Kravitz 1996.
Methods | RCT; Unit of allocation: Patient | |
Participants | Patients with cancer admitted to the hospital within the past 48 hr with a diagnosis of malignancy and having at least "moderate pain" during the baseline assessment. Setting / country: University hospital in southern California and its affiliated VA Medical Center / USA Type of cancer: Any type Phase of care: Treatment Sample size at randomisation: 87 |
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Interventions | Bedside charting of pain level: Patients had daily pain assessments by study staff who graphically recorded their reported pain intensity levels on bedside wall charts. The sheet was placed behind patients' vital signs on a clipboard in their hospital room. Both nurses and physicians were able to review the information during their daily rounds and incorporate the information into their pain management plans. "Current pain" (dots) and "worst pain" (Xs) were charted in red ink on a 0‐10 scale each day. To highlight trends in symptomatology, dots and Xs were connected by solid lines. The display sheet also contained space to record patients' estimates of the number of hours sleep obtained during the past 24 hr, a short outline of pain management guidelines and an equianalgesic dosing table. Control: Patients had periodic pain assessments by study staff but did not have this information displayed. |
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Outcomes | Patient: Pain, sleep duration, symptoms, QoL, sleep latency Professional: Pain management |
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Notes | Length of follow‐up: 5 days | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: " Patients with either current pain or worst pain were asked for informed consent and then randomised to either the intervention or control group using a random numbers table." |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment in the paper |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Research assistants performed the assessment but there is no mention of blinding in the paper. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Measurements were not available for some patients on days 3 and 5 because of early discharge, weekend or holiday schedules, or absence from the wards for diagnostic testing. For these patients, we substituted measures taken on day 2 (instead of day 3) or day 4 (instead of day 5). We could not measure day 5 outcomes for 28 patients due to their having been discharged before day 4." Comment: From Table 1 we can infer that the was a proportion of 36% missing data (28/78), but there is no data on the proportion in each experimental group. Imputation used was not acceptable. There are not enough data to verify if missing data could change study results. |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods are reported in Results. |
Other bias | Low risk | No evidence of any other bias |
Baseline outcomes similar? | Unclear risk | Current pain, worst pain, Quality of life, Opioid analgesic score : YES Sleep duration, Sleep latency, Symptom scale: UNCLEAR |
Baseline characteristics similar? | Unclear risk | Comment: Only 3 patient characteristics were presented: age, gender and white/non‐white. There are no description of the type of malignancy, prognosis, or other. |
Protected against contamination? | High risk | Quote: "The intervention was intended to affect pain control primarily by influencing physician prescribing behaviour. In the two teaching hospitals where the study was conducted, physicians in their first postgraduate year of internal medicine training were responsible for writing all medication orders and were therefore the main target of the intervention. Because some interns cared for both intervention and control‐group patients, their exposure to intervention patients might have carried over into their care of control patients; this would tend to reduce the observed benefit of the intervention." |