Better development and use of Non-Drug Interventions

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1 Better development and use of Non-Drug Interventions Paul Glasziou Centre for Research in Evidence-Based Practice, Bond University Royal Newcastle Hospital Heritage Oration, 2014

2 Introduction Inala Community Centre Beaumont St, Oxford

3 Is bed rest ever helpful? A systematic review of trials* 10 trials of bed rest after spinal puncture no change in headache with bed rest Increase in back pain Protocols in UK neurology units - 80% still recommend bed rest after LP Serpell M, BMJ 1998;316: evidence of harm available for 17 years preceding... *Allen, Glasziou, Del Mar. Lancet, 1999

4 Overview Effective non-drug treatments Barriers to better use

5 Non-pharmacological interventions 1. Exercise particularly for the ill 2. Information / self-management 3. Diet & Nutrition 4. Procedures 5. Other

6 Exercise& the GP: a paper & 2 patients

7 Exercise for heart failure Bellardinelli 10-year results

8 When is exercise effective in illnesses? 1. Heart Failure 2. COPD ( pulmonary rehab ) 3. Coronary heart disease 4. Osteoarthritis 5. Weight management 6. Chronic Fatigue 7. Cancer fatigue 8. Claudication 9. And lots of others! 1-day conference, May, 2014, 15

9 Example: a patient with COPD Long term smoker with chronic obstructive airways disease has recently quit smoking. Has tried medications but does not like any. Asks: are any breathing exercises I can recommend?

10 What about didgeridoo playing? Rx Didgeridoo t.d.s (1) Dr Paul Glasziou

11 Pulmonary Rehabilitation is effective Great but what is pulmonary rehabilitation??

12 Pulmonary rehabilitation integrates 3 excepts from the Description of Included Studies

13 Found: a good description of pulmonary rehabilitation My consultant at King s offered me pulmonary rehabilitation. I didn t know what that was, so I asked and he said it was an exercise program. I thought the man was mad because I couldn t get out of a chair. (Later interview she is much improved)

14 Exercise for CFS Prescription for graded exercise Exercise every 2 nd day Target RPE of > Every 2 weeks increase duration by 2-5 minutes Wallman. Med J Aust Aug 1;183(3):142-3.

15 When is exercise effective in illnesses? 1. Heart Failure 2. COPD ( pulmonary rehab ) 3. Coronary heart disease 4. Osteoarthritis 5. Weight management 6. Chronic Fatigue 7. Cancer fatigue 8. Claudication 9. And lots of others! 1-day conference, May, 2014, 15

16 2. Diet & Nutrition Weight loss tips Salt for Blood Pressure Oral rehydration Mediterranean Diet FODMAPs diet

17 Leaflet: 10 tips for weight loss 104 adults BMI 31; randomized to Leaflet & weekly weigh Leaflet & monthly weigh Control International Journal of Obesity (2008) 32,

18 3. Information & Self-Management Depression & Anxiety BeyondBlue; several books LUTS Irritable Bowel Syndrome Low back pain

19 Lower Urinary Track Symptoms 60 year old man with symptomatic BPH asks about pros and cons of surgery What things have you tried so far?

20 Lower Urinary Tract Symptoms BMJ 2006 Advise a daily fluid intake of ml (minor adjustments made for climate and activity), avoid inadequate or excessive intake on the basis of a frequency / volume chart Advise fluid restriction when symptoms are most inconvenient e.g. long journeys or when out in public Avoid caffeine by substituting with alternatives e.g. decaffeinated or non-caffeinated drinks Avoid alcohol in the evening if nocturia is bothersome Advise bladder retraining. Using distraction techniques (predetermined mind exercise, perineal pressure or pelvic floor exercises) aim to increase the minimum time between voids to 3 hours

21 LUTS trial: lower failure at 1 year P<0.001 Brown, BMJ 2006

22 The (missing) guidebook for IBS TRIAL: Self-help interventions in patients with a primary care diagnosis of irritable bowel syndrome. Gut At one year, patients in the guidebook group had a 60% reduction in primary care consultations (p,0.001) and a reduction in perceived symptom severity (p,0.001) compared with controls. PROBLEM: Missing details of guidebook. No response from author to 3 s Colleague said booklet was on sale Google search found the book Price: 8.99

