INQ - CR WS-135/2 Page 1 - Ihrdni
Witness Statement Ref. No.NAME OF CHILD:135/2Claire RobertsName: Dr Bernadette O’HareTitle: Senior Lecturer in Child Health, College of Medicine, University of Malawi, MalawiPresent position and institution:Lecturer in Child Health, College of Medicine, University of Malawi, MalawiPrevious position and institution:[As at the time of the child’s death]Specialist Paediatric Registrar in Northern Ireland Paediatric Training Rotation based at Royal BelfastHospital for Sick Children, Belfast, and N.Ireland at the time of the child’s death. Registrar trainingcommenced January 1986, ended July 2001Membership of Advisory Panels and Committees:[Identify by date and title all of those between December 2011 – May 2012]Previous Statements, Depositions and Reports:[Identify by date and title all those made in relation to the child’s death]OFFICIAL USE:List of previous statements, depositions and reports:Ref:Date:WS-135/1UndatedInquiry Witness Statement1INQ - CR
IMPORTANT INSTRUCTIONS FOR ANSWERING:Please attach additional sheets if more space is required. Please identify clearly any document to which you referor rely upon for your answer. If the document has an Inquiry reference number, e.g. Ref: 049-001-001 which is‘Chart No.1 Old Notes’, then please provide that number.If the document does not have an Inquiry reference number, then please provide a copy of the document attachedto your statement.I. FURTHER QUERIES ARISING OUT OF YOUR FIRST INQUIRY WITNESS STATEMENT(1) Answer to Question 9(e) and (f) at p. 5:“There was no evening handover when the consultant and the resident on call staff would havemade contact.”(a) State at what time the following clinicians would have come on duty at RBHSC (RoyalBelfast Hospital for Sick Children) on the evenings of Monday 21st October 1996 and ofTuesday 22nd October 1996:(i) The on call consultant - 9am Monday 21st and 9am Tuesday 22nd(ii) The on call registrar – 9am Monday 21st and 9am Tuesday 22nd(iii) The on call SHO - 9am Monday 21st and 9am Tuesday 22nd(b) State whether there would have been any further change to the on call team before 0900hrsthe following mornings (22nd October and 23rd October), and if so, state when and in whatrespects. In 1996, as far as I recall, all grades of staff were on during the day and remained oncall until the following morning and in the case of the registrar worked the next day as well i.e.36 hours shift(c) State the reasons why there was no “evening handover”. The culture of handover becamewidespread after the introduction of the European Working Time Directive, when it was no longerlegal for junior doctors to work long shifts and handovers between shifts became necessary. From2003 junior doctors were no longer allowed to work more than 56 hours per week, but in 1996 longshifts were the norm and handovers between shifts were not routine except informally.(d) State between which clinicians a handover, other than an “evening handover”, would usuallyhave taken place in October 1996 in relation to the patients on Allen Ward. As far as I recallthere was no formal handover, registrars may have informally handed over betweenthemselves.(e) State where and when a handover, other than an “evening handover”, would usually havetaken place. As far as I recall there was no formal handover.2INQ - CRWS-135/2 Page 2
(f) If “there was no evening handover”, on the evenings of 21st October and 22 October 1996,explain how each of the following clinicians would have been aware of the issues/concernsrelating to Claire’s condition and how Claire would be managed and cared for overnight:(i) The on call consultant On the evening of the 21st October the on call consultant could onlyhave been aware of Claire had the on call registrar contacted them. On the evening of the22nd October the on call consultant could only have been aware of her condition, if the oncall registrar contacted them or the Allen Ward consultant had handed over to them.(ii) The on call registrar Claire was not on the ward during the day of the 21st so there wouldhave been no hand over between the day and evening shift. On the 22nd the day registrarmay have informed the on call registrar of her condition informally but there was noformal handover in 1996(iii) The on call SHO On the 22nd the day SHO on Allen ward may have informed the on callSHO of Claire’s condition informally but there was no formal handover between teams in1996(2) Answer to Question 11(k) at p. 7:“The nurse transferring the patient would have informed the ward nurse of the diagnosis.”