Survival

Very low to moderate quality evidence (GRADE table 1) from one systematic review and meta-analysis which included 40 studies (randomised trials and observational) (Schlesinger et al, 2009) showed protective isolation with any combination of methods that included air quality control reduced the risk of death at 30 days (RR=0.6; 95% CI 0.5–0.72; 15 studies, 6280 patients); 100 days (RR=0.79, 95% CI, 0.73–0.87; 24 studies, 6892 patients) and at the longest available follow-up (between 100 days and 3 years) (RR=0.86, 95% CI 0.81–0.91; 13 studies, 6073 patients).

GRADE Table 1

Isolation compared to No isolation/Placebo for low risk patients.

Infection related Mortality, Risk of Infection, Antibiotic use

Very low to moderate quality evidence (GRADE table 1) from one systematic review and meta-analysis which included 40 studies (randomised trials and observational) (Schlesinger et al, 2009) showed protective isolation reduced the occurrence of clinically and/or microbiologically documented infections (RR=0.75 (0.68–0.83) per patient; 20 studies, 1904 patients; RR=0.53 (0.45–0.63); per patient day, 14 studies, 66431 patient days).

Very low to moderate quality evidence (GRADE table 1) from one systematic review and meta-analysis which included 40 studies (randomised trials and observational) (Schlesinger et al, 2009) showed no significant benefit of protective isolation (all studies used air quality control) was observed in relation to mould infections (RR=0.69, 0.31–1.53; 9 studies, 979 patients) nor was the need for systemic antifungal treatment reduced (RR=1.02, 95% CI 0.88–1.18; 7 studies, 987 patients).

Very low to moderate quality evidence (GRADE table 1) from one systematic review and meta-analysis which included 40 studies (randomised trials and observational) (Schlesinger et al, 2009) showed gram positive and gram negative infections were significantly reduced, though barrier isolation was needed to show a reduction in gram negative infections (RR= 0.49 (0.40–0.62) with barrier isolation (12 trials/n=1136) versus RR=0.87 (0.61–1.24) without barrier isolation (4 trials/n=328).

In very low to moderate quality evidence (GRADE table 1) from one systematic review and meta-analysis which included 40 studies (randomised trials and observational) (Schlesinger et al, 2009), the need for systemic antibiotics did not differ when assessed on a per patient basis (RR=1.01, 0.94–1.09; 5 studies, 955 patients) but the number of antibiotic days was significantly lower with protective isolation (RR=0.81, 0.78–0.85; 3 studies, 6617 patient days).

Room facilities

Very low quality evidence from one retrospective cohort-control study (GRADE table 1) comparing outcomes before and after ward renovation in 63 patients (Hutter et al, 2009) reported that patients treated before renovation (two patients per room, six patients sharing a toilet placed outside the room, washing basin inside the room, shower across the hospital corridor, no ventilation system, air filtration or room pressurisation, no false ceilings) stayed three days longer compared with those treated on the newly renovated ward (two patients per room, separate rest room in each room equipped with toilet, wash basin and shower, no ventilation system, air filtration or room pressurisation, no false ceilings). 39% of pre-renovation patients and 34% of post-renovation patients developed an invasive pulmonary aspergillosis (p=0.79) with the diagnosis usually determined on CT scan.

Survival

Very low quality evidence (GRADE table 2) from one systematic review and meta-analysis (Schlesinger et al, 2009), showed febrile patients were discharged for further antibiotic treatment at home if stable. All cause mortality was significantly lower in the outpatient setting (RR=0.72, 95% CI 0.53–0.97) at longest follow-up (median follow-up 12 months; range 1–36).

GRADE Table 2

Ambulatory Care versus inpatient care.

Unpublished data collected by the Sheffield Ambulatory Care Unit and University College Hospital, London Ambulatory Care Unit reported no deaths in the Ambulatory Care Unit between during the period January 2011–March 2015 (Appendix 1).

Hospital Admissions and length of stay

Very low quality evidence (GRADE table 2) from one UK audit of a hotel based, ambulatory care unit (Sive et al, 2012b) showed there were 1443 admissions to the ambulatory care unit (ACU) (9126 patient days) during the study period(688 patients from 18–79 years of age), whose length of stay ranged from 1 to 42 days (median 5). 82% of admissions were in haematology oncology patients with lymphoma being the largest single group of patients by days of use.

