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Data Monitoring and Safety Committee 107 inclusion and exclusion data 107 informed consent 107 non-randomised controlled clinical trials 101 observations 116, 1624 phase I-IV studies 102 planning stage 100 pragmatic and explanatory trials 110 primary and secondary outcomes 106--7 protocols pitfalls ; 103 randomisation checklist 114 and stratification 100, 106, 114 sample size considerations 108--10 sampling strategies 104--5 study conduct and statistical methods 104--15, 1624 study design 100--3 tests 1624 see also research incl. future further research recommendations ; above general recommendations, specific patient groups 120--33 children 127, 1625 elderly incl. frail elderly ; 124--6, 649, 1625 FI 129--30, 1625 interstitial cystitis painful bladder 130--1 men with LUTS 120--1, 1625 neurogenic LUT dysfunction 127--8, 1625 nocturia 132 painful bladder syndrome 130--1, 1625 pelvic organ prolapse 122, 131--2, 1626 women with LUTS 121--3, 1625 outcomes research in LUTS 115--30 baseline clinical and demographic data 115 clinicians' observation and objective measures 116 definitions 122 design of continence products devices 156--7 for economic analysis 80--5 follow-up 118 frail, older and disabled people 125 health related quality of life HRQOL ; 118--19 methodology 115--30 participants' observations and subjective measures 116 quality of life assessment 118--19 quantification of symptoms bladder diary pad tests ; 117 recommendations on socioeconomic outcomes in incontinence 120 socioeconomic data as outcome measures 119--20 tests 117--19 urodynamics 117--18 women with LUTS 121--3 specific types of research 133--40, 1626 behavioural and physiotherapy 133, 1626 intervention trials 125 pharmacotherapy trials 135--6, 1626 questionnaires 554--7 surgical trials 136--40, 1626 writing protocols pitfalls ; 103 summary recommendations 1624--6 see also controlled trials RCTs ; reservoir calculi 1021--2 reservoir rupture, complications of surgery for neurogenic bladder 1020 residential care see institutional care residual urine see post-void residual urine resiniferatoxin evidence recommendation 819 idiopathic DO 1261, 1262 intravesical therapy 1502--4 neurogenic bladder--sphincter dysfunction 1084 properties 835, 836. Your home for health & balance and epivir. The Australian Journal of Physiotherapy published a systematic review 2 ; of 90 trials of manipulative therapy for chronic low back pain. The manipulative techniques were compared with sham treatment and with NSAIDs. They also conducted a meta-analysis of suitable trials. They found that spinal manipulative therapy neither produced a clinically significant reduction in pain when compared with sham treatment, nor a significant improvement in disability when compared to NSAIDs in patients with chronic low back pain. The meta-analysis was hampered by the small sizes of many of the trials, however, there was some indication that manipulative therapy is more effective than NSAIDs for pain reduction in chronic back pain. A Cochrane Collaboration Review 3 ; combined the results of 39 high quality trials in order to resolve discrepancies related to the use of spinal manipulative therapy following from previous reviews. They found that spinal manipulative therapy had benefits only compared with sham treatments or treatments known to be harmful traction, corset, bed rest, topical therapy, no treatment, diathermy and minimal massage. ; When compared with normal GP care, analgesics, physical therapy, exercises or back school, spinal manipulative therapy had neither clinically nor even statistically significant benefits. The authors conclude that this reveals that the efficacy of spinal manipulative therapy is less than previously believed for both acute and chronic low back pain and that, therefore, spinal manipulative therapy should be considered as one of a number of options of modest effectiveness for treatment. They are confident that this is a true result as they had more trials and more advanced meta-analysis techniques than previous systematic reviews. One systematic review 4 ; concentrated on chiropractic manipulation only. 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