(a) Identify by name and job title the nurse who transferred Claire to Allen Ward and “informedthe ward nurse of the diagnosis”.I do not recall the individual, this is my recollection of the normal procedure of transferring apatient(3) Answer to Question 12(i) and (j) at p. 9:“This normally would have been the responsibility of the staff transferring Claire from A&E toAllen Ward.”(a) Identify by name and job title “.the staff transferring Claire from A&E to Allen Ward.”I do not recall the individual, this is my recollection of normal procedure(4) Answer to Question 13(b) at p. 10:“The two reports are in the notes at 090-030-094 and 090-030-097.”The two reports “in the notes at 090-030-094 and 090-030-097” relate to urine samples. Pleasestate at what time the blood sample was taken from Claire.There is no time recorded, I requested that the blood sample be taken at 8 pm and it probablywould have been drown shortly after this time.(5) Answer to Question 15(h) at p. 12.3INQ - CRWS-135/2 Page 3
“It would not have been usual to restrict fluids in a child who was vomiting unless the electrolytesindicated that they were significantly hyponatraemic.”(a) Explain what you mean by “significantly hyponatraemic”.A significant hyponatraemia is a level of serum sodium which would trigger an action or a change inmanagement.(b) Explain how “the electrolytes” would indicate that “they were significantly hyponatraemic”.A serum sodium of 125 mmol/L is considered as severe hyponatraemia, a serum sodium of 125130 is moderate hyponatraemia. a serum sodium of 130-134 would be considered mildhyponatraemia. If the serum sodium had been below 130 this would have been significanthyponatraemia.Specify what measurement (mmol/l) and/or range of measurements would have indicated inOctober 1996 that the electrolytes, and in particular sodium was/were “significantlyhyponatraemic”. . If the serum sodium had been below 130 this would have been significanthyponatraemia and triggered a change in management.(2) Answer to Question 34 at p. 19:“In 1996 there was no system of handing over patients between shifts .each of us went to ourwards and started our ward rounds first thing in the morning. Critically unwell patients whorequired immediate review would have been identified to us by the nurses on the ward.”(a) Please clarify whether “[i]n 1996 there was no system of handing over patients between shifts”:(i) between clinicians As far as I recall there was no designated time or place for juniordoctors to hand over patients between shifts, although this may have happened informallyfor example a particular doctors finding the doctor on a given ward and handing over theirconcerns with regard to a given patient.(ii) between nurses I cannot comment(b) If “there was no system of handing over patients between shifts ”, explain how an incomingdoctor commencing his/her duty would obtain the necessary and relevant information on:(i)any patient The doctor would do a ward round on all patients and read the notes, talk toparents and to nursing staff.(ii) a patient who was other than “[c]ritically unwell [requiring] immediate review ”In these cases the nurse in charge of the ward would have bleeped the doctors to comeimmediately to review a critically unwell patient or in a less urgent case, alerted the doctoras soon as they arrived to start the routine ward round that there was a patient who shouldbe prioritized.(c) What was the general practice when clinicians changed shifts?4INQ - CRWS-135/2 Page 4