Patients receiving less myelosuppressive regimens tended to be discharged home on treatment completion while patients receiving more intensive treatment almost always required readmission to the ward at some point. 813/1443 (56%) patients were discharged directly home; 53/630 (9%) patients admitted to the ward were scheduled in advance.

Very low quality evidence (GRADE table 2) from one UK audit of a hotel based, ambulatory care unit (Sive et al, 2012b), 456/576 (79%) of unscheduled ward admissions were within ACU working hours, 66 (11%) were out of hours and 54 (9%) had no time recorded. The most common reason for unscheduled admission included infection or fever, nausea and vomiting and poor oral intake or dehydration.

Very low quality evidence (GRADE table 2) from one retrospective study in which patients who were fit for home care were given a choice between home care and inpatient care (Sopko et al, 2012), 17/41 patients required ambulatory management only while 24 patients required re-hospitalisation, primarily due to febrile neutropenia.

In 36 febrile episodes a microbiologically documented infection was the most common cause of fever (61%) with the remaining episodes being of unknown origin.

Patients re-hospitalised were admitted for a mean 10.9 days (6–35 days) versus a mean hospitalisation time of 30 days for inpatients (17–38). Mean duration of hospitalisation for inpatients from the time they became febrile to discharge was 14.3 days (7–22 days).

Very low quality evidence (GRADE table 2) from one retrospective analysis of 30 patients (Bakhshi et al, 2009) showed 25/69 consolidation cycles resulted in hospital admission and all were associated with febrile neutropenic episodes or documented infections. Hospital stay was significantly shorter in outpatient cycles compared with inpatient cycles (p<0.001) leading to a saving of 269 patient-days for the entire study group.

Unpublished data collected by the Sheffield Ambulatory Care Unit and University College Hospital, London Ambulatory Care Unit was combined to calculate inpatient bed days saved through the use of an ambulatory care program. An average of sixteen inpatient bed days per patient was saved for Acute Myeloid Leukaemia, an average of nine inpatient bed days were saved for Acute Lymphoblastic Leukaemia and sixteen inpatient bed days for Burkitt Lymphoma (Appendix 1)

Infections

Very low quality evidence (GRADE table 2) from one systematic review and meta-analysis (Schlesinger et al, 2009) showed febrile patients were discharged for further antibiotic treatment at home if stable and febrile neutropenia or documented infections occurred less often in the outpatient group (RR=0.78, 95% CI 0.7–0.88; 8 studies, 757 patients), rates of bacteraemia were lower in the outpatient group but the difference was not significant (RR=0.68, 95% CI 0.43–1.05; 2 studies. 252 patients).

Very low quality evidence (GRADE table 2) from one retrospective analysis of 30 patients (Bakhshi et al, 2009) showed significantly fewer outpatients required second line antibiotics compared with inpatients (p=0.03) and mean duration of antibiotic administration was significantly lower in the outpatient group (p=0.04).

Transfusions

Very low quality evidence (GRADE table 2) from one retrospective analysis of 30 patients (Bakhshi et al, 2009) reported a median of 1 (0–4) unit of packed red blood cells was transfused per consolidation cycle in the outpatient setting and 2 (0–5) in the inpatient setting and a median of 1 (0–13) platelet transfusions were administered at the outpatient clinic and 2 (0–12) in the inpatient setting.

Quality of Life

In very low quality evidence (GRADE table 2) from one randomised cross over trial (Stevens et al, 2005) quality of life for 29 paediatric patients treated at home or in hospital (standard care) was assessed. Children were assigned to home or hospital chemotherapy for 6 months (phase 1) and home patients were transferred to hospital administration for phase 2 and vice-versa.

Children in the home group experienced a decrease in factor 1 (sensitivity to restrictions in physical functioning and ability of maintain a normal physical routine) of the Paediatric Oncology Quality of Life Scale (POQOLS) measures when they switched from home based treatment to hospital based treatment with an average change of+ 5.2 (an increase in score indicates a decline in quality of life) while hospital care patients experienced an improvement in quality of life (QoL) when they switched to home based treatment with an average score of −10.5 (p=0.023). There was no significant difference (p=0.60) in factor 1 values between the two groups at long-term comparison, measured at 6 months after the start of phase 2.

Changes in factor 2 (emotional distress) and factor 3 (reaction to current medical treatment) measures did not differ significantly between the two patient groups. Patients in the home-based group had significantly higher scores for factor 2 (emotional distress) measures, indicating lower quality of life, compared with the hospital treatment group (pair wise comparison at the end of each 6 months phase p=0.043).

