Article Figures & Data
Figures
- Figure 1. Flow diagram of the STEP-UP trial (pragmatic design RCT).
- Figure 2. Systematic screening of GP information systems during a 3.5-month period. LRS = lumbosacral radicular syndrome.
Tables
Design A pragmatic, multicentre, open-label, randomised controlled trial with parallel group design, in general practices with a 3-month follow-up period Setting General practices in the southwestern area of the Netherlands Objective To assess the clinical and cost-effectiveness of two pain medication prescription strategies in general practice over a 12-week period Eligibility criteria Inclusion criteria
Age 18–65 years
No use of opioids
Radiating (pain) complaints in one leg below the knee
Severity of radiating leg pain scored ≥7 on an 11-point numerical rating scale (0 = ‘no pain’; 10 = ‘worst pain imaginable’)
Duration of the (pain) complaints <12 weeks
Presence of at least one of the following symptoms:
More pain on coughing, sneezing, or straining
Decreased muscle strength in the leg
Sensory deficits in the leg
Decreased reflex activity in the leg
Positive straight leg raising test
Exclusion criteria
An episode of radiating (pain) complaints in the preceding 6 months
Back surgery in the past 3 years
Treated with epidural injections
Pregnancy
Comorbidity that primary determines overall wellbeing (for example, an osteoporotic fracture, malignity, herpes zoster, or Lyme’s disease)
Hypersensitivity to paracetamol, NSAID, or opioids
Previous or active peptic ulcer
Direct indication for surgery (fast progression of paresis of cauda equine syndrome)
History of substance addiction or abuse
Outcome Primary outcome was the severity of radiating leg pain measured daily over a 6-week follow-up period using an 11-point numerical rating scale (score range 0–10), with a higher score indicating more pain. Reasons for insufficient recruitment GPs: n (%)a Shared decision-making process: (strong) patient preference and/or GP preference for specific medication, diagnostics, randomisation outcome 11 (50) Low incidence rate 6 (27) Restrictive eligibility criteria 6 (27) Priority setting: too many other responsibilities/administrative burden, time consuming/time pressure 6 (27) No further delay wished 5 (23) Forgetfulness 5 (23) Lack of motivation 4 (18) Other reasons 4 (18) aMore than one answer was possible.
Number Written responses of the 22 GPs Summary of reasons 1 Lack of patients who fulfilled eligibility criteria.
Most patients that considered participation didn’t want to use morphine.
A few patients with a language barrier or contra-indication for the use of either morphine or NSAIDs.
If, after this, patients could still be included, it was hard to include them and was too demanding in time and effort from the GP.
As a GP I am already used to prescribe morphine in case of severe pain.
In the trial design phase these problems were mentioned by GPs; for example in the GP network meeting, but I have the feeling this wasn’t taken into account enough.
Eligibility criteria
Shared decision making
Priority setting
Other
2 The threshold for patients (and doctor) is (too) high when it comes to prescribing morphine for pain relief. It takes a lot of effort from us as GPs to use diagnostics and titrate patients to morphine: usually this takes 1–2 patient contacts a week. A referral to the neurologist is faster. The low response is a pity: in my opinion it is a very relevant research question. Shared decision making
Priority setting
3 My suspicion is that the researchers overestimated the incidence from ICPC L86. Maybe GPs encode inaccurately. Speaking for myself: when in doubt, if I can choose between L02, L03 or L86, I prefer L03 or L02. L86 seems to have much more consequences; as a GP I prefer some supporting diagnostics to code L86 with certainty. I consider the physical examination alone too limited to do so. Incidence
4 It is hard to remember the trial at the right moment.
What would help? A financial reward for the GP for admitting a patient to the trial. It’s a pity, but that is the case. With €50 per patient you would see an increase in trial participants.
Forgetfulness
Motivation
5 Low amount of eligible patients.
Because of this, I don’t think about including a patient in the trial at the right moment; I forget it.