In 1996 we worked 36 hour shifts. Between 9am until 5 pm on the first day we covered our ownward. From 5pm until 9am the next day we were responsible for all the wards in the hospital. From9am the second day until 5pm the second day we were responsible for our own ward. After hoursi.e after 5 pm we would be responsible for all wards and would be alerted to any problems on thosewards by either a junior member of the medical team or a member of the nursing team bleeping us.There was no designated time or place for a handover to on call teams, although this may happenon occasion informally.(d) Identify by job title who determined or would have determined in October 1996 whether apatient was “[c]ritically unwell [requiring] immediate review ”, and in particular statewhether a nurse or clinician determined this and the basis of that determination.In this context, if the doctor arrived on the ward to start a routine ward round the seniornursing staff may alert them to the presence of a critically ill child on the ward. Thedetermination of a critically ill child is generally made by the most senior staff available, eithermedical or nursing.(e) Describe what contact clinicians coming on duty and going off duty on Allen Ward wouldhave had in October 1996.In 1996, as far as I recall the medical staff responsible for Allen ward and all the other wards inthe hospital, overnight would then return to being only responsible for only their own ward at9am. There was no formal handover between the staff who provided the nighttime cover andthe day time staff.(f) Although you say that “there was no system of handing over patients between shifts”, statewhether there was any informal/usual practice “of handing over patients between shifts”inOctober 1996, and if so, describe that practice, between whom it was adopted and how itoperated.On occasion, there may have been informal handover of patients between shifts if a doctor had aparticular concern about a given patient or wished the day staff to complete a task for a givenpatient but from memory this was not the usual practice at this time. The on call person wouldhave been responsible for many wards and would therefore need to contact many individualdoctors while at the same time needing to start their own daytime duties such as clinics or wardrounds.(g) State whether a system of ‘handing over patients’ was introduced in RBHSC after 23 October1996. If so, state when this system commenced and why was it implemented.From 2003 junior doctors were no longer allowed to work more than 56 hours per week and it isaround the middle of 2000-2010 that formal handover with designated time and place becamecommonplace is most hospitals. I cannot comment when formal handover was introduced toRBHSC.THIS STATEMENT IS TRUE TO THE BEST OF MY KNOWLEDGE AND BELIEFSigned:Dated:5INQ - CRWS-135/2 Page 5
Downloaded from adc.bmj.com on September 12, 2012 - Published by group.bmj.com828ORIGINAL ARTICLEHypotonic versus isotonic saline in hospitalisedchildren: a systematic reviewK Choong, M E Kho, K Menon, D Bohn.Arch Dis Child 2006;91:828–835. doi: 10.1136/adc.2005.088690The Appendices can beviewed on the ADCwebsite (http://www.archdischild.com/supplemental)See end of article forauthors’ affiliations.Correspondence to:Dr K Choong, Departmentof Paediatrics, McMasterUniversity, Hamilton,Ontario, Canada;choongk@mcmaster.caAccepted 24 May 2006Published Online First5 June 2006.Background: The traditional recommendations which suggest that hypotonic intravenous (IV) maintenancefluids are the solutions of choice in paediatric patients have not been rigorously tested in clinical trials, andmay not be appropriate for all children.Aims: To systematically review the evidence from studies evaluating the safety of administering hypotonicversus isotonic IV maintenance fluids in hospitalised children.Methods: Data sources: Medline (1966–2006), Embase (1980–2006), the Cochrane Library, abstractproceedings, personal files, and reference lists. Studies that compared hypotonic to isotonic maintenancesolutions in children were selected. Case reports and studies in neonates or patients with a pre-existinghistory of hyponatraemia were excluded.Results: Six studies met the selection criteria. A meta-analysis combining these studies showed thathypotonic solutions significantly increased the risk of developing acute hyponatraemia (OR 17.22; 95% CI8.67 to 34.2), and resulted in greater patient morbidity.Conclusions: The current practice of prescribing IV maintenance fluids in children is based on limitedclinical experimental evidence from poorly and differently designed studies, where bias could possiblyraise doubt about the results. They do not provide evidence for optimal fluid and electrolyte homoeostasisin hospitalised children. This systematic review indicates potential harm with