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Cochrane Database of Systematic Reviews Protocol - Intervention

Interventions to aid employment for people on dialysis and their families

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To evaluate the effectiveness of interventions aimed at assisting employment for people on dialysis, or their family caregivers.

Background

Description of the condition

Chronic kidney disease (CKD) is a long‐term illness where the functioning of the kidneys is progressively reduced. End‐stage kidney disease (ESKD) occurs when kidney function is reduced to less than 15% of normal function, and affects about 5% of the population with CKD. ESKD is irreversible and renal replacement therapy with dialysis or kidney transplantation is usually undertaken. It is estimated that over 2 million people worldwide were receiving dialysis in 2010 (Liyanage 2015) and this figure is expected to double by 2030.

Dialysis is an intensive and time consuming treatment, involving attachment to a dialysis machine or fluid exchange system either several times a week, or several times a day. People on dialysis may have other medical problems including cardiovascular disease, diabetes, bone disorders, anaemia, visual impairment, malnutrition, depression, and changes in cognition. Survival for people on dialysis aged between 40 to 44 years is approximately 8 years (USRDS 2013) however people who start dialysis in their late twenties can expect to live for another 20 years (UK Renal Registry 2009).

Employment for people on dialysis has been recently highlighted as a patient‐important outcome in kidney management and research. People of working age managed on dialysis are much more likely to be unemployed than age‐matched healthy individuals (Essue 2013; Helantera 2012; Kutner 2008; Molsted 2004; Muehrer 2011; van Manen 2001) although many indicate they would like to return to work in either a full‐time or part‐time capacity (Curtin 1996). The factors associated with job loss after starting dialysis are older age (i.e. over 49 years); female gender; concurrent chronic diseases; haemodialysis rather than peritoneal dialysis as first treatment modality; poor health insurance coverage; and low or no erythropoietin usage before ESKD (Helantera 2012; Kutner 1991; Muehrer 2011). Family caregivers are also at risk of job loss, due to the time demands of caring for someone on dialysis (Morton 2011).

Description of the intervention

There are several different types of interventions that may assist an adult on dialysis to retain employment. These can include 1) vocational interventions such as flexible working hours, working from home arrangements; 2) workplace adjustments such as a private room for peritoneal dialysis exchanges; 3) government policies such as paid caregiver‐assisted home dialysis; 4) skills training after extended time away from work due to hospitalisation; 5) psycho‐social interventions to assist with re‐adjustment to new roles; 6) drug interventions to reduce uraemic symptoms; 7) provision of nocturnal dialysis therapies such as automated peritoneal dialysis or nocturnal home haemodialysis may also be considered, as well as 8) dialysis machine adjustments to facilitate work‐based tasks. The interventions may be delivered by the employer, the government, a kidney charity, dialysis industry, or the renal unit. Interventions that free up the time of a family caregiver such as the provision of patient transport to attend dialysis, or home assistance with dialysis‐related duties may assist caregiver work retention.

How the intervention might work

A Cochrane review in oncology reported that multi‐faceted interventions are likely to assist in return to work after cancer treatments (de Boer 2015). Multi‐disciplinary interventions involving physical exercises combined with patient education, counselling, biofeedback assisted behavioural training and/or vocational counselling, led to higher return‐to‐work rates than care as usual (RR 1.15, 95% CI 1.01 to 1.30). It is anticipated that multi‐faceted interventions will be most effective for dialysis patients.

Why it is important to do this review

"Large numbers of patients give up jobs or reduce work hours before or after initiating dialysis. Unemployment of working‐age individuals is associated with greater physical and psychological problems such as anxiety, depression, and loss of self‐esteem. Unemployment is also financially burdensome, for the individual concerned and their family caregivers." (Muehrer 2011).

This review was undertaken because employment for people on dialysis was rated by kidney patients and carers, as the 4th highest research priority, in a 2014 national exercise hosted by Kidney Health Australia and the Australian Government. The findings from this Cochrane review will provide evidence of effectiveness of interventions aimed at employment for people on dialysis and their family members. This evidence can be used by stakeholders to support the implementation of effective interventions.

Objectives

To evaluate the effectiveness of interventions aimed at assisting employment for people on dialysis, or their family caregivers.

Methods

Criteria for considering studies for this review

Types of studies

All randomised trials (RCTs), quasi‐RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods), and cluster RCTs. We will also include cohort studies, controlled before and after studies, interrupted time series studies, qualitative studies and case studies.

Types of participants

The population was limited to people aged ≥ 15 years who had been diagnosed with CKD stage 5, or were in paid employment prior to starting dialysis; and family caregivers who were in paid employment prior to their family member starting dialysis. The review aims to include all types of dialysis treatment and study participants from low and middle income countries.

