| Methods |
Patients were stratified into bands of low, medium, or high knowledge of their rheumatoid arthritis (RA) by means of a validated patient knowledge questionnaire. 21 patients in each band were randomly allocated to the Education Group and Control Group using a separate computer‐generated code for each band. This was done to ensure that the 2 groups had comparable levels of initial knowledge. Allocation was carried out by a clerk who had no study input or patient contact |
| Participants |
Rheumatologists referred 100 patients with active RA; all were deemed to require D‐penicillamine (DPA) as their slow‐acting antirheumatic drugs (SAARD). Entry criteria required that all patients were aged 18 years or above, had a positive diagnosis of RA using the American Rheumatism Association criteria, a plasma viscosity (PV) > 1.75 mPa.s or a C reactive protein (CRP) > 10 mg/l. In addition, they should have 2 out of 3 clinical features: an articular index > 15, morning stiffness > 45 minutes, a minimum of moderate levels of pain. Patients were excluded if they had received DPA previously, had a contraindication such as kidney impairment or pregnancy, or were receiving incompatible concomitant drugs. Patients who were awaiting hospital admission were excluded as the nursing staff often give drugs during their stay |
| Interventions |
The chosen intervention was a Patient Education program taught by a rheumatology nurse practitioner. Where practicable, variables that could confound the results were eliminated. All patients took the same SAARD, were given the same number and length of appointments, and were seen by the same rheumatology nurse practitioner. All patients were seen by the rheumatology nurse practitioner for a 30 minute appointment at monthly intervals over a 6‐month period comprising 7 visits. The Education Group received a comprehensive program of patient education based on the theory of self efficacy: a person's confidence in their ability to perform a specific task or achieve a certain objective. The non‐education cohort received the same DPA drug information leaflet as the intervention group. This was in question and answer format and supplied information about DPA, how and when to take it, unwanted side effects, and described safety monitoring |
| Outcomes |
Clinical health outcomes included: PV, CRP, 3 clinical assessments ‐ articular index (AI), morning stiffness, pain score |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information on sequence generation. (pg 869) "The study was a randomised controlled design comparing an experimental group (EG) receiving a full programme of patient education (PE) with a control group (CG)." |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 869) "The study was a randomised controlled design comparing an experimental group (EG) receiving a full programme of PE with a control group (CG)." |
| Selective reporting (reporting bias) |
Unclear risk |
All pre‐specified outcomes seem to be reported; no protocol available to confirm |
| Other bias |
Unclear risk |
No obvious bias detected but unclear |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) PHARMACOLOGICAL MARKER ‐ (pg 870) "An independent blind assessor carried out all clinical assessments. Withdrawal criteria were ( a ) any patient who requested withdrawal was immediately removed from the study; ( b ) decisions on withdrawal from the trial owing to adverse drug events were made by an impartial observer (HB), who was unaware of the group allocation." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) PLASMA VISCOSITY ‐ (pg 870) "An independent blind assessor carried out all clinical assessments." "However, bias was minimised by ensuring that clinical assessments and all data collection were undertaken by the blinded observer." |
| Blinding of participants (performance bias)
Adherence measure |
Low risk |
(PRIMARY) PHARMACOLOGICAL MARKER ‐ (pg 870) "The independent assessor invited patients to take part in the research but did not mention PE or adherence. Patients were advised that their DPA would contain a small dose of phenobarbitone to assess the efficacy of the drug. All patients agreed to participate. It has been suggested that former educational level is a predictor of prognosis, behavioral variables, and knowledge of disease. Patients were therefore stratified into bands of low, medium, or high knowledge of their RA by means of a validated patient knowledge questionnaire. Patients in each band were allocated to the EG and CG using a separate computer generated code for each band. This was done to ensure that the 2 groups had comparable levels of initial knowledge. Allocation was carried out by a clerk who had no study input or patient contact." |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) PLASMA VISCOSITY ‐ Objective outcome. (pg 871) "GROUP ASSIGNMENT AND BLINDING The independent assessor invited patients to take part in the research but did not mention PE or adherence. Patients were advised that their DPA would contain a small dose of phenobarbitone to assess the efficacy of the drug. All patients agreed to participate. It has been suggested that former educational level is a predictor of prognosis, behavioral variables, and knowledge of disease. Patients were therefore stratified into bands of low, medium, or high knowledge of their RA by means of a validated patient knowledge questionnaire. Patients in each band were allocated to the EG and CG using a separate computer generated code for each band. This was done to ensure that the two groups had comparable levels of initial knowledge. Allocation was carried out by a clerk who had no study input or patient contact". |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) PHARMACOLOGICAL MARKER ‐ (pg 870) "The independent assessor invited patients to take part in the research but did not mention PE or adherence. Patients were advised that their DPA would contain a small dose of phenobarbitone to assess the efficacy of the drug. All patients agreed to participate. It has been suggested that former educational level is a predictor of prognosis, behavioral variables, and knowledge of disease. Patients were therefore stratified into bands of low, medium, or high knowledge of their RA by means of a validated patient knowledge questionnaire. Patients in each band were allocated to the EG and CG using a separate computer generated code for each band. This was done to ensure that the 2 groups had comparable levels of initial knowledge. Allocation was carried out by a clerk who had no study input or patient contact". |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA VISCOSITY ‐ No mention of blinding of other staff |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) PHARMACOLOGICAL MARKER ‐ Reasons for dropouts recorded but dropouts not even across groups |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA VISCOSITY ‐ Reasons for withdrawals reported but dropouts not even across groups |