hypotonic solutions inchildren, which can be anticipated and avoided with isotonic solutions. No single fluid rate or compositionis ideal for all children. However, isotonic or near-isotonic solutions may be more physiological, andtherefore a safer choice in the acute phase of illness and perioperative period.Intravenous (IV) maintenance fluids are designed toprovide free water and electrolyte requirements in a fastingpatient. The prescription for IV maintenance fluids wasoriginally described in 1957 by Holliday and Segar, whoequated free water requirements from energy expenditure inhealthy children.1 They rationalised adding 3.0 and 2.0 mEq/100 kcal/24 h of sodium and potassium respectively, as itapproximates the electrolyte requirements and urinaryexcretion in healthy infants.2 3 This is the basis for thecurrent recommendation that hypotonic IV maintenancesolutions are ideal for children.4 5 The Holliday–Segar systemremains the most universally used to date, because of thesimplicity of their formula. While these recommendations maybe appropriate for the healthy child, they do not necessarilyapply in acute illness, where energy expenditure and electrolyterequirements deviate significantly from this formula.6The numbers of deaths and significant neurologicalsequelae from hospital acquired hyponatraemia in childrenreceiving hypotonic maintenance solutions have increased inthe past 10 years.7–11 Several narrative reviews have suggestedpotential harm with these solutions and recommend thatroutine use in children be reconsidered.12 13 Despite theseconcerns, standard texts and guidelines continue to recommend hypotonic maintenance solutions for all paediatricpatients.4 5 The objective of this systematic review was toevaluate the safety of hypotonic versus isotonic IV maintenance solutions in hospitalised children. Our secondaryobjective was to identify subgroups who are at greater risk ofmorbidity, in whom hypotonic solutions should be avoided.METHODSSearch strategyWe searched Medline (1966–2006), Embase (1980–2006),and the Cochrane Library, using the terms: ‘‘fluid therapy’’,INQ - CRwww.archdischild.com‘‘hypotonic solution’’, ‘‘isotonic solution’’, and synonyms orrelated terms (Appendix 1; see http://www.archdischild.com/supplemental). We searched online (FirstSearch, ConferenceProceedings) or published conference proceedings, andCurrent Controlled Trials (www.controlled-trials.com).Abstracts from the following 2002–05 scientific forums werehand searched: World Congress on Pediatric Intensive Care,Society for Pediatric Research, Critical Care Congress, andAmerican Academy of Pediatrics. We reviewed the referencelists of all identified studies and reviews, and also personalfiles, and contacted experts and first authors to identify otherpublished or unpublished studies.Study selectionCitations considered potentially relevant by either of tworeviewers (KC or MK) were retrieved using the followinginclusion criteria:NNNControlled trials, cohort, and case-control studies. Cohortstudies had to compare patients receiving hypotonic IVmaintenance solutions with a control group or unexposedcohort who received isotonic solutions. Case-controlstudies had to compare cases, to a control group who didnot have the outcomes of interest.Children (1 month to 17 years) hospitalised for anymedical or surgical condition. We included a diversepaediatric population to capture all potential patients whocurrently receive ‘‘standard IV maintenance therapy’’.Intervention: currently used hypotonic and isotonic IVmaintenance solutions. Solutions were classified asAbbreviations: CI, confidence interval; ECF, extracellular fluid; IV,intravenous; PNa, plasma sodium; RCT, randomised controlled trial;WMD, weighted mean differenceWS-135/2 Page 6