Inclusion criteria

  • People aged between 15 and 80 years, diagnosed with CKD stage 5 or ESKD who have commenced dialysis

  • Family caregivers of adults on dialysis.

Exclusion criteria

  • People who are managed with pre‐emptive kidney transplantation, or who have not had a period of chronic dialysis prior to transplantation

  • People with ESKD < 15 years

  • Caregivers of paediatric dialysis patients aged < 15 years.

Types of interventions

  • Vocational interventions

  • Workplace adjustments

  • Government policies

  • Skills training

  • Psycho‐social interventions

  • Drug interventions

  • Dialysis treatment interventions (e.g. dialysis modality: facility HD, home HD, PD)

  • Dialysis equipment interventions.

Types of outcome measures

  • Employment in a full‐time or part‐time capacity following dialysis initiation

  • Unemployment, job loss or redundancy following dialysis initiation

  • Time to return to work following dialysis initiation

  • Durability ‐ or length of time employed

  • Sick leave, disability pension rates / or disability pension duration

  • Carers' allowance rates / or carers' allowance duration

  • Change in household equivalised income.

Primary outcomes  The main outcome is employment in a full‐time or part‐time capacity at any time point up to 5 years following initiation of chronic dialysis. This may be measured as a dichotomous outcome (i.e. Yes / No); as a rate (i.e. number of persons employed / number of persons of working age); or as a continuous variable (i.e. number of working hours per week).
Primary outcomes

The main outcome is employment in a full‐time or part‐time capacity at any time point up to five years following initiation of chronic dialysis. This may be measured as a dichotomous outcome (Yes/No); as a rate (number of persons employed/number of persons of working age); or as a continuous variable (number of working hours per week).

Secondary outcomes

  • Time to return to work following dialysis initiation, (e.g. measured in weeks or months)

  • Days of sick leave, disability pension rates or disability pension duration, (e.g. measured in days, weeks or rates)

  • Carers' allowance rates or carers' allowance duration (e.g. measured in monetary terms, a proportion of median income, or measured in weeks /months).

  • Change in household income (e.g. measured in monetary terms, proportion increase or decrease, or income categories)

  • Reasons for unemployment, job loss, redundancy or early retirement following dialysis initiation, (e.g. narrative report).

Search methods for identification of studies

Electronic searches

We will search the Cochrane Kidney and Transplant Specialised Register through contact with the Information Specialist using search terms relevant to this review. The Cochrane Kidney and Transplant Specialised Register contains studies identified from several sources.

  1. Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL)

  2. Weekly searches of MEDLINE OVID SP

  3. Handsearching of kidney‐related journals and the proceedings of major kidney conferences

  4. Searching of the current year of EMBASE OVID SP

  5. Weekly current awareness alerts for selected kidney and transplant journals

  6. Searches of the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Studies contained in the Specialised Register are identified through search strategies for CENTRAL, MEDLINE, and EMBASE based on the scope of Cochrane Kidney and Transplant. Details of these strategies, as well as a list of handsearched journals, conference proceedings and current awareness alerts, are available in the Specialised Register section of information about Cochrane Kidney and Transplant.

For non‐RCTs, we will also search MEDLINE, EMBASE, PsycINFO and NHS Economic Evaluation Database.

See Appendix 1 for search terms used in strategies for this review.

Searching other resources

  1. Reference lists of review articles, relevant studies and clinical practice guidelines.

  2. Letters seeking information about unpublished or incomplete studies to investigators known to be involved in previous studies.

  3. Conference proceedings, government reports and theses.

Data collection and analysis

Selection of studies

The search strategy described will be used to obtain titles and abstracts of studies that may be relevant to the review. The titles and abstracts will be screened independently by two authors, who will discard studies that are not applicable, however studies and reviews that might include relevant data or information on studies will be retained initially. Two authors will independently assess retrieved abstracts and, if necessary the full text, of these studies to determine which studies satisfy the inclusion criteria.

Data extraction and management

Data extraction will be carried out independently by two authors using standard data extraction forms. Studies reported in non‐English language journals will be translated as required, to facilitate assessment. Where more than one publication of one study exists, reports will be grouped together and all relevant study data will be used in the analyses. Any discrepancy between published versions will be highlighted.

Assessment of risk of bias in included studies

Randomised controlled trials

The following items in studies of RCTs will be independently assessed by two authors using the risk of bias assessment tool Higgins 2011 (see Appendix 2).

  • Was there adequate sequence generation (selection bias)?

  • Was allocation adequately concealed (selection bias)?

  • Was knowledge of the allocated interventions adequately prevented during the study?

    • Participants and personnel (performance bias)

    • Outcome assessors (detection bias)

  • Were incomplete outcome data adequately addressed (attrition bias)?

  • Are reports of the study free of suggestion of selective outcome reporting (reporting bias)?