23 2. Procedures Epley for BPPV Mother s Kiss Knee taping for OA Nit combs for lice Light box for SAD Counterpressure for syncope

24 Frequent Dizziness Frequent short dizzy episodes Triggered by change of posture Medication has not helped

25 The Epley for BPPV (Vertigo) Frequent short dizzy episodes Triggered by change of posture Medication has not helped

26 A bead in the nose The Mother s Kiss technique Child with nasal foreign body Dislodged with Parent Kiss method Case series of success 15/19 (Botma J Laryngol Otol 2000)

27 Some immediate & dramatic effects don t need Randomized Trials* * Glasziou, Chalmers, Rawlins, McCulloch BMJ 2007 Tensilon test: Before/After Cogan

28 Deep Brain Stimulation (DBS) Parkinson s tremor Switch symptoms on and off with DBS

29 Overcoming barriers to use Non-drug treatments are: Less researched Poorly described Harder to learn Harder to find Weakly marketed

30 Trials of non-drug treatments in UK Chalmers bmj.com2003;327:1017

31 What is the treatment? BMJ paper s description of sodium reduction "Individual and weekly group counseling sessions were offered initially, with less intensive counseling and support thereafter, specific to sodium reduction."??????? TOHP Study BMJ, Apr 2007; 334: 885

32 What is sodium reduction? The paper s description "Individual and weekly group counseling sessions were offered initially, with less intensive counseling and support thereafter, specific to sodium reduction." Previous reference (i) an individual session followed by 10 weekly group 90 minute sessions with a nutritionist, followed by a transitional stage of some additional sessions (ii) Topics in the weekly sessions included Getting Started, sodium basics, the morning meal, midday sources of sodium, the main meal, planning ahead, creative cooking, eating out, food cues, and social support, (iii) the sessions included sampling of foods, discussion of articles on sodium reduction, and problem-solving, (iv) patients kept diaries at least 6 days per week, and urine sodiums were measured.

33 Descriptions in 80 treatment studies selected for EBM journal were often inadequate Description sufficient to replicate 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Overall Trials Metaanalysis Drug Non drug Initial Final Glasziou et al BMJ, 2008

34 Can you replicate this intervention? 5 questions for author including is DVD available? Schedule of exercises? Yes as free iphone App (in Dutch)

35 Treatment checklist I keep six honest serving-men (They taught me all I knew); Their names are What and Why and When And How and Where and Who. Rudyard Kipling CONSORT Item 5: The interventions for each group with sufficient details to allow replication, including what, why, when, how, where, and who

36 TIDieR Checklist for Treatments Item Item Where located number Primary paper (page or appendix number) Other (details) BRIEF NAME 1. Provide the name or a phrase that describes the intervention. WHY 2. Describe any rationale, theory, or goal of the elements essential to the intervention. WHAT 3. Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g. online appendix, URL). WHY: Describe any rationale, theory, or goal of the elements essential to the intervention 4. Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities. WHO PROVIDED 5. For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given. HOW 6. Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group. Hoffmann T, et al BMJ 2014

37 Harder to learn: The Epley for Vertigo STUDY: Self-treatment for benign paroxysmal positional vertigo of the posterior semicircular canal. Neurology TREATMENT: Each head position has to be maintained for more than 30 seconds. Patients received illustrated instructions for the specific maneuver All agreed useful 3 months later only 2 doctors did it Put video in intranet Another 3 months later Still only 2 doctors Trained each person to do

38 Learning the how to of Epley 1. Bookmark the video (on YouTube) 2. Tip: watch with patient first!!

39 Finding Non-Drug Treatments The Pharmacopoeia Chinese edition 3000 BC Nuovo Receptario, 1498 Pharmacopeia, Occo 1564 The Non-Pharmacopoeia RACGP initiates 2011 Pilot version 2013 Nuovo Receptario Composito Florence in 1498

40 Handbook of Non-Drug Interventions

41 HANDI Entries in AFP, Jan/Feb

42 HANDI development process 1. Is there clear evidence of effectiveness? Member presents evidence to committee Systematic review of 2+ trials or equivalent 2. Draft Entry with details of practicalities Detailed descriptions Handouts, links, etc Videos for some processes

43 Summary Some Non-Drug treatments are effective Exercise, diet, procedures, self-management,. Poor awareness, description, and use Effort needed to better develop & use Medical training should include nonpharmacology

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