Downloaded from adc.bmj.com on September 12, 2012 - Published by group.bmj.comHypotonic versus isotonic saline in hospitalised childrenmethodological quality of included studies was assessedusing predefined criteria (Appendices 2 and 3; see lly relevant studiesidentifiedn 104(Database: 87, handsearch: 12,author contact: 4)Studies excluded:Met exclusion criteria: 12Duplication of data: 40Potentially relevant studiesretrieved for assessmentn 52Studies excluded:Study protocol: 140Narrative reviews: 14Letters/commentary: 4Case reports/series: 14Studies retrieved for moredetailed evaluation n 19Studies excluded:Interventions of interest notcompared/described: 7No control group: 4Outcomes of interest notdescribed: 2Studies with usable informationby outcome n 6Figure 1 Flow diagram of the study selection process for this systematicreview.33‘‘hypotonic’’ if they contained ,0.9% NaCl, or ‘‘isotonic ornear isotonic’’ (i.e. 0.9% NaCl or Ringers Lactate). Weexcluded case reports and studies of fluid resuscitationand oral rehydration therapy. Studies enrolling neonates,patients with pre-existing hyponatraemia and co-morbidities which result in sodium derangements (e.g. renaldisease, diabetes insipidus, diuretic therapy), were alsoexcluded.Study outcomesStudies were included if any of the following outcomesrelated to the development of acute hospital acquired plasmasodium (PNa) derangements and/or their attributed morbidity were reported: fluid balance, clinical evidence of volumeoverload, hypertension, seizures, cerebral oedema, death,paediatric intensive care unit admission, and length of stay.We used PNa as a surrogate outcome, as it is a convenientreflection of tonicity balance, and represents the potential forfluid shifts between intracellular and extracellular fluid(ECF) compartments. This in turn may result in clinicallyrelevant morbidity, such as the defined outcomes of interest.A priori, we defined hyponatraemia as PNa ,136 mmol/l,and severe hyponatraemia as PNa ,130 mmol/l, or any levelof hyponatraemia associated with symptoms. We alsoexamined hypernatraemia since the arguments against theuse of isotonic solutions in children include renal soluteloading and the risk of increasing PNa. We definedhypernatraemia as PNa .145 mmol/l.Data abstraction and study qualityIn duplicate and independently, we abstracted data todescribe the methodological quality and clinical characteristics of these trials. We contacted authors where necessaryfor additional data on outcomes of interest. We extracted thefollowing information: study population, sample size, intervention, duration, and type of exposure and outcomes. TheINQ - CR829Data analysisCohen’s Kappa statistic was used to calculate agreementbetween raters. For categorical outcomes, treatment effectswere expressed as odds ratios (OR) and 95% confidenceintervals (CI). We described treatment effects of continuousoutcomes using weighted mean differences (WMD) and 95%CI. We calculated summary risk differences and 95% CI usinga random effects model (RevMan Version 4.2). Wherestatistical pooling was not possible, we described our findingsqualitatively.RESULTSStudy selectionWe identified 52 potentially relevant articles from 104citations (fig 1); 33 did not meet inclusion criteria. Of the19 studies retrieved for detailed evaluation, seven did notdescribe or compare the interventions of interest, four did notdescribe a control group, and two did not report any of theoutcomes of interest. Six studies satisfied all criteria (table 1).Cohen’s Kappa for inclusion decisions was 0.81 (almostperfect agreement).Study characteristicsWe report the characteristics of the six included studies intable 1. There were two unmasked randomised controlledtrials (RCT),14 15 and one non-randomised controlled trial.16Three were observational studies.17–19 Tables 3–5 outline thestudy quality and methodological characteristics—the overallquality of included studies was often limited; allocationconcealment, blinding of patients, clinicians, outcomesassessors, and outcomes were inconsistently or not reportedacross studies.Clinical outcomesPlasma sodiumThe standard deviations (SD) were not presented for PNa inone of the studies.14 Thus, we calculated a pooled SD tocompare the PNa across studies. Hypotonic maintenancesolutions significantly increased the risk of developinghyponatraemia (OR 17.22; 95% CI 8.67 to 34.2) (fig 2).Mean PNa in patients following hypotonic solutions wassignificantly lower (23.39 mmol/l; 95% CI 25.35 to 21.43),than those who received isotonic solutions (fig 3). The PNaalso decreased significantly greater in patients who receivedhypotonic solutions (25.37 mmol/l; 95% CI 28.79 to 21.94,fig 4). None of the studies reported the development ofhypernatraemia. However, three studies reported a decrease inPNa despite the infusion of isotonic