examine withdrawal rate and identify variables associated with withdrawal among the total cohort, patients age < 75 years, and patients age ≥ 75 years, along with those with early (eGFR > 10.5 ml/min per 1.73 m(2)) and those with late (eGFR ≤ 10.5 ml/min per 1.73 m(2)) initiation of dialysis, using a Cox proportional hazard model in patients starting dialysis between 2001 and 2009, with follow-up to December 31, 2009. RESULTS: Median follow-up duration was 23.0 (interquartile range [IQR], 34.3) months. Rate of withdrawal per 100 patient-years doubled from 1.5 to 3.0, and withdrawal as cause of death increased from 7.9% to 19.5% between 2001 and 2009. Early initiation of dialysis was associated with increased withdrawal risk (hazard ratio, 1.17; 95% confidence interval, 1.06-1.30; P=0.002), as were older age, female sex, white race, and late referral to nephrologist. Patients age ≥ 75 years withdrew earlier after dialysis initiation (median, 15.9 [IQR, 27.9] months) compared to those age < 75 years (21.6 [IQR, 35.2] months). Early-start patients withdrew earlier (median, 15.6 [IQR, 28.5] months) compared with late-start patients (20.2 [IQR, 32.9] months). CONCLUSIONS: In Canada, withdrawal from dialysis has increased significantly over recent years, especially among patients starting with higher eGFRs and in the elderly.

Changes in patient and technique survival over time among incident peritoneal dialysis patients in Canada.

BACKGROUND AND OBJECTIVES: In the last 15 years in Canada, there have been less stringent guidelines for peritoneal dialysis (PD) adequacy, availability of novel PD solutions, and lower PD-related peritonitis rates. Effects of these changes on outcomes of incident patients treated with PD during this period are unknown. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Risk of PD technique failure and mortality were compared among three incident cohorts of PD patients who initiated dialysis during the following periods: 1995-2000, 2001-2005, and 2006-2009. A multivariable model was used to evaluate time to PD technique failure using inverse probability of treatment and censoring weights accounting for changing survival and transplantation rates. RESULTS: Between 1995 and 2009,13,120 incident adult PD patients were identified from the Canadian Organ Replacement Register. Compared with the 1995-2000 cohort (n=5183), the risk of PD technique failure was lower among patients between 2001 and 2005 (n=4316) but similar among incident patients between 2006 and 2009 (n=3621). Cause-specific PD technique failure revealed no difference in PD peritonitis-related technique failure over time. PD technique failure due to inadequate PD was initially higher in the 2001-2005 cohort but lower in the 2006-2009 cohort compared with the 1995-2000 cohort. Relative to incident patients between 1995 and 2000, adjusted mortality was lower among incident patients between 2001 and 2005 and 2006 and 2009. CONCLUSIONS: Survival on PD continues to improve with only modest changes in PD technique failure. Peritonitis remains an ongoing and modifiable source of PD technique failure.

Hemodialysis vascular access modifies the association between dialysis modality and survival.

Several comparisons of peritoneal dialysis (PD) and hemodialysis (HD) in incident patients with ESRD demonstrate superior survival in PD-treated patients within the first 1 to 2 years. These survival differences may be due to higher HD-related mortality as a result of high rates of incident central venous catheter (CVC) use or due to an initial survival advantage conferred by PD. We compared the survival of incident PD patients with those who initiated HD with a CVC (HD-CVC) or with a functional arteriovenous fistula or arteriovenous graft (HD-AVF/AVG). We used multivariable piece-wise exponential nonproportional and proportional hazards models to evaluate early (1 year) mortality as well as overall mortality during the period of observation using an intention-to-treat approach. We identified 40,526 incident adult dialysis patients from the Canadian Organ Replacement Register (2001 to 2008). Compared with the 7412 PD patients, 1-year mortality was similar for the 6663 HD-AVF/AVG patients but was 80% higher for the 24,437 HD-CVC patients (adjusted HR, 1.8; 95% confidence intervals [CI], 1.6 to 1.9). During the entire period of follow-up, HD-AVF/AVG patients had a lower risk for death, and HD-CVC patients had a higher risk for death compared with patients on PD. In conclusion, the use of CVCs in incident HD patients largely accounts for the early survival benefit seen with PD.

Impact of dialysis modality on survival after kidney transplant failure.