  • Was the study apparently free of other problems that could put it at a risk of bias?

Non‐randomised controlled trials

For non‐randomised studies we will use the Newcastle‐Ottawa scale (Wells 2015) that identifies issues of study quality according to three domains: (representativeness of cohorts); comparability (cohort design or analysis); and outcomes (assessment and follow‐up). Domains are subdivided into eight questions, which will be represented in risk of bias tables in this review. A high‐quality choice is represented by a star, with the selection, comparability and outcome domains having four, one and three possible stars respectively (see Appendix 3, Appendix 4).

For qualitative studies the Consolidated criteria for reporting qualitative research (COREQ): a 32‐item checklist for interviews and focus groups will be used (Tong 2007).

Risk of bias assessments will be summarised at the outcome level.

Measures of treatment effect

For dichotomous outcomes (e.g. employment, unemployment) results will be expressed as risk ratio (RR) with 95% confidence intervals (CI). Where continuous scales of measurement are used to assess the effects of treatment (e.g. duration of employment or unemployment; household income) the mean difference (MD) will be used, or the standardised mean difference (SMD) if different scales have been used.

Unit of analysis issues

The units of analysis in this review will vary depending on the outcome presented. We will adopt a person‐centred analysis in that we will report effectiveness of employment interventions in terms of the numbers of people employed, or the number who incur job losses, rather than numbers of jobs created or retained, or productivity gains.

Dealing with missing data

Any further information required from the original author will be requested by written correspondence (e.g. emailing corresponding author) and any relevant information obtained in this manner will be included in the review. Attrition rates, for example drop‐outs, losses to follow‐up and withdrawals will be investigated. Issues of missing data and imputation methods (e.g. last‐observation‐carried‐forward) will be critically appraised (Higgins 2011).

Assessment of heterogeneity

We will first assess the heterogeneity by visual inspection of the forest plot. We will quantify statistical heterogeneity using the I2 statistic, which describes the percentage of total variation across studies that is due to heterogeneity rather than sampling error (Higgins 2003). A guide to the interpretation of I2 values will be as follows.

  • 0% to 40%: might not be important

  • 30% to 60%: may represent moderate heterogeneity

  • 50% to 90%: may represent substantial heterogeneity

  • 75% to 100%: considerable heterogeneity.

The importance of the observed value of I2 depends on the magnitude and direction of treatment effects and the strength of evidence for heterogeneity (e.g. P‐value from the Chi2 test, or a confidence interval for I2) (Higgins 2011).

Assessment of reporting biases

If possible, funnel plots will be used to assess for the potential existence of publication bias (Deeks 2011).

Data synthesis

Data from RCTs will be pooled using random‐effects. Data from non‐randomised studies is expected to be heterogeneous, originating from different study designs and may not be suitable for pooling. In this case, effect estimates adjusted for confounding will be displayed in a forest plot. Data from qualitative studies, particularly regarding reasons for job loss will be reported using thematic synthesis following methods described by Thomas and Harden (Thomas 2008).

Subgroup analysis and investigation of heterogeneity

Subgroup analysis will be used to explore possible sources of heterogeneity. Sources of heterogeneity at study level could be type of dialysis, women or men, class of occupation, patients or carers, country of study or geographic region, social security or social insurance system, and employment interventions. Heterogeneity among participants could be related to age and co‐morbid status (e.g. < 50 years, with concurrent heart disease or cancer). Adverse effects will be tabulated and assessed with descriptive techniques, as they are likely to be different for the various interventions used. Where possible, the risk difference with 95% CI will be calculated for each adverse effect, either compared to no employment intervention or usual care.

Sensitivity analysis

We will perform sensitivity analyses in order to explore the influence of the following factors on effect size.

  • Repeating the analysis excluding unpublished studies

  • Repeating the analysis taking account of risk of bias, as specified

  • Repeating the analysis excluding any very long or large studies to establish how much they dominate the results

  • Repeating the analysis excluding studies using the following filters: language of publication, source of funding (industry versus other), and country.

'Summary of findings' tables

We will present the main results of the review in 'Summary of findings' tables. These tables present key information concerning the quality of the evidence, the magnitude of the effects of the interventions examined, and the sum of the available data for the main outcomes (Schunemann 2011a). The 'Summary of findings' tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach (GRADE 2008). The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The quality of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schunemann 2011b). We plan to present the following outcomes in the 'Summary of findings' tables.

  • Employment in a full‐time or part‐time capacity following dialysis initiation

  • Unemployment, job loss or redundancy following dialysis initiation

  • Time to return to work following dialysis initiation

  • Sick leave, disability pension rates / or disability pension duration

  • Carers' allowance rates / or carers' allowance duration

  • Change in household equivalised income.