or near-isotonic IVmaintenance fluids (table 1).15 17Morbidity attributed to hyponatraemiaAdverse clinical outcomes were reported in three studies.17–19Wilkinson reported seizures in 2/26 patients receivinghypotonic fluids (OR 6.22; 95% CI 0.29 to 135.8).19 Hoornreported nausea and vomiting more commonly in patientswith hospital acquired hyponatraemia (68%, p 0.008)18than isonatraemic controls. The presence of increasedpulmonary interstitial fluid on chest x ray was reported byBurrows in 15/20 of patients receiving hypotonic solutionsand 2/4 in the near-isotonic group.20 The clinical significanceof this finding was not commented on by the authors. Otheroutcomes of interest as listed in our objectives were notreported.WS-135/2 Page 7www.archdischild.com
INQ - CRwww.archdischild.comNoneNoneMore nausea and vomitingreported in hyponatraemic groupNot describedAll cases by definition21/31 in Gp 1, 2/21 inGp 25/22 in Gp 1 (PNa(130); 0/22 in Gp 2None describedCases: PNa dropped from139¡3 to 133¡2 mmol/l in19¡10 hoursControls: PNa 140¡2 mmol/l1487¡637 patients with hospital acquiredhyponatraemia, 111 isonatraemichistorical controlsCase controlStandard prescription formaintenance IV fluidsHoorn (2004)18Mean PNa after 4 hours:Gp 1 134.3 mmol/l (2.1)Gp 2 136.3 mmol/l (3.3)RCT, unmaskedGp1: 0.45% NaClGp 2: 0.9% NaCl1046 months–14 yearsGastroenteritis withdehydrationNeville (2006)1511 in hypotonic group20/26 patients in hypotonicgroup, 2/30 in isotonic groupMedian PNa: 130.5 (121–136)in hypotonic Gp; 139 in isotonicgroupRetrospective chart reviewIsotonic (LR or NS), n 30Hypotonic (0.16–0.5% NaCl),n 26562 months–14 yearsCraniofacial surgeryWilkinson (1992)19Increased interstitial pulmonary Seizures: 2/26 in hypotonicgroupfluid in hypotonic group(p,0.05)NoneNoneGreater fall in PNa inhypotonic group:6.2¡2.9 mEq/l (p(0.05);3.0¡0.8 mEq/l in isotonicgroupPost-op PNa: 131¡2.8 inhypotonic group; 135¡1.9mmol/l in isotonic group5 patients in hypotonic group246–16Previously healthy patientswith idiopathic scoliosisundergoing surgical correctionCohort studyPostoperative maintenancefluids:Isotonic (LR), n 4Hypotonic (0.25–0.5% NaCl),n 20Burrows (1983)17CVS, cardiovascular; LR, Lactated Ringers; NS, normal saline; PNa, plasma sodium; pre/post-op, pre- or postoperative; Gp, group; NaCl, sodium chloride; RCT, randomised controlled trial.NoneNot mentionedNoneNot described4 in hypotonic groupSevere hyponatraemia(PNa ,130)Clinical sequelae related tohyponatraemiaHypernatraemia (PNa .145)PNa in hypotonic group(Gp 3): 133.3¡4.6 mEq/l(p,0.05)Not describedPost-op PNa in Gp 3significantly lower (p,0.05).No significant change in Gp1 and 21 patient in LR group, 7 inhypotonic groupGreater and more sustaineddrop in PNa in hypotonicgroup (p,0.01)Controlled trialGp 1: LRGp 2: 1% Dextrose in LRGp 3: 3.3% Dextrose in 0.3%NaCl601–12ASA 1 patients undergoingelective minor surgeryDagli (1997)16Hyponatraemia (PNa ,136)OutcomesPNa mmol/lMethodologyIntervention (all solutions includedappropriate dextrose contentunless otherwise stated)1212.3–18.1Adolescent femalesundergoing idiopathicscoliosis repairRCT, unmaskedNear isotonic solution(LR), n 5; v hypotonicsolutions: (0.3%–0.18% NaCl),n 7Brazel (1996)14Characteristics of included studiesParticipantsnAge (years)Inclusion criteriaTable 1830Downloaded from adc.bmj.com on September 12, 2012 - Published by group.bmj.comChoong, Kho, Menon, et alWS-135/2 Page 8
INQ - CRMethodsParticipantsDescription of learAllocationconcealmentQuality assessment; controlled trialsAuthorTable 3NoNoYesMethod ll e taker/ptblindingNot describedNot describedHypotonic or isotonic fluidsFluid restriction v maintenance plus deficitreplacementNot describedIV/PO fluid therapyIsotonic IV fluidGp 1: perioperative NS IV fluid. GP 2:NPO, no IV fluidsHypotonic IV fluids v moderate oral fluidrestrictionType of fluids not described individuallyIsotonic fluidHypotonic fluidHypotonic IV fluidsInterventionsInterventionPatients admitted with hyponatraemiaPatients with PNa.165 or Na,130Elective paediatric general surgical casesChildren with meningitis8 healthy children undergoing scoliosisrepairFatal cases of post-op hyponatraemiaChildren with meningitisPost-op craniofacial patients (n 16)Hospital acquired severe hyponatraemiawithin 48 h admission (n 23).103 cases, 31 age matched