McKegney 1981.
Methods | Cluster‐RCT; Unit of allocation: Counties in Vermont that were paired on the basis of population density, distance from the Medical Centre, socio‐economic status, local medical facilities, referral patterns, and local social services resources. | |
Participants | Patients receiving palliative radiation and/or chemotherapy having an expected survival of greater than 3 months but less than 1 year. Setting / country: Medical Center Hospital of Vermont / USA Type of cancer: Any type Phase of care: Treatment, palliative care Sample size at randomisation: 199 |
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Interventions | Home visits by trained oncology nurse practitioners + multidisciplinary care: Nurse practitioners with extensive experience in care of the patients with advance cancer were selected. The home visit by the nurses was primarily focused on attending to the needs of the patient, and interactions with family members were incidental to that task. In addition to providing physical care, much of the nurses time was spent in talking with the patient about their illness and its implications. The nurse frequently mobilised family and other social resources to meet the patients needs and also coordinated with the patients local physician. These nurses thus served in the well‐known public health, or visiting nurse role, with the difference that the project nurse had the benefit of a multidisciplinary healthcare team back‐up resource. A Protocol for Management of Pain was developed by the team and used by the nurses as part of their wide range of physical treatments and psychosocial interventions. This protocol was based upon sound pharmacological principles, many of which are often ignored (additional details provided in the article). The patients also received multidisciplinary care at the Medical Center Hospital of Vermont (MCHV) and/or from their private physicians. Regular participants in the multidisciplinary team consisted of medical and radiation oncologists, psychiatrists, social workers, physical therapists, nutritionists, occupational therapists, enterostomal therapists, and clergymen. Patients with an expected survival of less than 3 months were visited by nurses biweekly and those expected to live longer were visited monthly. Control: Multidisciplinary care alone: patients in this group were not visited at home by nurses but received multidisciplinary care at the hospital and care was otherwise the same as that of the intensive group. |
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Outcomes | Patient: Psychological symptoms, internal ‐ external expectation of control, pain, health status | |
Notes | Length of follow‐up: 48 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from ref #1:"Counties in Vermont were paired on the basis of population density, distance from the Medical Center, socioeconomic status, local medical facilities, referral patterns, and local social services resources. The paired counties were randomly separated into two groups, with one designated intensive and the other non‐intensive. |
Allocation concealment (selection bias) | Unclear risk | See quote first item. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "Follow‐up data bases were gathered from both intensive and non‐intensive patients by trained independent raters, using structured interviews in the patients’ homes, done at the same frequency as the nurses’ visits, which were based upon the patients’ prognosis." Comment: Although the raters are described as independent, there is no mention that they were blind to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quotes from ref #1: "A total of 199 patients, 98 in the intensive and 101 in the non‐intensive groups, were followed; at the close of the four‐year study 139 had died." "Of the 139 patients who died during the study, 38 intensive and 45 non‐intensive patients had a sufficient number of pain ratings (three or more) to compare the effectiveness of pain management over time in the two groups." Comment: This study only uses data collected from the patients that died. Among those that died, they only kept the ones that had 3 or more assessments made before their deaths. The number of patients who died in each group are not presented, we only know the amount of patients who died AND had enough data collected in each group. We thus cannot infer the proportion of missing data in each group. The choice made to use only data from the patients with 3 or more assessments appears unacceptable. |
Selective reporting (reporting bias) | High risk | No results of the KPS at follow‐up were presented. |
Other bias | Low risk | Quote: "Another major problem in this study involved the trained observers who gathered follow‐up data from patients in their homes. These observers were continually instructed to limit their activities to asking questions, observing behavior, and recording data. Early in the study, it became apparent that these home observers could no their needs became apparent in the process of data gathering." Comment: This bias might have led to an underestimation of treatment effect. Because the intervention had a significant effect on pain, then we consider that the bias was either small or that treatment effect was considerable, The bias could not have led the observation of a wrong effect. |
Baseline outcomes similar? | Low risk | Quotes: "The initial, on‐study scores on the CMI, 1‐E, and KIS did not differ significantly between the intensive and non‐intensive groups." "It should be briefly noted that the intensive and non‐intensive patients did not differ in terms of length of survival, nor did these two groups differ in several other quality of life outcomes such as physical activity, nutrition, optimism, or overall health status as defined by the KPS (7)." |
Baseline characteristics similar? | Low risk | Quote from ref #1: "A comparison of patient characteristics for these two groups demonstrated similarities in cancer diagnosis, sex, age, social class, and religious preference (Table 1)." |
Protected against contamination? | Low risk | Comment: Randomisation was clustered by counties. |