Eligibility criteria
Forgetfulness
6 When the trial was presented, we thought the research question to be very relevant. From the start of the trial I realised I found it hard to leave the choice for pain medication out of hands. In two cases with approximately the same amount of pain, you still choose a different pain management method per patient, depending on many other factors than just the pain. I didn’t want ‘the randomisation’ to decide this. But it’s a pity that this means we will not have an answer to the research question. Shared decision making
7 It is difficult to ask a patient to participate in research before starting an intervention (for example, start of medication). So in this case it also didn’t help to select patients later with the screening, most of them were already using medication. And for ... research: the GP ‘just’ forgets about it. The GP assistant is the first contact moment with the patient; it would already help if they ... put a note in the patient's file about the possibility of participating in the trial. Shared decision making
Delay
Forgetfulness
8 Too many research projects at the same time! Motivation
Priority setting
9 Low incidence of the disease. In 12 months I didn’t see any new patient with sciatica.
Not enough time in daily practice for informed consent.
For screening the patient information system for prevalent cases there is no binding contract concerning patient privacy for the research assistant.
Incidence
Priority setting
Other
10 Research topic not that interesting.
Opioid pain medication often has a lot of side effects that are often underestimated. They made a phrase for this for a reason: opioid rotation. Well, and then a lot of patients die after a little while.
Low frequency of patients with sciatica.
Too many research projects.
Incidence
Shared decision making
Motivation
Priority setting
11 Probably less ‘feeling’ with the research question.
I had the experience that a patient I submitted was excluded for the trial.
Patients often didn’t want to participate.
Later in the trial I lost my motivation.
Shared decision making
Motivation
12 The pain score threshold for inclusion in the trial was very high (inherent to the possibility of opioid medication as painkillers): that is just quite rare.
And secondly: in such pain, patients have often already tried a lot of pain medication themselves, which makes participation in a trial and randomisation to the control arm feel like starting over with something you already knew it didn’t help.
Shared decision making
Eligibility criteria
13 The trial concerns a group of patients that demands and needs direct help. The research setting then causes an unnecessary and unwelcome delay. Shared decision making
Delay
14 Incidence of the disease in general practice is too low. Incidence
15 Forgetfulness about the study before inclusion.
Our general practice joined the trial in January 2016 only.
The inclusion criteria were very specific and narrow; especially concerning the pain score.
Eligibility criteria
Forgetfulness
Other
16 Sciatica is apparently less prevalent than expected.
Or maybe patients go to the physiotherapist by themselves and they don’t visit their GP anymore for this complaint? [Note: since 2005 a GP referral is no longer needed to consult a physiotherapist; everyone in the Netherlands is allowed direct access]
Incidence
Other
17 Very limited number of patients that presented themselves for consultation with sciatica complaints; and then additionally were also eligible for participation in the trial. Incidence
Eligibility criteria
18 Attention in our general practice is mostly claimed by countless organisational tasks and duties like accreditation, new legislations (recently two new laws) and so on. We can’t handle more than sporadic and ad hoc duties. Priority setting
19 These are often patients with impatience, demanding a quick solution. As a GP you want to take away the agitation (and sometimes the 'demanding' behaviour) and quickly offer a bit of relief and structure through explanation and medication. The procedure through trial participation is too exhaustive.
As a GP, I don’t want 'this' patient to be randomised in the control arm; because I already changed my prescribing patterns a few years ago, so the treatment arm is how I currently treat my patients.
Shared decision making
Delay
20 In the acute phase you already act on your findings; so if morphine is needed, you have already prescribed this before the trial comes into focus. Delay
21 This is a proactive study, therefore I have to remember it at the moment itself.
Usually the treatment of choice is the result of a — sort of — negotiation between patient and GP.
Often patients already used paracetamol, or react like: 'Paracetamol?', and they feel unheard.
Shared decision making
Forgetfulness
22 Myths about opioids by patients.
Patients want to start with medication directly.
In our general practice there’s often a language barrier which increases difficulty when it comes to explaining the trial and answering questionnaires.
Shared decision making
Eligibility criteria
Delay
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