In very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005) 33 health practitioners (hospital and community based) reported that home-based care appeared to have a positive impact on daily life and psychological well-being of children and families particularly in relation to disruption and psychological stress, reporting a reduction in disruption due to reduced travelling, reduced hospital clinic waiting time and reduced time missed from school and work.

“I think the big advantage is certainly it helps the children and their families to maintain a more normal routine on that day – to be able to avoid having to miss work and school – and have a big disruption and cost added to their day to come all the way down here for treatment that could be provided in a much shorter period and at a time that’s more convenient for them.”

Health practitioners also reported noting fewer signs of psychological distress in children and parents during the home chemotherapy phase; children appeared happier and more comfortable while parents appeared to have more of a sense of control over the illness and treatment.

“Most kids seem to like it [chemotherapy] at home; they are happier. But I find that with community nursing in general. Some of the kids are so withdrawn when they come into the hospital, and are so different at home. So are the parents. Parents are usually more at ease at home, feel they have more control at home.”

The advantages conferred by consistency in personnel and practice were emphasised by hospital based practitioners. Children in the hospital setting were seen by the same practitioner helping parents and children become comfortable and trusting while in the community setting, care providers were less consistent.

“I’m the consistent person that gives the chemotherapy and the children; they adapt to you and the way you do things, and you get to know them. That’s consistent, that helps them.” [Clinic Nurse]

“Whoever was working that day would go to see the patients. It was mostly the three of us…whoever was working was going. It took longer, but generally not in the first time but within a few times; they would get comfortable with the procedure” [Community Nurse]

Patient Satisfaction

Very low quality evidence (GRADE table 2) from one retrospective study in which 17 patients were treated at home for 46 cycles (Luthi et al, 2012), patients reported that they were ‘very satisfied’ with home care and one case reported being ‘satisfied’. None of the patients showed a preference for inpatient care for the next chemotherapy cycles.

38% of patients stated a preference for home care and others had no declared preference. Patient reported benefits of home care included a higher comfort level (100%), freedom and the possibility to organise their own time (94%) and the reassurances and comfort of having a relative present (88%).

78% of patients were not concerned about the absence of a nurse and 87% did not record any anxiety during home care treatment

Very low quality evidence (GRADE table 2) from one retrospective study in which 17 patients were treated at home for 46 cycles (Luthi et al, 2012) showed that the main patient reported disadvantages were feelings of dependency on a relative (19%) and or being a burden (6%) however, relatives who returned questionnaires (63%) and all were in favour of home care and 97% were in favour of home care for next treatment.

Primary concerns about home care included the presence of strangers (nurse, physician) at home (16%), request for continuous presence as patients were not allowed to be alone for more than one hour (14%), anxiety and fatigue (14%) and lack of freedom for leisure and holidays (14%).

Burden of Care

Very low quality evidence (GRADE table 2) from one randomised cross over trial (Stevens et al, 2005) including 29 paediatric patients treated at home or in hospital (standard care) reported no evidence of an effect of the location of chemotherapy administration was observed on the parental burden of care (assessed using the care giving burden scale).

Impact on Practitioners

In very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005), it was suggested that community health practitioners should have specific education in relation to home care, administration of chemotherapy to children and meeting psychological needs of children with cancer and their families. Four home care nurses took part in a three day educational session on chemotherapy administration and reported that they found the course extremely valuable.

Very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005), health practitioners agreed that the major benefit of hospital treatment was that the resources and treatments were all centralised and orchestrated.

“Their [children and parents] only experience has been with [hospital name] and you whip your child in and they get a little finger poke and then sometimes an hour or two later the results are back and then it’s very smooth.”

While having home chemotherapy, children had to go to community laboratories to have their blood test done, many technicians lacked paediatric experience and were insensitive to their needs.

“The biggest one [problem] we have run into has been the whole lab issue and the fact that we’ve discovered that laboratories in the community are not very child friendly [hospital programme director]

There was also an issue with laboratory results not being communicated to the community nurses for subsequent drug prescription and home delivery resulting in increased workload while nurses retrieving results from hospital physicians. It was suggested that there should be one central person to liaise between the hospital and community.

Very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005), showed that some hospital physicians reported feeling less confident about prescribing chemotherapy agents for children due to the inability to assess the child directly and be in charge of the healthcare process in the community. They also reported feeling unclear about issues relating to liability and responsibility.

From very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005), two clinic nurses and three paediatric oncologists reported no change in their workload; five clinic nurses and 1 physician reported an increase due to the higher volume of paperwork and three clinic nurses reported a decrease.

