Chan 2009.
Methods | Randomised trial | |
Participants | 175 patients (total group), mean age 48.4 years (control), 50.2 years (intervention); 49% male (in total) 1 nurse and unknown number of doctors |
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Interventions |
Intervention: patient care after gastric endoscopy allocated to nurse Control: patient care after gastric endoscopy allocated to doctor Detailed description of the intervention: Compared 2 groups providing follow‐up for patients with dyspepsia after direct access gastroscopy.
Patients included were those with mild gastroesophageal reflux disease (GORD – non‐erosive or grade A and B oesophagitis, hiatus hernia), those with non‐ulcer dyspepsia (NUD) (mild and moderate gastritis or duodenitis), and those with normal findings. After gastroscopy, endoscopists maintained their routine practice in giving verbal and written advice to patients and documented treatment recommendations to GPs in a formal report. Clinical management was structured, based on national and local guidelines, with reference to each patient's predominant symptoms. Patients were given counselling and lifestyle advice, supplemented with relevant locally devised leaflets (i.e. reflux, non‐ulcer dyspepsia, weight control), and an individualised treatment plan was agreed upon. Further investigation such as the urea breath test, motility studies, and barium meal were initiated, if required, as per routine clinical practice. To ensure practice consistency and reproducibility, 'history taking' and 'lifestyle advice' proformas were devised and used. Supervision, oversight: Studied interventional patients were seen in the nurse‐led clinic within secondary care, without direct supervision from any consultant gastroenterologists. However, cases could be discussed with a doctor, if deemed necessary. |
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Outcomes |
Patient outcomes: Gladys, health status short form (SF‐12) |
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Notes |
Country: UK Study period: 6 months Nurse role: ongoing care (follow‐up) after gastroendoscopy Nurse title: gastrointestinal nurse practitioner Nurse educational background: EQF level 8 Nurse years of experience: The nurse had been qualified as a State Registered Nurse for 20 years and specialised in gastro nursing for 4 years and 2 months. Nurse additional training: Clinic consultation skill was developed with the help of a named GI consultant. Initially, the nurse sat in that clinic (2 months) as an observer. The next stage was to see patients who had been filtered by the consultant from that clinic on that day. The nurses’ consulting room was next to the GI consultants’ room to effect direct supervision, as each patient case was presented to the GI and treatment identified (6 months). Finally, a nurse‐led clinic was established and was formally running alongside the GI clinics, with pre‐identified patients advanced from all GI consultants. Some 18 months later, the nurse was authorised to discuss selective cases with the patient’s named consultant, if required. Three monthly reviews were performed initially; this was reduced to yearly and was incorporated in the annual appraisal. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The sequence process included a random component. "Patients eligible for entry after endoscopy were randomised into intervention (GNP) and control (GP) groups, with a password protected, computer generated random number table”. |
Allocation concealment (selection bias) | Low risk | Participants and investigators enrolling participants could not foresee assignment. "with a password protected, computer generated random number table" |
Baseline characteristics | Low risk | Baseline characteristics were reported and were similar for both groups. "The baseline Gladys scores (high scores equal higher burden of disease and symptoms) were similar (10.0 vs 9.9) but the SF12 scores (672.0 vs 627.7) were higher (high scores equal better health) in the GP group (see Table 1). The cost of UHD used, 6 months prior to the investigation, was lower in the GP group (£52.4 vs £59.5)". But, "The two groups were compared by the change from baseline to month 6 in the key outcome variables – Gladys score, SF12 and overall UHDs cost, adjusted for baseline values by including the baseline levels of the outcome in the ANOVA as a covariate; p < 0.05 was taken as being significant". |
Baseline outcome measurement | Low risk | Baseline outcome measurements were reported and adjusted analyses performed. "Adjusted for baseline level using ANOVA" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of assessment was performed. "A researcher blinded to the patients' study status and diagnosis interviewed all participants by telephone, at a prearranged time suitable to the patient, six months after randomisation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up of patients > 80% "199 unselected patients were approached and 196 (98.5%) were recruited. One hundred and seventy five (89.3%) patients were eligible after investigation. Of the 21 ineligible patients, 16 did not meet the criteria (Barrett's oesophagus: 6, oesophagitis grade C: 2, oesophageal stricture: 1, peptic ulcer disease: 3, possible cancer: 1). Three cases were deemed unsuitable by the endoscopist, as symptoms were attributed to other conditions (rhinitis 1, angina 2)". Two did not have the procedure (failed intubation 1, food in stomach 1). "Early withdrawals (GP n = 3, GNP n = 4) after randomisation were experienced in both groups (Figure 1). Three in the 'GP' group decided not to see their GP. The four in the GNP group were due to work commitments (2), leaving the area (1) and after own GP consultation (1)". |
Selective reporting (reporting bias) | Unclear risk | The protocol was not available. |
Contamination | Low risk | Patients in the intervention group went to a nurse‐led clinic, and controls went to their doctor. Therefore, it is unlikely that both groups were contaminated. |
Bias due to lack of power | Low risk | Number of included patients was approximately similar to results of the sample size calculation. |