controlsCraniofacial patients (n 10)Tonsillectomy (n 13)Children with gastroenteritis (n 52)ADH, antidiuretic hormone; IV, intravenous; PO, oral.Retrospective chart reviewRetrospective chart reviewRetrospective chart reviewRCTWattad (1992)37Dunn (1997)3839McCormick (1999)Powell (1990)23Cohort studyRetrospective chart review20RCTArieff (1999)36Cowley (1988)35Case-control studyCohort studyCase-control studyGerick (1996)2124Levine (2001)Judd (1990)34Duke (2002)Cohort studyRetrospective chart reviewCohort studyCupido (2000)2530Halberthal (2001)15Characteristics of excluded studiesNeville (2005)StudyTable 2Primary outcome of studyNoNoNoBlindingYesYesYesSufficient ( 90%)Follow upNoNoNoI TTAetiology of hyponatraemiaAetiology of hospital acquired PNa derangementsNot describedPNa, plasma AVP levelsVolume of fluid administeredSerum and urine electrolytes, ADH and renin activitySurvival and neurological statusPNa, osmolality, ADH, urine electrolytes andosmolality, cortisol, and thyroid hormonePNaFactors contributing to hospital acquiredhyponatraemiaADH and plasma renin activity in cases v controlsSerum and urine electrolytesSerum electrolytes, ADH, and plasma renin activityReason for exclusionNoNoNoAdjustment forconfoundersAnalysisYesYesYesData provided toconfirm resultsOutcomes of interest not describedNo control groupOnly one intervention of interestdescribedOnly one intervention of interestdescribedType of fluids not individuallydescribedIntervention not described, primarilyadult studyInterventions of interest not describedInterventions of interest not describedOutcomes of interest not describedType of fluids not individuallydescribedNo control groupNo control groupNo control groupHypotonic versus isotonic saline in hospitalised childrenDownloaded from adc.bmj.com on September 12, 2012 - Published by group.bmj.com831www.archdischild.comWS-135/2 Page 9
Downloaded from adc.bmj.com on September 12, 2012 - Published by group.bmj.com832Choong, Kho, Menon, et alTable 4 Quality assessment; observational studies—cohort essof exposed cohortBurrowsWilkinsonSelection ofnon-exposedcohortAscertainmentof exposure***Outcome of interestnot present at startof studyOutcomeAssessmentFollow up:outcomesFollow up:cohorts******Table 5 Quality assessment; observational studies—case-control epresentativenessHoorn**Selection ofcontrolsDefinition ofControls*Volume of IV fluid administrationHoorn reported that patients with hospital acquired hyponatraemia did not receive significantly greater total fluidvolume than isonatraemic patients, however the calculatedelectrolyte-free water intake was three times greater compared to the isonatraemic controls (p , 0.001). The totalsodium intake in mmol/kg/h was not significantly differentbetween the two groups.18 The volume of IV fluid infused wasnot a determinant of the change in PNa at four hours inNeville’s study of patients with gastroenteritis.15 Fluidbalance and volumes of fluid infused were not specificallypresented in the other studies, but described as ‘‘same in bothgroups’’.SubgroupsFour of the included studies were in surgical patients,14 16 17 19and one study enrolled patients with gastroenteritis.15 Hoornidentified more surgical patients in the hospital acquiredhyponatraemia group (16%), than in the isonatraemiccontrols (5%, p 0.04).18 All studies examined associationsusing univariate analyses; none used multivariate analyses toadjust for confounding inmentMethod en the small number of studies, we chose to include andanalyse
Name: Dr Bernadette O’Hare Title: Senior Lecturer in Child Health, College of Medicine, University of Malawi, Malawi Present position and institution: Lecturer in Child Health, College of Medicine, University of Malawi, Malawi Previous position and institution: [As at the time of the child’s death]
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The purpose of this addendum is to present changes to ANSI/ASHRAE Standard 135-2012 and Addenda. These modifications are the result of change proposals made pursuant to the ASHRAE continuous maintenance procedures and of deliberations within Standing Standard Project Committee 135. The changes are summarized below. 135-2012ba-1. Add CSML Descriptions of BACnet Devices, p. 2 135-2012ba-2. Add .
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