13/14 community health practitioners reported an increase in workload primarily due to increased paperwork and increased time communicating with other health practitioners to expedite the process.

“It has added to my responsibilities, the day before having to give chemo, I am doing a lot of phone calling. Labs, clinic, chemo… it can be very time consuming and very frustrating but the actual visit time is not the issue.” [community nurse]

Community practitioners reported they had increased their repertoire of skills and ‘felt good’ about helping families which increased their personal satisfaction. It was also reported that partnership between community and hospital was enhanced by effective communication with opportunities to collaborate and share ideas and optimise treatments.

Very low quality evidence (GRADE table 2) from a nested qualitative study (Stevens et al, 2004) within a randomised cross over trial (Stevens et al, 2005), the home chemotherapy programme was associated with less interaction with children and families which was considered to be both a positive (fewer patients in outpatient clinics, health practitioners less busy, more time for children in attendance) and negative (distressing because they were not sure how the children were coping with treatment) process.

“You look forward to their visits, I do anyways. Because the communication of how they’re really doing and how things are going is sort of broken down, there’s a gap because you don’t see them every two weeks.” [hospital clinic nurse]

Responses suggested an increased level of frustration as the home chemotherapy programme was challenging to accommodate in terms of scheduling between health practitioners and families.

“I found that we were juggling a lot. Trying to work around the teenagers schedules because you would end up calling them to say that you were going to come and do the chemo and they would say ‘Oh no I’m off to something or other tonight’ So I had to go the home early at 7:30 the next morning. So of course we tried to do that but when you have a lot of patients you just cannot do it. We can’t always work around their schedule and I think that really needs to be made clear.” [community nurse]

Feasibility

Very low quality evidence (GRADE table 2) from one retrospective study in which 17 patients were treated at home for 46 cycles (Luthi et al, 2012), reported that home treatment required one physician visit and two nurse visits per day accounting for 621 visits during 46 treatment cycles (207 days of home treatment). 32 additional home visits were required as a result of technical problems with the pump (median, 1 visit per cycle; range 0–4 visits per cycle) and most visits were needed at the start of treatment.

Pump failure due to air bubbles was the main technical problem and was resolved by flushing the tube (n=21 cases).

Partial disconnection at the exit channel occurred in nine cases and needle disconnection from the port of the catheter occurred in two cases.

Two major pump failures were reported resulting in one overnight hospitalisation and a four day hospitalisation.

Advice on restrictions on social contact, pets and food

From one retrospective audit of 336 institutions in 27 countries (Lehrnbecher et al, 2012), 107 centres (32%) had written protocols for non-pharmacological anti-infective approaches and n=64 (64%) had a general agreement without a written policy. In 85 centres (25%) practitioners used an individualised approach

A physician was involved in the instruction of parents in 89% (n=299) of centres and a nurse in 71% of centres (n=238).

A handout was provided to parents in 52% (n=174) of centres and was the only information given in 4% (n=14) of cases.

42% of parents received a handout and were additionally provided with verbal information by a nurse or physician.

Restriction scores in Europe were significantly higher than in USA, suggesting greater restrictions; restriction scores did not differ by centre.

In relation to social contact, most centres did not allow children with AML to visit indoor public places, attend day care, nursery or school while recommendations for patients with ALL varied considerably. Restrictions mostly related to neutropenia (58%) and to chemotherapy regimens and the health of surrounding people was a pre-condition for reduced restrictions in 16% of centres.

In relation to pets, there was wide variation in recommendations for both AML and ALL patients. Restrictions under certain circumstances related to appropriate hand-washing after contact (27%), keeping animals already at home without introducing new pets (25%), restriction of pets in the bedroom or on the bed (22%), ensuring pets were assessed by a veterinary specialist (17%) and restrictions on cleaning of cages/litter trays (16%).

In relation to food, most centres had restrictions on raw meat, raw seafood and unpasteurised milk for both AML and ALL patients. There were wide variations in food restrictions around salad, nuts, takeaway food and unpeeled vegetables. In 68% of cases, restrictions were generally related to neutropenia and specific chemotherapy regimens .If uncooked vegetables or salad were allowed, appropriate cleaning was advised (12%).

In relation to the use of face masks, 9% (n=30) institutions recommended children with ALL wear face masks in public while 34% (n=114) recommended face masks for AML patients. 54% (n=181) never suggest facemasks for children with ALL and 41% (n=138) never suggest facemasks for children with AML.