BACKGROUND AND OBJECTIVES: An increasing number of patients are returning to dialysis after allograft loss (DAGL). These patients are at a higher mortality risk compared with incident ESRD patients. Among transplant-naïve patients, those treated with peritoneal dialysis (PD) enjoy an early survival advantage compared with those treated with hemodialysis (HD), but this advantage is not sustained over time. Whether a similar time-dependent survival advantage exists for PD-treated patients after allograft loss is unclear and may impact dialysis modality selection in these patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We identified 2110 adult patients who initiated dialysis after renal transplant failure between January 1991 and December 2005 from The Canadian Organ Replacement Register. Multivariable regression analysis was used to evaluate the impact of initial dialysis modality on early (2 years), late (after 2 years), and overall mortality using an intention-to-treat approach. RESULTS: After adjustment, there was no difference in overall survival between HD- and PD-treated patients (hazard ratio((HD:PD)), 1.05; 95% confidence interval, 0.85 to 1.31), with similar results seen for both early and late survival. Superior survival was seen in more contemporary cohorts of patients returning to DAGL. CONCLUSIONS: The use of PD compared with HD is associated with similar early and overall survival among patients initiating DAGL. Differences in both patient characteristics and predialysis management between patients returning to DAGL and transplant-naive incident dialysis patients may be responsible for the absence of an early survival advantage with the use of PD in DAGL patients.

Exercise program to enhance physical performance and quality of life of older hemodialysis patients: a feasibility study.

OBJECTIVE: Evaluate the feasibility of implementing a combined in-hospital and home-based exercise program in older hemodialysis (HD) patients. DESIGN: A prospective longitudinal 12-week pilot study. SETTING: A university hospital HD unit and patients' homes. PARTICIPANTS: A convenience sample of nine older (>55 years) patients undergoing HD. INTERVENTIONS: An individualized exercise program performed on HD days (3/week) and at home (2-3/week), including aerobic, flexibility, strength exercises and patient education. MAIN OUTCOME MEASURES: Feasibility measure: patient participation. Exercise performance: Duke Activity Status Index (DASI); 2-min walk test (2MWT); Timed-up-and-go (TUG). Quality of life: The Illness Intrusiveness Ratings Scale (IIRS); The Kidney Disease Quality of Life Questionnaire (KDQOL). RESULTS: The mean (SD) age of the patients was 68.1 (7.1). Participation in the in-hospital supervised exercise program was high, with patients exercising during 89% of HD sessions, but was lower for the unsupervised home-based component (56% exercised ≥ 2 times/week). Patients showed a gradual increase in the amount of exercise performed over 12 weeks. The 2MWT, TUG, IIRS and the KDQOL physical composite score demonstrated moderate responsiveness, while the DASI score exhibited only limited responsiveness. CONCLUSIONS: This exercise program and the outcome measures were feasible for older HD patients: in-hospital participation was high, and physical performance and QOL measures exhibited moderate levels of responsiveness. Future, larger studies are needed to demonstrate whether intra-dialysis exercise, with or without home exercise, can lead to improved outcomes in this population.

Patient and technique survival of diabetics on peritoneal dialysis: one-center's experience and review of the literature.

BACKGROUND: Diabetes is the leading cause of end-stage renal disease (ESRD). This retrospective study investigated the long-term patient and technique survival and sought to identify the predictors of mortality in diabetic patients receiving PD. METHODS: Patients, aged 17 years or more who commenced home PD between January 31, 1994, and December 31, 2001 were included. Clinical data were available for 358 patients out of 418 total patients who started PD during this period. They were followed until cessation of PD, death, or to January 31, 2003. Survival probabilities were generated according to the Kaplan-Meier method, and multivariate Cox proportional hazards models were used to assess predictors of survival. RESULTS: A total of 358 patients were enrolled in the study. Among them, 139 patients (38.8%) were diabetics. The 1-, 2-, 3- and 5-year patient survival rates were 91%, 76%, 66% and 47% in diabetics and 94%, 89%, 84% and 69% in non-diabetics, respectively. Median actuarial patient survival for diabetic patients (51.8 months; 95% CI 36.0 â 67.5 months) was significantly shorter than that of non-diabetic patients (log rank 14.117, p < 0.001). Death-censored technique survival rates at 1-, 2-, 3- and 5-year were 90%, 83%, 67% and 58% in diabetic, and 94%, 87%, 77% and 70% in non-diabetic patients, respectively. Similar to patient survival, the median technique survival time was significantly shorter for diabetic patients (63.9 months; 95% CI 35.7 - 92.2 months) than that of non-diabetic patients (log rank 4.884, p = 0.027). Multivariate Cox regression analysis showed that advancing age was the only independent predictor of death in the diabetic patients, whereas higher age and wider pulse pressure were associated with mortality in non-diabetic patients. CONCLUSION: Long-term patient and technique survival for diabetic patients on PD seem to be improved compared to our previous report and other studies. The mortality of diabetic patients was predicted predominantly by advancing age. PD remains a viable form of long-term renal replacement therapy for diabetic patients with ESRD.